Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis, Coronary Artery Stenosis, Myocardial Ischemia, Stent Thrombosis, Total Coronary Occlusion, Vascular Disease
Conditions
Keywords
Stents, Angioplasty, Total coronary occlusions, Coronary restenosis, Stent thrombosis, Everolimus
Brief summary
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.
Detailed description
SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions. The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results. The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria. Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT Women study after 2 years.
Interventions
DEVICEXIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
DEVICECYPHER SELECT
XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Patient must be female. * Patient must be at least 18 years of age. * Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site. * Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia). * Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. * Patient must agree to undergo all protocol-required follow-up examinations. * Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment. Angiographic Inclusion Criteria: * Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents. * Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy). * Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available. * Target lesion greater than or equal to 28 mm in length by visual estimate. General
Exclusion criteria
* Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). * Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. * Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days. * Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon. * Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | at 1 year | This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure. |
| In-stent Late Loss (LL) (Main Secondary Endpoint) | at 270 days | In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Procedure Success | Intra-operative | Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events. |
| Adjudicated Stent Thrombosis (Definite, Probable, Possible) | 30 days to 1 year (Late) | — |
| Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). | at 30 days | — |
| Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. | at 240 days | — |
| Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | at 30 days | — |
| Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). | at 30 days | — |
| Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). | at 30 days | — |
| In-segment Late Loss (LL) | at 270 days | LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up |
| Adjudicated Stent Thrombosis (Definite, Probable) | < 1 day (Acute) | — |
| In-segment Angiographic Binary Restenosis Rates | at 270 days | Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA). |
| In-stent Percent Diameter Stenosis | at 270 days | — |
| In-segment Percent Diameter Stenosis | at 270 days | — |
| Adjudicated Revascularization (TLR/TVR/All Revascularizations) | at 30 days | Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations |
| Aneurysm | at 270 days | All subjects with aneurysm of the target lesion up to the 270 day follow-up visit |
| Thrombus | at 270 days | All subjects with thrombus of the target lesion up to the 270 day follow-up visit |
| Persisting Dissection | at 270 days | All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit |
| In-stent Angiographic Binary Restenosis Rates | at 270 days | Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA). |
| Clinical Device Success | Intra-operative | Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system. |
Countries
Argentina, Austria, Belgium, Brazil, Denmark, France, Germany, Hungary, Italy, Latvia, Netherlands, Norway, Poland, Spain, Switzerland
Participant flow
Recruitment details
Patients were recruited between 30 Sept 2008 and 02 December 2009, from the general female interventional cardiology population who had been admitted for a PCI procedure.
Participants by arm
| Arm | Count |
|---|---|
| XIENCE V® / XIENCE PRIME® Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event. | 304 |
| CYPHER® SELECT Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event. | 151 |
| Total | 455 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | XIENCE V® / XIENCE PRIME® | CYPHER® SELECT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 199 Participants | 109 Participants | 308 Participants |
| Age, Categorical Between 18 and 65 years | 105 Participants | 42 Participants | 147 Participants |
| Age Continuous | 68.37 years STANDARD_DEVIATION 10.14 | 69.85 years STANDARD_DEVIATION 10.54 | 68.86 years STANDARD_DEVIATION 10.29 |
| Region of Enrollment Argentina | 11 participants | 6 participants | 17 participants |
| Region of Enrollment Austria | 3 participants | 3 participants | 6 participants |
| Region of Enrollment Belgium | 6 participants | 4 participants | 10 participants |
| Region of Enrollment Brazil | 5 participants | 1 participants | 6 participants |
| Region of Enrollment Denmark | 16 participants | 5 participants | 21 participants |
| Region of Enrollment France | 24 participants | 17 participants | 41 participants |
| Region of Enrollment Germany | 26 participants | 13 participants | 39 participants |
| Region of Enrollment Hungary | 41 participants | 12 participants | 53 participants |
| Region of Enrollment Italy | 62 participants | 31 participants | 93 participants |
| Region of Enrollment Latvia | 16 participants | 11 participants | 27 participants |
| Region of Enrollment Netherlands | 8 participants | 2 participants | 10 participants |
| Region of Enrollment Norway | 7 participants | 5 participants | 12 participants |
| Region of Enrollment Poland | 12 participants | 3 participants | 15 participants |
| Region of Enrollment Spain | 24 participants | 13 participants | 37 participants |
| Region of Enrollment Switzerland | 43 participants | 25 participants | 68 participants |
| Sex: Female, Male Female | 304 Participants | 151 Participants | 455 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 297 | 11 / 149 |
| serious Total, serious adverse events | 120 / 304 | 61 / 151 |
Outcome results
Primary
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.
Time frame: at 1 year
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | 21.5 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | 22 Percentage of Participants |
Primary
In-stent Late Loss (LL) (Main Secondary Endpoint)
In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.
Time frame: at 270 days
Population: The angiographic analysis population may be than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V® / XIENCE PRIME® | In-stent Late Loss (LL) (Main Secondary Endpoint) | 0.20 millimeters | Standard Deviation 0.38 |
| CYPHER® SELECT | In-stent Late Loss (LL) (Main Secondary Endpoint) | 0.12 millimeters | Standard Deviation 0.36 |
Secondary
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 1 year
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). | 13.99 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). | 15.33 Percentage of Participants |
Secondary
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 240 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). | 12.67 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). | 13.25 Percentage of Participants |
Secondary
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 30 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). | 11.51 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). | 13.25 Percentage of Participants |
Secondary
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 1 year
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). | 27.99 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). | 30 Percentage of Participants |
Secondary
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 30 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). | 12.17 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). | 13.91 Percentage of Participants |
Secondary
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 240 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). | 18.0 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). | 17.88 Percentage of Participants |
Secondary
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Time frame: at 30 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | 11.51 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | 13.25 Percentage of Participants |
Secondary
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Time frame: at 240 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | 15.33 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). | 15.23 Percentage of Participants |
Secondary
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Time frame: at 240 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. | 14.67 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. | 14.57 Percentage of Participants |
Secondary
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Time frame: at 1 year
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. | 18.77 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. | 18.67 Percentage of Participants |
Secondary
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).
Time frame: at 30 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). | 11.51 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). | 13.25 Percentage of Participants |
Secondary
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Time frame: at 1 year
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Revascularization (TLR/TVR/All Revascularizations) | 18.09 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Revascularization (TLR/TVR/All Revascularizations) | 19.33 Percentage of Participants |
Secondary
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Time frame: at 240 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Revascularization (TLR/TVR/All Revascularizations) | 8.0 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Revascularization (TLR/TVR/All Revascularizations) | 5.96 Percentage of Participants |
Secondary
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Time frame: at 30 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Revascularization (TLR/TVR/All Revascularizations) | 0.66 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Revascularization (TLR/TVR/All Revascularizations) | 1.99 Percentage of Participants |
Secondary
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: 30 days to 1 year (Late)
Population: Based on Intent to Treat (ITT) population. Population change based on follow up timeframe.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Stent Thrombosis (Definite, Probable) | 0.0 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Stent Thrombosis (Definite, Probable) | 0.69 Percentage of Participants |
Secondary
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: 1 to 30 days (Sub-Acute)
Population: Based on Intent to Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Stent Thrombosis (Definite, Probable) | 0.0 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Stent Thrombosis (Definite, Probable) | 0.66 Percentage of Participants |
Secondary
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: < 1 day (Acute)
Population: Based on Intent to Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Stent Thrombosis (Definite, Probable) | 0.0 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Stent Thrombosis (Definite, Probable) | 0.0 Percentage of Participants |
Secondary
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time frame: 30 days to 1 year (Late)
Population: Based on Intent to Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Adjudicated Stent Thrombosis (Definite, Probable, Possible) | 0.35 Percentage of Participants |
| CYPHER® SELECT | Adjudicated Stent Thrombosis (Definite, Probable, Possible) | 1.39 Percentage of Participants |
Secondary
Aneurysm
All subjects with aneurysm of the target lesion up to the 270 day follow-up visit
Time frame: at 270 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Aneurysm | 0.0 % of target lesions with aneurysm |
| CYPHER® SELECT | Aneurysm | 0.0 % of target lesions with aneurysm |
Secondary
Clinical Device Success
Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.
Time frame: Intra-operative
Population: Based on Intent to Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Clinical Device Success | 91.1 Percentage of evaluated lesions |
| CYPHER® SELECT | Clinical Device Success | 93.5 Percentage of evaluated lesions |
Secondary
Clinical Procedure Success
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.
Time frame: Intra-operative
Population: Based on Intent to Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Clinical Procedure Success | 85.2 Percentage of Participants |
| CYPHER® SELECT | Clinical Procedure Success | 84.1 Percentage of Participants |
Secondary
In-segment Angiographic Binary Restenosis Rates
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
Time frame: at 270 days
Population: The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | In-segment Angiographic Binary Restenosis Rates | 4.3 Percentage of target lesions |
| CYPHER® SELECT | In-segment Angiographic Binary Restenosis Rates | 2.1 Percentage of target lesions |
Secondary
In-segment Late Loss (LL)
LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up
Time frame: at 270 days
Population: The angiographic analysis population may be less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V® / XIENCE PRIME® | In-segment Late Loss (LL) | 0.10 millimeters | Standard Deviation 0.41 |
| CYPHER® SELECT | In-segment Late Loss (LL) | 0.04 millimeters | Standard Deviation 0.37 |
Secondary
In-segment Percent Diameter Stenosis
Time frame: at 270 days
Population: The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V® / XIENCE PRIME® | In-segment Percent Diameter Stenosis | 22.26 % diameter stenosis | Standard Deviation 13.45 |
| CYPHER® SELECT | In-segment Percent Diameter Stenosis | 20.14 % diameter stenosis | Standard Deviation 12.63 |
Secondary
In-stent Angiographic Binary Restenosis Rates
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
Time frame: at 270 days
Population: The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | In-stent Angiographic Binary Restenosis Rates | 3.2 Percentage of Target Lesions |
| CYPHER® SELECT | In-stent Angiographic Binary Restenosis Rates | 0.7 Percentage of Target Lesions |
Secondary
In-stent Percent Diameter Stenosis
Time frame: at 270 days
Population: The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V® / XIENCE PRIME® | In-stent Percent Diameter Stenosis | 15.77 % diameter stenosis | Standard Deviation 14.19 |
| CYPHER® SELECT | In-stent Percent Diameter Stenosis | 13.62 % diameter stenosis | Standard Deviation 11.1 |
Secondary
Persisting Dissection
All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit
Time frame: at 270 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Persisting Dissection | 0.0 Percentage of evaluated lesions |
| CYPHER® SELECT | Persisting Dissection | 0.0 Percentage of evaluated lesions |
Secondary
Thrombus
All subjects with thrombus of the target lesion up to the 270 day follow-up visit
Time frame: at 270 days
Population: Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V® / XIENCE PRIME® | Thrombus | 0.3 Percentage of evaluated lesions |
| CYPHER® SELECT | Thrombus | 1.3 Percentage of evaluated lesions |