Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (Part 1: Above the knee)

Abstract

Objective: To evaluate 1 to 36 month follow-up outcomes of different endovascular treatment strategies in above-the-knee (ATK) arterial segments in patients with intermittent claudication (IC) and critical limb ischemia (CLI).

Methods: Studies indexed in Medline and Embase from 1980 to November 2013 of randomized controlled trials comparing balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another were included. Methodological quality of each trial was assessed using the Cochrane Collaboration tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were quality of life, walking capacity evaluated by treadmill or questionnaire, change in Rutherford classification, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, amputation, death, major adverse cardiac events, or event-free survival with follow-up periods of at least 1 month.

Results: Twenty-three trials including 3314 patients in total were identified. Eighty-five per cent patients had IC and 15% CLI. Fifteen trials showed no systematic benefit of BS over PTA. One trial comparing DES and PTA reported no significant differences in walking capacity or Rutherford classification. Four trials showed a beneficial effect on TLR rate, but not on Rutherford classification of DEB compared with PTA. In four trials DES did not systematically perform better than BS.

Conclusion: In general, performing PTA with optional bailout stenting for ATK lesions is the preferred strategy in patients with IC. For CLI, more studies are needed for recommending an optimal treatment strategy.

Keywords: Critical limb ischemia; Drug-eluting balloon; Drug-eluting stent; Intermittent claudication; Meta-analysis; Percutaneous transluminal angioplasty; Stent; Systematic review.