CardioExchange Archive

May 24th, 2013

Rivaroxaban Gains Approval in Europe for ACS Indication

Larry Husten, PHD

Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive […]

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May 9th, 2013

Bruise Control: Continued Warfarin Beats Heparin Bridging During Device Implantation

Larry Husten, PHD

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 […]

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April 30th, 2013

Anticoagulation Update: New Agent for Urgent Anticoagulation Reversal, Pradaxa Label Revised

Larry Husten, PHD

Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation. The FDA yesterday approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Unlike plasma, which is currently the only available method to reverse […]

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April 4th, 2013

Registry Study Offers Reassurance About Safety and Efficacy of Dabigatran

Larry Husten, PHD

As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American […]

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March 22nd, 2013

Europe and U.S. Diverge on Two New Drugs

Larry Husten, PHD

The U.S. FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected — for the second time — an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the […]

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March 18th, 2013

Vena Cava Filters: Little Evidence and Wide Variation in Use

Larry Husten, PHD

Despite the absence of any evidence demonstrating benefit or showing how best to use them, vena cava filters (VCF) are used in most hospitals. Now a new study published in JAMA Internal Medicine suggests that this same lack of evidence results in an extremely broad rate of use in different hospitals. An accompanying viewpoint raises the […]

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March 13th, 2013

FDA Officials Calm Concerns Over Excessive Bleeding with Dabigatran

Larry Husten, PHD

Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases of bleeding associated […]

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March 5th, 2013

FDA Again Rejects ACS Indication for Rivaroxaban

Larry Husten, PHD

For the second time the FDA has turned down the supplemental new drug application (sNDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary syndrome (ACS). Despite early hopes, the ACS indication has proved tantalizingly elusive for the drug.  When the pivotal ATLAS ACS 2-TIMI 51 trial was unveiled in 2011 it […]

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February 20th, 2013

New Studies Examine Prolonged Anticoagulation for VTE Recurrence

Larry Husten, PHD

Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE). In the RE-MEDY and the RE-SONATE trials, the role of dabigatran was examined in patients who had completed at least 3 months […]

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February 14th, 2013

No Aspirin After DES? Is This The Wild, Wild WOEST?

Richard A. Lange, MD, MBA and L. David Hillis, MD

According to the recently published results of the WOEST trial, patients receiving anticoagulation thereapy who undergo stenting have better outcomes with clopidogrel only than with clopidogrel plus aspirin. Rick Lange and David Hillis ask: Are you ready to stop prescribing aspirin to these patients?

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