Sunday, March 01, 2009

Esprit and Charisma


2006 European Stroke Conference in Brussels,
include results from the European/Australian Stroke
Prevention in Reversible Ischemia Trial (ESPRIT),
which assessed the incremental efficacy of aspirin
+ ER dipyridamole over aspirin alone. Data also
included results from a substudy of patients
enrolled in CHARISMA who experienced stroke
during study treatment with aspirin + clopidogrel
or aspirin alone.


SPIRIT—the Stroke Prevention in Reversible
Ischemia Trial.1 The objective of SPIRIT (n=1316)
was to compare the efficacy and safety of oral
anticoagulation (to an international normalized ratio
[INR] 3.0 to 4.5) vs low-dose aspirin (30 mg/d) for
secondary prevention of cardio- and cerebrovascular
events after TIA or minor stroke.8 SPIRIT
reported an excess of primary outcome events—
vascular death, nonfatal stroke, nonfatal MI, or
nonfatal major bleeding complication—in the group
treated with oral anticoagulation.8 This excess was
predominantly due to a high rate of bleeding
complications, which increased by a factor of 1.43
with each 0.5-unit increase in INR; this high
incidence of anticoagulant-related bleeding
resulted in early termination of SPIRIT at only 17%
of its expected number of observed patient-years.

BLOGGER COMMENT- Overdosed warfarin, underdoses ASA


SUMMARY
n Current secondary event–prevention guidelines
from the AHA recommend intervention
with antiplatelet agents in patients who have
suffered NCS or TIA; however, questions
remain about which regimen is optimal
n Although oral anticoagulation therapy is a
mainstay for treatment of patients with
cardiogenic cerebral embolism, it has not
shown sufficient efficacy in NCS to justify the
substantial risk of bleeding complications. In
CHARISMA, clopidogrel + aspirin tended to
increase moderate-to-severe bleeding risk
compared with aspirin alone. In ESPRIT, while
major bleeding was less frequent with aspirin
+ dipyridamole than with aspirin alone,
investigators thought this may have been a
chance effect
n New data presented at ESC 2006 provide
further evidence on optimization of antiplatelet
therapy. These data come from 2 clinical
studies (ESPRIT and the CHARISMA Stroke
Substudy)
n The objective of ESPRIT was to determine if
aspirin + ER dipyridamole provided greater
preventive benefit than aspirin alone; this
result was documented in the earlier ESPS-2
trial, but there was some uncertainty about
the result, owing to conflicting findings in
other studies
n Results from ESPRIT confirm that aspirin +
dipyridamole is more effective than aspirin
alone in the prevention of vascular events
following NCS or TIA
n ESPRIT also confirmed that there is no
significant increase in bleeding events with
aspirin + dipyridamole vs aspirin alone

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