AntiThrombotic Therapy in the Cath Lab: Preliminary Results from the NICE Trials
Cindy L. Grines, M.D.
William Beaumont Hospital
Royal Oak, Michigan
Karsh, JACC 1996;28:1437
*30% of PTCA pts required additional heparin boluses
?
?
?
?
?
? p < .001
TFPI = tissue factor pathway inhibitor
ACT
(s)
aPTT
(s)
TFPI
(ng/ml)
Anticoagulation Effect: IV Enoxaparin vs IV Heparin
Characteristic
Enoxaparin
(n=30)
Unfractionated
Heparin
(n=30)
p
Value
Post-PTCA stenosis (%)
TIMI 3 flow (% pts)
Major dissection post-PTCA (% pts)
Ischemic complications (% pts)
Bleeding events (% pts)
Vascular events (% pts)
14 ± 18.2
97
3
0
1
0
16 ± 18.1
93
0
3
0
1
0.70
1.00
0.24
0.24
0.49
1.00
IV Enoxaparin For Elective PTCA
Conclusions:
Compared to conventional unfractionated heparin, a single bolus of IV enoxaparin
was safe
achieved more consistent antithrombotic effect with less anticoagulant effect
may eliminate need for hematologic monitoring
LMWH For Interventional Procedures
What is Yet To Be Determined?
Is IV LMWH clinically superior to conventional heparin?
Are higher doses (greater anti-Xa effect) necessary to be superior to heparin?
What is the appropriate dose of LMWH if a SQ dose has been given, or if IIb/IIIa agents are given?
Ongoing Studies Of IV Enoxaparin Instead Of Conventional Heparin For Coronary Intervention
Study
PI
n
Dose
Goal
NICE 1
NICE 4
Grines
Kereiakes
810
(complete)
818
(complete)
1 mg/kg
0.75 mg/kg
plus abciximab
Safety
Safety
Goals of NICE 1 and NICE 4
Safety - major bleeding, MACE
Large non-randomized data set ? compare to recent historical controls (EPILOG and EPISTENT)
Inclusion criteria - similar to EPILOG
NICE 1 and 4: Preliminary Results
NICE 1
NICE 4
Complete data
Enoxaparin dose (mg)
Abciximab bolus (mg)
infusion (?g/min)
# Vessels PCI
1 (%)
2 (%)
3 (%)
4 (%)
5 (%)
Stent utilization (%)
(any lesion)
309 (38%)
86
0
0
50.2
30.7
13.3
3.2
1.9
84.8
310 (38%)
65
21.5
10.0
47.4
31.9
16.5
2.6
1.0
85.5
Safety Data
NICE
1
NICE
4
Major bleeding, 30d (%)
Non CABG bleed (%)
Any transfusion (%)
> 30% ? in platelets (%)
Platelets < 50,000
0.6
0.3
1.6
2.6
0
0.3
0
1.3
8.9
1.6
EPI-
LOG
(Abciximab/
Low dose
heparin)
EPI-
STENT
(Stent/
abciximab)
2.0
1.1
1.6
NR
NR
1.4
0.6
3.1
NR
NR
NICE 1 and 4: Clinical Outcomes at 30 Days
NICE 1
(Enoxaparin)
(n=309)
NICE 4
(Enoxaparin/Abciximab)
(n=310)
Death (%)
MI (%)*
Urgent Revasc. (%)
Death + MI (%)
Death, MI,
Urgent Revasc. (%)
1.3
2.6
1.9
3.6
4.9
0.3
1.9
0.6
2.3
2.3
* Investigator defined
NICE 1 and 4: Myocardial Infarction
NICE 1
(Enoxaparin)
(n=309)
NICE 4
(Enoxaparin/Abciximab)
(n=310)
Clinical infarction (%)
Any CK ? 3 x normal
Any MB ? 3 x normal
(CK may be normal)
2.6
3.3
7.8
1.9
4.2
12.4
Conclusions Based on Preliminary NICE Results
IV enoxaparin, used instead of UFH for coronary interventions:
Is associated with low rate of major bleeding
Slightly higher rates of CKMB release may represent more aggressive PCI (paradoxically higher with abciximab)
Appears safe and effective