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Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy - TACTICS-TIMI 18
Description:
Invasive vs. conservative management of acute coronary syndromes after tirofiban.
Hypothesis:
To address the clinical and economic outcomes of invasive versus conservative management for acute coronary syndromes treated with tirofiban.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 2220
Mean Follow Up: 6 months
Mean Patient Age: 62 years mean
Female: 34
Patient Populations:
Anginal pain within 24 hours
Candidates for angiography and revascularization
Accelerated or prolonged recurrent ECG symptoms or abnormal enzymes
ECG evidence of ischemia, or abnormal cardiac enzymes, or prior documented coronary disease
Exclusions:
Persistent ST elevation
Secondary angina
PTCA or CABG within 6 months
History of gastrointestinal bleeding, platelet disorder, or thrombocytopenia
History of hemorrhagic cerebrovascular disease
Non-hemorrhagic stroke or TIA within 1 year
Severe congestive heart failure or cardiogenic shock
Clinically important systemic disease
Serum creatinine >2.5 mg/dl
Treatment with abciximab within 96 hours
Current long-term treatment with ticlopidine, clopidogrel, or warfarin
Primary Endpoints:
Death, MI, rehospitalization for acute coronary syndrome at 6 months
Secondary Endpoints:
Correlation between baseline tropinin T and I levels and optimal management strategy
Drug/Procedures Used:
2220 patients with unstable angina and myocardial infarction without ST-segment elevation who had electrocardiographic evidence of changes in the ST segment or T wave, elevated levels of cardiac markers, a history of coronary artery disease, or all three findings were enrolled. All patients were treated with aspirin, heparin, and the glycoprotein IIb/IIIa inhibitor tirofiban. They were randomly assigned to an early invasive strategy, which included routine catheterization within 4 to 48 hours and revascularization as appropriate, or to a more conservative (selectively invasive) strategy, in which catheterization was performed only if the patient had objective evidence of recurrent ischemia or an abnormal stress test. The primary end point was a composite of death, nonfatal myocardial infarction, and rehospitalization for an acute coronary syndrome at six months.
Concomitant Medications:
Aspirin, heparin, tirofiban for either treatment strategy. Additional medical therapy recommended following the AHCPR Clinical Guideline for the Diagnosis and Management of Unstable Angina.
Principal Findings:
At six months, the rate of the primary endpoint was 15.9 percent with use of the early invasive strategy and 19.4 percent with use of the conservative strategy (odds ratio, 0.78; 95 percent confidence interval, 0.62 to 0.97; P=0.025). The rate of death or nonfatal myocardial infarction at six months was similarly reduced (7.3 percent vs. 9.5 percent; odds ratio, 0.74; 95 percent confidence interval, 0.54 to 1.00; P<0.05).
Interpretation:
Both TIMI IIIB and VANQWISH evaluated conservative and invasive treatment strategies in unstable angina and non-ST-segment elevated myocardial infarction. TIMI IIIb found the strategies similar, but the VANQWISH investigators observed a trend towards higher mortality for the invasive strategy. Both trials were conducted before glycoprotein IIb/IIIa antagonists and coronary stenting became common. The TACTICS study re-examines the question of which management strategy is optimal in the current era. In patients with unstable angina and myocardial infarction without ST-segment elevation who were treated with the glycoprotein IIb/IIIa inhibitor tirofiban, the use of an early invasive strategy significantly reduced the incidence of major cardiac events. These data support a policy involving broader use of the early inhibition of glycoprotein IIb/IIIa in combination with an early invasive strategy in such patients.
References:
1. Am J Cardiol 1998;82:731-6. Study design and rationale. 2. Cannon CP, Weintraub WS, Demopoulos LA, Vicari R, Frey MJ, Lakkis N, Neumann FJ, Gibson CM, Robertson DH, DeLucca PT, McCabe CH, Braunwald E for the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy (TACTICS)-TIMI 18 Investigators. Comparison of early invasive versus early conservative strategies in patients with unstable angina and non-ST elevation myocardial infarction treated with early glycoprotein IIb/IIIa inhibition. N Engl J Med. 2001 Jun 21;344(25):1879-87.
Keywords: Odds Ratio, Myocardial Infarction, Acute Coronary Syndrome, Platelet Aggregation Inhibitors, Heparin, Fibrinolytic Agents, Electrocardiography, Tyrosine, Research Personnel, Catheterization, Confidence Intervals, Exercise Test, Platelet Glycoprotein GPIIb-IIIa Complex
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