STITCH: No advantage to surgery
compared to medical therapy in primary analysis for heart failure patients, but
a closer look suggests more
When it comes to overall survival, patients with heart
failure caused by atherosclerosis may do just as well with medication alone as
when bypass surgery is added to the treatment plan, according to research presented
at the American College of Cardiology's 60th Annual Scientific Session. Coronary
artery bypass grafting (CABG) does, however, significantly reduce the risk of
death specifically from heart disease, as well as the combined risk of death or
hospitalization, the Surgical Treatment of Ischemic Heart Failure (STICH) trial
found.
"We were unable to show a significant benefit for CABG in our primary
analysis, but if you dive deeper, the data are much more supportive of bypass
surgery," said Eric J. Velazquez, M.D., an associate professor of medicine
and director of both the cardiac diagnostic unit and echocardiography laboratories
at Duke University Medical Center in Durham, NC. "This information fills
an important gap in how we should evaluate the opportunity for CABG in these patients."
STICH is the largest randomized, controlled study ever to compare CABG plus
the best possible medical therapy to aggressive medical therapy alone in patients
with coronary artery disease and heart failure.
In about two-thirds of patients with heart failure, the underlying cause is
clogged coronary arteries, which deprive the heart muscle of enough blood and
oxygen and impair its ability to pump fluids to the rest of the body. In bypass
surgery, healthy arteries and veins are used to re-route blood around the blockages,
in hopes of restoring heart function. Until now it has been unclear whether the
risks of bypass surgery were worth taking, given recent life-saving advances in
medical therapy.
For the study, researchers at 99 medical centers in 22 countries recruited
patients with heart failure caused by coronary artery disease or a previous heart
attack, randomly assigning 602 to ideal medical therapy alone and 610 to CABG
plus ideal medical therapy. After an average of nearly five years of follow-up,
they found that bypass surgery reduced the risk of death from any cause by 14
percent when compared to medical therapy. However, the finding was not statistically
significant.
Bypass surgery also reduced the risk of cardiovascular death by 19 percent
and the combined risk of death from any cause plus hospitalization for heart disease
by 26 percent. Both findings were statistically significant (p=0.05 and p<0.001,
respectively).
Fifty-five patients who were assigned to the surgery group never actually had
the procedure, whereas 100 who were assigned to medical therapy eventually had
CABG. When researchers analyzed the data only on patients who had their assigned
treatment, they found that bypass surgery reduced the risk of death from any cause
by 25 percent (p=0.005). Similarly, when they analyzed the data according to the
treatment patients actually had, including the "crossovers" into the
opposite group, they found that bypass surgery reduced the risk of death from
any cause by 30 to 50 percent.
Researchers did note that bypass surgery had a higher upfront risk than medical
treatment alone. In fact, it was only after two years that survival was better
with bypass surgery.
"Although the totality of information supports CABG, there is an early
hazard," Velazquez said. "The fairest approach is to evaluate each patient's
prognosis. If they have a low likelihood of living two years or don't want to
take the risk of having surgery, medical therapy may be the better option."
A separate STICH substudy evaluated whether imaging could be used to identify
which patients are likely to benefit from bypass surgery. Researchers recruited
a total of 601 patients to have one of two types of imaging tests: a nuclear perfusion
scan or dobutamine echocardiography. These tests use different methods to evaluate
poorly functioning heart tissue and determine if it is still alive. Viable tissue,
as it is called, can often recover function once it has an adequate blood supply,
while irreversibly damaged tissue cannot.
After nearly five years of follow-up, researchers found no relationship between
the results of viability imaging and the effectiveness of bypass surgery. Imaging
did provide valuable information on the likelihood of long-term survival, however.
Overall, patients with living heart tissue were 40 percent less likely to die
during follow-up when compared to patients with irreversible heart damage.
"Assessing myocardial viability is useful in identifying the risk of patients
and getting information about prognosis," said Robert O. Bonow, M.D., a professor
of medicine and director of the Center for Cardiovascular Innovation at Northwestern
University Feinberg School of Medicine in Chicago. "But when weighing results
of viability testing versus other characteristics, it's not helpful in identifying
which patients will benefit from surgery."
The STICH trial and STICH Viability substudy were funded by the National Heart,
Lung, and Blood Institute. Velazquez and Bonow have no potential conflicts of
interest to report.
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