CAPITAL-AMI研究
Combined Angioplasty and Pharmacological Intervention Versus Thrombolytics Alone in Acute Myocardial Infarction
Presented at
American College of Cardiology
Scientific Sessions 2004
Presented by Dr. Michel R. Le May
CAPITAL AMI Trial
Endpoints (30 days and 6 months):
Composite of death, reinfarction, recurrent unstable ischemia, or stroke
CAPITAL AMI Trial
Presented at ACC Scientific Sessions 2004
170 patients presenting with ST elevation acute MI with chest pain ≥30 minutes and within six hours of symptom onset
Randomized, open-label, multicenter
Thrombolytic Therapy
Full-dose Tenectaplase (TNK)
n=84
Thrombolytic Therapy,
Transfer, and PCI
Full-dose Tenectaplase (TNK) followed by transfer and subsequent percutaneous coronary intervention (PCI)
n=86
In-Hospital Composite Event Rate
p=0.017
Presented at ACC Scientific Sessions 2004
CAPITAL AMI Trial
%
The composite in-hospital event rate of death, reinfarction, recurrent unstable ischemia, or stroke was lower in the TNK+PCI arm compared with the TNK alone arm, driven by a reduction in reinfarction and recurrent unstable ischemia.
TNK
TNK+PCI
TNK
TNK+PCI
In-Hospital Reinfarction
p=0.046
In-Hospital Recurrent Unstable Ischemia
p=0.02
Presented at ACC Scientific Sessions 2004
CAPITAL AMI Trial
%
PCI was performed in 91% of patients in the combination therapy arm. In the TNK alone arm, 47% of patients underwent PCI during the index hospitalization. Anterior MI location was present in 49% in the TNK alone arm and 52% in the TNK+PCI arm.
There was no difference in TIMI major bleed or ejection fraction (EF) at day 7 or day 30.
TNK
TNK+PCI
TNK
TNK+PCI
TNK
TNK+PCI
TIMI Major Bleed
p=NS
EF at Day 7
p=NS
EF at Day 30
p=NS
Primary Composite
Endpoint at 30 days
p=0.034
Presented at ACC Scientific Sessions 2004
CAPITAL AMI Trial
%
Composite event rate remained lower in the TNK+PCI arm at 30 days, again driven by reductions in reinfarction and recurrent unstable ischemia, with no difference in mortality (2.3% vs. 3.6%).
Length of hospital stay shorter in the TNK+PCI arm (5 vs. 6 days, p=0.009).
TNK
TNK+PCI
TNK
TNK+PCI
30-Day Reinfarction
30-Day Recurrent Unstable Ischemia
Among patients with STEMI, treatment with full-dose TNK with transfer for PCI was associated with a lower rate of the composite of death, reinfarction, recurrent unstable ischemia, or stroke at 30 days compared with TNK alone, without an increased risk of major bleeding.
Results of the present trial differ from earlier trials such as the TIMI II trial, which showed no benefit of medical therapy plus percutaneous transluminal coronary angioplasty (PTCA) over medical therapy alone.
Differing results are not unexpected, given the substantial changes in practice patterns since the earlier trials (widespread use of stents, optimal anticoagulation, and use of thienopyridines).
Event rates at 6 months are pending.
CAPITAL AMI Trial