Dive Brief:
·
A federally funded randomized trial assessing treatment
strategies for patients with stable ischemic heart disease found interventional
procedures are no better for reducing major cardiovascular events compared to
medication-based therapy alone.
·
Investors in stent manufacturers like Boston Scientific had
anticipated the results from ISCHEMIA (International
Study Of Comparative Health Effectiveness With Medical And Invasive
Approaches), presented this weekend at the American Heart Association's
Scientific Sessions, because of their potential to deter doctors from
recommending interventional procedures.
·
But the top-line results were largely unsurprising and within
expectations, numerous sell-side analysts said. Additionally, secondary
quality-of-life results indicated people with chest pain symptoms experienced
meaningful benefits from interventional procedures, perceived as a win for
medtechs.
Dive Insight:
The goal of
ISCHEMIA was to settle the debate over which management strategy is best for
higher-risk patients with stable ischemic heart disease. Specifically,
investigators want to know whether cardiac catheterization followed by optimal
revascularization, on top of
optimal medical therapy, or drugs, would result in better outcomes on a
cardiovascular events composite compared to drugs alone.
Funded by the
National Heart, Lung, and Blood Institute, the more than 5,000-participant,
320-site study assessed individuals 21 years of age or older who
demonstrated at least moderate ischemia on a qualifying stress test.
The primary
outcome measure was a composite of cardiovascular death, heart attack,
resuscitated cardiac arrest or hospitalization for unstable angina or heart
failure, with approximately 3.5 year follow-up. The secondary purpose of
the study was to determine whether a surgery as an initial strategy would
improve symptoms and quality of life.
Patients in the
conservative strategy group were put on a behavior change course related to
diet, physical activity and smoking cessation as well as drugs like
antiplatelets and statins. The invasive strategy group also was put
on the lifestyle changes in addition to implementation of cardiac
catheterization, coronary artery bypass graft surgery and percutaneous
coronary intervention.
"The trial
showed that heart procedures added to taking medicines and making lifestyle
changes did not reduce the overall rate of heart attack or death compared with
medicines and lifestyle changes alone," the trial's investigators concluded.
"However, for people with chest pain symptoms, heart procedures improved
symptoms better than medicines and lifestyle changes alone. The more chest pain
to begin with, the more symptoms improved after getting a stent or bypass
surgery."
In the months
leading up to the AHA meeting, investors had braced for impact from potentially
unfavorable results, which could reduce doctors' readiness to recommend
interventional procedures within the stable heart disease population. Boston
Scientific's stents account for about 7% of the company's overall sales, per
Needham analyst Mike Matson. Other major medtechs with exposure to a decline in
PCI procedures include Medtronic and Abbott.
Boston
Scientific CEO Mike Mahoney previously called impact from ISCHEMIA's unknown
results "highly manageable in all scenarios." He said on the
company's third quarter earnings
call Oct. 23 that a potential $40 million loss, resulting from a possible 5% to
10% drop in revenue related to treatment of patients with coronary syndromes,
would be the worst-case scenario.
Global Chief
Medical Officer Ian Meredith added that 80% of patients undergoing percutaneous
coronary intervention procedures in the U.S. have unstable angina or acute
coronary syndromes, which were not the populations of focus in ISCHEMIA.
"Given
that only around 20% of patients treated with coronary stents have stable
angina, and within this population there are a significant range of
considerations which could influence clinicians’ decision to treat with a stent
vs. guideline directed medical therapy (GDMT), we expect the ISCHEMIA study to
have only a modest and gradual impact on treatment patterns," analysts at
Credit Suisse wrote in a note to investors.
The Credit
Suisse analysts also noted that patient compliance and adherence to medications
are more closely monitored in a trial like ISCHEMIA, which could cast doubt on
whether the outcomes in the conservative approach cohort would be a strong in
the 'real world'.
Analysts at
Stifel pegged the volume of PCI procedures on the line as being closer to 2%,
when considering the various stable angina patients who had factors excluding
them from inclusion in the trial.
"While
ISCHEMIA may have shown 2% of patients do not benefit from PCI, there is good
reason to believe that there will not be a 100% headwind to this portion of
procedures ... Even if the 2% of stable asymptomatic PCI procedures did go
away, BSX management indicated that there could be some potential offset from
currently symptomatic patients that had withheld treatment now getting a
procedure due to the convincing quality of life benefit," analysts at
Stifel wrote. "Essentially, fewer inappropriate patients will get PCI than
are treated today, but more appropriate patients not treated today will be
treated."
In a note to
investors Sunday, Jefferies analysts cited a previous survey of 29
interventional cardiologists conducted by the investment firm demonstrating
that in the event of apparent equivalence between the conservative and invasive
arms, less than half (34%) expected a decline in PCI volumes. The average
decline expected was 18%.
As such,
Jefferies is modeling a negative $13 million impact on Boston Scientific's
sales, which it says equates to 0.1% of the $12.1 billion it's forecasting in
total revenue for the company in 2020.
Shares in
Boston Scientific, Medtronic and Abbott were all roughly stable in early
trading Monday.
Results from
ISCHEMIA will likely be published in medical journals beginning in early 2020,
according to the trial's website.
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