April 10th, 2011

Questioning the Guidelines

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CardioExchange welcomes R Scott Wright, the chair of the recently published focused update of the ACC/AHA Unstable Angina/NSTEMI guidelines. Dr. Wright generously agreed to answer questions about the guidelines posed by the CardioExchange editors.

CardioExchange Editors: For clinicians reading this guidelines update, what would you highlight as the most important new or revised recommendations that should be considered in current practice?

Dr. Wright: I think there are several things of interest to practicing clinicians in the revisions we have published including:

  1. Clarification regarding the role and timing of invasive management in ACS patients. New data continue to emphasize the benefit of early invasive management in high risk ACS patients as well as the appropriate role of initial medical stabilization in low and intermediate risk patients.
  2. Clarification, using the latest evidence based medicine, on which patient subgroups should have dual anti-platelet therapy (DAPT) versus triple antiplatelet (TAPT) therapy. TAPT can be reserved for those who undergo PCI or at highest risk prior to PCI. We also highlighted the potential bleeding risks for TAPT and hope clinicians will think carefully and act responsibly when using TAPT.
  3. The potential benefit of invasive management in renal dysfunction as well as the paucity of evidence to drive an invasive strategy in those with severe renal dysfunction (CKD IV, V).
  4. The critical importance of using risk stratification tools to better understand individual patients’ short and longer term risks and how risk estimate influences selection of initial management strategies.
  5. The critical importance of every US hospital and provider to be engaged in quality improvement measures and to use systems approaches to manage, monitor and follow patients as well as drive innovation in health care system delivery. It is no longer acceptable to say your hospital should be in a registry. It should and so should you as a provider and the data you get back should prompt you to improve how you practice medicine and deliver care
  6. There are a lack of data to drive measuring platelet function and genotyping. Clinicians should only use these tools if such data will alter clinical decision making. This type of testing should not be done just to know the data. It is also important to understand that there is insufficient evidence currently available to say that knowing these data and changing the dose or type of thienopyridine prescribed will improve outcomes. We hope most clinicians will wait on the data from multiple, ongoing RCT’s examining these issues.
  7. The role of prasugrel in patients with ACS. We tried to follow the FDA package insert regarding how to use this agent as we felt the FDA weighed the evidence carefully. We hope that clinicians will be aware of the potential for bleeding and will avoid using it in the high risk subgroups identified by the package insert.

Editors: In light of more information provided from new research — but less definitive evidence and what appears to be fewer class A recommendations overall — what would you consider to be the main take home points for clinicians reading this update?
Wright: This is a great and insightful question. The astute reader will note that we downgraded the level of evidence for one recommendation, now adhering to a stricter standard set by the ACC Board of Trustees and endorsed by the Guidelines Governanance Task Force and our Working Group. We had heard a number of concerns by clinicians that some in industry were using previous guidelines recommendations to aggressively market products, perhaps not consistent with the spirit and intent of the 2007 edition.

Our goals with the 2011 revision were:

  • to incorporate new evidence in a clinically meaningful way,
  • to insist that more recommendations by backed by larger RCT evidence or multiple smaller RCT’s whenever possible,
  • to try to focus the update on issues that are of clinical relevance to today’s practicing physicians, and
  • to encourage clinicians to consider quality improvement participation.

Editors: Did the committee find it difficult to reach a consensus on controversial issues such as the role of prasugrel, platelet-function and genetic testing, and PPIs?

Wright: Yes, the committee thoroughly discussed, considered and vetted each of these issues. Our work was enhanced greatly by the large number of thoughtful, not-shy peer reviewers who challenged us on our first version and helped us clarify our thoughts and ideas. We had peer review from across the USA, Europe and Latin America. We also worked across specialty lines by having input from non-cardiologists: Heart Surgeons, internists, family physicians, ED physicians, Nurse practitioners and others. We met for a strategic review with our counterparts at the ESC and reviewed what each of our respective groups thought were key areas for improvement in the ACS guidelines. Finally, we shared our ideas with other working groups like the PCI task force so that we could gain from their expertise as well.

At the end of the day, there were very few slim majorities. My style of leadership was to build consensus and have at least a 2/3 majority on most things. I felt that we needed that degree of support to ensure we reflected the many faces of medicine fairly and did not have any one strong opinion or conflicted interest influencing things. My co-Chair Dr. Jeffrey Anderson was very helpful with his insight, leadership and experience at leading these types of working groups. Jeff deserves a lot of credit for our finished product.

We were aided in our work on PPI and Platelet function testing issues by the recently published consensus statements by the ACC/AHA. Those documents are well written, well referenced and offer practical advice. We thought their discussions were superb and did not deviate from them to any great extent. We also reviewed evidence presented as late as the ESC and AHA 2010 and incorporated new findings into our work.

Finally, we strictly enforced the ACC/AHA policy that those with a conflict of interest in any given area could not vote. The ACC Staff working with us were fantastic at helping us remain compliant with this and with the COI’s from our peer review group. No member of the working group with a COI ever tried to dominate discussion or push the revision in a given direction. I truly believe we used a fair, transparent and patient-centered process. Dr. William Mayo is quoted at my work place, the Mayo Clinic, as saying “The interests of the patients are the only interests to be considered…” It was a privilege to work with my fellow Task Force members as each of them reflected that value quite well.

Editors: What do you predict will be on the horizon for future updates to the UA-NSTEMI guidelines?
Wright: I am hopeful that several changes will come with the next full revision including:

  • Requiring a higher percentage of the recommendations to be supported by RCT evidence,
  • Making the guidelines more patient centric so that the clinician reading them will better understand how to apply them in everyday clinical scenarios,
  • reduced redundancy within a specific guideline document and more harmony across guideline documents (for example, the PCI, STEMI and UA/NSTEMI guidelines) and
  • continued emphasis on the use of quality improvement processes and registries to guide implementation, application and revision of evidence based practices as well as understand how such improvements reduce mortality.

 

One Response to “Questioning the Guidelines”

  1. Hasty update of Clinical Practice Guidelines indicates possibilities of potential conflict of interest cannot be ruled out confidently,such as sudden update of AHA-ACCF Guideline on AF focusing on dabigatran. I afraid among the writing groups a significant number might have financial relation with Pharma-industries,even-though many of the writing group remembers denied such ties.
    Virtually I find noway out, such as, conflict of interest. Even if conflict of interest are disclosed,how a clinician will interprets it? Will he/she be refrain from prescribing as recommended by the said guideline or simply ignore it?