OPTIMA:OPTIMA:

OpOptimal timal TimTiming of PCI in Unstable ing of PCI in Unstable AAnginangina

Prospective, Randomized Evaluation of Immediate Versus Deferred Prospective, Randomized Evaluation of Immediate Versus Deferred Angioplasty in Patients with High Risk Acute Coronary SyndromesAngioplasty in Patients with High Risk Acute Coronary Syndromes

RK Riezebos1, E Ronner1, E Ter Bals1, T Slagboom1, F Kiemeneij1,G Amoroso1, MS Patterson1, JG Tijssen2, MJ Suttorp3, GJ Laarman1

1Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands2Amsterdam Medical Center, Amsterdam, The Netherlands

3St Antonius Hospital, Nieuwegein, The Netherlands

Current controlled trial number: ISRCTN80874637

IntroductionIntroduction

• Current guidelines recommend an early Current guidelines recommend an early invasive strategy in high risk NSTE-ACSinvasive strategy in high risk NSTE-ACS

• The precise timing of early PCI is controversial. The precise timing of early PCI is controversial. ImmediateImmediate PCI may prevent (spontaneous) PCI may prevent (spontaneous)

cardiac eventscardiac events DeferredDeferred PCI may lead to less peri-procedural PCI may lead to less peri-procedural

complicationscomplications

OPTIMA trialOPTIMA trial

• OpOptimal timal timtiming of PCI in unstable ing of PCI in unstable aanginangina

• To compare immediate with To compare immediate with 24–4824–48 hours deferred PCI in the early hours deferred PCI in the early invasive management of NSTE-ACSinvasive management of NSTE-ACS

• Hypothesis: Hypothesis: In high risk NSTE-ACS In high risk NSTE-ACS immediate PCI reduces cardiac eventsimmediate PCI reduces cardiac events

PatientsPatients

• Patients with high risk NSTE-ACSPatients with high risk NSTE-ACS

• No indication for urgent PCINo indication for urgent PCI

• Immediate coronary angiographyImmediate coronary angiography

• Culprit lesion amenable for PCICulprit lesion amenable for PCI

Randomized treatmentsRandomized treatments

• Randomization in cathlab after angiographyRandomization in cathlab after angiography

• Immediate PCIImmediate PCI PCI of culprit lesion in same sessionPCI of culprit lesion in same session

• Deferred PCIDeferred PCI PCI of culprit lesion after repeat angiography PCI of culprit lesion after repeat angiography

24-48 hours later24-48 hours later

• Triple antiplatelet therapyTriple antiplatelet therapy Abciximab, clopidogrel and aspirinAbciximab, clopidogrel and aspirin

n

No significant CAD 55

CABG is better treatment 27

ISR 9

Clinically driven immediate PCI 8

Culprit lesion not amenable for PCI 6

CTO 4

Flow chartFlow chart

0 12 24 36 480

20

40

60

80

100

Immediate PCI Deferred PCI

< 0.0001p

median 30 minutes median 25 hours

Time since randomization (hours)

% p

ati

en

ts w

ith

PC

ITime from randomization to PCITime from randomization to PCI

Clinical events at 30 days Clinical events at 30 days

Immediate PCI (n=73)

Deferred PCI (n=69)

p

• Mortality 0 (0) 0 (0)• MI 44 (60) 26 (37) 0.007

• MI at randomization 16 (22) 12 (17) 0.5• MI after randomization 28 (38) 14 (20) 0.03

• Unplanned revascularization 1 (1) 3 (4) 0.3

Composite endpoint 44 (60) 27 (39) 0.01

0 10 20 300

20

40

60

80

100

Immediate PCI

Deferred PCI

0.0041p=

RR 1.5 CI1.09-2.05

Time since randomization (days)

% p

ati

en

tsPrimary endpoint at 30 daysPrimary endpoint at 30 days

%

peak CKMB:P<0.01

CKMB (median): 9.8 4.9 (ng/L)

ConclusionsConclusions

• Immediate PCI increased the rate of Immediate PCI increased the rate of periprocedural MI compared to a cooling periprocedural MI compared to a cooling down strategy of deferred PCIdown strategy of deferred PCI

• The results of the study suggest that there The results of the study suggest that there is no need to rush to PCI in non-refractory is no need to rush to PCI in non-refractory high risk NSTE-ACS patientshigh risk NSTE-ACS patients