Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia
| Autor: | Koen Keirse, Michel M.P.J. Reijnen, Antonio Micari, Thomas Zeller, Pierfrancesco Veroux, Suzanne Holewijn, Seung-Whan Lee, Pei Li, Despina Voulgaraki, Iris P.S. van Wijck |
|---|---|
| Přispěvatelé: | Multi-Modality Medical Imaging |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Target lesion
Male Biocompatible Time Factors medicine.medical_treatment Superficial femoral artery UT-Hybrid-D Coated Materials Biocompatible Ischemia Risk Factors 80 and over Amputation Aged 80 and over Stenosis Clinical Trials as Topic Critical limb ischemia Equipment Design Middle Aged Progression-Free Survival Femoropopliteal segment Femoral Artery Cohort Female medicine.symptom Cardiology and Cardiovascular Medicine Vascular Access Devices medicine.medical_specialty Paclitaxel Target lesion revascularization Popliteal artery Critical Illness Amputation Surgical Lesion Peripheral Arterial Disease Amputation Claudication Critical limb ischemia Drug-coated balloon Femoropopliteal segment Limb salvage Peripheral artery disease Popliteal artery Stenosis Superficial femoral artery Target lesion revascularization Aged Aged 80 and over Angioplasty Balloon Cardiovascular Agents Clinical Trials as Topic Critical Illness Equipment Design Female Humans Intermittent Claudication Ischemia Limb Salvage Male Middle Aged Paclitaxel Peripheral Arterial Disease Progression-Free Survival Risk Factors Time Factors Vascular Patency Coated Materials Biocompatible Femoral Artery Popliteal Artery Vascular Access Devices Angioplasty Techniques in the Iliac and Infrainguinal Arteries medicine Limb salvage Humans Radiology Nuclear Medicine and imaging Vascular Patency Aged Peripheral artery disease business.industry amputation claudication critical limb ischemia drug-coated balloon femoropopliteal segment limb salvage peripheral artery disease popliteal artery stenosis superficial femoral artery target lesion revascularization Coated Materials Cardiovascular Agents Intermittent Claudication Intermittent claudication Surgery Claudication Drug-coated balloon business Angioplasty Balloon Balloon |
| Zdroj: | Journal of Endovascular Therapy Journal of Endovascular Therapy, 26(3), 305-315. Sage |
| ISSN: | 1526-6028 |
| DOI: | 10.1177/1526602819839044 |
| Popis: | Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|