This Time, Medtronic-Backed Heart-Failure Study Hits Mark
March 31 2009 - 9:45AM
Dow Jones News
New clinical-trial data released Tuesday showed an expensive
implanted device that coordinates beating in erratic hearts helped
delay the worsening of symptoms over two years for patients with
mild heart failure.
The latest details on 262 patients from the Medtronic Inc.
(MDT)-sponsored "Reverse" trial come a year after data on a bigger
Reverse group failed to establish this benefit. The fresh results,
set for presentation Tuesday at the American College of
Cardiology's annual conference, are also a prelude to a bigger
study that - if successful later this year - could energize what
has become a sluggish market for heart-rhythm devices.
Medtronic is the biggest company in that market, where it
competes with Boston Scientific Corp. (BSX) and St. Jude Medical
Inc. (STJ).
Their cardiac resynchronization therapy, or CRT, heart devices
use power to constantly organize beating. The devices are also
often designed to provide high-voltage shocks when hearts beat
dangerously fast, and these versions cost about $32,000, which is
more than the typical implanted defibrillator.
CRT devices are currently approved for patients with more severe
cases of heart failure, as defined by the New York Heart
Association, but manufacturers would love to tap the vast pool of
less-sick and sometimes asymptomatic patients.
The Reverse study has shown this is challenging, however.
It was designed to see whether CRT devices combined with the
best-available drug therapy might help restrain the worsening of
symptoms for less-sick patients based on a mix of measurements. All
610 patients in the trial had a device implanted and were on drug
therapy, but some patients didn't have the device turned on.
One-year data unveiled last year didn't show a statistically
significant benefit when it came to delaying the worsening of
symptoms for CRT patients, which meant the trial failed its main
goal despite some other benefits, such as improvement for enlarged
hearts. Trial investigators hypothesized that because these
patients slowly worsen, waiting two years to compare the therapies
would have been a better idea.
Per the study's original design, it remained blinded for 262
patients in Europe, and the main goal for them was reached at two
years. Specifically, 19% of the 180 patients with their CRT device
switched on worsened over that span, compared with 34% of the 82
patients who worsened in the group without their devices on. The
difference is considered statistically significant.
The devices don't stop the progression of heart disease, but
appeared able to slow the magnitude of that progression.
The latest data also indicated some other benefits from CRT
devices, such as reducing enlarged hearts while improving their
pumping efficiency. The devices didn't deliver a significant
benefit on some other measures, such as quality of life or exercise
capacity, perhaps because of these patients' milder symptoms.
The study shows "the longer the time, the greater the benefit,"
said Cecilia Linde, a cardiologist at Karolinska University
Hospital in Stockholm, in an interview. She is also Reverse's
world-wide principal investigator and has received research grants
from Medtronic.
Leerink Swann analyst Rick Wise said ahead of the results that
Reverse is unlikely to be "market-shifting as a standalone trial"
due to its early issues. But positive trends could provide insights
into a much bigger, upcoming study sponsored by Boston
Scientific.
Called Madit-CRT, that study includes 1,820 patients and goes
about testing CRT devices in a different way - it focuses on
whether they will help prevent death or heart-failure events
compared with regular implanted defibrillators. Boston Scientific
Chief Executive James Tobin said at a recent financial conference
that he expects Madit-CRT to succeed and that results could be
ready for release at the Heart Rhythm Society's conference in
mid-May.
He downplayed the chances the study will help the heart-rhythm
market in the near term, but analyst Wise said it "could be a
groundbreaking trial that expands usage."
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com