Despite a lack of evidence, circulatory support with intraaortic balloon counterpulsation (IABP) has a class 1 recommendation in the guidelines and is often used in patients in cardiogenic shock following myocardial infarction for whom early revascularization is planned. That situation may change soon, as no benefit was found for the use of IABP in the…
ESC: Trial Finds No Benefit For Intraaortic Balloon Counterpulsation In Cardiogenic Shock
August 27, 2012 by 2 Comments
TRILOGY At ESC: No Advantage For Prasugrel Over Clopidogrel In Medical ACS Patients
August 26, 2012 by Leave a Comment
The newer antiplatelet agent prasugrel was no better than the old standby clopidogrel for treating patients with acute coronary syndrome (ACS) who are not undergoing revascularization. The results of the TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) trial were presented by Matt Roe at the European Society of…
New Universal Definition Of MI Unveiled At ESC 2012
August 25, 2012 by 1 Comment
A new universal definition of myocardial infarction (MI) was unveiled today at the European Society of Cardiology meeting in Munich. The document was developed jointly by the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA) and the World Heart Federation (WHF) and will be published in five journals:…
NHLBI Announces 7000 Patient Trial Testing Inflammation Hypothesis
August 22, 2012 by 2 Comments
The National Heart, Lung, and Blood Institute (NHLBI) has announced the launch of a large clinical trial testing the inflammation hypothesis. Paul Ridker is the principal investigator of the trial, which will be known as the Cardiovascular Inflammation Reduction Trial (CIRT). CIRT will enroll 7,000 patients who are stable following a heart attack but are at high…
TNF Inhibitors Linked To MI Reduction In Psoriasis Patients
August 20, 2012 by 1 Comment
Psoriasis patients who take TNF inhibitors have a significant reduction in the risk for myocardial infarction (MI), according to a retrospective cohort study published in Archives of Dermatology. Although previous research suggested that the anti-inflammatory effects of methotrexate, an older therapy, may be beneficial in this population, the cardiovascular effects of TNF inhibitors had not been well…
Troponin Test May Allow Rapid MI Rule-Out in the Emergency Department
August 13, 2012 by Leave a Comment
More than three-quarters of people with chest pain can be triaged within an hour of arrival at the emergency department with a novel strategy utilizing high-sensitivity cardiac troponin (hs-cTnT), according to a study from Switzerland published in the Archives of Internal Medicine. The strategy is promising, according to anaccompanying editorial, but much work remains before it can be implemented…
RIFLE-STEACS: Radial Access Improves Outcome In Early Invasive Therapy
August 1, 2012 by Leave a Comment
For early invasive therapy for ST-segment elevation acute coronary syndrome (STEACS), the use of radial access instead of femoral access reduces bleeding complications and improves outcomes, according to the results of the first large randomized trial testing the two approaches in this population. The results of the Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary…
ROMICAT-II Provokes Opposing Views On CT Angiography In The Emergency Department
July 25, 2012 by 1 Comment
For patients with suspected acute coronary syndromes (ACS) CT angiography (CTA) compared to standard treatment can reduce the time in the emergency department (ED), according to results of the ROMICAT-II (Rule Out Myocardial Infarction/Ischemia Using Computer-Assisted Tomography) trial published in the New England Journal of Medicine. However, CTA resulted in more tests being performed and…
Elevated Risk of Acute MI Following Total Hip And Knee Replacement Surgery
July 23, 2012 by 1 Comment
A large study reports a high increased risk for acute MI (AMI) in the first 6 weeks after total-hip replacement (THR) or total-knee replacement (TKR) surgery. Analyzing a nationwide cohort from Denmark that included 95,227 patients who underwent THR or TKR and matched controls, Arief Lalmohamed and colleagues calculated the adjusted hazard ratios (HR) for AMI. Their…
Ticagrelor Joins Clopidogrel And Prasugrel In Updated NSTEMI Guidelines
July 16, 2012 by Leave a Comment
Ticagrelor (Brilinta, AstraZeneca) gains equal standing with prasugrel (Effient, Lilly) and clopdiogrel in the newly released focused update of the ACCF/AHA guidelines for unstable angina and non-ST-elevation myocardial infarction (NSTEMI). The change had been widely anticipated since last year’s FDA approval of ticagrelor. “We have put it on equal footing with two other antiplatelet medications,…
Stem Cell Therapy Company Hypes Preliminary Results
July 5, 2012 by 3 Comments
Update (July 6)– I have heard from several investigators in the trial that the Osiris press release was issued without any input or consultation from the site investigators. In fact, the site investigators, including several who are extremely experienced clinical trialists, have expressed frustration and disappointment because their input has not been sought at any point…
FDA Rejects ACS Indication for Rivaroxaban (Xarelto)
June 21, 2012 by 2 Comments
The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending the new indication, which was based on…
Live Blog: The FDA Advisory Panel For Rixaroxaban for ACS
May 23, 2012 by 1 Comment
Here’s my live-blogg of the FDA’s Cardiovascular and Renal Drugs Advisory Committee meeting to consider the supplemental new drug application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. Here is a link to the FDA briefing documents. ========================= 4:48: Meeting adjourned! J&J has just issued a press release…
Rivaroxaban For ACS Gets Positive FDA Review, But Questions About ATLAS Trial Conduct Persist
May 21, 2012 by 2 Comments
The FDA will offer generally positive but also highly mixed advice to the FDA’s Cardiovascular and Renal Drugs Advisory Committee when it meets on Wednesday to consider the supplemental new drug application for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. The FDA posted the briefing documents…
The Medicines Company Collaborates with AstraZeneca To Sell Brilinta (ticagrelor)
April 25, 2012 by Leave a Comment
The Medicines Company will collaborate with AstraZeneca to help sell Brilinta (ticagrelor), AstraZeneca’s struggling oral antiplatelet drug. The collaboration is the first stage of “a global collaboration for acute ischemic heart disease compound” announced by the two companies today. AstraZeneca will pay $15 million per year for The Medicines Company’s Brilinta-related sales activities, scheduled to begin in May….
Study Supports CT Angiography to Rule Out CAD in Chest-Pain Patients
March 26, 2012 by Leave a Comment
Six million people each year in the US go to the emergency department (ED) with acute chest pain. Although only 10-15% of them turn out to have an acute coronary syndrome (ACS), most are admitted to the hospital. Coronary CT angiography (CCTA) has been proposed as a good method to quickly establish the presence or absence…
Novel Antiplatelet Agent Reduces CV Events But Increases Bleeding
March 24, 2012 by 1 Comment
Vorapaxar, the novel antiplatelet agent from Merck, appears to effectively reduce cardiovascular death and ischemic events in patients with MI, ischemic stroke, or peripheral vascular disease, but its potential utility is clouded by bleeding complications, including intracranial hemorrhage. Results from the TRA 2P-TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) trial were presented…
Questions Raised About Antiplatelet Therapy in Chronic Kidney Disease
March 19, 2012 by Leave a Comment
Many people develop chronic kidney disease (CKD) as they grow older, and many people with CKD take antiplatelet agents to prevent cardiovascular events. However, the efficacy of antiplatelet therapy in CKD has not been examined, despite the fact that people with CKD are more likely to die from nonatherosclerotic conditions and are more likely to…
FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients
February 28, 2012 by Leave a Comment
The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk of cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months…
Bleeding Problems Continue To Bedevil Merck’s Novel Antiplatelet Agent Vorapaxar
February 7, 2012 by 1 Comment
In the large TRA-2P study of more than 26,000 patients with MI, ischemic stroke, or documented peripheral vascular disease, the novel antiplatelet agent vorapaxar significantly reduced the primary endpoint of CV death, MI, stroke or urgent coronary revascularization. But vorapaxar treatment resulted in a significant increase in bleeding, including intracranial hemorrhage. The fate of vorapaxar now appears to…
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