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Presented at The American College of Cardiology Scientific Session 2006

Rapamycin- and Paclitaxel-Eluting Stents With Identical Biodegradable Polymeric Coating and Design Trial. Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Rainer Wessley. RES and PES with Identical Biodegradable Polymeric Coating and Design: Background.

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Presented at The American College of Cardiology Scientific Session 2006

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  1. Rapamycin- and Paclitaxel-Eluting Stents With Identical Biodegradable Polymeric Coating and Design Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Rainer Wessley

  2. RES and PES with Identical Biodegradable Polymeric Coating and Design: Background • Recent clinical trials have shown that drug-eluting stents offer long-term clinical advantages • This current trial sought to determine whether rapamycin or paclitaxel-eluting stents would be more efficient in the prevention of restenosis – using an identical drug-eluting stent platform with a biodegradable polymer Presented at ACC 2006

  3. RES and PES with Identical Biodegradable Polymeric Coating and Design: Study Design 91 patients with a de novo coronary lesion suitable for stent implantation Randomized. mean follow-up 9 months; exclusions: left main stenosis, acute myocardial infarction Paclitaxel-eluting Stent (0.25 mcg/mm2) Rapamycin-eluting Stent (2.0 mcg/mm2) Follow-up Angiography at 6 months Clinical Follow-up at 9 months • Primary Endpoint: In-stent late lumen loss • Secondary Endpoint: Death, myocardial infarction, in-segment late loss, binary restenosis, target lesion revascularization Presented at ACC 2006

  4. RES and PES with Identical Biodegradable Polymeric Coating and Design: Primary Endpoint Angiographic In-stent Late Lumen Loss at 6 months (mm) p<0.001 • At 6 month follow-up, late lumen loss was smaller with the rapamycin-eluting stent compared to the paclitaxel-eluting stent (0.34 mm vs 0.94 mm; p<0.001). Presented at ACC 2006

  5. RES and PES with Identical Biodegradable Polymeric Coating and Design: Secondary Endpoints Clinical TLR (%) (9 month) p=0.03 Angiographic Restenosis (%) (6 month) p<0.0001 • Angiographic restenosisrates were decreased with the rapamycin-eluting stent compared to the paclitaxel-eluting stent • Clinical target lesion revascularization rates also decreased with the rapamycin-eluting stent compared to the paclitaxel-eluting stent Presented at ACC 2006

  6. RES and PES with Identical Biodegradable Polymeric Coating and Design: Limitations • The trial involved a small sample size. • These findings cannot be extrapolated to other technologies involving differing stent platforms and polymers with different release kinetics. • Large randomized trials must be conducted to better assess the treatment efficacies. Presented at ACC 2006

  7. RES and PES with Identical Biodegradable Polymeric Coating and Design: Summary • Among patients with de novo coronary lesions, using a specific stent and biodegradable polymer delivery system, rapamycin-eluting stents were associated with less late lumen loss compared to paclitaxel-eluting stents • Rapamycin-eluting stents also showed lower TLR rates and thus a reduced need for repeat revascularization Presented at ACC 2006

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