CULPRIT-SHOCK (1-year follow-up)
Trial question
What is the role of the PCI of the culprit lesion among patients with acute MI and cardiogenic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.7% female
76.3% male
N = 706
706 patients (161 female, 524 male).
Inclusion criteria: patients who had acute MI that was complicated by cardiogenic shock.
Key exclusion criteria: resuscitation for > 30 minutes, no intrinsic heart action, an assumed severe deficit in cerebral function with fixed dilated pupils, a mechanical cause of cardiogenic shock, the onset of shock > 12 hours before randomization.
Interventions
N=344 culprit-lesion-only PCI (treatment of the culprit lesion with all other lesions left untreated at the time of the initial procedure).
N=342 multivessel PCI (treatment of the culprit lesion with all additional lesions, including chronic total occlusions).
Primary outcome
Death at 1 year follow-up
50%
56.9%
56.9 %
42.7 %
28.4 %
14.2 %
0.0 %
Culprit-lesion-only percutaneous coronary
intervention
Multivessel percutaneous coronary
intervention
No significant
difference ↔
No significant difference in death at 1 year follow-up (50% vs. 56.9%; RR 0.88, 95% CI 0.76 to 1.01).
Secondary outcomes
No significant difference in recurrent MI at 1 year (1.7% vs. 2.1%; RR 0.85, 95% CI 0.29 to 2.5).
No significant difference in death, recurrent infarction, or rehospitalization for HF at 1 year (55.2% vs. 59.5%; RR 0.87, 95% CI 0.93 to 1.06).
Significant decrease in death or recurrent infarction (50.9% vs. 58.4%; RR 0.87, 95% CI 0.76 to 1).
Safety outcomes
No significant differences in stroke, bleeding.
Significant differences in rehospitalization for congestive HF (5.2% vs. 1.2%), repeat revascularization (32.3% vs. 9.4%).
Conclusion
In patients who had acute MI that was complicated by cardiogenic shock, culprit-lesion-only PCI was not superior to multivessel PCI with respect to death at 1 year follow-up.
Reference
Holger Thiele, Ibrahim Akin, Marcus Sandri et al. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710.
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