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

www. Clinical trial results.org RES and PES with Identical Biodegradable Polymeric Coating and Design: Background Recent clinical trials have shown that drug-eluting stents offer long-term clinical advantagesRecent 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 polymerThis 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 Recent clinical trials have shown that drug-eluting stents offer long-term clinical advantagesRecent 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 polymerThis 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

www. Clinical trial results.org RES and PES with Identical Biodegradable Polymeric Coating and Design: Study Design Presented at ACC 2006  Primary Endpoint: In-stent late lumen loss  Secondary Endpoint: Death, myocardial infarction, in-segment late loss, binary restenosis, target lesion revascularization  Primary Endpoint: In-stent late lumen loss  Secondary Endpoint: Death, myocardial infarction, in-segment late loss, binary restenosis, target lesion revascularization Rapamycin-eluting Stent (2.0 mcg/mm 2 ) Rapamycin-eluting Stent (2.0 mcg/mm 2 ) Paclitaxel-eluting Stent (0.25 mcg/mm 2 ) Paclitaxel-eluting Stent (0.25 mcg/mm 2 ) 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 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 Follow-up Angiography at 6 months Clinical Follow-up at 9 months

www. Clinical trial results.org RES and PES with Identical Biodegradable Polymeric Coating and Design: Primary Endpoint Presented at ACC 2006 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).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). Angiographic In-stent Late Lumen Loss at 6 months (mm) p<0.001

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

www. Clinical trial results.org RES and PES with Identical Biodegradable Polymeric Coating and Design: Limitations The trial involved a small sample size.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.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.Large randomized trials must be conducted to better assess the treatment efficacies. The trial involved a small sample size.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.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.Large randomized trials must be conducted to better assess the treatment efficacies. Presented at ACC 2006

www. Clinical trial results.org 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 stentsAmong 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 revascularizationRapamycin-eluting stents also showed lower TLR rates and thus a reduced need for repeat revascularization 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 stentsAmong 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 revascularizationRapamycin-eluting stents also showed lower TLR rates and thus a reduced need for repeat revascularization Presented at ACC 2006