Antithrombotic treatment in patients undergoing transcatheter aortic valve implantation (TAVI)

Summary

Transcatheter aortic valve implantation (TAVI) is an established treatment option for symptomatic patients with severe aortic valvular disease who are not suitable for conventional surgical aortic valve replacement. Despite improving experience and techniques, ischaemic and bleeding complications after TAVI remain prevalent and impair survival in this generally old and comorbid-rich population. Due to changing aetiology of complications over time, antiplatelet and anticoagulant therapy after TAVI should be carefully balanced. Empirically, a dual antiplatelet strategy is generally used after TAVI for patients without an indication for oral anticoagulation (OAC; e. g. atrial fibrillation, mechanical mitral valve prosthesis), including aspirin and a thienopyridine. For patients on OAC, a combination of OAC and aspirin or thienopyridine is generally used. This review shows that current registries are unfit to directly compare antithrombotic regimens. Small exploring studies suggest that additional clopidogrel after TAVI only affects bleeding and not ischemic complications. However, these studies are lack in quality in terms of Cochrane criteria. Currently, three randomised controlled trials are recruiting to gather more knowledge about the effects of clopidogrel after TAVI.

Keywords

Transcatheter aortic valve implantation (TAVI) - antithrombotic - antiplatelet - anticoagulation - bleeding - stroke - clopidogrel

• References

• 1 Leon MB, Smith CR, Mack M. et al. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. N Engl J Med 2010; 363: 1597-1607.
• 2 Kapadia SR. Five-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) in “Inoperable” Patients With Severe Aortic Stenosis: The PARTNER Trial. In: On behalf of The PARTNER Trial Investigators. 2014. p. TCT 2014 | September 13, 2014 Washington:
• 3 Smith CR, Leon MB, Mack MJ. et al. Transcatheter vs surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364: 2187-2198.
• 4 Adams DH, Popma JJ, Reardon MJ. et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis. N Engl J Med 2014; 370: 1790-1798.
• 5 Généreux P, Head SJ, Van Mieghem NM. et al. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol 2012; 59: 2317-2326.
• 6 Nishimura RA, Otto CM, Bonow RO. 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. Epub ahead of print
• 7 Holmes DR, Mack MJ, Kaul S. et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 2012; 59: 1200-1254.
• 8 Webb J, Rodés-Cabau J, Fremes S. et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol 2012; 28: 520-528.
• 9 Vahanian A, Alfieri O, Andreotti F. et al. Guidelines on the management of valvular heart disease (version 2012). Eur Hear J 2012; 33: 2451-2496.
• 10 Lip GYH, Windecker S, Huber K. et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on . Eur Heart J. 2014. Epub ahead of print
• 11 Leon MB, Piazza N, Nikolsky E. et al. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol 2011; 57: 253-269.
• 12 Kappetein AP, Head SJ, Généreux P. 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: 1438-1454.
• 13 Abdel-Wahab M, Mehilli J, Frerker C. et al. Comparison of Balloon-Expandable vs Self-expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Med Assoc 2014; 311: 1503-1514.
• 14 Godino C, Maisano F, Montorfano M. et al. Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience. JACC Cardiovasc Interv 2010; 03: 1110-1121.
• 15 Ussia GP, Scarabelli M, Mulè M. et al. Dual antiplatelet therapy vs aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 2011; 108: 1772-1776.
• 16 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: 624-627.
• 17 Poliacikova P, Cockburn J, de Belder A, Trivedi U, Hildick-Smith D. Antiplatelet and antithrombotic treatment after transcatheter aortic valve implantation – comparison of regimes. J Invasive Cardiol 2013; 25: 544-548.
• 18 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: 355-360.
• 19 Grube E, Laborde JC, Zickmann B. et al. First report on a human percutaneous transluminal implantation of a self-expanding valve prothesis for interventional treatment of aortic valve stenosis. Catheter Cardiovasc Interv 2005; 66: 465-469.
• 20 Jilaihawi H, Doctor N, Chakravarty T. et al. Major thrombocytopenia after balloon-expandable transcatheter aortic valve replacement: Prognostic implications and comparison to surgical aortic valve replacement. Catheter Cardiovasc Interv. 2014. Epub ahead of print
• 21 Mueller KAL, Werner S, Mueller II. et al. Time course of platelet aggregation and platelet activation in patients under dual antiplatelet therapy undergoing percutaneous aortic valve replacement. Eur Heart J 2012; 33: 580.
• 22 Tousek P, Kocka V, Sulzenko J, Bednar F, Linkova H, Widimsky P. Pharmacodynamic effect of clopidogrel in patients undergoing transcatheter aortic valve implantation. Biomed Res Int 2013; 2013: 386074.
• 23 Gallet R, Seemann A, Yamamoto M. et al. Effect of transcatheter (via femoral artery) aortic valve implantation on the platelet count and its consequences. Am J Cardiol 2013; 111: 1619-1624.
• 24 Rodés-Cabau J, Webb JG, Cheung A. et al. Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian multicenter experience. J Am Coll Cardiol 2012; 60: 1864-1875.
• 25 Gallego P, Roldan V, Marín F. et al. Cessation of oral anticoagulation in relation to mortality and the risk of thrombotic events in patients with atrial fibrillation. Thromb Haemost 2013; 110: 1189-1198.
• 26 Bernard a, Fauchier L, Pellegrin C. et al. Anticoagulation in patients with atrial fibrillation undergoing coronary stent implantation. Thromb Haemost 2013; 110: 560-568.
• 27 Hansen ML, Sørensen R, Clausen MT. et al. Risk of Bleeding With Single, Dual, or Triple Therapy With Warfarin, Aspirin, and Clopidogrel in Patients With Atrial Fibrillation. Arch Intern Med 2010; 170: 1433-1441.
• 28 Dans AL, Connolly SJ, Wallentin L. et al. Concomitant Use of Antiplatelet Therapy with Dabigatran or Warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Trial. Circulation 2013; 127: 634-640.
• 29 Karjalainen PP, Porela P, Ylitalo A. et al. Safety and efficacy of combined antiplatelet-warfarin therapy after coronary stenting. Eur Hear J 2007; 28: 726-732.
• 30 Sørensen R, Hansen ML, Abildstrom SZ. et al. Risk of bleeding in patients with acute myocardial infarction treated with different combinations of aspirin, clopidogrel, and vitamin K antagonists in Denmark: a retrospective analysis of nationwide registry data. Lancet 2009; 374: 1967-1974.
• 31 Mérie C, Køber L, Skov Olsen P. et al. Association of Warfarin Therapy Duration After Bioprosthetic Aortic Valve Replacement With Risk of Mortality, Thromboembolic Complications, and Bleeding. J Am Med Assoc 2012; 308: 2118-2125.
• 32 Noble S, Asgar A, Cartier R, Virmani R, Bonan R. Anatomo-pathological analysis after CoreValve Revalving system implantation. EuroIntervention 2009; 05: 78-85.
• 33 Trepels T, Martens S, Doss M. et al. Images in cardiovascular medicine. Thrombotic restenosis after minimally invasive implantation of aortic valve stent. Circulation 2009; 120: e23-e24.
• 34 Kefer J, Astarci P, Renkin J. et al. Thrombotic aortic restenosis after transapical sapien valve implantation. Circ Cardiovasc Interv 2010; 03: 289-292.
• 35 Cota L, Stabile E, Agrusta M. et al. Bioprostheses “thrombosis” after transcatheter aortic valve replacement. J Am Coll Cardiol 2013; 61: 789-791.
• 36 Latib A, Messika-Zeitoun D, Maisano F. et al. Reversible edwards sapien XT dysfunction due to prosthesis thrombosis presenting as early structural deterioration. J Am Coll Cardiol 2013; 61: 787-789.
• 37 Pergolini A, Pino PG, Zampi G. et al. Thrombotic aortic restenosis after transapical SAPIEN valve implantation. J Card Surg 2014; 29: 204-208.
• 38 Pache G, Blanke P, Zeh W. et al. Cusp thrombosis after transcatheter aortic valve replacement detected by computed tomography and echocardiography. Eur Heart J 2013; 34: 3546.
• 39 Greason KL, Mathew V, Sarano ME. et al. Early transcatheter aortic valve thrombosis. J Card Surg 2013; 28: 264-266.
• 40 Lancellotti P, Radermecker M a, Weisz SH. et al. Subacute transcatheter CoreValve thrombotic obstruction. Circ Cardiovasc Interv 2013; 06: e32-e33.
• 41 Pingpoh C, Pache G, Nawras D. et al. Valve thrombosis 7 months after transcatheter aortic valve implantation. Ann Thorac Surg 2014; 98: 1079-1081.
• 42 Al-Rashid F, Konorza TFM, Plicht B. et al. Transient increase in pressure gradients after termination of dual antiplatelet therapy in a patient after transfemoral aortic valve implantation. Circ Cardiovasc Interv 2012; 05: 318-320.
• 43 Piazza N, Grube E, Gerckens U. et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. EuroIntervention 2008; 04: 242-249.
• 44 Lefèvre T, Kappetein AP, Wolner E. et al. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Hear J 2011; 32: 148-157.
• 45 Wenaweser P, Pilgrim T, Roth N. et al. Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes. Am Heart J 2011; 161: 1114-1124.
• 46 Tay ELW, Gurvitch R, Wijesinghe N. et al. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv 2011; 04: 1290-1297.
• 47 Zahn R, Gerckens U, Grube E. et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Hear J 2011; 32: 198-204.
• 48 Nuis R-J, Van Mieghem NM, Schultz CJ. et al. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol 2012; 109: 1637-1643.
• 49 Abramowitz Y, Banai S, Katz G. et al. Comparison of early and late outcomes of TAVI alone compared to TAVI plus PCI in aortic stenosis patients with and without coronary artery disease. Catheter Cardiovasc Interv 2014; 83: 649-654.
• 50 Avanzas P, Munoz-Garcia AJ, Segura J. et al. Percutaneous implantation of the CoreValve(registered trademark) self-expanding aortic valve prosthesis in patients with severe aortic stenosis: Early experience in Spain. Rev Esp Cardiol 2010; 63: 141-148.
• 51 Rodés-Cabau J, Webb JG, Cheung A. et al. Transcatheter Aortic Valve Implantation for the Treatment of Severe Symptomatic Aortic Stenosis in Patients at Very High or Prohibitive Surgical Risk. J Am Coll Cardiol 2010; 55: 1080-1090.
• 52 Tchetche D, Van der Boon RMA, Dumonteil N. et al. Adverse impact of bleeding and transfusion on the outcome post-transcatheter aortic valve implantation: insights from the Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC Plus) initiative. Am Heart J 2012; 164: 402-409.
• 53 Gilard M, Eltchaninoff H, Iung B. et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012; 366: 1705-1715.
• 54 Ussia GP, Scarabelli M, Mulè M. et al. Dual antiplatelet therapy vs aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 2011; 108: 1772-1776.
• 55 Kodali SK, O’Neill WW, Moses JW. et al. Early and late (one year) outcomes following transcatheter aortic valve implantation in patients with severe aortic stenosis (from the United States REVIVAL trial). Am J Cardiol 2011; 107: 1058-1064.
• 56 Gurvitch R, Toggweiler S, Willson AB. et al. Outcomes and complications of transcatheter aortic valve replacement using a balloon expandable valve according to the Valve Academic Research Consortium (VARC) guidelines. EuroIntervention 2011; 07: 41-48.
• 57 Borz B, Durand E, Godin M. et al. Incidence, predictors and impact of bleeding after transcatheter aortic valve implantation using the balloon-expandable Edwards prosthesis. Heart 2013; 99: 860-865.
• 58 Orvin K, Kornowski R, Bishara J. et al. The frequency and prognostic impact of fever following transcatheter aortic valve implantation. Cardiol 2014; 127: 203-210.
• 59 Abdel-Wahab M, Zahn R, Horack M. et al. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart 2011; 97: 899-906.
• 60 Abdel-Wahab M, Zahn R, Horack M. et al. Transcatheter aortic valve implantation in patients with and without concomitant coronary artery disease: comparison of characteristics and early outcome in the German multicenter TAVI registry. Clin Res Cardiol 2012; 101: 973-981.
• 61 Figini F, Latib A, Maisano F. et al. Managing patients with an indication for anticoagulant therapy after transcatheter aortic valve implantation. Am J Cardiol 2013; 111: 237-242.
• 62 Hayashida K, Bouvier E, Lefevre T. et al. Transcatheter aortic valve implantation for patients with severe bicuspid aortic valve stenosis. Circ Cardiovasc Interv 2013; 06: 284-291.
• 63 Spargias K, Toutouzas K, Chrissoheris M. et al. The ATHENS TAVR registry of newer generation transfemoral aortic valves: 30-day outcomes. Hell J Cardiol 2013; 54: 18-24.
• 64 Magri CJ, Chieffo A, Durante A. et al. Impact of mean platelet volume on combined safety endpoint and vascular and bleeding complications following percutaneous transfemoral transcatheter aortic valve implantation. Biomed Res Int 2013; 2013.
• 65 Van Mieghem NM, Van Der Boon RM, Faqiri E. et al. Complete revascularization is not a prerequisite for success in current transcatheter aortic valve implantation practice. JACC Cardiovasc Interv 2013; 06: 867-875.
• 66 Mack MJ, Brennan JM, Brindis R. et al. Outcomes following transcatheter aortic valve replacement in the United States. J Am Med Assoc 2013; 310: 2069-2077.
• 67 Thomas M, Schymik G, Walther T. et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 2010; 122: 62-69.
• 68 Ussia GP, Barbanti M, Petronio AS. et al. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Hear J 2012; 33: 969-976.
• 69 Bosmans JM, Kefer J, De Bruyne B. et al. Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: results of the Belgian national registry. Interact Cardiovasc Thorac Surg 2011; 12: 762-767.
• 70 Wenaweser P, Stortecky S, Heg D. et al. Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registry. EuroIntervention 2014; 1-20.
• 71 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: 3041-3053.
• 72 Linke A. CLaret Embolic Protection ANd TAVI – Trial (CLEAN-TAVI). p. TCT 2014. Washington.:
• 73 Van Mieghem NM, Schipper MEI, Ladich E. et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation 2013; 127: 2194-2201.
• 74 Hynes BG, Rodes-Cabau J. Transcatheter aortic valve implantation and cerebrovascular events: The current state of the art. Ann NY Acad Sci 2012; 1254: 151-163.
• 75 Makkar RR, Fontana GP, Jilaihawi H. et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012; 366: 1696-1704.
• 76 Kahlert P, Knipp SC, Schlamann M. et al. Silent and apparent cerebral ischaemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation 2010; 121: 870-878.
• 77 Ribeiro HB, Webb JG, Makkar RR. et al. Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry. J Am Coll Cardiol 2013; 62: 1552-1562.
• 78 Devereaux PJ, Mrkobrada M, Sessler DI. et al. Aspirin in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2014. 140331050018004.
• 79 Griese DP, Reents W, Diegeler A. et al. Simple, effective and safe vascular access site closure with the double-ProGlide preclose technique in 162 patients receiving transfemoral transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2013; 82: E734-E741.
• 80 Halliday BP, Dworakowski R, Brickham B. et al. Usefulness of periprocedural bleeding to predict outcome after transcatheter aortic valve implantation. Am J Cardiol 2012; 109: 724-728.
• 81 Stabile E, Sorropago G, Pucciarelli A. et al. SAT-TAVI (single antiplatelet therapy for TAVI) study: A randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation. J Am Coll Cardiol 2011; 58: B218.
• 82 Van Mieghem NM, Nuis R-J, Tzikas A. et al. Prevalence and prognostic implications of baseline anaemia in patients undergoing transcatheter aortic valve implantation. EuroIntervention 2011; 07: 184-191.
• 83 Kodali SK, Williams MR, Smith CR. et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012; 366: 1686-1695.
• 84 Freeman J V, Zhu RP, Owens DK. et al. Original Research Cost-Effectiveness of Dabigatran Compared With Warfarin for Stroke Prevention in Atrial Fibrillation. Ann Intern Med 2011; 154: 1-11.
• 85 Holmes Jr. DR, Mack MJ, Kaul S. et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. Catheter Cardiovasc Interv 2012; 79: 1023-1082.
• 86 Avanzas P, Munoz-Garcia AJ, Segura J. et al. Percutaneous Implantation of the CoreValve(registered trademark) Self-Expanding Aortic Valve Prosthesis in Patients With Severe Aortic Stenosis: Early Experience in Spain. Rev Esp Cardiol 2010; 63: 141-148.
• 87 Wenaweser P, Pilgrim T, Kadner A. et al. Clinical outcomes of patients with severe aortic stenosis at increased surgical risk according to treatment modality. J Am Coll Cardiol 2011; 58: 2151-2162.
• 88 Tay ELW, Gurvitch R, Wijesinghe N. et al. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv 2011; 04: 1290-1297.
• 89 Petronio AS, De Carlo M, Bedogni F. et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circ Cardiovasc Interv 2010; 03: 359-366.
• 90 Tamburino C, Capodanno D, Ramondo A. et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 2011; 123: 299-308.
• 91 Fusari M, Bona V, Muratori M. et al. Transcatheter vs surgical aortic valve replacement: A retrospective analysis assessing clinical effectiveness and safety. J Cardiovasc Med 2012; 13: 229-241.