A three-drug regimen is equal to a
double-dose two-drug approach in preventing clots after angioplasty, says new
research presented this week at the American College of Cardiology’s 61st
Annual Scientific Session.
The
three-drug regimen, favored in Asia to increase anti-clotting effect, was found
to be as safe and effective as a double-dose two-drug treatment commonly used
in Western countries.
Angioplasty
– a procedure that improves blood flow to the heart through dilation of the
artery and insertion of a metal stent – comes with a known risk of blood clots
as platelet cells rush to the injured area and clump together in a natural
healing response.
For
that reason, treatment with anti-platelet drugs such as clopidogrel is standard
after angioplasty. Double-dose dual anti-platelet therapy (DDAT), using aspirin
and double-dose (150 mg) clopidogrel, is a potent anti-platelet regimen for
high-risk patients undergoing angioplasty.
In
Asia, cilostazol is added to dual anti-platelet therapy (DAT: aspirin and 75 mg
of clopidogrel) in high-risk patients, and the regimen is known as triple
anti-platelet therapy, or TAT.
Several
studies have demonstrated that cilostazol does more than prevent platelet
clumping; it also shows activity in preventing new tissue overgrowth where the
stent has been placed (restenosis), widening blood vessels (vasodilation),
protecting kidneys, and improving blood levels of lipids like cholesterol and
triglycerides.
“TAT is
widely used in Korea and Japan because we experienced the benefit of cilostazol
in terms of major adverse cardiovascular events (MACE) after angioplasty,” said
principal investigator Dr. Hyo-Soo Kim, director of cardiac catheterization and
coronary intervention at Seoul National University Hospital.
“In the
numerous clinical studies about angioplasty, we have an impression that the
MACE rate is lower in Korean studies than in Western ones.”
Although
previous studies support the addition of cilostazol to conventional dual anti-platelet
therapy, cilostazol is not familiar to many Western physicians because it was
developed by a Japanese company that has neither marketed it widely outside
Asia nor sponsored a large clinical trial of the drug.
“Most
clinical evidence supporting cilostazol’s benefit comes from
investigator-initiated trials like ours,” Kim said. “HOST-ASSURE is the first
large-scale randomized trial to directly compare the two treatment strategies
and confirm the non-inferiority of TAT compared with DDAT.”
In the
HOST-ASSURE trial, patients were randomly assigned to TAT (1,879 patients) or
to DDAT (1,876 patients). TAT group patients received 100 mg of cilostazol
twice daily in addition to DAT for a month after the procedure; DDAT group
patients recieved the maintenance regimen of 150 mg of clopidogrel with
aspirin.
One
month after angioplasty, 23 patients (1.2 percent) in the TAT group and 27
patients (1.4 percent) in the DDAT group experienced events such as
cardiovascular-related death, non-fatal heart attack, stroke and major
bleeding, demonstrating non-inferiority of the three-drug regimen compared with
the double-dose two-drug treatment.
“This
study provides evidence for the already popular adjunctive use of cilostazol in
clinical practice in Asia – in particular in Korea and Japan,” Kim said.
“If TAT
is equivalent to a potent regimen such as DDAT that is used for high-risk
patients, TAT would be preferred because it has additional vascular biologic
benefit on top of its anti-platelet effect.”
Anusuya
Das
AsianScientist
Source: American College of Cardiology
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