OPTIMA: Optimal Timing of PCI in Unstable Angina

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OPTIMA Optimal Timing of PCI in Unstable Angina

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

Current controlled trial number ISRCTN80874637
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
Netherlands 2Amsterdam Medical Center, Amsterdam,
The Netherlands 3St Antonius Hospital,
Nieuwegein, The Netherlands
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Disclosure Statement of Financial Interest

• I, Robert Riezebos DO NOT have a financial
  interest/arrangement or affiliation with one or
  more organizations that could be perceived as a
  real or apparent conflict of interest in the
  context of the subject of this presentation.

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Introduction

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

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OPTIMA trial

• Optimal timing of PCI in unstable angina
• To compare immediate with 2448 hours deferred
  PCI in the early invasive management of NSTE-ACS
• Hypothesis In high risk NSTE-ACS immediate PCI
  reduces cardiac events

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Patient selection

• Screening at hospital admission
• Chest pain at rest lt 6 hours
• At least one of the following
• Cardiac troponin T gt 0.01 ng/l
• ST depression gt 0.1 mV in 2 contiguous leads
• History of coronary artery disease
• 2 or more risk factors for coronary artery
  disease
• No clinical indication for urgent PCI
• Written informed consent (before angiography)

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Angiographic inclusion

• Immediate angiography
• Culprit lesion amenable to PCI
• Angiographic exclusions
• CABG preferred treatment
• CTO culprit
• ISR culprit

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Randomized treatments

• Randomization in cathlab after angiography
• Immediate PCI
• Ad hoc PCI of culprit lesion
• Deferred PCI
• PCI of culprit lesion 24-48 hours later
• Triple antiplatelet therapy
• Abciximab, clopidogrel and aspirin

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Primary endpoint

• Composite of
• Death
• Non fatal MI
• Unplanned revascularization
• within 30 days

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Sample size

• Event rate in control group 30,
• Immediate PCI 35 relative risk reduction
• Power 80, a 0.05 (two-sided)
• 2 x 300 randomized patients
• After enrollment of 251 patients interim analysis
  was performed
• 142 patients were randomized

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Flow chart
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Baseline demographics
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Baseline risk factors
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Baseline characteristics ACS
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Time from randomization to PCI
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PCI characteristics
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Medication
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Primary endpoint at 30 days
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Primary endpoint at 30 days
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Clinical events at 30 days
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MI at 30 days
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Adjusted composite endpoint (negative CKMB at
randomization)
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Infarct size during initial hospitalization
peak CKMB
Plt0.01

CKMB (median) 9.8 4.9 (ng/L)
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Other clinical events at 30 days
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Limitations

• Limited sample size due to early discontinuation
  of patient inclusion
• Unexpected results opposite to hypothesis
• The play of chance

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Conclusions

• 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