Yoshimitsu Soga1, Mitsuyoshi Takahara2, Osamu Iida3, Masatsugu Nakano4, Yasutaka Yamauchi5, Kan Zen6, Daizo Kawasaki7, Kenji Ando8. 1. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan sogacchy@yahoo.co.jp. 2. Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Osaka, Japan. 3. Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan. 4. Division of Cardiology, Tokyo General Hospital, Tokyo, Japan. 5. Cardiovascular Center, General Takatsu Central Hospital, Kawasaki, Japan. 6. Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Omihachiman, Japan. 7. Cardiovascular Division, Department of Internal Medicine, Morinomiya Hospital, Morinomiya, Japan. 8. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Abstract
PURPOSE: To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS). METHODS: A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis. RESULTS: The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup. CONCLUSION: These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions.
PURPOSE: To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS). METHODS: A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis. RESULTS: The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup. CONCLUSION: These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions.