Division of Vascular Surgery, Duke University Health System, Durham, North Carolina, USA.
Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
Am Heart J. 2019 Nov;217:42-51. doi: 10.1016/j.ahj.2019.07.014. Epub 2019 Jul 25.
With the growing use of drug-coated balloons for the treatment of peripheral artery disease, information regarding the safety and effectiveness of drug-coated balloons in current practice is needed. We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons.
This is a retrospective cohort analysis utilizing Medicare data for 100% of fee-for-service beneficiaries from 2015 to 2016 who had a claim for femoropopliteal intervention. The use of drug-coated balloons was identified via specific transitional pass-through codes. All-cause mortality, all-cause hospitalization, repeat femoropopliteal intervention, and major lower extremity amputation at 1 year were the clinical outcomes of interest.
In total, 83,225 patients underwent femoropopliteal intervention, and drug-coated balloons were utilized in 29% of all procedures. Patients treated with drug-coated balloons had a lower cumulative incidence of all-cause hospitalization, all-cause mortality, and major lower extremity amputation, but were more likely to undergo repeat femoropopliteal intervention when compared with patients treated with conventional balloon angioplasty. After adjustment for measured confounders, patients treated with drug-coated balloons had lower rates of hospitalization (HR 0.91 (0.88, 0.93), P < .001), all-cause mortality (HR 0.89 [0.84, 0.94], P < .001), and major amputation (HR 0.93 [0.88, 0.99], P = .017).
Patients who underwent femoropopliteal intervention with drug-coated balloons had lower observed rates of all-cause mortality, all-cause hospitalization, and major amputation at 1 year. Interestingly, there was not a reduction in rates of repeat revascularization, and further work is required to understand this finding. Nevertheless, the use of drug-coated balloons appears to be safe in this large study of contemporary patients in the United States.
随着药物涂层球囊在治疗外周动脉疾病中的应用日益增多，我们需要了解当前实践中药物涂层球囊的安全性和有效性。我们研究了接受药物涂层球囊外周血管介入治疗的患者的患者、医生和治疗过程特征以及心血管和肢体事件。
这是一项回顾性队列分析，利用了 2015 年至 2016 年 Medicare 数据中 100%的付费服务受益人的数据，这些患者有股腘段干预的索赔。药物涂层球囊的使用是通过特定的过渡性转流通代码来识别的。所有原因死亡率、所有原因住院、1 年内重复股腘段干预和主要下肢截肢是感兴趣的临床结果。
总共有 83225 名患者接受了股腘段介入治疗，其中 29%的患者使用了药物涂层球囊。与接受传统球囊血管成形术治疗的患者相比，接受药物涂层球囊治疗的患者的全因住院、全因死亡率和主要下肢截肢的累积发生率较低，但更有可能接受重复股腘段介入治疗。在调整了测量混杂因素后，接受药物涂层球囊治疗的患者的住院率（HR 0.91（0.88，0.93），P<0.001）、全因死亡率（HR 0.89（0.84，0.94），P<0.001）和主要截肢（HR 0.93（0.88，0.99），P=0.017）较低。
接受药物涂层球囊股腘段介入治疗的患者在 1 年内全因死亡率、全因住院率和主要截肢率较低。有趣的是，重复血运重建率并没有降低，需要进一步的工作来理解这一发现。然而，在这项对美国当代患者的大型研究中，药物涂层球囊的使用似乎是安全的。
