SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00307047

Enrollment

3687

Registered

2006-03-27

Start date

2006-08-31

Completion date

2012-05-31

Last updated

2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Stents, Angioplasty, Total coronary occlusion, coronary restenosis, stent thrombosis

Brief summary

The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific. TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Detailed description

The completion of the SPIRIT IV clinical trial at three years is justified by the consistent long-term clinical evidence supporting the safety and efficacy of the XIENCE V EECSS in complex, real-world patients across multiple geographies. As SPIRIT IV was designed as a continued access trial, completing the clinical follow-up at the three-year visit does not conflict with any FDA requirements. Abbott Vascular is committed to providing clinical outcomes through three years. The clinical evidence provided from across multiple geographies, in complex populations thus supports Abbott Vascular's proposal to complete the SPIRIT IV RCT at the three-year clinical follow-up. The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE V®: TAXUS®). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) ≥ 2.5 mm to ≤ 4.25 mm and lesion lengths ≤ 28 mm. (NOTE: RVD ≥ 2.5 mm to ≤ 3.75 mm until 4.0 mm TAXUS® is commercially available). All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, and 3 years.

Interventions

DEVICEXIENCE V® Everolimus Eluting Coronary Stent

Drug eluting stent implantation stent in the treatment of coronary artery disease.

DEVICETAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

General Inclusion Criteria: * Subject must be at least 18 years of age * Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure * Subject 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) * Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery * Subject must agree to undergo all protocol-required follow-up procedures * Subject must agree not to participate in any other clinical study for a period of one year following the index procedure Angiographic Inclusion Criteria: * Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to ≤3.75 mm until 4.0 mm TAXUS® is commercially available) * Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent) * If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria * If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria * The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1 * Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done ≥ 9 months prior to the index procedure * Non-study percutaneous intervention for lesions in a non-target vessel involving: * Successful and uncomplicated (visually estimated diameter stenosis \< 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be \< 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted * Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to the index procedure * Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure * Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done ≥ 9 months after the index procedure General

Exclusion criteria

* Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure * The subject is currently experiencing clinical symptoms consistent with AMI * Subject has current unstable arrhythmias * Subject has a known left ventricular ejection fraction (LVEF) \< 30% * Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant * Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure * Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) * Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin) * Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated * Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure * Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) * Subject has known renal insufficiency (e.g., serum creatinine level of \> 2.5 mg/dL or subject on dialysis) * Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions * Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months * Subject has had a significant GI or urinary bleed within the past six months * Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion * Subject 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 protocol, confound the data interpretation or is associated with a life expectancy of less than one year * Subject is already participating in another clinical study that has not yet reached its primary endpoint * Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used up to 1 year following the index procedure) * Angiographic

Design outcomes

Primary

Measure	Time frame	Description
Ischemia Driven Target Lesion Failure (TLF)	1 year	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Secondary

Measure	Time frame	Description
Ischemia Driven Target Vessel Failure (TVF)	30 days	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Ischemia Driven Target Lesion Revascularization (TLR)	30 days	Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Ischemia Driven Target Vessel Revascularization (TVR)	30 days	Revascularization of a lesion within the target vessel associated with any of the following: * positive functional ischemia study * ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Ischemia Driven Major Adverse Cardiac Events (MACE)	30 days	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Acute Success (Clinical Device)	Acute: At time of index procedure	Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.
Acute Success (Clinical Procedure)	Acute: At time of index procedure	Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.
All Myocardial Infarction (MI)	30 days	—
All MI	180 days	—
All Cause Mortality	30 days	—
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	30 days	—
Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition	0-30 days	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute\: 0-24 hours post implantation Subacute\: \>24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: \>1 year post \* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization.
Definite + Probable Stent Thrombosis Rate Based on ARC Definition	31-393 days	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute\: 0-24 hours post implantation Subacute\: \>24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: \>1 year post \* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization.
Protocol Defined Stent Thrombosis Rate	0-30 days	ST will be categorized as acute (≤ 1day), subacute (\>1 day to ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of ST * In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Cardiac Death or Target Vessel MI Rate	30 days	—
Ischemia Driven Target Lesion Failure (TLF)	30 days	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Countries

United States

Participant flow

Recruitment details

Subjects enrolled into this trial were comprised of male and female subjects from the general interventional cardiology population. Recruitment may have, but was not limited to a hospital or an interventional cardiology clinic. The enrollment period was August 10, 2006 through July 30, 2008.

Pre-assignment details

Patients who met inclusion/exclusion criteria were offered participation in the study, and randomized until the total trial population was reached.

Participants by arm

Arm	Count
XIENCE V® Patients recieving the XIENCE V® stent	2,458
TAXUS™ EXPRESS 2™ Patients receiving the TAXUS™ EXPRESS 2™ stent	1,229
Total	3,687

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	All death, all MI, all Revascularization	27	16
Overall Study	Lost to Follow-up	35	24
Overall Study	Lost to follow-up for other reasons	0	1
Overall Study	Physician Decision	1	2
Overall Study	Withdrawal by Subject	6	6

Baseline characteristics

Characteristic	TAXUS™ EXPRESS 2™	XIENCE V®	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	552 Participants	1085 Participants	1637 Participants
Age, Categorical Between 18 and 65 years	677 Participants	1373 Participants	2050 Participants
Age Continuous	63.34 years STANDARD_DEVIATION 10.23	63.25 years STANDARD_DEVIATION 10.52	63.28 years STANDARD_DEVIATION 10.42
Region of Enrollment United States	1229 participants	2458 participants	3687 participants
Sex: Female, Male Female	396 Participants	793 Participants	1189 Participants
Sex: Female, Male Male	833 Participants	1665 Participants	2498 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	762 / 2,436	407 / 1,214
serious Total, serious adverse events	913 / 2,436	468 / 1,214

Outcome results

Primary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Time frame: 1 year

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Failure (TLF)	4.2 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Failure (TLF)	6.8 Percentage of participants

Secondary

Acute Success (Clinical Device)

Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.

Time frame: Acute: At time of index procedure

Population: clinical device success is computed per lesion

Arm	Measure	Value (NUMBER)
XIENCE V®	Acute Success (Clinical Device)	92.0 Percent of success
TAXUS™ EXPRESS 2™	Acute Success (Clinical Device)	90.7 Percent of success

Secondary

Acute Success (Clinical Procedure)

Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.

Time frame: Acute: At time of index procedure

Population: Clinical procedure success is computed per subject

Arm	Measure	Value (NUMBER)
XIENCE V®	Acute Success (Clinical Procedure)	98.6 Percentage of success
TAXUS™ EXPRESS 2™	Acute Success (Clinical Procedure)	98.1 Percentage of success

Secondary

All Cause Mortality

Time frame: 180 days

Arm	Measure	Value (NUMBER)
XIENCE V®	All Cause Mortality	0.5 Percentage of participants
TAXUS™ EXPRESS 2™	All Cause Mortality	0.6 Percentage of participants

Secondary

All Cause Mortality

Time frame: 270 days

Arm	Measure	Value (NUMBER)
XIENCE V®	All Cause Mortality	0.7 Percentage of participants
TAXUS™ EXPRESS 2™	All Cause Mortality	0.9 Percentage of participants

Secondary

All Cause Mortality

Time frame: 3 years

Arm	Measure	Value (NUMBER)
XIENCE V®	All Cause Mortality	3.4 Percentage of participants
TAXUS™ EXPRESS 2™	All Cause Mortality	5.2 Percentage of participants

Secondary

All Cause Mortality

Time frame: 2 years

Arm	Measure	Value (NUMBER)
XIENCE V®	All Cause Mortality	2.1 Percentage of participants
TAXUS™ EXPRESS 2™	All Cause Mortality	2.7 Percentage of participants

Secondary

All Cause Mortality

Time frame: 1 year

Arm	Measure	Value (NUMBER)
XIENCE V®	All Cause Mortality	1.0 Percentage of participants
TAXUS™ EXPRESS 2™	All Cause Mortality	1.3 Percentage of participants

Secondary

All Cause Mortality

Time frame: 30 days

Arm	Measure	Value (NUMBER)
XIENCE V®	All Cause Mortality	0.0 Percentage of participants
TAXUS™ EXPRESS 2™	All Cause Mortality	0.2 Percentage of participants

Secondary

All MI

Time frame: 1 year

Arm	Measure	Value (NUMBER)
XIENCE V®	All MI	1.9 Percentage of participants
TAXUS™ EXPRESS 2™	All MI	3.1 Percentage of participants

Secondary

All MI

Time frame: 270 days

Arm	Measure	Value (NUMBER)
XIENCE V®	All MI	1.8 Percentage of participants
TAXUS™ EXPRESS 2™	All MI	3.0 Percentage of participants

Secondary

All MI

Time frame: 2 years

Arm	Measure	Value (NUMBER)
XIENCE V®	All MI	2.6 Percentage of participants
TAXUS™ EXPRESS 2™	All MI	3.9 Percentage of participants

Secondary

All MI

Time frame: 180 days

Arm	Measure	Value (NUMBER)
XIENCE V®	All MI	1.6 Percentage of participants
TAXUS™ EXPRESS 2™	All MI	2.9 Percentage of participants

Secondary

All MI

Time frame: 3 years

Arm	Measure	Value (NUMBER)
XIENCE V®	All MI	3.1 Percentage of participants
TAXUS™ EXPRESS 2™	All MI	4.7 Percentage of participants

Secondary

All Myocardial Infarction (MI)

Time frame: 30 days

Arm	Measure	Value (NUMBER)
XIENCE V®	All Myocardial Infarction (MI)	1.5 Percentage of participants
TAXUS™ EXPRESS 2™	All Myocardial Infarction (MI)	2.1 Percentage of participants

Secondary

Cardiac Death or Target Vessel MI Rate

Time frame: 3 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Cardiac Death or Target Vessel MI Rate	4.1 Percentage of participants
TAXUS™ EXPRESS 2™	Cardiac Death or Target Vessel MI Rate	5.5 Percentage of participants

Secondary

Cardiac Death or Target Vessel MI Rate

Time frame: 2 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Cardiac Death or Target Vessel MI Rate	3.2 Percentage of participants
TAXUS™ EXPRESS 2™	Cardiac Death or Target Vessel MI Rate	4.3 Percentage of participants

Secondary

Cardiac Death or Target Vessel MI Rate

Time frame: 1 year

Arm	Measure	Value (NUMBER)
XIENCE V®	Cardiac Death or Target Vessel MI Rate	2.2 Percentage of participants
TAXUS™ EXPRESS 2™	Cardiac Death or Target Vessel MI Rate	3.2 Percentage of participants

Secondary

Cardiac Death or Target Vessel MI Rate

Time frame: 270 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Cardiac Death or Target Vessel MI Rate	2.1 Percentage of participants
TAXUS™ EXPRESS 2™	Cardiac Death or Target Vessel MI Rate	3.0 Percentage of participants

Secondary

Cardiac Death or Target Vessel MI Rate

Time frame: 180 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Cardiac Death or Target Vessel MI Rate	1.8 Percentage of participants
TAXUS™ EXPRESS 2™	Cardiac Death or Target Vessel MI Rate	2.8 Percentage of participants

Secondary

Cardiac Death or Target Vessel MI Rate

Time frame: 30 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Cardiac Death or Target Vessel MI Rate	1.5 Percentage of participants
TAXUS™ EXPRESS 2™	Cardiac Death or Target Vessel MI Rate	2.1 Percentage of participants

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Time frame: 2 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	15.5 Percentage of participants
TAXUS™ EXPRESS 2™	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	16.2 Percentage of participants

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Time frame: 270 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	7.2 Percentage of participants
TAXUS™ EXPRESS 2™	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	9.3 Percentage of participants

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Time frame: 1 year

Arm	Measure	Value (NUMBER)
XIENCE V®	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	9.0 Percentage of participants
TAXUS™ EXPRESS 2™	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	10.5 Percentage of participants

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Time frame: 30 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	2.4 Percentage of participants
TAXUS™ EXPRESS 2™	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	3.6 Percentage of participants

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Time frame: 3 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	21.4 Percentage of participants
TAXUS™ EXPRESS 2™	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	22.5 Percentage of participants

Secondary

Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

Time frame: 180 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	5.5 Percentage of participants
TAXUS™ EXPRESS 2™	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)	7.5 Percentage of participants

Secondary

Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition

ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute\*: 0-24 hours post implantation Subacute\*: \>24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: \>1 year post \* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization.

Time frame: 0-30 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition	0.16 Percentage of participants
TAXUS™ EXPRESS 2™	Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition	0.74 Percentage of participants

Secondary

Definite + Probable Stent Thrombosis Rate Based on ARC Definition

Time frame: 0-758 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	0.48 Percentage of participants
TAXUS™ EXPRESS 2™	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	1.32 Percentage of participants

Secondary

Definite + Probable Stent Thrombosis Rate Based on ARC Definition

Time frame: 31-393 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	0.13 Percentage of participants
TAXUS™ EXPRESS 2™	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	0.42 Percentage of participants

Secondary

Definite + Probable Stent Thrombosis Rate Based on ARC Definition

Time frame: 0 -393 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	0.29 Percentage of participants
TAXUS™ EXPRESS 2™	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	1.10 Percentage of participants

Secondary

Definite + Probable Stent Thrombosis Rate Based on ARC Definition

Time frame: 0-1123 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	0.62 Percentage of participants
TAXUS™ EXPRESS 2™	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	1.73 Percentage of participants

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Time frame: 180 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Major Adverse Cardiac Events (MACE)	2.6 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Major Adverse Cardiac Events (MACE)	5.3 Percentage of participants

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Time frame: 2 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Major Adverse Cardiac Events (MACE)	7.2 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Major Adverse Cardiac Events (MACE)	10.2 Percentage of participants

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Time frame: 3 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Major Adverse Cardiac Events (MACE)	9.8 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Major Adverse Cardiac Events (MACE)	12.3 Percentage of participants

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Time frame: 1 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Major Adverse Cardiac Events (MACE)	4.2 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Major Adverse Cardiac Events (MACE)	6.9 Percentage of participants

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Time frame: 270 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Major Adverse Cardiac Events (MACE)	3.5 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Major Adverse Cardiac Events (MACE)	6.2 Percentage of participants

Secondary

Ischemia Driven Major Adverse Cardiac Events (MACE)

Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

Time frame: 30 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Major Adverse Cardiac Events (MACE)	1.6 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Major Adverse Cardiac Events (MACE)	2.7 Percentage of participants

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Time frame: 180 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Failure (TLF)	2.5 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Failure (TLF)	5.1 Percentage of participants

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Time frame: 3 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Failure (TLF)	9.5 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Failure (TLF)	11.9 Percentage of participants

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Time frame: 30 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Failure (TLF)	1.6 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Failure (TLF)	2.7 Percentage of participants

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Time frame: 270 days

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Failure (TLF)	3.4 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Failure (TLF)	6.1 Percentage of participants

Secondary

Ischemia Driven Target Lesion Failure (TLF)

Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Time frame: 2 years

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Failure (TLF)	7.0 Percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Failure (TLF)	10.0 Percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

Time frame: 180 days

Population: ITT population

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Revascularization (TLR)	1.1 percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Revascularization (TLR)	3.2 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Time frame: 30 days

Population: ITT population.

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Revascularization (TLR)	0.4 percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Revascularization (TLR)	1.1 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Time frame: 3 years

Population: ITT population.

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Revascularization (TLR)	6.3 percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Revascularization (TLR)	7.9 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Time frame: 2 years

Population: ITT population.

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Revascularization (TLR)	4.4 percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Revascularization (TLR)	6.9 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Time frame: 1 year

Population: ITT population.

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Revascularization (TLR)	2.5 percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Revascularization (TLR)	4.6 percentage of participants

Secondary

Ischemia Driven Target Lesion Revascularization (TLR)

Time frame: 270 days

Population: ITT population

Arm	Measure	Value (NUMBER)
XIENCE V®	Ischemia Driven Target Lesion Revascularization (TLR)	1.9 percentage of participants
TAXUS™ EXPRESS 2™	Ischemia Driven Target Lesion Revascularization (TLR)	4.1 percentage of participants

Secondary