Safety and efficacy of the XIENCE V everolimus-eluting stent compared to first-generation drug-eluting stents in contemporary clinical practice. - 2012

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

Data from randomized clinical trials have shown the safety and efficacy of the XIENCE V in selected populations. However, limited data are available comparing the XIENCE V to the first-generation CYPHER sirolimus-eluting stent. This study aimed to assess the long-term safety and clinical efficacy of the XIENCE V everolimus-eluting stent compared to first-generation stents in an unselected patient population. This retrospective analysis included 6,069 patients treated with CYPHER, TAXUS, and XIENCE stents from 2003 to 2009 at our institution. The patients were followed up for >=1 year after the index procedure. The baseline characteristics were generally comparable among the 3 groups, with the exception of a significantly greater prevalence of diabetes mellitus, systemic hypertension, and a history of angioplasty and coronary bypass surgery among the XIENCE patients. The XIENCE patients also had a twofold greater rate of type C lesions. One-year follow-up data were available for 82% of the patients. The 1-year major adverse cardiovascular events rate was 9.3% for the XIENCE stent versus 9.8% for the CYPHER stent and 11.5% for the TAXUS stent (p = 0.11). Mortality was lower in the XIENCE group than in the CYPHER and TAXUS groups (3.6% vs 4.9% vs 7.2%, respectively, p <0.001), and target lesion revascularization was similar (5.9% vs 5.2% vs 5.6%, respectively; p = 0.34). Stent thrombosis was lower in the XIENCE patients (0.2% vs 1.2% vs 0.7%, p = 0.007). In conclusion, in a contemporary United States clinical practice with an unselected patient population, use of the XIENCE V stent was associated with an improved safety profile and reduction of all-cause mortality and stent thrombosis compared to first-generation drug-eluting stents. The XIENCE V failed to demonstrate superiority for overall major adverse cardiovascular events, Q-wave myocardial infarction, and revascularization rates. Copyright 2012 Elsevier Inc. All rights reserved.


English

0002-9149


*Angioplasty, Balloon, Coronary/mt [Methods]
*Coronary Artery Disease/th [Therapy]
*Drug-Eluting Stents
*Sirolimus/aa [Analogs & Derivatives]
Aged
Antineoplastic Agents, Phytogenic/pd [Pharmacology]
Coronary Angiography
Coronary Artery Disease/ra [Radiography]
Coronary Restenosis/pc [Prevention & Control]
Female
Follow-Up Studies
Humans
Immunosuppressive Agents/pd [Pharmacology]
Male
Middle Aged
Paclitaxel
Prosthesis Design
Retrospective Studies
Sirolimus/pd [Pharmacology]
Treatment Outcome


MedStar Heart & Vascular Institute


Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't