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Disappointing results here for novel anticoagulants in patients with mechanical heart valves

Old CardioBrief

Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board

The RE-ALIGN trial was an open-label, 12-week randomized comparison of warfarin and dabigatran in 400 patients who received a mechanical valve. The first arm randomized patients during their initial hospital stay. The second arm randomized patients more than 3 months after their surgery.

Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for one of the newer oral anticoagulants has been stopped.

In October Boehringer told members of its speakers bureau that the post-surgery arm of…

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This post refers to

‘Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data’ by Carl Heneghan and others of The Self-Monitoring Trialist Collaboration  that was published in The Lancet – 28 January 2012, Vol. 379, Issue 9813, Pages 322-334 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61294-4/abstract?rss=yes

I never wanted this to be a medico-political blog but it has been difficult to avoid given the barbs that have fired at cardiologists over the last few weeks. I’m sure there will be more to come…

Anyway, for now at least, it’s nice to get back to reading some science.

One of my mentors as a medical student, in fact the senior physician on my first medical rotation at medical school, was the diabetes expert Prof. Robert Tattersall. Undoubtedly, Tattersall’s major contribution to medicine was his work promoting home blood glucose monitoring for people with diabetes. In his book, Diabetes: The Biography, he hands most of the credit to Dr Clara Lowy of St Thomas’s who allowed a pregnant diabetic patient to monitor her own blood sugar at home using a machine loaned by the hospital. This might not seem extraordinary now but at the time, as recently as 1975, this was seen as ‘irresponsible and dangerous’ by many colleagues. Tattersall is too modest about his part in this revolution, neglecting to mention that he led the ‘Nottingham Group’ that in 1978 published their experience alongside that of Lowy, in Issue 8067 of The Lancet.

So this meta-analysis concerning self-testing and management of anticoagulation from Oxford, caught my eye. The findings are particularly relevant to patients with mechanical artificial heart valves. Although the risk of thrombo-embolic complications is low with modern mechanical valves self-management of anticoagulation appears to have a fairly dramatic effect in reducing this risk further, without any increase in bleeding. This didn’t translate into a reduction in mortality although the trend was in favour.

Despite being available for some years self management of anticoagulation has never really caught on, probably for a variety of reasons. In Australia cost has been a significant hurdle. Nevertheless, inertia amongst the medical community, similar to that experienced by Tattersall and Lowy has probably also played its part.

Given the bad press surrounding the new oral anticoagulant dabigatran, and the lack of a defined role in patients with mechanical valves, it seems that warfarin still has some years to run. The Last Cardiologist will be taking another look at the whole place of self management of warfarin for his patients, and particularly those with mechanical valves.