Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis
| Autor: | Wang-de Zhang, Chuan-jun Liao, Sheng-han Song, Yang Zhang, Tan Li |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Time Factors medicine.medical_treatment Constriction Pathologic 030204 cardiovascular system & hematology 030230 surgery Revascularization Single Center Balloon Amputation Surgical law.invention 03 medical and health sciences Peripheral Arterial Disease 0302 clinical medicine Restenosis Randomized controlled trial law Angioplasty medicine Humans Popliteal Artery Single-Blind Method Prospective Studies Prospective cohort study Vascular Patency Aged business.industry Middle Aged medicine.disease Surgery Femoral Artery Treatment Outcome Amputation Female Stents Cardiology and Cardiovascular Medicine business Angioplasty Balloon |
| Zdroj: | International angiology : a journal of the International Union of Angiology. 38(5) |
| ISSN: | 1827-1839 |
| Popis: | Background To assess the efficacy and safety of Orchid drug-coated balloon (DCB) for treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) in Chinese patients. Methods The study is a prospective, single center, single-blinded, randomized controlled trial (RCT) that randomized (1:1) 74 patients to DCB group (N.=38) and PTA group (N.=36). The primary efficacy endpoint was primary patency of the target lesion at 12 months. Second efficacy endpoint included clinically-driven target-lesion revascularization (CD-TLR) and ABI change at 12 months. The primary safety endpoint included peri-operative death at 30 days, all-cause death, major amputation, and other major adverse events (MAEs) at 12 months. The primary functional endpoint included Walking Impairment Questionnaire (WIQ), quality-of-life measures (EQ-5D) and 6-minute walking test (6MWT). Results The DCB group had higher primary patency (87.9% vs. 51.6%; P=0.001) and lower rates of CD-TLR (6.1% vs. 35.5%; P=0.003) than the PTA group at 12 months. There were no peri-operative deaths, and no major amputations at 12 months in two groups. There were 1(2.6%) in the DCB group and 2 (5.6%) in the PTA group of all-cause deaths (P=0.524). Conclusions Results from the study showed superior treatment effect with Orchid DCB versus PTA for the treatment of FP ISR, and without an apparent difference in safety. |
| Databáze: | OpenAIRE |
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