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2011最新房颤的治疗指南

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2011最新房颤的治疗指南 ISSN: 1524-4539 Copyright © 2011 American Heart Association. All rights reserved. Print ISSN: 0009-7322. Online 72514 Circulation is published by the American Heart Association. 7272 Greenville Avenue, Dallas, TX DOI: 10.1161/CIR.0b013e31820f14c0 published onl...
2011最新房颤的治疗指南
ISSN: 1524-4539 Copyright © 2011 American Heart Association. All rights reserved. Print ISSN: 0009-7322. Online 72514 Circulation is published by the American Heart Association. 7272 Greenville Avenue, Dallas, TX DOI: 10.1161/CIR.0b013e31820f14c0 published online Feb 14, 2011; Circulation Richard L. Page, David J. Slotwiner, William G. Stevenson and Cynthia M. Tracy Michael D. Ezekowitz, Warren M. Jackman, Craig T. January, James E. Lowe, L. Samuel Wann, Anne B. Curtis, Kenneth A. Ellenbogen, N.A. Mark Estes, III, Guidelines Cardiology Foundation/American Heart Association Task Force on Practice Atrial Fibrillation (Update on Dabigatran): A Report of the American College of 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With http://circ.ahajournals.org/cgi/content/full/CIR.0b013e31820f14c0/DC1 Data Supplement (unedited) at: http://circ.ahajournals.org located on the World Wide Web at: The online version of this article, along with updated information and services, is http://www.lww.com/reprints Reprints: Information about reprints can be found online at journalpermissions@lww.com 410-528-8550. E-mail: Fax:Kluwer Health, 351 West Camden Street, Baltimore, MD 21202-2436. Phone: 410-528-4050. Permissions: Permissions & Rights Desk, Lippincott Williams & Wilkins, a division of Wolters http://circ.ahajournals.org/subscriptions/ Subscriptions: Information about subscribing to Circulation is online at at VA MED CTR BOISE on February 19, 2011 circ.ahajournals.orgDownloaded from ACCF/AHA/HRS Focused Update 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran) A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines 2011 WRITING GROUP MEMBERS L. Samuel Wann, MD, MACC, FAHA, Chair*; Anne B. Curtis, MD, FACC, FAHA*; Kenneth A. Ellenbogen, MD, FACC, FHRS†; N.A. Mark Estes III, MD, FACC, FHRS‡§; Michael D. Ezekowitz, MB, ChB, FACC*§; Warren M. Jackman, MD, FACC, FHRS*; Craig T. January, MD, PhD, FACC*; James E. Lowe, MD, FACC*; Richard L. Page, MD, FACC, FHRS, FAHA†; David J. Slotwiner, MD, FACC†§; William G. Stevenson, MD, FACC, FAHA�; Cynthia M. Tracy, MD, FACC* 2006 WRITING COMMITTEE MEMBERS Valentin Fuster, MD, PhD, FACC, FAHA, FESC, Co-Chair; Lars E. Ryde´n, MD, PhD, FACC, FESC, FAHA, Co-Chair; David S. Cannom, MD, FACC; Harry J. Crijns, MD, FACC, FESC; Anne B. Curtis, MD, FACC, FAHA; Kenneth A. Ellenbogen, MD, FACC, FHRS†; Jonathan L. Halperin, MD, FACC, FAHA; G. Neal Kay, MD, FACC; Jean-Yves Le Heuzey, MD, FESC; James E. Lowe, MD, FACC; S. Bertil Olsson, MD, PhD, FESC; Eric N. Prystowsky, MD, FACC; Juan Luis Tamargo, MD, FESC; L. Samuel Wann, MD, MACC, FAHA, FESC ACCF/AHA TASK FORCE MEMBERS Alice K. Jacobs, MD, FACC, FAHA, Chair; Jeffrey L. Anderson, MD, FACC, FAHA, Chair-Elect; Nancy Albert, PhD, CCNS, CCRN, FAHA; Mark A. Creager, MD, FACC, FAHA; Steven M. Ettinger, MD, FACC; Robert A. Guyton, MD, FACC; Jonathan L. Halperin, MD, FACC, FAHA; Judith S. Hochman, MD, FACC, FAHA; Frederick G. Kushner, MD, FACC, FAHA; Erik Magnus Ohman, MD, FACC; William G. Stevenson, MD, FACC, FAHA; Clyde W. Yancy, MD, FACC, FAHA *ACCF/AHA Representative. †HRS Representative. ‡ACCF/AHA Task Force on Performance Measures Representative. §Recused from voting on Section 8.1.4.2.5, Recommendation for Use of Oral Direct Thrombin Inhibitor Anticoagulant Agents. �ACCF/AHA Task Force on Practice Guidelines Liaison. This document was approved by the American College of Cardiology Foundation Board of Trustees, the American Heart Association Science Advisory and Coordinating Committee, and the Heart Rhythm Society in January 2011. The online-only Data Supplement is available with this article at http://circ.ahajournals.org/cgi/content/full/10.1161/CIR.0b013e31820f14c0/DC1. The American Heart Association requests that this document be cited as follows: Wann LS, Curtis AB, Ellenbogen KA, Estes NAM 3rd, Ezekowitz MD, Jackman WM, January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG, Tracy CM, writing on behalf of the 2006 ACC/AHA/ESC Guidelines for the Management of Patients With Atrial Fibrillation Writing Committee. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;123:●●●–●●●. This article is copublished in the Journal of the American College of Cardiology and HeartRhythm. Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.cardiosource.org), the American Heart Association (my.americanheart.org), and the Heart Rhythm Society (www.hrsonline.org). A copy of the document is also available at http:// www.americanheart.org/presenter.jhtml?identifier�3003999 by selecting either the “topic list” link or the “chronological list” link. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com. Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. Instructions for obtaining permission are located at http://www.americanheart.org/presenter.jhtml? identifier�4431. A link to the “Permission Request Form” appears on the right side of the page. (Circulation. 2011;123:00-00.) © 2011 by the American College of Cardiology Foundation, the American Heart Association, Inc., and the Heart Rhythm Society. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIR.0b013e31820f14c0 1 at VA MED CTR BOISE on February 19, 2011 circ.ahajournals.orgDownloaded from Table of Contents Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .000 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .000 1.1. Methodology and Evidence Review . . . . . . . . . .000 1.2. Organization of the Writing Committee. . . . . . . .000 1.3. Document Review and Approval. . . . . . . . . . . . .000 8. Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .000 8.1.4.2.5. Recommendation for Use of Oral Direct Thrombin Inhibitor Anticoagulant Agents . . . . . . . . . . . . . . . .000 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .000 Appendix 1. Author Relationships With Industry and Other Entities . . . . . . . . . . . . . . . . . . .000 Appendix 2. Reviewer Relationships With Industry and Other Entities . . . . . . . . . . . . . . . . . . .000 Preamble A primary challenge in the development of clinical practice guide- lines is keeping pace with the stream of new data on which recommendations are based. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation/ American Heart Association (ACCF/AHA) Task Force on Practice Guidelines (Task Force) has created a “focused update” process to revise the existing guideline recommendations that are affected by the evolving data or opinion. Before the initiation of this focused approach, periodic updates and revisions of existing guidelines required up to 3 years to complete. Now, however, new evidence will be reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care. Evidence will be reviewed at least twice a year, and updates will be initiated on an as-needed basis and completed as quickly as possible while main- taining the rigorous methodology that the ACCF and AHA have developed during their partnership of more than 20 years. These updated guideline recommendations reflect a consen- sus of expert opinion after a thorough review primarily of late-breaking clinical trials identified through a broad-based vetting process as being important to the relevant patient population, as well as other new data deemed to have an impact on patient care (see Section 1.1, Methodology and Evidence Review, for details). This focused update is not intended to represent an update based on a full literature review from the date of the previous guideline publication. Specific criteria/ considerations for inclusion of new data include the following: ● publication in a peer-reviewed journal; ● large, randomized, placebo-controlled trial(s); ● nonrandomized data deemed important on the basis of results affecting current safety and efficacy assumptions; ● strength/weakness of research methodology and findings; ● likelihood of additional studies influencing current findings; ● impact on current and/or likelihood of need to develop new performance measure(s); ● request(s) and requirement(s) for review and update from the practice community, key stakeholders, and other sources free of relationships with industry or other potential bias; ● number of previous trials showing consistent results; and ● need for consistency with a new guideline or guideline revisions. In analyzing the data and developing the recommendations and supporting text, the focused update writing group used evidence-based methodologies developed by the Task Force that are described elsewhere.1 The committee reviewed and ranked evidence supporting current recommendations with the weight of evidence ranked as Level A if the data were derived from multiple randomized clinical trials or meta-anal- yses. The committee ranked available evidence as Level B when data were derived from a single randomized trial or nonrandomized studies. Evidence was ranked as Level C when the primary source of the recommendation was consen- sus opinion, case studies, or standard of care. In the narrative portions of these guidelines, evidence is generally presented in chronological order of development. Studies are identified as observational, retrospective, prospective, or randomized when appropriate. For certain conditions for which inade- quate data are available, recommendations are based on expert consensus and clinical experience and ranked as Level C. An example is the use of penicillin for pneumococcal pneumonia, for which there are no randomized trials and treatment is based on clinical experience. When recommen- dations at Level C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues where sparse data are available, a survey of current practice among the clinicians on the writing committee was the basis for Level C recommendations and no references are cited. The schema for classification of recommendation and level of evidence is summarized in Table 1, which also illustrates how the grading system provides an estimate of the size and the certainty of the treatment effect. A new addition to the ACCF/AHA method- ology is a separation of the Class III recommendations to delineate whether the recommendation is determined to be of “no benefit” or associated with “harm” to the patient. In addition, in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment/strategy with respect to an- other for Class I and IIa, Level A or B only have been added. The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of relationships with industry and other entities (RWI) among the writing group. Specifically, all members of the writing group, as well as peer reviewers of the document, are asked to disclose all current relationships and those existing 12 months before initi- ation of the writing effort. In response to implementation of a newly revised RWI policy approved by the ACC and AHA, it is also required that the writing group chair plus a majority of the writing group (50%) have no relevant RWI. All guideline recommendations require a confidential vote by the writing group and must be approved by a consensus of the members voting. Members who were recused from voting are noted on the title page of this document and in Appendix 1. Members must recuse themselves from voting on any recommendation to which their RWI apply. Any writing group member who develops a new RWI during his or her tenure is required to notify guideline 2 Circulation March 15, 2011 at VA MED CTR BOISE on February 19, 2011 circ.ahajournals.orgDownloaded from staff in writing. These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing group and are updated as changes occur. For detailed information about guideline policies and procedures, please refer to the ACCF/AHA methodology and policies manual.1 Authors’ and peer reviewers’ RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. In addition, to ensure complete transparency, writing group members’ comprehensive disclosure information—including RWI not pertinent to this document—is available online as a supplement to this document. Disclosure information for the Task Force is also available online at www.cardiosource.org/ACC/About-ACC/Leadership/ Guidelines-and-Documents-Task-Forces.aspx. The work of the writing group was supported exclusively by the ACCF and AHA and Heart Rhythm Society (HRS) without commercial support. Writing group members volunteered their time for this effort. The ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America. As such, drugs that are currently unavailable in North America are discussed in the text without a specific classification of recommendation. For studies performed in large numbers of subjects outside of North America, each writing group reviews the potential impact of different practice patterns and patient populations on the treatment effect and the relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation. Table 1. Applying Classification of Recommendations and Level of Evidence * Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. †For comparative effectiveness recommendations (Class I and IIa; Level of Evidence: A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated. Wann et al Atrial Fibrillation Focused Update: Dabigatran 3 at VA MED CTR BOISE on February 19, 2011 circ.ahajournals.orgDownloaded from The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches for the diagnosis, man- agement, and prevention of specific diseases or conditions. These practice guidelines represent a consensus of expert opinion after a thorough review of the available current scientific evidence and are intended to improve patient care. The guidelines attempt to define practices that meet the needs of most patients in most circum- stances. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. Thus, there are circum- stances in which deviations from these guidelines may be appropri- ate. Clinical decision making should consider the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force recognizes that situations arise for which additional data are needed to better inform patient care; these areas will be identified within each respective guideline when appropriate. Prescribed courses of treatment in accordance with these recommendations are effective only if they are followed. Be- cause lack of patient understanding and adherence may ad- versely affect outcomes, physicians and other healthcare provid- ers should make every effort to engage the patient’s active participation in prescribed medical regimens and lifestyles. The recommendations in this focused update will be considered current until they are superseded by another focused update or the full-text guideline is revised. This focused update is published in the Journal of the American College of Cardiology, Circulation, and HeartRhythm as an update to the full-text guideline, and it is also available on the ACC (www.cardiosource.org), AHA (my.americanheart.org), and HRS (www.hrsonline.org) World Wide Web sites. A revised version of the full-text guideline with links to the focused update is e-published in the March 15, 2011, issues of the Journal of the American College of Cardiology and Circulation. For easy reference, this online-only version denotes sections that have been updated. Alice K. Jacobs, MD, FACC, FAHA Chair, ACCF/AHA Task Force on Practice Guidelines 1. Introduction 1.1. Methodology and Evidence Review The publication of the RE-LY (Randomized Evaluation of Long- Term Anticoagulation Therapy) trial was considered important enough to prompt a focused update of the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation.2 To provide clinicians with a comprehensive set of data, whenever deemed appropriate or when published, the absolute risk difference and number needed to treat or harm will be provided in the guideline, along with confidence intervals (CI) and data related to the relative treatment effects such as odds ratio, relative risk (RR), hazard ratio, or incidence rate ratio. Consult the full-text version or executive summary of the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation for policy on clinical areas not covered by the focused update.2 The individual recom- mendations in this focused update will be incorporated into future revisions and/or updates of the full-text guideline. 1.2. Organization of the Writing Committee For this focused update, all eligible members of the 2006 Atrial Fibrillation Writing Committee were invited to partic- ipate; those who agreed (referred to as the 2011 focused update writing group) were required to disclose all RWI relevant to the data under consideration. The HRS was invited to be a partner on this update and provided 3 representatives. 1.3. Document Review and Approval This document was reviewed by 2 official reviewers each nominated by the ACCF, AHA, and HRS and 5 individual content reviewers (including members of the ACCF Electro- physiology Committee, the ACCF/AHA Task Force on Per- formance Measures, and the ACCF/AHA Atrial Fibrillation Data Standards Committee). All information on reviewers’ RWI was collected and distributed to the writing committee and is published in this report (Appendix 2). This document was approved for publication by the gov- erning bodies of the ACCF, AHA, and HRS. 8. Management This guideline update focuses on the use of dabigatran, a new antithrombotic agent that was recently approved by the US Food and Drug Administration (FDA), for the management of patients with atrial fibrillation (AF). 8.1.4.2.5. Recommendation for Use of Oral Direct Thrombin Inhibitor Anticoagulant Agents (See Table 2). Dabigatra
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