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Comparison between paclitaxel-coated balloon and standard uncoated balloon in the treatment of femoropopliteal long lesions in diabetics.

ABSTRACT: Atherosclerotic diseases may include femoropopliteal artery stenosis or occlusion. Percutaneous transluminal angioplasty (PTA) is an effective and minimally invasive treatment strategy for atherosclerotic femoropopliteal artery stenosis/occlusion disease. Balloon angioplasty is a widely used technique in the management of occlusive disease in almost all arterial segments.We enrolled 111 diabetics with long femoropopliteal lesions, among which 54 received PTA with paclitaxel-coated balloon (the Paclitaxel group), and 57 with standard balloon catheters (the Control group).The primary outcome was set as angiographic late lumen loss (LLL) within 6 months; the secondary angiographic outcome was binary restenosis. Clinical outcomes included Rutherford clarification, ankle-brachial index (ABI) and rate of clinically driven target lesion revascularization (TLR). Two groups had similar basal clinical features, angiographic and procedural characteristics. Compared to controls, the Paclitaxel group had a significantly lower 6-month LLL rate, 12-month binary restenosis rate, 12-month TLR, lower Rutherford grades at 3 and 6 months, and higher ABI at 3 months. For all factors which might influence outcomes, fasting blood glucose was negatively correlated with ABI; the blood urea nitrogen (BUN) was positively related with the Rutherford clarification grades. In addition, the coronary heart disease (CHD) and smoking histories were positively correlated with residual stenosis after treatment.Collectively, the paclitaxel-coated balloon angioplasty can yield more favorable angiographic and clinical outcomes than standard uncoated balloon angioplasty, even in the more challenging lesions (the long and occlusive femoropopliteal lesions) in diabetics, when it had a similar safety profile to the traditional balloon. Blood glucose, BUN, CHD, and smoking imply poor curative effects.

SUBMITTER: Du X

PROVIDER: S-EPMC6455750 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Comparison between paclitaxel-coated balloon and standard uncoated balloon in the treatment of femoropopliteal long lesions in diabetics.

Du Xin X Wang Feng F Wu Dan-Ming DM Zhang Min-Hong MH Jia Xin X Zhang Ji-Wei JW Zhuang Bai-Xi BX Zhao Yu Y Guo Ping-Fan PF Bi Wei W Fu Wei-Guo WG Guo Wei W Wang Shen-Ming SM

Medicine 20190301 13

Atherosclerotic diseases may include femoropopliteal artery stenosis or occlusion. Percutaneous transluminal angioplasty (PTA) is an effective and minimally invasive treatment strategy for atherosclerotic femoropopliteal artery stenosis/occlusion disease. Balloon angioplasty is a widely used technique in the management of occlusive disease in almost all arterial segments.We enrolled 111 diabetics with long femoropopliteal lesions, among which 54 received PTA with paclitaxel-coated balloon (the P ...[more]

PMID: 30921183

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Project description:BackgroundNumerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB.MethodsThis was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months.ResultsPatients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014).ConclusionsSuperiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Project description:ObjectivesThe long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study.MethodsThe IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events.ResultsIn this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years.ConclusionsThis subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.

Project description:BackgroundEndovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty.MethodsThis randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months.DiscussionAlthough concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated.Trial registrationClinicalTrials.gov NCT04475783 . Registered on 17 July 2020 EUDAMED No. CIV-20-11-035172, DRKS00022452.

Project description:PurposeTo summarize the 5-year outcomes of drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with diabetes mellitus (DM) or chronic limb-threatening ischemia (CLTI) compared to non-DM and intermittent claudication (IC).MethodsThe IN.PACT Global study was a real-world prospective, multicenter, international, single-arm study that enrolled 1535 participants. Post hoc analyses were conducted for participants with DM (n = 560) versus non-DM (n = 842) and CLTI (n = 156) versus IC (n = 1246). Assessments included freedom from clinically driven target lesion revascularization (CD-TLR) through 60 months, a composite safety outcome (freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and freedom from CD-target vessel revascularization within 60 months), and major adverse events (MAEs).ResultsKaplan-Meier estimates of 60-month freedom from CD-TLR were 67.7% and 70.5% (p = 0.25) in the DM and non-DM cohorts; and 60.7% and 70.5% (p = 0.006) in the CLTI and IC cohorts. The Kaplan-Meier 60-month composite safety outcomes were 65.1% DM versus 68.9% non-DM (p = 0.12); 53.2% CLTI versus 69.1% IC (p < 0.001). Between DM and non-DM, MAE rates were not significantly different through 60 months except for all-cause mortality which was higher in DM (23.8% versus 16.6%; p < 0.001). Participants with CLTI had a higher cumulative incidence of major target limb amputation (6.8% versus 1.1%; p < 0.001) and all-cause mortality (37.4% versus 17.4%; p < 0.001) through 60 months compared to IC.ConclusionsIn this real-world study, 5-year reintervention rates following DCB angioplasty were similar between DM and non-DM, but mortality rates were expectedly higher in patients with DM. Reintervention, mortality, and amputation rates were all higher in CLTI patients compared to IC, which is consistent with the known frailty of this patient population.Level of evidenceLevel 3, Non-randomized controlled cohort/follow-up study.

Project description:IntroductionThe combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease.MethodsPatients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed.ResultsFifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR.ConclusionsIn this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.

Dataset Information

Comparison between paclitaxel-coated balloon and standard uncoated balloon in the treatment of femoropopliteal long lesions in diabetics.

Publications

Comparison between paclitaxel-coated balloon and standard uncoated balloon in the treatment of femoropopliteal long lesions in diabetics.

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