Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty

Abstract

Purpose The post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty. Methods In 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. Results A 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). Conclusion DCB 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.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

“…This might be due to a reduced neointimal proliferation with age. Accordingly, a previous EffPac multivariable analysis showed less LLL at 6 months with advanced age independent of whether DCB or POBA was used [ 26 ]. Whether patients with poor distal runoff benefit more from DCB remains to be assessed.…”

Atherectomy plus drug-coated balloon versus drug-coated balloon only for treatment of femoropopliteal artery lesions: A systematic review and meta-analysis

“…4 Nevertheless, there is currently poor evidence demonstrating that DCB is efficient for the treatment of calcified and longer lesions, which may lead to a higher rate of bail-out stent. 5,6 Large calcium distributed in the arterial wall would be an impermeable barrier for the drug and therefore partial calcium removal before DCB application could theoretically improve the outcome. 7 Atherectomy device can safely and effectively remove the atheromatous plaque from the vessel lumen and increase luminal diameter.…”

Comparison of mid-outcome among bare metal stent, atherectomy with or without drug-coated balloon angioplasty for femoropopliteal arterial occlusion

“…Compared with traditional angioplasty procedures, DCB angioplasty improves the long-term patency rate and limb salvage rate of patients, but complex lesions such as long-segment occlusion, restenosis and severe calcification may affect the drug delivery efficiency of DCB balloons, thus affecting the outcome of the procedure 9 , 10 , 29 , 30 . However, the AT procedure could improve the effect of vessel preparation and is more conducive to the use of DCBs.…”