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 < .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

Object Details

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch
• Notes: Catheterization and cardiovascular interventions. - 96, 5 (2020) , 1087-1099, ISSN: 1522-726X

Contributors, Places and Time

• Event: Veröffentlichung
• (where): Freiburg
• (who): Universität
• (when): 2020
• Creator: Schneider, Peter A. ; Brodmann, Marianne ; Mauri, Laura ; Laird, John R. ; Soga, Yoshimitsu ; Micari, Antonio ; Ansel, Gary M. ; Shishehbor, Mehdi H. ; Krishnan, Prakash ; Gao, Qi ; Ouriel, Kenneth ; Zeller, Thomas

Further information

• DOI: 10.1002/ccd.29152
• URN: urn:nbn:de:bsz:25-freidok-1695961
• Rights: Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Last update: 25.03.2025, 1:57 PM CET