RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PLATELET GLYCOPROTEIN IIB IIIA BLOCKADE WITH PRIMARY ANGIOPLASTY FOR ACUTE MYOCARDIAL-INFARCTION/

BRENER SJ BARR LA BURCHENAL JEB KATZ S GEORGE BS JONES AA COHEN ED GAINEY PC WHITE HJ CHEEK HB MOSES JW MOLITERNO DJ EFFRON MB TOPOL EJ

Sj. Brener et al., RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PLATELET GLYCOPROTEIN IIB IIIA BLOCKADE WITH PRIMARY ANGIOPLASTY FOR ACUTE MYOCARDIAL-INFARCTION/, Circulation, 98(8), 1998, pp. 734-741

28

INGLESE

Article

Peripheal Vascular Diseas",Hematology,"Cardiac & Cardiovascular System

Circulation → ACNP

0009-7322

98

8

1998

734 - 741

ISI

0009-7322(1998)98:8<734:RPTOPG>2.0.ZU;2-D

Background-The benefit of catheter-based reperfusion for acute myocard ial infarction (MI) is limited by a 5% to 15% incidence of in-hospital major ischemic events, usually caused by infarct artery reocclusion, and a 20% to 40% need for repeat percutaneous or surgical revasculariz ation. Platelets play a key role in the process of early infarct arter y reocclusion, but inhibition of aggregation via the glycoprotein IIb/ IIIa receptor has not been prospectively evaluated in the setting of a cute MI. Methods and Results-Patients with acute MI of <12 hours' dura tion were randomized, on a double-blind basis, to placebo or abciximab if they were deemed candidates for primary PTCA. The primary efficacy end point was death, reinfarction, or any (urgent or elective) target vessel revascularization (TVR) at 6 months by intention-to-treat (ITT ) analysis. Other key prespecified end points were early (7 and 30 day s) death, reinfarction, or urgent TVR. The baseline clinical and angio graphic variables of the 483 (242 placebo and 241 abciximab) patients were balanced. There was no difference in the incidence of the primary 6-month end point (ITT analysis) in the 2 groups (28.1% and 28.2%, P= 0.97, of the placebo and abciximab patients, respectively). However, a bciximab significantly reduced the incidence of death, reinfarction, o r urgent TVR at all time points assessed (9.9% versus 3.3%, P=0.003, a t 7 days; 11.2% versus 5.8%, P=0.03, at 30 days; and 17.8% versus 11.6 %, P=0.05, at 6 months). Analysis by actual treatment with PTCA and st udy drug demonstrated a considerable effect of abciximab with respect to death or reinfarction: 4.7% versus 1.4%, P=0.047, at 7 days; 5.8% v ersus 3.2%, P=0.20, at 30 days; and 12.0% versus 6.9%, P=0.07, at 6 mo nths. The need for unplanned, ''bail-out'' stenting was reduced by 42% in the abciximab group (20.4% versus 11.9%, P=0.008). Major bleeding occurred significantly more frequently in the abciximab group (16.6% v ersus 9.5%, P=0.02), mostly at the arterial access site. There was no intracranial hemorrhage in either group. Conclusions-Aggressive platel et inhibition with abciximab during primary PTCA for acute MI yielded a substantial reduction in the acute (30-day) phase for death, reinfar ction, and urgent target vessel revascularization. However, the bleedi ng rates were excessive, and the 6-month primary end point, which incl uded elective revascularization, was not favorably affected.