Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation

被引:786
作者
Douketis, James D. [1 ,2 ]
Spyropoulos, Alex C. [4 ]
Kaatz, Scott [3 ,5 ]
Becker, Richard C. [6 ]
Caprini, Joseph A. [7 ]
Dunn, Andrew S.
Garcia, David A. [9 ]
Jacobson, Alan [10 ]
Jaffer, Amir K. [8 ]
Kong, David F. [11 ]
Schulman, Sam
Turpie, Alexander G. G. [3 ]
Hasselblad, Vic [11 ]
Ortel, Thomas L. [12 ]
机构
[1] Duke Univ, Med Ctr, Box 3422, Durham, NC 27710 USA
[2] McMaster Univ, Dept Med, Hamilton, ON, Canada
[3] McMaster Univ, Hamilton Hlth Sci Ctr, Hamilton, ON, Canada
[4] Mt Sinai Med Ctr, Long Isl Jewish Sch Med, Hofstra North Shore, Manhasset, NY USA
[5] Hurley Med Ctr, Flint, MI USA
[6] Univ Cincinnati, Coll Med, Cincinnati, OH USA
[7] NorthShore Univ Healthsyst, Evanston, IL USA
[8] Rush Univ, Med Ctr, Chicago, IL 60612 USA
[9] Univ Washington, Med Ctr, Seattle, WA 98195 USA
[10] Vet Affairs Loma Linda Healthcare Syst, Loma Linda, CA USA
[11] Duke Univ, Duke Clin Res Inst, Durham, NC USA
[12] Duke Univ, Ctr Med, Dept Med, Durham, NC USA
基金
美国国家卫生研究院;
关键词
MOLECULAR-WEIGHT HEPARIN; TERM ORAL ANTICOAGULANTS; VITAMIN-K-ANTAGONISTS; TEMPORARY INTERRUPTION; WARFARIN INTERRUPTION; CLINICAL-OUTCOMES; MANAGEMENT; THERAPY; SURGERY; DABIGATRAN;
D O I
10.1056/NEJMoa1501035
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND It is uncertain whether bridging anticoagulation is necessary for patients with atrial fibrillation who need an interruption in warfarin treatment for an elective operation or other elective invasive procedure. We hypothesized that forgoing bridging anticoagulation would be noninferior to bridging with low-molecular-weight heparin for the prevention of perioperative arterial thromboembolism and would be superior to bridging with respect to major bleeding. METHODS We performed a randomized, double-blind, placebo-controlled trial in which, after perioperative interruption of warfarin therapy, patients were randomly assigned to receive bridging anticoagulation therapy with low-molecular-weight heparin (100 IU of dalteparin per kilogram of body weight) or matching placebo administered subcutaneously twice daily, from 3 days before the procedure until 24 hours before the procedure and then for 5 to 10 days after the procedure. Warfarin treatment was stopped 5 days before the procedure and was resumed within 24 hours after the procedure. Follow-up of patients continued for 30 days after the procedure. The primary outcomes were arterial thromboembolism (stroke, systemic embolism, or transient ischemic attack) and major bleeding. RESULTS In total, 1884 patients were enrolled, with 950 assigned to receive no bridging therapy and 934 assigned to receive bridging therapy. The incidence of arterial thromboembolism was 0.4% in the no-bridging group and 0.3% in the bridging group (risk difference, 0.1 percentage points; 95% confidence interval [CI], -0.6 to 0.8; P = 0.01 for noninferiority). The incidence of major bleeding was 1.3% in the no-bridging group and 3.2% in the bridging group (relative risk, 0.41; 95% CI, 0.20 to 0.78; P = 0.005 for superiority). CONCLUSIONS In patients with atrial fibrillation who had warfarin treatment interrupted for an elective operation or other elective invasive procedure, forgoing bridging anticoagulation was noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreased the risk of major bleeding.
引用
收藏
页码:823 / 833
页数:11
相关论文
共 47 条
[1]  
[Anonymous], 2010, STATXACT VERS 9 CYT
[2]  
[Anonymous], 2012, CHEST S
[3]   The perioperative management of warfarin therapy [J].
Ansell, JE .
ARCHIVES OF INTERNAL MEDICINE, 2003, 163 (08) :881-883
[4]  
BARNARD GA, 1947, BIOMETRIKA, V34, P123, DOI 10.1093/biomet/34.1-2.123
[5]   CURRENT CONCEPTS Management of Antithrombotic Therapy in Patients Undergoing Invasive Procedures [J].
Baron, Todd H. ;
Kamath, Patrick S. ;
McBane, Robert D. .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (22) :2113-2124
[6]   Peri-interventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC registry [J].
Beyer-Westendorf, Jan ;
Gelbricht, Vera ;
Foerster, Kati ;
Ebertz, Franziska ;
Koehler, Christina ;
Werth, Sebastian ;
Kuhlisch, Eberhard ;
Stange, Thoralf ;
Thieme, Christoph ;
Daschkow, Katharina ;
Weiss, Norbert .
EUROPEAN HEART JOURNAL, 2014, 35 (28) :1888-1896
[7]   Pacemaker or Defibrillator Surgery without Interruption of Anticoagulation [J].
Birnie, David H. ;
Healey, Jeff S. ;
Wells, George A. ;
Verma, Atul ;
Tang, Anthony S. ;
Krahn, Andrew D. ;
Simpson, Christopher S. ;
Ayala-Paredes, Felix ;
Coutu, Benoit ;
Leiria, Tiago L. L. ;
Essebag, Vidal .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (22) :2084-2093
[8]   Predictors of Intraoperative Hypotension and Bradycardia [J].
Cheung, Christopher C. ;
Martyn, Alan ;
Campbell, Norman ;
Frost, Shaun ;
Gilbert, Kenneth ;
Michota, Franklin ;
Seal, Douglas ;
Ghali, William ;
Khan, Nadia A. .
AMERICAN JOURNAL OF MEDICINE, 2015, 128 (05) :532-538
[9]   Dabigatran versus Warfarin in Patients with Atrial Fibrillation. [J].
Connolly, Stuart J. ;
Ezekowitz, Michael D. ;
Yusuf, Salim ;
Eikelboom, John ;
Oldgren, Jonas ;
Parekh, Amit ;
Pogue, Janice ;
Reilly, Paul A. ;
Themeles, Ellison ;
Varrone, Jeanne ;
Wang, Susan ;
Alings, Marco ;
Xavier, Denis ;
Zhu, Jun ;
Diaz, Rafael ;
Lewis, Basil S. ;
Darius, Harald ;
Diener, Hans-Christoph ;
Joyner, Campbell D. ;
Wallentin, Lars .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (12) :1139-1151
[10]   Patterns of Initiation of Oral Anticoagulants in Patients with Atrial Fibrillation-Quality and Cost Implications [J].
Desai, Nihar R. ;
Krumme, Alexis A. ;
Schneeweiss, Sebastian ;
Shrank, William H. ;
Brill, Gregory ;
Pezalla, Edmund J. ;
Spettell, Claire M. ;
Brennan, Troyen A. ;
Matlin, Olga S. ;
Avorn, Jerry ;
Choudhry, Niteesh K. .
AMERICAN JOURNAL OF MEDICINE, 2014, 127 (11) :1075-+