Department of Medicine, Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA.
EuroIntervention. 2023 Apr 3;18(16):e1378-e1387. doi: 10.4244/EIJ-D-22-00609.
The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking. Aims: This study sought to determine the long-term safety of atherectomy in contemporary practice. Methods: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes. Results: Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01).
The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.
在外周血管腔内介入治疗(PVI)中,动脉切除术的应用显著增加,但关于其安全性和有效性的数据仍缺乏。目的:本研究旨在确定当代实践中动脉切除术的长期安全性。方法:通过程序索赔代码,从 2015 年至 2018 年,在 100%的住院、门诊和运营商文件数据中确定接受股浅动脉 PVI 的医疗保险按服务付费受益人的样本。主要暴露是动脉切除术的使用。采用逆概率治疗加权法调整患者人群的测量差异。采用 Kaplan-Meier 方法和多变量 Cox 比例风险回归比较结局。结果:在 168553 例接受 PVI 的患者中,59142 例(35.1%)接受了动脉切除术。患者平均年龄为 77.0±7.6 岁,44.9%为女性,81.9%为白人,46.7%有慢性肢体威胁性缺血。在中位随访时间 993 天(四分位间距 319-1377 天)期间,动脉切除术的使用与死亡和截肢的复合终点风险(调整后的危险比[HR]0.99,95%置信区间[CI]:0.97-1.01;p=0.19)或主要不良肢体事件(HR 1.02,95%CI:0.99-1.05;p=0.26)的风险均无差异。接受动脉切除术的患者截肢或手术血运重建的风险略有降低(HR 0.92,95%CI:0.90-0.94;p<0.01),但随后接受 PVI 的风险增加(HR 1.19,95%CI:1.16-1.21;p<0.01)。结论:在外周动脉疾病患者的股浅动脉 PVI 中使用动脉切除术与长期不良安全性结局的风险增加无关。