Skip to main content
Top
Published in: Cardiology and Therapy 1/2018

Open Access 01-06-2018 | Original Research

Impact of Antithrombotic Regimen on Mortality, Ischemic, and Bleeding Outcomes after Transcatheter Aortic Valve Replacement

Authors: Anubodh Varshney, Ryan A. Watson, Andrew Noll, KyungAh Im, Jeffrey Rossi, Pinak Shah, Robert P. Giugliano

Published in: Cardiology and Therapy | Issue 1/2018

Login to get access

Abstract

Introduction

Optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains unclear. We evaluated the association between antithrombotic regimens and outcomes in TAVR patients.

Methods

We retrospectively analyzed consecutive patients who underwent TAVR at a single academic center from April 2009 to March 2014. Antithrombotic regimens were classified as single or dual antiplatelet therapy (AP), single antiplatelet plus anticoagulant (SAC), or triple therapy (TT). The primary endpoint was a composite of death, myocardial infarction (MI), stroke, and major bleeding. Adjusted hazard ratios (HRs) were obtained with best subset variable selection methods using bootstrap resampling.

Results

Of 246 patients who underwent TAVR, 241 were eligible for analysis with 133, 88, and 20 patients in the AP, SAC, and TT groups, respectively. During a median 2.1-year follow-up, 53.5% had at least one endpoint—the most common was death (68%), followed by major bleeding (23%), stroke (6%), and MI (3%). At 2 years, the composite outcome occurred in 70% of TT, 42% of SAC, and 31% of AP patients. Compared to AP, adjusted HRs for the composite outcome were 2.88 [95% Confidence intervals (CI) (1.61–5.16); p = 0.0004] and 1.66 (95% CI [1.13-2.42]; p = 0.009) in the TT and SAC groups, respectively. Mortality rates at 2 years were 61% in the TT, 32% in the SAC, and 26% in the AP groups (p = 0.005).

Conclusions

The risk of the composite outcome of death, MI, stroke, or major bleeding at 2-year follow-up was significantly higher in TAVR patients treated with TT or SAC versus AP, even after multivariate adjustment.
Literature
1.
go back to reference Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.CrossRefPubMed Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.CrossRefPubMed
2.
go back to reference Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–98.CrossRefPubMed Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–98.CrossRefPubMed
3.
go back to reference Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790–8.CrossRefPubMed Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790–8.CrossRefPubMed
4.
go back to reference Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609–20.CrossRefPubMed Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609–20.CrossRefPubMed
5.
go back to reference Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Søndergaard L, Mumtaz M, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376:1321–31.CrossRefPubMed Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Søndergaard L, Mumtaz M, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376:1321–31.CrossRefPubMed
6.
go back to reference Eggebrecht H, Schmermund A, Voigtländer T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012;8:129–38.CrossRefPubMed Eggebrecht H, Schmermund A, Voigtländer T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012;8:129–38.CrossRefPubMed
7.
go back to reference Généreux P, Cohen DJ, Mack M, Rodes-Cabau J, Yadav M, Xu K, et al. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2014;64:2605–15.CrossRefPubMed Généreux P, Cohen DJ, Mack M, Rodes-Cabau J, Yadav M, Xu K, et al. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2014;64:2605–15.CrossRefPubMed
8.
go back to reference Khatri PJ, Webb JG, Rodés-Cabau J, Fremes SE, Ruel M, Lau K, et al. Adverse effects associated with transcatheter aortic valve implantation: a meta-analysis of contemporary studies. Ann Intern Med. 2013;158:35–46.CrossRefPubMed Khatri PJ, Webb JG, Rodés-Cabau J, Fremes SE, Ruel M, Lau K, et al. Adverse effects associated with transcatheter aortic valve implantation: a meta-analysis of contemporary studies. Ann Intern Med. 2013;158:35–46.CrossRefPubMed
9.
go back to reference Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Guyton RA, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:e57–185.CrossRefPubMed Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Guyton RA, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:e57–185.CrossRefPubMed
10.
go back to reference Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, Alfieri O, Andreotti F, Antunes MJ, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012;33:2451–96.CrossRef Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, Alfieri O, Andreotti F, Antunes MJ, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012;33:2451–96.CrossRef
11.
go back to reference Webb J, Rodés-Cabau J, Fremes S, Pibarot P, Ruel M, Ibrahim R, et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol. 2012;28:520–8.CrossRefPubMed Webb J, Rodés-Cabau J, Fremes S, Pibarot P, Ruel M, Ibrahim R, et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol. 2012;28:520–8.CrossRefPubMed
12.
go back to reference Holmes DR, Mack MJ, Kaul S, Agnihotri A, Alexander KP, Bailey SR, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59:1200–54.CrossRefPubMed Holmes DR, Mack MJ, Kaul S, Agnihotri A, Alexander KP, Bailey SR, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59:1200–54.CrossRefPubMed
13.
go back to reference Rossi JE, Noll A, Bergmark B, McCabe JM, Nemer D, Okada DR, et al. Variability in antithrombotic therapy regimens peri-TAVR: a single academic center experience. Cardiol Ther. 2015;4:197–201.CrossRefPubMedPubMedCentral Rossi JE, Noll A, Bergmark B, McCabe JM, Nemer D, Okada DR, et al. Variability in antithrombotic therapy regimens peri-TAVR: a single academic center experience. Cardiol Ther. 2015;4:197–201.CrossRefPubMedPubMedCentral
14.
go back to reference Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438–54.CrossRefPubMed Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438–54.CrossRefPubMed
15.
go back to reference Austin PC, Tu JV. Bootstrap methods for developing predictive models. Am Stat. 2004;58:131–7.CrossRef Austin PC, Tu JV. Bootstrap methods for developing predictive models. Am Stat. 2004;58:131–7.CrossRef
16.
go back to reference Carnicelli AP, O’Gara PT, Giugliano RP. Anticoagulation after heart valve replacement or transcatheter valve implantation. Am J Cardiol. 2016;118:1419–26.CrossRefPubMed Carnicelli AP, O’Gara PT, Giugliano RP. Anticoagulation after heart valve replacement or transcatheter valve implantation. Am J Cardiol. 2016;118:1419–26.CrossRefPubMed
17.
go back to reference Abdul-Jawad Altisent O, Durand E, Muñoz-García AJ, Nombela-Franco L, Cheema A, Kefer J, et al. Warfarin and antiplatelet therapy versus warfarin alone for treating patients with atrial fibrillation undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2016;9:1706–17.CrossRefPubMed Abdul-Jawad Altisent O, Durand E, Muñoz-García AJ, Nombela-Franco L, Cheema A, Kefer J, et al. Warfarin and antiplatelet therapy versus warfarin alone for treating patients with atrial fibrillation undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2016;9:1706–17.CrossRefPubMed
18.
go back to reference Stanger DE, Abdulla AH, Wong FT, Alipour S, Bressler BL, Wood DA, et al. Upper gastrointestinal bleeding following transcatheter aortic valve replacement: a retrospective analysis. Cathet Cardiovasc Interv. 2017;90:E53–61.CrossRef Stanger DE, Abdulla AH, Wong FT, Alipour S, Bressler BL, Wood DA, et al. Upper gastrointestinal bleeding following transcatheter aortic valve replacement: a retrospective analysis. Cathet Cardiovasc Interv. 2017;90:E53–61.CrossRef
19.
go back to reference Riaz H, Alansari SAR, Khan MS, Riaz T, Raza S, Luni FK, et al. Safety and use of anticoagulation after aortic valve replacement with bioprostheses: a meta-analysis. Circ Cardiovasc Qual Outcomes. 2016;9:294–302.CrossRefPubMedPubMedCentral Riaz H, Alansari SAR, Khan MS, Riaz T, Raza S, Luni FK, et al. Safety and use of anticoagulation after aortic valve replacement with bioprostheses: a meta-analysis. Circ Cardiovasc Qual Outcomes. 2016;9:294–302.CrossRefPubMedPubMedCentral
20.
go back to reference Rodés-Cabau J, Masson J-B, Welsh RC, Garcia Del Blanco B, Pelletier M, Webb JG, 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;10:1357–65.CrossRefPubMed Rodés-Cabau J, Masson J-B, Welsh RC, Garcia Del Blanco B, Pelletier M, Webb JG, 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;10:1357–65.CrossRefPubMed
Metadata
Title
Impact of Antithrombotic Regimen on Mortality, Ischemic, and Bleeding Outcomes after Transcatheter Aortic Valve Replacement
Authors
Anubodh Varshney
Ryan A. Watson
Andrew Noll
KyungAh Im
Jeffrey Rossi
Pinak Shah
Robert P. Giugliano
Publication date
01-06-2018
Publisher
Springer Healthcare
Published in
Cardiology and Therapy / Issue 1/2018
Print ISSN: 2193-8261
Electronic ISSN: 2193-6544
DOI
https://doi.org/10.1007/s40119-018-0111-4

Other articles of this Issue 1/2018

Cardiology and Therapy 1/2018 Go to the issue