title: Safety and efficacy of the XIENCE V everolimus-eluting stent compared to first-generation drug-eluting stents in contemporary clinical practice.
abstract: 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.
authors.affiliation: Interventional Cardiology, Washington Hospital Center, DC, USA. ron.waksman@medstar.net
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Israel M
authors.initials: IM
authors.lastname: Barbash
authors.forename: Danny
authors.initials: D
authors.lastname: Dvir
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
authors.forename: Itsik
authors.initials: I
authors.lastname: Ben-Dor
authors.forename: Gabriel
authors.initials: G
authors.lastname: Maluenda
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xue
authors.forename: Lowell F
authors.initials: LF
authors.lastname: Satler
authors.forename: William O
authors.initials: WO
authors.lastname: Suddath
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Kent
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel; D011474:Prosthesis Design; D012189:Retrospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007166:Immunosuppressive Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus