Drug-eluting stents for in-stent restenosis ISAR-DESIRE Trial Drug-eluting stents for in-stent restenosis Presented at European Society of Cardiology Congress 2004 Presented by Dr. A. Kastrati

ISAR-DESIRE Trial 300 patients with in-stent restenosis in a native vessel randomized to: Balloon angioplasty n=100 Sirolimus-eluting stents n=100 Paclitaxel-eluting stents n=100 Primary Endpoint: Restenosis in-segment at 6 month angiography, defined as stenosis ≥50% Primary analysis for balloon angioplasty vs drug-eluting stent comparison Secondary analysis for sirolimus-eluting stent vs paclitaxel-eluting comparison Presented at ESC 2004

Restenosis (in-segment) on 6 month angiography ISAR-DESIRE Trial Restenosis (in-segment) on 6 month angiography Primary endpoint of in-segment restenosis on 6 month angiography ↓ in DES groups than balloon angioplasty group For the analysis comparing the sirolimus vs paclitaxel DES, p=0.19 p<0.001 p=0.001 p=0.19 Presented at ESC 2004

Clinical target vessel revascularization at 9 months ISAR-DESIRE Trial Clinical target vessel revascularization at 9 months Clinical target vessel revascularization at 9 months less frequent in DES groups than balloon angioplasty group For the analysis comparing the sirolimus vs paclitaxel DES, clinical TVR ↓ in sirolimus DES group than paclitaxel DES group p<0.001 p=0.02 p=0.02 Presented at ESC 2004

ISAR-DESIRE Trial MI by 6 months Using ICTUS definition p = 0.006 Using TACTICS-TIMI 18 definition p = 0.082 Using FRISC-2 definition p = 0.010 % Presented at ESC 2004

ISAR-DESIRE Trial Among patients with in-stent restenosis, treatment with a drug-eluting stent was associated with a lower rate of restenosis compared with balloon angioplasty Additionally, use of sirolimus DES was associated with a lower TVR rate and smaller late lumen loss than use of paclitaxel DES in patients with in-stent restenosis While findings are provocative, larger studies needed to validate results, given small sample size Additionally, study was conducted in patients with in-stent restenosis, not de novo lesions, and extrapolation to other populations may not be valid Upcoming, much larger REALITY trial will compare sirolimus versus paclitaxel DES in patients with de novo lesions