Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial

被引：368

作者：

Kahn, Susan R. ^{[1
]}

Shapiro, Stan ^{[1
,2
]}

Wells, Philip S. ^{[3
,4
]}

Rodger, Marc A. ^{[4
,5
]}

Kovacs, Michael J. ^{[6
]}

Anderson, David R. ^{[7
,8
]}

Tagalakis, Vicky ^{[1
]}

Houweling, Adrielle H. ^{[1
]}

Ducruet, Thierry ^{[1
]}

Holcroft, Christina ^{[9
,10
]}

Johri, Mira ^{[11
,12
]}

Solymoss, Susan ^{[14
,15
]}

Miron, Marie-Jose ^{[17
]}

Yeo, Erik ^{[18
]}

Smith, Reginald ^{[19
,20
]}

Schulman, Sam ^{[21
,22
,23
]}

Kassis, Jeannine ^{[24
]}

Kearon, Clive ^{[21
]}

Chagnon, Isabelle ^{[13
]}

Wong, Turnly ^{[25
]}

Demers, Christine ^{[26
]}

Hanmiah, Rajendar ^{[27
]}

Kaatz, Scott ^{[28
]}

Selby, Rita ^{[29
,30
,31
]}

Rathbun, Suman ^{[32
]}

Desmarais, Sylvie ^{[33
]}

Opatrny, Lucie ^{[16
]}

Ortel, Thomas L. ^{[34
]}

Ginsberg, Jeffrey S. ^{[21
]}

机构：

[1] McGill Univ, Jewish Gen Hosp, Ctr Clin Epidemiol, Montreal, PQ H3T 1E2, Canada

[2] McGill Univ, Dept Epidemiol & Biostat, Montreal, PQ H3T 1E2, Canada

[3] Univ Ottawa, Dept Med, Ottawa Hosp, Ottawa, ON, Canada

[4] Ottawa Hosp Res Inst, Ottawa, ON, Canada

[5] Univ Ottawa, Dept Med, Div Hematol, Thrombosis Program, Ottawa, ON, Canada

[6] London Hlth Sci Ctr, Div Hematol, London, ON, Canada

[7] Dalhousie Univ, Dept Med, Halifax, NS, Canada

[8] Capital Hlth, Halifax, NS, Canada

[9] Tufts Med Ctr, Inst Clin Res & Hlth Policy Studies, Boston, MA USA

[10] Tufts Univ, Tufts Clin & Translat Sci Inst, Boston, MA 02111 USA

[11] Univ Montreal Hosp Res Ctr, Int Hlth Unit, Montreal, PQ, Canada

[12] Univ Montreal, Fac Med, Dept Hlth Adm, Montreal, PQ H3C 3J7, Canada

[13] Univ Montreal, Dept Med, Hop Sacre Coeur, Montreal, PQ H3C 3J7, Canada

[14] Montreal Gen Hosp, Div Hematol, Montreal, PQ H3G 1A4, Canada

[15] St Marys Hosp, Montreal, PQ, Canada

[16] St Marys Hosp, Profess Serv, Montreal, PQ, Canada

[17] Hop Notre Dame de Bon Secours, Dept Med, Montreal, PQ H2L 4K8, Canada

[18] Univ Hlth Network, Div Hematol, Toronto, ON, Canada

[19] Victoria Heart Inst Fdn, Div Cardiol, Victoria, BC, Canada

[20] Victoria Heart Inst Fdn, Div Thrombosis, Victoria, BC, Canada

[21] McMaster Univ, Dept Med, Hamilton, ON, Canada

[22] Thrombosis & Atherosclerosis Res Inst, Hamilton, ON, Canada

[23] Karolinska Inst, Stockholm, Sweden

[24] Hop Maison Neuve Rosemont, Div Hematol, Montreal, PQ, Canada

[25] Univ Manitoba, Dept Med, St Boniface Gen Hosp, Winnipeg, MB, Canada

[26] CHU Quebec, Div Hematol, Quebec City, PQ, Canada

[27] St Josephs Hosp, Div Gen Internal Med, Hamilton, ON, Canada

[28] Hurley Med Ctr, Flint, MI USA

[29] Univ Toronto, Sunnybrook Hlth Sci Ctr, Dept Med, Toronto, ON, Canada

[30] Univ Toronto, Sunnybrook Hlth Sci Ctr, Dept Clin Pathol, Toronto, ON, Canada

[31] Univ Toronto, Univ Hlth Network, Toronto, ON, Canada

[32] Univ Oklahoma, Hlth Sci Ctr, Dept Med, Oklahoma City, OK USA

[33] Hop Pierre Boucher, Dept Med, Longueuil, PQ, Canada

[34] Duke Univ, Med Ctr, Div Hematol, Durham, NC USA

来源：

LANCET | 2014年 / 383卷 / 9920期

基金：

加拿大健康研究院;

关键词：

DEEP VENOUS THROMBOSIS; QUALITY-OF-LIFE; VEIN THROMBOSIS; DETERMINANTS; DISEASE; VILLALTA; OUTCOMES; BURDEN; SCALE; LEG;

D O I：

10.1016/S0140-6736(13)61902-9

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Post-thrombotic syndrome (PTS) is a common and burdensome complication of deep venous thrombosis (DVT). Previous trials suggesting benefit of elastic compression stockings (ECS) to prevent PTS were small, single-centre studies without placebo control. We aimed to assess the efficacy of ECS, compared with placebo stockings, for the prevention of PTS. Methods We did a multicentre randomised placebo-controlled trial of active versus placebo ECS used for 2 years to prevent PTS after a first proximal DVT in centres in Canada and the USA. Patients were randomly assigned to study groups with a web-based randomisation system. Patients presenting with a first symptomatic, proximal DVT were potentially eligible to participate. They were excluded if the use of compression stockings was contraindicated, they had an expected lifespan of less than 6 months, geographical inaccessibility precluded return for follow-up visits, they were unable to apply stockings, or they received thrombolytic therapy for the initial treatment of acute DVT. The primary outcome was PTS diagnosed at 6 months or later using Ginsberg's criteria (leg pain and swelling of >= 1 month duration). We used a modified intention to treat Cox regression analysis, supplemented by a prespecified per-protocol analysis of patients who reported frequent use of their allocated treatment. This study is registered with ClinicalTrials.gov, number NCT00143598, and Current Controlled Trials, number ISRCTN71334751. Findings From 2004 to 2010, 410 patients were randomly assigned to receive active ECS and 396 placebo ECS. The cumulative incidence of PTS was 14.2% in active ECS versus 12.7% in placebo ECS (hazard ratio adjusted for centre 1.13, 95% CI 0.73-1.76; p=0.58). Results were similar in a prespecified per-protocol analysis of patients who reported frequent use of stockings. Interpretation ECS did not prevent PTS after a first proximal DVT, hence our findings do not support routine wearing of ECS after DVT.

引用

页码：880 / 888

页数：9

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