Staff Writer

Abbott Laboratories had a busy Transcatheter Cardiovascular Therapeutics (TCT) 2019 conference. Among the news it generated was the unveiling of new analyses of the COAPT trial on the cost-effectiveness of Mitraclip vs. guideline-directed medical therapy (GDMT) alone in heart failure patients with secondary mitral regurgitation (MR).

In addition, the Abbott Park, Ill.-based company reported new data on its investigational Triclip device, which is aiming to help those with tricuspid regurgitation (TR). Abbott noted that Triclip was found to be safe and associated with strong clinical improvement at six months.

After six months, the TRILUMINATE feasibility study showed patients who received Abbott's Triclip device saw a number of benefits, such as a reduction of TR. A full 87% of patients had a reduction in their TR at six months. They also saw quality of life improvements, including better Kansas City Cardiomyopathy Questionnaire (KCCQ) scores and a reduction in symptoms that are associated with a reduced burden of their clinical condition and improved physical output.

The prospective, single-arm, multicenter TRILUMINATE feasibility study investigated the performance of Triclip, in 21 sites across the U.S. and Europe.

Word of these results comes about a month after Abbott reported that it had initiated a pivotal study to evaluate Triclip in those with severe TR. (See BioWorld MedTech, Sept. 6, 2019.) That study is expected to enroll about 700 patients in the U.S., Canada and Europe and randomize them to either Triclip or medical therapy. The primary outcome is the proportion of patients with all-cause mortality or tricuspid valve surgery, rate of heart failure hospitalizations and quality of life improvement, as seen in the KCCQ.

"There are currently no commercially approved minimally invasive devices on the market to treat a leaky tricuspid valve; the advancements shown in the TRILUMINATE feasibility study offer hope for people suffering from this difficult-to-manage and difficult-to-treat structural heart disease," said Neil Moat, chief medical officer of Abbott's structural heart business. "We have seen the need for a safe and effective device to treat the tricuspid valve without open heart surgery, so we have focused efforts to support this patient population."

Looking to Mitraclip

As the meeting kicked off, Larry Biegelsen, of Wells Fargo, wrote on a note on a meeting with Abbott's management, during which the company predicted a U.S. national coverage decision (NCD) for functional mitral regurgitation will come by June 2020. That move will expand the eligible population for Mitraclip from about 20,000 patients to more than 200,000.

Against this backdrop came the positive cost-effectiveness data. The company noted that transcatheter mitral valve repair using Mitraclip in those with significant secondary MR could boost life-expectancy by 1.13 years and quality-adjusted life-years by 0.82 years.

In addition, Mitraclip-treated patients with significant secondary MR yielded an incremental cost-effectiveness ratio (ICER) of $55,600 per quality-adjusted life year vs. GDMT. An ICER score of $55,600 implies that Mitraclip provides a positive health economic value.

In addition to the positive news related to cost effectiveness, COAPT data presented during second late-breaking data presentation showed that Mitraclip continued to remain safe over a longer term follow-up period, with durable MR reduction, reduced hospitalization rates, and improved survival and quality of life vs. medical therapy alone.

The three-year results from the study could help inform a coverage review being conducted by the Centers for Medicare and Medicaid Services for the expanded NCD of the procedure.

Structural heart standing out

Miles White, CEO of Abbott, highlighted the structural heart business during the company's second-quarter earnings call in July, calling out Triclip and Amplatzer Amulet, its left atrial appendage device to reduce the risk of stroke in patients with atrial fibrillation. Mitraclip also was mentioned positively.

"With the rapid adoption of Mitraclip in a highly underpenetrated market, as well as a pipeline of technologies targeting new growth areas that will launch over the next several years, our structural heart business is well positioned for strong, steady growth for years to come."

Indeed, Cowen analyst Joshua Jennings saw the company's structural heart business as making strides at TCT, also highlighting the Portico self-expanding transcatheter aortic valve replacement valve. Portico was shown to be noninferior to available valves – namely Edwards Lifescience Corp.'s Sapien and Medtronic plc's Corevalve, in extreme or high-risk aortic stenosis patients at one year. (See BioWorld MedTech, Sept. 30, 2019.)

"The news should be well received by clinicians and investors alike, as the clinical program had suffered setbacks including an extended enrollment period during which ABT addressed reduced leaflet mobility findings," Jennings noted.

For his part, Wells Fargo's Larry Biegelsen sees an unclear role for the device, particularly as the rate of paravalvular leak (PVL), vascular complications, and new pacemakers were higher in the Portico arm vs. control arm. While the new Flexnav delivery system, used in 100 patients, did lower the rate of vascular complications and pacemakers, PVL rates were not affected.

"We expect the next-generation Portico valve, which is being studied in a clinical trial now, to reduce the rate of PVL because it has a skirt."

Biegelsen said the next-generation device in the U.S. is expected in 2021, but should only capture about 4% of the transcatheter aortic valve replacement (TAVR) market. Jennings acknowledged that the Portico's role in TAVR has been the subject of debate, but its ease of deployment is a plus. "Abbott will, however, likely need to undercut competitors on price to gain market access according to our checks. MDT would most likely be a share donator in this scenario," he added.

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