Conflict Persists Between Guidelines and Practice When It Comes to Treating CAD in TAVR Candidates

PCI should be considered for major coronary arteries with significant proximal stenoses before TAVR is performed, according to a new consensus statement from the Interventional Section of the Leadership Council of the American College of Cardiology.

That approach has become standard practice in the United States but conflicts with guidelines and appropriate use criteria that discourage PCI in patients with severe aortic stenosis, senior author Lloyd Klein, MD (Rush Medical College, Chicago, IL), told TCTMD. The documents don’t address the specific issue of PCI before TAVR, however.

When the pivotal TAVR trials were designed, patients with significant coronary disease were not allowed to undergo the procedure; balloon angioplasty and stenting had to be performed at least 1 month before TAVR for patients to be eligible. Klein pointed out that there are no studies specifically evaluating whether that’s the best tactic, although nonrandomized US and European studies support its safety. In addition, he said, the Centers for Medicare & Medicaid Services will not reimburse for TAVR unless significant coronary lesions have been treated first.

“So this puts us in a bind because on the one hand, you have clinical practice which says this is how you handle coronary disease prior to TAVR and on the other hand, you have guidelines and the appropriate use criteria which say that doing coronary stenting in patients with critical aortic stenosis is a class III contraindicated procedure and according to the appropriate use criteria [is] in the rarely appropriate category,” Klein said.

The purpose of the consensus statement, which was published early ahead of print in the December 12, 2016, issue of JACC: Cardiovascular Interventions, is “to call attention to the fact that you have this conflict between the various [types of] documentation and to say that what we ought to do is pass an exception in the appropriate use criteria and change the guidelines to match what standard clinical practice is,” Klein said.

Individualized Management Recommended

Klein, lead author Stephen Ramee, MD (Ochsner Medical Center, New Orleans, LA), and co-authors make several recommendations and provide an algorithm to aid the decision process. According to Klein, none of the recommendations differ much from what clinicians are currently doing in practice:

• Management should be individualized based on overall clinical condition and anatomy
• PCI should be considered in all patients with significant proximal stenoses in major coronary arteries before TAVR; generally only stenoses > 70% in proximal epicardial arteries should be considered for intervention
• PCI on a chronic total occlusion in the absence of ischemia or symptoms before TAVR is not advised

“When the patient is symptomatic with combined CAD and [aortic stenosis], and TAVR is being considered as a treatment option, the risks of PCI must be evaluated from a different perspective than for most patients with stable ischemic heart disease,” the authors note. “Untreated significant stenoses may potentially exclude patients from consideration for TAVR. Conversely, if the PCI procedure poses a high risk, then the advisability of a TAVR strategy may need to be reevaluated.”

They point out that prior studies have shown that PCI can be performed safely before TAVR in carefully selected cases. Factors that should be considered when deciding on revascularization include LVEF, lesion location and severity, morphologic complexity, technical feasibility, patient frailty, bleeding risk, and vascular access.

Clinicians should know that “there is an accepted way of managing their aortic stenosis patients who are candidates for TAVR even if they have significant coronary disease, that there is an accepted and low-risk alternative to surgery, which could be high-risk, and that even though the current guidelines and appropriate use criteria will give you a ding for doing it that that’s still the right thing to do,” Klein said. “And I hope that they know that we’re working to try to get this all changed and to get all the incentives aligned in the patients’ best interest.”

Commenting on the statement for TCTMD, Gilbert Tang, MD (Westchester Medical Center, Valhalla, NY), said the decision about which lesions are likely to cause issues during a TAVR procedure and should be revascularized falls to the heart team.

"Hemodynamically significant lesions in a dominant territory should be revascularized first prior to TAVR, and most interventional cardiologists would agree with that because there’s certain types of transcatheter valves that after the valve is implanted going back to reengage the coronary to do any kind of diagnostic or interventional work would potentially be more challenging,” Tang said.

He added, however, that more research is needed in this area, particularly as TAVR becomes increasingly used in intermediate-risk patients.

“The question,” Tang said, “is whether [surgical replacement] and CABG is more appropriate in some of these patients versus PCI and TAVR, and in terms of the timing of that, is the PCI first and then TAVR more appropriate given some of the challenges associated with doing the PCI after the TAVR with some of these newer transcatheter valves.”