Matthew C Bunte1, David J Cohen2, Michael R Jaff3, William A Gray4, Elizabeth A Magnuson1, Haiyan Li1, Andrew Feiring5, Marco Cioppi6, Robert Hibbard7, Bruce Gray8, Yazan Khatib9, David Jessup10, Roberto Patarca11, Jing Du12, Hans-Peter Stoll13, Joe Massaro14, David M Safley1. 1. St Luke's Hospital and University of Missouri-Kansas City School of Medicine, Saint Luke's Mid America Heart Institute, Kansas City, Missouri. 2. CardioVascular Institute, Division of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, MA. 3. Eifers Cardiovascular Center, Newton-Wellesley Hospital, Newton, Massachusetts. 4. Main Line Health, Lankenau Heart Group, Wynnewood, Pennsylvania. 5. Division of Cardiology, Columbia St. Mary's Hospital, Milwaukee, Wisconsin. 6. Vascular Surgery Associates, P.C., Huntsville, Alabama. 7. Bryan LGH Heart Institute, Lincoln, Nebraska. 8. Department of Surgery, Vascular Medicine Division, Greenville Hospital, Greenville, South Carolina. 9. First Coast Cardiovascular Institute, Jacksonville, Florida. 10. CarolinaEast Heart Center, New Bern, North Carolina. 11. Johnson and Johnson, New Brunswick, New Jersey. 12. Cordis Clinical Research, Milpitas, California. 13. Biosensors Clinical Research, Morges, Switzerland. 14. Harvard Clinical Research Institute, Boston, Massachusetts.
Abstract
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.
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.
Authors: Poghni A Peri-Okonny; Jingyan Wang; Kensey L Gosch; Manesh R Patel; Mehdi H Shishehbor; David L Safley; J Dawn Abbott; Herbert D Aronow; Carlos Mena-Hurtado; Qurat-Ul-Ain Jelani; Yuanyuan Tang; Matthew Bunte; Clementine Labrosciano; John F Beltrame; John A Spertus; Kim G Smolderen Journal: Circ Cardiovasc Qual Outcomes Date: 2021-05-05