Author + information
- Received September 10, 2011
- Revision received February 10, 2012
- Accepted February 18, 2012
- Published online June 1, 2012.
- Srihari S. Naidu, MD⁎,⁎ (, )
- Mitchell W. Krucoff, MD†,
- David R. Rutledge, PharmD‡,
- Vivian W. Mao, MD, MPH‡,
- Weiying Zhao, MD, PhD‡,
- Qing Zheng, MS‡,
- Olivia Wilburn, MD, PhD‡,
- Krishnankutty Sudhir, MD, PhD‡,
- Charles Simonton, MD‡ and
- James B. Hermiller, MD§
- ↵⁎Reprint requests and correspondence:
Dr. Srihari S. Naidu, Cardiac Catheterization Laboratory, Division of Cardiology, Winthrop University Hospital, 120 Mineola Boulevard, Suite 500, Mineola, New York 11501
Objectives The aim of this study was to identify predictors of clinical events after XIENCE V (Abbott Vascular, Santa Clara, California) stenting.
Background The XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System [EECSS] USA Post-Approval) study is a prospective, multicenter, Food and Drug Administration-required post-approval study to examine safety and effectiveness in real-world settings. After an initial 5,062 patients, 2,999 more were included as part of the DAPT (Dual Antiplatelet Therapy) trial (total n = 8,061).
Methods One-year clinical events, including stent thrombosis (ST), cardiac death/myocardial infarction (MI), target lesion failure, and target lesion revascularization, were adjudicated according to Academic Research Consortium criteria, with ST and cardiac death/MI as primary and co-primary endpoints. Demographic, clinical, and procedural variables were assessed by multivariable analysis. A time-dependent covariate assessed the association between DAPT usage and ST.
Results Roughly 61% were off-label; 85.6% remained on DAPT without interruption through 1 year. Incidences of definite/probable ST, cardiac death/MI, target lesion failure, and target lesion revascularization were 0.80% (95% confidence interval [CI]: 0.61% to 1.03%), 7.1% (95% CI: 6.51% to 7.68%), 8.9% (95% CI: 8.30% to 9.60%), and 4.3% (95% CI: 3.82% to 4.75%), respectively. Several independent clinical and angiographic predictors were identified for each outcome. Predictors of ST included DAPT interruption ≤30 days (hazard ratio [HR]: 8.63, 95% CI: 2.69 to 27.73, p = 0.0003), renal insufficiency (HR: 3.72, 95% CI: 1.71 to 8.09, p = 0.0009), and total stent length (HR: 1.30, 95% CI: 1.16 to 1.47, p < 0.0001). A DAPT interruption >30 days was not predictive of ST.
Conclusions In this large, real-world population, XIENCE V demonstrated low event rates at 1 year, with several independent predictors. Early DAPT interruption (≤30 days) was the most potent predictor of ST, whereas delayed interruption (>30 days) was not predictive. (XIENCE V Everolimus Eluting Coronary Stent System [EECSS] USA Post-Approval Study; NCT00676520)
- drug-eluting stent (DES)
- dual-antiplatelet therapy
- percutaneous coronary intervention (PCI)
- stent thrombosis
The study was sponsored by Abbott Vascular (Santa Clara, California) and was presented as an oral abstract presentation at TCT 2011, San Francisco, California. The XIENCE V USA study was a condition-of-approval post-market study whose operational expenses were funded by the sponsor. Dr. Naidu is a consultant for Abbott Vascular (modest). Dr. Krucoff received reserach grants from and is a consultant for Abbott Vascular (study sponsor). Drs. Mao, Rutledge, and Sudhir are employees of Abbott Vascular and hold stock in the company. Drs. Zhao, Zheng, and Simonton are employees of Abbott Vascular. Dr. Wilburn has reported that she has no relationships relevant to the contents of this paper to disclose. Dr. Hermiller is a consultant for Abbott.
- Received September 10, 2011.
- Revision received February 10, 2012.
- Accepted February 18, 2012.
- American College of Cardiology Foundation