SynthesisOpen heart2025
Thrombolysis in non-ST-elevation myocardial infarction: systematic review and meta-analysis of randomised controlled trials.
Synthesis in Open heart, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
backgroundGuidelines strongly recommend reperfusion therapy, including thrombolysis and percutaneous coronary intervention, for ST-elevation myocardial infarction but contraindicate its use in most non-ST-elevation acute coronary syndromes (ACS). This practice largely stems from the landmark fibrinolytic therapy trialists (FTT) meta-analysis, which reported no benefit in patients without ST elevation (STE). However, the FTT included a subgroup from the ISIS-3 trial with substantial methodological issues, potentially obscuring a genuine treatment effect.
methodsWe conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) comparing thrombolysis vs placebo or no thrombolysis in ACS. Patients were grouped by ECG findings: STE, ST depression (STD) or absence of STE. All-cause mortality was extracted from each trial's short-term follow-up (typically 21-35 days). We reassessed outcomes with and without inclusion of the ISIS-3 'uncertain diagnosis' subgroup.
resultsNine RCTs (40 226 patients) were analysed. Thrombolysis significantly reduced mortality in patients without STE (excluding isolated STD) (risk ratio (RR): 0.799; 95% CI 0.668 to 0.956; I²=0%). Including the ISIS-3 'uncertain diagnosis' subgroup (representing 42% of the non-STE population) would have eliminated the statistical significance in non-STE patients (RR: 0.928; 95% CI 0.694 to 1.242) and markedly increased heterogeneity (I²=71%).
conclusionIn historical RCTs, thrombolysis was associated with lower short-term mortality in non-STE presentations excluding isolated ST-segment depression, while isolated STD showed no benefit. Legacy conclusions hinge on outdated methods, delayed treatment and heterogeneous ECG definitions (and are sensitive to ISIS-3). This study exposes a material evidence gap in the foundation of current guidelines. Contemporary randomised trials with prespecified ECG criteria, rapid treatment windows and rigorous safety adjudication are needed. PROSPERO REGISTRATION NUMBER: CRD42024573681.
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