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

• Published in: The American journal of cardiology Vol. 123; no. 9; pp. 1494 - 1500
• Main Authors: Nijenhuis, Vincent Johan, ten Berg, Jurrien Maria, Hengstenberg, Christian, Lefèvre, Thierry, Windecker, Stephan, Hildick-Smith, David, Kupatt, Christian, Van Belle, Eric, Tron, Christophe, Hink, Hans Ulrich, Colombo, Antonio, Claessen, Bimmer, Sartori, Samantha, Chandrasekhar, Jaya, Mehran, Roxana, Anthopoulos, Prodromos, Deliargyris, Efthymios N., Dangas, George
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2019; Elsevier Limited
• Subjects: Aged, 80 and over; Anticoagulants; Aortic stenosis; Aortic valve; Aortic Valve Stenosis - surgery; Aspirin; Bleeding; Cardiovascular diseases; Cerebral infarction; Clinical outcomes; Clopidogrel; Clopidogrel - administration & dosage; Complications; Confidence intervals; Dose-Response Relationship, Drug; Drug dosages; Europe - epidemiology; Female; Follow-Up Studies; Health risks; Heart attacks; Heparin; Humans; Implantation; Incidence; Inhibitors; Ischemia; Kidneys; Male; Myocardial infarction; North America - epidemiology; Older people; Patients; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Postoperative Complications - prevention & control; Preoperative Care - methods; Prospective Studies; Prostheses; Purinergic P2Y Receptor Antagonists - administration & dosage; Risk Assessment - methods; Risk Factors; Risk management; Sensitivity analysis; Sheaths; Stenosis; Stroke; Therapy; Thromboembolism; Thromboembolism - epidemiology; Thromboembolism - etiology; Thromboembolism - prevention & control; Time Factors; Transcatheter Aortic Valve Replacement - adverse effects; North America; Europe
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2019.01.049

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.