Prehospital Thrombolysis in Rural Emergency Room and Subsequent Transport to a Coronary Care Unit: Ravenna Myocardial Infarction (RaMI) Trial - RaMI

Description:

Ravenna Myocardial Infarction (RaMI) was a prospective parallel study of the feasibility, safety, and efficacy of thrombolysis in the emergency room of a rural hospital with no coronary care unit (CCU) compared to similar patients treated on arrival to a city hospital CCU.

Hypothesis:

Thrombolysis in the emergency room of a rural hospital with no CCU prior to transfer to a city hospital with a CCU is safe and effective.

Study Design

Study Design:

Patients Enrolled: 280
Mean Follow Up: 35 days
Mean Patient Age: 50-75
Female: ~30

Patient Populations:

Patients in whom the emergency room physician in the ambulance had a strong clinical suspicion of evolving acute myocardial infarction. Symptoms had to be present for at least 30 minutes, but no more than six hours, and resistant to sublingual nitrates. ECG had to demonstrate upsloping ST segments >2 mm in at least two precordial leads or >1 mm in at least two contiguous peripheral leads. There could be no reduction in pain or ST segments following a second evaluation in the emergency room.

Exclusions:

Thrombolytic therapy during the past six months, surgical or major invasive procedures during the last 10 days, active gastrointestinal (GI) bleeding or a history of GI bleeding during the past six months, stroke or neurosurgical procedure during the previous two months, endocranial aneurysm or tumors, hypocoagulant therapy or hemorrhagic diathesis or thrombocytopenia, proliferative diabetic retinopathy, high likelihood of pregnancy in course or severe vaginal hemorrhage, hypertension greater than 200/100 mm Hg, recent resuscitation with chest compressions >10 minutes, or former enrollment in the study

Primary Endpoints:

Time saving, accuracy of diagnosis, adverse events, left ventricular function, and survival

Drug/Procedures Used:

Patients strongly suspected of having acute myocardial infarction en route to rural hospitals in Israel were treated upon arrival to the rural hospital emergency room. Patients were enrolled in Israel, where ambulances are staffed by emergency room physicians. The ambulance physician transmitted the ECG to a CCU physician to confirm the diagnosis. Patients were treated with anistreplase 30 U via bolus injection over four minutes.

A parallel group of patients was enrolled in the CCU of a city hospital (S. Maria della Croce Hospital in Ravenna). This group received anistreplase on arrival to the city hospital CCU in a similar fashion to the rural patients. Following treatment, the rural patients were transferred to the city hospital CCU for further care.

Concomitant Medications:

Morphine for pain control, lidocaine, and atropine for arrhythmias; diuretics for pulmonary edema; and fluid or vasopressors for hypotension. Specific usage rates for groups were not reported.

Principal Findings:

A total of 102 patients were enrolled en route to rural emergency rooms (rural group), and 178 parallel patients were enrolled in the city hospital (city group). The two groups were matched for age (mean 62 for rural group vs. 64 for city group), gender, history of myocardial infarction, ECG infarct site, and systolic blood pressure. Diagnostic accuracy was similar between rural and city patients.

100% of rural patients were discharged with a diagnosis of acute coronary syndrome: 91% with acute myocardial infarction (77.4% Q wave), and 8.9% with unstable angina. The median pain to diagnosis time was not significantly different between groups, owing to long delays in patients seeking medical attention (70 minutes for rural patients vs. 90 minutes for city patients, p=NS). Door to needle time was significantly shorter for the rural patients (20 minutes vs. 45 minutes, p<0.001). There were no significant differences between groups for hemorrhages or strokes. Death at 35 days was lower for the rural patients (7.5% vs. 10.7%, p=NS).

The rural patients had significantly lower rates of hypotension (14.5% vs. 37.6%, p<0.0001), nonsustained ventricular tachycardia (VT) (28.6% vs. 0%, p<0.0001), and sustained VT (8.4% vs. 0.9%, p<0.0001). The echocardiographic wall motion index score was lower for rural patients than for city patients (3.5 vs. 5.6, p<0.001).

Interpretation:

Among patients with suspected acute myocardial infarction, early thrombolysis in rural emergency rooms was associated with a significant improvement in door to needle time, occurrence of hypotension and VT, and left ventricular function. This therapy was also associated with a nonsignificant reduction in mortality.

This study suggests that therapy with thrombolytics in a rural hospital emergency room and subsequent transfer to a city hospital CCU is safe and effective.

References:

Coccolini S, Berti G, Bosi S, Pretolani M, Tumiotto G. Prehospital thrombolysis in rural emergency room and subsequent transport to a coronary care unit: Ravenna Myocardial Infarction (RaMI) trial. Int J Cardiol 1995;49 Suppl:S47-58.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Dyslipidemia, SCD/Ventricular Arrhythmias, Lipid Metabolism, Novel Agents

Keywords: Thrombolytic Therapy, Myocardial Infarction, Acute Coronary Syndrome, Stroke, Ventricular Function, Left, Coronary Care Units, Hypotension, Blood Pressure, Hospitals, Rural, Emergency Service, Hospital, Electrocardiography, Tachycardia, Ventricular, Nitrates, Hospitals, Urban, Anistreplase, Needles


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