Secondary analysis
Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial
- Secondary analysis of the ISAR-DESIRE 3 randomised trial
- 10-year extended follow-up
- events independently adjudicated
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 patients · 500 lesions
- Comparison
- Plain balloon (PB) vs paclitaxel-coated balloon (PCB) vs paclitaxel-eluting stent (PES)
- PBn = 134reference
- PCBn = 137
- PESn = 131
- Primary endpoint
- Composite of:
- Cardiac death
- Target vessel MI
- Target lesion thrombosis
- Target lesion revascularization
- Follow-up
- 10 years
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 years · weighted 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 years · Cox | 0.81 (0.54–1.21) | |||||
| Target lesion revascularization (major secondary efficacy endpoint) · 10 years · Royston-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:10.1093/eurheartj/ehad026
Summarised from the published abstract; every number is checked against it