European Societies Release Updated Revascularization Guidelines for CAD
New clinical practice guidelines issued by the European Society of Cardiology (ESC) and the European Association of Cardio-Thoracic Surgeons (EACTS) emphasize the therapeutic benefit of revascularization among patients with coronary artery disease (CAD) across multiple subsets.
Among other changes, the document leans toward use of DES over BMS. New-generation DES in particular are said to carry a survival benefit over medical therapy and to show potential in treating STEMI patients.
The guidelines were presented at the ESC Congress in Barcelona on August 30, 2014, and published online ahead of print in the European Heart Journal, EuroIntervention, and the European Journal of Cardio-Thoracic Surgery. The task force, led by chairperson Stephan Windecker, MD, of Bern University Hospital (Bern, Switzerland), systematically reviewed evidence that included 100 trials in 93,553 patients, encompassing 262,090 patient-years of follow-up.
Trial Evidence Influential in Changes
The recommendations were influenced by a range of recent practice-changing randomized PCI and surgery trials— including 5-year results of the SYNTAX trial—and are based on both symptomatic and prognostic indications. As in the prior version of the guidelines, the importance of suitable anatomy is stressed.
Now, the guidelines state that PCI assumes a similar class and level of evidence as CABG in patients with lesions in the proximal LAD. Similarly, PCI has been upgraded to a Class I indication in simple left main disease (Syntax score < 22) and simple 3-vessel disease (Syntax score < 22). But the guidelines stress that complete revascularization should be achieved in multivessel disease, and they give PCI a Class III indication in complex 3-vessel disease (Syntax Score >22) and left main disease (Syntax Score >32). A section of the document devoted to risk models includes an algorithm to help in calculating Syntax scores.
Results of the FREEDOM trial, among others, influenced the recommendations for diabetic patients, resulting in a Class I indication for CABG in those with multivessel CAD and acceptable surgical risk.
In addition to recommending DES over BMS in nearly all patients and lesion subsets, the guidelines give a Class I indication for the use of DES in STEMI patients undergoing primary PCI.
In a prepared statement, Dr. Windecker said the upgrade is notable because there had been concern about the use of first-generation DES in the setting of STEMI, “but that has vanished with the advent of newer-generation DES." He further noted that “all stent-based coronary revascularization technologies were found to reduce the risk of repeat revascularization, whereas new-generation DES but no other percutaneous revascularization technology improved survival compared with medical treatment.”
Antithrombotic Therapy Guidance Revised
The guidelines also contain several updates regarding antithrombotic therapy. Based on results from the ACCOAST trial, for example, pretreatment with prasugrel before PCI is not recommended in patients with NSTE-ACS due to increased risk of bleeding. Additionally, the recommended duration of dual antiplatelet therapy (DAPT) after DES in stable CAD has been changed to 6 months, which Dr. Windecker said “recognizes that an extension beyond 6 months in patients with stable CAD is no longer necessary.” This decision was influenced by a number of large randomized trials comparing short- and long-term DAPT durations including EXCELLENT, OPTIMIZE, RESET, and PRODIGY.
Dr. Windecker and colleagues also downgrade the recommendation for use of bivalirudin in STEMI patients from a Class I to a Class IIa. The task force points out that “the mortality benefit observed in HORIZONS-AMI was not confirmed by EUROMAX, and the excess of stent thrombosis remained despite prolonged infusion of bivalirudin.”
The new guidelines also include a section on the relationship between volume and outcome for both CABG and PCI, providing guidance on minimum numbers of procedures for physicians and institutions, as well as recommendations for training, proficiency and operator/institutional competence.
Combines Clinical Scenarios, General Evidence
“It’s really remarkable how much they’ve covered in this document,” observed Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), in a telephone interview with TCTMD.
The goal of any guidelines document, he added, is to be user-friendly while incorporating the latest evidence, “and I definitely think they’ve tried to do that.”
Dr. Kirtane noted that unlike in the United States, there are not separate appropriate use criteria (AUC) and guidelines in Europe. “The issue that some have had with the American guidelines is that they’re so broad that they don’t necessarily cover specific clinical scenarios that clinicians have to deal with. This document does a good job of combining the scenarios with general evidence and that is quite an admirable effort as a whole,” he said.
Of interest to clinicians, Dr. Kirtane noted, is a chart specific to patients with depressed ventricular function and another on prognosis in stable ischemic heart disease with revascularization vs medical therapy. “This document draws on data that extends beyond the COURAGE trial and in fact states that proximal LAD stenosis > 50% is a Class Ia indication to revascularize for prognosis. [Revascularization for prognosis] is not something you see represented with Class Ia recommendations in current US guidelines,” he observed.
Another departure from US guidelines, he added, is that among high-risk patients, there seems to be an up-front preference for anatomic delineation of disease.
“In the US algorithms, one of the only ways you get to the cath lab for risk stratification is if you have a high-risk, non-invasive study, whereas in this document if you have a high pretest probability, those other tests are actually contraindicated. This certainly goes along with my personal practice patterns for high-risk patients, but I found it remarkable to see this mirrored in this guidance document,” he said.
Dr. Kirtane added that while some of the
reliance on the importance of subgoups within the SYNTAX trial still requires
further prospective validation, overall the document is a bit more “PCI
friendly” than the US guidelines. However, this this may be due to the fact
that patients coming to the cath lab are often seen later in the course of
their disease outside of the US, and that the ESC guidelines presuppose
appropriate indications for diagnostic testing and PCI, he noted. “Our
colleagues in Europe don’t often seem to be confronting or treating branch
vessel disease in an asymptomatic patient, which frankly is a good thing.”
Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2014;Epub ahead of print.
- Dr. Windecker reports speaker fees, honoraria, consulting fees and advisory board fees from Abbott, Astra Zeneca, Biosensors, Biotronik, Boston Scientific, Cordis, Edwards Lifesciences, Eli Lilly, and Medtronic. He also reports institutional research support from Abbott, Biosensors, Biotronik, Cordis, Medtronic, and St. Jude Medical.
- Dr. Kirtane reports institutional research support from Abbott Vascular, Abiomed, Boston Scientific, Medtronic, and St. Jude Medical.
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