Medtronic CoreValve® System Sustains Superior Survival Benefit Over Open Heart Surgery at Two Years
March 15 2015 - 1:45PM
Investigators
Conclude that Results Presented as ACC.15 Late-Breaking Clinical
Trial Suggest that Self-Expanding TAVR Should be Considered New
Standard of Care
DUBLIN and SAN DIEGO -
March 15, 2015 - Medtronic plc (NYSE: MDT)
today unveiled new, highly anticipated two-year data from the High
Risk Study of the CoreValve U.S. Pivotal Trial, which continued to
show superior survival benefit at two years for transcatheter
aortic valve replacement (TAVR) with the CoreValve®
System compared to patients who underwent surgical aortic valve
replacement (SAVR). The CoreValve US Pivotal High Risk Study is the
first and only head-to-head study to show statistically significant
survival differences favoring TAVR in aortic stenosis patients who
are considered high risk for surgery.
Presented as a late-breaking clinical trial at the
64th Annual Scientific Session of the American College of
Cardiology (ACC.15), the two-year outcomes from the CoreValve High
Risk Study found that the rate of all-cause mortality was
significantly lower in TAVR patients than in the SAVR patients
(22.2 percent vs. 28.6 percent, p=0.04), with
the absolute difference in all-cause mortality increasing between
the two groups from 4.8 percent at one year to 6.5 percent at two
years.
"In this trial CoreValve maintains a low and
stable stroke rate and the recovery advantages CoreValve
demonstrated at one year are maintained at two years. Current
ACC/AHA guidelines refer to TAVR as a reasonable alternative to
SAVR in high risk patients as judged by the heart team; however,
these clinical data suggest a change in these guidelines may be
warranted for the self-expanding valve in this patient population,"
said Michael Reardon, M.D., professor of cardiothoracic surgery at
Houston Methodist DeBakey Heart & Vascular Center, and chairman
of the patient screening committee of the CoreValve U.S. Pivotal
Trial. "Further, I believe that the results of this randomized
study suggest that self-expanding transcatheter valve therapy
should be considered standard of care and preferred over surgery in
this patient population."
Using robust prospective evaluation, the rate of
stroke was significantly lower in the TAVR group as compared to the
SAVR group at two years (10.9 percent vs 16.6 percent, p=0.05), and the major stroke rates were comparable
(6.8 percent vs. 9.8 percent; p=0.25). The
combined endpoint of all-cause mortality or major stroke
significantly favored the TAVR group (24.2 percent vs. 32.5
percent, p=0.01).
Rates of major adverse cardiovascular and
cerebrovascular events (MACCE) at one year were still superior at
two years and were statistically lower in the TAVR group than the
SAVR group (29.7 percent vs. 38.6 percent, p=0.01). While the echocardiographic parameters of
effective orifice area and mean aortic-valve gradient remained
stable for both groups over the two year period, the TAVR group
showed superior hemodynamics (blood flow) compared with the
surgical group at all time points during the clinical trial
follow-up (p=<0.001). Moderate to severe
paravalvular regurgitation (PVL) for the TAVR group at two years
(6.1 percent) proved consistent with the low one-year rate.
The CoreValve High Risk Study randomized 747
severe aortic stenosis patients at 45 centers in the United States
to treatment with either the CoreValve System or open-heart
surgery. The patients were estimated to have a predicted risk of
operative mortality of 15 percent or higher at 30 days, assessed by
two clinical site surgeons and confirmed by at least two surgeons
on a National Screening Committee. The average age of patients in
the study was 83.2 years old, and the study enrolled a nearly equal
number of men and women. In addition to the STS Predicted Risk of
Mortality estimate of 7.4 percent, these patients had documented
co-morbidities, frailty and disability that placed them at
increased risk for surgery.
The CoreValve System was approved by the U.S. Food and Drug
Administration (FDA) in 2014 for patients at extreme risk and high
risk for surgery. Since receiving CE (Conformité Européenne) Mark
in 2007, the CoreValve System has been implanted in more than
75,000 patients in more than 60 countries. In addition, the
CoreValve System offers the broadest range of sizes available to
accommodate more patients.
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular disease and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
around the world.
ABOUT MEDTRONIC
Medtronic plc (www.medtronic.com), headquartered
in Dublin, is the global leader in medical technology - alleviating
pain, restoring health and extending life for millions of people
around the world.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
- end -
Contacts:
Wendy Dougherty
Public Relations
+1-763-381-1204
Jeff Warren
Investor Relations
+1-763-505-2696
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information contained therein.
Source: Medtronic plc via Globenewswire
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