Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI
Gennaro Giustino1, Roxana Mehran1, George D Dangas1
1Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Cardiovascular Research Foundation, New York, New York.
Insights
The daily risk of bleeding events exceeded ischemic events within 30 days after primary percutaneous coronary intervention for ST-elevation myocardial infarction. Beyond 30 days, ischemic events became more frequent than bleeding events, supporting intensified antiplatelet therapy.
Area of Science:
- Cardiology
- Interventional Cardiology
- Thrombosis
Background:
- Risk of recurrent ischemic and bleeding events after primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) varies over time.
- This temporal variation may impact the benefit-risk balance of antithrombotic therapies.
Purpose of the Study:
- To characterize average daily ischemic rates (ADIRs) and average daily bleeding rates (ADBRs) in the first year post-primary PCI for STEMI.
- To evaluate the temporal trends of ischemic and bleeding events in STEMI patients undergoing primary PCI.
Main Methods:
- Analysis of 3,602 STEMI patients from the HORIZONS-AMI trial.
- Classification of ischemic and bleeding events into acute (≤24h), subacute (1 day-30 days), and late (30 days-1 year) periods.
- Calculation of ADIRs and ADBRs using a Poisson distribution and testing differences with generalized estimating equations.
Main Results:
- Both ADIRs and ADBRs decreased exponentially over time.
- In the subacute phase (≤30 days), ADBRs were significantly higher than ADIRs.
- In the late phase (>30 days), ADIRs significantly exceeded ADBRs.
Conclusions:
- ADIRs and ADBRs decrease significantly over the first year after primary PCI for STEMI.
- Bleeding risk outweighs ischemic risk in the early phase (≤30 days), while ischemic risk dominates later (>30 days).
- Findings support intensified platelet inhibition during the first year post-STEMI.
Background:
The risk of recurrent ischemic and bleeding events after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) may not be uniform over time, which may affect the benefit-to-risk ratio of guideline-recommended antithrombotic therapies in different intervals.
Objectives:
This study sought to characterize the average daily ischemic rates (ADIRs) and average daily bleeding rates (ADBRs) within the first year after primary PCI for STEMI.
Methods:
Among 3,602 patients with STEMI who were enrolled in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial, all ischemic and bleeding events, including recurrent events, were classified according to the timing of their occurrence as acute (≤24 h after PCI), subacute (1 day to 30 days), and late (30 days to 1 year). Patients were treated with aspirin and clopidogrel for the entire year. ADIRs included cardiac death, reinfarction, and definite stent thrombosis. ADBRs included non-coronary artery bypass graft-related Thrombolysis In Myocardial Infarction major and minor bleeding. ADIRs and ADBRs were calculated as the total number of events divided by the number of patient-days of follow-up in each interval assuming a Poisson distribution. Generalized estimating equations were used to test the absolute least square mean differences (LSMD) between ADIRs and ADBRs.
Results:
The ADIR and ADBR both exponentially decreased from the acute to the late periods (p < 0.0001). Although there were no significant differences in ADIR and ADBR in the acute phase (LSMD: +0.11%; 95% confidence interval [CI]: -0.35% to 0.58%; p = 0.63), the ADBR was greater than the ADIR in the subacute phase (LSMD: -0.39%; 95% CI: -0.58% to -0.20%; p < 0.0001). In the late phase, the ADIR exceeded the ADBR (LSMD: +1.51%; 95% CI: 1.04% to 1.98%; p < 0.0001).
Conclusions:
After primary PCI, the ADIR and ADBR both markedly decreased over time. Although the rates for bleeding exceeded those for ischemia within 30 days, the daily risk of ischemia significantly exceeded the daily risk of bleeding beyond 30 days, supporting the use of intensified platelet inhibition during the first year after STEMI.
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