Drug-eluting stents for in-stent restenosis
ISAR-DESIRE Trial
Presented at
European Society of Cardiology
Congress 2004
Presented by Dr. A. Kastrati
Balloon angioplasty
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
ISAR-DESIRE Trial
Presented at ESC 2004
300 patients with in-stent restenosis in a native vessel randomized to:
Sirolimus-eluting stents
n=100
Paclitaxel-eluting stents
n=100
ISAR-DESIRE Trial
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
Restenosis (in-segment) on 6 month angiography
Presented at ESC 2004
p=0.19
p<0.001
p=0.001
ISAR-DESIRE Trial
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
Clinical target vessel revascularization at 9 months
Presented at ESC 2004
p=0.02
p<0.001
p=0.02
ISAR-DESIRE Trial
MI by 6 months
%
Presented at ESC 2004
Using ICTUS definition
p = 0.006
Using TACTICS-TIMI 18 definition
p = 0.082
Using FRISC-2 definition
p = 0.010
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