Safety and Efficacy of Different Antithrombotic Strategies after Transcatheter Aortic Valve Implantation: A Network Meta-Analysis

Eliano Pio Navarese; Leonardo Grisafi; Enrico Guido Spinoni; Marco Giovanni Mennuni; Andrea Rognoni; Jakub Ratajczak; Przemysław Podhajski; Endrin Koni; Jacek Kubica; Giuseppe Patti

doi:10.1055/a-1496-8114

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2022; 122(02): 216-225
DOI: 10.1055/a-1496-8114

Cellular Haemostasis and Platelets

Safety and Efficacy of Different Antithrombotic Strategies after Transcatheter Aortic Valve Implantation: A Network Meta-Analysis

Eliano Pio Navarese

¹Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

,

Leonardo Grisafi

²Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy

³Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara, Italy

,

Enrico Guido Spinoni

²Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy

³Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara, Italy

,

Marco Giovanni Mennuni

³Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara, Italy

,

Andrea Rognoni

³Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara, Italy

,

Jakub Ratajczak

⁴Department of Health Promotion, Nicolaus Copernicus University, Bydgoszcz, Poland

⁵Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland

,

Przemysław Podhajski

⁵Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland

,

Endrin Koni

⁶Department of Interventional Cardiology, Santa Corona Hospital, Pietra Ligure, Italy

,

Jacek Kubica

¹Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

,

Giuseppe Patti

²Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy

³Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, Novara, Italy

› Author Affiliations

Abstract

Background The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) remains uncertain. We compared efficacy and safety of various antiplatelet and anticoagulant approaches after TAVI by a network meta-analysis.

Methods A total of 14 studies (both observational and randomized) were considered, with 24,119 patients included. Primary safety endpoint was the incidence of any bleeding complications during follow-up. Secondary safety endpoint was major bleeding. Efficacy endpoints were stroke, myocardial infarction, and cardiovascular mortality. A frequentist network meta-analysis was conducted with a random-effects model. The following strategies were compared: dual antiplatelet therapy (DAPT), single antiplatelet therapy (SAPT), oral anticoagulation (OAC), and OAC + SAPT. The mean follow-up was 15 months.

Results In comparison to DAPT, SAPT was associated with a 44% risk reduction of any bleeding (odds ratio [OR]: 0.56 [95% confidence interval, CI: 0.39–0.80]). SAPT was ranked as the safest strategy for the prevention of any bleeding (p-score: 0.704), followed by OAC alone (p-score: 0.476) and DAPT (p-score: 0.437). Consistent results were observed for major bleeding. The incidence of cardiovascular death and secondary ischemic endpoints did not differ among the tested antithrombotic approaches. In patients with indication for long-term anticoagulation, OAC alone showed similar rates of stroke (OR: 0.92 [95% CI: 0.41–2.05], p = 0.83) and reduced occurrence of any bleeding (OR: 0.49 [95% CI: 0.37–0.66], p < 0.01) versus OAC + SAPT.

Conclusion The present network meta-analysis supports after TAVI the use of SAPT in patients without indication for OAC and OAC alone in those needing long-term anticoagulation.

Keywords

TAVI - oral anticoagulation - antiplatelet therapy - bleeding events - mortality

Full Text

References

References
1 Baumgartner H, Falk V, Bax JJ. et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Rev Esp Cardiol (Engl Ed) 2018; 71 (02) 110
2 Otto CM, Nishimura RA, Bonow RO. et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2020; 143 (05) e72-e227
3 Higgins JPTGS. Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 [updated March 2011]. Accessed May 20, 2021 at: www.handbook.cochrane.org The Cochrane Collaboration; 2011
4 Hutton B, Salanti G, Caldwell DM. et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med 2015; 162 (11) 777-784
5 Mangieri A, Jabbour RJ, Montalto C. et al. Single-antiplatelet therapy in patients with contraindication to dual-antiplatelet therapy after transcatheter aortic valve implantation. Am J Cardiol 2017; 119 (07) 1088-1093
6 Seeger J, Rottbauer W, Wöhrle J. Reply: Apixaban in patients with atrial fibrillation after transfemoral aortic valve replacement. JACC Cardiovasc Interv 2017; 10 (09) 965-966
7 D'Ascenzo F, Benedetto U, Bianco M. et al. Which is the best antiaggregant or anticoagulant therapy after TAVI? A propensity-matched analysis from the ITER registry. The management of DAPT after TAVI. EuroIntervention 2017; 13 (12) e1392-e1400
8 Sherwood MW, Vemulapalli S, Harrison JK. et al. Variation in post-TAVR antiplatelet therapy utilization and associated outcomes: Insights from the STS/ACC TVT Registry. Am Heart J 2018; 204: 9-16
9 Butt JH, De Backer O, Olesen JB. et al. Vitamin K antagonists vs. direct oral anticoagulants after transcatheter aortic valve implantation in atrial fibrillation. Eur Heart J Cardiovasc Pharmacother 2021; 7 (01) 11-19
10 Jochheim D, Barbanti M, Capretti G. et al. Oral anticoagulant type and outcomes after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2019; 12 (16) 1566-1576
11 Kawashima H, Watanabe Y, Hioki H. et al; OCEAN-TAVI Investigator. Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation after TAVR. JACC Cardiovasc Interv 2020; 13 (22) 2587-2597
12 Durand E, Blanchard D, Chassaing S. et al. Comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 2014; 113 (02) 355-360
13 Ussia GP, Scarabelli M, Mulè M. et al. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 2011; 108 (12) 1772-1776
14 Stabile E, Pucciarelli A, Cota L. et al. SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation. Int J Cardiol 2014; 174 (03) 624-627
15 Rodés-Cabau J, Masson JB, Welsh RC. et al. Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with a balloon-expandable valve: the ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) randomized clinical trial. JACC Cardiovasc Interv 2017; 10 (13) 1357-1365
16 Dangas GD, Tijssen JGP, Wöhrle J. et al; GALILEO Investigators. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med 2020; 382 (02) 120-129
17 Nijenhuis VJ, Brouwer J, Delewi R. et al. Anticoagulation with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med 2020; 382 (18) 1696-1707
18 Brouwer J, Nijenhuis VJ, Delewi R. et al. Aspirin with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med 2020; 383 (15) 1447-1457
19 Piccolo R, Pilgrim T, Franzone A. et al. Frequency, timing, and impact of access-site and non-access-site bleeding on mortality among patients undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv 2017; 10 (14) 1436-1446
20 Steel N. Thresholds for taking antihypertensive drugs in different professional and lay groups: questionnaire survey. BMJ 2000; 320 (7247): 1446-1447
21 Shahim B, Malaisrie SC, George I. et al. Atrial fibrillation and outcomes after transcatheter or surgical aortic valve replacement (from the PARTNER 3 trial). Am J Cardiol 2021; 148: 116-123
22 Carroll JD, Mack MJ, Vemulapalli S. et al. STS-ACC TVT Registry of transcatheter aortic valve replacement. J Am Coll Cardiol 2020; 76 (21) 2492-2516

Supplementary Material

Supplementary Material