紫杉醇涂层器械在外周动脉疾病中的死亡率。
Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.
机构信息
From the Department of Molecular and Clinical Medicine, Institute of Medicine (J.N., P.S.) and the Department of Radiology, Institute of Clinical Sciences (K.L., M.F.), Sahlgrenska Academy, Gothenburg University, Gothenburg, the Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University (S.J., H.R.), and the Department of Surgical Sciences, Vascular Surgery, Uppsala University (B.K., B.S., G.T.), Uppsala, the Department of Clinical and Experimental Medicine, Linköping University, Linköping (Manne Andersson), Sweden and County Hospital Ryhov, Region Jönköping County, Department of Surgery, Jönköping (Manne Andersson), the Department of Vascular Surgery, Sunderby Hospital, Luleå (Mattias Andersson), the Department of Vascular Surgery, Halland Hospital, Halmstad (P.D.), the Department of Clinical Science and Education, Karolinska Institute (P.G.), the Departments of Surgery (P.G.) and Radiology (N.N.), Södersjukhuset, the Department of Radiology, Unit of Peripheral Interventional Radiology, Karolinska University Hospital (M.D., J.E.), and the Department. of Vascular Surgery, Karolinska University Hospital and the Karolinska Institute, (C.-M.W.), Stockholm, the Vascular Center, Department of Thoracic and Vascular Surgery, Skåne University Hospital, Malmö (T.F.), the Department of Vascular Surgery, Skaraborgs Hospital, Skövde (M.H.), the Department of Surgery, Kristianstad Hospital, Kristianstad (A.H.), the Department of Vascular Surgery, Växjö Hospital, Växjö (P.J.), the Department of Surgery, Gävle Hospital, Gävle (L.K.), the Department of Clinical Sciences, Faculty of Medicine (H.L.), Lund University (H.L., J.S.), Lund, the Vascular Unit, Department of Surgery, Helsingborg Hospital, Helsingborg (H.L.), the Section of Vascular Surgery, Surgical and Ear Clinic, Södra Älvsborg Hospital, Borås (K.L.), the Vascular Unit, the Department of Surgery, NU-Hospital Group, Trollhättan/Uddevalla (S.M.), the Department of Vascular Surgery, Karlstad Central Hospital, Karlstad (B.S.), the Department of Surgery, Västervik Hospital, Västervik (J.S.), the Department of Cardiothoracic and Vascular Surgery, Örebro University Hospital, Örebro (A.T.), the Department of Radiation Sciences, Radiology, Umeå University, Umeå (M.T.), the Department of Surgery, Sundsvall District Hospital, Sundsvall (J.W.), and the Department of Vascular Surgery, Kalmar Hospital, Kalmar (A.Ö.) - all in Sweden.
出版信息
N Engl J Med. 2020 Dec 24;383(26):2538-2546. doi: 10.1056/NEJMoa2005206. Epub 2020 Dec 9.
BACKGROUND
The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease.
METHODS
We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality.
RESULTS
No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively).
CONCLUSIONS
In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).
背景
最近的一项荟萃分析结果令人担忧，使用紫杉醇涂层的球囊和支架进行下肢血管腔内介入治疗有症状的外周动脉疾病与死亡风险增加有关。
方法
我们对一项多中心、随机、开放标签、基于注册的临床试验的数据进行了计划外的中期分析。在分析时，2289 名患者被随机分配接受药物涂层器械治疗（药物涂层器械组，1149 名患者）或未涂层器械治疗（未涂层器械组，1140 名患者）。根据患者是否患有慢性肢体威胁性缺血（1480 名患者）或间歇性跛行（809 名患者），按疾病严重程度分层进行随机分组。本次中期分析的主要终点为全因死亡率。
结果
无患者失访。所有药物涂层器械均使用紫杉醇作为涂层剂。在平均 2.49 年的随访中，共有 574 名患者死亡，其中药物涂层器械组 293 名（25.5%），未涂层器械组 281 名（24.6%）（风险比，1.06；95%置信区间，0.92 至 1.22）。在 1 年时，药物涂层器械组全因死亡率为 10.2%（117 例），未涂层器械组为 9.9%（113 例）。在整个随访期间，慢性肢体威胁性缺血患者（药物涂层器械组 33.4%[249 例]和未涂层器械组 33.1%[243 例]）和间歇性跛行患者（药物涂层器械组 10.9%[44 例]和未涂层器械组 9.4%[38 例]）的治疗组之间，全因死亡率无显著差异。
结论
在这项接受紫杉醇涂层或未涂层血管内器械治疗的外周动脉疾病患者的随机试验中，计划外的全因死亡率中期分析结果显示，在 1 至 4 年的随访期间，两组之间的死亡率无差异。（由瑞典研究理事会等资助；ClinicalTrials.gov 编号，NCT02051088）。
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