The findings of the
study will be presented at the Congress of the European Society of Cardiology
(ESC) in Barcelona, Spain in August 2017 and the results will appear in
‘Dual therapy with aspirin and rivaroxaban significantly reduces stroke and heart attack risk and improves survival in patients with stable coronary vessel disease’
Reducing Stroke and Heart Attack Risk Further In
The study was undertaken to explore the possibility of further reducing the incidence of
adverse events such as stroke
and death in patients with
stable cardiovascular disease.
standard treatment in such patients is aspirin or a similar agent. According to
Dr. John Eikelboom, efforts to further reduce risk have focused on adding
another antiplatelet agent to aspirin or replacing aspirin with another
antiplatelet drug such as clopidogrel. However these measures have only met
with limited success.
Dr Eikelboom and his
team decided to determine the safety and efficacy of a combination of an
antiplatelet agent with an anticoagulant such as rivaroxaban in reducing risk
of adverse cardiac events.
Details of the Study
The study involved 27400 persons with stable coronary or peripheral artery disease from across 33 countries
In this randomized study
, the effects of rivaroxaban at doses of 2.5 mg
twice-daily combined with 100 mg of aspirin once-daily
were compared to
rivaroxaban 5 mg twice-daily or to aspirin 100 mg once-daily.
The volunteers were followed up at 1 month, 6 months and six
. The notable findings of the study were as follows
- Combination therapy of aspirin and rivaroxaban reduces incidence
of heart attack and stroke and improves patient survival
- Combination therapy is associated with an increased incidence of
gastrointestinal bleeding but not intracranial bleeds and was not
associated with fatalities
The result of this
study clearly suggests that dual therapy
reduced strokes, heart attacks and mortality by nearly 25 percent in comparison
to either drug taken alone
in patients with stable coronary or peripheral
artery disease. The positive findings led to the study being stopped
early within 23 months
in February 2017.
In the words of Dr
Eikelboom, "Using a different approach, COMPASS showed that combining
aspirin with a low dose of an anticoagulant was substantially more effective
than aspirin alone. Even small improvements in the effectiveness of treatments
that prevent stroke and heart attack are important because cardiovascular disease
is very common. In COMPASS the treatment effect was unexpectedly large."
Effect of Combination Therapy in Peripheral Arterial
The same study also looked at the effectiveness of aspirin and rivaroxaban combination in
preventing loss of limb or severely affecting lower limb blood flow (ischemia)
in persons with peripheral arterial disease
The participants of
the study included 7470 persons with PAD. The combination therapy was shown to be effective in reducing lower limb
loss and ischemia in PAD by nearly 46 percent
. Similarly, the combination
increased the risk of gastrointestinal bleeding but not brain hemorrhage.
The PAD aspect of
the study was led by Dr Sonia Anand who states that the findings could prove to
be beneficial for patients with peripheral arterial disease.
The details and
findings of this study are due to be published in The Lancet
Stable Heart Disease and Its Management
Stable coronary artery disease (SCAD) refers to occurrence of predictable episodes of transient central chest pain (angina pectoris)
brought about by exercise, emotion or other forms of stress, due to reduced
blood flow to heart in response to increased demand in persons with known risk
factors. Persons known to have had obstructive or non-obstructive coronary
artery disease (CAD) in the past, but currently remaining stable on medical
therapy are also considered to have stable heart disease.
In persons with
stable heart disease, measures to
prevent adverse cardiac events and death focus on reducing the occurrence of
thrombotic events and improving left ventricular function
. These are
achieved by a combination of lifestyle
modification, pharmacological measures to control risk factors, drugs to
prevent plaque progression
and reduce inflammation thereby decreasing the
risk of plaque rupture and thrombosis.
thrombotic risk, antiplatelet and anti-inflammatory
aspirin or clopidogrel are
the drugs of choice
Although antiplatelet agents have been effective in reducing the risk of cardiac events,
the current study proves that dual therapy is more beneficial in decreasing
this risk in patients with stable heart disease. This is definitely good news
for physicians treating heart disease as well as patients and their families.
- Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS) - (https://clinicaltrials.gov/ct2/show/NCT01776424)