Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial.

PURPOSE

This study involves a prospective randomized trial comparing clinical and angiographic results of balloon angioplasty (BA) and Simpson directional atherectomy (DA) in patients with short lesions in the femoropopliteal artery causing symptoms of intermittent claudication.

MATERIALS AND METHODS

Thirty-five patients were treated with BA and 38 with DA. Procedural complications were seen in eight patients. Residual stenoses immediately after the procedure with between 30% and 50% diameter reduction (DR) were observed in three patients after BA and in five patients after DA. In all other patients, residual stenosis was less than 30% DR. Two study end-points during a 2-year follow-up were used: the angiographic occurrence of restenosis with a DR of 50% or greater or the recurrence of symptoms.

RESULTS

Clinical success after 2 years, according to the criteria of the Society for Vascular Surgery/International Society for Cardiovascular Surgery, was seen in 79% of the BA patients and 56% of the DA patients (P = .07). The 2-year primary angiographic patency rates were 67% in patients treated with BA and 44% in patients treated with DA (P = .06). The secondary angiographically determined patency rates were 80% and 65%, respectively (P = .15).

CONCLUSION

Simpson atherectomy is an interventional technique to treat arterial lesions in the femoropopliteal artery with an acceptably low complication rate. The clinical and angiographic results of DA and BA are comparable. DA should not be used to replace BA for routine treatment of short femoropopliteal lesions.