Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease

被引：130

作者：

Nordanstig, J. ^{[1
]}

James, S. ^{[3
,4
]}

Andersson, Manne ^{[6
,7
]}

Andersson, Mattias ^{[8
]}

Danielsson, P. ^{[9
]}

Gillgren, P. ^{[10
,11
]}

Delle, M. ^{[13
]}

Engstrom, J. ^{[13
]}

Fransson, T. ^{[16
]}

Hamoud, M. ^{[17
]}

Hilbertson, A. ^{[18
]}

Johansson, P. ^{[19
]}

Karlsson, L. ^{[2
,20
]}

Kragsterman, B. ^{[5
]}

Lindgren, H. ^{[21
,22
,23
]}

Ludwigs, K. ^{[24
]}

Mellander, S. ^{[25
]}

Nyman, N. ^{[12
]}

Renlund, H. ^{[3
,4
]}

Sigvant, B. ^{[5
,26
]}

Skoog, P. ^{[1
]}

Starck, J. ^{[22
,27
]}

Tegler, G. ^{[5
]}

Toivola, A. ^{[28
]}

Truedson, M. ^{[29
]}

Wahlgren, C. M. ^{[14
,15
]}

Wallinder, Jonas ^{[30
]}

Ojersjo, A. ^{[31
]}

Falkenberg, M. ^{[2
]}

机构：

[1] Gothenburg Univ, Sahlgrenska Acad, Inst Med, Dept Mol & Clin Med, Gothenburg, Sweden

[2] Gothenburg Univ, Sahlgrenska Acad, Inst Clin Sci, Dept Radiol, Bruna Straket 18B, S-4134R Gothenburg, Sweden

[3] Uppsala Univ, Dept Med Sci, Uppsala, Sweden

[4] Uppsala Univ, Uppsala Clin Res Ctr, Uppsala, Sweden

[5] Uppsala Univ, Dept Surg Sci, Vasc Surg, Uppsala, Sweden

[6] Linkoping Univ, Dept Clin & Expt Med, Linkoping, Sweden

[7] Cty Hosp Ryhov, Dept Surg, Jonkoping, Sweden

[8] Sunderby Hosp, Dept Vasc Surg, Lulea, Sweden

[9] Halland Hosp, Dept Vasc Surg, Halmstad, Sweden

[10] Karolinska Inst, Dept Clin Sci & Educ, Stockholm, Sweden

[11] Soder Sjukhuset, Dept Surg, Stockholm, Sweden

[12] Soder Sjukhuset, Dept Radiol, Stockholm, Sweden

[13] Karolinska Univ Hosp, Unit Peripheral Intervent Radiol, Dept Radiol, Stockholm, Sweden

[14] Karolinska Univ Hosp, Dept Vasc Surg, Stockholm, Sweden

[15] Karolinska Inst, Stockholm, Sweden

[16] Skane Univ Hosp, Dept Thorac & Vasc Surg, Vasc Ctr, Malmo, Sweden

[17] Skaraborgs Hosp, Dept Vasc Surg, Skovde, Sweden

[18] Kristianstad Hosp, Dept Surg, Kristianstad, Sweden

[19] Vaxjo Hosp, Dept Vasc Surg, Vaxjo, Sweden

[20] Gavle Cent Hosp, Dept Surg, Gavle, Sweden

[21] Fac Med, Dept Clin Sci, Lund, Sweden

[22] Lund Univ, Lund, Sweden

[23] Helsingborg Hosp, Dept Surg, Vasc Unit, Helsingborg, Sweden

[24] Sodra Alvsborg Hosp, Surg & Ear Clin, Sect Vasc Surg, Boras, Sweden

[25] NU Hosp Grp, Dept Surg, Vasc Unit, Trollhattan Uddevalla, Sweden

[26] Karlstad Cent Hosp, Dept Vasc Surg, Karlstad, Sweden

[27] Vastervik Hosp, Dept Surg, Vastervik, Sweden

[28] Orebro Univ Hosp, Dept Cardiothorac & Vasc Surg, Orebro, Sweden

[29] Umea Univ, Dept Radiat Sci, Radiol, Umea, Sweden

[30] Sundsvall Dist Hosp, Dept Surg, Sundsvall, Sweden

[31] Kalmar Hosp, Dept Vasc Surg, Kalmar, Sweden

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2020年 / 383卷 / 26期

基金：

芬兰科学院; 瑞典研究理事会;

关键词：

BALLOON; REVASCULARIZATION; THERAPY; RISK;

D O I：

10.1056/NEJMoa2005206

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.)

引用

页码：2538 / 2546

页数：9

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[J]. 四川生理科学杂志, 2020, 42 (04) : 491 - 491
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