Cutting balloons no better than conventional angioplasty


“Cutting balloon angioplasty has failed to demonstrate any advantage over balloon angioplasty with regard to reduction of restenosis in patients with de novo femoropopliteal or in-stent restenosis lesions in two small randomised trials,” said Erich Minar, Medical University Vienna, Austria.

He was reviewing the effectiveness of cutting balloon angioplasty, and told delegates at the Transcatheter Cardiovascular Therapeutics, San Francisco, USA, that the aims of cutting balloon angioplasty are to reduce the trauma, improve acute result, reduce stent frequency, and improve patency, through a controlled incision of the vessel wall. “Because of the longitudinal incisions, cutting balloon angioplasty dilates the target vessel with less force than conventional balloon angioplasty to potentially decrease the vessel wall trauma,” Minar said. Initially, the cutting balloon was used in haemodialysis access management and in lesions resistant to standard balloon angioplasty alone.

A non-randomised, comparative study of short- and mid-term primary patency rates of cutting balloon angioplasty versus standard balloon angioplasty for failing infra-inguinal vein grafts (Vikram et al Cardiovascular Interventional Radiology 2007; 30:607–610), concluded that cutting balloons offered no definite advantage over standard balloon angioplasty. The primary patency rate at 12 months was 9/25 (36%) for standard balloon angioplasty and 5/10 (50%) for cutting balloon angioplasty (p=0.47).

Initial reports on the use of cutting balloon angioplasty for the treatment of obstructive atherosclerotic disease of the superficial femoral artery have revealed promising results. However, Minar reported, “data from randomised studies involving comparisons between conventional balloon angioplasty and cutting balloon angioplasty in the coronary arteries have failed to prove the superiority of the cutting balloon procedure.

In the randomised, controlled trial “De novo superficial femoropopliteal artery lesions: Peripheral cutting balloon angioplasty and restenosis rates”, from Amighi et al, published in Radiology in 2008, cutting balloon angioplasty did not prove to be superior to conventional percutaneous transluminal angioplasty, and even increased restenosis at six months.

In another study “Infrainguinal cutting balloon angioplasty in de novo arterial lesions involving 128 consecutive patients with 203 lesions (183 stenoses, 20 occlusions) Canaud et al (Journal of Vascular Surgery 2008; 48:1182–1188) concluded that cutting balloon angioplasty is safe and feasible for the treatment of infrainguinal arterial occlusive disease, with relatively low mid-term restenosis rates compared to other endovascular treatments. The overall primary patency rates at one and two years were 64.4% and 51.9%, respectively.

Cotroneo et al have also found positive results for the technique. The non-randomised, restropective, single-centre study “Cutting balloon vs. conventional angioplasty in short femoropopliteal arterial stenoses” (Journal of Endovascular Therapy 2008; 15:283–291) involved 84 consecutive patients with a total of 142 focal (≤3cm), calcified femoropopliteal occlusive lesions. Forty patients (67 lesions) were treated with angioplasty, and 44 patients (75 lesions) underwent angioplasty with cutting balloon. At 24 months, the primary patency rate was 66.6% in the angioplasty group and 79.7% for the cutting balloon group (p<0.001). Cotroneo et al concluded that “Cutting balloon angioplasty seems to be a valuable tool in the endovascular treatment of short femoropopliteal stenotic lesions, achieving better patency at midterm compared to conventional percutaneous transluminal angioplasty.”

Minar also mentioned a prospective, randomised, single-centre, controlled pilot study analysing cutting balloon performance for in-stent restenosis. “Repeated conventional balloon angioplasty of in-stent restenosis is technically feasible and mostly yields acceptable immediate results. Unfortunately, the short and midterm rates of recurrent failure after repeat balloon angioplasty of in-stent restenosis remain high,” Minar said.

Dick et al (Radiology 2008; 248:297) concluded from their small randomised study that “cutting balloon angioplasty failed to prove superiority compared with balloon angioplasty for treatment of femoropopliteal in-stent restenosis in a pilot study. In restenotic lesions with an average length of approximately 8cm, both treatment modalities yielded disappointing six-month patency rates.”