Antiplatelet Therapy of Cilostazol or Sarpogrelate with Aspirin and Clopidogrel after Percutaneous Coronary Intervention: A Retrospective Cohort Study Using the Korean National Health Insurance Claim Database

<div><p>Background/Objectives</p><p>Addition of cilostazol or sarpogrelate to the standard dual antiplatelet therapy of aspirin and clopidogrel has been implemented in patients that underwent percutaneous coronary intervention (PCI) with stents in Korea. This study aimed to evaluate the efficacy and safety of triple antiplatelet therapies.</p><p>Methods</p><p>This retrospective cohort study was performed using the Korean National Insurance Claim Data of the Health Insurance Review and Assessment Service from January 1, 2009 to December 31, 2014. The study cohort population consisted of patients with ischemic heart diseases and a history of PCI. They were treated with antiplatelet therapy of aspirin, clopidogrel (AC); aspirin, clopidogrel, cilostazol (ACCi); or aspirin, clopidogrel, sarpogrelate (ACSa) during the index period from January 1, 2010 to December 31, 2011. During the follow-up period up to December 31, 2014, the major adverse cardiac or cerebral events (MACCE) including death, myocardial infarction, target lesion revascularization, and ischemic stroke were assessed. Bleeding complications were also evaluated as adverse drug events.</p><p>Results</p><p>Out of 93,876 patients with PCI during the index period, 69,491 patients started dual (AC) or triple therapy (ACSa or ACCi). The clinical outcomes of comparing ACSa and ACCi therapy showed beneficial effects in the ACSa group in the prevention of subsequent cardiac or cerebral events. After Propensity score-matching between ACSa and ACCi groups, there were significant differences in MI and revascularization, with corresponding HR of 0.38 (95% CI, 0.20–0.73) and 0.66 (95% CI, 0.53–0.82) in ACSa vs. ACCi at 12 months, respectively. At the 24-month follow-up, the triple therapy groups (ACS or ACC) had a higher incidence of MACCE compared to the dual therapy (AC) group; ACSa vs. AC HR of 1.69 (95% CI, 1.62–1.77); ACC vs. AC HR of 1.22 (95% CI, 1.06–1.41). There was no significant difference in severe or life-threatening bleeding risk among three groups; ACSa vs. AC, HR of 0.68 (95% CI, 0.37–1.24), ACCi vs. AC, HR of 0.91 (95% CI, 0.77–1.09).</p><p>Conclusion</p><p>Sarpogrelate-containing triple antiplatelet therapy demonstrated comparable rates of MACCE prevention to the conventional dual antiplatelet therapy after PCI without significantly increasing bleeding risk during the two-year follow-up period.</p></div

Extracting information from free-text electronic patient records to identify practice-based evidence of the performance of coronary stents

<div><p>Background and objective</p><p>Percutaneous coronary intervention (PCI) using drug-eluting stents (DES) is an indispensable treatment for coronary artery disease. However, to evaluate the performance of various types of stents for PCI, numerous resources are required. We extracted clinical information from free-text records and, using practice-based evidence, compared the efficacy of various DES.</p><p>Materials and methods</p><p>We developed a text mining tool based on regular expression and applied it to PCI reports stored in the electronic health records (EHRs) of Ajou University Hospital from 2010–2014. The PCI data were extracted from EHRs with a sensitivity of 0.996, a specificity of 1.000, and an F-measure of 0.995 when compared with a sample of 200 reports. Using these data, we compared the performance of stents by Kaplan-Meier analysis and the Cox hazard proportional regression.</p><p>Results</p><p>In the self-validation analysis comparing the first-generation to the second-generation DES, the second-generation DES was superior to the first-generation DES (hazard ratio [HR]: 0.423, 95% confidence interval [CI]: 0.284–0.630) in terms of target vessel revascularization (TVR), showing similar findings to the established results of previous studies. Among the second-generation DES, the biodegradable-polymer DES tended to be superior, with a risk of TVR (HR: 0.568, 95% CI: 0.281–1.147) falling below than that for the durable-polymer DES approximately 1 year after the index procedure. The Endeavor stent had the highest TVR risk among the newer generation DES (HR: 2.576, 95% CI: 1.273–5.210).</p><p>Conclusions</p><p>In this study, we demonstrated how to construct a PCI data warehouse of PCI-related parameters obtained from free-text electronic records with high accuracy for use in the post surveillance of coronary stents in a time- and cost effective manner. Post surveillance of the practice based evidence in the PCI data warehouse indicated that the biodegradable-polymer DES might have a lower risk of TVR than the durable-polymer DES.</p></div

Vessel and stent terms used in PCI reports and their categories in this study.

<p>Vessel and stent terms used in PCI reports and their categories in this study.</p

The percutaneous coronary intervention (PCI)-related parameter information extraction process from free-text PCI procedure reports.

<p>The percutaneous coronary intervention (PCI)-related parameter information extraction process from free-text PCI procedure reports.</p

Baseline characteristics of the study population.

<p>Baseline characteristics of the study population.</p

Hazard ratios of first- versus second-generation stents and the observed variables in PCI patients.

<p>Hazard ratios of first- versus second-generation stents and the observed variables in PCI patients.</p

Clinical outcomes of Incidence rates and relative risks of cardiac or cerebral events.

<p>Clinical outcomes of Incidence rates and relative risks of cardiac or cerebral events.</p

Adjusted TVR risk of each stent compared to the other second generation stents.

<p>Adjusted TVR risk of each stent compared to the other second generation stents.</p

Comparison of target vessel revascularization free survival between the first- and second-generation stents.

<p>Comparison of target vessel revascularization free survival between the first- and second-generation stents.</p

Clinical outcomes of incidence rates and relative risks of cardiac events between ACCi and ACSa.

<p>ACCi, aspirin+clopidogrel+cilostazol; ACSa, aspirin+clopidogrel+sarpogrelate; MACCE, major adverse cardiac cerebral events (composite events of death, myocardial infarction, ischemic stroke, revascularization).</p