Key result
Ischemia-guided non-culprit vessel PCI was non-inferior to routine non-culprit PCI in reducing ischemia burden, with an identical median ischemic myocardium of 2.9% in both arms (difference 0.13%).
Why the study?
In patients with multivessel disease presenting with STEMI, the efficacy and safety of ischemia-guided versus routine non-culprit vessel angioplasty had not been adequately studied.
Does ischemia-guided non-culprit vessel angioplasty improve percent ischemic myocardium compared to routine non-culprit vessel angioplasty in patients with STEMI and multi-vessel disease?
RCT (n=109)
Single-blind
Stratified block randomization
Yes
Does ischemia-guided non-culprit vessel angioplasty improve percent ischemic myocardium compared to routine non-culprit vessel angioplasty in patients with STEMI and multi-vessel disease?
Mean Difference: 0.13 (95% CI -1.32–1.6)
Absolute Event Rate: 2.9% vs 2.9%
p-value: p=<0.0001
An ischemia-guided strategy for non-culprit vessel PCI in STEMI patients with multi-vessel disease is non-inferior to routine non-culprit PCI in reducing ischemic burden, potentially offering cost savings.
Ischemia-guided non-culprit PCI is non-inferior for ischemia reduction post-STEMI; confirms selective revascularization as a viable alternative to routine multivessel PCI.
BACKGROUND: In patients with multi-vessel disease presenting with ST elevation myocardial infarction (STEMI), the efficacy and safety of ischemia-guided, vs routine non-culprit vessel angioplasty has not been adequately studied. METHODS: We conducted an international, randomized, non-inferiority trial comparing ischemia-guided non-culprit vessel angioplasty to routine non-culprit vessel angioplasty, following primary PCI for STEMI. The primary outcome was the between-group difference in percent ischemic myocardium at follow-up stress MPI. All MPI images were processed and analyzed at a central core lab, blinded to treatment allocation. RESULTS: In all, 109 patients were enrolled from nine countries. In the ischemia-guided arm, 25/48 (47%) patients underwent non-culprit vessel PCI following stress MPI. In the routine non-culprit PCI arm, 43/56 (77%) patients underwent angioplasty (86% within 6 weeks of randomization). The median percentage of ischemic myocardium on follow-up imaging (mean 16.5 months) was low, and identical (2.9%) in both arms (difference 0.13%, 95%CI - 1.3%-1.6%, P < .0001; non-inferiority margin 5%). CONCLUSION: A strategy of ischemia-guided non-culprit PCI resulted in low ischemia burden, and was non-inferior to a strategy of routine non-culprit vessel PCI in reducing ischemia burden. Selective non-culprit PCI following STEMI offers the potential for cost-savings, and may be particularly relevant to low-resource settings. (CTRI/2018/08/015384).
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Karthikeyan et al. (2022) conducted an RCT in ST segment elevation myocardial infarction (STEMI) and multi-vessel disease (n=109). Ischemia-guided non-culprit vessel angioplasty vs. Routine non-culprit vessel angioplasty was evaluated on Between-group difference in percent ischemic myocardium at follow-up stress MPI (Median difference 0.13%, 95% CI -1.32 to 1.60, p=<0.0001). Ischemia-guided non-culprit vessel PCI was non-inferior to routine non-culprit PCI in reducing ischemia burden, with an identical median ischemic myocardium of 2.9% in both arms (difference 0.13%).
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