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Percutaneous coronary intervention (PCI) is now considered "appropriate" in relatively benign three-vessel disease, according to an update of criteria for revascularization of complex coronary artery disease. It had previously been categorized as "uncertain."

A writing group representing major cardiology and cardiac surgery organizations made the updates of "appropriate use" criteria driven mainly by the SYNTAX trial results.

The update also moves PCI from "inappropriate" to "uncertain" for simple forms of left main disease, according to the document published online in the Journal of the American College of Cardiology.

"The publication of the randomized SYNTAX trial and a few other trials caused the writing committee and technical committee to reevaluate high-risk findings in complex coronary disease," Gregory J. Dehmer, MD, who represented the Society for Cardiovascular Angiography and Interventions (SCAI) on the writing group, told 麻豆传媒.

In the SYNTAX trial, PCI was compared with surgery in patients with complex coronary artery disease. "Results indicated that PCI was a viable option in patients with low-burden complex disease," said Dehmer, a professor of medicine at Texas A&M College of Medicine in Temple, Texas.

It's important to realize, Dehmer said, that the classification of "uncertain" merely means that more research and patient information is needed to classify the indication definitively. In fact, the document points out that "the writing group, technical panel, AUC Task Force, and clinical community do not believe an uncertain rating justifies denial of reimbursement for revascularization."

Another important change to reflect emerging data and also be consistent with guidelines is an update to the cutpoint for fractional flow reserve (FFR) from 0.75 to 0.80. This change was evident in the indication for one- or two-vessel coronary artery disease (CAD) with borderline stenosis (50% to 60%) in patients without prior bypass surgery who either have had equivocal test results or no noninvasive testing (indication #22 on a table explaining the criteria) .

The appropriateness use criteria were developed with five core variables considered:

• The clinical presentation, or the stability of the patient
• The symptom class (very mild or class 4 symptoms at rest)
• Extent of ischemia on noninvasive testing and the presence or absence of other prognostic factors, such as congestive heart failure, depressed left ventricular function, or diabetes
• Extent of medical therapy
• Extent of anatomic disease

Although there are a multitude of other variables that inform medical decision-making, such as age, gender, and comorbidities, "it would be impractical for us to create a classification for the myriad potential patient scenarios," Dehmer said. "The document would be too large and not very user-friendly."

So the classification of "uncertain" allows for clinical judgment on an individual basis. It also identifies areas where more focused research needs to be done, he said.

Most of the ratings in the document are listed by indication (i.e., ST-segment elevation myocardial infarction [STEMI], non-STEMI, one-vessel CAD involving the proximal left anterior descending artery [LAD]) and they are not intended to distinguish between different methods of revascularization.

However, the "writing group identified four indications possibly affected by results of the SYNTAX trial for reexamination. The writing group also split two of the indications to represent levels of disease burden, recognizing, however, that the ability to reproducibly quantify the SYNTAX score in routine clinical practice has challenges," according to the focused update document.

Coronary artery bypass grafting (CABG) is deemed "appropriate" in all of these indications. PCI is "appropriate" for two-vessel with proximal LAD stenosis and for three-vessel CAD with low CAD burden (i.e., three focal stenoses, low SYNTAX score).

PCI is deemed "uncertain" in three scenarios:

• Three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of chronic total occlusion, or high SYNTAX score)
• Isolated left main stenosis
• Left main stenosis and additional CAD with low CAD burden (i.e., one- to two-vessel additional involvement, low SYNTAX score)

Also updated is the "inappropriate" designation for performing PCI in patients with left main stenosis and additional CAD with intermediate to high CAD burden.

"The key is for surgeons and cardiologists to work together to determine the best course of action for the patient," Peter K. Smith, MD, chief of cardiothoracic surgery at Duke University in Durham, N.C., told 麻豆传媒.

Smith, who represented the Society of Thoracic Surgeons in the writing group, said the updated appropriateness criteria are in step with the updated CABG guidelines released in November, of which Smith was a member of the writing group.

Besides stressing the concept of the "heart team," the guidelines affirmed the results of the SYNTAX trial, that PCI is a viable option in patients with less severe complex disease and CABG is better in all other scenarios.

"The appropriateness use criteria and the updated CABG and PCI guidelines are complementary," Smith said.

The criteria were jointly developed by the American College of Cardiology Foundation, SCAI, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, Heart Failure Society of America, and Society of Cardiovascular Computed Tomography. They have been endorsed by the American Society of Echocardiography and Heart Rhythm Society.

From the American Heart Association:

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