Transcript OPTIMA: Optimal Timing of PCI in Unstable Angina

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
Medical Center, Amsterdam, The Netherlands
3St Antonius Hospital, Nieuwegein, The Netherlands
2Amsterdam
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
OPTIMA trial
• Optimal timing of PCI in unstable
angina
• 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
Patients
• Patients with high risk NSTE-ACS
• No indication for urgent PCI
• Immediate coronary angiography
• Culprit lesion amenable for PCI
Randomized treatments
• Randomization in cathlab after angiography
• Immediate PCI
PCI of culprit lesion in same session
• Deferred PCI
 PCI of culprit lesion after repeat angiography
24-48 hours later

• Triple antiplatelet therapy

Abciximab, clopidogrel and aspirin
Flow chart
Acute coronary
angiography
251
Patients randomized
142
Angiographic exclusion
109
n
Immediate PCI
73
Deferred (24-48h)
69
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
Time from randomization to PCI
% patients with PCI
100
80
Immediate PCI
Deferred PCI
median 30 minutes
median 25 hours
60
40
20
p < 0.0001
0
0
12
24
36
Time since randomization (hours)
48
Clinical events at 30 days
Immediate PCI Deferred PCI p
(n=73)
(n=69)
• Mortality
• MI
• MI at randomization
• MI after randomization
• Unplanned revascularization
Composite endpoint
0 (0)
0 (0)
44 (60)
26 (37)
0.007
16 (22)
28 (38)
12 (17)
14 (20)
0.5
0.03
1 (1)
3 (4)
0.3
44 (60)
27 (39)
0.01
Primary endpoint at 30 days
100
RR 1.5 CI1.09-2.05
p=0.0041
% patients
80
Immediate PCI
60
40
Deferred PCI
20
0
0
10
20
Time since randomization (days)
30
Infarct size during initial hospitalization
peak CKMB:
P<0.01
%
CKMB (median):
9.8
4.9
(ng/L)
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