Aortic & peripheral vascular disease
5-Year Outcomes of Drug-Coated Balloons for Peripheral Artery In-Stent Restenosis, Long Lesions, and Chronic Total Occlusions (CTOs)
Authors' conclusion
Results demonstrate long-term safety and effectiveness of this DCB in all 3 cohorts, with low reintervention rates in the LL and CTO cohorts and no safety issues.
Study context
- Population
- Complex femoropopliteal atherosclerotic lesions treated with a paclitaxel drug-coated balloon (DCB)
- Participants
- 132 / 158 / 127
- Exposure
- In-stent restenosis (ISR) vs long lesions (LL) vs CTO
- ISRn = 132
- LLn = 158
- CTOn = 127
- Outcome
- Freedom from clinically driven target lesion revascularization (CD-TLR)
- Follow-up
- 5 years
Methodological detailsprespecified imaging cohorts of the IN.PACT Global Study, international
- Prespecified imaging cohorts of the IN.PACT Global Study
- International
Main finding
As reported in the abstract
Freedom from CD-TLR (Kaplan-Meier)
Observational data: associations, not effects.
Further findings
Freedom from all-cause mortality (with vital status update) · 5 years
≥2 TLRs
Safety
Composite safety endpoint (freedom from device- and procedure-related death to 30 days, major target limb amputation and clinically driven target vessel revascularization within 60 months) · 5 years · cumulative incidence as printed
Original publication
5-Year Outcomes of Drug-Coated Balloons for Peripheral Artery In-Stent Restenosis, Long Lesions, and CTOs. JACC Cardiovasc Interv. Published 8 May 2023. doi:10.
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