Paclitaxel exposure: Long‐term safety and effectiveness of a<scp>drug‐coated</scp>balloon for claudication in pooled randomized trials
In: Catheterization and Cardiovascular Interventions, Jg. 96 (2020-08-24), S. 1087-1099
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Zugriff:
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
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Paclitaxel exposure: Long‐term safety and effectiveness of a<scp>drug‐coated</scp>balloon for claudication in pooled randomized trials
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Autor/in / Beteiligte Person: | Micari, Antonio ; Soga, Yoshimitsu ; Shishehbor, Mehdi H. ; Mauri, Laura ; Ouriel, Kenneth ; Krishnan, Prakash ; Gao, Qi ; Brodmann, Marianne ; Zeller, Thomas ; Laird, John R. ; Ansel, Gary M. ; Schneider, Peter |
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Zeitschrift: | Catheterization and Cardiovascular Interventions, Jg. 96 (2020-08-24), S. 1087-1099 |
Veröffentlichung: | Wiley, 2020 |
Medientyp: | unknown |
ISSN: | 1522-726X (print) ; 1522-1946 (print) |
DOI: | 10.1002/ccd.29152 |
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