Definition of clinically relevant non‐major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non‐surgical patients: communication from the SSC of the ISTH

Kaatz, Scott; Danesh, Ahmad; Spyropoulos, Alex C.; Schulman, Sam

doi:10.1111/jth.13140

Cited by 1,048 publications

(747 citation statements)

References 22 publications

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“…Thromboembolic events were defined as stroke or systemic embolism. Major bleeding was defined according to the criteria of the International Society on Thrombosis and Haemostasis 16, 17, 18. Minor bleeding was defined as bleeding events not meeting the major bleeding criteria.…”

Section: Methodsmentioning

confidence: 99%

Perioperative interruption of direct oral anticoagulants in patients with atrial fibrillation: A systematic review and meta‐analysis

Shaw

Woodfine

Douketis

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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Essentials Little evidence exists to guide procedural interruption of direct oral anticoagulants (DOACs).Conducted a meta‐analysis of the interruption of DOACs in patients with atrial fibrillation (AF).The 30‐day risk for thromboembolic and major bleeding events were 0.4% and 1.8%, respectively.Perioperative interruption of DOACs in patients with AF appears to be safe and effective. BackgroundPatients with atrial fibrillation (AF) frequently undergo invasive procedures that require temporary interruption of anticoagulation. There is little evidence to guide the perioperative interruption of direct oral anticoagulants (DOACs).MethodsA systematic literature search including studies that evaluated the perioperative interruption of DOACs for non‐emergent invasive procedures in patients with AF was performed. The primary outcomes of interest were the 30‐day risk of thromboembolic events and major bleeding. Secondary outcomes of interest included the 30‐day risk of minor bleeding and overall mortality. The systematic review protocol and search strategy were registered online (PROSPERO January 27th 2017:CRD42017056124).ResultsA total of 8 publications encompassing 14 446 patients and 17 107 periprocedural interruptions were included in our study. Our analysis revealed a pooled postoperative 30‐day thromboembolic complication risk of 0.41% (95% CI 0.29‐ 0.54), and a pooled 30‐day postoperative major bleeding risk of 1.81% (95% CI 0.84‐3.13). Pooled 30‐day postoperative risks of minor bleeding and overall mortality were 3.08% (95% CI 1.02‐6.20) and 0.67% (95% CI 0.29‐1.23), respectively. Meta‐analysis of the included comparative studies did not reveal any significant differences in these postoperative outcomes following the perioperative interruption of DOACs or vitamin K antagonists.ConclusionsThe perioperative interruption of DOACs in patients with AF was associated with 0.4% thromboembolic and 1.8% major bleeding events at 30 days post surgery. These findings seem reassuring, but require validation in large prospective management studies where pre‐operative DOAC levels are measured and compared with clinical outcomes in this patient population.

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Section: Methodsmentioning

confidence: 99%

Perioperative interruption of direct oral anticoagulants in patients with atrial fibrillation: A systematic review and meta‐analysis

Shaw

Woodfine

Douketis

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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“…Secondary outcomes of adverse events such as major and nonmajor bleeding, heparin-induced thrombocytopenia, increased liver enzymes, skin or allergic reactions, induction of labor, and cesarean section rates were recorded when available. 13,14 Of the eligible studies, data were extracted independently by 2 investigators utilizing a standardized pilot data extraction form (L.S. and M.C.).…”

Section: Data Extraction and Synthesismentioning

confidence: 99%

A meta-analysis of low-molecular-weight heparin to prevent pregnancy loss in women with inherited thrombophilia

Skeith

Carrier

Kaaja

et al. 2016

Blood

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We performed a meta-analysis of randomized controlled trials comparing low-molecularweight heparin (LMWH) vs no LMWH in women with inherited thrombophilia and prior late ( ‡10 weeks) or recurrent early (<10 weeks) pregnancy loss. Eight trials and 483 patients met our inclusion criteria. There was no significant difference in livebirth rates with the use of LMWH compared with no LMWH (relative risk, 0.81; 95% confidence interval, 0.55-1.19; P 5 .28), suggesting no benefit of LMWH in preventing recurrent pregnancy loss in women with inherited thrombophilia. (Blood. 2016;127(13):1650-1655 Case presentation Case 1. A 34-year-old woman with 3 consecutive unexplained miscarriages wants to get pregnant again. Would she benefit from thrombophilia testing?Case 2. A 25-year-old woman with 1 unexplained pregnancy loss at 16 weeks' gestation is found to be heterozygote for the factor V Leiden mutation. She has no personal history of thrombosis. She asks whether taking low-molecular-weight heparin (LMWH) could prevent a second pregnancy loss.

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“…Clinically relevant nonmajor bleeding was defined as overt bleeding that did not meet the criteria for major bleeding but was associated with the need for medical intervention, unscheduled contact with a physician, interruption or discontinuation of the study drug, or discomfort or impairment of activities of daily living. 26 (Further details regarding the criteria are provided in the Supplementary Appendix. )…”

Section: Outcome Measuresmentioning

confidence: 99%

Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism

et al. 2017

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BACKGROUNDAlthough many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full-or lower-intensity anticoagulation therapy or aspirin. METHODSIn this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding. RESULTSA total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups. CONCLUSIONSAmong patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates. (Funded by Bayer Pharmaceuticals; EINSTEIN CHOICE ClinicalTrials.gov number, NCT02064439.) a bs tr ac t

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Definition of clinically relevant non‐major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non‐surgical patients: communication from the SSC of the ISTH

Cited by 1,048 publications

References 22 publications

Perioperative interruption of direct oral anticoagulants in patients with atrial fibrillation: A systematic review and meta‐analysis

Perioperative interruption of direct oral anticoagulants in patients with atrial fibrillation: A systematic review and meta‐analysis

A meta-analysis of low-molecular-weight heparin to prevent pregnancy loss in women with inherited thrombophilia

Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism

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