Abstract 2570: The Unrestricted Use Of Paclitaxel-eluting Stents: Five-year Results Of The Research Registry
Objectives: Although the safety of drug-eluting stents (DES) has been under scrutiny, limited follow-up data up to 5 years are available, particularly among real-world patients. Therefore, we evaluated the 5-year clinical event rates in patients from the The Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry to establish the safety and efficacy of sirolimus-eluting stent (SES) in an unselected all-comer population.
Methods: On April 16, 2002, our institution commenced the use of SES (Cypher; Cordis Corporation, Miami Lakes, Florida) as the default strategy for all percutaneous coronary interventions at our institution. In the first 6 months of enrollment, 508 patients with de novo lesions were treated exclusively with SES (the SES group) and compared with a group of 450 consecutive patients treated with BMS for de novo lesions in the preceding 6 months (the pre-SES group), matched for stent diameter. Survival data was acquired from municipal civil registries. Health questionnaires have been sent to all living patients to obtain data on adverse clinical events were collected. Medical records will be reviewed and family doctors or referring cardiologists contacted as necessary. The primary end-point was composite major adverse events (MACE: all-cause death, myocardial infarction or target vessel revascularization [TVR]). Secondary endpoints included all-cause death, TVR and stent thrombosis. A propensity score-adjustment will be performed to compensate for differences in baseline characteristics between the groups.
Findings: Survival data is currently available for 94% of the patients after 5 years. The 5-year all-cause mortality rates were 14.0% for SES and 13.4% for BMS (p=0.9). Data on the other 5-year endpoints is currently being collected and will be presented at the time of the meeting.
Conclusions: There is no difference in the 5-year survival rates in the real-world unselected patients treated with SES, compared with BMS.