ACURATE neo’s (Boston Scientific) place in the treatment of severe aortic stenosis is unclear after failing to divulge noninferiority in a head-to-head comparison with one other self-expanding, supra-annular transcatheter valve and reporting lackluster outcomes at 1 year in the SCOPE I trial.
The valve stumbled final year in SCOPE I when it didn’t save noninferiority when in comparison with the balloon-expandable intra-annular Sapien 3 (Edwards Lifesciences) valve at 30 days.
Within the SCOPE II trial, the ACURATE neo took on the self-expanding CoreValve Evolut (Medtronic) in 796 older adults (mean age, 83 years; 67.5% females) with symptomatic severe aortic stenosis (STS-PROM safe, 4.6%).
The main endpoint of all-space off loss of life or any stroke at 1 year took place in 15.8% of ACURATE neo patients and 13.9% of CoreValve patients in an blueprint-to-take care of diagnosis (one-sided better 95% self assurance limit, 6.1%; P = .0549 for noninferiority).
In a per-protocol diagnosis, the main endpoint took place in 15.3% and 14.3%, respectively (one-sided better 95% self assurance limit 5.4%; P = .0314 for noninferiority).
The compare would per chance per chance no longer claim noninferiority, on the alternative hand, since the protocol required each analyses to divulge noninferiority at a margin of 6%, explained Corrado Tamburino, MD, PhD, University of Catania, Italy.
The findings were supplied in a dead-breaking scientific trial session on the virtual assembly of Transcatheter Cardiovascular Therapeutics (TCT) 2020 and printed concurrently in Circulation.
Rates of all-space off mortality and stroke were identical in each groups, even supposing cardiac deaths were vastly bigger in the ACURATE neo community in the blueprint-to-take care of (31 vs 14) and per-protocol (39 vs 13; P for every = .01) analyses.
Session co-moderator Martin Leon, MD, NewYork-Presbyterian/Columbia University Irving Scientific Center, New York City, said “loss of life events frequently form us worried” and identified that procedural and intraprocedural deaths were additionally bigger with ACURATE neo, at 8 vs 1. “Can you give us more clarity on the loss of life events that would per chance per chance per chance again us feel much less anxious that there in actual fact is a mortality distinction between these two units?”
Tamburino said they searched to be conscious of if there modified into as soon as a discovering out curve affect on the rate of events and “there modified into as soon as no longer, sadly. Because all centers — younger centers and skilled centers — had a identical rate.”
He noted that practically all of the cardiac deaths were unexpected deaths or coronary heart failure deaths going on in patients with soft postprocedure aortic regurgitation, “which we know is linked to paravalvular regurgitation.”
Sensible or severe aortic regurgitation modified into as soon as bigger in the patients handled with ACURATE neo at 30 days (9.6% vs 2.9%) and 1 year (4.0% vs 3.3%; P for every < .0001).
The ACURATE neo community, on the alternative hand, had vastly fewer fresh pacemaker implantations at 30 days (10.5% vs. 18.0%) and 1 year (11% vs. 18%) and no more left bundle division block at 1 year (14% vs 19%) in the blueprint-to-take care of cohort.
Head-to-head trials like this are more and more vital, provided that transcatheter aortic valve alternative (TAVR) is becoming more of a low-possibility direction of in the vast majority of patients, discussant Bernard Prendergast, MD, Guy’s and St Thomas’ NHS Foundation Belief, London, England, said. “So these outcomes — standing alongside the serene outcomes of SCOPE I — are vital in establishing this fresh technology in comparison with the most modern market leaders.”
He asked why a little nonetheless vital selection of patients didn’t get the supposed valve in either arm and observed that echocardiographic note-up modified into as soon as small. “If paravalvular aortic regurgitation is a wanted dimension in this compare, that can be a excellent-searching criticism of the note-up.”
The main space off of no longer receiving the assigned valve modified into as soon as thanks to a size distinction, Tamburino said. Of the 386 ACURATE neo patients in whom TAVR modified into as soon as initiated, 377 bought the assigned valve, five bought the CoreValve, and four bought a complete lot of valves. Of the 388 CoreValve patients in whom TAVR modified into as soon as initiated, 366 bought the CoreValve 26 mm or 29 mm, four bought the ACURATE neo, and 18 bought a complete lot of valves.
By technique of hemodynamics, the outcomes were identical, including valve gradients, between the ACURATE neo and CoreValve groups, he said. “However there modified into as soon as a extremely low rate of echocardiography at 1 year (236 ACURATE neo vs 242 CoreValve), so we omit a complete lot of serious files that can divulge some of the scientific events at note-up.”
Supplied that ACURATE neo, which is no longer celebrated in the USA, failed to form the main endpoint in SCOPE I and SCOPE II in comparison with the gold fashioned valves, Leon asked: “Carry out we raise out from this that it be an contaminated instrument or will we raise out it is an early generation instrument and in all likelihood there are operator ride components?”
“These trials have to be interested by a grain of salt; folk are discovering out in these trials and these valves are being iterated,” discussant Michael Reardon Houston Methodist Effectively being facility, Texas, said. “If you specialize in on the loss of life, that clearly worries us, [but] all these complications that we do no longer on the total companion with loss of life — stroke, bleeding, coronary obstruction, annular break — the total identical. Pacers and left bundles are better for the ACURATE and what modified into as soon as worse — paravalvular leak.
“Effectively the fresh one, neo2, is joining the ranks of the sturdy sealing skirts and optimistically will be better,” he said. “These are all iterations and I salvage to reduce again anybody off early, would per chance per chance per chance be a disservice to our field.”
SCOPE I at 1 three hundred and sixty five days
Two days later, SCOPE I investigators took to the virtual stage to narrative on 1-year note-up on hand for 96% of patients handled with the ACURATE neo and 97% handled with the Sapien 3.
At 1 year, all-space off loss of life or disabling stroke took place in 12.5% of the ACURATE neo community and 9.2% in the Sapien 3 community (hazard ratio, 1.28; 95% CI, 0.81 – 2.0).
Even though decrease charges of paravalvular regurgitation and acute kidney illness with the Sapien 3 drove the main endpoint at 30 days, there modified into as soon as no distinction at 1 year in all-space off or cardiovascular loss of life charges between patients with practical/severe or soft aortic regurgitation vs no regurgitation.
“So in the close, with this rather shorter 1-year note-up, the aortic regurgitation didn’t play a role referring to patients’ deaths,” Thomas Walther, MD, PhD, University Effectively being facility Frankfurt, Germany, said.
Scientific and useful outcomes were identical for the ACURATE neo and Sapien 3 groups, including all-space off loss of life (11.1% vs 8.5%), cardiovascular loss of life (6.9% vs 5.4%), disabling stroke (2.8%% vs 1.7%), need for a everlasting pacemaker (11.4% vs 12.0%), and NYHA class III (11.5% vs 14.2%) or class IV (0.7% vs 0.3%).
Patients who bought the ACURATE neo had decrease mean valve gradients (7.20 mm Hg vs 11.45 mm Hg; P < .001) and larger effective orifice areas (1.76 cm2 vs 1.50 cm2; P < .001), nonetheless charges of practical (7.1% vs 3.6%) or severe (1.8% vs 0%) paravalvular regurgitation remained bigger at 1 year (P = .006).
“Extended note-up files will be vital to search out out the affect of the differential valve performance on prolonged-time period outcomes,” he concluded.
Discussant David J. Cohen, MD, University of Missouri-Kansas City College of Medication, said it be unlikely this affirm valve will obtain well-known exhaust in the USA thanks to the regurgitation.
“I’m hopeful the following-generation instrument will seal better and obtain rid of the aortic regurgitation. Then I would per chance per chance specialize in this having a affirm role in locations the save we make a choice to make exhaust of self-expanding valves, the save there’s terror about annular break from loads annular calcification or outflow tract calcification,” he said. “However we additionally need coronary obtain entry to on story of that’s in actual fact the adaptation between this instrument and a complete lot of self-expanding units just like the CoreValve. This has very, very nice coronary obtain entry to attributable to the very open physique in the supra-annular location.”
SCOPE I modified into as soon as funded by Boston Scientific. SCOPE II modified into as soon as backed by Ceric Sàrl. Tamburino reported speaker expenses from Medtronic. Walther has disclosed no associated monetary relationships.
Circulation. Printed online October 15, 2020. Abstract
Transcatheter Cardiovascular Therapeutics (TCT) 2020: SCOPE II, supplied October 15, 2020; SCOPE I, supplied October 17, 2020.
Disclose Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Fb.
