Clinical outcome of drug-coated balloon angioplasty in patients with femoropopliteal disease: A real-world single-center experience
| Autor: | Elliot Adams, Meghan Davis, Ali F. AbuRahma, Elaine Davis, L. Scott Dean, Matthew Beasley, Zachary AbuRahma, Grant Scott |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.medical_treatment Arterial Occlusive Diseases Kaplan-Meier Estimate 030204 cardiovascular system & hematology Peripheral Arterial Disease 03 medical and health sciences 0302 clinical medicine Coated Materials Biocompatible Angioplasty medicine.artery medicine Humans Popliteal Artery 030212 general & internal medicine Vascular Patency Aged Retrospective Studies Aged 80 and over business.industry Mortality rate Cardiovascular Agents Perioperative Critical limb ischemia Middle Aged medicine.disease Thrombosis Popliteal artery Surgery Femoral Artery Amputation Female medicine.symptom Cardiology and Cardiovascular Medicine Claudication business Angioplasty Balloon Vascular Access Devices |
| Zdroj: | Journal of Vascular Surgery. 70:1950-1959 |
| ISSN: | 0741-5214 |
| DOI: | 10.1016/j.jvs.2019.03.072 |
| Popis: | Several multicenter industry-sponsored clinical trials reported satisfactory results in the use of drug-coated balloons (DCBs) for treatment of femoropopliteal occlusive disease. However, few single-center studies have been published to verify the outcome from real-world experience.In this study, 228 patients treated with DCB angioplasty (Lutonix 0.35; Bard, Tempe, Arizona) were analyzed. Perioperative major adverse events (death, amputation, target lesion thrombosis or reintervention) were calculated. Kaplan-Meier analysis was used to estimate primary patency rates (based on duplex ultrasound with or without ankle-brachial index) and limb salvage rates.Lesions treated were primarily TransAtlantic Inter-Society Consensus (TASC) type C and D lesions. Indications included claudication (Rutherford classes 2 and 3) in 40% and critical limb ischemia (CLI; Rutherford classes 4 and 5) in 60%. Lesions treated included 61% in the superficial femoral artery, 15% in the popliteal artery, and 24% in both superficial femoral artery and popliteal artery. Mean follow-up was 12.2 months (range, 1-42 months). Overall perioperative morbidity and mortality rates were 13% and 1%. The perioperative major adverse event rate was 3%. Symptom relief (improvement of one Rutherford category or more) was obtained in 64%. Primary patency rates were 56% and 39% at 1 year and 2 years, respectively. Limb salvage rates were 92% and 83% at 1 year and 2 years. Patients with claudication had a lower rate of early perioperative complications (4% vs 19%; P = .001). Symptom improvement was 76% for claudication vs 49% for CLI (P .001). Overall, major amputation rate was 0% for claudication vs 13% for CLI (P .001). The primary patency rates at 1 year and 2 years were 59% and 41% for claudication vs 54% and 37% for CLI (P = .307). The assisted primary patency rates at 1 year and 2 years were 72% and 52% for claudication vs 64% and 46% for CLI (P = .223). Primary patency rates at 1 year and 2 years were 82% and 71% for TASC A to C lesions vs 29% and 14% for TASC D lesions (P .001). Limb salvage rates at 1 year and 2 years were 100% and 100% for claudication vs 85% and 74% for CLI (P .001).Clinical outcomes after DCB angioplasty in femoropopliteal lesions were inferior to what has been reported in previous studies, particularly for TASC D lesions. Further investigation from real-world experience with long-term follow-up is needed to confirm these results. |
| Databáze: | OpenAIRE |
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