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Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-Year results of the PAINT trial
Catheterization and Cardiovascular Interventions, 08/12/09
Lemos PA et al. – Both novel drug-eluting stents (DES) effectively reduced neointimal hyperplasia and 1-yr re-intervention vs bare metal stents. Findings suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.
Methods- Test of 2 novel DES, covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus
- Comparison against bare metal stent (primary aim)
- Comparison of anti-restenosis effects of sirolimus vs paclitaxel (secondary aim)
- Subjects: 274 pts with de novo coronary lesions in native vessels scheduled for stent implantation
- Randomization (2:2:1 ratio) to paclitaxel (111 pts ), sirolimus (106), or bare metal stent (57) groups
- Angiographic follow-up at 9 mo
- Major cardiac adverse events follow-up to 12 mo
- Both paclitaxel and sirolimus stents reduced 9-mo in-stent late loss and 1-yr risk of target vessel revascularization and combined major adverse cardiac events vs controls
- Lower rate of late loss but similar 1-yr clinical outcomes for sirolimus vs paclitaxel stents
- No differences in risk of death, infarction, or stent thrombosis among study groups
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