TY - JOUR
T1 - Comparative 12-Month Outcomes of Drug-Coated Balloon Versus Non-Drug-Coated Balloon Revascularization Strategy in Chronic Limb-Threatening Ischemia
T2 - Results From the XLPAD Registry
AU - Giannopoulos, Stefanos
AU - Jeon-Slaughter, Haekyung
AU - Kahlon, Ravi S.
AU - Tejani, Ishita
AU - Baskar, Amutha
AU - Banerjee, Subhash
AU - Armstrong, Ehrin J.
N1 - Publisher Copyright:
© 2020
PY - 2020/10
Y1 - 2020/10
N2 - 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.
AB - 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.
KW - CLTI
KW - Chronic limb threatening ischemia
KW - DCB
KW - Drug-coated balloon
KW - Endovascular therapy
KW - Peripheral vascular disease
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U2 - 10.1016/j.carrev.2020.03.030
DO - 10.1016/j.carrev.2020.03.030
M3 - Article
C2 - 32249170
AN - SCOPUS:85082824125
SN - 1553-8389
VL - 21
SP - 1276
EP - 1284
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
IS - 10
ER -