The 2020 European Society of Cardiology (ESC) guidelines for non-ST elevation acute coronary syndrome (NSTE-ACS)provide impactful thrombotic risk criteria to help clinicians understand the management of patients undergoing percutaneous coronary intervention (PCI) in categories with a significant risk of major adverse cardiac events (MACE), a new analysis shows.
George Dangas, MD, PhD, of the Icahn School of Medicine at Mount Sinai, New York, presented these results during a late-breaking trial session Friday at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 in Phoenix.
Guidelines currently recommend more than 1 year of treatment with a second antithrombotic agent in select patients (recommendation class IIa/IIb) after PCI. High-bleeding-risk (HBR) criteria proposed by the Academic Research Consortium are frequently used to determine whether patients are, in fact, high-risk. Ischemic or thrombotic risk does not currently have a universal definition.
This analysis examined the value of the new ESC guidelines for management of NSTE-ACS as it pertains to the new subset of criteria created to identify patients with increased thrombotic risk who could benefit from an extended treatment plan with a second antithrombotic agent.
Patients (n=11,787) who underwent PCI at Mount Sinai Hospital, New York, from 2012 to 2019, were retrospectively evaluated for thrombotic risk, according to the new guidelines. Patients were categorized into low-risk (n=2,641, mean age=64.2±11.5 years, 24.4% female), moderate-risk (n=5,288, mean age=67.1±11.3 years, 31.1% female) or high-risk (n=3,860, mean age=67.0±11.8 years, 23.7% female).
The primary endpoint was a composite of all-cause death, myocardial infarction (MI) or stroke at 1-year post-PCI.
Primary-endpoint events occurred in 5.4% of high-risk patients, 4.1% of moderate-risk patients and 1.6% of low-risk patients. All-cause death occurred in 2.7% of high-risk patients, 2.3% of moderate-risk patients and 0.6% of low-risk patients.
Both moderate- and high-risk patients had increased clinical events at 1 year when compared to low-risk patients. Moderate-risk patients were more than 2.5 times as likely to experience a primary-endpoint event (hazard ratio [HR]: 2.53; 95% confidence interval [CI]: 1.78-3.58; p<0.001), while high-risk patients were more than three times as likely (HR: 3.39; 95% CI: 2.39-4.80; p<0.001).
Similar patterns were seen with the components of the primary endpoint and major bleeding but not stroke, where the confidence intervals for both moderate- and high-risk patients crossed 1, meaning that there was no statistical significance among the groups for stroke.
Dangas noted a few limitations. First, follow-up was solely at 1-year post-PCI, and three less common ESC thrombotic risk criteria were not available for analysis. Causes of death were also not available.
Overall, the ESC guidelines are suitable for analysis of patients undergoing PCI in categories with an incremental risk of MACE all-cause death, MI or target vessel revascularization at 1-year post-PCI, Dangas concluded.
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