Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction - CARESS in AMI - Presented at ESC 2007
The goal of the trial was to evaluate routine transfer for urgent percutaneous coronary intervention (PCI) or local management among ST-elevation myocardial infarction (STEMI) patients admitted to centers without PCI facilities who were initially treated with reteplase, heparin, and abciximab.
Patients Enrolled: 597
Mean Follow Up: 1 year
STEMI presenting within 12 hours from symptoms onset and having ≥1 of the following criteria of "high risk", summation of ST-segment elevation or depression ≥15 mm in all 12 ECG leads or new onset complete left bundle branch block, previous MI, Killip class 2 or 3, and left ventricular ejection fraction at transthoracic ultrasound <40%
Age ≥75 years; prior coronary artery bypass grafting or PCI involving the infarct-related artery; concomitant noncardiac disease likely to limit long-term prognosis; cardiogenic shock; need for concomitant major surgery; severe hepatic disease; acute or chronic renal impairment; transmural MI in different location within the previous week; previous administration of thrombolytics within 7 days; intolerance or contraindications to aspirin or clopidogrel; known leucopenia, neutropenia, or thrombocytopenia; documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months; previous hemorrhagic stroke; previous ischemic cerebrovascular event within 3 months; intracranial neoplasm; recent major surgery at risk of bleeding; episodes of uncontrolled hypertension in past 2 years; administration of oral anticoagulants within the previous 7 days unless INR ≤1.2; or severe recent trauma
Composite endpoint of death, reinfarction, or refractory ischemia at 30 days
Composite endpoint of death, reinfarction, refractory ischemia, stroke, or hospital admission for heart failure at 1 year; resource utilization; stroke through 30 days; and major and minor bleeding through 30 days
Patients admitted to hospitals without PCI capabilities and who were treated initially with reteplase, heparin, and abciximab were randomized to transfer for urgent PCI (n = 297) or continued local management (n = 300).
Aspirin (at least 250 mg IV); for stented patients, 300 mg clopidogrel loading dose and 75 mg/day clopidogrel for at least 1 month
The median time from symptom onset to reteplase administration was 170 minutes. In the facilitated PCI group, the median time from reteplase to angiography was 136 minutes, compared with 212 minutes in the patients in the control group who required rescue PCI. TIMI grade 3 flow was present prior to PCI in 60% of the facilitated PCI group.
The primary endpoint of death, reinfarction, or refractory ischemia at 30 days occurred less frequently in the facilitated PCI group (4.1% vs. 11.1%, p = 0.001), driven by a reduction in refractory ischemia (0.7% vs. 5.0%, p = 0.002) and a trend toward a reduction in reinfarction (0.3% vs. 1.7%, p = 0.104). There was no difference in death (3.1% vs. 4.4%, p = 0.403) or stroke (1.4% vs. 0.7%). Any bleeding occurred more frequently in the facilitated PCI group (12.2% vs. 7.4%, p = 0.032). Major bleeding occurred in 3.7% of the facilitated PCI group and 2.0% of the medical management group (p = 0.208).
Among STEMI patients admitted to centers without PCI facilities who were initially treated with reteplase, heparin, and abciximab, transfer for PCI was associated with a reduction in the primary endpoint of death, MI, or refractory ischemia at 30 days compared with continued medical management with revascularization only performed for rescue PCI.
The present trial compared a strategy of medical management with facilitated PCI since patients enrolled in the trial did not have immediate access to primary PCI. Conversely, other studies such as FINESSE and ASSENT-4 PCI have compared facilitated PCI with primary PCI.
When PCI facilities are rapidly available, primary PCI has been shown to be the superior method of reperfusion in STEMI patients. However, a large number of patients who experience MI cannot make it to the catheterization lab within the 90 minute, guideline-recommended time frame. The present study suggests that in these patients, a facilitated PCI approach may confer benefits when compared with medical therapy alone, although there was an increase in bleeding events in the facilitated PCI group.
Presented by Dr. Carlo Di Mario at the European Society of Cardiology Congress, September 2007, Vienna, Austria.
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