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Japan-United States of America Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (Japan-USA HARMONEE) study: primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome Spontaneous Coronary Artery Dissection: Pathophysiological Insights From Optical Coherence Tomography Double-Kissing Culotte Technique for Coronary Bifurcation Stenting - Technical evaluation and comparison with conventional double stenting techniques Prognostic Implications of Plaque Characteristics and Stenosis Severity in Patients With Coronary Artery Disease Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions: Endorsed by the Chinese Society of Cardiology Physiological Stratification of Patients With Angina Due to Coronary Microvascular Dysfunction Utilization and Outcomes of Measuring Fractional Flow Reserve in Patients With Stable Ischemic Heart Disease Randomized Comparison of FFR-Guided and Angiography-Guided Provisional Stenting of True Coronary Bifurcation Lesions: The DKCRUSH-VI Trial (Double Kissing Crush Versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions VI)

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Clinical TrialVolume 70, Issue 15, October 2017

JOURNAL：J Am Coll Cardiol. Article Link

Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI

Giustino G, Mehran R, Stone GW et al. Keywords: ST-segment elevation myocardial infarction; average daily rate; bleeding events; ischemic events; percutaneous coronary intervention

ABSTRACT

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.

Abstract

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Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI

ABSTRACT