Not giving bridging anticoagulation lowers risk of major bleeding in AF patients on warfarin
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News - June 23, 2015Forgoing bridging anticoagulation in patients with atrial fibrillation (AF) is non-inferior to perioperative bridging with low-molecular weight heparin for the prevention of arterial thromboembolism and decreases the risk of major bleeding, according to results presented at the International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress on Monday and published simultaneously in the New England Journal of Medicine.
Study investigator Thomas Ortel, chief of the division of hematology at Duke University Medical Center, Durham, North Carolina, U.S.A., discussed results of the BRIDGE trial, which evaluated the safety and efficacy of bridging anticoagulant therapy.
Bridging anticoagulation is frequently used in patients taking chronic oral anticoagulant therapy who need their anticoagulation transiently held for an operation or invasive procedure. The need for bridging anticoagulation never has been shown definitively, however, Ortel said in an interview.
“This is the first prospective, randomized, placebo-controlled, double-blind clinical trial to investigate the role of bridging anticoagulant therapy in patients with AF on chronic anticoagulation with warfarin who need the anticoagulant therapy held for an elective operation or invasive procedure,” Ortel said.
1,884 patients were evaluated in the trial, which compared bridging and no bridging in patients with non-valvular/valvular AF or atrial flutter who required warfarin interruption for elective surgery. The median age was 72.7 years, and 73% of patients were male. A total of 336 patients had a history of stroke or transient ischemic attack.
After stopping warfarin five days before the procedure, study participants received dalteparin, 100 IU kg-1 (934 patients) or matching placebo (950 patients) for three days before and 5–9 days after the procedure. Dalteparin/placebo was resumed 12–24 hours after minor surgery and 48–72 hours after major surgery. Warfarin was resumed 24 hours or less after the procedure. Follow-up lasted 30 ± 7 days after the procedure. Primary outcomes were arterial thromboembolism and major bleeding. Secondary outcomes were minor bleeding, death, myocardial infarction and venous thromboembolism. Protocol adherence occurred in 81% of patients pre-procedure, and in 94.5% of patients post-procedure.
The incidence of arterial thromboembolism was 0.4% in the no-bridging group, compared with 0.3% in the bridging group (95% CI, -0.6 to 0.8; p=0.01 for non-inferiority). 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).
“Current practice guidelines provide weak and inconsistent recommendations concerning the need for bridging anticoagulation,” Ortel said. “This study provides the highest level of evidence to support a strong recommendation concerning the role of bridging in this patient population.” He continued: “With the introduction of the direct oral anticoagulants, we will now need to develop peri-procedural approaches to manage patients on a variety of different agents. Warfarin continues to be extensively used in many of these patients, however, and the BRIDGE trial will contribute to improved management for these individuals.”
UPDATE: The European Society of Cardiology (ESC) has recommended uninterrupted anticoagulation with vitamin K antagonists during ablation and device implantation in a position paper presented June 23 at EHRA EUROPACE – CARDIOSTIM 2015 and published in EP Europace. The recommendations published today are an update of EHRA’s 2008 consensus document.
Three main topics are covered: antithrombotic management in patients undergoing ablation for various conditions such as atrial fibrillation; antithrombotic management for the implantation or exchange of cardiac implantable electronic devices (CIEDs) including pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchonisation therapy (CRT) systems; and peri-interventional bleeding complications on concurrent antiplatelet therapy.
Professor Christian Sticherling, chair of the writing group, said: “Traditionally we interrupted anticoagulation during device implantation and restarted it afterwards. And we bridged with heparin around the time of the operation. The new recommendation is to continue to give the vitamin K antagonist and perform the operation without any bridging. That shows the lowest rate of perioperative bleeding.”
Daily news release ISTH 2015 congress
Find the article online at New England Journal of Medicine.
ESC Press release on the recommendations 'Antithrombotic management in patients undergoing electrophysiological procedures: an European Heart Rhythm Association (EHRA) position document endorsed by the ESC Working Group Thrombosis, Heart Rhythm Society (HRS), and Asia Pacific Heart Rhythm Society (APHRS).' Europace. doi:10.1093/europace/euv190
Study investigator Thomas Ortel, chief of the division of hematology at Duke University Medical Center, Durham, North Carolina, U.S.A., discussed results of the BRIDGE trial, which evaluated the safety and efficacy of bridging anticoagulant therapy.
Bridging anticoagulation is frequently used in patients taking chronic oral anticoagulant therapy who need their anticoagulation transiently held for an operation or invasive procedure. The need for bridging anticoagulation never has been shown definitively, however, Ortel said in an interview.
“This is the first prospective, randomized, placebo-controlled, double-blind clinical trial to investigate the role of bridging anticoagulant therapy in patients with AF on chronic anticoagulation with warfarin who need the anticoagulant therapy held for an elective operation or invasive procedure,” Ortel said.
1,884 patients were evaluated in the trial, which compared bridging and no bridging in patients with non-valvular/valvular AF or atrial flutter who required warfarin interruption for elective surgery. The median age was 72.7 years, and 73% of patients were male. A total of 336 patients had a history of stroke or transient ischemic attack.
After stopping warfarin five days before the procedure, study participants received dalteparin, 100 IU kg-1 (934 patients) or matching placebo (950 patients) for three days before and 5–9 days after the procedure. Dalteparin/placebo was resumed 12–24 hours after minor surgery and 48–72 hours after major surgery. Warfarin was resumed 24 hours or less after the procedure. Follow-up lasted 30 ± 7 days after the procedure. Primary outcomes were arterial thromboembolism and major bleeding. Secondary outcomes were minor bleeding, death, myocardial infarction and venous thromboembolism. Protocol adherence occurred in 81% of patients pre-procedure, and in 94.5% of patients post-procedure.
The incidence of arterial thromboembolism was 0.4% in the no-bridging group, compared with 0.3% in the bridging group (95% CI, -0.6 to 0.8; p=0.01 for non-inferiority). 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).
“Current practice guidelines provide weak and inconsistent recommendations concerning the need for bridging anticoagulation,” Ortel said. “This study provides the highest level of evidence to support a strong recommendation concerning the role of bridging in this patient population.” He continued: “With the introduction of the direct oral anticoagulants, we will now need to develop peri-procedural approaches to manage patients on a variety of different agents. Warfarin continues to be extensively used in many of these patients, however, and the BRIDGE trial will contribute to improved management for these individuals.”
UPDATE: The European Society of Cardiology (ESC) has recommended uninterrupted anticoagulation with vitamin K antagonists during ablation and device implantation in a position paper presented June 23 at EHRA EUROPACE – CARDIOSTIM 2015 and published in EP Europace. The recommendations published today are an update of EHRA’s 2008 consensus document.
Three main topics are covered: antithrombotic management in patients undergoing ablation for various conditions such as atrial fibrillation; antithrombotic management for the implantation or exchange of cardiac implantable electronic devices (CIEDs) including pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchonisation therapy (CRT) systems; and peri-interventional bleeding complications on concurrent antiplatelet therapy.
Professor Christian Sticherling, chair of the writing group, said: “Traditionally we interrupted anticoagulation during device implantation and restarted it afterwards. And we bridged with heparin around the time of the operation. The new recommendation is to continue to give the vitamin K antagonist and perform the operation without any bridging. That shows the lowest rate of perioperative bleeding.”
Daily news release ISTH 2015 congress
Find the article online at New England Journal of Medicine.
ESC Press release on the recommendations 'Antithrombotic management in patients undergoing electrophysiological procedures: an European Heart Rhythm Association (EHRA) position document endorsed by the ESC Working Group Thrombosis, Heart Rhythm Society (HRS), and Asia Pacific Heart Rhythm Society (APHRS).' Europace. doi:10.1093/europace/euv190
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