ACC/AHA/SCAI Release Revised PCI Guideline

November 7, 2011—The American College of Cardiology Foundation (ACCF), American Heart Association (AHA), and Society for Cardiovascular Angiography and Interventions (SCAI) have released a revised guideline for the management of patients undergoing percutaneous coronary intervention (PCI). Glenn N. Levine, MD, et al published the guideline online ahead of print in Circulation: Journal of the American Heart Association, Journal of the American College of Cardiology, and Catheterization & Cardiovascular Intervention.

According to the societies, the 2011 PCI 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 2011 guideline was written under a new policy implemented by the ACC and AHA that requires more than 50% of the writing committee members—and the committee chair—to be free of relevant industry relationships, the societies noted.

“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,” commented 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 and supporting references in color tables.”

In addition, for the first time, a combined 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.

Dr. Levine, chair of the PCI guideline writing committee, 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, ST-segment elevation myocardial infarction (STEMI), stable ischemic heart disease, and unstable angina/non-STEMI guideline committees to determine joint recommendations for their separate documents. Dr. Levine added, “The 2011 guideline includes an unprecedented degree of collaboration in generating revascularization recommendations for patients with CAD.”

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, which was included as a class I recommendation for patients with unprotected left main or complex CAD. This approach 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 societies advised that 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 2009 by Patrick W. Serruys, MD, et al in the New England Journal of Medicine, 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, noted that although this calculation is complex, using the SYNTAX 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. The guideline provides recommendations on revascularizing patients based on improving both survival and symptoms. Dr. Blankenship stated that although it has historically been difficult 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 Dr. 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, although 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 after PCI with either a DES or bare-metal stent.

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 backup. The guideline also includes a class I recommendation for monitoring and recording procedural radiation data, the societies advised.

The ACCF and AHA also announced the release of the revised guideline for the management of patients undergoing CABG, which is available online ahead of print in the Journal of the American College of Cardiology and Circulation: Journal of the American Heart Association. The 2011 CABG guideline section on CAD revascularization includes the same discussion as the PCI guideline on determining which approaches should be used. The societies noted that this collaborative effort of the CABG and PCI guideline committees is the most extensive examination of the use of CABG or PCI for coronary revascularization and is the first time that two guideline committees have worked together to author a common section.

L. David Hillis, MD, chair of the CABG guideline writing committee, noted that the updated revascularization section will be of great interest to practicing clinicians. He said, “The question of whom to revascularize and how to do it comes up frequently in a busy practitioner's office. Thus, I think physicians will hone in on this section because it addresses an everyday question and because the debate over PCI versus CABG has seen the most action since the 2004 guideline was written.”

According to Dr. Hillis, this decision recently has become more complicated, as PCI is now being used in more cases. “What has happened over the last decade is that as PCI has become better; it is now being used for things that it wasn't being used for 10 to 15 years ago,” he said. “Just like the development of any new technology, as the PCI technology matured, the procedure has become better, and as the operators have gained more experience, they have also become more skilled.”