SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) - Study Results

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Conditions:	Stents Coronary Artery Disease Total Coronary Occlusion Coronary Artery Restenosis Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis
Interventions:	Device: XIENCE V® Everolimus Eluting Coronary Stent Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1002 subjects were recruited at 65 sites. Eligible subjects invited to participate either in-hospital or in-clinic prior to first procedure and required to provide signed informed consent prior to enrollment. Final eligibility based on angiogram before the intended procedure. Dates of recruitment: 6/22/05 through 3/15/06.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized via telephone randomization and stratified by single and dual lesion/vessel treatment, diabetes mellitus status, and study sites. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Participant Flow: Overall Study

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
STARTED	669	333^[1]
COMPLETED	653	320
NOT COMPLETED	16	13
Death	4	2
Lost to Follow-up	9	7
Withdrawal by Subject	3	3
Informed consent not signed	0	1

[1]	1 patient randomized never signed consent, therefore no data collected. Analysis group = 332.

Baseline Characteristics

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Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Baseline Measures

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS	Total
Number of Participants [units: participants]	669	333	1002
Age^[1] [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	376	191	567
>=65 years	293	141	434
Age^[2] [units: years] Mean ± Standard Deviation	63.23 ± 10.53	62.80 ± 10.24	63.08 ± 10.43
Gender^[3] [units: participants]
Female	200	114	314
Male	469	218	687
Region of Enrollment^[4] [units: participants]
United States	669	333	1002

[1]	1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[2]	1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[3]	1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[4]	1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Outcome Measures

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1. Primary:

Primary Endpoint: In-segment Late Loss (LL) [ 240 days ]

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2. Secondary:

Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) [ 270 days ]

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3. Secondary:

Target Vessel Failure (TVF) [ 30 days ]

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4. Secondary:

Target Vessel Failure (TVF) [ 180 days ]

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5. Secondary:

Target Vessel Failure (TVF) [ 1 year ]

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6. Secondary:

Target Vessel Failure (TVF) [ 2 year ]

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Measure Type	Secondary
Measure Title	Target Vessel Failure (TVF)
Measure Description	The composite endpoint comprised of: Cardiac death (death in which a cardiac cause cannot be excluded) Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Time Frame	2 year
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	637	305
Target Vessel Failure (TVF) [units: percentage of participants]	11.3	16.4

No statistical analysis provided for Target Vessel Failure (TVF)

7. Secondary:

Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 30 days ]

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8. Secondary:

Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 180 days ]

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9. Secondary:

Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 270 days ]

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10. Secondary:

Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 1 years ]

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11. Secondary:

Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 2 years ]

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12. Secondary:

Ischemia Driven Target Vessel Revascularization (ID-TVR) [ 30 days ]

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13. Secondary:

Ischemia Driven Target Vessel Revascularization (ID-TVR) [ 180 days ]

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14. Secondary:

Ischemia Driven Target Vessel Revascularization (ID-TVR) [ 270 days ]

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15. Secondary:

Ischemia Driven Target Vessel Revascularization (ID-TVR) [ 1 year ]

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16. Secondary:

Ischemia Drive Target Vessel Revascularization (ID-TVR) [ 2 years ]

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17. Secondary:

Ischemia Driven Major Adverse Cardiac Event (MACE) [ 30 days ]

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18. Secondary:

Ischemia Driven Major Adverse Cardiac Event (MACE) [ 180 days ]

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19. Secondary:

Ischemia Driven Major Adverse Cardiac Event (MACE) [ 270 days ]

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20. Secondary:

Ischemia Driven Major Adverse Cardiac Event (MACE) [ 1 year ]

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21. Secondary:

Ischemia Driven Major Adverse Cardiac Event(MACE) [ 2 years ]

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22. Secondary:

In-stent % Angiographic Binary Restenosis (% ABR) Rate [ at 240 days ]

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23. Secondary:

In-segment % Angiographic Binary Restenosis (% ABR) Rate [ 240 days ]

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24. Secondary:

Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection [ at 240 days ]

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25. Secondary:

Acute Success: Clinical Device [ In-hospital ]

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26. Secondary:

Acute Success: Clinical Procedure [ In-hospital ]

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27. Secondary:

Proximal Late Loss [ at 240 days ]

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28. Secondary:

Distal Late Loss [ 240 days ]

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29. Secondary:

In-stent Late Loss [ at 240 days ]

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30. Secondary:

% Volume Obstruction (% VO) [ at 240 days ]

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31. Secondary:

In-stent % Diameter Stenosis (% DS) [ at 240 days ]

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32. Secondary:

In-segment % Diameter Stenosis (% DS) [ 240 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Matt Kiely, Manager Medical Information
Organization: Abbott Vascular
phone: 408-845-3477
e-mail: matthew.kiely@av.abbott.com

Publications of Results:

Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13.

Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation. 2009 Feb 10;119(5):680-6. Epub 2009 Jan 26.

Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system:: clinical and angiographic results from the spirit III randomized trial. Catheter Cardiovasc Interv. 2009 Mar 24; [Epub ahead of print]

Responsible Party:	Abbott Vascular ( Abbott Vascular )
Study ID Numbers:	03-360
Study First Received:	September 13, 2005
Results First Received:	October 15, 2008
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00180479 History of Changes
Health Authority:	United States: Food and Drug Administration