Positive results supporting the use of non-invasive heart valve replacement as a potential alternative to surgery, plus evidence a new class of cholesterol-lowering drugs may also reduce the risk of cardiac events were just two of the highlights from the second day of the American College of Cardiology meeting this past weekend.
One of the most highly anticipated studies presented at the 64th annual ACC Scientific Sessions in San Diego Sunday were results from the PARTNER 1 trial that looked at outcomes of patients who underwent transcatheter aortic valve replacement who were deemed to be at high risk to have open heart surgery.
Five-year outcomes among TAVR patients were similar to those of surgical patients, according to the subsequent study published Sunday in the Lancet.
Data for the findings were based on 699 patients, of whom 348 received TAVR and 351 underwent surgery. At five years, risk of death was 67.8% in the TAVR group compared with 62.4% in the surgical aortic valve replacement group.
“Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes,” researchers wrote.
TAVR was first approved in the U.S. in 2011 by the Food and Drug Administration for use in patients not eligible for surgery. The technique involves inserting a prosthetic valve with a catheter threaded through an artery in the groin or rib cage. The method typically requires a shorter recovery time than open-heart surgery. Approval was granted in 2012 to expand TAVR for use in patients at high risk for surgery.
Valve replacement is the recommended treatment for severe cases of aortic stenosis, a condition in which the heart's aortic valve narrows; it affects more than 1 million Americans, most of them elderly.
Despite the results, cost concerns over a TAVR device, which can run more than $30,000 compared with the $4,000 to $7,000 price of surgical valves, could act as a barrier to increased use.
Also presented at the session on Sunday were results of a study that found patients who took PCSK9 inhibitors along with standard therapy saw a 61% drop in low-density lipoprotein cholesterol in 12 weeks, which was sustained over a period of 11 months. Findings were published in the New England Journal of Medicine and were based on a clinical random trial of more than 4,500 patients who took Amgen's new drug evolocumab.
“The reduction in LDL was profound and that may be why we saw a marked reduction in cardiovascular events so quickly,” study lead author Dr. Marc Sabatine said in a statement. “It suggests that if we can drive a patient's LDL cholesterol down a large amount to a very low level, we may start to see a benefit sooner than would be expected with a more modest intervention.”
PCSK9 inhibitors are being heralded by many as a potential breakthrough in lowering cholesterol. For years statins have been the primary drugs used for the conditions. But studies have shown they are not effective in some patients. PCSK9 inhibitors appear to work effectively to lower cholesterol in those patients where statins have not worked, making it a potential blockbuster drug.
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