Abstract

In this real-world, retrospective cohort study of 9753 patients in Japan prescribed dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI), we investigated DAPT duration and determined factors associated with early DAPT discontinuation and with event rates in patients who discontinued DAPT. The study period was April 1, 2012–March 31, 2018; endpoints comprised composite efficacy [death, myocardial infarction (MI), and stroke] and bleeding (intracranial, gastrointestinal, and requiring transfusion) endpoints. Overall, 68.8% of patients were continuing DAPT at 3 months post-PCI. Patients without major efficacy or safety events within 3 months after index PCI were included in a landmark analysis set (LAS; n = 7056), and categorized as DAPT ≥ 3 months (continuation) versus < 3 months (discontinuation). In the two LAS analysis groups, there was no difference in the composite bleeding endpoint (P = 0.067), although the incidence of the composite efficacy endpoint was higher in the discontinuation group (P < 0.001). In multivariate regression analysis, age ≥ 75 years, minor bleeding after PCI, history of cerebral infarction, history of cerebral or gastrointestinal bleeding, atrial fibrillation, dialysis, and anticoagulant use after PCI were associated with early DAPT discontinuation. Acute coronary syndrome, history of MI, kidney disorder, and anticoagulant use after PCI were associated with the composite efficacy endpoint in the discontinuation group. In conclusion, early DAPT discontinuation is more likely in patients at high bleeding risk, but may influence the occurrence of ischemic events in these patients. Determination of DAPT duration should take into account potential ischemic risk, even in patients at high bleeding risk.

Highlights

  • Coronary artery disease (CAD) is the second leading cause of death in Japan (15.2%), and the incidence of ischemic heart disease (IHD) in Japan is increasing, with more than 200,000 deaths due to heart disease reported in 2017 [1]

  • Studies have been conducted to determine the optimal duration of dual antiplatelet therapy (DAPT) by comparing efficacy and safety between short- and long-term DAPT, but the results reported vary considerably depending on the study design, methodology, and patient population [6]

  • Many characteristics were similar for patients in the full analysis set (FAS), the landmark analysis set (LAS) DAPT discontinuation group, and the LAS

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Summary

Introduction

Coronary artery disease (CAD) is the second leading cause of death in Japan (15.2%), and the incidence of ischemic heart disease (IHD) in Japan is increasing, with more than 200,000 deaths due to heart disease (excluding hypertension) reported in 2017 [1]. American Heart Association (AHA) guidelines recommend DAPT for varying durations depending on whether the patient has stable IHD or acute coronary syndrome (ACS) [4]. Studies have been conducted to determine the optimal duration of DAPT by comparing efficacy and safety between short- and long-term DAPT, but the results reported vary considerably depending on the study design, methodology, and patient population [6]. Few studies have considered real-world clinical settings, resulting in challenging clinical decisionmaking to determine which patients are eligible for DAPT treatment [7, 8]. It would be beneficial for physicians to understand the findings from the real-world setting in Japan to apply them in clinical practice. There is a need to clearly determine the background characteristics of PCI patients and the actual use and prognosis of DAPT after PCI in the Japanese clinical practice setting

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