Conflicting patient outcomes have been reported after the use of sirolimus-eluting stents or bare-metal stents. In this nonrandomized study, we examine the ...
Clinical Investigation
Muhammad Munir, MD Jonathan Aliota, MD Amany Ahmed, MD Anwarullah Mohammed, MD Vei Vei Lee, MS MacArthur A. Elayda, MD, PhD James M. Wilson, MD Key words: Angioplasty, balloon, coronary; baremetal stents/statistics & numerical data; coronary restenosis/prevention & control; drug delivery systems; drug-eluting stents/statistics & numerical data; hyperplasia/prevention & control; immunosuppressive agents; sirolimus/therapeutic use; thrombosis/prevention & control From: Departments of Cardiology (Drs. Ahmed, Aliota, Mohammed, Munir, and Wilson) and Biostatistics (Dr. Elayda and Ms Lee), Texas Heart Institute at St. Luke’s Episcopal Hospital; and Department of Medicine (Drs. Elayda and Wilson), Baylor College of Medicine; Houston, Texas 77030 The registry follow-up was partially funded by an unrestricted grant from Cordis Corporation, a Johnson & Johnson company. Dr. Wilson has previously received consulting fees and honoraria for speaking engagements from Cordis Corporation but no longer does.
Sirolimus-Eluting Stents versus Bare-Metal Stents in Routine Clinical Use A Nonrandomized Comparison Conflicting patient outcomes have been reported after the use of sirolimus-eluting stents or bare-metal stents. In this nonrandomized study, we examine the outcomes after placement of sirolimus-eluting versus bare-metal stents in an unselected population of patients who underwent percutaneous coronary revascularization. We used THIRD-base, a longitudinal data registry of patients who underwent revascularization at our institution, to compare demographics and outcomes in patients treated with a sirolimus-eluting or bare-metal stent from January 2001 through June 2006. Outcome measures included major acute coronary and cerebral events at 30 days, target- vessel failure at 9 months and at 3 years, and stent thrombosis. Target-vessel failure was defined as the composite of all-cause death, recurrent myocardial infarction in the treated vessel distribution, and target-vessel revascularization. Logistic regression and Cox proportional regression models were used to determine the predictors of outcome. Of the 6,425 patients analyzed, 2,581 patients (40.2%) received only sirolimus-eluting stents, and 3,844 patients (59.8%) received only bare-metal stents. Early major acute coronary and cerebral events and stent thrombosis at 30 days and 9 months were similar in both groups. Target-vessel failure was less frequent in sirolimus-eluting stent patients than in bare-metal stent patients at 9 months (4.84% vs 11.81%, P 65 yr
1,728 (45)
CCS angina class 4 NYHA functional class III/IV
418 (10.9) 1,372 (35.7)
1,249 (48.4)
0.0067
149 (5.8)
