Recurrence of stenoses following balloon angioplasty and simpson atherectomy of the femoro-popliteal segment. A randomised comparative 1-year follow-up study using colour flow duplex

Abstract

The results of balloon angioplasty (BA) and atherectomy (AT) with the Simpson atherocath, were compared in a randomised prospective study. Thirty-one patients were randomised to one of these methods for the treatment of symptomatic stenotic or occlusive lesions in the superficial femoral and popliteal arteries. One patient died after randomisation but before the procedure, thus 30 patients were available for analysis. All patients had intermittent claudication and BA was used in 14 and AT in 16 limbs. A surveillance protocol included colour flow duplex scanning of the femoro-popliteal arteries after 6 weeks and then at 3-monthly intervals during the 1st year and every 6 months thereafter. The average duration of follow-up was 9.7 months. For confirmation intra-arterial digital subtraction angiography (DSA) was performed in all patients at 1 year following the intervention, when clinical symptoms occurred or when colour flow duplex indicated greater than 49% restenosis. Three small dissections were the only postoperative complications and residual stenoses greater than 20% diameter reduction (DR) were observed in two patients following BA and in two after AT. Improvement of clinical category according to the "Standards for evaluating results of interventional therapy for peripheral vascular disease" occurred in 13 of 14 BA patients and in 15 of 16 AT patients. Follow-up results were expressed as cumulative patency and clinical success. Endpoints for patency were recurrence of the stenosis at the treated segment or new lesions in different segments and endpoints for clinical success were a drop in clinical category (symptoms, ankle pressure indices and post-exercise ankle pressures). One-year patency (no restenosis greater than 49% DR) was 77% in patients with BA and 25% in patients with AT (p = 0.017).(ABSTRACT TRUNCATED AT 250 WORDS)