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Primary percutaneous coronary intervention and bleeding risk in the era of drug-eluting stent: a long-term cohort study

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Abstract

Data of long-term efficacy and safety including bleeding risk associated with antithrombotic regimens after primary percutaneous coronary intervention (PCI) using first-generation drug-eluting stent (1st DES) are scarce. Consecutive 422 patients with ST-elevation myocardial infarction (STEMI) underwent primary PCI with DES (285 patients), bare metal stent (BMS, 58 patients) or balloon angioplasty (BA 79 patients). At a median follow-up of 44 months, major cardiovascular events were significantly lower for 1st DES compared with BMS and BA (11.9 vs. 25.9 vs. 16.5 %, p = 0.027). Cardiac death, recurrent myocardial infarction and target lesion revascularization (TLR), differed among the groups (DES 8.8 %; BMS 13.8 %; BA 17.7 %; p = 0.019), although the superiority of DES subsided beyond 1 year by increased late TLRs. Major bleedings were not higher in DES than in BMS and BA (4.6 vs. 6.9 vs. 1.5 %, p = 0.252). Multivariate logistic regression analysis revealed that both dual antiplatelet therapy (DAPT) >24 months and indefinite oral anticoagulation (OAC) were associated with a major bleeding. The risk was even greater with triple antithrombotic therapy (odds ratio 19.5; 95 % confidence interval 3.73–102.07; p < 0.0001). 1st DES showed favorable overall long-term clinical outcome in STEMI, with an inherent limitation of an increased risk of late TLR. Prolonged DAPT and OAC synergistically increase the risk of major bleeding after primary PCI.

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References

  1. Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction). Circulation. 2004;110:e82–292.

    Article  PubMed  Google Scholar 

  2. Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, et al. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. Lancet. 2011;377:2193–204.

    Article  CAS  PubMed  Google Scholar 

  3. Spaulding C, Teiger E, Commeau P, Varenne O, Bramucci E, Slama M, et al. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC Cardiovasc Interv. 2011;4:14–23.

    Article  PubMed  Google Scholar 

  4. Kalesan B, Pilgrim T, Heinimann K, Raber L, Stefanini GG, Valgimigli M, et al. Comparison of drug-eluting stents with bare metal stents in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012;33:977–87.

    Article  CAS  PubMed  Google Scholar 

  5. Kushner FG, Hand M, Smith SC Jr, King SB 3rd, Anderson JL, Antman EM, et al. 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009;120:2271–306.

    Article  PubMed  Google Scholar 

  6. Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, et al. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012;125:2015–26.

    Article  CAS  PubMed  Google Scholar 

  7. Yamashita T. Recent mortality and morbidity rates of Japanese atrial fibrillation patients: racial differences and risk stratification. Circ J. 2013;77:864–8.

    Article  PubMed  Google Scholar 

  8. Sorensen R, Hansen ML, Abildstrom SZ, Hvelplund A, Andersson C, Jorgensen C, 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;374:1967–74.

    Article  CAS  PubMed  Google Scholar 

  9. Naruse Y, Sato A, Hoshi T, Takeyasu N, Kakefuda Y, Ishibashi M, et al. Triple antithrombotic therapy is the independent predictor for the occurrence of major bleeding complications: analysis of percent time in therapeutic range. Circ Cardiovasc Interv. 2013;6:444–51.

    Article  CAS  PubMed  Google Scholar 

  10. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344–51.

    Article  PubMed  Google Scholar 

  11. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123:2736–47.

    Article  PubMed  Google Scholar 

  12. Thygesen K, Alpert JS, White HD, Jaffe AS, Apple FS, Galvani M, et al. Universal definition of myocardial infarction. Circulation. 2007;116:2634–53.

    Article  PubMed  Google Scholar 

  13. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138:1093–100.

    Article  PubMed  Google Scholar 

  14. Morice MC, Serruys PW, Sousa JE, Fajadet J. Ban Hayashi E, Perin M, et al., A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–80.

    Article  CAS  PubMed  Google Scholar 

  15. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007;369:667–78.

    Article  CAS  PubMed  Google Scholar 

  16. Kukreja N, Onuma Y, Garcia-Garcia H, Daemen J, van Domburg R, Serruys PW. Primary percutaneous coronary intervention for acute myocardial infarction: long-term outcome after bare metal and drug-eluting stent implantation. Circ Cardiovasc Interv. 2008;1:103–10.

    Article  PubMed  Google Scholar 

  17. Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, Hamon M, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol. 2007;49:1362–8.

    Article  PubMed  Google Scholar 

  18. Kimura T, Morimoto T, Nakagawa Y, Kawai K, Miyazaki S, Muramatsu T, et al. Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry. Circulation. 2012;125:584–91.

    Article  CAS  PubMed  Google Scholar 

  19. Ruiz-Garcia J, Lerman A, Weisz G, Maehara A, Mintz GS, Fahy M, et al. Age- and gender-related changes in plaque composition in patients with acute coronary syndrome: the PROSPECT study. EuroIntervention. 2012;8:929–38.

    Article  PubMed  Google Scholar 

  20. Kimura T, Morimoto T, Nakagawa Y, Kadota K, Nozaki Y, Tada T, et al. Antiplatelet therapy and long-term clinical outcome after sirolimus-eluting stent implantation: 5-year outcome of the j-Cypher registry. Cardiovasc Interv Ther. 2012;27:181–8.

    Article  CAS  PubMed  Google Scholar 

  21. Feres F, Costa RA, Abizaid A, Leon MB, Marin-Neto JA, Botelho RV, et al. Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial. JAMA. 2013;310:2510–22.

    CAS  PubMed  Google Scholar 

  22. Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006;354:1706–17.

    Article  CAS  PubMed  Google Scholar 

  23. Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362:1663–74.

    Article  CAS  PubMed  Google Scholar 

  24. Kirtane AJ, Leon MB, Ball MW, Bajwa HS, Sketch MH Jr, Coleman PS, et al. The “final” 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013;6:325–33.

    Article  PubMed  Google Scholar 

  25. Gao F, Zhou YJ, Wang ZJ, Shen H, Liu XL, Nie B, et al. Comparison of different antithrombotic regimens for patients with atrial fibrillation undergoing drug-eluting stent implantation. Circ J. 2010;74:701–8.

    Article  PubMed  Google Scholar 

  26. Wang TY, Robinson LA, Ou FS, Roe MT, Ohman EM, Gibler WB, et al. Discharge antithrombotic strategies among patients with acute coronary syndrome previously on warfarin anticoagulation: physician practice in the CRUSADE registry. Am Heart J. 2008;155:361–8.

    Article  PubMed  Google Scholar 

  27. Dewilde WJ, Oirbans T, Verheugt FW, Kelder JC, De Smet BJ, Herrman JP, et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet. 2013;381:1107–15.

    Article  CAS  PubMed  Google Scholar 

  28. Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31:2369–429.

    Article  PubMed  Google Scholar 

  29. Faxon DP, Eikelboom JW, Berger PB, Holmes DR, Bhatt DL, Moliterno DJ, et al. Consensus document: antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting. A North-American perspective. Thromb Haemost. 2011;106:572–84.

    Article  CAS  PubMed  Google Scholar 

  30. Dans AL, Connolly SJ, Wallentin L, Yang S, Nakamya J, Brueckmann M, 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;127:634–40.

    Article  CAS  PubMed  Google Scholar 

  31. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91.

    Article  CAS  PubMed  Google Scholar 

  32. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92.

    Article  CAS  PubMed  Google Scholar 

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Acknowledgments

The authors are indebted to Ms. Emiko Abe for assistance with the manuscript.

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Authors and Affiliations

  1. Department of Cardiology, Niigata City General Hospital, Shumoku 463-7, Chuo-ku, Niigata, 950-1197, Japan

    Keiichi Tsuchida, Ryutaro Ikegami, Michio Sato, Takeshi Okubo, Toshiaki Yano, Komei Tanaka, Tsuyoshi Kobayashi, Yukio Hosaka, Kazuyuki Ozaki, Kazuyoshi Takahashi, Tsutomu Miida & Hirotaka Oda

  2. Division of International Health, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan

    Yugo Shobugawa

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  1. Keiichi Tsuchida
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Tsuchida, K., Ikegami, R., Sato, M. et al. Primary percutaneous coronary intervention and bleeding risk in the era of drug-eluting stent: a long-term cohort study. Cardiovasc Interv and Ther 30, 216–226 (2015). https://doi.org/10.1007/s12928-014-0306-0

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  • DOI: https://doi.org/10.1007/s12928-014-0306-0

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