CAPTIVE (CardioShield Application
Protects During Transluminal Intervention of Vein
Grafts by Reducing Emboli) researchers reported
that an intention-to-treat analysis did not demonstrate
CardioShield’s superiority to no protection nor
did it demonstrate CardioShield’s noninferiority
to the Guardwire The cumulative total endpoint in
the CardioShield group was 10.4% vs. 11.9% in the
no protection group (P=.823). “It would never be
different at that level in this size trial,” said
Holmes, who presented the CAPTIVE results.
CAPTIVE was a prospective, multicenter, randomized
trial enrolling patients with diseased saphenous
vein grafts (SVG).
CAPTIVE had a single primary endpoint of major adverse
cardiac events through 30 days, including death,
Q-wave or non-Q-wave MI, and target vessel revascularization
including emergency CABG. A secondary endpoint for
safety included in-hospital major adverse cardiac
events; a secondary endpoint for efficacy included
technical success and embolic capture.
During the course of the trial, CAPTIVE changed
from a superiority (n=197) to a noninferiority trial
(n=652), said David R. Holmes, MD, of the Mayo Clinic
in Rochester, Minn. The superiority phase (Phase
1) measured the CardioShield vs. no protection and
the noninferiority phase (Phase 2) measured the
CardioShield vs. the GuardWire.
1) SUPERIORITY GROUP
Baseline demographics of patients in the superiority
arm were not significantly different between the
CardioShield and no-protection groups, even regarding
rest angina or three-vessel disease. About 1.1
lesions per patient were treated.
TIMI-3 flow was better in the CardioShield group
(P=.065), distal embolization was infrequent (0.0%)
and the technical success rate was excellent (91.5%).
The cumulative total endpoint in the CardioShield
group was 10.4% vs. 11.9% in the no protection
group (P=.823). “It would never be different at
that level in this size trial,” said Holmes, who
presented the CAPTIVE results here yesterday.
2)NONINFERIORITY GROUP
Baseline demographics of patients in the noninferiority
arm were not significantly different between the
CardioShield and GuardWire groups, particularly
regarding rest angina, severe angina or three-vessel
disease. Procedure outcomes in the CardioShield
group found that technical success was achieved
in 94.1% of patients and procedural success in
88.6%. Researchers were able to retrieve embolic
debris in 72.7% of cases, and final TIMI-3 flow
was seen in 97.3%.
MACE rates between the two embolic protection
devices were not significantly different.
Holmes stressed during his presentation that
if one less major adverse cardiac event had occurred
in the CardioShield noninferiority arm (37 instead
of 38 events), that would have shifted the P value
from P=.057 to P=.049. |
