OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Centre Hospitalier d'Avignon Avignon France

Chonnam National University Gwangju South Korea

Clinical Hospital Center Rijeka Rijeka Croatia

Clinique du Millénaire Montpellier France

Clinique Turin Paris Paris France

Department of Internal Medicine and Cardiology Charité Universitätsmedizin Berlin Campus Virchow Augustenburger Platz 1 D 13353 Berlin Germany

Gachon University Gil Medical Center Incheon South Korea

Hôpital Albert Schweitzer Colmar Colmar France

Hospital General Universitario de Ciudad Real Ciudad Real Spain

Hospital Universitari Germans Trias i Pujol Badalona Spain

Hospital Universitari Vall d'Hebron Barcelona Barcelona Spain

Hospital Universitario de Cruces Bilbao Spain

IKEM Prague Czech Republic

Medical Scientific Affairs B Braun Melsungen AG Berlin Germany

Pantai Ayer Keroh Hospital Malacca MLK Malaysia

SÚSCCH a s Banská Bystrica Slovak Republic

University Hospital Královské Vinohrady Prague Czech Republic

Cardiovasc Drugs Ther. 2022 Dec;36(6):1257-1258. doi: 10.1007/s10557-021-07290-z. PubMed

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ClinicalTrials.gov
NCT02905214, NCT02629575