• Pedro A Lemos, Bruno Moulin, Marco A Perin, Ludmilla A R R Oliveira, J Airton Arruda, Valter C Lima, Antonio A G Lima, Paulo R A Caramori, Cesar R Medeiros, Mauricio R Barbosa, Fabio S Brito, Expedito E Ribeiro, Eulógio E Martinez, and PAINT trial investigators.
• Catheterization Laboratory, Heart Institute (InCor), University of São Paulo Medical School (USP), Sao Paulo, Brazil. pedro.lemos@incor.usp.br
• Catheter Cardiovasc Interv. 2009 Nov 1; 74 (5): 665-73.

ObjectivesWe tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).BackgroundThe efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel.MethodsOverall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months.ResultsBoth paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups.ConclusionBoth novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.Copyright 2009 Wiley-Liss, Inc.

49 keywords...

hide…