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- W4386892298 abstract "To report the impact of race on the treatment of superficial femoral artery-popliteal artery in-stent restenosis with paclitaxel drug-coated balloon (DCB) angioplasty. We conducted a prospective, postmarket registry study of the IN.PACT Admiral DCB for the treatment of de novo or recurrent in-stent restonosis in the superficial femoral artery-popliteal artery at 43 Vascular Quality Initiative centers from December 2016 to January 2020. The primary end point was 12-month freedom from target lesion revascularization (F-TLR). Secondary end points included freedom from target vessel revascularization (F-TVR), freedom from major limb amputation, and survival at 24 months. Kaplan-Meier analyses are presented and stepwise regression multivariable Cox regression models with outcomes stratified by race. Black patients (n = 63) were younger (64 ± 10 vs 68 ± 10 years; P = .006) and more often female (57% vs 37%; P = .004) compared with White patients (n = 219). The majority had claudication (70% vs 84%) with Black patients have more frequent rest pain (30% vs 16%; P = .012). By Kaplan-Meier analysis, F-TLR was 91.3% vs 89.1% (P = .63) and 66.4% vs 74.0% (P = .41) through 12 and 24 months for Black vs White race, respectively. F-TVR was 87.8% vs 87.6% (P = .96) and 61.3% vs 70.6% (P = .29) through 12 and 24 months. Freedom from major target limb amputation was 100% vs 99.5% (P = .59) and 100% vs 99% (P = .45) through 12 and 24 months. Survival was 93.7% vs 95.9% (P = .47) and 84.1% vs 91.3% (P = .11) through 12 and 24 months. No significant predictors were identified for F-TLR or F-TVR through 24 months (P > .05). Dialysis (hazard ratio [HR], 27.7; 95% confidence interval [CI], 10.3-74.1; P < .001), coronary artery disease (HR, 2.8; 95% CI, 1.3-6.1; P = .009), and longer lesion length (HR, 1.04; 95% CI, 1.02-1.1; P = .001) were associated with increased risk of 24-month mortality. In multivariable analysis, race was not associated with increased risk of TLR, TVR, or mortality. In this postmarket, registry-based study the treatment of femoral-popliteal in-stent restonosis with paclitaxel DCB was equally safe and effective for patients of Black and White race. Despite an earlier presentation and higher likelihood of chronic limb0thratening ischemia, we only observed a nonsignificant trend of an elevated 24-month mortality for patients of Black race. The associations between these factors and outcomes require longer observation in a larger study." @default.
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- W4386892298 date "2023-10-01" @default.
- W4386892298 modified "2023-09-27" @default.
- W4386892298 title "Race and Treatment of Femoral-popliteal Artery In-stent Restenosis with Paclitaxel Angioplasty" @default.
- W4386892298 doi "https://doi.org/10.1016/j.jvs.2023.08.014" @default.
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