Apixaban to Prevent Venous Thromboembolism in Patients with Cancer

被引：630

作者：

Carrier, Marc ^{[1
]}

Abou-Nassar, Karim ^{[2
]}

Mallick, Ranjeeta ^{[1
]}

Tagalakis, Vicky ^{[3
]}

Shivakumar, Sudeep ^{[4
]}

Schattner, Ariah ^{[5
]}

Kuruvilla, Philip ^{[6
]}

Hill, Danny ^{[7
]}

Spadafora, Silvana ^{[7
]}

Marquis, Katerine ^{[8
]}

Trinkaus, Mateya ^{[9
]}

Tomiak, Anna ^{[10
]}

Lee, Agnes Y. Y. ^{[11
]}

Gross, Peter L. ^{[12
]}

Lazo-Langner, Alejandro ^{[13
]}

El-Maraghi, Robert ^{[14
]}

Goss, Glenwood ^{[1
]}

Le Gal, Gregoire ^{[1
]}

Stewart, David ^{[1
]}

Ramsay, Timothy ^{[1
]}

Rodger, Marc ^{[1
]}

Witham, Debra ^{[1
]}

Wells, Philip S. ^{[1
]}

机构：

[1] Univ Ottawa, Ottawa Hosp, Res Inst, Dept Med, Ottawa, ON, Canada

[2] Ctr Integre Sante & Serv Sociaux Outaouais, Gatineau, PQ, Canada

[3] McGill Univ, Lady Davis Inst Med Res, Jewish Gen Hosp, Montreal, PQ, Canada

[4] Nova Scotia Hlth Author, Halifax, NS, Canada

[5] Lakeridge Hlth, Oshawa, ON, Canada

[6] William Osler Hlth Ctr, Brampton, ON, Canada

[7] Sault Area Hosp, Sault Ste Marie, GA USA

[8] Hop Reg Rimouski, Rimouski, PQ, Canada

[9] Markham Stouffville Hosp, Markham, ON, Canada

[10] Kingston Gen Hosp, Kingston, ON, Canada

[11] Univ British Columbia, British Columbia Canc Agcy, Vancouver, BC, Canada

[12] Hamilton Hlth Sci, Hamilton, ON, Canada

[13] London Hlth Sci Ctr, London, ON, Canada

[14] Royal Victoria Reg Hlth Ctr, Barrie, ON, Canada

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2019年 / 380卷 / 08期

基金：

加拿大健康研究院;

关键词：

PATIENTS RECEIVING CHEMOTHERAPY; CUMULATIVE INCIDENCE; HIGH-RISK; THROMBOPROPHYLAXIS; PREDICTION; THROMBOSIS;

D O I：

10.1056/NEJMoa1814468

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND Patients with active cancer have an increased risk of venous thromboembolism, which results in substantial morbidity, mortality, and health care expenditures. The Khorana score (range, 0 to 6, with higher scores indicating a higher risk of venous thromboembolism) has been validated to identify patients with cancer at elevated risk for this complication and may help select those who could benefit from thromboprophylaxis. METHODS We conducted a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban (2.5 mg twice daily) for thromboprophylaxis in ambulatory patients with cancer who were at intermediate-to-high risk for venous thromboembolism (Khorana score, >= 2) and were initiating chemotherapy. The primary efficacy outcome was objectively documented venous thromboembolism over a follow-up period of 180 days. The main safety outcome was a major bleeding episode. RESULTS Of the 574 patients who underwent randomization, 563 were included in the modified intention-to-treat analysis. Venous thromboembolism occurred in 12 of 288 patients (4.2%) in the apixaban group and in 28 of 275 patients (10.2%) in the placebo group (hazard ratio, 0.41; 95% confidence interval [CI], 0.26 to 0.65; P<0.001). In the modified intention-to-treat analysis, major bleeding occurred in 10 patients (3.5%) in the apixaban group and in 5 patients (1.8%) in the placebo group (hazard ratio, 2.00; 95% CI, 1.01 to 3.95; P=0.046). During the treatment period, major bleeding occurred in 6 patients (2.1%) in the apixaban group and in 3 patients (1.1%) in the placebo group (hazard ratio, 1.89; 95% CI, 0.39 to 9.24). CONCLUSIONS Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate-to-high-risk ambulatory patients with cancer who were starting chemotherapy. The rate of major bleeding episodes was higher with apixaban than with placebo. (Funded by the Canadian Institutes of Health Research and Bristol-Myers Squibb-Pfizer Alliance; AVERT ClinicalTrials.gov number, NCT02048865.)

引用

页码：711 / 719

页数：9

共 23 条

[1] Semuloparin for Thromboprophylaxis in Patients Receiving Chemotherapy for Cancer [J].