%0 Journal Article
%T Drug
%A Antonio Micari
%A Eric J. Fernandez
%A Gary M. Ansel
%A Hong Wang
%A Koen Keirse
%A Krishna Rocha-Singh
%A Marianne Brodmann
%A Michael R. Jaff
%A Thomas Zeller
%A null
%J Journal of Endovascular Therapy
%@ 1545-1550
%D 2018
%R 10.1177/1526602818803119
%X 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<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). Conclusion: 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
%K angioplasty
%K drug-coated balloon
%K femoropopliteal segment
%K peripheral artery disease
%K popliteal artery
%K superficial femoral artery
%K target lesion revascularization
%K stenting
%U https://journals.sagepub.com/doi/full/10.1177/1526602818803119