Prospective, Randomized Evaluation of Immediate Versus Deferred Angioplasty in Patients with High Risk Acute Coronary Syndromes RK Riezebos 1, E Ronner 1, E Ter Bals 1, T Slagboom 1, F Kiemeneij 1, G Amoroso 1, MS Patterson 1, JG Tijssen 2, MJ Suttorp 3, GJ Laarman 1 1 Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands 2 Amsterdam Medical Center, Amsterdam, The Netherlands 3 St Antonius Hospital, Nieuwegein, The Netherlands Current controlled trial number: ISRCTN

Introduction Current guidelines recommend an early invasive strategy in high risk NSTE-ACS Current guidelines recommend an early invasive strategy in high risk NSTE-ACS The precise timing of early PCI is controversial. The precise timing of early PCI is controversial.  Immediate PCI may prevent (spontaneous) cardiac events  Deferred PCI may lead to less peri-procedural complications

OPTIMA trial Optimal timing of PCI in unstable angina Optimal timing of PCI in unstable angina To compare immediate with 24–48 hours deferred PCI in the early invasive management of NSTE-ACS To compare immediate with 24–48 hours deferred PCI in the early invasive management of NSTE-ACS Hypothesis: In high risk NSTE-ACS immediate PCI reduces cardiac events Hypothesis: In high risk NSTE-ACS immediate PCI reduces cardiac events

Patients Patients with high risk NSTE-ACS Patients with high risk NSTE-ACS No indication for urgent PCI No indication for urgent PCI Immediate coronary angiography Immediate coronary angiography Culprit lesion amenable for PCI Culprit lesion amenable for PCI

Randomized treatments Randomization in cathlab after angiography Randomization in cathlab after angiography Immediate PCI Immediate PCI  PCI of culprit lesion in same session Deferred PCI Deferred PCI  PCI of culprit lesion after repeat angiography hours later Triple antiplatelet therapy Triple antiplatelet therapy  Abciximab, clopidogrel and aspirin

n No significant CAD55 CABG is better treatment27 ISR9 Clinically driven immediate PCI8 Culprit lesion not amenable for PCI6 CTO4 Acute coronary angiography 251 Patients randomized 142 Immediate PCI 73 Deferred (24-48h) 69 Angiographic exclusion 109 Flow chart

Time from randomization to PCI

Clinical events at 30 days Immediate PCI (n=73) Deferred PCI (n=69) p Mortality0(0)0 MI44(60)26(37)0.007 MI at randomization 16(22)12(17)0.5 MI after randomization 28(38)14(20)0.03 Unplanned revascularization1(1)3(4)0.3 Composite endpoint44(60)27(39)0.01

Primary endpoint at 30 days

Infarct size during initial hospitalization % peak CKMB: P<0.01 CKMB (median): (ng/L)

Conclusions Immediate PCI increased the rate of periprocedural MI compared to a cooling down strategy of deferred PCI Immediate PCI increased the rate of periprocedural MI compared to a cooling down strategy of deferred PCI The results of the study suggest that there is no need to rush to PCI in non-refractory high risk NSTE-ACS patients The results of the study suggest that there is no need to rush to PCI in non-refractory high risk NSTE-ACS patients