Aortic & peripheral vascular diseaseRandomised controlled trial
Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial
- Randomised controlled trial
- prospective
- multicentre
- 7 centres in South Korea
- Enrolment May 2016 to August 2022; median follow-up 363 days
Authors' conclusion
Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months.
Study context
- Population
- Patients with femoropopliteal artery disease treated with drug-coated balloons204 (86.0%) completed
- Participants
- 237 patients
- Comparison
- Intravascular ultrasound (IVUS)-guided vs angiography-guided DCB angioplasty
- IVUSn = 119
- Angiographyn = 118reference
- Primary endpoint
- Primary patency
- Follow-up
- 12 months
Primary result
As reported in the abstract
Cumulative difference
19.6 %
95% CI 6.8–32.3
P = 0.01
By group
IVUS vs Angiography
cumulative difference 19.6 % (95% CI 6.8–32.3); P = 0.01
Further findings
| Outcome | IVUS | Angiography | difference (%) (95% CI) | P value | |
|---|---|---|---|---|---|
| Freedom from clinically driven target lesion revascularization · 12 months | 92.4% | 83.0% | 11.6 (3.1–20.1) | P = 0.02 | |
| −100102030Difference, % (linear scale) |
Sustained clinical improvement · 12 months
P = 0.01
Haemodynamic improvement · 12 months
P = 0.01
Post-procedural minimum lumen diameter
P = 0.03
Original publication
Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial. Eur Heart J. Published 5 July 2024. doi:10.1093/eurheartj/ehae372
Summarised from the published abstract; every number is checked against it