Outcomes in Diabetic and Nondiabetic Patients Treated With Everolimus- or Paclitaxel-Eluting Stents Results From the SPIRIT IV Clinical Trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System)

被引：77

作者：

Kereiakes, Dean J. ^{[1
,2
]}

Cutlip, Donald E. ^{[3
]}

Applegate, Robert J. ^{[4
]}

Wang, John ^{[5
]}

Yaqub, Manejeh ^{[6
]}

Sood, Poornima ^{[6
]}

Su, Xiaolu ^{[6
]}

Su, Guoping ^{[6
]}

Farhat, Naim ^{[7
]}

Rizvi, Ali ^{[8
]}

Simonton, Charles A. ^{[6
]}

Sudhir, Krishnankutty ^{[6
]}

Stone, Gregg W. ^{[9
,10
]}

机构：

[1] Christ Hosp, Heart & Vasc Ctr, Cincinnati, OH 45219 USA

[2] Carl & Edyth Lindner Ctr Res & Educ, Cincinnati, OH USA

[3] Harvard Clin Res Inst, Boston, MA USA

[4] Wake Forest Univ Hlth Sci, Winston Salem, NC USA

[5] Union Mem Hosp, Baltimore, MD USA

[6] Abbott Vasc, Santa Clara, CA USA

[7] EMH Reg Med Ctr, Elyria, OH USA

[8] Cardiovasc Specialists N Houston, Houston, TX USA

[9] Columbia Univ, Med Ctr, New York, NY USA

[10] Cardiovasc Res Fdn, New York, NY USA

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2010年 / 56卷 / 25期

关键词：

diabetes; drug-eluting stent(s); everolimus; major adverse cardiac event(s); POOLED ANALYSIS; ARTERY-DISEASE; MELLITUS; RESTENOSIS; IMPACT; LONG; REVASCULARIZATION;

D O I：

10.1016/j.jacc.2010.10.006

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objectives We compared the safety and efficacy of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) among the large cohort of randomized diabetic patients enrolled in the SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) trial. Background Diabetes mellitus remains a significant predictor of adverse clinical outcomes after percutaneous coronary intervention with drug-eluting stents, and the comparative outcomes of different drug-eluting stents in diabetic patients remains ill-defined. Methods In the SPIRIT IV trial, 3,687 patients with up to 3 de novo native coronary artery lesions were prospectively randomized 2: 1 to receive EES or PES. Randomization was stratified by the presence of diabetes and lesion complexity. The primary end point was the occurrence of target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Clinical outcomes were evaluated in randomized diabetic (n = 1,185 [786 EES; 399 PES]) and nondiabetic patients (n = 2,498 [1,669 EES; 829 PES]). Results The EES compared with PES reduced TLF in nondiabetic patients (3.1% vs. 6.7%, p < 0.0001), with significant reductions in myocardial infarction, stent thrombosis, and target lesion revascularization. In contrast, no difference in TLF (6.4% vs. 6.9%, respectively, p = 0.80) or any of its components was present among diabetic patients, regardless of insulin use. A significant interaction between the presence of diabetes and stent type on TLF (p(interaction) = 0.02) was observed. Conclusions In the SPIRIT IV randomized trial, EES compared with PES provided similar clinical outcomes in diabetic patients and superior clinical outcomes in nondiabetic patients at 1 year. (SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047) (J Am Coll Cardiol 2010;56:2084-9) (C) 2010 by the American College of Cardiology Foundation

引用

页码：2084 / 2089

页数：6

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