Stephen Ramee (Ochsner Medical Center, New Orleans, USA) and others outline in a paper in JACC: Cardiovascular Interventions, the rationale for performing percutaneous coronary intervention (PCI) prior to transcatheter aortic valve implantation (TAVI) in patients with concomitant aortic stenosis and coronary artery disease. In this interview, lead author Lloyd Klein (Rush Medical College, Chicago, USA) explains why this paper addresses a gap between current professional recommendations and current clinical practice for PCI candidates undergoing TAVI.
What proportion of patients being considered for TAVI will also have functionally significant coronary artery disease?
About half of all patients being considered for TAVI will also have coronary artery disease, but this does depend on the patients that have been selected for TAVI.
Your paper refers to a gap between current recommendations and current practice regarding the management of patients with aortic stenosis and coronary artery disease. Why is there a “gap”?
In the USA, appropriate use for criteria for PCI states that, when considering performing the procedure, you should use a stress test in patients with angina that is not controlled despite optimal medical therapy. However, a stress test is usually contraindicated in patients with aortic stenosis. Furthermore, several of the medications used for coronary artery disease may negatively affect the aortic stenosis. So in patients with aortic stenosis, you cannot do a stress test or treat them medically.
Another issue is that, based on data from the original TAVI trials, the Centers for Medicare & Medicaid Services (CMS) stipulate that TAVI cannot be performed in patients with untreated coronary artery disease. They say revascularisation should be performed at least month prior to TAVI. Additionally, the American Heart Association (AHA)/American College of Cardiology (ACC) revascularisation guidelines are little stuck in the past because they refer to a time when only surgical valve replacement was possible and angioplasty was contraindicated because the patient needed surgery anyway.
For these reasons, we believe that there should be an exception made for certain patients with aortic stenosis and coronary artery disease, so that they can undergo PCI prior to TAVI.
Why do you think, according to the paper, guidelines have been “silent” about the use of PCI in TAVI candidates?
They have been silent because the level of evidence that is usually required to develop a guideline is not available; there normally has to be randomised controlled trials but none have been performed.
I do not think that randomised controlled trials will ever be performed to answer this question because in aortic stenosis, medications for coronary artery disease and stress testing are contraindicated. Moreover, CMS states that TAVI cannot be performed in patients with coronary artery disease.
Why does your paper recommend that TAVI is performed prior to TAVI rather than afterwards?
The problem is that once you put in an aortic valve device, you change the access to the coronary arteries. Therefore if you perform TAVI first, you may not be able to perform angioplasty afterwards. Another problem is that if you perform TAVI first and you have a complication, the patient may develop severe haemodynamic instability.
Furthermore, sometimes when a patient presents with chest pain, you are not always sure if the coronary artery disease or the aortic stenosis is the main cause. Performing PCI may alleviate their chest pain to the extent that they no longer need to undergo TAVI. This is a good solution for these patients because, if they are inoperable, they will be older and much sicker—the less you can do to resolve their symptoms (with PCI being less invasive than TAVI), the better.
In your view, which patients are suitable candidates for PCI prior to TAVI?
We have created a whole algorithm, which recommends that PCI should only be performed in patients with substantial coronary artery disease in the large epicardial arteries. We do not advise that PCI be performed in patients with lesions in small branches and or the distal vessels.
If PCI is to be performed prior to TAVI, what should the duration of dual antiplatelet therapy (DAPT) be?
We go into this in some detail in the paper. Basically, duration of DAPT should be tailored to the individual risks of the patient. But with current drug-eluting stents, therapy can stopped after three to six months. If you can use a bare metal stent, which would allow you to stop DAPT after one month, that would be preferred.
Is there any scope for performing PCI in the same setting as TAVI (during the same hospitalisation)
Sometimes there is—for example, you do not think the patient will survive the time between performing PCI and performing TAVI. There is nothing wrong with performing PCI and TAVI at the same time but it is not following CMS guidelines and, therefore, one or both procedures may not be reimbursed.