Abstract
PurposeThe post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty.MethodsIn the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months.ResultsA total of 171 patients (69 ± 8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI − 0.04 to 1.3], p = 0.06 and − 0.3 per 10 years [95% CI − 0.5 to 0.01], p = 0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p = 0.01 and OR 0.1 [95% CI 0.01 to 0.6], p = 0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B: − 0.1 per 10 mm [95% CI − 0.1 to − 0.03], p = 0.001 and − 0.1 [95% CI − 1.7 to − 0.1], p = 0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04).ConclusionDCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.
Highlights
Numerous randomized trials on femoropopliteal artery disease demonstrated that drug-coated balloon (DCB) angioplasty effectively decreased late lumen loss (LLL) [1,2,3,4,5,6,7,8,9] and increased primary patency [10,11,12,13,14]
Different effect sizes of DCB across studies mainly originate from DCB types or study-specific procedure details, whereas effect size within studies may depend on patient and lesion characteristics
Fanelli et al described a worse impact of severe calcification on LLL and primary patency after DCB angioplasty [19], and severe dissections were identified as risk factor for restenosis after plain old balloon angioplasty (POBA) [20, 21]
Summary
Numerous randomized trials on femoropopliteal artery disease demonstrated that drug-coated balloon (DCB) angioplasty effectively decreased late lumen loss (LLL) [1,2,3,4,5,6,7,8,9] and increased primary patency [10,11,12,13,14]. Length after both DCB and plain old balloon angioplasty (POBA) [16, 17]. Fanelli et al described a worse impact of severe calcification on LLL and primary patency after DCB angioplasty [19], and severe dissections were identified as risk factor for restenosis after POBA [20, 21]
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