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Avatar of Larry Husten, PHD

FDA Panel Gives Cautious Endorsement to Novel Boston Scientific Device (9 Oct 2014)

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The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use. The panel wrestled…

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Avatar of Harlan M. Krumholz, MD, SM

Another Reason for Open Access to Clinical Trial Data? (7 Oct 2014)

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Harlan M. Krumholz, MD, SM

A correction to the RE-LY trial results, partly brought to light because of litigation, has Harlan Krumholz wondering if this is another example of why we should have open access to clinical trial data.

Avatar of Larry Husten, PHD

FDA Grants Apixaban Expanded Indication for Venous Thromboembolism (21 Aug 2014)

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The FDA today approved an expanded indication for the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. The supplemental new…

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Avatar of Larry Husten, PHD

Large Analysis Supports Thrombolysis for Stroke (5 Aug 2014)

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Although thrombolysis for ischemic stroke has been widely recognized as beneficial, its use has been limited because of concerns about its effects in patients treated after 3 hours, in older patients, and in patients with mild and with severe strokes. Now a meta-analysis published in the Lancet offers evidence that the use of thrombolysis should be…

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Avatar of Larry Husten, PHD

More Questions Raised About Dabigatran (23 Jul 2014)

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Once again, dabigatran (Pradaxa) has raised the wrath of the critics. Several articles (see here, here, and here) and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The…

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Can Bivalirudin Stand the HEAT? (14 Jul 2014)

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Peter B Berger, MD

Harlan Krumholz interviews Peter Berger, an editorialist for the HEAT-PPCI study, about the paper’s findings.

Avatar of Larry Husten, PHD

HEAT-PPCI: Heparin Beats Bivalirudin in Primary PCI (7 Jul 2014)

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Although there is broad consensus in the medical community that primary PCI is the best treatment for MI patients when it can be delivered promptly, there is no agreement about the best accompanying drug regimen, which usually entails a combination of antiplatelet and antithrombotic drugs. The role of one antithrombotic, bivalirudin (Angiomax, The Medicines Company) has…

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To Screen or Not for AF: Is That the Question? (26 Jun 2014)

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Up to one third of ischemic strokes are of uncertain etiology or “cryptogenic,” meaning that there is no overt explanation such as severe carotid stenosis, intracranial stenosis, or documented atrial fibrillation (AF). For some of these patients, intermittent AF may be present and could explain the ischemic stroke. This issue has been addressed by two…

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A Meta-Look at Thrombolysis vs. Conventional Anticoagulation for PE (17 Jun 2014)

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Jay Giri, MD, MPH and Saurav Chatterjee, MD

Jay Giri and Saurav Chatterjee discuss their meta-analysis of trials comparing thrombolytic therapy and conventional anticoagulation in patients at intermediate risk for pulmonary embolism.

Avatar of Larry Husten, PHD

Mixed Results for Thrombolysis in Pulmonary Embolism (17 Jun 2014)

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  The role of thrombolytic therapy for the treatment of pulmonary embolism has been unclear, as it has been difficult to measure the precise balance between enhanced clot-dissolving efficacy and greater bleeding risk produced by thrombolysis when compared with conventional anticoagulation. A new meta-analysis published in JAMA analyzed data from 16 randomized trials including 2115 patients….

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