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As clinicians, we are all familiar with the knowledge that clinical trials bring in terms of drugs and how management strategies compare with each other. However, the relationship between clinical trials and real-world practice is uncertain. Clinical trials enforce standard protocols which may not reflect what really happens in everyday practice. Registries are emerging as important and give us valuable insights into current clinical...

... practice.

AF (atrial fibrillation) is well known as a risk factor for stroke; effective anticoagulation is essential to reduce the impact of AF-related stroke on patients. Concomitant medical conditions, such as coronary artery disease or angina, increase the risk of AF and can influence its subsequent management. Data from several large registries recently presented at the European Society of Cardiology (ESC) congress, held in Munich from 25 to 29 August 2012, promise to help improve our understanding of this clinical problem.

Unstable angina and coronary artery disease both increase the risk of postoperative AF in patients after coronary artery bypass graft (CABG). Guidelines recommend pre-operative prophylaxis using beta-blockers or calcium channel blockers; however, data from the CAPS-Care STS registry, presented by Dr Piccini, highlight that, in routine clinical practice, prophylaxis may not significantly reduce the risk of AF. These findings further compound the uncertainty surrounding the effectiveness of AF prophylaxis before CABG.

ESC guidelines recommend that triple therapy with VKA, aspirin, clopidogrel be considered in the short-term in AF patients experiencing ACS; in the longer-term VKA plus clopidogrel is recommended. However, data from the GARFIELD registry, presented by Dr Verheugt, showed that 31.4% of all ACS patients received an oral anticoagulant (VKA) alone. Other data from GARFIELD highlighted considerable deviation from guideline recommendations for antithrombotic therapy across the range of patients with AF.

Catheter ablation for AF is an evolving treatment option for patients with drug-refractory paroxysmal and persistent AF. Data from the ORBIT-AF registry, presented by Dr Piccini, showed that despite the proven benefits, in US community practice, patients with anaemia, chronic obstructive pulmonary disease or prior myocardial infarction were less likely to receive ablative treatment for AF. Moreover, in those patients that had ablation a significant number still required antiarrhythmic therapy.

These real-world examples clearly highlight that further improvements are needed to reduce the risk of AF and manage it effectively, particularly in patients with other medical conditions. Other ongoing registries, including the recently announced GLORIA-AF, will provide additional information on AF and have the potential to guide real world clinical practice in the future.

Professor Alexander GG Turpie

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Drug News

PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors

19-06-2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the effects of the painkiller diclofenac on the heart and circulation when given systemically...

RELY-ABLE trial shows long-term safety profile of Pradaxa (Boehringer) in patients with Atrial Fibrillation

16-06-2013

Results from the RELY-ABLE trial, a long-term extension of the pivotal RE-LY study of Pradaxa (dabigatran etexilate), from Boehringer, in patients with non-valvular Atrial Fibrillation (NVAF),...

Study of Kendall Sequential Compression System (Covidien) shows reduced risk of DVT

02-06-2013

Data from the CLOTS 3 trial, a multicenter, parallel group trial of 2,876 immobile stroke patients indicates that intermittent pneumatic compression (IPC) treatment using Kendall SCD Sequential...

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Recent Drug Updates

Eliquis 2.5 mg film-coated tablets

06-03-2013

Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with...

Eliquis 5 mg film-coated tablets

06-03-2013

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA);...

Pradaxa 75 mg hard capsules

06-03-2013

Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery....

Clinical Guidelines

Ivabradine for treating chronic heart failure

Nov 2012

Ivabradine (Procoralan, Servier Laboratories) is a heart-rate-lowering agent that selectively and..

... specifically inhibits the cardiac pacemaker If current, which controls the spontaneous diastolic depolarisation in the sinus node that regulates the heart rate.

Alteplase for treating acute ischaemic stroke

Sep 2012

Alteplase (Actilyse, Boehringer Ingelheim) is a tissue plasminogen activator manufactured by..

... recombinant DNA technology. It activates the production of plasmin from its precursor plasminogen. Plasmin is an enzyme that degrades fibrin clots. The aim of treatment is to reduce the impact of ischaemia by restoring blood flow through the occluded (blocked) artery.

Clinical Trials

Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

05-04-2013

This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not..

... known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.

Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication (SATORI)

05-03-2013

National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an..

... improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.

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Medical Journal Abstracts

Safety and Efficacy of Ultra-high-dose, Short-term Thrombolysis with rt-PA for Acute Lower Limb Ischemia

European Journal of Vascular and Endovascular Surgery
May 2013

Objectives: The evaluation of success and complication rates of ultra high-dose recombinant tissue plasminogen activator (rt-PA) administered over a short time frame in the treatment of acute lower limb ischemia. Methods: This was a prospective single-center study. The outcome of treatment in 97 patients with acute..

25-hydroxyvitamin D concentrations and risk of venous thromboembolism in the general population with 18,791 participants

Journal of Thrombosis and Haemostasis
Dec 2012

Background: Vitamin D has potential antithrombotic effects suggesting that vitamin D analogs could be used as adjunctive antithrombotic agents. However, epidemiological evidence of an association between reduced 25-hydroxyvitamin D concentrations and risk of venous thromboembolism is lacking. Objectives: We tested the..

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