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


METHODS
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.


METHODS
During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PES 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=0.98) 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).


CONCLUSIONS
The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis.
Berger
Alexandre
A
Service of Cardiology, Clinic Cecil, Lausanne, Switzerland. alexandre.berger@bluewin.ch
Stauffer
Jean-Christophe
JC
Seydoux
Charles
C
Siegenthaler
Manon
M
Benoît
Alain
A
Goy
Jean-Jacques
JJ
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D017202:Myocardial Ischemia / Q000401:mortality / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D017239:Paclitaxel; D020123:Sirolimus