Published 1-Year STROLL Results Support the Cordis SMART Stent

December 29, 2014—William A. Gray, MD, et al published the 1-year outcomes from the STROLL study in the Journal of Vascular and Interventional Radiology (JVIR; 2015;26:21–28). The single-arm, multicenter STROLL study was conducted to assess the safety and efficacy of the self-expanding SMART vascular nitinol stent system (Cordis Corporation) in treatment of obstructive superficial femoral artery (SFA) disease.

Based on 1-year vessel patency and associated hemodynamic and clinical improvements, the investigators concluded that the SMART device proved to be safe and effective for endovascular treatment of obstructive SFA and proximal popliteal artery disease.

As summarized in JVIR, the STROLL study included 250 patients with 250 lesions in the SFA or proximal popliteal artery. The efficacy endpoint was primary patency defined by freedom from binary restenosis (peak systolic velocity ratio > 2.5) as derived by duplex ultrasound plus clinically driven target lesion revascularization at 12 months.

In STROLL, the mean age of patients was 67.7 years ± 10.3; 47.2% of patients had diabetes; distribution of Rutherford/Becker classes 2, 3, and 4 was 45.8%, 51.4%, and 2.8%. Mean lesion length and reference vessel diameter were 77.3 mm ± 35.3 and 4.9 mm ± 0.7, respectively (23.6% cases with total occlusions).

The investigators found that the 30-day freedom from major adverse events (death, index limb amputation, clinically driven target lesion revascularization) was 100%. The 1-year primary patency was 81.7% by Kaplan-Meier estimate. The presence of diabetes or total occlusion had no effect on primary patency. Ankle-brachial index was 0.4–0.8 in 84.6% of patients at baseline and improved to > 0.8 in 81% of patients at 12 months. The proportion of patients in Rutherford/Becker class 3–4 was reduced from 54.2% at baseline to 8% at 12 months. Four patients (2%) experienced single-stent strut fracture (type I) at 1 year without associated loss of stent patency, reported the STROLL investigators in JVIR.