Skip to main content
Top
Published in: Heart and Vessels 2/2021

01-02-2021 | Aortic Valve Replacement | Original Article

Short-term dual anti-platelet therapy decreases long-term cardiovascular mortality after transcatheter aortic valve replacement

Authors: Hirofumi Hioki, Yusuke Watanabe, Ken Kozuma, Akihisa Kataoka, Fumiaki Yashima, Toru Naganuma, Motoharu Araki, Norio Tada, Shinichi Shirai, Futoshi Yamanaka, Kazuki Mizutani, Minoru Tabata, Kensuke Takagi, Hiroshi Ueno, Masanori Yamamoto, Kentaro Hayashida, OCEAN-TAVI Investigators

Published in: Heart and Vessels | Issue 2/2021

Login to get access

Abstract

No data are available on extended dual anti-platelet therapy (DAPT) duration which may influence long-term prognosis (later than 1 year) after transcatheter aortic valve replacement (TAVR). Therefore, this study is aimed to evaluate whether discontinuing DAPT within 1 year had an impact on adverse events after TAVR. Using data from the OCEAN-TAVI registry, we assessed 1008 patients who survived the first year after TAVR with DAPT since discharge. Patients were divided into ‘DAPT group’ (n = 462), comprising patients who took DAPT at both discharge and 1 year, and ‘stop-DAPT group’ (n = 546), comprising patients who took DAPT at discharge and single anti-platelet therapy (SAPT) at 1 year. We compared the incidence of cardiovascular (CV) death, major and minor bleeding, and ischemic stroke later than 1 year after TAVR between the two groups. A total of 28 CV deaths were observed later than 1 year after TAVR. The stop-DAPT group had a significantly lower incidence of CV death than the DAPT group (1.8% vs. 4.9%, log-rank P = 0.029). Stop DAPT was associated with lower CV death later than 1 year of TAVR in Cox regression analysis (adjusted hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.20–0.99), and in analysis with inverse probability of treatment weighting method using propensity score (adjusted HR, 0.45; 95% CI, 0.20–0.98). Our study demonstrated that switching from DAPT to SAPT within 1 year of TAVR was significantly associated with a lower CV death later than 1 year after TAVR.
Appendix
Available only for authorised users
Literature
1.
go back to reference Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ, PARTNER Trial Investigators (2011) Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364:2187–2198CrossRef Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ, PARTNER Trial Investigators (2011) Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364:2187–2198CrossRef
2.
go back to reference Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG, PARTNER 2 Investigators (2016) Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 374:1609–1620CrossRef Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG, PARTNER 2 Investigators (2016) Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 374:1609–1620CrossRef
3.
go back to reference Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR, PARTNER 3 Investigators (2019) Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 380:1695–1705CrossRef Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR, PARTNER 3 Investigators (2019) Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 380:1695–1705CrossRef
4.
go back to reference Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL, ESC Scientific Document Group (2017) 2017 ESC/EACTS Guideline for the management of valvular disease. Eur Heart J 38:2739–2791CrossRef Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL, ESC Scientific Document Group (2017) 2017 ESC/EACTS Guideline for the management of valvular disease. Eur Heart J 38:2739–2791CrossRef
5.
go back to reference Chopard R, Teiger E, Meneveau N, Chocron S, Gilard M, Laskar M, Eltchaninoff H, Iung B, Leprince P, Chevreul K, Prat A, Lievre M, Leguerrier A, Donzeau-Gouge P, Fajadet J, Mouillet G, Schiele F, FRANCE-2 Investigators (2015) Baseline characteristics and prognostic implications of pre-existing and new-onset atrial fibrillation after transcatheter aortic valve implantation: results from the FRANCE-2 registry. JACC Cardiovasc Interv 8:1346–1355CrossRef Chopard R, Teiger E, Meneveau N, Chocron S, Gilard M, Laskar M, Eltchaninoff H, Iung B, Leprince P, Chevreul K, Prat A, Lievre M, Leguerrier A, Donzeau-Gouge P, Fajadet J, Mouillet G, Schiele F, FRANCE-2 Investigators (2015) Baseline characteristics and prognostic implications of pre-existing and new-onset atrial fibrillation after transcatheter aortic valve implantation: results from the FRANCE-2 registry. JACC Cardiovasc Interv 8:1346–1355CrossRef
6.
go back to reference Rodés-Cabau J, Masson JB, Welsh RC, Garcia Del Blanco B, Pelletier M, Webb JG, Al-Qoofi F, Généreux P, Maluenda G, Thoenes M, Paradis JM, Chamandi C, Serra V, Dumont E, Côté M (2017) Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with balloon-expandable valve: The ARTE (aspirin versus aspirin + clopidogrel following transcatheter aortic valve implantation) randomized clinical trial. JACC Cardiovasc Interv 10:1357–1365CrossRef Rodés-Cabau J, Masson JB, Welsh RC, Garcia Del Blanco B, Pelletier M, Webb JG, Al-Qoofi F, Généreux P, Maluenda G, Thoenes M, Paradis JM, Chamandi C, Serra V, Dumont E, Côté M (2017) Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with balloon-expandable valve: The ARTE (aspirin versus aspirin + clopidogrel following transcatheter aortic valve implantation) randomized clinical trial. JACC Cardiovasc Interv 10:1357–1365CrossRef
7.
go back to reference Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM, DAPT Study Investigators (2014) Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 371:2155–2166CrossRef Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM, DAPT Study Investigators (2014) Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 371:2155–2166CrossRef
8.
go back to reference Yamamoto M, Watanabe Y, Tada N, Naganuma T, Araki M, Yamanaka F, Mizutani K, Tabata M, Ueno H, Takagi K, Higashimori A, Shirai S, Hayashida K, OCEAN-TAVI investigators (2019) Transcatheter aortic valve replacement outcomes in Japan: Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry. Cardiovasc Revasc Med 20:843–851CrossRef Yamamoto M, Watanabe Y, Tada N, Naganuma T, Araki M, Yamanaka F, Mizutani K, Tabata M, Ueno H, Takagi K, Higashimori A, Shirai S, Hayashida K, OCEAN-TAVI investigators (2019) Transcatheter aortic valve replacement outcomes in Japan: Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry. Cardiovasc Revasc Med 20:843–851CrossRef
9.
go back to reference Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB (2012) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J 33:2403–2418CrossRef Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB (2012) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J 33:2403–2418CrossRef
10.
go back to reference Austin PC (2013) The performance of different propensity score methods for estimating marginal hazard effects. Stat Med 32:2837–2849CrossRef Austin PC (2013) The performance of different propensity score methods for estimating marginal hazard effects. Stat Med 32:2837–2849CrossRef
11.
go back to reference Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A (2017) 2017 AHA/ACC focused update of the 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 clinical practice guidelines. J Am Coll Cardiol 70:252–289CrossRef Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A (2017) 2017 AHA/ACC focused update of the 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 clinical practice guidelines. J Am Coll Cardiol 70:252–289CrossRef
12.
go back to reference Ahmad Y, Demir O, Rajkumar C, Howard JP, Shun-Shin M, Cook C, Petraco R, Jabbour R, Arnold A, Frame A, Sutaria N, Ariff B, Kanaganayagam G, Francis D, Mayet J, Mikhail G, Malik I, Sen S (2018) Optimal antiplatelet strategy after transcatheter aortic valve implantation: a meta-analysis. Open Heart 5:e000748CrossRef Ahmad Y, Demir O, Rajkumar C, Howard JP, Shun-Shin M, Cook C, Petraco R, Jabbour R, Arnold A, Frame A, Sutaria N, Ariff B, Kanaganayagam G, Francis D, Mayet J, Mikhail G, Malik I, Sen S (2018) Optimal antiplatelet strategy after transcatheter aortic valve implantation: a meta-analysis. Open Heart 5:e000748CrossRef
13.
go back to reference Gandhi S, Schwalm JD, Velianou JL, Natarajan MK, Farkouh ME (2015) Comparison of dual-antiplatelet therapy to mono-antiplatelet therapy after transcatheter aortic valve implantation: systemic review and meta-analysis. Can J Cardiol 31:775–784CrossRef Gandhi S, Schwalm JD, Velianou JL, Natarajan MK, Farkouh ME (2015) Comparison of dual-antiplatelet therapy to mono-antiplatelet therapy after transcatheter aortic valve implantation: systemic review and meta-analysis. Can J Cardiol 31:775–784CrossRef
14.
go back to reference Costa F, van Klaveren D, James S, Heg D, Räber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M, PRECISE-DAPT Study Investigators (2017) Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet 389:1025–1034CrossRef Costa F, van Klaveren D, James S, Heg D, Räber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M, PRECISE-DAPT Study Investigators (2017) Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet 389:1025–1034CrossRef
15.
go back to reference Helft G, Steg PG, Le Feuvre C, Georges JL, Carrie D, Dreyfus X, Furber A, Leclercq F, Eltchaninoff H, Falquier JF, Henry P, Cattan S, Sebagh L, Michel PL, Tuambilangana A, Hammoudi N, Boccara F, Cayla G, Douard H, Diallo A, Berman E, Komajda M, Metzger JP, Vicaut E, OPTImal DUAL Antiplatelet Therapy Trial Investigators (2016) Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J 37:365–374PubMed Helft G, Steg PG, Le Feuvre C, Georges JL, Carrie D, Dreyfus X, Furber A, Leclercq F, Eltchaninoff H, Falquier JF, Henry P, Cattan S, Sebagh L, Michel PL, Tuambilangana A, Hammoudi N, Boccara F, Cayla G, Douard H, Diallo A, Berman E, Komajda M, Metzger JP, Vicaut E, OPTImal DUAL Antiplatelet Therapy Trial Investigators (2016) Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J 37:365–374PubMed
16.
go back to reference Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ, Investigators CHARISMA (2006) Clopidogrel and aspirin versus aspirin alone for the prevention of atherosclerotic events. N Engl J Med 354:1706–1717CrossRef Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ, Investigators CHARISMA (2006) Clopidogrel and aspirin versus aspirin alone for the prevention of atherosclerotic events. N Engl J Med 354:1706–1717CrossRef
17.
go back to reference Xiong TY, Liao YB, Zhao ZG, Xu YN, Wei X, Zuo ZL, Li YJ, Cao JY, Tang H, Jilaihawi H, Feng Y, Chen M (2015) Causes of death following transcatheter aortic valve replacement: a systemic review and meta-analysis. J Am Heart Assoc 4:e002096PubMedPubMedCentral Xiong TY, Liao YB, Zhao ZG, Xu YN, Wei X, Zuo ZL, Li YJ, Cao JY, Tang H, Jilaihawi H, Feng Y, Chen M (2015) Causes of death following transcatheter aortic valve replacement: a systemic review and meta-analysis. J Am Heart Assoc 4:e002096PubMedPubMedCentral
18.
go back to reference Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L, DAPT Study Investigators (2015) Benefits and risks of extended duration dual antiplatelet therapy after pci in patients with and without acute myocardial infarction. J Am Coll Cardiol 65:2211–2221CrossRef Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L, DAPT Study Investigators (2015) Benefits and risks of extended duration dual antiplatelet therapy after pci in patients with and without acute myocardial infarction. J Am Coll Cardiol 65:2211–2221CrossRef
19.
go back to reference Murali-Krishnan R, Iqbal J, Rowe R, Hatem E, Parviz Y, Richardson J, Sultan A, Gunn J (2015) Impact of frailty on outcomes after percutaneous coronary intervention: a prospective cohort study. Open Heart 2:e000294CrossRef Murali-Krishnan R, Iqbal J, Rowe R, Hatem E, Parviz Y, Richardson J, Sultan A, Gunn J (2015) Impact of frailty on outcomes after percutaneous coronary intervention: a prospective cohort study. Open Heart 2:e000294CrossRef
20.
go back to reference Hao Q, Tampi M, O'Donnell M, Foroutan F, Siemieniuk RA, Guyatt G (2018) Clopidogrel plus aspirin versus aspirin alone for acute minor ischaemic stroke or high risk transient ischemic attack: systematic review and meta-analysis. BMJ 363:k5108CrossRef Hao Q, Tampi M, O'Donnell M, Foroutan F, Siemieniuk RA, Guyatt G (2018) Clopidogrel plus aspirin versus aspirin alone for acute minor ischaemic stroke or high risk transient ischemic attack: systematic review and meta-analysis. BMJ 363:k5108CrossRef
21.
go back to reference Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC (2019) Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J 40:2632–2653CrossRef Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC (2019) Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J 40:2632–2653CrossRef
22.
go back to reference Li L, Geraghty OC, Mehta Z, Rothwell PM, Oxford Vascular Study (2017) Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet 390:490–499CrossRef Li L, Geraghty OC, Mehta Z, Rothwell PM, Oxford Vascular Study (2017) Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet 390:490–499CrossRef
Metadata
Title
Short-term dual anti-platelet therapy decreases long-term cardiovascular mortality after transcatheter aortic valve replacement
Authors
Hirofumi Hioki
Yusuke Watanabe
Ken Kozuma
Akihisa Kataoka
Fumiaki Yashima
Toru Naganuma
Motoharu Araki
Norio Tada
Shinichi Shirai
Futoshi Yamanaka
Kazuki Mizutani
Minoru Tabata
Kensuke Takagi
Hiroshi Ueno
Masanori Yamamoto
Kentaro Hayashida
OCEAN-TAVI Investigators
Publication date
01-02-2021
Publisher
Springer Japan
Published in
Heart and Vessels / Issue 2/2021
Print ISSN: 0910-8327
Electronic ISSN: 1615-2573
DOI
https://doi.org/10.1007/s00380-020-01693-y

Other articles of this Issue 2/2021

Heart and Vessels 2/2021 Go to the issue