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Drug-coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded from Clinical Trials
Gary M. AnselMarianne BrodmannKoen KeirseAntonio MicariMichael R. JaffKrishna J. Rocha-SinghEric J. FernandezHong WangThomas Zeller
其他書名
12-month Findings from the IN.PACT Global Study
出版Universität, 2018
URLhttp://books.google.com.hk/books?id=iiFh0AEACAAJ&hl=&source=gbs_api
註釋Abstract: Purpose:
To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded. Methods: The 1406 subjects enrolled in the IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires.
Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p