Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI

被引:56
作者
Valgimigli, Marco [1 ,2 ]
Cao, Davide [3 ]
Angiolillo, Dominick J. [4 ]
Bangalore, Sripal [5 ]
Bhatt, Deepak L. [6 ]
Ge, Junbo [7 ]
Hermiller, James [8 ]
Makkar, Raj R. [9 ]
Neumann, Franz-Josef [10 ]
Saito, Shigeru [11 ]
Picon, Hector [12 ]
Toelg, Ralph [13 ]
Maksoud, Aziz [14 ,15 ]
Chehab, Bassem M. [16 ]
Choi, James W. [17 ]
Campo, Gianluca [18 ]
Hernandez, Jose M. De la Torre [19 ]
Kunadian, Vijay [20 ,21 ]
Sardella, Gennaro [22 ]
Thiele, Holger [23 ,24 ]
Varenne, Olivier [25 ]
Vranckx, Pascal [26 ,27 ]
Windecker, Stephan [2 ]
Zhou, Yujie [28 ]
Krucoff, Mitchell W. [29 ,30 ]
Ruster, Karine [31 ]
Zheng, Yan [31 ]
Mehran, Roxana [3 ]
机构
[1] Ente Osped Cantonale, Cardioctr Ticino Inst, Lugano, Switzerland
[2] Bern Univ Hosp, Bern, Switzerland
[3] Icahn Sch Med Mt Sinai, New York, NY 10029 USA
[4] Univ Florida Coll Med Jacksonville, Jacksonville, FL USA
[5] New York Univ Langone Med Ctr, New York, NY USA
[6] Harvard Med Sch, Brigham & Womens Hosp, Heart & Vasc Ctr, Boston, MA 02115 USA
[7] Fudan Univ, Zhongshan Hosp, Shanghai, Peoples R China
[8] St Vincents Med Ctr Indiana, Indianapolis, IN USA
[9] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA
[10] Univ Heart Ctr Freiburg, Bad Krozingen, Germany
[11] Shonan Kamakura Gen Hosp, Kamakura, Kanagawa, Japan
[12] Redmond Reg Med Ctr, Rome, GA USA
[13] Segeberger Kliniken GmbH, Herzzentrum, Bad Segeberg, Germany
[14] Kansas Heart Hosp, Wichita, KS USA
[15] Univ Kansas, Sch Med, Wichita, KS 67214 USA
[16] Ascens Via Christi Hosp, Wichita, KS USA
[17] Baylor Scott & White Heart & Vasc Hosp, Dallas, TX USA
[18] Azienda Osped Univ Ferrara, Cona, FE, Italy
[19] Hosp Univ Marques de Valdecilla, IDIVAL, Santander, Spain
[20] Newcastle Univ, Translat & Clin Res Inst, Newcastle Upon Tyne, Tyne & Wear, England
[21] Newcastle Tyne Hosp NHS Fdn Trust, Freeman Hosp, Ctr Cardiothorac, Newcastle Upon Tyne, Tyne & Wear, England
[22] Policlin Umberto I Roma, Rome, Italy
[23] Univ Leipzig, Heart Ctr Leipzig, Leipzig, Germany
[24] Leipzig Heart Inst, Leipzig, Germany
[25] Hosp Cochin, Paris, France
[26] Heart Ctr Hasselt, Hasselt, Belgium
[27] Univ Hasselt, Hasselt, Belgium
[28] Beijing AnZhen Hosp, Beijing, Peoples R China
[29] Duke Univ, Med Ctr, Durham, NC USA
[30] Duke Clin Res Inst, Durham, NC USA
[31] Abbott, Santa Clara, CA USA
关键词
bleeding; everolimus-eluting stent; high bleeding risk; short DAPT; thrombosis; PERCUTANEOUS CORONARY INTERVENTION; ACADEMIC RESEARCH CONSORTIUM; EVEROLIMUS-ELUTING STENT; BARE-METAL STENT; MYOCARDIAL-INFARCTION; OPEN-LABEL; ANTITHROMBOTIC THERAPY; DE-ESCALATION; 1-MONTH DAPT; MULTICENTER;
D O I
10.1016/j.jacc.2021.08.074
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown. OBJECTIVES The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug eluting stent implantation. METHODS The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI. RESULTS A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3 month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference-0.2%; 95% CI:-2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference-2.5%; 95% CI:-4.6% to-0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference-1.1%; 95% CI:-2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015). CONCLUSIONS Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742) (J Am Coll Cardiol 2021;78:2060-2072) (c) 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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页码:2060 / 2072
页数:13
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