Many patients receiving an ICD or a pacemaker are already receiving oral anticoagulants. Current guidelines recommend replacement of the oral anticoagulant with the temporary use of heparin as a bridging strategy. Now a new study, BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial), offers convincing evidence that this strategy is not beneficial and, in fact, results in an increase in device-pocket hematoma. Results of the trial were presented today at the Heart Rhythm Society meeting in Denver and published simultaneously in the New England Journal of Medicine.
A group of mostly Canadian investigators randomized 681 patients undergoing ICD or pacemaker implantation with an annual risk for thromboembolic events greater than 5% to either heparin bridging or continued warfarin. The trial was terminated early after a prespecified interim analysis by the data and safety monitoring board. The primary outcome — clinically significant device-pocket hematoma, which the investigators defined as a hematoma that led to prolonged hospitalization, interruption of anticoagulation, or hematoma evacuation — was significantly reduced in the continued-warfarin group, as were all three components of the endpoint:
Primary outcome: 3.5% with continued warfarin versus 16% with heparin bridging (RR 0.19, CI 0.10-0.36, p<0.001).
Click here to read the full story on Forbes.
The recent arrival of novel oral anticoagulants has provided important new options for venous thromboembolism (VTE) treatment and prevention. New indications for these drugs have been granted for patients with atrial fibrillation and following orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not appear likely in the near future, as a new trial published in the New England Journal of Medicine shows that one of these novel drugs, though effective at preventing VTE, also resulted in a significant increase in bleeding risk.
In the Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Acutely Ill Medical Patients Comparing Rivaroxaban with Enoxaparin (MAGELLAN), first presented at the American College of Cardiology meeting in 2011, more than 8,000 medically ill patients were randomized to subcutaneous enoxaparin for 1o days or oral rivaroxaban for 35 days.
Click here to read the full post in Forbes.
Don’t miss this very practical discussion about the new generation of anticoagulants over on CardioExchange. Here are a few excerpts.
Christian Thomas Ruff:
I believe the addition of the 3 currently approved novel anticoagulants (dabigatran, rivaroxaban, and apixaban) will eventually translate into a greater proportion of eligible patients being treated; it certainly has in my practice…
Although I think it is important to continue to develop reversal agents for the novel anticoagulants, I don’t think the lack of such an agent is sufficient reason to avoid using a novel anticoagulant.
I think that price is one of the most important factors that has hindered uptake of the novel agents. Although these drugs may well be “cost-effective” in complicated analyses that focused on the costs and benefits to society at large, it is the out of pocket expense for the drugs that really matters to patients…
Andrew E. Epstein:
It is highly unlikely that a direct comparison of the new anticoagulants will ever be done. Thus, we will have to choose between one or another based on pharmacokinetics, convenience, and perhaps formulary availability. Substudy analyses are also important…
I am concerned that although the elderly often have the most to gain from the new anticoagulants, they are also the patients at greatest risk for bleeding, especially if renal function is labile with drugs cleared by the kidneys. For such patients, warfarin should be considered.
Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that Pradaxa is now contraindicated in patients with mechanical heart valves. The change was based on a recent decision of the FDA, BI told its investigators.
The FDA action follows a similar decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which announced last week that it had recommended that Pradaxa be contraindicated in patients with prosthetic heart valves.
Both the FDA and the CHMP actions appear to be based on findings from the RE-ALIGN trial in patients with mechanical heart valves, which Boehringer Ingelheim announced last week had been stopped prematurely. (Click here for the CardioBrief story.) 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
One cardiologist who is a dabigatran investigator told CardioBrief that the label change
is consistent with the findings in Re-Align, although I wish it were presented and published in a peer reviewed journal. I do understand the urgency on behalf of the FDA to ensure that the use does not stray beyond its labeling for A-fib given both the prospective, randomized data from Re-Align and case reports of strokes on Pradaxa with mechanical valves. I don’t think this is the final word on Pradaxa (or other new generation anticoagulants), but if we are to use them, the doses will undoubtedly be different, and presumably higher, than the doses used for A-fib. The question is whether one can find a dose that prevents thromboembolic strokes with the new generation anticoagulants at an acceptable level of bleeding. It’s also worth noting that they did not recommend Pradaxa in patients with bioprosthetic valves, but didn’t absolutely contraindicate it. Yet.