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Comparative 12-Month Outcomes of Drug-Coated Balloon Versus Non-Drug-Coated Balloon Revascularization Strategy in Chronic Limb-Threatening Ischemia: Results From the XLPAD Registry
- Source :
- Cardiovascular Revascularization Medicine. 21:1276-1284
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- Background Endovascular therapy is often the preferred first treatment option for chronic limb threatening ischemia (CLTI) patients. Drug coated balloons (DCB) reduce restenosis rates compared to percutaneous transluminal angioplasty (PTA), however DCB use has not been studied systematically in patients with CLTI. Thus, the optimal treatment option for these complex lesions remains controversial. Methods We report on 327 patients with CLTI treated either with DCB (n = 105) or non-DCB (n = 222) for femoropopliteal disease. Data were retrieved from the Excellence in Peripheral Artery Disease (XLPAD) registry ( NCT01904851 ). Two DCB types were used at the discretion of the operator: Lutonix® (BARD Peripheral Vascular, Inc., Tempe, AZ, USA) and IN.PACT AdmiralTM (Medtronic, Santa Rosa, CA, USA). Odds ratios and the respective 95% confidence interval were synthesized to examine the association between the two groups in terms of all-cause mortality, target limb repeat endovascular or surgical revascularization, target vessel revascularization (TVR), major and minor amputation at 12 months of follow up. Results The mean lesion length was 150.0 mm (SD:123.2) and 151.2 mm (SD:108.3) for the DCB and non-DCB group respectively. No difference between the two groups was detected in terms of all-cause mortality (2.86%vs2.7%,p = .94), target limb repeat endovascular or surgical revascularization (16.19%vs12.61%,p = .25), TVR (16.19%vs.11.71%,p = .26) or minor amputation (15.24%vs10.81%,p = .25) at 12 months of follow up. Although a higher incidence of 12 months major amputation was observed in the DCB group (11%vs.4%,p = .01), after adjusting for several risk factors the odds of major amputation were not statistically different between the DCB and non-DCB groups (OR:1.54;95%CI:0.53–4.51;p = .43). Conclusions Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CLTI. No differences were identified between the DCB and non-DCB group in terms of late outcomes during 12 months of follow up.
- Subjects :
- medicine.medical_specialty
Time Factors
Percutaneous
medicine.medical_treatment
Ischemia
030204 cardiovascular system & hematology
Revascularization
Peripheral Arterial Disease
03 medical and health sciences
0302 clinical medicine
Coated Materials, Biocompatible
Restenosis
medicine
Humans
Popliteal Artery
Registries
030212 general & internal medicine
Vascular Patency
business.industry
Incidence (epidemiology)
Cardiovascular Agents
General Medicine
Odds ratio
Limb Salvage
medicine.disease
Confidence interval
Surgery
Femoral Artery
Treatment Outcome
Pharmaceutical Preparations
Amputation
Cardiology and Cardiovascular Medicine
business
Angioplasty, Balloon
Vascular Access Devices
Subjects
Details
- ISSN :
- 15538389
- Volume :
- 21
- Database :
- OpenAIRE
- Journal :
- Cardiovascular Revascularization Medicine
- Accession number :
- edsair.doi.dedup.....d1434ae7c0ad7dcaaa1a924a42a2137e