American College of Cardiology Announces Late-Breaking Clinical Trials Reply

The American College of Cardiology announced the lineup of late-breaking clinical trials for its upcoming annual meeting in Washington, DC. The opening session will include the most eagerly anticipated trials– the main results of Symplicity HTN-3 and the  comparison of Corevalve and surgery in high risk patients. Subsequent sessions will include several phase 3 trials of  PCSK9 inhibitors. Here is the complete list of trials:

Click here to read the full post on Forbes.

 

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Minority Report: Five Guideline Authors Reject Change In Blood Pressure Goal Reply

It didn’t seem possible but the guideline situation just got even more confusing. Last December, after  years of delay and other twists and turns, the Eighth Joint National Committee (JNC 8) hypertension guideline was published in JAMA. The previous guideline recommended that all adults have a target systolic blood pressure below 140 mm Hg. In the new guideline, the target remained the same for adults under 60 years of age but for people over the age of 60 the new guideline set a more conservative, easier-to-achieve target of 150 mm Hg or lower.

Now, however,  five of the 17 JNC 8 authors have written a commentary, published in Annals of Internal Medicine, disagreeing with this change. They say they are in agreement with the other major recommendations of JNC 8 but that they reject the new target, arguing that the evidence does not support the change, and predict that the change may well lead to harmful consequences.

Click here to read the full post on Forbes.

Confusion

 

Eplerenone May Help Prevent Heart Failure In Acute STEMI Patients Reply

A new trial presented at the ACC in San Francisco suggests that the mineralocorticoid receptor antagonist eplerenone Pfizer, Inspra) may help prevent the development of heart failure when given acutely in STEMI patients without preexisting heart failure.

In the REMINDER trial 1,012 STEMI patients were randomized to eplerenone or placebo. After 10.5 months of followup, the primary endpoint– the time to CV mortality, rehospitalization or extended initial hospital stay due to diagnosis of HF, sustained ventricular tachycardia or fibrillation, EF ≤40% after 1 month, or an elevation of BNP/NT-proBNP after 1 month– occurred in 18.4% of the eplerenone group versus 29.6% of the placebo group ((HR, 0.581; 95% CI; 0.449-0.753; P<0.0001).

Click here to read the full story in Forbes.

ACC And STS Break New Ground To Test TAVR For Unapproved Uses Reply

In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and hope to gain an IDE for at least two more trials. The news was first reported by The Gray Sheet (subscription required) on February 8.

The new development represents a significant enlargement of the TVT registry, already run by the ACC and STS, which tracks all TAVR usage in the US.

Click here to read the entire post on Forbes.

ACC STS TVT logo