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Randomized Evaluation of Salvage Angioplasty with Combined Utilization of Endpoints - RESCUE
Description:
Rescue angioplasty for LV function in high-risk anterior MI.
Hypothesis:
Early coronary angioplasty may successfully open 75% to 85% of occluded arteries in patients after treatment with IV thrombolytic therapy.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 151
Mean Patient Age: 59 ±11 years
Female: 18
Patient Populations:
Anterior MI with ST-segment elevation >2 mV in at least two of six precordial leads with cardiac catheterization within six hours of chest pain onset.
With severe ongoing chest pain, the time window could be extended to within eight hours at the discretion of the investigator.
Treatment with any acceptable IV thrombolytic regimen (including but not limited to streptokinase [1.5 million U], tissue-type plasminogen activator [TPA; 100 to 12 mg], and urokinase [3 million U].
Age 21 to 79 years.
TIMI flow grade 0-1 in the left anterior descending coronary artery after intracoronary nitrate administration and at least 90 minutes after initiation of thrombolytic therapy.
Ability to give informed consent.
Exclusions:
Cardiogenic shock (systolic blood pressure <90 mmHg after fluid resuscitation and treatment of bradycardia <60 beats per minute)
Previous MI
Left main stenosis >50% in diameter
Primary Endpoints:
25- to 35-day ejection fraction, with a value imputed for nonsurvivors; sensitivity analyses were also performed using no imputations and imputations of 0% for nonsurvivors.
Secondary Endpoints:
Composite of death, severe (NYHA functional class III or IV), heart failure, ventricular tachycardia (sustained or nonsustained occurring at least 48 hours after infarction onset).
Drug/Procedures Used:
Conservative therapy; angioplasty; patients randomized to angioplasty; additional streptokinase (500,000 U) or urokinase (1 million U)
Concomitant Medications:
Aspirin, 80 to 325 mg/day; IV nitrates for at least 24 hours; IV or high-dose (>10,000 U bid) subcutaneous heparin for at least 3 days as tolerated; heart failure: digitalis; diuretics; angiotensin-converting enzyme inhibitor
Principal Findings:
Angioplasty was technically successful in 72 of 78 randomized patients (92%). Two patients randomized to conservative therapy crossed over to angioplasty within 72 hours.
Resting 30-day ejection fraction was 40 ±11% in the angioplasty group and 39 ±12% in the conservative group (P = .49), but ejection fraction with exercise was 43 ±15% and 38 ±13% for the angioplasty and conservatively treated groups, respectively (P = .04).
Adverse clinical outcomes included death in 5% and 10% (P = .18), severe heart failure in 1% and 7% (P = .11), and either death or severe heart failure in 6% and 17% (P = .05) of the angioplasty and conservatively managed groups, respectively.
Interpretation:
When applied to patients with first anterior infarction, rescue angioplasty appears to be useful in the prevention of death or severe heart failure, with improvement in exercise, but not resting, ejection fraction. This strategy deserves further study and highlights the potential advantage of early mechanical restoration of infarct vessel patency when thrombolytic therapy has failed.
References:
1. Circulation 1994;90:2280-2284. Final results
Keywords: Thrombolytic Therapy, Myocardial Infarction, Streptokinase, Urokinase-Type Plasminogen Activator, Heart Failure, Coronary Disease, Fibrinolytic Agents, Angioplasty, Balloon, Coronary
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