Abstract
Background
The current American College of Cardiology and American Heart Association (ACC/AHA) guidelines recommend dual antiplatelet therapy (DAPT) with aspirin and clopidogrel for 6 months followed by lifelong aspirin after transcatheter aortic valve replacement (TAVR). However, studies that have DAPT with aspirin following TAVR have questioned this recommendation as DAPT has been associated with more bleeding events compared to aspirin. We performed a systematic review and meta-analysis of all the RCTs comparing DAPT (aspirin plus clopidogrel) with aspirin alone as antithrombotic treatment following transcatheter aortic valve replacement.
Methods
The databases of Embase, PubMed, and Cochrane library were searched from inception to Oct 1, 2020, and randomized controlled trials (RCTs) reporting aspirin plus clopidogrel with aspirin alone as antithrombotic treatment after TAVI were included. Revman 5.3 was used to conduct the analysis.
Results
After screening 152 articles, four studies involving 1086 patients (541 patients in the aspirin group and 545 patients in the DAPT group) were included. The results demonstrated that, at 30 days follow-up, compared with DAPT, aspirin was not associated with a statistically significant difference in the rate of bleeding events (RR = 1.22, 95% CI 0.62 to 2.39, P = 0.57), all-cause mortality (RR = 1.21, 95% CI 0.52 to 2.84, P = 0.66), stroke (RR = 0.81, 95% CI 0.24 to 2.79, P = 0.74), and MI (RR = 4.00, 95% CI 0.45 to 35.22, P = 0.21). However, at the 6 to 12 months follow-up, DAPT appeared to increase the risk of bleeding events compared with aspirin alone (RR = 1.67, 95% CI 1.24 to 2.24, P < 0.001), and there was no significant difference in the rate of all-cause mortality (RR = 0.89, 95% CI 0.53 to 1.48, P = 0.65), stroke (RR = 1.04, 95% CI 0.57 to 1.92, P = 0.90), and MI (RR = 1.65, 95% CI 0.52 to 5.26, P = 0.40) among the two groups.
Conclusions
Our systematic review and meta-analysis suggested that aspirin alone could decrease the risk of bleeding and was not associated with higher risk of mortality, stroke or myocardial infarction compared with DAPT.
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Data Availability
All data generated or analyzed during this study was included in the article.
References
Makkar RR, Fontana GP, Jilaihawi H, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696–704.
Mangieri A, Regazzoli D, Ruparelia N, Colombo A, Latib A. Recent advances in transcatheter aortic valve replacement for high-risk patients. Expert Rev Cardiovasc Ther. 2015;13:1237–49.
Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med Overseas Ed. 2016;374:1609–20.
Auffret V, Regueiro A, Del Trigo M, et al. Predictors of earlycerebrovascular events in patients with aortic stenosis undergoing transcatheter aortic valve replacement. J Am Coll Cardiol. 2016;68:673–84.
Søndergaard L, Steinbrüchel DA, Ihlemann N, et al. Two-year outcomes in patients with severe aortic valve stenosis randomized to transcatheter versus surgical aortic valve replacement. Circulation. 2016;9:e003665.
Zhou Y, Wang Y, Wu Y, et al. Transcatheter versus surgical aortic valve replacement in low to intermediate risk patients: a meta-analysis of randomized and observational studies. Int J Cardiol. 2017;228:723–8.
Mohr FW, Holzhey D, Möllmann H, et al. The German aortic valve registry: 1-year results from 13,680 patients with aortic valve disease. Eur J Cardiothorac Surg. 2014;46:808–16.
Vahanian A, Alferi O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012): the joint task force on the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2012;33:2451–96.
Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary. J Am Coll Cardiol. 2014;63:2438–88.
Généreux P, Cohen DJ, Williams MR, et al. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I trial (placement of aortic transcatheter valve). J Am Coll Cardiol. 2014;63:1100–9.
Makkar RR, Fontana GP, Jilaihawi H, et al. PARTNER trial investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696–704.
Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease. J Am Coll Cardiol. 2017;70:252–89.
Sherwood MW, 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.
Brouwer J, et al. Aspirin with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med. 2020;383(15):1447–57.
Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264–9.
Higgins JPT, Green S (eds). Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane collaboration; 2011. Available from: www.cochrane-handbook.org.
Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ 2003;327:557e560.
Rodés-Cabau J, et al. Aspirin versus aspirin plus Clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with a balloon-expandable valve. ARTE Randomized Clin Trial JACC Cardiovasc Interv. 2017;10(13):1357–65.
Ussia, et al. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol. 2011;108(12):1772–6.
Stabile E, et al. SAT-TAVI study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation. Int J Cardiol. 2014;174(3):624–7.
Ahmad Y, Demir O, Rajkumar C, et al. Optimal antiplatelet strategy after transcatheter aortic valve implantation: a meta-analysis. Open Heart. 2018;5:e000748.
Hassell ME, Smith DH, Durand E, et al. Antiplatelet therapy following transcatheter aortic valve implantation. Heart. 2015;101:1118–25.
Hu X, Yang FY, Wang Y, Zhang Y, Chen M. Single versus dual antiplatelet therapy after transcatheter aortic valve implantation: a systematic review and meta-analysis. Cardiology. 2018;141:52–65.
Siddamsetti S, Balasubramanian S, Yandrapalli S, et al. Meta-analysis comparing dual antiplatelet therapy versus single antiplatelet therapy following Transcatheter aortic valve implantation. Am J Cardiol. 2018;122:1401–8.
Osman M, Syed M, Balla S, et al. Meta-analysis of aspirin monotherapy versus dual antiplatelet therapy after transcatheter aortic valve implantation. Am J Cardiol. 2020;135:187–8.
Ahmad Y, Demir O, Rajkumar C, et al. Optimal antiplatelet strategy after transcatheter aortic valve implantation: a meta-analysis. Open Heart. 2018;5(1):e000748.
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):e1392–400.
Poliacikova P, Cockburn J. Adam de Belder, et al. antiplatelet and antithrombotic treatment after transcatheter aortic valve implantation-comparison of regimes. J Invasive Cardiol. 2013;25(10):544–8.
Ichibori Y, Mizote I, Maeda K, et al. Clinical outcomes and bioprosthetic valve function after transcatheter aortic valve implantation under dual antiplatelet therapy vs. aspirin alone. Circ J. 2017;81(3):397–404.
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(2):355–60.
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(7):1088–93.
Rodés-Cabau J, Dauerman HL, Cohen MG, et al. Antithrombotic treatment in transcatheter aortic valve implantation: insights for cerebrovascular and bleeding events. J Am Coll Cardiol. 2013;62:2349–59.
Nombela-Franco L, Webb JG, de Jaegere PP, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation. 2012;126:3041–53.
Miller DC, Blackstone EH, Mack MJ, et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012;143:832–43.
Zhu Y, Meng S, Chen M, et al. Comparing anticoagulation therapy alone versus anticoagulation plus single antiplatelet drug therapy after transcatheter aortic valve implantation in patients with an indication for anticoagulation: a systematic review and meta-analysis. Cardiovasc Drugs Ther. 2020. https://doi.org/10.1007/s10557-020-07081-y.
Puri R, Auffret V, Rodés-Cabau J. Bioprosthetic valve thrombosis. J Am Coll Cardiol. 2017;69:2193–211.
Chakravarty T, Søndergaard L, Friedman J, et al. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017;389(10087):2383–92.
Code Availability
We conducted the statistical analysis in the present study using Review Manager version 5.3 (Cochrane Collaboration; Copenhagen, Denmark).
Funding
This study was supported by the National Natural Science Foundation of China (Grant Nos. 81800284), the Ministry of Science and Technology of China (Grant Nos.2019YFC0120705), the Science and Technology Foundation of Zhejiang Province of China (Grant Nos. BQ20H020001 and 2020C03018), the Science and Technology Foundation of Hangzhou of China (Grant Nos. 20191203B82), the Natural Science Foundation of Jiangsu Province of China (Grant Nos. BK20180144), the Zhejiang Natural Science Foundation (LY15H020003, LBQ20H020001), the Science Technology Department of Zhejiang Province (2016C33207), the Health and Family Planning Commission of Zhejiang Province (2016ZDB010), the Key research and development program of Zhejiang province (2020C03018), and Subproject of National key research and development program of China (2019YFC0120705).
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All authors were responsible for the study conception and design. LXX and WS contributed to data extraction, assessment of study quality, analysis and interpretation of data, and drafting of the manuscript. The comprehensive literature search was completed by LXX and WS. HJY, GYH and WL critically evaluated and revised the manuscript. All authors read and approved the final manuscript.
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Lin, X., Wang, S., Wang, L. et al. Aspirin Alone Versus Dual Antiplatelet Therapy after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Cardiovasc Drugs Ther 36, 271–278 (2022). https://doi.org/10.1007/s10557-021-07145-7
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DOI: https://doi.org/10.1007/s10557-021-07145-7