Only STEMI Clearly Benefit from Urgent (ASAP) Revascularization

TACTICS-TIMI 18

Comparison of Early Invasive and Conservative Strategies in Patients with unstable Coronary Syndromes treated with the Glycoprotein IIb/IIIa Inhibitor Tirofiban

N Engl J Med, Vol. 344 (25): 1879-1887

History

-Only STEMI clearly benefit from urgent (ASAP) revascularization

-Still unclear if pts with NSTEMI/UA benefit from early (within 48h) revasc vs. conservative mgt

-Conservative mgt means cath is performed only if pt has recurrent isch or positive stress testing

-Earlier trials (TIMI IIIB, VANQWISH, MATE,) had studied this question, but most found no difference in mortality; many did show decreased rehospitalizations/recurrent ischemia

-Many factors changed since these studies: newer drugs (IIb/IIIa), PTCA, lower mortality CABG

-FRISC II (Lancet 99) first to show mortal benefit early intervention vs. conserve mgt c LMWH

-However, conservative group may be too conserve (only 10% cath), not c/w guidelines

-Goal: Show benefit of early revasc using PTCA, IIb/IIIa versus modern conservat management

Methods

-Randomized Control Trial, 2220 patientsConservative vs. Early Invasive

-Inclusion Criteria:

-Episode of sx c/w UA within preceeding 24h, candidates for revasc, >18 yo

-One of:a)STD 0.05 b)transient STE 0.1mm c)TWI 0.3mm 2 leads d)enzymes e)h/o CAD

-Exclusion Criteria:

-Persistent STE, PCI/CABG last 6 mos, risk for increased bleeding, LBBB/paced

severe CHF, cardiogenic shock, serious systemic illness, Cr> 2.5, on coum

-Meds used: 325mg ASA, IV Heparin with bolus, tirofiban (load plus drip) for 48 h or 12h p cath

-Conservative Mgt – Medical mgt, stress test (83% with imaging) before discharge

-Cath only if: prolonged/recurrent angina a/w EKG changes or enzymes, hemodyn unstab

-Early Invasive – Angiography between 4-48h, revasc based on anatomy

-Primary Endpoint – Combined incidence of death, nonfatal MI, rehosp for ACS at 6 months

Results

-Patient Characteristics: 40% were older than 65yrs, mostly white males, ¼ Diabetic,

-Half had elevated enzymes, half had ST or TW changes and ¼ had only h/o CAD

-Early invasive group had cath median of 22h; 60% underwent PCI or CABG

-Half of conservative group ultimately cath median 79h; 36% underwent PCI or CABG

Primary Endpoint:
Early invasive 15.9% vs. conservat 19.4%
(odds ratio 0.78, CI 0.62-0.97)
Similar reduction noted 1wk/30days
Subgroup: Greater benefit with
-ST changes
-Not on home ASA
-TIMI risk 3+
No diff in CVA/major bleeding /

Conclusions

-With the advent IIb/IIIa’s, + stents, early invasive tx superior to conserv mgt in UA/NSTEMI

-Again, the higher the risk, the greater the benefit…use TIMI risk score; low risk->conserv mgt.

-As better meds and surgical/cath techniques develop, need to readdress this question

Marco Perez, CCU 1/04