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TACTICS-TIMI-18 TRIAL |
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| Problem | ACS (UA/NSTEMI) |
| Format | Multi-center RCT |
| Treatment | PCI |
| Control | Conservative management |
| Population | 2220 patients |
| Inclusion criteria | Aged 18 or above Episode of angina (with an accelerating pattern or prolonged [>20 minutes] or recurrent episodes at rest or with minimal effort) within the preceding 24 hours Were candidates for coronary revascularization Had at least one of the following -A new finding of ST-segment depression of at least 0.05 mV -Transient (<20 minutes) ST-segment elevation of at least 0.1 mV -T-wave inversion of at least 0.3 mV in at least two leads -Elevated levels of cardiac markers -Coronary disease, as documented by a history of catheterization, revascularization, or myocardial infarction. |
| Exclusion criteria | Persistent ST-segment elevation Secondary angina History of percutaneous coronary revascularization or coronary-artery bypass grafting within the preceding six months Factors associated with an increased risk of bleeding Left bundle-branch block or paced rhythm Severe congestive heart failure or cardiogenic shock Serious systemic disease Serum creatinine level of more than 2.5 mg per deciliter (221 Î_mol per liter) Current participation in another study of an investigational drug or device Concurrent use of warfarin Had received ticlopidine or clopidogrel for more than three days before enrollment |
| Follow-up | 6 months |
| Primary endpoint | Composite of death, nonfatal myocardial infarction, and rehospitalization for an acute coronary syndrome at six months |
| Secondary endpoint(s) | . |
| Details | Both the PCI and control group received tirofiban. In the conservative-strategy group, 478 patients (43%) met the protocol criteria for failure of medical therapy during the initial hospitalization: 56% of these patients had an abnormal stress test, 37% had recurrent angina at rest with electrocardiographic changes, 4% had hemodynamic instability, and 4% had recurrent myocardial infarction. In an additional 8 percent, medical therapy failed during follow-up, and the patients were rehospitalized for unstable angina or myocardial infarction. Of the patients who were randomly assigned to the conservative strategy, 51 percent underwent catheterization and 36 percent underwent revascularization during the initial hospitalization. |
| Brief summary: | PCI in troponin positive patients improved composite death/MI. Trop negative did not benefit. |
| PAPER: Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. | |
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| Date | 21 Jun 2001 |
| Journal | N Engl J Med. 2001 Jun 21;344(25):1879-87. |
| Information | In UA/STEMI - PCI (+ tirofiban) vs. medical therapy (+tirofiban): -Reduced death/non-fatal MI/hospitalisation for ACS (OR 0.78; p=0.025) Trop T subgroup analysis: -Trop T negative: no advantage in intervention -Trop T positive: intervention superior (p<0.001) Analysis on TIMI risk score -Intervention superior in intermediate/high score (>3) -Intervention similar to conservative in low scores (<2) N.B. 51% of control underwent angio and 36% revasc due to failed medical therapy |