Rapamycin- and Paclitaxel-Eluting Stents With Identical Biodegradable Polymeric Coating and Design - Rapamycin- and Paclitaxel-Eluting Stents With Identical Biodegradable Polymeric Coating and Design
Randomized trial comparing identical drug eluting stents coated with a biodegradable polymer eluding rapamycin or paclitaxel
On identical drug-eluting stent platform with a biodegradable polymer, rapamycin would be more efficient for the prevention of restenosis than paclitaxel
Patients Enrolled: 91
Mean Follow Up: 9 months
De novo coronary lesion suitable for stent implantation
Left main, acute myocardial infaction
In-stent late lumen loss
Death, myocardial infarction, in-segment late loss, binary restenosis, target lesion revascularization
Patients were randomized to rapamycin or paclitaxel coated stent. The coronary stents had a biodegradable polymeric matrix that is completely degraded within weeks after stent placement. Stents were coated with rapamycin at a concentration of 2.0 mcg/mm2 stent surface or with paclitaxel at 0.25 mcg/mm2). Clinical follow-up at 9 months. Follow-up angiography at 6 months.
Baseline clinical and angiographic characteristics were well matched. At 30 days and 9 months,no death or stent thrombosis were noted. One non-ST segment myocardial infarction was reported.
At 6 month angiographic follow-up, late loss was larger with paclitaxel compared with rapamycin (0.94 mm vs. 0.34 mm; p<0.001). Angiographic (34.8% vs. 10.2%; p<0.0001) and clinical restenosis (TLR) rates were increased with the paclitaxel compared with the rapamycin stent (24.0% vs. 8.3%; p=0.03).
Among patients with de novo coronary lesions, using a specific stent and biodegradeable polymer delivery system, rapamycin-eluting stents were associated with less late loss and need for repeat revascularization compared with paclitaxel-eluting stents. These findings cannot be extrapolated to other technologies involving differing stent platforms and polymers with differing release kinetics.
Wessely R, Kastrati A, Mehilli J, Dibra A, Pache J, Schömig A. Randomized trial of rapamycin- and paclitaxel-eluting stents with identical biodegradable polymeric coating and design. Eur Heart J. 2007 Nov;28(22):2720-5.
Presented by Dr. Rainer Wessley at the March 2006 i2 Summit Annual Scientific Session, Atlanta, GA.
Keywords: Paclitaxel, Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Polymers, Sirolimus, Kinetics, Stents
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