Purpose: To report the 1-year results of a
prospective multicenter trial to evaluate the safety and efficacy of treating
symptomatic femoropopliteal occlusive disease using 4-F–compatible
materials and no closure device.
Methods: The non-randomized 4-EVER trial
(4-F
endovascular
treatment
approach to infrainguinal disease)
was conducted at 5 European hospitals (ClinicalTrials.gov identifier NCT01413139). The
protocol mandated the use of only 4-F sheaths, self-expanding nitinol stents
(Astron Pulsar or Pulsar-18 stent), and balloons from a single manufacturer.
Between June 2010 and June 2011, 120 symptomatic patients (82 men; mean age
71±9.7 years, range 47–90), primarily claudicants, treated for 120
femoropopliteal lesions (>90% TASC A/B) were enrolled. The mean
lesion length was 71.0±45.9 mm. Follow-up evaluations were scheduled on
day 1 and at 1, 6, 12, and 24 months. A duplex ultrasound was performed on all
follow-up visits to determine vessel patency (primary outcome measure at 1
year), and biplanar radiography was performed at 12 and 24 months to assess
stent fracture.
Results: Stents were successfully implanted in all
patients: an Astron Pulsar stent in 70 (58.3%) lesions and a Pulsar-18
stent in 46 (38.3%); 4 (3.3%) patients had both stents implanted
for flow-limiting dissection after predilation. No closure devices were used;
the mean manual compression time was 8.1 minutes (2–15). Four
(3.3%) patients developed significant hematoma at the puncture site, but
none required surgical repair. The overall 12-month primary patency rate was
81.4%: 85.2% for the Astron Pulsar and 73.4% for the
Pulsar-18 (p=0.236). Freedom from target lesion revascularization at 12
months for the entire cohort was 89.3%.
Conclusion: Compared to published historical data
for superficial femoral artery type A/B lesion stenting using 6-F devices, the
4-F devices applied in this trial showed similar patency at 12 months, fewer
access site complications, and shorter manual compression times, supporting the
supposition that 4-F endovascular treatment is safe and effective.
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