Items filtered by date: March 2017

Statins and secondary prevention of venous thromboembolism: pooled analysis of published observational cohort studies

European Heart Journal

Data from observational cohort studies suggest beneficial effect of statin on venous thromboembolism recurrence. In pooled analysis of 7 trials, relative risk (RR) was 0.73 (0.68–0.79) vs. no use. RRs for recurrent PE and DVT were 0.75(0.58–0.96) and 0.66 (0.60–0.71) respectively.

 

FDA fast track designation granted for recombinant ADAMTS13 for treatment of hereditary thrombotic thrombocytopenic purpura

Biospace Inc.

Recombinant ADAMTS13 is intended for treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura in patients with a constitutional deficiency of the von Willebrand factor-cleaving protease ADAMTS13. Shire is initiating open-label, 2-period crossover RCT.

 

Should we screen extensively for cancer after unprovoked venous thrombosis?

British Medical Journal

Prevalence of occult cancer in patients with 1st unprovoked venous thromboembolism seems to be lower (~4%) than previously reported (10%). Review notes high quality data from recently completed trials suggest no additional value for extensive screening strategies.

 

Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants

British Journal of Clinical Pharmacology

Real-life cohort study (n=30146) suggests risk of acute myocardial infarction was doubled with direct oral anticoagulants or aspirin vs. vitamin k antagonists (HR 2.11; 95% CI 1.08 – 4.12 and 1.91; 1.45-2.51, respectively). Further research from is required.

 

Two Paradigms for Endovascular Thrombectomy After Intravenous Thrombolysis for Acute Ischemic Stroke

JAMA Neurology

French study of 159 patients ultimately treated by mechanical thrombectomy, of which 100 received IV thrombolysis before transport to a more fully equipped hospital, and 59 did not, found no difference in functional independence at 3 months after stroke between the 2 groups.

 

Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism

New England Journal of Medicine

RCT of 3365 patients randomised after 6-12months anticoagulant therapy found symptomatic recurrent fatal/nonfatal venous thromboembolism occurred in 1.5% patients given 20 mg and 1.2% given 10 mg rivaroxaban, vs. 4.4% given aspirin (p<0.001 vs. aspirin for both).

 

Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: multinational prospective cohort management study

British Medical Journal

This validation study (n= 2785) of the HERDOO2 clinical assessment tool found that women with 0 or 1 of the 4 criteria have a low risk of recurrent venous thromboembolism and can safely discontinue anticoagulants after completing short term treatment.

 

Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation

New England Journal of Medicine

The RE-CIRCUIT trial (n= 704) found that the incidence of major bleeding events after ablation was lower with dabigatran versus warfarin in patients with atrial fibrillation (1.6% vs 6.9%; absolute risk difference, −5.3%; 95% CI, −8.4 to −2.2; P<0.001).

 

Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial

The Lancet

RCT (n= 3,037) found that low-dose rivaroxaban with a P2Y12 inhibitor (clopidogrel or ticagrelor) had a similar risk of clinically significant bleeding as aspirin and a P2Y12 inhibitor for the treatment of patients with acute coronary syndromes (5% both groups).

 

Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study

The Lancet

Registry data analysis found that leaflet thrombosis was less frequently observed in patients using warfarin or novel oral anticoagulants (eight [4%] of 224) than in those using dual antiplatelet or monoantiplatelet therapy (98 [15%] of 666; p<0•0001).

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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Interruption to antiplatelet therapy early after acute ischaemic stroke: A nested case-control study

British Journal of Clinical Pharmacology

Study of 194 cases and 776 matched controls, of whom 10 and 58, respectively, stopped/interrupted antiplatelets found no significant link between interrupted/cessation of use and risk of CV events, though study had limited power and clinically important risk cannot be excluded.

 

2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

Circulation

Several RCTs have been published since 2014 guideline. Major areas of change include indications for transcatheter aortic valve replacement, surgical management of primary/secondary mitral regurgitation, and management of patients with valve prostheses.

 

Efficacy and safety of extended thromboprophylaxis for medically ill patients. A meta-analysis of randomised controlled trials

Thrombosis and Haemostasis

Review of 4 RCTs (n=28,105) found that extended thromboprophylaxis was associated with a lower risk of DVT though PE and VTE related mortality differences were not significant. The NNT for DVT prevention was 339, with a NNH for major bleed as 247.

 

Association of Preceding Antithrombotic Treatment With Acute Ischemic Stroke Severity and In-Hospital Outcomes Among Patients With Atrial Fibrillation

Journal of the American Medical Association

A study of 94,474 patients with acute ischemic stroke and AF found that 84% did not receive guideline-recommended therapeutic anticoagulation preceding the stroke. Therapeutic anticoagulation was associated with lesser stroke severity and lower odds of in-hospital mortality.

 

Fixed dose subcutaneous low molecular weight heparins versus adjusted dose unfractionated heparin for the initial treatment of venous thromboembolism

Cochrane Database of Systematic Reviews

Moderate-level data suggest that fixed dose LMWH reduced incidence of recurrent thrombotic complications and occurrence of major haemorrhage during initial treatment; and low-quality data suggest fixed dose LMWH reduced thrombus size vs UFH for the initial treatment of VTE.

 

Early non-persistence with dabigatran and rivaroxaban in patients with atrial fibrillation

Heart

Study (n=25,976) found at 6 months, 36.4 and 31.9% of patients were non-persistent to dabigatran and rivaroxaban, respectively. Stroke/TIA/death was higher with non-persistence vs. persistence (HR 1.76, 95% CI 1.60-1.94 and 1.89, 1.64-2.19; p<0.0001 for both, respectively).

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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Subcutaneous unfractionated heparin for the initial treatment of venous thromboembolism

Cochrane Database of Systematic Reviews

This review of 16 RCTs (n=3593; general low quality) concludes that there is no evidence of a difference between subcutaneous unfractionated heparin (UFH) and intravenous UFH or subcutaneous low molecular weight heparin for preventing recurrent clots, mortality or major bleeding.

 

Oral anticoagulants for primary prevention, treatment and secondary prevention of venous thromboembolic disease, and for prevention of stroke in atrial fibrillation: systematic review, network meta-analysis and cost-effectiveness analysis

National Institute for Health Research

NOACs have advantages over warfarin in AF patients, but there was no strong evidence they should replace warfarin/low molecular weight heparin in primary prevention (PV), treatment or secondary PV of venous thromboembolism. Findings limited by lack of head to head NOAC studies.

 

Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials

The Lancet

This paper describes PRECISE-DAPT score, a simple 5-item risk score (age, creatinine clearance, haemoglobin, white-blood-cell count, previous spontaneous bleeding), which provides a standardised tool for prediction of out-of-hospital bleeding during dual antiplatelet therapy.

 

Anticoagulation for pregnant women with mechanical heart valves: a systematic review and meta-analysis

European Heart Journal

Review highlights that when compared with earlier systematic review, increased use of mechanical valves with lower thrombogenic potential has not necessarily resulted in lower risk of adverse outcomes, and optimal method of anticoagulation remains undetermined in this population.

 

Comparative effectiveness of venous thromboembolism prophylaxis options for the patient undergoing total hip and knee replacement: a network meta-analysis

Journal of Thrombosis and Haemastasis

Relative to low-molecular-weight heparin, direct oral Xa inhibitors had a more favorable profile of venous thromboembolism and haemorrhage risk, whereas vitamin K antagonists had a less favorable profile. The profile of other agents was not more or less favourable.

 

Pharmacokinetics and pharmacodynamics of single doses of rivaroxaban in obese patients prior to and after bariatric surgery

British Journal of Clinical Pharmacology

Analysis of 6 Roux-en-Y gastric bypass and 6 sleeve gastrectomy patients found bariatric surgery does not appear to alter pharmacokinetics of rivaroxaban in clinically relevant way. Effective prophylactic postbariatric anticoagulation is supported by changes in pharmacodynamics.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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Personalising the decision for prolonged dual antiplatelet therapy: development, validation and potential impact of prognostic models for cardiovascular events and bleeding in myocardial infarction survivors

European Heart Journal

This modelling study was developed from data taken from UK population-based electronic health records (n=12694 and 5613, respectively), and quantified the potential benefits and harms of prolonged dual antiplatelet therapy (DAPT) in MI survivors.

 

Duration of dual antiplatelet therapy in acute coronary syndrome

Heart

Review notes it has been 15 years since CURE trial showed benefit of dual antiplatelet therapy following ACS and yet optimal duration remains uncertain. It highlights need for broad inclusive safety trial of shorter durations of therapy in real world populations of ACS patients.

 

Association of Antithrombotic Drug Use With Subdural Hematoma Risk

Journal of the American Medical Association

Study (10,010 patients, 400,380 controls) found antithrombotic use increased risk of subdural haematoma. Highest odds were associated with combined use of vitamin K antagonist+antiplatelet (aspirin or clopidogrel, OR 4.00, 95%CI 3.40-4.70, and 7.93, 4.49-14.02, respectively).

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

Published in News