Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Occlusion, Coronary Restenosis, Myocardial Ischemia, Thrombosis (Stent Thrombosis), Vascular Disease
Conditions
Keywords
Drug eluting stents, Stents, Angioplasty
Brief summary
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) (CYPHER SELECT PLUS) during commercial use in China.
Detailed description
Objectives * Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China * Evaluate patient compliance with dual antiplatelet therapy (DAPT) * Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization
Interventions
DEVICEXIENCE V EECSS
Patients who will receive this stent.
DEVICECYPHER SELECT PLUS SECSS
Patients who will receive this stent.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria 1. Patient must be at least 18 years of age 2. The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure. 3. Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up. 4. Patient must not currently be and must agree not to become a participant in any other clinical trial until completion of his/her 2-year follow-up. Angiographic Inclusion Criteria 1. Target lesion(s) must be located in a native de novo coronary artery with a visually estimated diameter between ≥ 2.25 and ≤ 4.0 mm. 2. Target lesion(s) must measure ≤ 28 mm in length by visual estimation. 3. A maximum of two de novo lesions can be treated, ie, 1. One lesion in one vessel, OR 2. One lesion in each of two vessels, OR 3. Two lesions in one vessel
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent Late Loss (LL) | >=13 months | This is the primary angiographic endpoint. In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent) |
| Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | 12 months | The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave). |
| Ischemia-driven Target Vessel Failure (ID-TVF) | 12 months | This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up In-segment Angiographic Binary Restenosis (ABR) | ≥13 months | — |
| Major Bleeding Complications | 30 days | Secondary safety endpoint. |
| Definite / Probable Stent Thrombosis | Acute (<1 day) | Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation. |
| Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 30 days | — |
| Acute Device Success | < or = 1 day | Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of \< 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction. |
| Acute Procedure Success | < or = 1 day | Per-protocol procedure success is defined as the achievement of a final in-stent DS of \< 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay. |
| Procedure Time | On day 0, during the procedure. | This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter. |
| Amount of Contrast Used | On day 0, during the procedure. | Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter. |
| Fluoroscopy Time | On day 0, during the procedure. | This is the procedure related endpoint. |
| XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire | During the procedure | A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure. |
| Follow-up Late Loss | ≥13 months. | This is one of the Secondary Angiographic Endpoint. |
| Follow-up In-stent Minimum Lumen Diameter (MLD) | ≥13 months | — |
| Follow-up In-stent Percent Diameter Stenosis (DS) | ≥13 months | — |
| Follow-up In-stent Angiographic Binary Restenosis (ABR) | ≥13 months | — |
| Follow-up In-segment Minimum Lumen Diameter (MLD) | ≥13 months | — |
| Follow-up In-segment Percent Diameter Stenosis (DS) | ≥13 months | — |
| Percent Diameter Stenosis | pre procedure | — |
| Percent Diameter Stenosis (%DS) | post procedure on 0 day | — |
| Acute Gain | post procedure on 0 day | — |
| Ischemia-driven Target Vessel Failure (ID-TVF) | 30 days | Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\]) |
| Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). | 30 days | — |
| Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | 9 months | — |
| Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | 12 months | The is the major Secondary Efficacy Endpoint. |
| Ischemia-driven Target Lesion Failure (ID-TLF) | 30 days | Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR |
| Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 30 days | — |
| All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 30 days | This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\]. |
| Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 30 days | — |
| Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 30 days | — |
| All Revascularization (TLR, TVR, and Non-TVR) | 30 Days | — |
| All Death | 30 days | This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular. |
| All Protocol MI (Including Q-wave or Non-Q-wave) | 30 days | This is one of the secondary safety endpoint. |
| Target Vessel Protocol MI (TV-MI) | 30 days | This is one of the secondary safety endpoint. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ID-TVF Rate in Single Vessel Treated Subgroup | 24 months | ID-TVF rate in Patients with single vessels treated during the index procedure. |
| ID-TVF Rate in Dual Vessel Treated Subgroup | 24 months | ID-TVF rate in Patients with dual vessel treated during the index procedure. |
| The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease. | 24 months | The composite of ST, all death, and all MI rate in All Diabetes patients. |
| The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease | 24 months | The composite of ST, all death, and all MI rate in Non Diabetes |
| The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup | 24 months | The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure |
| The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup | 24 months | The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure |
| The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup | 24 months | The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure. |
| The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup | 24 months | The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure. |
| ID-TLR Rate in Patients With Diabetic Disease. | 24 months | Ischemia-driven target lesion revascularization rate in All Diabetes patients. |
| ID-TLR Rate in Patients Without Diabetic Disease | 24 months | Ischemia-driven target lesion revascularization rate in Non Diabetes |
| ID-TLR Rate in Single Lesion Treated Subgroup | 24 months | Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure |
| ID-TLR Rate in Dual Lesion Treated Subgroup | 24 months | Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure |
| ID-TLR Rate in Single Vessel Treated Subgroup | 24 months | Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure. |
| ID-TLR Rate in Dual Vessel Treated Subgroup | 24 months | Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure. |
| ID-TVF Rate in Patients With Diabetic Disease | 24 months | ID-TVF rate in All Diabetes patients. |
| ID-TVF Rate in Dual Lesion Treated Subgroup | 24 months | ID-TVF rate in Patients with dual lesion treated during the index procedure |
| ID-TVF Rate in Single Lesion Treated Subgroup | 24 months | ID-TVF rate in Patients with single lesion treated during the index procedure |
| ID-TVF Rate in Patients Without Diabetic Disease | 24 months | ID-TVF rate in Non Diabetes |
Countries
China
Participant flow
Recruitment details
A total of 488 patients in the Per-protocol (PP) population for final analysis. First Patient Enrolled on August 18, 2010, Last Patient Enrolled on August 31, 2011 and the Final Database Lock was on September 26, 2013. The total patient enrollment rate was 0.5 patients/site/week based on 489 patients enrolled over 54 weeks at 20 sites.
Pre-assignment details
All of the 546 patients, 57 (28:XIENCE;29:CYPHER)were excluded from the Per-protocol (PP) population, leaving a baseline population of 489 patients. Whereas because of patient disposition results in a total of 488 patients in the PP population for final analysis.
Participants by arm
| Arm | Count |
|---|---|
| XIENCE V EECSS Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent. | 367 |
| CYPHER SELECT PLUS SECSS Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent. | 121 |
| Total | 488 |
Baseline characteristics
| Characteristic | CYPHER SELECT PLUS SECSS | Total | XIENCE V EECSS |
|---|---|---|---|
| Age, Continuous | 58.74 years STANDARD_DEVIATION 9.12 | 58.64 years STANDARD_DEVIATION 10.28 | 58.60 years STANDARD_DEVIATION 10.65 |
| Age, Customized Age < 65 years | 88 participants | 360 participants | 272 participants |
| Age, Customized Age ≥ 65 years | 33 participants | 128 participants | 95 participants |
| Race/Ethnicity, Customized Chinese | 121 participants | 488 participants | 367 participants |
| Region of Enrollment China | 121 participants | 488 participants | 367 participants |
| Sex: Female, Male Female | 40 Participants | 135 Participants | 95 Participants |
| Sex: Female, Male Male | 81 Participants | 353 Participants | 272 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 360 | 14 / 120 |
| serious Total, serious adverse events | 53 / 360 | 24 / 120 |
Outcome results
Primary
Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave).
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | 1.6 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | 1.7 percentage of participants |
Primary
In-stent Late Loss (LL)
This is the primary angiographic endpoint. In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)
Time frame: >=13 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | In-stent Late Loss (LL) | 0.19 Millimeter | Standard Deviation 0.28 |
| CYPHER SELECT PLUS SECSS | In-stent Late Loss (LL) | 0.21 Millimeter | Standard Deviation 0.28 |
Primary
Ischemia-driven Target Vessel Failure (ID-TVF)
This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 4.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 6.6 percentage of participants |
Secondary
Acute Device Success
Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of \< 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.
Time frame: < or = 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Acute Device Success | 97.2 percentage of participants |
| CYPHER SELECT PLUS SECSS | Acute Device Success | 98.4 percentage of participants |
Secondary
Acute Gain
Time frame: post procedure on 0 day
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XIENCE V EECSS | Acute Gain | In-Stent | 1.79 Millimeter | Standard Deviation 0.44 |
| XIENCE V EECSS | Acute Gain | In-Segment | 1.48 Millimeter | Standard Deviation 0.49 |
| XIENCE V EECSS | Acute Gain | Proximal | 2.03 Millimeter | Standard Deviation 0.53 |
| XIENCE V EECSS | Acute Gain | Distal | 1.54 Millimeter | Standard Deviation 0.54 |
| CYPHER SELECT PLUS SECSS | Acute Gain | Distal | 1.60 Millimeter | Standard Deviation 0.51 |
| CYPHER SELECT PLUS SECSS | Acute Gain | In-Stent | 1.77 Millimeter | Standard Deviation 0.43 |
| CYPHER SELECT PLUS SECSS | Acute Gain | Proximal | 2.06 Millimeter | Standard Deviation 0.49 |
| CYPHER SELECT PLUS SECSS | Acute Gain | In-Segment | 1.52 Millimeter | Standard Deviation 0.44 |
Secondary
Acute Procedure Success
Per-protocol procedure success is defined as the achievement of a final in-stent DS of \< 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay.
Time frame: < or = 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Acute Procedure Success | 98.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Acute Procedure Success | 99.2 percentage of participants |
Secondary
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death | 0.3 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death | 0.0 percentage of participants |
Secondary
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death | 0.0 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death | 0.0 percentage of participants |
Secondary
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death | 0.5 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death | 0.8 percentage of participants |
Secondary
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death | 0.8 percentage of participants |
Secondary
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death | 0.5 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death | 0.8 percentage of participants |
Secondary
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 2.2 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 5.0 percentage of participants |
Secondary
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 1.7 percentage of participants |
Secondary
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 8.5 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 11.6 percentage of participants |
Secondary
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 6.3 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 10.7 percentage of participants |
Secondary
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 1.6 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) | 2.5 percentage of participants |
Secondary
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 0.8 percentage of participants |
Secondary
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 0.8 percentage of participants |
Secondary
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 0.8 percentage of participants |
Secondary
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 0.8 percentage of participants |
Secondary
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Protocol MI (Including Q-wave or Non-Q-wave) | 0.8 percentage of participants |
Secondary
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 30 Days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Revascularization (TLR, TVR, and Non-TVR) | 0.3 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Revascularization (TLR, TVR, and Non-TVR) | 0.8 percentage of participants |
Secondary
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 6 Months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Revascularization (TLR, TVR, and Non-TVR) | 0.5 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Revascularization (TLR, TVR, and Non-TVR) | 1.7 percentage of participants |
Secondary
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 9 Months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Revascularization (TLR, TVR, and Non-TVR) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Revascularization (TLR, TVR, and Non-TVR) | 3.3 percentage of participants |
Secondary
All Revascularization (TLR, TVR, and Non-TVR)
One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Revascularization (TLR, TVR, and Non-TVR) | 6.6 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Revascularization (TLR, TVR, and Non-TVR) | 9.9 percentage of participants |
Secondary
All Revascularization (TLR, TVR, and Non-TVR)
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | All Revascularization (TLR, TVR, and Non-TVR) | 4.6 percentage of participants |
| CYPHER SELECT PLUS SECSS | All Revascularization (TLR, TVR, and Non-TVR) | 9.1 percentage of participants |
Secondary
Amount of Contrast Used
Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.
Time frame: On day 0, during the procedure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | Amount of Contrast Used | 132.1 Milliliter | Standard Deviation 53.2 |
| CYPHER SELECT PLUS SECSS | Amount of Contrast Used | 145.4 Milliliter | Standard Deviation 59.2 |
Secondary
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time frame: Acute (<1 day)
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Definite / Probable Stent Thrombosis | 0.27 percentage of participants |
| CYPHER SELECT PLUS SECSS | Definite / Probable Stent Thrombosis | 0.00 percentage of participants |
Secondary
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time frame: Subacute (1 - 30 days)
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Definite / Probable Stent Thrombosis | 0.27 percentage of participants |
| CYPHER SELECT PLUS SECSS | Definite / Probable Stent Thrombosis | 0.00 percentage of participants |
Secondary
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time frame: Very late (366 - 772 days)
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Definite / Probable Stent Thrombosis | 0.00 percentage of participants |
| CYPHER SELECT PLUS SECSS | Definite / Probable Stent Thrombosis | 0.00 percentage of participants |
Secondary
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time frame: Overall (0 - 772 days)
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Definite / Probable Stent Thrombosis | 0.54 percentage of participants |
| CYPHER SELECT PLUS SECSS | Definite / Probable Stent Thrombosis | 0.00 percentage of participants |
Secondary
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time frame: Late (31 - 365 days)
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Definite / Probable Stent Thrombosis | 0.00 percentage of participants |
| CYPHER SELECT PLUS SECSS | Definite / Probable Stent Thrombosis | 0.00 percentage of participants |
Secondary
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time frame: Early (0 - 30 days)
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Definite / Probable Stent Thrombosis | 0.54 percentage of participants |
| CYPHER SELECT PLUS SECSS | Definite / Probable Stent Thrombosis | 0.00 percentage of participants |
Secondary
Fluoroscopy Time
This is the procedure related endpoint.
Time frame: On day 0, during the procedure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | Fluoroscopy Time | 7.0 Minutes | Standard Deviation 4.7 |
| CYPHER SELECT PLUS SECSS | Fluoroscopy Time | 7.4 Minutes | Standard Deviation 4.7 |
Secondary
Follow-up In-segment Angiographic Binary Restenosis (ABR)
Time frame: ≥13 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Follow-up In-segment Angiographic Binary Restenosis (ABR) | 2.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Follow-up In-segment Angiographic Binary Restenosis (ABR) | 3.1 percentage of participants |
Secondary
Follow-up In-segment Minimum Lumen Diameter (MLD)
Time frame: ≥13 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | Follow-up In-segment Minimum Lumen Diameter (MLD) | 2.34 Millimeter | Standard Deviation 0.52 |
| CYPHER SELECT PLUS SECSS | Follow-up In-segment Minimum Lumen Diameter (MLD) | 2.33 Millimeter | Standard Deviation 0.5 |
Secondary
Follow-up In-segment Percent Diameter Stenosis (DS)
Time frame: ≥13 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | Follow-up In-segment Percent Diameter Stenosis (DS) | 16.79 percent Diameter stenosis | Standard Deviation 12.36 |
| CYPHER SELECT PLUS SECSS | Follow-up In-segment Percent Diameter Stenosis (DS) | 18.79 percent Diameter stenosis | Standard Deviation 12.42 |
Secondary
Follow-up In-stent Angiographic Binary Restenosis (ABR)
Time frame: ≥13 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Follow-up In-stent Angiographic Binary Restenosis (ABR) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Follow-up In-stent Angiographic Binary Restenosis (ABR) | 1.0 percentage of participants |
Secondary
Follow-up In-stent Minimum Lumen Diameter (MLD)
Time frame: ≥13 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | Follow-up In-stent Minimum Lumen Diameter (MLD) | 2.62 Millimeter | Standard Deviation 0.5 |
| CYPHER SELECT PLUS SECSS | Follow-up In-stent Minimum Lumen Diameter (MLD) | 2.63 Millimeter | Standard Deviation 0.48 |
Secondary
Follow-up In-stent Percent Diameter Stenosis (DS)
Time frame: ≥13 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | Follow-up In-stent Percent Diameter Stenosis (DS) | 10.56 percent Diameter stenosis | Standard Deviation 10.18 |
| CYPHER SELECT PLUS SECSS | Follow-up In-stent Percent Diameter Stenosis (DS) | 11.82 percent Diameter stenosis | Standard Deviation 10.3 |
Secondary
Follow-up Late Loss
This is one of the Secondary Angiographic Endpoint.
Time frame: ≥13 months.
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XIENCE V EECSS | Follow-up Late Loss | In-Segment | 0.15 Millimeter | Standard Deviation 0.35 |
| XIENCE V EECSS | Follow-up Late Loss | Proximal | 0.20 Millimeter | Standard Deviation 0.34 |
| XIENCE V EECSS | Follow-up Late Loss | Distal | 0.11 Millimeter | Standard Deviation 0.32 |
| CYPHER SELECT PLUS SECSS | Follow-up Late Loss | In-Segment | 0.27 Millimeter | Standard Deviation 0.35 |
| CYPHER SELECT PLUS SECSS | Follow-up Late Loss | Proximal | 0.33 Millimeter | Standard Deviation 0.39 |
| CYPHER SELECT PLUS SECSS | Follow-up Late Loss | Distal | 0.20 Millimeter | Standard Deviation 0.33 |
Secondary
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 1.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 1.7 percentage of participants |
Secondary
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 1.9 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 1.7 percentage of participants |
Secondary
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 0.8 percentage of participants |
Secondary
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 0.8 percentage of participants |
Secondary
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 1.6 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI | 1.7 percentage of participants |
Secondary
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 1.7 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 1.7 percentage of participants |
Secondary
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 0.8 percentage of participants |
Secondary
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 0.8 percentage of participants |
Secondary
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 1.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 1.7 percentage of participants |
Secondary
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 1.6 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) | 1.7 percentage of participants |
Secondary
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | 1.9 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | 1.7 percentage of participants |
Secondary
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | 1.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) | 1.7 percentage of participants |
Secondary
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). | 0.8 percentage of participants |
Secondary
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). | 0.8 percentage of participants |
Secondary
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 3.9 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 5.0 percentage of participants |
Secondary
Ischemia-driven Target Lesion Failure (ID-TLF)
Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 0.8 percentage of participants |
Secondary
Ischemia-driven Target Lesion Failure (ID-TLF)
Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 0.8 percentage of participants |
Secondary
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 1.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 2.5 percentage of participants |
Secondary
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 3.5 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Lesion Failure (ID-TLF) | 5.0 percentage of participants |
Secondary
Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
The is the major Secondary Efficacy Endpoint.
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | 1.9 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | 3.3 percentage of participants |
Secondary
Ischemia-driven Target Vessel Failure (ID-TVF)
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\])
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 1.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 3.3 percentage of participants |
Secondary
Ischemia-driven Target Vessel Failure (ID-TVF)
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\])
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 0.8 percentage of participants |
Secondary
Ischemia-driven Target Vessel Failure (ID-TVF)
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\]).
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 0.8 percentage of participants |
Secondary
Ischemia-driven Target Vessel Failure (ID-TVF)
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\])
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 4.7 percentage of participants |
| CYPHER SELECT PLUS SECSS | Ischemia-driven Target Vessel Failure (ID-TVF) | 7.4 percentage of participants |
Secondary
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 1.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 2.5 percentage of participants |
Secondary
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 3.9 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 5.0 percentage of participants |
Secondary
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 0.8 percentage of participants |
Secondary
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 0.8 percentage of participants |
Secondary
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 3.5 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) | 5.0 percentage of participants |
Secondary
Major Bleeding Complications
Secondary safety endpoint.
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Bleeding Complications | 0.0 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Bleeding Complications | 0.0 percentage of participants |
Secondary
Major Bleeding Complications
Secondary safety endpoint.
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Bleeding Complications | 0.0 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Bleeding Complications | 0.0 percentage of participants |
Secondary
Major Bleeding Complications
Secondary safety endpoint.
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Bleeding Complications | 0.5 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Bleeding Complications | 0.0 percentage of participants |
Secondary
Major Bleeding Complications
Secondary safety endpoint.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Bleeding Complications | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Bleeding Complications | 0.0 percentage of participants |
Secondary
Major Bleeding Complications
Secondary safety endpoint.
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Major Bleeding Complications | 0.0 percentage of participants |
| CYPHER SELECT PLUS SECSS | Major Bleeding Complications | 0.0 percentage of participants |
Secondary
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 99.2 percentage of participants |
| CYPHER SELECT PLUS SECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 97.5 percentage of participants |
Secondary
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 99.2 percentage of participants |
| CYPHER SELECT PLUS SECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 99.2 percentage of participants |
Secondary
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 58.0 percentage of participants |
| CYPHER SELECT PLUS SECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 55.4 percentage of participants |
Secondary
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 94.5 percentage of participants |
| CYPHER SELECT PLUS SECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 93.4 percentage of participants |
Secondary
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 98.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Patient Compliance With Dual Antiplatelet Therapy (DAPT) | 95.9 percentage of participants |
Secondary
Percent Diameter Stenosis
Time frame: pre procedure
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | Percent Diameter Stenosis | 64.97 percent Diameter stenosis | Standard Deviation 11.9 |
| CYPHER SELECT PLUS SECSS | Percent Diameter Stenosis | 64.95 percent Diameter stenosis | Standard Deviation 12.01 |
Secondary
Percent Diameter Stenosis (%DS)
Time frame: post procedure on 0 day
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XIENCE V EECSS | Percent Diameter Stenosis (%DS) | in-stent %DS | 8.09 Percent Diameter stenosis | Standard Deviation 6.31 |
| XIENCE V EECSS | Percent Diameter Stenosis (%DS) | in-segment %DS | 14.40 Percent Diameter stenosis | Standard Deviation 8.09 |
| CYPHER SELECT PLUS SECSS | Percent Diameter Stenosis (%DS) | in-stent %DS | 8.56 Percent Diameter stenosis | Standard Deviation 5.78 |
| CYPHER SELECT PLUS SECSS | Percent Diameter Stenosis (%DS) | in-segment %DS | 12.46 Percent Diameter stenosis | Standard Deviation 7.41 |
Secondary
Procedure Time
This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.
Time frame: On day 0, during the procedure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| XIENCE V EECSS | Procedure Time | 29.6 Minutes | Standard Deviation 19.3 |
| CYPHER SELECT PLUS SECSS | Procedure Time | 28.6 Minutes | Standard Deviation 15.8 |
Secondary
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Time frame: 30 days
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Target Vessel Protocol MI (TV-MI) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Target Vessel Protocol MI (TV-MI) | 0.8 percentage of participants |
Secondary
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Time frame: 12 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Target Vessel Protocol MI (TV-MI) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Target Vessel Protocol MI (TV-MI) | 0.8 percentage of participants |
Secondary
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Time frame: 9 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Target Vessel Protocol MI (TV-MI) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Target Vessel Protocol MI (TV-MI) | 0.8 percentage of participants |
Secondary
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Time frame: 6 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Target Vessel Protocol MI (TV-MI) | 0.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | Target Vessel Protocol MI (TV-MI) | 0.8 percentage of participants |
Secondary
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | Target Vessel Protocol MI (TV-MI) | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | Target Vessel Protocol MI (TV-MI) | 0.8 percentage of participants |
Secondary
XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire
A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.
Time frame: During the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire | 93.2 percentage of participants |
Other Pre-specified
ID-TLR Rate in Dual Lesion Treated Subgroup
Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TLR Rate in Dual Lesion Treated Subgroup | 0.00 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TLR Rate in Dual Lesion Treated Subgroup | 12.5 percentage of participants |
Other Pre-specified
ID-TLR Rate in Dual Vessel Treated Subgroup
Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TLR Rate in Dual Vessel Treated Subgroup | 0.0 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TLR Rate in Dual Vessel Treated Subgroup | 14.3 percentage of participants |
Other Pre-specified
ID-TLR Rate in Patients With Diabetic Disease.
Ischemia-driven target lesion revascularization rate in All Diabetes patients.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TLR Rate in Patients With Diabetic Disease. | 3.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TLR Rate in Patients With Diabetic Disease. | 3.4 percentage of participants |
Other Pre-specified
ID-TLR Rate in Patients Without Diabetic Disease
Ischemia-driven target lesion revascularization rate in Non Diabetes
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TLR Rate in Patients Without Diabetic Disease | 1.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TLR Rate in Patients Without Diabetic Disease | 3.3 percentage of participants |
Other Pre-specified
ID-TLR Rate in Single Lesion Treated Subgroup
Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TLR Rate in Single Lesion Treated Subgroup | 2.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TLR Rate in Single Lesion Treated Subgroup | 2.7 percentage of participants |
Other Pre-specified
ID-TLR Rate in Single Vessel Treated Subgroup
Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TLR Rate in Single Vessel Treated Subgroup | 2.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TLR Rate in Single Vessel Treated Subgroup | 2.6 percentage of participants |
Other Pre-specified
ID-TVF Rate in Dual Lesion Treated Subgroup
ID-TVF rate in Patients with dual lesion treated during the index procedure
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TVF Rate in Dual Lesion Treated Subgroup | 3.3 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TVF Rate in Dual Lesion Treated Subgroup | 12.5 percentage of participants |
Other Pre-specified
ID-TVF Rate in Dual Vessel Treated Subgroup
ID-TVF rate in Patients with dual vessel treated during the index procedure.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TVF Rate in Dual Vessel Treated Subgroup | 4.2 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TVF Rate in Dual Vessel Treated Subgroup | 14.3 percentage of participants |
Other Pre-specified
ID-TVF Rate in Patients With Diabetic Disease
ID-TVF rate in All Diabetes patients.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TVF Rate in Patients With Diabetic Disease | 5.7 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TVF Rate in Patients With Diabetic Disease | 13.8 percentage of participants |
Other Pre-specified
ID-TVF Rate in Patients Without Diabetic Disease
ID-TVF rate in Non Diabetes
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TVF Rate in Patients Without Diabetic Disease | 4.4 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TVF Rate in Patients Without Diabetic Disease | 5.5 percentage of participants |
Other Pre-specified
ID-TVF Rate in Single Lesion Treated Subgroup
ID-TVF rate in Patients with single lesion treated during the index procedure
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TVF Rate in Single Lesion Treated Subgroup | 4.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TVF Rate in Single Lesion Treated Subgroup | 7.1 percentage of participants |
Other Pre-specified
ID-TVF Rate in Single Vessel Treated Subgroup
ID-TVF rate in Patients with single vessels treated during the index procedure.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | ID-TVF Rate in Single Vessel Treated Subgroup | 4.7 percentage of participants |
| CYPHER SELECT PLUS SECSS | ID-TVF Rate in Single Vessel Treated Subgroup | 7.0 percentage of participants |
Other Pre-specified
The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup
The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup | 3.3 percentage of participants |
| CYPHER SELECT PLUS SECSS | The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup | 0.0 percentage of participants |
Other Pre-specified
The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup
The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup | 4.2 percentage of participants |
| CYPHER SELECT PLUS SECSS | The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup | 0.0 percentage of participants |
Other Pre-specified
The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.
The composite of ST, all death, and all MI rate in All Diabetes patients.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease. | 1.1 percentage of participants |
| CYPHER SELECT PLUS SECSS | The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease. | 3.4 percentage of participants |
Other Pre-specified
The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease
The composite of ST, all death, and all MI rate in Non Diabetes
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease | 2.2 percentage of participants |
| CYPHER SELECT PLUS SECSS | The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease | 1.1 percentage of participants |
Other Pre-specified
The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup
The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup | 1.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup | 1.8 percentage of participants |
Other Pre-specified
The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup
The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.
Time frame: 24 months
Population: The number of participants with angiographic follow up available was analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V EECSS | The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup | 1.8 percentage of participants |
| CYPHER SELECT PLUS SECSS | The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup | 1.8 percentage of participants |