This analysis of data from an already published study, “Bypass Versus Angioplasty in Severe Ischemia of the Limb (BASIL-1),” confirms the superiority of bypass over balloon angioplasty, with or without stenting, in patients with chronic lower limb ischemia who require a femoropopliteal intervention.
While analyzed interventions took place between 1999 and 2003 (a fact subject of complaint by many endovascular interventional professionals), there are no recent randomized data contradicting this older work. Consequently, the BASIL 1 study constitutes a reference point against which much more recent works (such as BASIL 2, BASIL 3, and BEST-CLI) are compared.
The aim of this work (soon to be published in Eur J Vasc Endovasc Surg) was to compare the outcomes in patients with chronic lower limb ischemia due to femoropopliteal disease (with or without associated infrapopliteal disease) who underwent surgery (with vein or synthetic bypass) or angioplasty, with or without stenting.
Events reported were immediate technical success, freedom from major adverse target limb events, further reinterventions, amputation free survival, overall survival, and limb salvage.
In total, 128 patients underwent surgery (89 vein, 39 synthetic) and 183 underwent balloon angioplasty (6 of whom required stenting). The follow-up was 46.2 and 43.6 months, respectively.
There were no differences in angiography and technical difficulty between groups.
Immediate technical success was significantly higher in patients who underwent surgery (98% vs. 81%; p < 0.001), but they had a longer index hospital stay. At twelve months, such difference in hospitalization days between strategies disappeared.
Survival free from major adverse target limb events (hazard ratio [HR]: 1.51; p = 0.04) and freedom from reinterventions (HR: 1.68; p = 0.02) were better with surgery, unlike amputation free survival, overall survival, and limb salvage.
While amputation free survival, overall survival, and limb salvage were similar between groups, surgery was associated with less major adverse target limb events and less reinterventions. Despite being less resource-consuming/expensive (in most regions) and presenting less short-term morbidity, angioplasty does not seem to be the best option in the long term. Data from this work support the conclusions from the original BASIL study: surgery as initial revascularization strategy in patients with chronic ischemia and femoropopliteal disease.
Original Title: A Comparison of Clinical Outcomes Following Femoropopliteal Bypass or Plain Balloon Angioplasty with Selective Bare Metal Stenting in the Bypass Versus Angioplasty in Severe Ischaemia of the Limb (BASIL) Trial.
Reference: Lewis Meecham et al. Eur J Vasc Endovasc Surg. Article in press.
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