Randomized trial of rapamycin- and paclitaxel-eluting stents with identical biodegradable polymeric coating and design.
OBJECTIVE
This prospective, randomized study sought to directly compare the performance of paclitaxel and rapamycin on an otherwise identical, polymer-coated drug-eluting stent (DES) platform.


RESULTS
Stents with identical design and biodegradable polymeric coating that elute either rapamycin or paclitaxel over a 2 months time period were utilized. In this pilot trial that included 91 patients, both stent platforms proved safe with no case of death, Q-wave myocardial infarction or stent thrombosis within a 9 months follow-up period. Late-lumen loss was markedly greater in the paclitaxel-eluting stent group compared with the rapamycin-eluting stent group (0.96 +/- 0.75 vs. 0.33 +/- 0.46 mm, P < 0.0001). Likewise, the rate of angiographic restenosis was higher in the paclitaxel-eluting stent group compared with the rapamycin-eluting stent group [39.0 vs. 12.2%; relative risk (RR) 3.20 (95% confidence interval, 1.29-7.92), P = 0.005]. Concomitantly, the need for target lesion revascularization was higher in the paclitaxel-eluting stent group compared with the rapamycin-eluting stent group [26.7 vs. 8.7%; RR 3.07 (1.07-8.80), P = 0.02].


CONCLUSIONS
The results of this clinical trial that is the first to directly compare the performance of paclitaxel and rapamycin on a DES platform otherwise identical in design and polymeric coating imply that rapamycin is more effective for the prevention of coronary restenosis on a DES platform with mid-term drug release and less dependent on release kinetics than paclitaxel. Thus, to ensure efficacy, drug release from a paclitaxel-coating stent platform must be prolonged and well controlled to achieve results that are comparable with the FDA-approved paclitaxel-eluting stent platform.
Wessely
Rainer
R
Deutsches Herzzentrum and 1. Medizinische Klinik, Klinikum rechts der Isar, University of Technology, Lazarettstr. 36, 80636 Munich, Germany. rwessely@web.de
Kastrati
Adnan
A
Mehilli
Julinda
J
Dibra
Alban
A
Pache
Jürgen
J
Schömig
Albert
A
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D004338:Drug Combinations; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*
D004338:Drug Combinations; D050257:Tubulin Modulators; D017239:Paclitaxel; D020123:Sirolimus