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

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

Target Vessel Failure (TVF) [ 30 days ]

Show Outcome Measure 3

4. Secondary:

Target Vessel Failure (TVF) [ 180 days ]

Show Outcome Measure 4

5. Secondary:

Target Vessel Failure (TVF) [ 1 year ]

Show Outcome Measure 5

6. Secondary:

Target Vessel Failure (TVF) [ 2 year ]

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

14. Secondary:

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

Show Outcome Measure 14

15. Secondary:

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

Show Outcome Measure 15

16. Secondary:

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

Show Outcome Measure 16

17. Secondary:

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

Show Outcome Measure 17

18. Secondary:

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

Show Outcome Measure 18

19. Secondary:

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

Show Outcome Measure 19

20. Secondary:

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

Show Outcome Measure 20

21. Secondary:

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

Show Outcome Measure 21

22. Secondary:

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

Show Outcome Measure 22

23. Secondary:

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

Hide Outcome Measure 23

Measure Type	Secondary
Measure Title	In-segment % Angiographic Binary Restenosis (% ABR) Rate
Measure Description	Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA
Time Frame	240 days
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.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

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]	344	158
In-segment % Angiographic Binary Restenosis (% ABR) Rate [units: percentage of participants]	4.7	8.9

No statistical analysis provided for In-segment % Angiographic Binary Restenosis (% ABR) Rate

24. Secondary:

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

Show Outcome Measure 24

25. Secondary:

Acute Success: Clinical Device [ In-hospital ]

Show Outcome Measure 25

26. Secondary:

Acute Success: Clinical Procedure [ In-hospital ]

Show Outcome Measure 26

27. Secondary:

Proximal Late Loss [ at 240 days ]

Show Outcome Measure 27

28. Secondary:

Distal Late Loss [ 240 days ]

Show Outcome Measure 28

29. Secondary:

In-stent Late Loss [ at 240 days ]

Show Outcome Measure 29

30. Secondary:

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

Show Outcome Measure 30

31. Secondary:

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

Show Outcome Measure 31

32. Secondary:

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

Show Outcome Measure 32

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

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