This article is a collaboration between MedPage Today and:
WASHINGTON -- Transcatheter aortic valve replacement (TAVR) with CoreValve had durable survival benefits at 2 years for extreme-risk aortic stenosis patients and was cost-effective for high-risk patients too, studies showed.
In one study, the rate of all-cause mortality or major stroke risk at 2 years was 38.0% in the extreme-surgical risk group, outdoing the performance goal of 57.9%, , of OhioHealth Research Foundation in Columbus, and colleagues found.
Action Points
- Note that these studies were published as abstracts and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
In the high-risk cohort of the same pivotal CoreValve trial, the more modest 0.24 years of life gained by the procedure in the first year versus surgical treatment still appeared cost-effective, they reported here at the Transcatheter Cardiovascular Therapeutics meeting.
Based on results of the second study, the projected lifetime incremental cost-effectiveness ratios were about $67,000 per quality-adjusted life-year (QALY) gained and $57,000 per life-year gained, reported , of the Harvard Clinical Research Institute in Boston, and colleagues.
Lowering the cost of the initial hospitalization for the procedure by about $2,000 to $4,000 per patient in sensitivity analysis lowered those ratios to under the $50,000 mark suggested by the American College of Cardiology and American Heart Association to be high value.
"I think we can go back [home] and say we don't do what we did 3 years ago; we're much more sophisticated now," commented Jeffrey J. Popma, MD, at a TCT press briefing. "This is a worst case analysis, and things are just going to get better."
Popma, an interventional cardiologist at Beth Israel Deaconess Medical Center in Boston, was not involved in the trial.
"It is hard to imagine 5 years from now that TAVR won't be the routine choice," agreed , of Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J., who also wasn't involved in the trial.
One question was what to think about the paravalvular leak findings from the CoreValve trial analyses, he noted.
The analysis included all 489 patients in the single-arm, extreme-risk cohort of the trial who received the device via iliofemoral access. Among them, 250 survived to be followed up at year 2.
Paravalvular regurgitation results were roughly identical at year two as at year one, with mild leak in 30.8% of participants and moderate leak in 4.4%. No patients had severe leaks.
Mild or moderate paravalvular regurgitation had no association with mortality, unlike in the extreme-risk cohort of the pivotal PARTNER trial with the Sapien TAVR device, reported at the same TCT session.
Moderate to severe leak was associated with 74.6% cardiovascular mortality at 5 years compared with 51.3% with no more than mild regurgitation in that analysis (P=0.043).
"This begs comparison with the PARTNER-B results," Turi commented, though noting the difference in surgical risk score between trials. "It is somewhat reassuring, if you keep in mind the Sapien 2-year results showed a significant relationship between paravalvular leak and mortality .... Some of us thought there was an association and not causality."
Regardless, "there should be every effort -- whether it's associated with mortality or not -- to reduce the incidence of paravalvular leak," cautioned , of Columbia University Medical Center/New York-Presbyterian Hospital in New York City and TCT press conference moderator.
Other 2-year CoreValve findings included:
- Improvement in New York Heart Association classification by at least one class in 92% of patients and by at least two classes in 58%
- Durable improvement in hemodynamic valve performance
The cost-effectiveness analysis included all 747 patients in an as-treated population of the high-risk portion of the trial, which randomized patients to surgical or transcatheter valve replacement. It assumed a cost of $32,000 for the device itself and no further survival advantage to TAVR beyond 12 months.
The results did look more cost-effective if assuming some benefit beyond that time point as well, Reynolds noted.
Disclosures
The trial was funded by Medtronic.
Yakubov disclosed no relationships with industry.
Reynolds disclosed relationships with Medtronic and Edwards Lifesciences.
Primary Source
Transcatheter Cardiovascular Therapeutics
Source Reference: Reynolds MR, et al "US CoreValve High Risk Trial: Cost-effectiveness analysis from a prospective, randomized trial of transcatheter aortic valve replacement with a self-expanding device versus surgical aortic valve replacement in high-risk patients with aortic stenosis" TCT 2014; LBCT 2.
Secondary Source
Transcatheter Cardiovascular Therapeutics
Source Reference: Yakubov SJ, et al "The CoreValve US Pivotal Trial: Two-year results with a self-expanding bioprosthesis in extremely high-risk patients with aortic stenosis" TCT 2014; First Report 1.