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Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.

ABSTRACT: Background: Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.

Objectives: To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.

Methods: The IN.PACT randomized trials (SFA, N =?331 and Japan, N =?100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3?years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.

Results: The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5?years, HR 1.39, log-rank p =?.286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p =?.381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p
Conclusions: In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.

SUBMITTER: Schneider PA

PROVIDER: S-EPMC7693077 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.

Schneider Peter A PA Brodmann Marianne M Mauri Laura L Laird John J Soga Yoshimitsu Y Micari Antonio A Ansel Gary G Shishehbor Mehdi H MH Krishnan Prakash P Gao Qi Q Ouriel Kenneth K Zeller Thomas T

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20200824 5

<h4>Background</h4>Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.<h4>Objectives</h4>To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.<h4>Methods</h4>The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each com ...[more]

PMID: 32830913

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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:Procedural safety and high rates of in-stent recurrent stenotic lesions (ISR) remain a concern in the endovascular treatment of intracranial atherosclerotic disease (ICAD). In the present study technical feasibility, safety and efficacy of the paclitaxel eluting balloon-expandable coronary stent Coroflex(®) Please was assessed in the treatment of ICAD.A total of 95 patients (79 male; median age 68 years) with 106 intracranial atherosclerotic stenotic lesions underwent endovascular treatment using Coroflex(®) Please stents (B. Braun, Melsungen, Germany). Location and degree of target stenoses before and after treatment and at follow-up and adverse clinical sequelae of treatment were registered. Post-procedural medication included 100 mg acetylsalicylic acid (ASA) and 75 mg clopidogrel for 1 year. Angiographic follow-up was scheduled for 6, 12, 26 and 52 weeks after the treatment.The lesion locations were as follows: internal carotid artery (ICA) petrous (n = 44, 42%), ICA cavernous (n = 43, 41%), ICA paraclinoid (n = 4, 4%), intradural vertebral artery (VA; n = 11, 10%) and basilar artery (BA; n = 4, 4%). Of the lesions seven could not be treated due to difficult anatomy and stent stiffness (7% technical failure rate). The combined post-interventional neurological morbidity and mortality rate, including stroke, intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH) and carotid cavernous fistula (CCF) was n = 4 (3.7%) within and n = 1 (0.9%) at and beyond 30 days, respectively. Angiographic and clinical follow-up examinations were carried out for 78 (78%) of the lesions (mean 16.1 months, maximum 48 months). Asymptomatic recurrent stenosis was seen in 3 out of 78 (3.8%) lesions and there was 1 case of late stent thrombosis (0.9%).Treatment of ICAD using drug-eluting coronary stents is safe and effective but technical failure due to stent stiffness remains a problem. Application of the more flexible, newest generation thin-strut stents, however, shows promising results.

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Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.

Publications

Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.

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