Plavix use could be shortened after stenting-study

* 6 months therapy deemed non-inferior to 12 months

* Larger studies needed to confirm results

By Bill Berkrot

NEW ORLEANS, April 5 (Reuters) – Six months of therapy
using Plavix and aspirin to prevent dangerous blood clots from
forming in stents following artery-clearing procedures may be
as effective as current guidelines calling for 12 months or
longer, according to a study presented on Tuesday.

The data demonstrating the effectiveness of six months of
so-called dual anti-platelet therapy could prove cost saving
and reduce the risk of dangerous bleeding in patients in need
of later emergency procedures should much larger clinical
trials confirm the findings, researchers said.

However, any changes in practice or guidelines of Plavix
use resulting from such a study would come too late to damage
sales for Sanofi-Aventis (SASY.PA: Quote, Profile, Research) and Bristol-Myers Squibb Co.
(BMY.N: Quote, Profile, Research)

The world’s second-biggest prescription medicine, with
annual sales of more than $9 billion, is expected to face
competition from cheaper generic versions next year. Once
multiple generic rivals reach the market, sales of branded
drugs quickly lose 80 to 90 percent of sales.

Subjects in the 1,428-patient study had all received
drug-coated stents to prop open their cleared arteries and were
on standard therapy of aspirin and Plavix, known chemically as
clopidogrel.

In those who received the blood clot preventing therapy for
six months, 4.7 percent suffered target vessel failure —
defined as cardiac death, heart attack or need for repeat
stenting procedure. That compared with 4.4 percent in the group
who took Plavix and aspirin for 12 months.

The results for six months, which amounted to a difference
of three patients, were deemed to be non-inferior, meeting the
main goal of the study, researchers said.

“We have no data to support the current guidelines that
recommend at least 12 months duration with clopidogrel, just
observational studies,” said Dr. Hyeon-Cheol Gwon, who
presented the study at the American College of Cardiology
scientific meeting in New Orleans.

Blood thinners such as Plavix increase the risk of major
bleeding, so patients who might require urgent surgery are at
much higher risk if they are on the drug at the time of such a
procedure, explained Gwon, a cardiologist at Samsung Medical
Center in Seoul.

If the duration of the dual anti-platelet therapy could be
safely halved, that risk would be eliminated after six months
instead of a year or more, he said.

“Our results may be very reassuring for many physicians who
may need to discontinue clopidogrel before the routinely
recommended 12-month duration for various reasons,” Gwon said.
(For more on the American College of Cardiology meeting, see
[ID:nN03204254] )
(Reporting by Bill Berkrot, editing by Matthew Lewis)

Plavix use could be shortened after stenting-study