Three-Year Results Published From STROLL Study of Cordis' S.M.A.R.T. Stent

August 15, 2018—Long-term results from the STROLL study were published by Matthew C. Bunte, MD, et al in Catheterization and Cardiovascular Interventions (2018;92:106–114).

STROLL sought to evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.) nitinol self‐expanding stent (Cordis, a Cardinal Health company) through 3 years of follow‐up.

The investigators concluded that treatment with the device was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits in patients with moderately complex SFA disease.

The multicenter, prospective, core lab–adjudicated study was composed of 250 patients with de novo or restenotic femoropopliteal arterial lesions who were treated with the S.M.A.R.T. stent.

As summarized in Catheterization and Cardiovascular Interventions, the primary endpoint of target vessel patency (a composite of ultrasound‐assessed patency and freedom from clinically driven target lesion revascularization [TLR]) was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease‐specific instruments, including the Peripheral Artery Questionnaire (PAQ).

The study demonstrated at 3‐year follow‐up that Kaplan‐Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%.

The PAQ summary score was markedly impaired at baseline (mean, 37.3 ± 19.6 points) and substantially improved at 1 month (mean change from baseline, 31.4 points; 95% confidence interval [CI], 28.5–34.3; P < .001). Disease‐specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow‐up (mean change from baseline, 28.0 points; 95% CI, 24.3–31.7; P < .0001), reported the investigators in Catheterization and Cardiovascular Interventions.