Abstract 6008: The Unrestricted Use of Paclitaxel-Eluting Stents: Four-Year Results of the T-SEARCH Registry
Although drug-eluting stents (DES) reduce the rate of repeat revascularization compared with bare metal stents (BMS) in carefully selected patients, the long-term safety of DES remains a concern, particularly amongst real-world patients. Furthermore, long-term comparisons between different DES types in a real-world setting are scarce. We therefore evaluated the 4-year clinical event rates in patients from the Taxus Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry, to establish the safety and efficacy of different DES in an unselected all-comer population. On 16th February 2003, the paclitaxel-eluting stent (PES, Taxus) gained Conformité Européenne (CE) approval and was immediately adopted as the default stent for all percutaneous coronary interventions at our institution. The first 576 patients treated exclusively with PES for de novo lesions were enrolled in the T-SEARCH registry. These patients were compared with 508 consecutive patients treated with sirolimus-eluting stents (SES, Cypher) from 16th April 2002 onwards from the RESEARCH registry. Annual survival status was acquired from municipal civil registries and questionnaires sent to all living patients to obtain data on adverse clinical events. Medical records were reviewed and family doctors or referring cardiologists contacted as necessary. The primary endpoint was composite major adverse events (MACE: all-cause death, any myocardial infarction or target vessel revascularization [TVR]). Secondary endpoints included all-cause death, TVR and stent thrombosis. Cox proportional hazards regression analysis will be performed to compensate for differences in baseline characteristics between the groups. Four-year follow-up data is currently available for 95% of the patients. The 4-year cumulative MACE rates were 30.5% and 30.7% for SES and PES (p=0.9). The 4-year cumulative all-cause mortality rates were 10.9% for SES and 10.1% for PES (p=0.7). Four-year survival and event-free survival rates are similar in real-world all-comer patients treated with SES or PES.