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Paclitaxel exposure: Long‐term safety and effectiveness of a drug‐coated balloon for claudication in pooled randomized trials
Author(s) -
Schneider Peter A.,
Brodmann Marianne,
Mauri Laura,
Laird John,
Soga Yoshimitsu,
Micari Antonio,
Ansel Gary,
Shishehbor Mehdi H.,
Krishnan Prakash,
Gao Qi,
Ouriel Kenneth,
Zeller Thomas
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.29152
Subject(s) - medicine , claudication , randomized controlled trial , hazard ratio , cumulative incidence , angioplasty , proportional hazards model , surgery , revascularization , intermittent claudication , target lesion , incidence (geometry) , confidence interval , cohort , myocardial infarction , vascular disease , percutaneous coronary intervention , arterial disease , physics , optics
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 < .001). Causes of death did not differ by treatment arm. Conclusions In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.