anticoagulants

It is reasonable to stop anticoagulants post successful ablation if there has been no reoccurrence of atrial fibrillation for 1 year or more. James W. Mold, MD, MPH

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Context
Current guidelines recommend indefinite anticoagulation after ablation of atrial fibrillation (AF) in patients with a CHA2DS2-VASc score ≥2–3, but few data support this practice. In a recent randomized trial (ALONE-AF), stopping anticoagulation 1 year after ablation did not raise stroke risk; now, another trial (OCEAN) has examined the same issue.

Researchers randomized 1300 patients with successful catheter ablation (no AF at 1 year clinically or on Holter monitoring) to receive rivaroxaban 15 mg or low-dose aspirin. Exclusion criteria included severe renal disease, hypercoagulability, and age >85. The mean CHA2DS2-VASc score was 2.2; only 10% of patients had scores ≥4.

Key Results
At 3 years, the incidence of the composite outcome (stroke, systemic embolism, or new covert stroke on MRI) did not differ significantly between treatment groups (0.8% with rivaroxaban and 1.4% with aspirin).
Major bleeding occurred slightly more often with rivaroxaban than with aspirin (1.6% and 0.6%), but this did not reach significance.

Author/s:

Mark S. Link

Superficial Vein Thrombosis: A Review

Megan George — Tue, 16 Sep 2025 13:16:35 +0000

Date Added:

September 16, 2025

Journal/Publication:

JAMA

Publication Date:

September 15, 2025

URL:

Superficial Vein Thrombosis: A Review

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2025.15222

Keywords

surgery

vascular surgery

Venous Thromboembolism

Cardiology

anticoagulants

PMID (1):

40952730

MeSH

A review of what we know about superficial venous thrombosis. James W. Mold, MD, MPH

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Importance: Superficial vein thrombosis (SuVT) is characterized by thrombus in the superficial veins, typically in the lower or upper extremities, and has an estimated annual incidence of 64 to 131 per 100 000 person-years. Approximately 10% of patients with SuVT progress to deep vein thrombosis (DVT) or pulmonary embolism (PE).

Observations: Endothelial injury (caused by infection or intravenous devices), venous stasis (such as from chronic venous insufficiency or prolonged immobility), and hypercoagulability (due to cancer or pregnancy) are pathophysiologic factors associated with SuVT. Clinical risk factors for lower extremity SuVT are similar to those of DVT and PE and include pregnancy, varicose veins, and active cancer. The incidence of SuVT is greater in females than males (78-167 compared with 49-116 per 100 000 person-years). In contrast with lower extremity SuVT, upper extremity SuVT is primarily caused by indwelling intravenous catheters. Patients typically present with a tender, red, palpable cord under the skin in the upper or lower extremity. D-dimer testing has a sensitivity of approximately 48% to 74.3% and, therefore, is not reliable for excluding SuVT. Approximately 25% of patients with lower extremity SuVT present with concomitant DVT, likely because risk factors for SuVT and DVT are similar and because SuVT can extend into deep veins. In people without classic symptoms and signs of SuVT, ultrasonography can establish the presence and extent of the thrombus. Management may include elastic compression stockings and nonsteroidal anti-inflammatory drugs. For patients with SuVTs that are at least 5 cm long or those with persistent or worsening symptoms despite several days of conservative therapy, treatment includes anticoagulation with fondaparinux 2.5 mg. Alternative anticoagulation treatment includes rivaroxaban 10 mg once daily and low-molecular-weight heparins (eg, enoxaparin 40 mg once daily), which may reduce subsequent venous thromboembolic events. SuVT located within 3 cm of a deep vein should be treated with therapeutic doses of anticoagulation such as direct oral anticoagulants.

Conclusions and relevance: SuVT typically presents as a tender, painful, palpable cord under the skin. Management may include elastic compression stockings, nonsteroidal anti-inflammatory drugs, and systemic anticoagulation with fondaparinux 2.5 mg or rivaroxaban 10 mg. SuVTs within 3 cm of a deep vein should be treated with therapeutic dose anticoagulation.

Author/s:

Gregory Piazza, Darsiya Krishnathasan, Nada Hamade

Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial

Megan George — Tue, 02 Sep 2025 13:46:16 +0000

Date Added:

September 2, 2025

Journal/Publication:

JAMA

Publication Date:

August 31, 2025

URL:

Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2025.14679

Keywords

clinical pharmacy and pharmacology

PMID (1):

40886309

MeSH

ischemic attack, transient

Discontinuation of anticoagulants after catheter ablation for atrial fibrillation appears to be am appropriate option. James W. Mold, MD, MPH

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Importance: Data from randomized clinical trials on a long-term anticoagulation strategy for patients after catheter-based ablation for atrial fibrillation (AF) are lacking.

Objective: To evaluate whether discontinuing oral anticoagulant therapy provides superior clinical outcomes compared with continuing oral anticoagulant therapy in patients without documented atrial arrhythmia recurrence after catheter ablation for AF.

Design, setting, and participants: A randomized clinical trial including 840 adult patients (aged 19-80 years) who were enrolled and randomized from July 28, 2020, to March 9, 2023, at 18 hospitals in South Korea. Enrolled patients had at least 1 non-sex-related stroke risk factor (determined using the CHA2DS2-VASc score [range, 0-9]) and no documented recurrence of atrial arrhythmia for at least 1 year after catheter ablation for AF. The CHA2DS2-VASc score is used as an assessment of stroke risk among patients with AF (calculated using point values for congestive heart failure, hypertension, ≥75 years of age, diabetes, stroke or transient ischemic attack, vascular disease, between 65 and 74 years of age, and sex category). The date of final follow-up was June 4, 2025.

Interventions: The patients were randomly assigned in a 1:1 ratio to discontinue oral anticoagulant therapy (n = 417) or continue oral anticoagulant therapy (with direct oral anticoagulants; n = 423).

Main outcomes and measures: The primary outcome was the first occurrence of a composite of stroke, systemic embolism, and major bleeding at 2 years. Individual components of the primary outcome (such as ischemic stroke and major bleeding) were assessed as secondary outcomes.

Results: Of the 840 adults randomized, the mean age was 64 (SD, 8) years, 24.9% were women, the mean CHA2DS2-VASc score was 2.1 (SD, 1.0), and 67.6% had paroxysmal AF. At 2 years, the primary outcome occurred in 1 patient (0.3%) in the discontinue oral anticoagulant therapy group vs 8 patients (2.2%) in the continue oral anticoagulant therapy group (absolute difference, -1.9 percentage points [95% CI, -3.5 to -0.3]; P = .02). The 2-year cumulative incidence of ischemic stroke was 0.3% in the discontinue oral anticoagulant therapy group vs 0.8% in the continue oral anticoagulant therapy group (absolute difference, -0.5 percentage points [95% CI, -1.6 to 0.6]). Major bleeding occurred in 0 patients in the discontinue oral anticoagulant therapy group vs 5 patients (1.4%) in the continue oral anticoagulant therapy group (absolute difference, -1.4 percentage points [95% CI, -2.6 to -0.2]).

Conclusions and relevance: Among patients without documented atrial arrhythmia recurrence after catheter ablation for AF, discontinuing oral anticoagulant therapy resulted in a lower risk for the composite outcome of stroke, systemic embolism, and major bleeding vs continuing direct oral anticoagulant therapy.

Trial registration: ClinicalTrials.gov Identifier: NCT04432220.

Author/s:

Daehoon Kim, MD, Jaemin Shim, MD, Eue-Keun Choi, MD

Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation

Megan George — Tue, 02 Sep 2025 13:36:10 +0000

Date Added:

September 2, 2025

Journal/Publication:

New England Journal of Medicine

Publication Date:

August 30, 2025

URL:

Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2507532

Keywords

Chronic Coronary Syndrome

Oral Anticoagulation

aspirin

atherothrombotic risk

stent implantation

PMID (1):

40888725

MeSH

aspirin

Fibrinolytic Agents

follow-up studies

Clinical Trials Data Monitoring Committees

Confidence Intervals

random allocation

myocardial infarction

coronary artery disease

In patients with high-risk CAD already on an anticoagulant, the addition of aspirin increases the risk of adverse events. James W. Mold, MD, MPH

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Background: The appropriate antithrombotic regimen for patients with chronic coronary syndrome who are at high atherothrombotic risk and receiving long-term oral anticoagulation remains unknown.

Methods: We conducted a multicenter, double-blind, randomized, placebo-controlled trial in France involving patients with chronic coronary syndrome who had undergone a previous stent implantation (>6 months before enrollment) and were at high atherothrombotic risk and currently receiving long-term oral anticoagulation. The patients were randomly assigned in a 1:1 ratio to receive aspirin (100 mg once daily) or placebo; all the patients continued to receive their current oral anticoagulation therapy. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia. The key safety outcome was major bleeding.

Results: A total of 872 patients underwent randomization; 433 were assigned to the aspirin group, and 439 to the placebo group. The trial was stopped early at the advice of the independent data and safety monitoring board after a median follow-up of 2.2 years because of an excess of deaths from any cause in the aspirin group. A primary efficacy outcome event occurred in 73 patients (16.9%) in the aspirin group and in 53 patients (12.1%) in the placebo group (adjusted hazard ratio, 1.53; 95% confidence interval [CI], 1.07 to 2.18; P = 0.02). Death from any cause occurred in 58 patients (13.4%) in the aspirin group and in 37 (8.4%) in the placebo group (adjusted hazard ratio, 1.72; 95% CI, 1.14 to 2.58; P = 0.01). Major bleeding occurred in 44 patients (10.2%) in the aspirin group and in 15 patients (3.4%) in the placebo group (adjusted hazard ratio, 3.35; 95% CI, 1.87 to 6.00; P<0.001). A total of 467 and 395 serious adverse events were reported in the aspirin group and placebo group, respectively.

Conclusions: Among patients with chronic coronary syndrome at high atherothrombotic risk who were receiving an oral anticoagulant, the addition of aspirin led to a higher risk of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia than placebo, as well as higher risks of death from any cause and major bleeding. (Funded by the French Ministry of Health and Bayer Healthcare; ClinicalTrials.gov number, NCT04217447.).

Author/s:

Gilles Lemesle, M.D., Ph.D., Romain Didier, M.D., Ph.D., Philippe Gabriel Steg, M.D., Tabassome Simon, M.D., Ph.D., Gilles Montalescot, M.D., Ph.D., Nicolas Danchin, M.D., Christophe Bauters, M.D., Ph.D.

Anticoagulation and Antiplatelet Therapy for Atrial Fibrillation and Stable Coronary Disease: Meta-Analysis of Randomized Trials

Alex Haga — Mon, 24 Feb 2025 17:49:34 +0000

Date Added:

February 24, 2025

Journal/Publication:

Journal of the American College of Cardiology

Publication Date:

January 17, 2025

URL:

Anticoagulation and Antiplatelet Therapy for Atrial Fibrillation and Stable Coronary Disease: Meta-Analysis of Randomized Trials

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.jacc.2024.12.030

Keywords

anticoagulants

atrial fibrillation

coronary artery disease

ischemia

platelet aggregation inhibitors

PMID (1):

39918465

MeSH

coronary artery disease

Platelet Aggregation Inhibitors

Atrial Fibrillation* / diagnosis

anticoagulants

A meta-analysis suggesting that patients with atrial fib and stable CAD do better on oral anticoagulants alone than on oral anticoagulants plus an antiplatelet agent. James W. Mold, MD, MPH

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Background: The optimal long-term antithrombotic strategy in patients with atrial fibrillation (AF) and stable coronary artery disease (CAD) remains uncertain. Individual randomized controlled trials (RCTs) had variations in their reported results and were not powered for effectiveness outcomes.

Objectives: This study aimed to pool the results of RCTs comparing the effectiveness and safety of oral anticoagulation (OAC) monotherapy vs OAC plus single antiplatelet therapy (SAPT) in patients with AF and stable CAD.

Methods: We systematically searched PubMed, Embase, and ClinicalTrials.gov until September 09, 2024. The primary effectiveness outcome was a composite of myocardial infarction, ischemic stroke, systemic embolism, or death. The primary safety outcome was major bleeding. We obtained unpublished results from principal investigators of the included RCTs, as needed, to calculate pooled HRs and 95% CIs and to perform prespecified subgroup analyses.

Results: Among 690 screened records, 4 RCTs with 4,092 randomized patients were included (2 using edoxaban, 1 using rivaroxaban, and 1 using any oral anticoagulant; mean age 73.9 years, 20.1% women). The median follow-up durations ranged from 12 to 30 months (overall estimated weighted mean follow-up of 21.9 months). There were no statistically significant differences between OAC monotherapy vs OAC plus SAPT in the primary effectiveness outcome (7.3% vs 8.2%; HR: 0.90; 95% CI: 0.72-1.12), myocardial infarction (1.0% vs 0.7%; HR: 1.51; 95% CI: 0.75-3.04), ischemic stroke (1.9% vs 2.1%; HR: 0.89; 95% CI: 0.57-1.37), all-cause death (4.2% vs 5.3%; HR: 0.94; 95% CI: 0.49-1.80), or cardiovascular death (2.4% vs 3.0%; HR: 0.79; 95% CI: 0.54-1.15). OAC monotherapy was associated with a lower risk of major bleeding than OAC plus SAPT (3.3% vs 5.7%; HR: 0.59; 95% CI: 0.44-0.79). Subgroup analyses did not show significant interactions for effectiveness but suggested that the magnitude of bleeding reduction may be greater among men (Pinteraction = 0.03) and among patients with diabetes mellitus (Pinteraction = 0.04).

Conclusions: In patients with AF and stable CAD, OAC monotherapy, compared with OAC plus SAPT, was not associated with a statistically significant increased risk of ischemic events but resulted in a significantly reduced risk of bleeding.

Author/s:

Sina Rashedi, Mohammad Keykhaei, Alyssa Sato, Philippe Gabriel Steg

Perioperative Management of Patients Taking Direct Oral Anticoagulants

Alex Haga — Tue, 20 Aug 2024 19:58:18 +0000

Date Added:

August 20, 2024

Journal/Publication:

JAMA

Publication Date:

August 12, 2024

URL:

Perioperative Management of Patients Taking Direct Oral Anticoagulants

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2024.12708

Keywords

Perioperative

oral

anticoagulants

PMID (1):

39133476

MeSH

Venous Thromboembolism

hemorrhage

A review of the perioperative management of patients on oral anticoagulants. James W. Mold, MD, MPH

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Importance: Direct oral anticoagulants (DOACs), comprising apixaban, rivaroxaban, edoxaban, and dabigatran, are commonly used medications to treat patients with atrial fibrillation and venous thromboembolism. Decisions about how to manage DOACs in patients undergoing a surgical or nonsurgical procedure are important to decrease the risks of bleeding and thromboembolism.

Observations: For elective surgical or nonsurgical procedures, a standardized approach to perioperative DOAC management involves classifying the risk of procedure-related bleeding as minimal (eg, minor dental or skin procedures), low to moderate (eg, cholecystectomy, inguinal hernia repair), or high risk (eg, major cancer or joint replacement procedures). For patients undergoing minimal bleeding risk procedures, DOACs may be continued, or if there is concern about excessive bleeding, DOACs may be discontinued on the day of the procedure. Patients undergoing a low to moderate bleeding risk procedure should typically discontinue DOACs 1 day before the operation and restart DOACs 1 day after. Patients undergoing a high bleeding risk procedure should stop DOACs 2 days prior to the operation and restart DOACs 2 days after. With this perioperative DOAC management strategy, rates of thromboembolism (0.2%-0.4%) and major bleeding (1%-2%) are low and delays or cancellations of surgical and nonsurgical procedures are infrequent. Patients taking DOACs who need emergent (<6 hours after presentation) or urgent surgical procedures (6-24 hours after presentation) experience bleeding rates up to 23% and thromboembolism as high as 11%. Laboratory testing to measure preoperative DOAC levels may be useful to determine whether patients should receive a DOAC reversal agent (eg, prothrombin complex concentrates, idarucizumab, or andexanet-α) prior to an emergent or urgent procedure.

Conclusions and relevance: When patients who are taking a DOAC require an elective surgical or nonsurgical procedure, standardized management protocols can be applied that do not require testing DOAC levels or heparin bridging. When patients taking a DOAC require an emergent, urgent, or semiurgent surgical procedure, anticoagulant reversal agents may be appropriate when DOAC levels are elevated or not available.

Author/s:

James D Douketis, Alex C Spyropoulos

Perioperative Management of Antithrombotic Therapy

Alex Haga — Thu, 27 Jun 2024 23:25:26 +0000

Date Added:

June 27, 2024

Journal/Publication:

JAMA

Publication Date:

June 20, 2024

URL:

Perioperative Management of Antithrombotic Therapy

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2024.5880

Keywords

anticoagulants

Antithrombotic Therapy

Perioperative

PMID (1):

38900436

MeSH

anticoagulants

Fibrinolytic Agents

Perioperative Period

Important guidance from the American College of Chest Physicians regarding peri- and intra-operative management of anticoagulants. James W. Mold, MD, MPH

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Guideline title Perioperative Management of Antithrombotic Therapy: An American College of Chest Physicians Clinical Practice Guideline

Release date November 2022

Developer and funding source American College of Chest Physicians

Target population Patients taking oral anticoagulation or antiplatelet therapy who are undergoing an elective surgery or procedure

Selected recommendations

For patients requiring aspirin therapy who are undergoing an elective noncardiac surgery, continuing aspirin through the surgery is suggested (conditional recommendation; moderate certainty of evidence [COE]).

For patients with atrial fibrillation taking vitamin K antagonists (VKAs) who are undergoing an elective surgery or procedure with low to moderate risk of thromboembolism, temporary use of therapeutic heparin doses during interruption of VKA (heparin bridging) is not recommended (strong recommendation; moderate COE).

For patients with a mechanical heart valve with low to moderate risk of thromboembolism who require VKA interruption for an elective surgery or procedure, heparin bridging is not suggested (conditional recommendation; very low COE).

For patients receiving a direct oral anticoagulant (DOAC) who will be undergoing an elective surgery or procedure, discontinuing DOAC therapy is suggested with the timing dependent on the specific DOAC and the bleeding risk of the procedure (conditional recommendation; very low COE).

Author/s:

Maureen D Lyons, Bailey Pope, Jason Alexander

Transient ischemic attack and minor stroke: diagnosis, risk stratification and management

Aubrey Delammermore — Sat, 28 Jan 2023 06:00:00 +0000

Date Added:

January 28, 2023

Journal/Publication:

CMAJ

Publisher:

CMA Impact

Publication Date:

October 11, 2022

Issue:

Volume:

194

Pages:

E1344-E1349

URL:

Transient ischemic attack and minor stroke: diagnosis, risk stratification and management

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1503/cmaj.220344

Keywords

PMID (1):

36220167

MeSH

ischemic attack, transient

Hydroxymethylglutaryl-CoA Reductase Inhibitors

antihypertensive agents

Platelet Aggregation Inhibitors

anticoagulants

Evidence-based guidance for evaluation and management of patients with suspected transient ischemic attack. James W. Mold, MD, MPH

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Patients with suspected cerebral ischemia should be urgently assessed to distinguish between transient ischemic attack (TIA), minor stroke or mimics such as migraine, seizure, vertigo or syncope.

The Canadian TIA Score can be used to determine risk for early subsequent stroke in patients with a suspected TIA or minor stroke.

All patients with TIA or minor stroke should undergo urgent electrocardiography and computed tomography of the head.

Clinicians should order early vascular imaging for patients at moderate or high risk of subsequent stroke; urgent revascularization should be considered if there is more than 50% arterial stenosis congruent with symptom presentation.

Clinicians should prescribe dual antiplatelet drugs for high-risk patients, single antiplatelet agents for low-risk patients or direct oral anticoagulants for patients with atrial fibrillation.

All patients with TIA or minor stroke should be counselled about modifiable lifestyle factors (including smoking cessation), be treated with statins and take steps toward optimizing blood pressure, including treatment with antihypertensive drugs, if necessary.

Author/s:

Perry, J. J., Yadav, K., Syed, S., Shamy, M.

International normalized ratio and activated partial thromboplastin time testing

Aubrey Delammermore — Thu, 08 Sep 2022 05:00:00 +0000

Date Added:

September 8, 2022

Journal/Publication:

CMAJ

Publisher:

CMA Impact Inc

Publication Date:

August 29, 2022

Issue:

194

Volume:

Pages:

E1135

URL:

International normalized ratio and activated partial thromboplastin time testing

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

https://doi.org/10.1503/cmaj.220629

Keywords

Bleeding disorder

direct oral anticoagulants

activated partial thromboplastin

International normalized ratio

Specimen handling

MeSH

Partial Thromboplastin time

Hemophilia A

anticoagulants

Radiology, interventional

von Willdebrand diseases

Expert advice on the use of INR and PTT in patients with suspected bleeding disorders. James W. Mold, MD, MPH

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International normalized ratio (INR) and activated partial thromboplastin time (aPTT) have limited clinical utility
The INR and aPTT should be used only for specific clinical indications (see Appendix 1, available at www.cmaj.ca/lookup/doi/10.1503/cmaj.220629/tab-related-content).1

Bleeding history is the most important predictor of an inherited bleeding disorder
The INR and aPTT have poor sensitivity (1.0%–2.1%) for bleeding disorders. 1 Clinicians considering an inherited bleeding disorder should first use a Bleeding Assessment Tool (BAT).2 A negative BAT score has a sensitivity approaching 100% to rule out von Willebrand disease (the most common inherited bleeding disorder).2 A positive BAT score should prompt referral to a hematologist for consideration of specialized coagulation testing.1

International normalized ratio and aPTT testing are not indicated before low-risk surgery or interventional radiology
Abnormal INR or aPTT results are not associated with an increased bleeding risk in the setting of low-risk procedures.3,4 An abnormal result with no bleeding history or anticoagulant use should be repeated to rule out artifact or sample handling error. Investigation is generally not indicated for an aPTT of less than 4 seconds above the upper limit of normal.2

An abnormal INR or aPTT in a patient who is bleeding suggests a potential medical emergency
Actionable causes of bleeding such as anticoagulant use, severe liver disease or acquired hemophilia may be indicated by the elevated INR or aPTT, respectively.5

Clinical history and drug pharmacokinetics are more important than INR or aPTT results in guiding clinical decision-making in patients taking direct oral anticoagulants (DOACs)
Direct oral anticoagulants variably and inconsistently affect INR and aPTT results. If a patient is bleeding, decisions on the use of a reversing blood product or drug should be based on the last reported drug dose, renal function and pharmacokinetics. In some centres, DOAC-calibrated assays are available to evaluate the presence of clinically relevant drug activity.6

Author/s:

Chornenki, N. L. J., Fralick, M., Sholzberg, M.

Adverse Events Associated With the Addition of Aspirin to Direct Oral Anticoagulant Therapy Without a Clear Indication

Saige Blanchard — Tue, 08 Jun 2021 05:00:00 +0000

Date Added:

June 8, 2021

Journal/Publication:

Journal of the American Medical Association

Publisher:

American Medical Association

Publication Date:

June 1, 2021

Issue:

Volume:

181

Pages:

817-824

URL:

Adverse Events Associated With the Addition of Aspirin to Direct Oral Anticoagulant Therapy Without a Clear Indication

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamainternmed.2021.1197

Keywords

aspirin

anticoagulant therapy

treatment

heart-valve replacement

thrombosis

PMID (1):

33871544

MeSH

Patients at risk for thrombotic events almost never require the combination of a DOAC and low-dose aspirin. Those taking both are at significantly increased risk of bleeding and no reduction in thrombosis. James W. Mold, MD, MPH

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Importance: It is unclear how many patients treated with a direct oral anticoagulant (DOAC) are using concomitant acetylsalicylic acid (ASA, or aspirin) and how this affects clinical outcomes.

Objective: To evaluate the frequency and outcomes of prescription of concomitant ASA and DOAC therapy for patients with atrial fibrillation (AF) or venous thromboembolic disease (VTE).

Design, setting, and participants: This registry-based cohort study took place at 4 anticoagulation clinics in Michigan from January 2015 to December 2019. Eligible participants were adults undergoing treatment with a DOAC for AF or VTE, without a recent myocardial infarction (MI) or history of heart valve replacement, with at least 3 months of follow-up.

Exposures: Use of ASA concomitant with DOAC therapy.

Main outcomes and measures: Rates of bleeding (any, nonmajor, major), rates of thrombosis (stroke, VTE, MI), emergency department visits, hospitalizations, and death.

Results: Of the study cohort of 3280 patients (1673 [51.0%] men; mean [SD] age 68.2 [13.3] years), 1107 (33.8%) patients without a clear indication for ASA were being treated with DOACs and ASA. Two propensity score-matched cohorts, each with 1047 patients, were analyzed (DOAC plus ASA and DOAC only). Patients were followed up for a mean (SD) of 20.9 (19.0) months. Patients taking DOAC and ASA experienced more bleeding events compared with DOAC monotherapy (26.0 bleeds vs 31.6 bleeds per 100 patient years, P = .01). Specifically, patients undergoing combination therapy had significantly higher rates of nonmajor bleeding (26.1 bleeds vs 21.7 bleeds per 100 patient years, P = .02) compared with DOAC monotherapy. Major bleeding rates were similar between the 2 cohorts. Thrombotic event rates were also similar between the cohorts (2.5 events vs 2.3 events per 100 patient years for patients treated with DOAC and ASA compared with DOAC monotherapy, P = .80). Patients were more often hospitalized while undergoing combination therapy (9.1 vs 6.5 admissions per 100 patient years, P = .02).

Conclusion and relevance: Nearly one-third of patients with AF and/or VTE who were treated with a DOAC received ASA without a clear indication. Compared with DOAC monotherapy, concurrent DOAC and ASA use was associated with increased bleeding and hospitalizations but similar observed thrombosis rate. Future research should identify and deprescribe ASA for patients when the risk exceeds the anticipated benefit.

Author/s:

Schaefer, J. K., Errickson, J., Li, Y., Kong, X., Alexandris-Souphis, T., Ali, M. A., Decamillo, D., Haymart, B., Kaatz, S., Kline-Rogers, E., Kozlowski, J. H., Krol, G. D., Shankar, S, R., Sood, S. L., Froehlich, J. B., Barnes, G. D.

St. John Health System Grand Rounds: Direct Oral Anticoagulants— The Good, The Bad, The Bloody

Brian Desmarais — Sat, 02 May 2020 20:27:44 +0000

Date Added:

May 2, 2020

Journal/Publication:

Oklahoma State Medical Association Journal

Publisher:

Oklahoma State Medical Association

Publication Date:

January 1, 2020

Issue:

Volume:

113

Pages:

22-27

URL:

St. John Health System Grand Rounds: Direct Oral Anticoagulants— The Good, The Bad, The Bloody

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

Keywords

St. John's Health System

MeSH

This article from a recent St. John’s Health System Grand Rounds reviews the indications and contraindications for direct oral anticoagulants. James W. Mold, MD, MPH

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Not available.

Author/s:

Lepley, S., Strnad, C., Dixon, R., Wenger, J., Chow, G., Lesselroth, B., Ledbetter, M., Corbett, A.

Outcomes Associated With Oral Anticoagulants Plus Antiplatelets in Patients With Newly Diagnosed Atrial Fibrillation

John Bayhi — Fri, 28 Feb 2020 14:21:39 +0000

Date Added:

February 28, 2020

Journal/Publication:

JAMA Network Open

Publisher:

American Medical Association

Publication Date:

February 5, 2020

Issue:

Volume:

Pages:

e200107

URL:

Outcomes Associated With Oral Anticoagulants Plus Antiplatelets in Patients With Newly Diagnosed Atrial Fibrillation

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamanetworkopen.2020.0107

Keywords

PMID (1):

32101311

MeSH

acute coronary syndrome

coronary artery disease

Platelet Aggregation Inhibitors

stroke

hemorrhage

Registries

The results of this cohort study suggest that for patients with atrial fibrillation, adding an antiplatelet agent to an oral anticoagulant results in more strokes and bleeding and does not protect them from MI. James W. Mold, MD, MPH

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IMPORTANCE:

Patients with nonvalvular atrial fibrillation at risk of stroke should receive oral anticoagulants (OAC). However, approximately 1 in 8 patients in the Global Anticoagulant Registry in the Field (GARFIELD-AF) registry are treated with antiplatelet (AP) drugs in addition to OAC, with or without documented vascular disease or other indications for AP therapy.

OBJECTIVE:

To investigate baseline characteristics and outcomes of patients who were prescribed OAC plus AP therapy vs OAC alone.

DESIGN, SETTING, AND PARTICIPANTS:

Prospective cohort study of the GARFIELD-AF registry, an international, multicenter, observational study of adults aged 18 years and older with recently diagnosed nonvalvular atrial fibrillation and at least 1 risk factor for stroke enrolled between March 2010 and August 2016. Data were extracted for analysis in October 2017 and analyzed from April 2018 to June 2019.

EXPOSURE:

Participants received either OAC plus AP or OAC alone.

MAIN OUTCOMES AND MEASURES:

Clinical outcomes were measured over 3 and 12 months. Outcomes were adjusted for 40 covariates, including baseline conditions and medications.

RESULTS:

A total of 24 436 patients (13 438 [55.0%] male; median [interquartile range] age, 71 [64-78] years) were analyzed. Among eligible patients, those receiving OAC plus AP therapy had a greater prevalence of cardiovascular indications for AP, including acute coronary syndromes (22.0% vs 4.3%), coronary artery disease (39.1% vs 9.8%), and carotid occlusive disease (4.8% vs 2.0%). Over 1 year, patients treated with OAC plus AP had significantly higher incidence rates of stroke (adjusted hazard ratio [aHR], 1.49; 95% CI, 1.01-2.20) and any bleeding event (aHR, 1.41; 95% CI, 1.17-1.70) than those treated with OAC alone. These patients did not show evidence of reduced all-cause mortality (aHR, 1.22; 95% CI, 0.98-1.51). Risk of acute coronary syndrome was not reduced in patients taking OAC plus AP compared with OAC alone (aHR, 1.16; 95% CI, 0.70-1.94). Patients treated with OAC plus AP also had higher rates of all clinical outcomes than those treated with OAC alone over the short term (3 months).

CONCLUSIONS AND RELEVANCE:

This study challenges the practice of coprescribing OAC plus AP unless there is a clear indication for adding AP to OAC therapy in newly diagnosed atrial fibrillation.

Author/s:

Fox, KAA, Velentgas, P, Camm, AJ, Bassand, JP, Fitzmaurice, DA, Gersh, BJ, Goldhaber, SZ, Goto, S, Haas, S, Misselwitz, F, Pieper, KS, Turpie, AGG, Verhegut, FWA, Dabrowski, E, Luo, K, Gibbs, L, Kakkar, AK, GARFIELD-AF Investigators

Diagnosis of Pulmonary Embolism with d-Dimer Adjusted to Clinical Probability

John Bayhi — Wed, 04 Dec 2019 18:30:19 +0000

Date Added:

December 4, 2019

Journal/Publication:

The New England Journal of Medicine

Publisher:

Massachusetts Medical Society

Publication Date:

November 28, 2019

Issue:

Volume:

381

Pages:

2125-2134

URL:

Diagnosis of Pulmonary Embolism with d-Dimer Adjusted to Clinical Probability

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1909159

Keywords

pulmonary embolism

d-dimer

computed tomography

PMID (1):

31774957

MeSH

Humans

prospective studies

retrospective studies

Venous Thromboembolism

Computed Tomography Angiography

anticoagulants

Angiography

Though the full article is not freely available, I thought the abstract was worth sharing. In primary care patients with low or moderate probability of a pulmonary embolus, PE can essentially be ruled out with D-dimer testing. James W. Mold, MD, MPH

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BACKGROUND:

Retrospective analyses suggest that pulmonary embolism is ruled out by a d-dimer level of less than 1000 ng per milliliter in patients with a low clinical pretest probability (C-PTP) and by a d-dimer level of less than 500 ng per milliliter in patients with a moderate C-PTP.

METHODS:

We performed a prospective study in which pulmonary embolism was considered to be ruled out without further testing in outpatients with a low C-PTP and a d-dimer level of less than 1000 ng per milliliter or with a moderate C-PTP and a d-dimer level of less than 500 ng per milliliter. All other patients underwent chest imaging (usually computed tomographic pulmonary angiography). If pulmonary embolism was not diagnosed, patients did not receive anticoagulant therapy. All patients were followed for 3 months to detect venous thromboembolism.

RESULTS:

A total of 2017 patients were enrolled and evaluated, of whom 7.4% had pulmonary embolism on initial diagnostic testing. Of the 1325 patients who had a low C-PTP (1285 patients) or moderate C-PTP (40 patients) and a negative d-dimer test (i.e., <1000 or <500 ng per milliliter, respectively), none had venous thromboembolism during follow-up (95% confidence interval [CI], 0.00 to 0.29%). These included 315 patients who had a low C-PTP and a d-dimer level of 500 to 999 ng per milliliter (95% CI, 0.00 to 1.20%). Of all 1863 patients who did not receive a diagnosis of pulmonary embolism initially and did not receive anticoagulant therapy, 1 patient (0.05%; 95% CI, 0.01 to 0.30) had venous thromboembolism. Our diagnostic strategy resulted in the use of chest imaging in 34.3% of patients, whereas a strategy in which pulmonary embolism is considered to be ruled out with a low C-PTP and a d-dimer level of less than 500 ng per milliliter would result in the use of chest imaging in 51.9% (difference, -17.6 percentage points; 95% CI, -19.2 to -15.9).

CONCLUSIONS:

A combination of a low C-PTP and a d-dimer level of less than 1000 ng per milliliter identified a group of patients at low risk for pulmonary embolism during follow-up. (Funded by the Canadian Institutes of Health Research and others; PEGeD ClinicalTrials.gov number, NCT02483442.).

Author/s:

Kearon, C, de Wit, K, Parpia, S, Schulman, S, Afilalo, M, Hirsch, A, Spencer, FA, Sharma, S, D'Aragon, F, Deshaies, JF, Le Gal, G, Lazo-Langer, A, Wu, C, Rudd-Scott, L, Bates, SM, Julian, JA, PEGeD Study Investigators

Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome: A Randomized Noninferiority Trial

Brian Desmarais — Thu, 17 Oct 2019 14:29:29 +0000

Date Added:

October 17, 2019

Journal/Publication:

Annals of Internal Medicine

Publication Date:

October 15, 2019

URL:

Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome: A Randomized Noninferiority Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.7326/M19-0291

Keywords

MeSH

International Normalized Ratio

Antiphospholipid Syndrome

Rivaroxaban apparently doesn’t work as well as warfarin at preventing recurrent venous thrombosis in patients with antiphospholipid syndrome. That suggests to me that patients should be tested for that condition before recommending a non-warfarin option. James W. Mold, MD, MPH

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BACKGROUND:

The potential role of new oral anticoagulants in antiphospholipid antibody syndrome (APS) remains uncertain.

OBJECTIVE:

To determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic APS.

DESIGN:

3-year, open-label, randomized noninferiority trial. (EU Clinical Trials Register: EUDRA [European Union Drug Regulatory Authorities] code 2010-019764-36).

SETTING:

6 university hospitals in Spain.

PARTICIPANTS:

190 adults (aged 18 to 75 years) with thrombotic APS.

INTERVENTION:

Rivaroxaban (20 mg/d or 15 mg/d, according to renal function) versus dose-adjusted VKAs (target international normalized ratio, 2.0 to 3.0, or 3.1 to 4.0 in patients with a history of recurrent thrombosis).

MEASUREMENTS:

The primary efficacy outcome was the proportion of patients with new thrombotic events; the primary safety outcome was major bleeding. The prespecified noninferiority margin for risk ratio (RR) was 1.40. Secondary outcomes included time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding.

RESULTS:

After 3 years of follow-up, recurrent thrombosis occurred in 11 patients (11.6%) in the rivaroxaban group and 6 (6.3%) in the VKA group (RR in the rivaroxaban group, 1.83 [95% CI, 0.71 to 4.76]). Stroke occurred more commonly in patients receiving rivaroxaban (9 events) than in those receiving VKAs (0 events) (corrected RR, 19.00 [CI, 1.12 to 321.9]). Major bleeding occurred in 6 patients (6.3%) in the rivaroxaban group and 7 (7.4%) in the VKA group (RR, 0.86 [CI, 0.30 to 2.46]). Post hoc analysis suggested an increased risk for recurrent thrombosis in rivaroxaban-treated patients with previous arterial thrombosis, livedo racemosa, or APS-related cardiac valvular disease.

LIMITATION:

Anticoagulation intensity was not measured in the rivaroxaban group.

CONCLUSION:

Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.

PRIMARY FUNDING SOURCE:

Bayer Hispania.

Author/s:

Ordi-Ros, J, Sáez-Comet, L., Pérez-Conesa, M., Vidal, X., Riera-Mestre, A., Castro-Salomó, A., Cuquet-Pedragosa, J., Ortiz-Santamaria, V., Mauri-Plana, M., Solé, C., Cortés-Hernández, J.

Meta-Analysis of Oral Anticoagulant Monotherapy as an Antithrombotic Strategy in Patients With Stable Coronary Artery Disease and Nonvalvular Atrial Fibrillation

John Bayhi — Thu, 12 Sep 2019 13:06:34 +0000

Date Added:

September 12, 2019

Journal/Publication:

The American Journal of Cardiology

Publisher:

Elsevier Inc.

Publication Date:

September 15, 2019

Issue:

Volume:

124

Pages:

879-885

URL:

Meta-Analysis of Oral Anticoagulant Monotherapy as an Antithrombotic Strategy in Patients With Stable Coronary Artery Disease and Nonvalvular Atrial Fibrillation

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.amjcard.2019.05.072

Keywords

atrial fibrillation

coronary artery disease

CAD

myocardial infarction

stroke

PMID (1):

31311662

MeSH

atrial fibrillation

coronary artery disease

Percutaneous Coronary Intervention

myocardial infarction

anticoagulants

stroke

This systematic review found that it is unwise to add low-dose aspirin to warfarin in patients with CAD and non-valvular atrial fibrillation (no benefit; more bleeding). James W. Mold, MD, MPH

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Guidelines recommend oral anticoagulant (OAC) monotherapy without antiplatelet therapy (APT) in patients with nonvalvular atrial fibrillation (AF) with stable coronary artery disease (CAD) of >1 year after myocardial infarction or percutaneous coronary intervention. More evidences are required for the safety and efficacy of OAC monotherapy compared with OAC plus APT. PubMed, EMBASE, and Cochrane Database of Systematic Reviews were systematically searched up to February 2019. Nonrandomized studies and randomized clinical trials comparing OAC monotherapy with OAC plus single APT (SAPT) for patients with stable CAD and nonvalvular AF. The primary end point was major adverse cardiovascular events (composite of ischemic or thrombotic events) and secondary outcomes included major bleeding, stroke, all-cause death, and net adverse events (composite of ischemic, thrombotic, or bleeding events). From 6 trials, 8,855 patients were included. There was no significant difference in major adverse cardiovascular event in patients with AF treated using OAC plus SAPT compared with those treated with OAC monotherapy (hazard ratio [HR] 1.09; 95% confidence interval [CI] 0.92 to 1.29). OAC plus SAPT was associated with a significantly higher risk of major bleeding compared with OAC monotherapy (HR 1.61; 95% CI 1.38 to 1.87), as well as in terms of net adverse event (HR 1.21; 95% CI 1.02 to 1.43). There were no significant differences in rates of stroke and all-cause death. In conclusion, in this meta-analysis, OAC monotherapy and OAC plus SAPT treatment showed similar effectiveness, but OAC monotherapy was significantly associated with a lower risk of bleeding compared with OAC plus SAPT in patients with nonvalvular AF and stable CAD.

Author/s:

Lee, SR, Rhee, TM, Kang, DY, Choi, EK, Oh, S, Lip, GYH