Three-year follow-up of the first prospective randomized comparison between paclitaxel and sirolimus stents:: The TAXi-LATE trial

Goal: Analysis of the 3-year outcome of the original population of the TAXi trial which compared the efficacy of the paclitaxel (PES) and the sirolimus (SES) stents in a randomized "real world" investigation. History: The widespread use of drug-eluting stents strongly modified the world of interventional cardiology. The TAXi trial was a randomized comparison between PES and SES and showed similar efficacy between the two prostheses. Recently, emerging discussions raised questions about potential long-term risk with the use of DES. The present work attempts to describe the long-term outcome of the patients compared during the TAXi trial. Method: During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PIES group (102 patients) and to the SES group (100 patients). The primary aim of the present investigation was the comparison of combined incidence of cardiac death, myocardial infarction, and target lesion revascularization within 36-months. Results: No difference in mortality of all causes was noted in the PES and the SES groups (3% vs. 7%, P = 0.31). No difference in cardiac death was observed between PES and SES prostheses (1% vs. 4%, P = 0.98) or in major adverse cardiac event free survival (89% vs. 83%, P = 0.28). Four stent thromboses were observed, two in the PES group (205 and 788 days) and two in the SES group (210 and 772 days). Conclusion: The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis. (C) 2007 Wiley-Liss, Inc.