Aortic & peripheral vascular disease
Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions
Primary result · Primary patencyResult — go to the resultRR for primary patency (SA vs SP) 0.995 95% CI 0.818–1.210Authors' conclusion
Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months.
Study context
- Population
- Patients with symptomatic complex femoropopliteal lesions (Rutherford 2–4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions)
- Participants
- 120 patients
- Comparison
- Stent-avoiding vs stent-preferred strategy
- Primary endpoint
- Primary patency
- Follow-up
- 12 months
Methodological detailsprospective, multicentre, pilot study, 1:1 randomisation, Lesion preparation incl. plaque modification/removal devices at operators' discretion in both arms
- Prospective
- Multicentre
- Pilot study
- 1:1 randomisation
- Lesion preparation incl. plaque modification/removal devices at operators' discretion in both arms
Primary result
As reported in the abstract
RR for primary patency (stent-avoiding (SA) vs stent-preferred (SP))
0.995
95% CI 0.818–1.210
P = 1.0
Events by treatment group
SAvs SP
RR for primary patency (SA vs SP) 0.995 (95% CI 0.818–1.210); P = 1.0
Further findings
Lesion preparation performed
P = 0.038
- Provisional stenting (SA)
- 48.3% · 29 events
Safety
| Outcome | SA | SP | RR for freedom from major adverse events (SA vs SP) (95% CI) | P value | |
|---|---|---|---|---|---|
| Freedom from major adverse events · 12 months | 93.1% | 94.9% | 0.981 (0.895–1.075) | P = 0.717 | |
| 0.512RR for freedom from major adverse events (SA vs SP) (log scale) |
- Freedom from major adverse events: all adverse events attributable to clinically driven target lesion revascularization
Original publication
Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv. Published 13 May 2024. doi:10.
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