The 2011 guideline emphasizes careful consideration before determining treatment for coronary artery disease (CAD)—including the use of a “heart team” approach —and provides the most extensive section yet comparing coronary artery bypass graft surgery (CABG) and PCI.
“The overarching goal of our guideline effort is to maintain relevance and ease of use at the point of care while guiding evidence-based clinical practice,” said Alice K. Jacobs, MD, chair of the ACCF/AHA Task Force on Practice Guidelines. “The PCI guideline piloted several new initiatives including a focus on replacing and limiting text with evidence/summary tables and highlighting recommendations with their level of evidence (LOE) and supporting references in color tables,” she noted. In addition, for the first time, a combined a section on revascularization was crafted together by the PCI and CABG writing committees for ease of use by the clinician. The Task Force also instituted a new format where members of several writing committees work together to draft recommendations that overlap multiple guidelines during a Consensus Conference in an effort to shorten the development time and maintain concordance.
“The 2011 guideline includes an unprecedented degree of collaboration in generating revascularization recommendations for patients with CAD,” said Glenn N. Levine, MD, chair of the PCI guideline writing committee, who noted that the extensive CAD revascularization section examines both who should be revascularized and whether it should be performed using CABG or PCI. The PCI writing committee also worked with members from the CABG, STEMI, stable ischemic heart disease, and unstable angina/non-STEMI guideline committees to determine joint recommendations for their separate documents.
In addition to undergoing a more collaborative writing process, the 2011 writing committee members also added new concepts to the guideline, including that of the “heart team” approach. This approach—which was included as a Class I recommendation (the highest level) for patients with unprotected left main or complex CAD—encourages interventional cardiologists and cardiothoracic surgeons to jointly review the patient’s condition/coronary anatomy, evaluate the pros and cons of each treatment option, and then present this information to the patient, along with their recommendation.
The 2011 guideline also advocates using a SYNTAX score in decisions regarding treatment of patients with multivessel disease. Introduced in the SYNTAX study that was published in the New England Journal of Medicine in 2009, this scoring system estimates the extent and complexity of CAD by entering the patient’s angiography results into a computer-based “SYNTAX score calculator.” James C. Blankenship, MD, vice chair of the PCI guideline writing committee, notes that while this calculation is complex, using the score to classify extent of disease more objectively may help guide decisions regarding CABG or PCI.
The revised guideline further helps eliminate ambiguity by providing specific recommendations for the first time for every anatomic subgroup of patients with stable CAD. Recommendations on revascularizing patients are provided based on improving both survival and symptoms. Blankenship notes while it has historically been hard to obtain data for each subgroup—leading to their exclusion from the guideline—the 2011 committee conducted an extensive effort to find information so that each group could be included, whether at a level of evidence A (multiple randomized, controlled trials) or a level of evidence C (expert recommendations or case studies).
According to Levine, great effort was also taken to ensure a “careful and balanced approach” to stenting in general—and drug-eluting stents (DES) in particular—when writing the 2011 recommendations. Specifically, while the use of DES to decrease the incidence of blood vessel renarrowing was given a Class I recommendation, this was “counterbalanced” by a recommendation that before performing PCI, physicians must first evaluate patients to determine if they can tolerate and comply with dual antiplatelet therapy.
In their revision of the antiplatelet section, Levine notes that the committee simplified the recommendations regarding aspirin by including a Class IIA recommendation (meaning “it is reasonable”) for using 81 mg of aspirin per day after PCI instead of higher maintenance doses. The committee also provided recommendations regarding the use of ticagrelor, a new P2Y12 inhibitor that was approved by the FDA after the release of the previous guideline. Alongside Class I recommendations for clopidogrel and prasugrel, the committee provided a Class I recommendation for giving 180 mg of ticagrelor as a loading dose and for giving 90 mg twice daily for at least 12 months following PCI with either a DES or bare-metal stent (BMS).
The 2011 guideline expands and adds recommendations on numerous other topics. Ethical aspects of PCI—including informed consent, self-referral, and potential conflicts of interest—are addressed, as are recommendations on statin therapy, the use of vascular closure devices, and PCI in hospitals without on-site surgical back-up. The guideline also includes a Class I recommendation for monitoring and recording procedural radiation data.
The 2011 guideline was written under a new policy implemented by the ACC and AHA that requires more than 50 percent of the writing committee members—and the committee chair—to be free of relevant industry relationships.
CLICK HERE to download the complete “2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention.”
A summary of the guidelines will be published in the December 2011 issue of Catheterization and Cardiovascular Interventions.