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.

中文翻译：

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来自随机对照EffPac试验的临床数据的多变量回归分析：股F药物涂层球囊血管成形术的疗效。

目的EffPac研究数据的事后多变量分析旨在确定股pop动脉血管成形术疗效的解释变量。方法在前瞻性，随机对照EffPac研究中，将患者分配至DCB或普通旧球囊血管成形术。进行了包括相互作用分析在内的多变量回归，以评估所选变量对6个月时晚期管腔丢失（LLL），二元再狭窄，靶病变血运重建（TLR），临床改善和12个月时血流动力学改善的预后指标的影响。 。结果在德国的11个中心共治疗了171例患者（69±8岁，111例男性）。高血压增加，高龄者的LLL降低（B系数[B]：0.7 [95％CI-0.04至1.3]，p = 0.06和-每10年-0.3 [95％CI-0.5至0.01]，p = 0.06，分别）。DCB血管成形术降低了12个月TLR和二元再狭窄的几率（分别为OR 0.4 [95％CI 0.2至0.8]，p = 0.01和OR 0.1 [95％CI 0.01至0.6]，p = 0.02）。病变长度和严重钙化降低了临床改善率（B：-每10毫米0.1 [95％CI-0.1至-0.03]，p = 0.001和-0.1 [95％CI-1.7至-0.1]，p = 0.03） 。前吸烟者的DCB血管成形术改善了ABI（0.2 [95％CI 0.01至0.5]，p = 0.04）。结论DCB血管成形术可降低12个月再狭窄和TLR的发生率。病灶长度增加和严重钙化减少了临床改善。高血压被认为可以促进老年人的发展，并减轻其年龄。DCB改善了以前吸烟者的ABI。01和OR 0.1 [95％CI 0.01至0.6]，p = 0.02）。病变长度和严重钙化降低了临床改善率（B：-每10毫米0.1 [95％CI-0.1至-0.03]，p = 0.001和-0.1 [95％CI-1.7至-0.1]，p = 0.03） 。前吸烟者的DCB血管成形术改善了ABI（0.2 [95％CI 0.01至0.5]，p = 0.04）。结论DCB血管成形术可降低12个月再狭窄和TLR的发生率。病灶长度增加和严重钙化减少了临床改善。高血压被认为可以促进老年人的发展，并减轻其年龄。DCB改善了以前吸烟者的ABI。01和OR 0.1 [95％CI 0.01至0.6]，p = 0.02）。病变长度和严重钙化降低了临床改善率（B：-每10毫米0.1 [95％CI-0.1至-0.03]，p = 0.001和-0.1 [95％CI-1.7至-0.1]，p = 0.03） 。前吸烟者的DCB血管成形术改善了ABI（0.2 [95％CI 0.01至0.5]，p = 0.04）。结论DCB血管成形术可降低12个月再狭窄和TLR的发生率。病灶长度增加和严重钙化减少了临床改善。高血压被认为可以促进老年人的发展，减轻其LLL。DCB改善了以前吸烟者的ABI。前吸烟者的DCB血管成形术改善了ABI（0.2 [95％CI 0.01至0.5]，p = 0.04）。结论DCB血管成形术可降低12个月再狭窄和TLR的发生率。病灶长度增加和严重钙化减少了临床改善。高血压被认为可以促进老年人的发展，并减轻其年龄。DCB改善了以前吸烟者的ABI。前吸烟者的DCB血管成形术改善了ABI（0.2 [95％CI 0.01至0.5]，p = 0.04）。结论DCB血管成形术可降低12个月再狭窄和TLR的发生率。病灶长度增加和严重钙化减少了临床改善。高血压被认为可以促进老年人的发展，减轻其LLL。DCB改善了以前吸烟者的ABI。