COMMENTARY

EuroPCR 2019 Practice-Changing Highlights – Part 1 

Mamas A. Mamas, BM, BCh, MA, DPhil, FRCP

Disclosures

May 29, 2019

This transcript has been edited for clarity.

Welcome to Medscape UK. My name is Mamas Mamas. I'm Professor of Cardiology at Keele University, and I'm presenting from EuroPCR. We're going to do two videos today, related to some of the key studies that have been presented at the meeting. The first video that we're going to talk about will be related to two important aspects of interventional cardiology practice. First and foremost, related to major bleeding, and particularly in identifying patients at high-risk of bleeding complications. And secondly, in primary PCI [percutaneous cardiovascular interventions].

PCI Complications

Complications of PCI are important. So one of the most important complications being that of major bleeding. Approximately 1 in 12 patients following a PCI will sustain a major bleed, and major bleeding is not benign. Major bleeding results in a threefold increase in the risk of mortality. So it's crucial that we are able to identify patients at high-risk of bleeding complications. Classically, these have been undertaken by a number of different risk scores where patients are scored according to different demographics, different criteria, to give a risk of major bleeding complications.

The Academic Research Consortium has now published a document called the high bleeding risk assessment or high bleeding risk score, and they presented this at this meeting,  EuroPCR. And this is very interesting because they defined high bleeding risk as a BARC (Bleeding Academic Research Consortium) 3 to 5 risk of bleeding greater than 4% in 1 year, or a greater risk of intracranial haemorrhage at 1% at 1 year. They defined a number of criteria that can be used to define high bleeding risk, and these include age greater than 75, anaemia, liver with cirrhosis, active cancer, oral anticoagulation, planned surgery, previous strokes, particularly haemorrhagic strokes, and bleeding diatheses, low platelet counts, and also previous bleeding complications.

And they score these according to major or minor criteria, and to define high bleeding risk staging either require one high bleeding risk major criteria or two minor criteria.

Why is this important? Well, I think it's important for a number of reasons. First and foremost, it's important to personalise the treatments of our patients undergoing PCI. We can definitely reduce the risk of bleeding by using abbreviated dual antiplatelet regimens, or modifying the type of anti-platelet regimen we offer patients. And I think it's also important in the consent process to be able to consent patients for risks and complications, with procedure and bleeding being one of them.

I think that where the challenges lie is that often ischaemic complications and bleeding complications go hand in hand. And so patients at high-risk of bleeding are also at high-risk of ischaemic complications. And so that makes this challenging to treat these patients.

Secondly, I think that a number of other key factors that are important in defining bleeding risk have been missed from this consensus document, and particularly around frailty. We know, that patients that are frail, have a marked increased risk of bleeding. Now, this may be related to how we define that frailty because there's not really an international gold standard agreement for what frailty is, what frailty means, whereas something like age is fairly easy, cut-off binary, you're either less or greater than 75 years old.

And finally, another important aspect is cancer, and they've lumped all the cancers together. But having prostate cancer with no metastases is not associated with increased risk of bleeding from our work, whereas something like colon cancer has a markedly increased risk of bleeding. And so I think, perhaps from the active cancer perspective, greater resolution of other types of cancer would be important.

REVELATION trial

Primary PCI is the gold standard for revascularisation of STEMI [ST-elevation myocardial infarction]. In primary PCI, we use stents, but a recent interesting trial has been presented at EuroPCR. This trial, the REVELATION trial, was a randomised controlled trial of 120 patients randomised to a paclitaxel-eluting balloon versus conventional stent therapy.

The raison d'etre for this trial was that often in young patients that have a STEMI, one is often reluctant to implant stents, particularly if they'll have the stent in place for 30, 40 years. And so there's often a reluctance to do this. And so the idea was whether we can safely, and with great efficacy, use a balloon angioplasty technique in these patients.

So in these 120 patients that were randomised either to paclitaxel or a drug-eluting stent, the endpoint was a safety endpoint at 9 months. What this trial showed was that at 9 months, there was no significant difference in angiographic restenosis rates, and secondarily, there were no significant differences in pressure wire measurements. So the FFR [fractional flow reserve] at 9 months was 0.92 and 0.93 respectively, in the two arms.

So does that mean that we should do away with stents? Does that mean that we should go back to drug-eluting balloons? No. In 20% of the drug-eluting balloon arm, the patients received the stent, there were a small number of abrupt vessel closures that required stents as well. And restenosis isn't well measured by FFR measurements, or angiographic restenosis. So I think it's interesting as a proof of concept study, but I still think that PCI with stents remains the current gold standard.

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