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Low-Risk TAVR in Spotlight at ACC

NEW ORLEANS — The future of aortic valve procedures will be decided here at the American College of Cardiology meeting with presentation of the PARTNER 3 and CoreValve trials in low-surgical risk patients.

The two large-scale trials pitting transcatheter aortic valve replacement (TAVR) devices against surgery in patients at no more than a 3% to 4% predicted risk of 30-day surgical mortality are widely expected to lead to regulatory approval for TAVR to expand into this much larger population.

In high- or intermediate-risk patients, “the previous studies have already demonstrated for us that the transcatheter replacement of the aortic valve is an alternative to surgical approaches, and not surprisingly many patients prefer a nonsurgical strategy when it is a reasonable strategy,” said conference vice-chair Pamela Morris, MD, speaking at a press briefing before the meeting.

So for low-risk patients, “these trials are potentially practice changing,” said Morris, of the Medical University of South Carolina in Charleston.

The vast majority of aortic valve replacement candidates are at low surgical risk, noted conference chair Andrew Kates, MD, of Washington University School of Medicine in St. Louis, Missouri. However, he cautioned on the briefing call that there will be more to the story: “The challenge will be to see the durability of catheter valve replacement in the population over the long term.”

Nor did the studies address mechanical valves, which for many younger patients may still be an important consideration, Kates noted.

Another headliner for the ACC meeting will be comprehensive primary prevention guidelines, slated for release on Sunday afternoon.

These joint recommendations from the ACC and American Heart Association “will update and consolidate previous prevention guidelines,” Morris said. “This would include the 2013 cardiovascular risk assessment guideline, the 2013 lifestyle guideline, [the] 2013 overweight and obesity guideline, and then include information from the 2017 hypertension and the 2018 cholesterol guidelines, particularly where they relate to primary prevention.” Other facets include recommendations on diet, exercise, and alcohol use, she added.

Among the key late-breaking clinical trials on the docket is the Apple Heart Study, which looks at the Apple Watch’s optical sensors in screening for arrhythmias. The findings are to be presented Saturday morning.

“What’s going to be important to see is if the study does show that wearable devices are helpful in predicting atrial fibrillation,” said Kates. “We get approached on a regular basis by patients using these devices for our feedback as to whether or not they are helpful.”

However, Morris noted that the outcomes, as listed on clinicaltrials.gov, still don’t get at hard clinical outcomes such as stroke or cardiovascular mortality. Self-reported contact with a health provider and accuracy compared with ECG monitoring are secondary endpoints.

For patients with diagnosed atrial fibrillation, the AUGUSTUS trial will attempt to nail down the best combination of antiplatelet and anticoagulant agents after a recent coronary event. “It will impact clinical practice,” predicted Morris.

Along with AUGUSTUS on Sunday’s program are subanalyses from the COAPT trial, which just gained the MitraClip device an indication in secondary (functional) mitral regurgitation. Echocardiographic and quality of life findings are slated for presentation.

“If it doesn’t improve quality of life, then I think it may give us some equipoise in how much we utilize that as a technology moving forward,” Kates said.

Then on Monday — just days after the first pivotal trial of novel oral LDL-lowering drug bempedoic acid was published — the companion trial, CLEAR Wisdom, will be presented. Topline results already released showed safety and modest efficacy, but the details will be fleshed out.

“Due to the expense of the PCSK9 inhibitors, there is a gap in affordable oral agents that can help to further lower LDL in high-risk patients,” Morris noted.

1969-12-31T19:00:00-0500

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