Facilitated PCI in patients with ST-elevation myocardial infarction.
BACKGROUND
We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI).


METHODS
In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization.


RESULTS
A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49).


CONCLUSIONS
Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 [ClinicalTrials.gov].)
Ellis
Stephen G
SG
Department of Cardiovascular Medicine, the Cleveland Clinic, F25, 9500 Euclid Ave., Cleveland, OH 44195, USA. elliss@ccf.org
Tendera
Michal
M
de Belder
Mark A
MA
van Boven
Ad J
AJ
Widimsky
Petr
P
Janssens
Luc
L
Andersen
H R
HR
Betriu
Amadeo
A
Savonitto
Stefano
S
Adamus
Jerzy
J
Peruga
Jan Z
JZ
Kosmider
Maciej
M
Katz
Olivier
O
Neunteufl
Thomas
T
Jorgova
Julia
J
Dorobantu
Maria
M
Grinfeld
Liliana
L
Armstrong
Paul
P
Brodie
Bruce R
BR
Herrmann
Howard C
HC
Montalescot
Gilles
G
Neumann
Franz-Josef
FJ
Effron
Mark B
MB
Barnathan
Elliot S
ES
Topol
Eric J
EJ
D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D002544:Cerebral Infarction / Q000139:chemically induced; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D009203:Myocardial Infarction / Q000145:classification / Q000150:complications / Q000401:mortality / Q000628:therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D011994:Recombinant Proteins; C087896:reteplase; D010959:Tissue Plasminogen Activator; D000077284:Abciximab