1. 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

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. 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

4. 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

5. 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

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