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. 2020 Jun;34(3):335-344.
doi: 10.1007/s10557-020-06963-5.

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease

Florian Krackhardt  1 , Matthias Waliszewski  2   3 , Viktor Kočka  4 , Petr Toušek  4 , Bronislav Janek  5 , Martin Hudec  6 , Fernando Lozano  7 , Koldobika Garcia-San Roman  8 , Bruno Garcia Del Blanco  9 , Josepa Mauri  10 , Tay Mok Heang  11 , Tae Hoon Ahn  12 , Myung Ho Jeong  13 , Denny Herberger  3 , Vjekoslav Tomulic  14 , Gilles Levy  15 , Laurent Sebagh  16 , Jérôme Rischner  17 , Michel Pansieri  18
Affiliations

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease

Florian Krackhardt et al. Cardiovasc Drugs Ther. 2020 Jun.

Erratum in

Abstract

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.

Keywords: Clopidogrel; Dual antiplatelet therapy; Polymer-free; Sirolimus-eluting stent; Ticagrelor.

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Conflict of interest statement

The authors provide a full disclosure of real or perceived conflicts of interests. Dr. Florian Krackhardt (honoraria speaker fees with B.Braun, AstraZeneca), Denny Herberger and Dr. Matthias Waliszewski (full-time employees B.Braun), all other authors: unrestricted research grant to recruit and document patients on a pay-by-patient basis. Co-authors of previously published DES studies with polymer-free sirolimus-eluting stents (all authors).

Figures

Fig. 1
Fig. 1
Potential factors for clinical events and stent thrombosis following DES implantations, modified after to Byrne et al. [2]
Fig. 2
Fig. 2
Post hoc analysis selection of patients with stable CAD or ACS, who were treated with clopidogrel or ticagrelor
Fig. 3
Fig. 3
Forest plot and odds ratios for ticagrelor use for various covariates
See this image and copyright information in PMC

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