Author + information
- Received September 12, 2018
- Revision received November 12, 2018
- Accepted December 3, 2018
- Published online May 6, 2019.
- Yasushi Ueki, MDa,
- Alexios Karagiannis, PhDb,
- Christian Zanchin, MDa,
- Thomas Zanchin, MDa,
- Stefan Stortecky, MDa,
- Konstantinos C. Koskinas, MD, MSca,
- George C.M. Siontis, MD, PhDa,
- Fabien Praz, MDa,
- Tatsuhiko Otsuka, MDa,
- Lukas Hunziker, MDa,
- Dik Heg, PhDb,
- Aris Moschovitis, MDa,
- Christian Seiler, MDa,
- Michael Billinger, MDa,
- Thomas Pilgrim, MDa,
- Marco Valgimigli, MD, PhDa,
- Stephan Windecker, MDa and
- Lorenz Räber, MD, PhDa,∗ ()
- aDepartment of Cardiology, Bern University Hospital, Bern, Switzerland
- bInstitute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland
- ↵∗Address for correspondence:
Prof. Lorenz Räber, Department of Cardiology, Bern University Hospital, Freiburgstrasse 18, 3010 Bern, Switzerland.
Objectives This study sought to validate European Society of Cardiology guideline-endorsed high-risk features of stent-related recurrent ischemic events for the prediction of ischemic and bleeding outcomes including a stratification according to the PRECISE-DAPT score estimated bleeding risk.
Background The 2017 European Society of Cardiology–focused update on dual-antiplatelet therapy endorsed high-risk features of stent-related recurrent ischemic events. Because patients with high ischemic risk also have an increased bleeding risk, appropriate risk stratification for ischemic and bleeding events is crucial.
Methods Between January 2009 and December 2015, a total of 10,236 consecutive patients undergoing clinically indicated percutaneous coronary intervention were prospectively included in the Bern PCI Registry. Guideline-endorsed high-risk features were retrospectively assessed. The primary ischemic endpoint was device-oriented composite endpoint (DOCE) (cardiac death, target-vessel myocardial infarction, and target lesion revascularization) at 1 year, and the primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) 3–5 at 1 year.
Results A total of 5,323 (52.0%) patients had at least 1 high-risk feature. Among patients with high-risk features, DOCE (12.3% vs. 5.5%; p < 0.001) and BARC 3–5 bleeding (4.9% vs. 2.2%; p < 0.001) occurred more frequently compared with those without. There was a graded risk increase for DOCE (0: 5.5%; 1 to 2: 11.3%; and ≥3: 16.7%; p < 0.001) and BARC 3–5 bleeding (0: 2.2%; 1 to 2: 4.5%; and ≥3: 6.6%; p < 0.001) as the number of high-risk features increased. High-PRECISE-DAPT score (≥25) was associated with an increased risk of DOCE and BARC 3–5 bleeding, irrespective of number of high-risk features.
Conclusions The European Society of Cardiology guideline-endorsed high-risk features were associated with increased ischemic and bleeding risks following percutaneous coronary intervention in routine clinical practice. (CARDIOBASE Bern PCI Registry; NCT02241291)
Prof. Pilgrim has received research grants to the institution from Biotronik, Symetis/Boston Scientific, and Edwards Lifesciences; and speaker fees from Biotronik and Boston Scientific. Prof. Valgimigli has received research grants to the institution from Terumo, Medicure, Abbott, and AstraZeneca; and honorarium fees from Abbott, Chiesi, Bayer, Daiichi Sankyo, Amgen, Terumo, AstraZeneca, Alvimedica, and Biosensors. Prof. Windecker has received research grants to the institution from Abbott, Amgen, Bayer, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Terumo, and St. Jude Medical. Prof. Räber has received research grants to the institution from Abbott Vascular, Sanofi, and Regeneron. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 12, 2018.
- Revision received November 12, 2018.
- Accepted December 3, 2018.
- 2019 American College of Cardiology Foundation
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