Key result
Early routine PCI after fibrinolysis for STEMI reduced 30-day death or re-MI in low-intermediate risk patients (2.9% vs 8.1%) but increased it in high-risk patients (27.8% vs 13.8%; P-int<0.001).
Why the study?
Does pharmacoinvasive therapy (early routine PCI) reduce death or re-MI in STEMI patients receiving tenecteplase when stratified by baseline risk?
RCT (n=1,059)
Does pharmacoinvasive therapy (early routine PCI) reduce death or re-MI in STEMI patients receiving tenecteplase when stratified by baseline risk?
A pharmacoinvasive strategy after fibrinolysis for STEMI may improve outcomes only in patients with low-intermediate GRACE risk scores, while potentially worsening outcomes in high-risk patients.
Answers are grounded in this paper and cite their sources.
May support selective early PCI post-fibrinolysis only in low-intermediate risk STEMI; leaves open randomized confirmation of GRACE interaction.
AIMS: We sought to determine the effectiveness of early routine percutaneous coronary intervention (PCI) post-fibrinolysis for ST-elevation myocardial infarction (STEMI) in relation to baseline risk status. METHODS AND RESULTS: In this post hoc subgroup analysis of Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI), we stratified 1059 STEMI patients receiving tenecteplase into low-intermediate [Global Registry of Acute Coronary Events (GRACE) risk score<155; n=889] vs. high-risk (GRACE risk score ≥155; n=170) groups, based on the GRACE risk score for in-hospital mortality. There was a significant interaction between treatment assignment and risk status for the composite endpoint of death/re-MI at 30 days (P for interaction<0.001). Compared with the standard treatment, pharmacoinvasive therapy (early routine PCI) was associated with a lower rate of death/re-MI at 30 days in the low-intermediate risk stratum (8.1 vs. 2.9%, P<0.001), but a higher rate of death/re-MI in the high-risk group (13.8 vs. 27.8%, P=0.025). We found similar heterogeneity in the treatment effects on 30-day mortality and death/re-MI at 1 year (P for interaction=0.008 and 0.001, respectively), when the GRACE risk score was analysed as a continuous variable (P for interaction<0.001) and when patients were stratified by the Thrombolysis In Myocardial Infarction (TIMI) risk score (P for interaction=0.001). CONCLUSION: We observed a strong heterogeneity in the treatment effects of a pharmacoinvasive strategy after fibrinolysis for STEMI, which is associated with improved outcomes only among patients with a low-intermediate GRACE risk score. Conversely, the early invasive strategy is associated with worse outcomes in high-risk patients. These novel findings should be considered exploratory only and require confirmation in other trials and meta-analyses. CLINICAL TRIAL REGISTRATION INFORMATION: http://www.clinicaltrials.gov/ct2/show/NCT00164190 ClinicalTrials.gov number, NCT00164190.
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Yan et al. (2011) conducted an RCT in ST-elevation myocardial infarction (STEMI) (n=1,059). Pharmacoinvasive therapy (early routine PCI) vs. Standard treatment was evaluated on Composite of death/re-MI at 30 days (p=<0.001). Early routine PCI after fibrinolysis for STEMI reduced 30-day death or re-MI in low-intermediate risk patients (2.9% vs 8.1%) but increased it in high-risk patients (27.8% vs 13.8%; P-int<0.001).
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