Items filtered by date: May 2019

Efficacy and safety of direct oral factor Xa inhibitors compared with warfarin in patients with morbid obesity: a single-centre, retrospective analysis of chart data

The Lancet Haematology

Retrospective analysis of data evaluating safety and efficacy of direct oral anticoagulants and warfarin in 795 morbidly obese patients (BMI>40kg/m2) suggests concludes similar efficacy and safety of apixaban and rivaroxaban, compared to warfarin in patients with AF and VTE.

 

Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial

European Heart Journal

Study (n=1,859) showed no significant difference in major cardiovascular events occurring in 9.7% ticagrelor patients vs. 8.2% aspirin patients [HR 1.19; 95% CI 0.87–1.62; p= 0.28]), or in major bleeding. RCT was terminated early & underpowered however due to recruitment issues.

 

 

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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Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study

Journal of Clinical Oncology

Observational study of 695 patients with cancer and incidental diagnosis of PE suggests despite anticoagulant therapy, recurrent VTE occurred in 6% of patients, strengthening current guideline advice to treat incidental PE as symptomatic PE for at least 3 to 6 months.

 

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

The Lancet

RCT (n=537) reports 4% of participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage vs 9% allocated to avoid antiplatelet therapy (HR 0.51, p=0.060), whilst 7% and 9% of patients respectively experienced major haemorrhagic events (HR 0.71, p=0.27).

 

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention: A Consensus Document From the Academic Research Consortium for High Bleeding Risk

Circulation

The consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

 

Extending thrombolysis to 4·5–9 h and wake-up stroke using perfusion imaging: a systematic review and meta-analysis of individual patient data

The Lancet

Review of 3 RCTs (n=414) found that more patients given alteplase achieved excellent functional outcomes at 3 months vs placebo (36% vs 29%, OR 1.86, p=0.011). Intracerebral haemorrhage was more common with alteplase (5% vs 1%, OR 9.7, p=0.031).

 

Revised SPC@ Pradaxa (dabigatran etexilate mesilate) hard capsules (all strengths)

electronic Medicines compendium

Section 4.4 has been updated to include a warning regarding thromboembolic risk in patients with antiphospholipid syndrome.

 

Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing

Medicines and Healthcare products Regulatory Agency

Following an increased risk of pulmonary embolism and overall mortality with tofacitinib 10 mg twice-daily in the study A3921133 rheumatoid arthritis study, a safety review has started and this dose (authorised for ulcerative colitis) is contraindicated in patients at high risk of VTE.

 

Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial

European Heart Journal

Study suggests that early discharge with continuation of rivaroxaban at home is safe and effective in certain low-risk patients with acute PE. Rate of symptomatic recurrent VTE or PE-related death within 3 months (primary outcome) occurred in 3 of 525 patients (0.6%; P <0.0001).

 

The rise and fall of aspirin in the primary prevention of cardiovascular disease

The Lancet

This narrative review discusses the role of aspirin in primary prevention of cardiovascular disease, contextualising data from historical and contemporary trials.

 

 

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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Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source

New England Journal of Medicine

RCT (n=5390) found that dabigatran was not superior to aspirin in preventing recurrent stroke, which occurred in 6.6% (4.1%/year) and 7.7% (4.8%/year), of patients, respectively. Incidence of major bleeding was not significantly greater in dabigatran group (1.7 vs. 1.4%).

 

Frequency of Intracranial Hemorrhage With Low-Dose Aspirin in Individuals Without Symptomatic Cardiovascular Disease: A Systematic Review and Meta-analysis

JAMA Neurology

Review of 13 RCTs (n=134,446) reports low-dose aspirin use among individuals without symptomatic cardiovascular disease (primary prevention) was associated with an increased risk of any intracranial bleeding especially in Asians, or people with a low body mass index.

 

Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions

Cochrane Database of Systematic Reviews

Review found 2 RCTs of 59 haemophiliacs only and reports beneficial effect of systemically administered tranexamic acid & epsilon aminocaproic acid in preventing postoperative bleeding. Definite efficacy in oral or dental procedures however is uncertain, due to limited evidence.

 

Less dementia and stroke in low-risk patients with atrial fibrillation taking oral anticoagulation

European Heart Journal

Study (n=91,254 with baseline CHA2DS2-VASc score ≤ 1) reports treatment with oral anticoagulation was associated with lower risk of dementia (subhazard ratio 0.6, 95% CI 0.48–0.81) in people aged >65 years; but the risk: benefit profile in <60 years is not so favourable.

 

Fragmin (dalteparin sodium) approved by FDA as first anticoagulant for children

PharmaTimes

The FDA has approved use in paediatric patients' ≥ 1 month of age to reduce recurrence of symptomatic venous thromboembolism. Approval was based on a single trial of 38 children with symptomatic deep vein thrombosis and pulmonary embolism treated with Fragmin for up to 3 months.

 

 

 

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

 

 

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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Spontaneous haemorrhage on apixaban masquerading as obstructive cholangitis after heart surgery

European Heart Journal

This case was a 73-year-old with a presentation of obstructive cholangitis, likely secondary to migration of blood into the common bile duct as a complication of apixaban (2.5 mg 2×/day) 16 days post coronary artery bypass grafting.

 

Meta-Analysis of Direct-Acting Oral Anticoagulants Compared With Warfarin in Patients >75 Years of Age

American Journal of Cardiology

Review (5 studies, n=28,135) reports DOACs have superior efficacy compared to warfarin in reducing stroke or systemic embolisation (HR 0.76, 95% CI 0.67 to 0.86, p <0.01). Apixaban appeared to have the best benefit vs risk profile in this population.

 

Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke

New England Journal of Medicine

RCT (n=225) found use of alteplase between 4.5 and 9.0 hours after stroke onset resulted in higher proportion of patients with no/minor neurologic deficits vs placebo (35.4 vs.29.5%;risk ratio, 1.44; 95% CI, 1.01 to 2.06; p=0.04) but more cases of symptomatic cerebral haemorrhage.

 

 

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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Stroke and transient ischaemic attack in over 16s: diagnosis and initial management – guidance (NG128)

National Institute for Health and Care Excellence

This guideline covers interventions in the acute stage of a stroke or transient ischaemic attack (TIA). It offers the best clinical advice on the diagnosis and acute management of stroke and TIA in the 48 hours after onset of symptoms.

 

Outpatient versus inpatient treatment for acute pulmonary embolism

Cochrane Database of Systematic Reviews

Low‐quality evidence (2 RCTs; n= 451) suggests that there is no clear difference between the interventions in overall mortality, bleeding and recurrence of pulmonary embolism.

 

Optimal Timing of P2Y12 Inhibitor Loading in Patients Undergoing PCI: A Meta-Analysis

Thrombosis and Haemostasis

Review of 23 studies (n=60,907) reported that early P2Y12 inhibitor loading (> 2 hours pre-PCI) was associated with better outcomes vs versus late (< 2 hours pre-PCI or post-PCI; RRR; 22% for MACE, 30% for MI, 25% for death; all p<0.001), without an impact on major bleeding.

 

Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial

JAMA Neurology

Secondary analysis of POINT RCT (n= 4881) reported a low risk of major hemorrhages in patients receiving either clopidogrel plus aspirin or aspirin alone (0.9% vs 0.2%; HR, 3.57; P = 0.003; NNH, 159). However, risk was still increased with dual therapy vs aspirin monotherapy.

 

Comparative Risk of Venous Thromboembolism in Rheumatoid Arthritis Patients Receiving Tofacitinib Versus Those Receiving Tumor Necrosis Factor Inhibitors: An Observational Cohort Study

Arthritis & Rheumatology

Review of 2 databases (n=50,865) found that occurrence of venous thromboembolism when initiating treatment with tofacitinib or a TNF inhibitor was infrequent (<1 per 100 person‐years), with no statistically significant difference in risk between the two treatments.

 

Combination Antiplatelet and Oral Anticoagulant Therapy in Patients With Coronary and Peripheral Artery Disease

Circulation

This review discusses developments in the roles of platelets and coagulation factors in atherothrombosis and addresses the rationale and clinical evidence for combining antiplatelet and oral anticoagulant therapy in patients with coronary and peripheral artery disease.

 

Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials

The Lancet

Analysis (20 RCTs;n=26,616) found risk of primary outcome was reduced with new-generation drug-eluting vs. bare-metal stents (HR 0.84, 95% CI 0.78–0.90,p<0·001) due to reduced risk of MI (HR 0·79,0·71–0·88;p<0.001) and possible slight but non-significant cardiac mortality benefit.

 

Individual Treatment Effect Estimation of 2 Doses of Dabigatran on Stroke and Major Bleeding in Atrial Fibrillation: Results from the RE-LY Trial

Circulation

Paper describes the derivation and validation of a prediction model for ischaemic stroke/ systemic embolism (SE) and major bleeding in patients with AF from the 3 treatment arms of the RE-LY trial (n=11,955 in derivation cohort, n=6,158 in validation cohort).

 

Atrial fibrillation type and renal dysfunction as important predictors of left atrial thrombus

Heart

In a real-world population of patients with AF, most on oral anticoagulation, left atrial appendage (LAA) thrombus was found in ~6%. Two variables not included in CHA2DS2-VASc score (AF type and renal dysfunction) proved strong, independent predictors of LAA thrombus.

 

Perception of the Risk of Stroke and the Risks and Benefits of Oral Anticoagulation for Stroke Prevention in Patients With Atrial Fibrillation: A Cross-Sectional Study

Mayo Clinic Proceedings

Study of 227 patients with mean CHA2DS2-VASc score 4.3, and HAS-BLED score 2.3, found negligible correlation between patient perceived and estimated risk of stroke (r=0.07; p=0.32), and bleeding (r=0.16; p=0.02). Most patients overestimated their risks of stroke and bleeding.

 

 

 

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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