Heparin-Bonded Covered Stents Versus Bare Metal Stents for Complex Femoro-Popliteal Artery Lesions: The Randomized VIASTAR Trial

Study Questions:

What is the relative safety and efficacy of covered stents compared with bare-metal stents (BMS) in patients with long femoro-popliteal artery disease?

Methods:

The authors performed a randomized, single-blind, multicenter study of 141 patients with symptomatic peripheral arterial disease who were assigned to treatment with heparin-bonded, covered stents (VIABAHN, n = 72 patients) or BMS (n = 69 patients). The primary safety endpoint was a composite of serious procedural adverse events, including death, myocardial infarction, study limb amputation, access site and treatment site complications requiring surgery, blood transfusion, or prolonged hospital stay within 30 days of the index procedure. The primary efficacy endpoint was the primary patency rate measured at 1 year postprocedure.

Results:

The average lesion length was 19.0 cm versus 17 cm in the VIABAHN versus BMS group. Major complications within 30 days were observed in 1.4%. There were six patients in each arm who had to be excluded due to protocol violation. In the intention-to-treat analysis, there was no difference in the 12-month primary patency rates in the VIABAHN and BMS group (70.9% vs. 55.1%, p = 0.11). There was no difference in freedom from target lesion revascularization (84.6% vs. 77.0%, p = 0.37).

Conclusions:

The authors concluded that there was better patency with the covered stent for superficial femoral artery (SFA) disease (in per-protocol analysis), but this did not translate into a reduction in target lesion revascularization rates.

Perspective:

This study tested the use of covered stents for SFA disease and demonstrated better patency, but no difference in target lesion revascularization rates. While patients with covered stents were more likely to maintain patency, failures, when they occurred, were more likely to be thrombotic with covered stents and present with acute limb ischemia. This study had a high protocol violation rate (~8%), and larger, better designed studies are needed to define the role for covered stents in the femoro-popliteal bed.

Clinical Topics: Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine

Keywords: Blood Transfusion, Myocardial Infarction, Heparin, Cardiovascular Diseases, Femoral Artery, Peripheral Arterial Disease, Single-Blind Method, Popliteal Artery, Stents, Length of Stay


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