title: Three-year clinical follow-up of the unrestricted use of sirolimus-eluting stents as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry.
abstract: Sirolimus-eluting stents (SESs) have been shown to decrease restenosis compared with bare metal stents (BMSs). Currently, there are limited data on the long-term efficacy of these devices in a real-world patient population. Furthermore, the potential of a late restenotic phenomenon has not yet been excluded. From April to October 2002, 508 consecutive patients with de novo lesions exclusively treated with SESs were enrolled and compared with 450 patients treated with BMSs in the preceding 6 months (control group). Patients in the SES group more frequently had multivessel disease and type C lesions, received more stents, and had more bifurcation stenting. After 3 years, the cumulative incidence of major adverse cardiac events (comprising death, myocardial infarction, and target vessel revascularization) was significantly lower in the SES group compared with the pre-SES group (18.9% vs 24.7%, hazards ratio 0.73, 95% confidence interval 0.56 to 0.96, p = 0.026). The 3-year risk of target lesion revascularization was 7.5% in the SES group versus 12.6% in the pre-SES group (hazards ratio 0.57, 95% confidence interval 0.38 to 0.87, p = 0.01). In conclusion, the unrestricted use of SESs is safe and superior to the use of BMSs. The beneficial effects, reported after 1 and 2 years in reducing major adverse cardiac events, persisted with no evidence of a clinical late restenotic "catch-up" phenomenon.
authors.affiliation: The Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Joost
authors.initials: J
authors.lastname: Daemen
authors.forename: Andrew T L
authors.initials: AT
authors.lastname: Ong
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.forename: Keiichi
authors.initials: K
authors.lastname: Tsuchida
authors.forename: Helle
authors.initials: H
authors.lastname: Spindler
authors.forename: Georgios
authors.initials: G
authors.lastname: Sianos
authors.forename: Peter P T
authors.initials: PP
authors.lastname: de Jaegere
authors.forename: Ron T
authors.initials: RT
authors.lastname: van Domburg
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000367:Age Factors; D000789:Angina, Unstable / Q000453:epidemiology; D000800:Angioplasty, Balloon; D016022:Case-Control Studies; D023903:Coronary Restenosis / Q000517:prevention & control*; D003920:Diabetes Mellitus / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization; D009426:Netherlands / Q000453:epidemiology; D011474:Prosthesis Design; D012042:Registries; D012044:Regression Analysis; D012770:Shock, Cardiogenic / Q000453:epidemiology; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus