Abstract
Background There is a paucity of real-world data regarding the clinical impact of dual antiplatelet therapy (DAPT) interruption (temporary or permanent) among patients at high ischemic risk. The aim of this study was to assess the risk of cardiovascular events after interruption of DAPT in high-risk PCI population. Methods This study used data from the Fuwai PCI registry, a large, prospective cohort of consecutive patients who underwent PCI. We assessed 3,931 patients with at least 1 high ischemic risk criteria of stent-related recurrent ischemic events proposed in the 2017 ESC guidelines for focused update on DAPT who were free of major cardiac events in the first 12 months. The primary ischemic endpoint was 30-month major adverse cardiac and cerebrovascular events, and the key safety endpoints were BARC class 2, 3, or 5 bleeding and net adverse clinical events. Results DAPT interruption within 12 months occurred in 1,122 patients (28.5%), most of which were due to bleeding events or patients' noncompliance to treatment. A multivariate Cox regression model, propensity score (PS) matching, and inverse probability of treatment weighting (IPTW) based on the propensity score demonstrated that DAPT interruption significantly increased the risk of primary ischemic endpoint compared with prolonged DAPT (3.9% vs. 2.2%; Cox-adjusted hazard ratio (HR): 1.840; 95% confidence interval (CI): 1.247 to 2.716; PS matching-HR: 2.049 [1.236–3.399]; IPTW-adjusted HR: 1.843 [1.250–2.717]). This difference was driven mainly by all-cause death (1.8% vs. 0.7%) and MI (1.3% vs. 0.5%). Furthermore, the rate of net adverse clinical events (4.9% vs. 3.2%; Cox-adjusted HR: 1.581 [1.128–2.216]; PS matching-HR: 1.639 [1.075–2.499]; IPTW-adjusted HR: 1.554 [1.110–2.177]) was also higher in patients with DAPT interruption (≤12 months), whereas no significant differences between groups were observed in terms of BARC 2, 3, or 5 bleeding. These findings were consistent across various stent-driven high-ischemic risk subsets with respect to the primary ischemic endpoints, with a greater magnitude of harm among patients with diffuse multivessel diabetic coronary artery disease. Conclusions In patients undergoing high-risk PCI, interruption of DAPT in the first 12 months occurred infrequently and was associated with a significantly higher adjusted risk of major adverse cardiovascular events and net adverse clinical events. 2017 ESC stent-driven high ischemic risk criteria may help clinicians to discriminate patient selection in the use of long-term DAPT when the ischemic risk certainly overcomes the bleeding one.
Highlights
Dual antiplatelet therapy (DAPT) of aspirin and a P2Y12 inhibitor has been a therapeutic cornerstone after percutaneous coronary intervention (PCI) or acute coronary syndrome (ACS); its optimal duration in different clinical scenarios is currently a matter of debate [1,2]
Many clinical trials have suggested that the benefits of lower risk of bleeding events with abbreviated DAPT followed by aspirin-based single antiplatelet therapy (SAPT) were counterbalanced by higher rates of stent thrombosis [6,7,8,9], while an individual participant data meta-analysis showed that P2Y12 inhibitor monotherapy after short DAPT was associated with lower major bleeding and similar risks of fatal and ischemic events compared with traditional DAPT [10]
The prognostic significance of interruption or any nonadherence to DAPT in the first 12 months in higher-risk routine practice populations remains unclear. erefore, using prospective data from a contemporary real-world group of patients undergoing PCI, we focused on a subset of patients who satisfied high ischemic risk criteria based on patient-related clinical and angiographic characteristics and PCI-related features to estimate the incidence of DAPT interruption in the first 12 months after PCI and evaluate the efficacy and safety of DAPT interruption ≤12 months as compared with longer than 12 months of DAPT for these high-risk patients
Summary
Dual antiplatelet therapy (DAPT) of aspirin and a P2Y12 inhibitor has been a therapeutic cornerstone after percutaneous coronary intervention (PCI) or acute coronary syndrome (ACS); its optimal duration in different clinical scenarios is currently a matter of debate [1,2]. Based on lower rates of late stent thrombosis with newer-generation DES, the risk of thrombotic events is not increased even with 1 to 6 months of DAPT [5]. Many clinical trials (most of which were relatively small and open-label noninferiority trials) have suggested that the benefits of lower risk of bleeding events with abbreviated DAPT followed by aspirin-based single antiplatelet therapy (SAPT) were counterbalanced by higher rates of stent thrombosis [6,7,8,9], while an individual participant data meta-analysis showed that P2Y12 inhibitor monotherapy after short DAPT was associated with lower major bleeding and similar risks of fatal and ischemic events compared with traditional DAPT [10]. The prognostic significance of interruption or any nonadherence to DAPT in the first 12 months in higher-risk routine practice populations remains unclear. erefore, using prospective data from a contemporary real-world group of patients undergoing PCI, we focused on a subset of patients who satisfied high ischemic risk criteria based on patient-related clinical and angiographic characteristics and PCI-related features (using the 2017 ESC updates for DAPT guidelines) to estimate the incidence of DAPT interruption (temporary or permanent) in the first 12 months after PCI and evaluate the efficacy and safety of DAPT interruption ≤12 months as compared with longer than 12 months of DAPT for these high-risk patients
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