Aims: To investigate the medium term (2 year) clinical outcome of the use of the paclitaxel-eluting stent (PES) compared to the sirolimus-eluting stent (SES). To date, there are no direct comparative data on the efficacy of these stents over medium term follow-up. Furthermore, a possible late restenotic phenomenon has not been excluded.
Methods and results: The Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry compared 576 consecutive "all-comer" patients, exclusively treated with PES, with 508 patients who received SES from the RESEARCH registry in the preceding period. Patients were enrolled irrespective of clinical or angiographic features. At 2 years, major adverse cardiac event (death, myocardial infarction or target vessel revascularisation) rates were comparable in the two groups: 15.4% in the SES group versus 18.9% in the PES group (HR 1.26, 95% CI 0.94-1.69, p=0.12). Correcting for differences in both groups resulted in an adjusted HR of 1.11 (95% CI 0.82-1.50, p=0.51, using significant univariate variables). Target vessel revascularisation was 8.0% in the SES group compared with 9.6% in the PES group (HR 1.23, 95% CI 0.81-1.86, p=0.33).
Conclusions: The unrestricted use of SES and PES was safe at two years of follow-up. No significant difference was found between the two devices in terms of death or MI, MACE, TVR or TLR. No late clinical restenotic phenomenon was observed.