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- Title
Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study.
- Authors
Ansel, Gary M.; Brodmann, Marianne; Koen Keirse; Micari, Antonio; Jaff, Michael R.; Rocha-Singh, Krishna; Fernandez, Eric J.; Hong Wang; Zeller, Thomas; Keirse, Koen; Wang, Hong; IN.PACT Global Study Investigators
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852).<bold>Conclusion: </bold>Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial.
- Subjects
PERIPHERAL vascular disease treatment; BIOMEDICAL materials; BLOOD vessels; CLINICAL trials; COMPARATIVE studies; FEMORAL artery; VASCULAR resistance; RESEARCH methodology; MEDICAL cooperation; MEDICAL equipment; PERIPHERAL vascular diseases; RESEARCH; TIME; TRANSLUMINAL angioplasty; PRODUCT design; EVALUATION research; RETROSPECTIVE studies; PATIENT selection; POPLITEAL artery
- Publication
Journal of Endovascular Therapy, 2018, Vol 25, Issue 6, p673
- ISSN
1526-6028
- Publication type
journal article
- DOI
10.1177/1526602818803119