scholarly journals Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients with Atrial Fibrillation After Acute Coronary Syndrome or PCI: Insights from The AUGUSTUS Trial

Circulation ◽  
2021 ◽  
Author(s):  
Ziad Hijazi ◽  
John H. Alexander ◽  
Zhuokai Li ◽  
Daniel M. Wojdyla ◽  
Roxana Mehran ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Kidney Function ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Exclusion Criterion ◽  
Risk Of Death ◽  
Coronary Syndrome ◽  
Risk Of Bleeding ◽  
Ischemic Events

Background: In the AUGUSTUS trial, apixaban resulted in less bleeding and fewer hospitalizations than vitamin K antagonists (VKA), and aspirin caused more bleeding than placebo in patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention treated with a P2Y 12 inhibitor. We evaluated the risk-benefit balance of antithrombotic therapy according to kidney function. Methods: In 4456 patients, the CKD-EPI formula was used to calculate baseline estimated glomerular filtration rate (eGFR). The effect of apixaban vs. VKA and aspirin vs. placebo was assessed across kidney function categories using Cox models. The primary outcome was ISTH major or clinically relevant non-major bleeding. Secondary outcomes included death or hospitalization and ischemic events (death, stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization). Creatinine clearance below 30 mL/min was an exclusion criterion in the AUGUSTUS trial. Results: Overall, 30%, 52%, and 19% had an eGFR of >80, >50 to 80, and 30-50 mL/min/1.73m 2 , respectively. During 6-months follow-up a total of 543 primary outcomes of bleeding, 1125 death or hospitalizations, and 282 ischemic events occurred. Compared with VKA, patients assigned apixaban had lower rates for all 3 outcomes across most eGFR categories without significant interaction. The absolute risk reduction with apixaban was most pronounced in those with an eGFR of 30-50 mL/min/1.73m 2 for bleeding events with rates of 13.1% vs. 21.3%; HR (95% CI) 0.59 (0.41-0.84). Patients assigned aspirin had a higher risk of bleeding in all eGFR categories with an even greater increase among those with eGFR >80 mL/min/1.73m 2 : 16.6% vs. 5.6%; HR 3.22 (2.19-4.74); p for interaction=0.007). The risk of death or hospitalization and ischemic events were comparable with aspirin and placebo across eGFR categories with HR ranging from 0.97 (0.76-1.23) to 1.28 (1.02-1.59) and from 0.75 (0.48-1.17) to 1.34 (0.81-2.22), respectively. Conclusions: The safety and efficacy of apixaban was consistent irrespective of kidney function, as compared with warfarin, and in accordance with the overall trial results. The risk of bleeding with aspirin was consistently higher across all kidney function categories. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02415400

scholarly journals Cost-effectiveness analysis of apixaban versus vitamin K antagonists for antithrombotic therapy in patients with atrial fibrillation after acute coronary syndrome or percutaneous coronary intervention in Spain

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259251
Author(s):  
Simone Rivolo ◽  
Manuela Di Fusco ◽  
Carlos Polanco ◽  
Amiee Kang ◽  
Devender Dhanda ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Cost Effectiveness ◽  
Vitamin K ◽  
Treatment Strategy ◽  
Coronary Intervention ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Ischemic Events

Background/Objective AUGUSTUS trial demonstrated that, for patients with atrial fibrillation (AF) having acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI), an antithrombotic regimen with apixaban and P2Y12 resulted in less bleeding, fewer hospitalizations, and similar ischemic events than regimens including a vitamin K antagonist (VKA), aspirin, or both. This study objective was to evaluate long-term health and economic outcomes and the cost-effectiveness of apixaban over VKA, as a treatment option for patients with AF having ACS/PCI. Methods A lifetime Markov cohort model was developed comparing apixaban versus VKA across multiple treatment strategies (triple [with P2Y12 + aspirin] or dual [with P2Y12] therapy followed by monotherapy [apixaban or VKA]; triple followed by dual and then monotherapy; dual followed by monotherapy). The model adopted the Spanish healthcare perspective, with a 3-month cycle length and costs and health outcomes discounted at 3%. Results Treatment with apixaban resulted in total cost savings of €883 and higher life years (LYs) and quality-adjusted LYs (QALYs) per patient than VKA (net difference, LYs: 0.13; QALYs: 0.11). Bleeding and ischemic events (per 100 patients) were lower with apixaban than VKA (net difference, –13.9 and –1.8, respectively). Incremental net monetary benefit for apixaban was €3,041, using a willingness-to-pay threshold of €20,000 per QALY. In probabilistic sensitivity analysis, apixaban was dominant in the majority of simulations (92.6%), providing additional QALYs at lower costs than VKA. Conclusions Apixaban was a dominant treatment strategy than VKA from both the Spanish payer’s and societal perspectives, regardless of treatment strategy considered.

Abstract 15664: Prior Oral Anticoagulant Status and Outcomes in Patients With Atrial Fibrillation With an Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention: Insights From the Augustus Trial

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Robert C Welsh ◽  
Renato D Lopes ◽  
Daniel Wojdyla ◽  
Ronald Aronson ◽  
Christopher B Granger ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Oral Anticoagulant ◽  
Lower Risk ◽  
Coronary Intervention ◽  
Risk Of Death ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Ischemic Events

Background: Managing antithrombotic therapy transitions at hospital admission and discharge in patients with atrial fibrillation (AF) and an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) is challenging and is affected by prior treatment. We examined oral anticoagulant (OAC) use prior to enrollment and the relationship with outcomes in the AUGUSTUS trial. Methods: Patients in AUGUSTUS (N=4,614) were analyzed according to whether they were [n=2262] or were not [n=2352] on a prior OAC. Bleeding and clinical outcomes were compared by Kaplan-Meier (KM) estimates at 180 days. For each outcome, KM estimates and treatment interactions were determined by randomized arm and prior OAC status. Results: Those with prior OAC use had higher CHA 2 DS 2 -VASC and HAS-BLED scores and more comorbid medical conditions (hypertension, heart failure, diabetes, prior stroke), and were more likely to have been enrolled following elective PCI. Prior OAC use included vitamin K antagonists (VKAs) 47%, rivaroxaban 22%, apixaban 22%, dabigatran 12%, and edoxaban 1%. There was no difference in combined ISTH major/clinically relevant non-major (CRNM) bleeding with or without prior OAC use (13.5% vs. 13.5%; HR 1.00, 95% CI 0.85-1.18). Patients with prior OAC use had lower risk of death or ischemic events (5.4% vs. 7.6%; HR 0.72, 95% CI 0.57-0.91). No interactions were observed between randomized treatment (apixaban vs. VKA and aspirin vs. placebo) and prior OAC status for outcomes other than MI where apixaban (vs. VKA) was associated with a lower risk of MI in those with prior OAC use (Figure). Conclusion: In AUGUSTUS, OAC prior to enrollment was more common in patients with comorbidities and those enrolled following elective PCI. Prior OAC was associated with fewer ischemic events but not more bleeding. Our results support the use of apixaban plus a P2Y12 inhibitor without aspirin for patients with AF and ACS/PCI, irrespective of prior OAC use.

scholarly journals Elderly patient with atrial fibrillation and coronary risks

2021 ◽  
pp. 51-57
Author(s):  
I. S. Yavelov
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Randomized Controlled Trial ◽  
Acute Coronary Syndrome ◽  
Vitamin K ◽  
Coronary Atherosclerosis ◽  
Controlled Trial ◽  
Vitamin K Antagonists ◽  
Coronary Syndrome ◽  
Randomized Controlled

The incidence of atrial fibrillation (AF) and coronary heart disease (CHD) increases with age. Obviously, this is largely due to the coincidence of risk factors for the occurrence and progression of AF and risk factors for the occurrence and progression of atherosclerosis, including coronary atherosclerosis. Vitamin K antagonists, which are necessary for stroke prevention in patients with AF, are also reported to be able to prevent thrombotic complications of coronary atherosclerosis. No studies specifically designed to compare direct oral anticoagulants (DOACs) and vitamin K antagonists in the prevention of coronary thrombosis have been conducted, However, analysis of the results of randomized controlled trials ARISTOTLE, AUGUSTUS, PIONEER AF-PCI, REDUAL PCI, RE-LY and ROCKET AF indicates that in general DOACs are not inferior to warfarin in the ability to protect patients with AF from myocardial infarction and stent thrombosis. Accordingly, in stable patients with non-valvular AF (who have not suffered an acute coronary syndrome in the next 1 year or planned coronary stenting in the next 6 months) they can be used as monotherapy, without simultaneous administration of antiaggregants. Taking into account the data obtained in patients with sinus rhythm who recently had acute coronary syndrome in the randomized controlled trial ATLAS-ACS 2, as well as with stable atherosclerotic disease in the randomized controlled trial COMPASS, the greatest evidence base in the prevention of coronary complications has been accumulated with rivaroxaban. At the same time, the results of the COMPASS study, as well as analysis of daily medical practice indicate its additional benefits in patients with peripheral atherosclerosis.

scholarly journals Antithrombotic strategy in patients with atrial fibrillation and acute coronary syndrome

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
I Almeida ◽  
H Santos ◽  
M Santos ◽  
H Miranda ◽  
J Chin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Antithrombotic Therapy ◽  
De Novo ◽  
Vitamin K Antagonists ◽  
Antiplatelet Agent ◽  
P2y12 Inhibitors ◽  
Coronary Syndrome ◽  
Short Period ◽  
St Elevation

Abstract Background Atrial fibrillation (AF) is frequent in patients admitted with acute coronary syndromes (ACS). The development of this arrhythmia occurs in 2–21% of patients with non ST-elevation ACS and 21% of ST-elevation ACS. According with the most recent European guidelines, a short period up to 1 week of triple antithrombotic therapy (TAT) is recommended, followed by dual antithrombotic therapy (DAT) using a NOAC and a single antiplatelet agent, preferably clopidogrel. Objective To compare the antithrombotic strategy (DAT vs TAT) used and its prognostic value in patients with AF and ACS. Methods Retrospective analysis of patients' data admitted with ACS in a multicentric registry between 10/2010–09/2019. TAT was defined as the prescription of dual antiplatelet therapy and one anticoagulant and DAT as one antiplatelet and one anticoagulant. Survival and rehospitalization were evaluated through Kaplan-Meier curve. Results 1067 patients were included, mean age 67±14 years, 72.3% male. Patients who developed de novo AF during hospitalization due to ACS were older (75±12 vs 66±14 years, p<0.001) and with higher prevalence of cardiovascular risk factors and cardiovascular disease. AF was more often in patients with ST elevation ACS (53.4%). During hospitalization, AF patients were more often medicated with aspirin, glycoprotein inhibitor, heparin, fondaparinux and vitamin K antagonists. No difference was found regarding P2Y12 inhibitors. AF patients presented more often obstructive coronary disease (normal coronaries 5.4 vs 8.5%, p<0.001) so they were more often submitted to PCI (79.5 vs 70.9%, p<0.001). AF patients presented with higher rates of adverse in-hospital events as re-infarction, heart failure, shock, ventricular arrhythmias, cardiac arrest, stroke, major bleeding and death (p<0.001). At discharge, AF patients were less prescribed with aspirin or ticagrelor, but the rate of clopidogrel prescription was higher, such as vitamin K antagonists or any of the new anticoagulants. In the AF group, 21.5% patients were discharged with TAT and 30.3% with DAT. Concerning patients discharged with TAT, 1-year follow-up revealed no significant differences in mortality (p=0.578), re-admission for cardiovascular causes (p=0.301) and total re-admission rates (p=0.291). Patients discharged with DAT had similar mortality (p=0.623) and re-admission for cardiovascular causes rates (p=0.138), but significant differences were identified regarding total re-admissions (p=0.024). Conclusions In patients with ACS and de novo AF, a low percentage of patients was discharged with oral anticoagulation (51.8%). In those whose anticoagulation was initiated, DAT was the preferred strategy. 1-year outcomes were not different between the antithrombotic strategy, except for all cause re-admission. FUNDunding Acknowledgement Type of funding sources: None.

Long-term quality of VKA treatment and clinical outcome after extreme overanticoagulation in 14,777 AF and VTE patients

2015 ◽  
Vol 113 (04) ◽  
pp. 881-890 ◽  
Author(s):  
Nic J. G. M. Veeger ◽  
Nakisa Khorsand ◽  
Hanneke C. Kluin-Nelemans ◽  
Hilde A. M. Kooistra ◽  
Karina Meijer ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Clinical Outcome ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
P Value ◽  
Risk Of Bleeding ◽  
Increased Risk

SummaryVitamin K antagonists (VKA) are widely used in atrial fibrillation and venous thromboembolism (VTE). Their efficacy and safety depend on individual time in the therapeutic range (iTTR). Due to the variable dose-response relationship within patients, also patients with initially stable VKA treatment may develop extreme overanticoagulation (EO). EO is associated with an immediate bleeding risk, but it is unknown whether VKA treatment will subsequently restabilise. We evaluated long-term quality of VKA treatment and clinical outcome after EO. EO was defined as international normalized ratio (INR) ≥ 8.0 and/or unscheduled vitamin K supplementation. We included a consecutive cohort of initially stable atrial fibrillation and venous thromboembolism patients. In EO patients, the 90 days pre- and post-period were compared. In addition, patients with EO were compared with patients without EO using a matched 1:2 cohort. Of 14,777 initially stable patients, 800 patients developed EO. The pre-period was characterised by frequent overanticoagulation, and half of EO patients had an inadequate iTTR (< 65 %). After EO, underanticoagulation became more prevalent. Although the mean time between INR-measurements decreased from 18.6 to 13.2 days, after EO inadequate iTTR became more frequent (62 %), p-value < 0.001. A 2.3 times (95 % confidence interval [CI] 2.0–2.5) higher risk for iTTR< 65 % after EO, was accompanied by increased risk of bleeding (hazard ratio [HR] 2.1;CI 1.4–3.2), VKA-related death 17.0 (HR 17.0;CI 2.1–138) and thrombosis (HR 5.7;CI 1.5–22.2), compared to the 1600 controls. In conclusion, patients continuing VKA after EO have long-lasting inferior quality of VKA treatment despite intensified INR-monitoring, and an increased risk of bleeding, thrombosis and VKA-related death.Note: There have been no previous presentations, reports or publications of the complete data that appear in the article. Parts of the data in this article have been presented as a poster at the American Society of Hematology (ASH) congress 2013, New Orleans, United States.

scholarly journals Combination of Oral Anticoagulants and Single Antiplatelets versus Triple Therapy in Nonvalvular Atrial Fibrillation and Acute Coronary Syndrome: Stroke Prevention among Asians

2020 ◽  
Vol 29 (02) ◽  
pp. 088-097
Author(s):  
Anwar Santoso ◽  
Sunu B. Raharjo
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Triple Therapy ◽  
Stroke Prevention ◽  
Thrombus Formation ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Nonvalvular Atrial Fibrillation ◽  
Coronary Syndrome

AbstractAtrial fibrillation (AF), the most prevalent arrhythmic disease, tends to foster thrombus formation due to hemodynamic disturbances, leading to severe disabling and even fatal thromboembolic diseases. Meanwhile, patients with AF may also present with acute coronary syndrome (ACS) and coronary artery disease (CAD) requiring stenting, which creates a clinical dilemma considering that majority of such patients will likely receive oral anticoagulants (OACs) for stroke prevention and require additional double antiplatelet treatment (DAPT) to reduce recurrent cardiac events and in-stent thrombosis. In such cases, the gentle balance between bleeding risk and atherothromboembolic events needs to be carefully considered. Studies have shown that congestive heart failure, hypertension, age ≥ 75 years (doubled), diabetes mellitus, and previous stroke or transient ischemic attack (TIA; doubled)–vascular disease, age 65 to 74 years, sex category (female; CHA2DS2-VASc) scores outperform other scoring systems in Asian populations and that the hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile international normalized ratio (INR), elderly (>65 years), drugs/alcohol concomitantly (1 point each; HAS-BLED) score, a simple clinical score that predicts bleeding risk in patients with AF, particularly among Asians, performs better than other bleeding scores. A high HAS-BLED score should not be used to rule out OAC treatment but should instead prompt clinicians to address correctable risk factors. Therefore, the current review attempted to analyze available data from patients with nonvalvular AF who underwent stenting for ACS or CAD and elaborate on the direct-acting oral anticoagulant (DOAC) and antiplatelet management among such patients. For majority of the patients, “triple therapy” comprising OAC, aspirin, and clopidogrel should be considered for 1 to 6 months following ACS. However, the optimal duration for “triple therapy” would depend on the patient's ischemic and bleeding risks, with DOACs being obviously safer than vitamin-K antagonists.

Risk of myocardial infarction and death in patients with atrial fibrillation treated with dabigatran or vitamin K antagonists

2016 ◽  
Vol 116 (12) ◽  
pp. 1150-1158 ◽  
Author(s):  
Walid Darwiche ◽  
Theodora Bejan-Angoulvant ◽  
Denis Angoulvant ◽  
Dominique Babuty ◽  
Laurent Fauchier
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Vitamin K ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Routine Practice ◽  
Adjusted Risk ◽  
Statistical Homogeneity ◽  
Risk Of Death ◽  
Adjusted Dose

SummaryThe safety of dabigatran versus adjusted-dose vitamin K antagonist (VKA) treatment is the subject of debate. We evaluated the risk of myocardial infarction (MI) or mortality in patients with atrial fibrillation (AF) treated in clinical practice with dabigatran or a VKA. We performed a meta-analysis of observational studies that included an adjusted or matched analysis and reported MI, or death in AF patients treated with dabigatran or a VKA. Ten published analyses met the inclusion criteria. Of the 539,559 patients, 17,365 (3%) patients were on dabigatran 110 mg twice daily (bid), 150,948 (28%) were on dabigatran 150 mg bid, and 371,246 (69%) were on VKA. Adjusted risk for MI versus VKA was 0.71 (0.47–1.07; p=0.10) in patients starting oral anticoagulant (OAC) treatment with dabigatran 110 mg, 0.82 (0.71–0.96; p=0.01) in patients starting dabigatran 150 mg, 1.40 (1.04–1.88; p=0.03) in patients switching OAC treatment to dabigatran 110 mg, and 1.28 (0.88–1.87; p=0.19) in patients switching OAC treatment to dabigatran 150 mg, with statistical homogeneity in each subgroup. Risk of death was consistently lower in patients treated with dabigatran 110 mg (HR 0.79; 0.65–0.96; p=0.02) or 150 mg (HR 0.65; 0.57–0.73; p<0.00001) versus VKA. In conclusion, dabigatran use, as currently prescribed in routine practice for AF patients, was associated with a lower risk of MI in OAC-naïve patients treated with dabigatran 150 mg compared with VKA, and a higher risk of MI in patients switching from VKA to dabigatran 110 mg. Risk of death was lower in AF patients treated with either dose of dabigatran versus VKA.

Efficacy and safety of new oral anticoagulants as part of triple antithrombotic therapy in patients with atrial fibrillation and acute coronary syndrome. Data from an observational study

Kardiologiia ◽  
2020 ◽  
Vol 60 (7) ◽  
pp. 53-63
Author(s):  
N. A. Sycheva ◽  
L. Yu. Koroleva ◽  
V. P. Nosov ◽  
G. V. Kovaleva ◽  
N. N. Paikova ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Treatment Group ◽  
Antithrombotic Therapy ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Coronary Syndrome ◽  
Warfarin Treatment ◽  
Ischemic Events ◽  
Triple Antithrombotic Therapy

Aim To study efficacy and safety of a triple antithrombotic therapy with direct oral anticoagulants (DOAC) versus warfarin in patients with atrial fibrillation after acute coronary syndrome, for 12 months following discharge from the hospital.Materials and methods This single-site cohort, prospective, observational study performed at the Regional Vascular Center 2 of the N.A. Semashko Nizhniy Novgorod Regional Clinical Hospital included 402 patients. It was possible to maintain contacts with 206 patients for 12 months. These patients were divided into two groups, the DOAC treatment (n=105) and the warfarin treatment (n=101) as a part of triple antithrombotic therapy upon discharge. Clinical observation was performed at 1, 3, 6, and 12 months after the discharge by structured telephone interview. Predetermined efficacy endpoints included cardiovascular death, myocardial infarction, stent thrombosis, and ischemic stroke. Safety endpoints included bleeding defined as small, medium (clinically significant), and major in accordance with the TIMI classification.Results At 12 months of follow-up, 80 patients (76.19%) continued taking DOAC and 39 patients (38.61%, p<0.001) continued taking warfarin; in this process, only 25 patients (24.75%) monitored their INR on a regular basis. With a regular INR monitoring and TTR >70%, death rate did not differ in the warfarin and the DOAC treatment groups. However, there was a difference in reaching the composite efficacy endpoint (p=0.048): ischemic events occurred statistically significantly more frequently in the warfarin treatment group than in the DOAC treatment group.Conclusions In 12 months after discharge from the hospital, compliance with the DOAC treatment as a part of the antithrombotic therapy was significantly higher than compliance with the warfarin treatment. The triple antithrombotic therapy with DOAC was safer than the warfarin treatment by the number of hemorrhagic complications and more effective in prevention of ischemic events, primarily due to no need for monitoring of lab test values.

Bleeding in patients receiving vitamin K antagonists who would have been excluded from trials on which the indication for anticoagulation was based

Blood ◽  
2008 ◽  
Vol 111 (9) ◽  
pp. 4471-4476 ◽  
Author(s):  
Marcel Levi ◽  
G. Kees Hovingh ◽  
Suzanne C. Cannegieter ◽  
Marinus Vermeulen ◽  
Harry R. Büller ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Careful Consideration ◽  
Exclusion Criterion ◽  
Exclusion Criteria ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Risk Of Hemorrhage ◽  
Control Study

Abstract Vitamin K antagonists (VKAs) are effective antithrombotic agents and advocated in guidelines for the management of cardiovascular disease. However, in the trials underlying these guidelines, many patients were excluded. We performed a case-control study in 993 patients receiving VKAs, who required hospitalization for bleeding, and contrasted them to 993 matched control patients on VKAs, who were hospitalized for an infection. We analyzed whether patients and controls would have been eligible for the clinical trials on which their indication for anticoagulation was based, and estimated the risk of hemorrhage associated with exclusion criteria as applied in those trials. Approximately one quarter (23% [95% CI: 21%-26%]) of controls had one or more exclusion criteria for the trials, supporting the use of anticoagulation for their condition. Forty percent of patients presenting with bleeding had one or more exclusion criteria (95% CI: 37%-43%). Having one exclusion criterion resulted in a 2.9-fold increased risk of bleeding (95% CI: 2.2-3.9), and this risk increased sharply when more than one exclusion criterion was present. VKAs are often prescribed to patients who would not have qualified for clinical trials, and in these patients a careful consideration should be made regarding the expected efficacy and the risk of bleeding.

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