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Results From a Randomized Trial

David A. Morrow, MD,MPH; Christopher P. Cannon, MD; Nader Rifai, PhD; Martin J. Frey, MD; Ralph Vicari, MD; Nasser Lakkis, MD; Debbie H. Robertson, RD,MS; Darcy A. Hille, MS; Paul T. DeLucca, PhD; Peter M. DiBattiste, MD; Laura A. Demopoulos, MD; William S. Weintraub, MD; Eugene Braunwald, MD; for the TACTICS-TIMI 18 Investigators

JAMA. 2001;286:2405-2412.

Context  Cardiac troponins I (cTnI) and T (cTnT) are useful for assessing prognosis in patients with unstable angina and non–ST-segment elevation myocardial infarction (UA/NSTEMI). However, the use of cardiac troponins for predicting benefit of an invasive vs conservative strategy in this patient population is not clear.

Objective  To prospectively test whether an early invasive strategy provides greater benefit than a conservative strategy in acute coronary syndrome patients with elevated baseline troponin levels.

Design  Prospective, randomized trial conducted from December 1997 to June 2000.

Setting  One hundred sixty-nine community and tertiary care hospitals in 9 countries.

Participants  A total of 2220 patients with acute coronary syndrome were enrolled. Baseline troponin level data were available for analysis in 1821, and 1780 completed the 6-month follow-up.

Interventions  Patients were randomly assigned to receive (1) an early invasive strategy of coronary angiography between 4 and 48 hours after randomization and revascularization when feasible based on coronary anatomy (n = 1114) or (2) a conservative strategy of medical treatment and, if stable, predischarge exercise tolerance testing (n = 1106). Conservative strategy patients underwent coronary angiography and revascularization only if they manifested recurrent ischemia at rest or on provocative testing.

Main Outcome Measure  Composite end point of death, MI, or rehospitalization for acute coronary syndrome at 6 months.

Results  Patients with a cTnI level of 0.1 ng/mL or more (n = 1087) experienced a significant reduction in the primary end point with the invasive vs conservative strategy (15.3% vs 25.0%; odds ratio [OR], 0.54; 95% confidence interval [CI], 0.40-0.73). Patients with cTnI levels of less than 0.1 ng/mL had no detectable benefit from early invasive management (16.0% vs 12.4%; OR, 1.4; 95% CI, 0.89-2.05; P<.001 for interaction). The benefit of invasive vs conservative management through 30 days was evident even among patients with low-level (0.1-0.4 ng/mL) cTnI elevation (4.4% vs 16.5%; OR, 0.24; 95% CI, 0.08-0.69). Directionally similar results were observed with cTnT.

Conclusion  In patients with clinically documented acute coronary syndrome who are treated with glycoprotein IIb/IIIa inhibitors, even small elevations in cTnI and cTnT identify high-risk patients who derive a large clinical benefit from an early invasive strategy.

Author Affiliations: Cardiovascular Division, Brigham and Women's Hospital, Boston, Mass (Drs Cannon, Morrow, and Braunwald); Emory University, Atlanta, Ga (Dr Weintraub); Merck and Co, Inc, West Point, Pa (Drs Dempoulos, DiBattiste, and DeLucca, and Mss Robertson and Hille); Heart Center of Sarasota, Sarasota, Fla (Dr Frey); Holmes Regional Medical Center, Melbourne, Fla (Dr Vicari); Baylor College of Medicine, Houston Tex (Dr Lakkis); and Children's Hospital, Boston (Dr Rifai). A complete listing of the TACTICS-TIMI 18 investigators was published previously (N Engl J Med. 2001;344:1879-1887).

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