Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

• Published in: Catheterization and cardiovascular interventions Vol. 92; no. 1; pp. 106 - 114
• Main Authors: Bunte, Matthew C., Cohen, David J., Jaff, Michael R., Gray, William A., Magnuson, Elizabeth A., Li, Haiyan, Feiring, Andrew, Cioppi, Marco, Hibbard, Robert, Gray, Bruce, Khatib, Yazan, Jessup, David, Patarca, Roberto, Du, Jing, Stoll, Hans‐Peter, Massaro, Joe, Safley, David M.
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-07-2018
• Subjects: Durability; Femoral artery; Femur; health status; Implants; Lesions; Memory; Nickel titanides; peripheral artery disease; Quality of life; revascularization; Stenosis; Ultrasound; Veins & arteries; health status; revascularization; peripheral artery disease
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.27569

Objectives
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 through 3 years of follow‐up.
Background
Limited long‐term data are available describing the durability of benefits after femoropopliteal revascularization.
Methods
In a multicenter, prospective, core‐lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. 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).
Results
At 3‐year follow‐up, 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 improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5‐34.3; P < 0.001). 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 < 0.0001).
Conclusions
In patients undergoing revascularization for moderately complex SFA disease, use of the self‐expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.