Rate of Severe Arterial Dissections After Femoropopliteal Angioplasty by Long Versus Short Time of Balloon Inflation: the LOVES Randomized Controlled Trial

Background. Arterial dissections represent the typical complication of the percutaneous transluminal angioplasty for femoropopliteal disease, with an incidence of 20-60% depending of the severity of treated lesion and reporting standards. Post-angioplasty dissections have negative impact upon the outcomes of the endovascular treatment of lower limb arterial disease. Severe flow limiting dissections require immediate treatment by bailout stenting. Although this strategy is effective in the short term there is a substantial risk of in-stent restenosis, stent thrombosis, and stent fracture with the long-term follow-up. Moreover, it was demonstrated that even minor dissections that required no treatment during the initial procedure with time can progress to significant arterial stensosis. Finally, stenting significantly increases the cost of intervention.

Improved results of peripheral arterial balloon angioplasty with balloon inflation time of 3 minutes comparing to 1 minute were reported previously. A randomized study performed in patients with stenosis of the vascular access for haemodialysis demonstrated 14% difference in technical success of angioplasty, favouring the 3 minutes balloon inflation time vs one minute. Recently published retrospective single centre study demonstrated that balloon angioplasty with a prolonged inflation time >3 minutes may be effective as an initial angioplasty strategy to prevent severe dissection in femoropopliteal lesions. Type C or higher dissections according to NHLBI (National Heart, Lung and Blood Institute) classification were observed less frequently after >3 minutes balloon inflation - 22.7% vs 50.9% in <3-minute group. However, the rate of provisional stenting was not significantly different between groups.

Objective. The study is aimed to test the hypothesis that a prolonged (6 minutes) time of inflation of angioplasty balloon would reduce the rate of severe (grade C-F) arterial dissections and necessity in bailout stenting during the treatment of occlusive-stenotic femoropopliteal lesions in patients with chronic limb threatening ischemia.

Methods. The LOVES (LOng VErsus Short) trial is a single centre, two parallel groups, open label, controlled trial with 1:1 randomization. The eligible participants in the study will be adults aged 18 years or over who met the inclusion criteria.

Recruitment. Participants in the LOVES trial will be recruited starting with September 2020 among the patients hospitalized in Vascular Surgery Department of Institute of Emergency Medicine, Chisinau, Republic of Moldova. All patients eligible for enrollment in to the study will be asked to sign informed consent. Only one extremity per patient may be included in the trial. If both legs meet the inclusion criteria, the leg with the most severe complaints will be treated first and will be included in the trial.