Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial
Authors' conclusion
Ten years after PCI for DES-ISR, the primary and major secondary endpoints between PCB and PES were not significantly different.
Study context
- Population
- Patients with drug-eluting stent (DES) in-stent restenosis undergoing percutaneous coronary intervention (PCI)
- Participants
- 402 patients500 lesions
- Comparison
- Plain balloon vs paclitaxel-coated balloon vs paclitaxel-eluting stent for DES in-stent restenosis
- Plain balloon (PB)n = 134reference
- Paclitaxel-coated balloon (PCB)n = 137
- Paclitaxel-eluting stent (PES)n = 131
- Primary endpoint
- Composite of:
- Cardiac death
- Target vessel MI
- Target lesion thrombosis
- Target lesion revascularization
- Follow-up
- 10 years
Methodological details10-year extended follow-up, events independently adjudicated
- 10-year extended follow-up
- Events independently adjudicated
Primary result
As reported in the abstract
PCB vs PESHazard ratio (95% CI)P value
Weighted Cox; multiplicity-adjusted P
1.10(0.80–1.51)
P = 0.610Cox
1.10(0.79–1.52)
Royston-Parmar
1.08(0.72–1.60)
Secondary outcomes
| Outcome | PB | PCB | PES | HR (95% CI) | P value | |
|---|---|---|---|---|---|---|
| Target lesion revascularization (major secondary efficacy endpoint) · 10 yearsWeighted Cox; multiplicity-adjusted P | 58.0% | 43.9% | 38.6% | 0.83 (0.56–1.22) | P = 0.282 | |
| Target lesion revascularization (major secondary efficacy endpoint) · 10 yearsCox | 0.81 (0.54–1.21) | |||||
| Target lesion revascularization (major secondary efficacy endpoint) · 10 yearsRoyston-Parmar | 0.75 (0.47–1.20) | |||||
| 0.512Hazard ratio (log scale) |
- Target lesion revascularization (major secondary efficacy endpoint): overall P < 0.0001
- Target lesion revascularization (major secondary efficacy endpoint): Grambsch-Therneau P = 0.002
Landmark analyses: death and cardiac death · within 5 years
- Excess of death and cardiac death with PES vs PCB within 5 years; 10-year differences not significant after multiplicity adjustment
Competing risk analysis
- No significant difference in TLR between PCB and PES; increased risk of death with PES vs PCB
Lesion-level and per-protocol analyses
- Consistent
Safety
Major secondary safety endpoint (cardiac death, target vessel MI or target lesion thrombosis) · 10 years
- Major secondary safety endpoint (cardiac death, target vessel MI or target lesion thrombosis): P = 0.564
Original publication
Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial. Eur Heart J. Published 21 February 2023. doi:10.
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