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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.

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Drug-eluting stents for in-stent restenosis

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

  2. 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

  3. 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

  4. 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

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

  6. 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

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