VA NQWISH Veterans Affairs Non-Q Wave Infarction Strategies In-Hopsital Trial

VA NQWISH l Compare outcomes of patients with non-Q wave MI, managed with an early invasive stategy vs. an early conservative strategy Goal

VA NQWISH Inclusion / Exclusion l Inclusion Criteria: Clinical presentation consistent with acute MI Clinical presentation consistent with acute MI CK-MB > 1.5 times upper limit of normal CK-MB > 1.5 times upper limit of normal No Q wave on ECG (could be ST elev without Q waves) No Q wave on ECG (could be ST elev without Q waves) Onset within 72 hours of randomization Onset within 72 hours of randomization l Exclusion Criteria: s High risk (ongong ischemia, CHF, arrhythmias) s Recent revascularization

VA NQWISH Treatment Strategies l Invasive: s Cardiac catheterization within 3-7 days s Revascularization if possible s (PTCA for 1 or 2VD, CABG for 3VD) l Conservative: s Mecical management s RVG s ETT / Thallium pre-discharge s Cath if ETT + or recurrent ischemia at rest with ECG changes

VA NQWISH Statistics l Equivalence Design: l i.e, No difference in clinical outcome between the two strategies l Primary End Point: Death or non-fatal MI through follow-up (minimum 1 year) l Assumed 20% event rate in each arm. l 85% power, p=0.05

VA NQWISH Patient Flow 17 VA Hosptial Across U.S.

VA NQWISH Catheterization / Revascularization No. Pts Cath (%) < H Disch < H Disch >H Disch >H Disch Revasc. (%) Time to revasc (mean, days) Invasive Invasive Conservative

VA NQWISH Outcomes No. Pts Death/MI to F/U (%) Death (%) Non-fatal MI (%) Death < H Disch Death >H Disch L.O.S. (days) Invasive Invasive Conservative NS0.007NS<0.001 P value P value

VA NQWISH Conservative vs. Invasive Death/MIMortality ( ) ( ) Hazard Ratios Hazard Ratio 95% Conf. Interval

VA NQWISH F In-hosptial deaths: 21 Invasive vs. 6 Conservative F 11 of 21 deaths were post CABG (13.4% perioperative mortality) F 0 deaths post PTCA F Recent Ontario study CABG patients : F Total perioperative mortality 3.14% F Patients with recent MI = mortality 12.6% Peri-Procedural Complications

VA NQWISH F Patients with non-Q wave MI in this trial did not benefit from early invasive strategy and may be harmed. F A conservative, “ischemia-guided” management approach is both safe and effective Conclusions

Observations from TIMI IIIB and VANQWISH F An invasive strategy did not prevent recurrent MI F Outcome of invasive strategy depends on peri- procedural complication rate, influenced by: n Procedure (PTCA vs. CABG) n Hospital n Patient population

100$2,353,671 No. Pts Total Costs Invasive100$2,184,092 Conservative Conservative Cost Analysis - Invasive vs. Conservative (using TIMI IIIB as a model) Conti CR. Clin Cardiol 1995;18: Invasive strategy $1696 per patient added cost (1.5% lower rate of death or MI by 1 year)