Rapamycin- and Paclitaxel-Eluting Stents With Rapamycin- and Paclitaxel-Eluting Stents With Identical Biodegradable Polymeric Coating and Identical Biodegradable Polymeric Coating and

Design TrialDesign Trial

Rapamycin- and Paclitaxel-Eluting Stents With Rapamycin- and Paclitaxel-Eluting Stents With Identical Biodegradable Polymeric Coating and Identical Biodegradable Polymeric Coating and

Design TrialDesign Trial

Presented atPresented atThe American College of CardiologyThe American College of Cardiology

Scientific Session 2006Scientific Session 2006

Presented by Dr. Rainer WessleyPresented by Dr. Rainer Wessley

www. Clinical trial results.org

RES and PES with Identical Biodegradable RES and PES with Identical Biodegradable Polymeric Coating and Design: BackgroundPolymeric Coating and Design: BackgroundRES and PES with Identical Biodegradable RES and PES with Identical Biodegradable

Polymeric Coating and Design: BackgroundPolymeric Coating and Design: Background

• Recent clinical trials have shown that drug-eluting stents Recent clinical trials have shown that drug-eluting stents offer long-term clinical advantagesoffer long-term clinical advantages

• This current trial sought to determine whether rapamycin This current trial sought to determine whether rapamycin or paclitaxel-eluting stents would be more efficient in the or paclitaxel-eluting stents would be more efficient in the prevention of restenosis – using an identical drug-eluting prevention of restenosis – using an identical drug-eluting stent platform with a biodegradable polymerstent platform with a biodegradable polymer

• Recent clinical trials have shown that drug-eluting stents Recent clinical trials have shown that drug-eluting stents offer long-term clinical advantagesoffer long-term clinical advantages

• This current trial sought to determine whether rapamycin This current trial sought to determine whether rapamycin or paclitaxel-eluting stents would be more efficient in the or paclitaxel-eluting stents would be more efficient in the prevention of restenosis – using an identical drug-eluting prevention of restenosis – using an identical drug-eluting stent platform with a biodegradable polymerstent platform with a biodegradable polymer

Presented at ACC 2006Presented at ACC 2006

www. Clinical trial results.org

RES and PES with Identical Biodegradable RES and PES with Identical Biodegradable Polymeric Coating and Design: Study DesignPolymeric Coating and Design: Study DesignRES and PES with Identical Biodegradable RES and PES with Identical Biodegradable

Polymeric Coating and Design: Study DesignPolymeric Coating and Design: Study Design

Presented at ACC 2006Presented at ACC 2006

Primary Endpoint: In-stent late lumen loss Primary Endpoint: In-stent late lumen loss Secondary Endpoint: Death, myocardial infarction, in-segment late loss, binary Secondary Endpoint: Death, myocardial infarction, in-segment late loss, binary

restenosis, target lesion revascularizationrestenosis, target lesion revascularization

Primary Endpoint: In-stent late lumen loss Primary Endpoint: In-stent late lumen loss Secondary Endpoint: Death, myocardial infarction, in-segment late loss, binary Secondary Endpoint: Death, myocardial infarction, in-segment late loss, binary

restenosis, target lesion revascularizationrestenosis, target lesion revascularization

Rapamycin-eluting Stent(2.0 mcg/mm2)

Rapamycin-eluting Stent(2.0 mcg/mm2)

Paclitaxel-eluting Stent(0.25 mcg/mm2)

Paclitaxel-eluting Stent(0.25 mcg/mm2)

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 monthsFollow-up Angiography at 6 months

Clinical Follow-up at 9 monthsClinical Follow-up at 9 months

www. Clinical trial results.org

RES and PES with Identical Biodegradable Polymeric RES and PES with Identical Biodegradable Polymeric Coating and Design: Primary EndpointCoating and Design: Primary Endpoint

RES and PES with Identical Biodegradable Polymeric RES and PES with Identical Biodegradable Polymeric Coating and Design: Primary EndpointCoating and Design: Primary Endpoint

Presented at ACC 2006Presented at ACC 2006

• At 6 month follow-up, At 6 month follow-up, late lumen loss was late lumen loss was smaller with the smaller with the rapamycin-eluting rapamycin-eluting stent compared to the stent compared to the paclitaxel-eluting paclitaxel-eluting stent (0.34 mm vs stent (0.34 mm vs 0.94 mm; p<0.001).0.94 mm; p<0.001).

0.34

0.94

0.0

0.2

0.4

0.6

0.8

1.0

Rapamycin-elutingStent

Paclitaxel-elutingStent

0.34

0.94

0.0

0.2

0.4

0.6

0.8

1.0

Rapamycin-elutingStent

Paclitaxel-elutingStent

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 RES and PES with Identical Biodegradable Polymeric Coating and Design: Secondary EndpointsCoating and Design: Secondary Endpoints

RES and PES with Identical Biodegradable Polymeric RES and PES with Identical Biodegradable Polymeric Coating and Design: Secondary EndpointsCoating and Design: Secondary Endpoints

Presented at ACC 2006Presented at ACC 2006

• Angiographic restenosisAngiographic restenosis rates were decreased with the rapamycin-eluting stent rates were decreased with the rapamycin-eluting stent compared to the paclitaxel-eluting stentcompared to the paclitaxel-eluting stent

• Clinical target lesion revascularization rates also decreased with the rapamycin-Clinical target lesion revascularization rates also decreased with the rapamycin-eluting stent compared to the paclitaxel-eluting stenteluting stent compared to the paclitaxel-eluting stent

10.2%

34.8%

0%

10%

20%

30%

40%

Rapamycin-elutingStent

Paclitaxel-elutingStent

10.2%

34.8%

0%

10%

20%

30%

40%

Rapamycin-elutingStent

Paclitaxel-elutingStent

8.3%

24.0%

0%

10%

20%

30%

40%

Rapamycin-elutingStent

Paclitaxel-elutingStent

8.3%

24.0%

0%

10%

20%

30%

40%

Rapamycin-elutingStent

Paclitaxel-elutingStent

Angiographic Restenosis (%) (6 month)p<0.0001

Clinical TLR (%) (9 month)

p=0.03

www. Clinical trial results.org

RES and PES with Identical Biodegradable RES and PES with Identical Biodegradable Polymeric Coating and Design: LimitationsPolymeric Coating and Design: LimitationsRES and PES with Identical Biodegradable RES and PES with Identical Biodegradable Polymeric Coating and Design: LimitationsPolymeric 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 These findings cannot be extrapolated to other technologies involving differing stent platforms and technologies involving differing stent platforms and polymers with different release kinetics.polymers with different release kinetics.

• Large randomized trials must be conducted to better Large randomized trials must be conducted to better assess the treatment efficacies.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 These findings cannot be extrapolated to other technologies involving differing stent platforms and technologies involving differing stent platforms and polymers with different release kinetics.polymers with different release kinetics.

• Large randomized trials must be conducted to better Large randomized trials must be conducted to better assess the treatment efficacies.assess the treatment efficacies.

Presented at ACC 2006Presented at ACC 2006

www. Clinical trial results.org

RES and PES with Identical Biodegradable RES and PES with Identical Biodegradable Polymeric Coating and Design: SummaryPolymeric Coating and Design: Summary

RES and PES with Identical Biodegradable RES and PES with Identical Biodegradable Polymeric Coating and Design: SummaryPolymeric Coating and Design: Summary

• Among patients with de novo coronary lesions, using a Among patients with de novo coronary lesions, using a specific stent and biodegradable polymer delivery system, specific stent and biodegradable polymer delivery system, rapamycin-eluting stents were associated with less late rapamycin-eluting stents were associated with less late lumen loss compared to paclitaxel-eluting stentslumen loss compared to paclitaxel-eluting stents

• Rapamycin-eluting stents also showed lower TLR rates Rapamycin-eluting stents also showed lower TLR rates and thus a reduced need for repeat revascularizationand thus a reduced need for repeat revascularization

• Among patients with de novo coronary lesions, using a Among patients with de novo coronary lesions, using a specific stent and biodegradable polymer delivery system, specific stent and biodegradable polymer delivery system, rapamycin-eluting stents were associated with less late rapamycin-eluting stents were associated with less late lumen loss compared to paclitaxel-eluting stentslumen loss compared to paclitaxel-eluting stents

• Rapamycin-eluting stents also showed lower TLR rates Rapamycin-eluting stents also showed lower TLR rates and thus a reduced need for repeat revascularizationand thus a reduced need for repeat revascularization

Presented at ACC 2006Presented at ACC 2006