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 Patients who received the less-invasive implant had fewer strokes
and a lower mortality rate after one year than those whose valve was
replaced through open heart surgery, the Sapien 3 study showed.
The procedure, called transcatheter aortic valve replacement (TAVR),
is currently available only for patients considered unlikely to
survive open heart surgery or at high risk for complications.
The new data, presented Sunday at the American College of Cardiology
meeting in Chicago, will be used to seek U.S. regulatory approval
for Edwards Lifesciences’ Sapien 3 valve in patients deemed at
intermediate risk for complications with open heart surgery.
“It seems likely that TAVR will become the new benchmark for the
treatment of severe aortic stenosis in intermediate-risk patients,”
Dr. Vinod Thourani, professor at Emory University School of Medicine
and a lead investigator for the study, said in an interview.
TAVR involves threading the valve into place through blood vessels
using a catheter. Medtronic Plc also sells TAVR systems in the
United States.
The Sapien 3 study found that 4.6 percent of patients who received
Edwards’ valve had a stroke and 7.4 percent died within a year of
their procedure. Among surgery patients, 8.2 percent suffered a
stroke and 13 percent died.
Surgery resulted in less valve leakage, or aortic regurgitation,
than TAVR, but few people in either group experienced the
complication, which affected 1.5 percent of the TAVR patients,
Thourani said.
The Sapien 3 study compared 1,078 TAVR patients with outcomes for
944 patients who had open heart surgery in a related trial called
Partner II. The Partner II study, presented on Saturday, showed
Edwards’ older-model Sapien XT valve was as effective as surgery in
intermediate-risk patients.
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Edwards expects U.S. regulators to review data from both studies to
approve an expanded indication for the Sapien 3 valve before the end
of the year, Chief Executive Michael Mussallem said in an interview.
“The only option up until now has been open surgery, which is very
effective, but many patients would not opt for that,” he said.
Approval would more than double the pool of patients eligible for
the catheter-based approach, Mussallem said.
“We expect the treatment paradigm for intermediate-risk patients to
change almost overnight and for the TAVR market to accelerate
dramatically,” J.P. Morgan analyst Michael Weinstein said in a note
to clients Saturday.
(Editing by Andrew Roche)
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