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Clinical Trial: SPIRIT III - A Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System (CSS) in the Treatment of Subjects with De Novo Native Coronary Artery Lesions
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(Cardiovascular Therapeutics) |
CT00370
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| Sponsoring Company: |
| • |
Abbott Vascular Devices |
| • |
Boston Scientific Corporation |
| • |
Guidant Corporation (Abbott Vascular Devices) |
|
| Product: |
| • |
XIENCETM V everolimus-eluting coronary artery stent system
|
| • |
TAXUS® Express2 paclitaxel-eluting coronary stent system
|
|
| Objective: |
| • |
To demonstrate the safety and efficacy of the XIENCE V everolimus eluting coronary stent system as compared to the TAXUS paclitaxel eluting coronary stent system in patients with coronary artery disease in a large-scale pivotal study |
|
| Inclusion Criteria: |
| • |
Target lesion(s) in a major artery or branch with visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≤ 1
|
|
| Exclusion Criteria: |
| • |
Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
|
| • |
Lesion involving a bifurcation ≥ 2 mm in diameter, ostial lesion > 50% stenosed by visual estimation, or a side branch requiring predilatation
|
| • |
Located in a major epicardial vessel that has been previously treated with brachytherapy or PCI < 9 months prior to index procedure
|
| • |
Total occlusion (TIMI flow 0)
|
| • |
Target vessel contains thrombus
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| • |
A significant lesion (> 40 %DS) located in the same epicardial vessel as the target lesion
|
|
| Primary Endpoints: |
| • |
In-segment LLL at 240 days
Assume LL = 0.24 0.47 mm in both arms
Non-inferiority margin = 0.195 mm, one-sided = 0.025
564 total pts -> 99% power (assuming 10% dropout)
Pre-specified sequential non-inferiority and superiority tests
In pts with 2 lesions, primary endpoint analysis based on a randomly assigned analysis lesion
|
| Secondary Endpoints: |
| • |
Major adverse cardiac events (cardiac death, MI, TLR) |
| • |
Death (cardiac and non cardiac) |
| • |
MI (Q-wave and non Q-wave) |
| • |
Stent thrombosis (ACS + angiographic thrombus, or unexplained death or STEMI/Q-wave MI in target lesion distribution within 30 days) |
| • |
Endpoints measured at 30 days, 6 months, 9 months, and yearly through 5 years |
| • |
Major secondary endpoint: Ischemia-driven TVF at 270 days
|
| PI: |
| • |
Stone, Gregg W., MD; and Rogers, Campbell D.K., MD |
|
| PI Study Site: |
| • |
Columbia University Medical Center, New York, NY; and Brigham and Women's Hospital, Boston, MA
|
|
| Enrollment: |
| • |
1,002 |
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| Trial Start Date: |
| • |
June 2005 |
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|
| Trial Design: |
|
| Patient Demographics: |
|
Demographics at Enrollment
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Patients
|
XIENCE V
n=669
|
TAXUS
n=333
|
P Value
|
Age (in years)
|
63.2 ±10.5
|
62.8 ±10.2
|
0.54
|
| Male (%) |
70.1
|
65.7
|
0.17
|
| Hypertension (%) |
76.2
|
74.0
|
0.48
|
| Hypercholesterolemia (%) |
74.2
|
71.5
|
0.36
|
| Diabetes mellitus (%) |
29.6
|
27.9
|
0.60
|
Insulin requiring (%)
|
7.8
|
5.5
|
0.19
|
| Current smoker (%) |
23.4
|
22.5
|
0.81
|
| Prior MI (%) |
19.9
|
18.0
|
0.49
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| Unstable angina (%) |
18.7
|
25.1
|
0.02
|
Angiography at Enrollment
|
Patients
|
XIENCE V
lesions=767
|
TAXUS
lesions=382
|
P Value
|
Lesion location
|
--
|
--
|
--
|
| LAD |
41.3%
|
42.9%
|
0.61
|
| LCX |
27.6%
|
28.3%
|
0.83
|
| RCA |
31.0%
|
28.5%
|
0.41
|
| LMCA |
0.1%
|
0.3%
|
0.55
|
QCA
|
--
|
--
|
--
|
| RVD (mm) |
2.77 ±0.45
|
2.76 ±0.46
|
0.87
|
| MLD (mm) |
0.82 ±0.41
|
0.83 ±0.40
|
0.79
|
| % DS |
70.0 ±13.3
|
69.4 ±13.6
|
0.54
|
Lsn length (mm)
|
14.7 ±5.6
|
14.7 ±5.7
|
0.92
|
Primary Endpoint: 8 Mo In-segment LL
|
Patients
|
Xience V
|
TAXUS
|
Total at Randomization (n=564)
|
376
|
188
|
| Lost to f/u |
3
|
3
|
| Patient Withdrawal |
2
|
3
|
| Death |
2
|
1
|
| No Qualifying Angio |
67
|
37
|
Total at 8 month angioF/U*(N=446; 79%)
|
302
|
144
|
|
| Results: |
Antiplatelet Agent Utilization
|
Patients
|
XIENCE V
n=669
|
TAXUS
n=333
|
P Value
|
Aspirin
|
--
|
--
|
--
|
| 180 Days |
96.6%
|
96.1%
|
0.72
|
| 270 Days |
96.1%
|
94.6%
|
0.26
|
| 365 Days |
94.9%
|
92.4%
|
0.15
|
Thienopyridine
|
--
|
--
|
--
|
| 180 Days |
94.5%
|
94.0%
|
0.77
|
| 270 Days |
74.4%
|
76.7%
|
0.44
|
| 365 Days |
71.2%
|
70.4%
|
0.82
|
Patient Flow Through Clinical
|
Patients
|
Xience V
|
TAXUS
|
Total at Randomization (n=1002)
|
669
|
333
|
| Lost to f/u |
9
|
8
|
| Patient Withdrawal |
5
|
4
|
Total at 12 Month Follow-Up (n=976; 97.4%)
|
655
|
321
|
1-Year Results
|
Events,(Patients if different)
|
XIENCE V
n=655
|
TAXUS
n=321
|
P Value
|
Death, all cause
|
1.2%
|
1.2%
|
1.0
|
| Cardiac |
0.8%
|
0.9%
|
0.72
|
| Non cardiac |
0.5%
|
0.3%
|
1.0
|
| MI, all |
2.8%
|
4.1%
|
0.33
|
| Q-wave |
0.3%
|
0.3%
|
1.0
|
Non Q-wave
|
2.5%
|
3.8%
|
0.31
|
| TVR |
6.1%
|
7.5%
|
0.41
|
| TLR |
3.4%
|
5.6%
|
0.12
|
| TVR remote |
3.1%
|
4.4%
|
0.35
|
Stent Thrombosis, All
|
5/647 (0.8%)
|
2/317 (0.6%)
|
1.0
|
| 0 - 30 Days |
3/667 (0.4%)
|
0/330 (0%)
|
0.55
|
| 30-365 Days |
2/646 (0.3%)
|
2/317 (0.6%)
|
0.60
|
| ARC definite/probable |
7/652 (1.1%)
|
2/319 (0.6%)
|
0.73
|
| Definite |
5/652 (0.8%)
|
0/319 (0%)
|
0.18
|
Probable
|
2/652 (0.3%)
|
2/319 (0.6%)
|
0.60
|
| 0 - 30 Days |
4/667 (0.6%)
|
0/330 (0%)
|
0.31
|
| 30-365 Days |
3/651 (0.5%)
|
2/319 (0.6%)
|
0.67
|
|
|
|
| Conclusion: |
| • |
The everolimus-eluting XIENCE V stent was both noninferior and superior to the TAXUS stent in reducing in-segment late loss (primary endpoint).
|
| • |
The XIENCE V stent demonstrated noninferior rates of target vessel failure at 9 months, with a significant 44% reduction in major adverse cardiovascular events. It also showed a strong trend toward reduced ischemia-driven target lesion revascularization, with a significant reduction in any target lesion revascularization.
|
| • |
Post hoc: Stent thrombosis defined by ARC definitions |
| • |
The XIENCE V stent significantly reduced in-stent late loss at 8 months and reduced angiographic follow-up diameter stenosis with a strong trend toward lower binary restenosis
|
| • |
Top 20 PI Sites
(PI Site, PI, Patients Enrolled)
- California
- Good Samaritan Hosp., Los Angeles, CA, R. Matthews, 16 Patients
- Scripps Memorial Hospital, La Jolla, CA, R. Fortuna, 20 Patients
Indiana
- The Heart Center of IN, Indianapolis, IN, J. Hermiller, 48 Patients
Kentucky
- Jewish Hospital, Louisville, KY, N. Xenopoulos, 29 Patients
Massachusetts
- Brigham & Women’s Hospital, Boston, MA, L. Mauri, 18 Patients
Maryland
- St. Joseph Medical Center, Towson, MD, M. Midei, 107 Patients
Michigan
- Borgess Medical Center, Kalamazoo, MI, A. Carter, 24 Patients
- Northern Michigan Hospital, Petoskey, MI, L. Cannon, 18 Patients
Montana
- St. Patrick Hospital, Missoula, MT, M. Sanz, 60 Patients
North Carolina
- N. Carolina Baptist Hosp., NC, R. Applegate, 29 Patients
- Presbyterian Hospital, Charlotte, NC, J. Williams, 41 Patients
- Wake Medical Center, Raleigh, NC, W. Newman, 90 Patients
Nebraska
- Nebraska Heart Hospital, Lincoln, NE, D. Netz, 14 Patients
New York
- Columbia Univ. Med. Ctr., New York, NY, M. Collins, 19 Patients
- St. Joseph’s Hospital, Syracuse, NY, R. Caputo, 32 Patients
Ohio
- The Christ Hospital, Cincinnati, OH, J. Young, 27 Patients
- EMH Regional Medical Center, Elyria, N. Farhat, OH, 39 Patients
Rhode Island
- The Miriam Hospital, Providence, RI, P. Gordon, 29 Patients
- Rhode Island Hospital, Providence, RI, D. Williams, 23 Patients
Vermont
- Fletcher Allen Healthcare, Burlington, VT, H. Dauerman, 16 Patients
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| • |
Trial enrollment will be updated when SPIRIT III has been published.
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Last Update: January 31, 2008 |
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