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Am J Cardiol. 2019 Feb 10. pii: S0002-9149(19)30180-8. doi: 10.1016/j.amjcard.2019.01.049. [Epub ahead of print]

Usefulness of Clopidogrel Loading in Patients Who Underwent Transcatheter Aortic Valve Implantation (from the BRAVO-3 Randomized Trial).

Author information

1
Department of Cardiology, St. Antonius hospital, Nieuwegein, the Netherlands.
2
DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany; Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
3
Institut cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Ramsay générale de santé, Massy, France.
4
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
5
Sussex Cardiac Centre-Brighton & Sussex University Hospitals NHS Trust, Brighton, East Sussex, United Kingdom.
6
DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany; Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; Walter-Brendel-Centre for Experimental Medicine, Ludwig Maximilian University of Munich, Munich, Germany.
7
Department of Cardiology CHU Lille, Inserm, U1011, Univ. Lille, Institut Pasteur de Lille-EGID, Lille, France.
8
Department of Cardiology, Rouen University Hospital, hôpital Charles-Nicolle, Rouen, France.
9
Department of Cardiology, Johannes Gutenberg University Hospital, Mainz, Germany.
10
Department of Cardiology, San Raffaele Hospital, Milan, Italy.
11
The Zena and Michael A. Wiener Cardiovascular Institute, The Icahn School of Medicine, Mount Sinai, New York.
12
The Medicines Company, Zurich, Switzerland.
13
Science and Strategy Consulting Group, Basking Ridge, New Jersey.
14
Science and Strategy Consulting Group, Basking Ridge, New Jersey. Electronic address: g.dangas@crf.org.

Abstract

P2Y12-inhibitor initiation with clopidogrel using a loading dose (LD) versus no LD (NLD) provides more rapid inhibition of platelet activation and reduced risk of ischemic events after coronary stenting. Whether a similar beneficial effect is achieved in the setting of transcatheter aortic valve implantation (TAVI) is unknown. We evaluate the effects of preprocedural clopidogrel LD versus no NLD on 48-hour and 30-day clinical outcomes after TAVI. In the BRAVO-3 trial, 802 patients with severe aortic stenosis who underwent transfemoral TAVI were randomized to intraprocedural anticoagulation with bivalirudin or unfractionated heparin. Administration of clopidogrel LD was left to the discretion of the treating physician. For this analysis, patients were stratified according to receiving clopidogrel LD (n = 294, 36.6%) or NLD (n = 508, 63.4%) before TAVI. LD patients more often received a self-expandable prosthesis using larger sheaths. P2Y12-inhibitor maintenance therapy pre-TAVI was similar in patients with LD versus NLD (28.2% vs 33.1%, p = 0.16). LD versus NLD was associated with similar incidences of major adverse cardiovascular events (i e., death, myocardial infarction, or stroke) (4.1% vs 4.1%, p = 0.97) and major bleeding (8.5% vs 7.7%, p = 0.68), but a higher rate of major vascular complications (11.9% vs 7.1%, p = 0.02). Multivariable adjustment showed that clopidogrel LD did not affect any of the studied clinical events, including major vascular complications (odds ratio 0.91, 95% confidence interval 0.60 to 1.39, p = 0.67). Also patients on clopidogrel maintenance therapy and thus considered in steady state were not at reduced risk of major adverse cardiovascular events compared with patients not on clopidogrel (3.7% vs 5.2%, p = 0.36). In conclusion, in patients who underwent TAVI, use of clopidogrel LD was associated with higher vascular complications and otherwise similar clinical events compared to NLD patients.

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