The new guidelines include for the first time a strong recommendation that hospitals adopts a “heart team” approach in choosing a treatment strategy for patients with coronary artery disease. For patients with unprotected left main or complex CAD, the team approach is a Class I recommendation.
“The 2011 guideline includes an unprecedented degree of collaboration in generating revascularization recommendations for patients with CAD,” said Glenn Levine, the chair of the PCI guideline writing committee, in a press release from the ACC and AHA. The PCI and CABG committees coordinated their efforts and joined forces to write the section comparing the two revascularization procedures.
The PCI guidelines recommend using the SYNTAX score in patients with multivessel disease, and include specific recommendations for every anatomic subgroup of patients with stable CAD.
Drug-eluting stents (DES) gain a Class 1 recommendation to decrease the incidence of restenosis but this recommendation is “counterbalanced,” according to Levine, by the recommendation that before implanting a DES patients should be evaluated to assess whether they are suitable for dual antiplatelet therapy.
Low dose aspirin gains a Class IIA recommendation while clopidogrel, prasugrel, and ticagrelor all receive Class I recommendations following PCI.
L. David Hillis, chair of the CABG guideline writing committee, said that physicians will pay close attention to the section on “whom to revascularize and how to do it,” in particular “because the debate over PCI versus CABG has seen the most action since the 2004 guideline was written.”
Because PCI has improved so much since the previous guidelines were issued in 2004, the new guidelines support the use of PCI as “a reasonable alternative to CABG in stable patients with left main CAD who have a low risk of PCI complications and an increased risk of adverse surgical outcomes.” CABG, however, still retains the advantage over PCI for most patients with 3-vessel disease.
Here are the 2 press releases from the ACC and the AHA:
ACC/AHA/SCAI Release Revised PCI Guidelines
2011 guideline represents ‘unprecedented’ collaboration, advocates careful revascularization decision making
The American College of Cardiology Foundation (ACCF), American Heart Association (AHA), and Society for Cardiovascular Angiography and Interventions (SCAI) today released a revised guideline for the management of patients undergoing percutaneous coronary intervention (PCI). 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, which was co-written by the PCI and CABG writing committees.
“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—which was written together by the PCI and CABG committees—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.
The revised guideline will be published in the December 6, 2011, issue the Journal of the American College of Cardiology and available before print on Monday, November 7, 2011, at 2 pm ET at www.cardiosource.org. It will also be co-published in the December 6, 2011, issue of Circulation: Journal of the American Heart Association and available before print on Monday, November 7, 2011, at 2 pm ET atwww.heart.org, and in the December 2011 issue of Catheterization and Cardiovascular Interventions and available before print on Monday, November 7, 2011, at 2 pm ET at www.scai.org.
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ACC/AHA Release Revised CABG Guideline
2011 guideline includes most extensive, collaborative examination of CABG versus PCI
The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) today released a rewritten set of guidelines for the management of patients undergoing coronary artery bypass graft surgery (CABG). The 2011 guideline contains the most extensive examination of using CABG or percutaneous coronary intervention (PCI) for coronary revascularization, with the writing committee working collaboratively with members of the PCI guideline writing committee.
The 2011 guideline represents the first time that two writing committees have worked together to author a common section. The coronary artery disease (CAD) revascularization section—which discusses who should be revascularized and whether it should be accomplished with CABG or PCI—is included in revisions to both the 2011 CABG guideline and the 2011 PCI guideline, which were also released by the ACC, AHA and the Society for Cardiovascular Angiography and Interventions (SCAI) today.
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. “The question of whom to revascularize and how to do it comes up frequently in a busy practitioner’s office,” he said. “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 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 10-15 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.”
Hillis cites the example of left main CAD to illustrate the growing use of PCI. A decade ago, the standard of care for these patients was to receive CABG. Now, however, depending on the specifics of their coronary arterial anatomy, some patients can receive PCI. Specifically, the 2011 guideline states that PCI to improve patient survival is a reasonable alternative to CABG in stable patients with left main CAD who have a low risk of PCI complications and an increased risk of adverse surgical outcomes. The guideline also confirms the superiority of CABG compared to medical therapy and to PCI for most patients with 3-vessel disease.
The guideline further recommends using a “heart team” approach to determine which procedure should be used. This approach means that the interventional cardiologist and the cardiac surgeon will review the patient’s condition, determine the pros and cons of each treatment option, and then present this information to the patient, allowing him or her to make a more informed decision.
“It has become apparent that the best recommendations come from the surgeon and cardiologist working together,” said Peter K. Smith, MD, vice chair of the CABG guideline writing committee. “The evidence that we used in writing this recommendation is based on trials where patients were randomized by this sort of a team, and it follows that this is the way we should practice.”
These trials include SYNTAX, which informed decisions on many of the recommendations included in the 2011 guideline. This randomized, controlled trial—which was published in the New England Journal of Medicine in 2009—compared CABG versus PCI in 1,800 patients. It showed that PCI led to outcomes that were comparable to those of CABG for patients with certain coronary arterial anatomic features. Overall, the revised guideline was based on a formal literature review of studies published in the past 10 years.
In addition to the discussion of CABG versus PCI, the 2011 guideline addresses numerous other issues, such as the appropriate choice of bypass graft conduit; the use of off-pump CABG versus traditional on-pump CABG; and CABG in specific patient subsets, such as those with diabetes mellitus. One of the most significant issues, notes Hillis, is the examination of preoperative and postoperative antiplatelet therapy.
“Since the last guideline was released, our ability to inhibit platelet aggregation has become much better, since there are now more drugs available,” he said. “It’s no longer just a choice of ‘do they or do they not receive aspirin.’ It is now ‘do they receive aspirin, clopidogrel, a glycoprotein IIb/IIIa inhibitor, or another drug.”
Specifically, the 2011 guideline notes that aspirin should be administered to CABG patients preoperatively, and that in patients receiving elective CABG, clopidogrel and ticagrelor should be discontinued for at least 5 days before elective surgery (or at least 24 hours, if possible, for patients needing urgent CABG). Postoperatively, aspirin should be given within 6 hours of surgery (if it was not initiated preoperatively) and then continued indefinitely. Clopidogrel is a “reasonable alternative” in patients who are allergic to aspirin.
While the 2011 guideline includes for the first time a collaborative section on CABG versus PCI, they also mark another first—the implementation of a new policy for relationships with industry and other entities. The new policy requires that the writing committee chair and more than 50 percent of the committee members have no relevant industry relationships.
The revised guideline will be published in the December 6, 2011, issue the Journal of the American College of Cardiology and available before print on Monday, November 7, 2011, at 2 pm ET at http://content.onlinejacc.org/cgi/content/full/j.jacc.2011.08.009. They will also be co-published in the December 6, 2011, issue of Circulation: Journal of the American Heart Association and available before print on Monday, November 7, 2011, at 2 pm ET at www.heart.org.
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