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Yvonne Bausback Tim Wittig Andrej Schmidt Thomas Zeller Marc Bosiers Patrick Peeters Steffen Brucks Aaron E. Lottes Dierk Scheinert Sabine Steiner 《Journal of the American College of Cardiology》2019,73(6):667-679
Background
Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing.Objectives
The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months.Methods
Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes.Results
More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months.Conclusions
Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441) 相似文献32.
Simone Budassi MD Carlo Zivelonghi MD Joseph Dens MD PhD Alan J. Bagnall MD PhD Paul Knaapen MD PhD Alexandre Avran MD James C. Spratt MD Simon Walsh MD Benjamin Faurie MD Pierfrancesco Agostoni MD PhD of all the RECHARGE investigators 《Catheterization and cardiovascular interventions》2021,97(1):E51-E60
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