Prof. Roxana Mehran: How to make antiplatelet strategy for patients with high bleeding risk after PCI？

At present, percutaneous coronary intervention (PCI) has become one of the effective methods for the treatment of coronary heart disease. In patients with acute coronary syndrome (ACS), risk factors for bleeding and ischemic events often coexist.Therefore, antiplatelet therapy during PCI perioperative period is particularly important. In the antiplatelet therapy of ACS patients, the balance between bleeding and ischemia has always been a serious challenge in the treatment decision of high-risk patients. At this CIT 2020 online, this journal specially invited Professor Roxana Mehran of Mount Sinai Medical School through the overseas connection to explore antiplatelet therapy strategies for patients with high bleeding risk (HBR) after PCI.

International Circulation: What are the implications of the TWILIGHT and Onyx ONE studies for antithrombotic therapy in PCI patients? Could you share us your opinion?

Prof. Roxana Mehran: I think the TWILIGHT and Onyx ONE studies are important trials to talk about how we can shorten the duration of dual antiplatelet therapy (DAPT). TWILIGHT was the largest prospective randomized study in a double-blind placebo fashion to drop aspirin for the first time in patients undergoing PCI with complex lesions. The study showed that if we choose the patients to whom we want to give aspirin/ticagrelor after PCI, and watch them for three months on that regimen, at the three-month mark they can be evaluated, if compliant and without events (severe bleeding, ischemic events like myocardial infarction, or the need for another revascularization), to continue on with ticagrelor monotherapy. If you do that, you can reduce bleeding events, compared to leaving them on aspirin/ticagrelor for twelve months. You can reduce bleeding and not cause any harm at all. So it seems like a viable option in those patients that I described. In Onyx ONE, the largest randomized study of two-stent platforms in very high bleeding risk patients, they received only one month of dual antiplatelet therapy before going to a single antiplatelet regimen. They showed that these two-stent platforms are safe and effective. The BioFreedom stent had already been shown to be superior to bare metal stents. So bare metal stents are out for high bleeding risk patients, and we can choose the BioFreedom stent or the Onyx stent, and just give one month of DAPT. The stents were similar.

 

International Circulation:What are the evaluation criteria for patients with high bleeding risk (HBR) in the relevant guidelines?

Prof.Roxana Mehran: The guidelines are going to have to be revisited after all of these trials. At the moment, the high bleeding risk patients are those who are on oral anticoagulants, the elderly, anemic patients and so on, but the Academic Research Consortium (ARC) recently put together consensus criteria that we hope everyone will use for high bleeding risk. There are major and minor criteria. Patients need at least one major or two minor criteria to qualify. Interestingly, age >75 is a minor criteria. Not all elderly patients are at high bleeding risk. Hopefully, we can use these criteria to assess high bleeding risk, and then revisit whether they are validated and translatable into real-world patients, and that we are not missing high bleeding risk patients by applying these criteria. This is important.

 

International Circulation: How to formulate antiplatelet strategy for patients with high bleeding risk after PCI?

Prof.Roxana Mehran: It’s a very good question. How do we plan a strategy for patients with high bleeding risk after PCI? Who gets one month? Who gets three months? It is a big question. What we have to do is take into account the ischemic risk, first and foremost, because if there is a high burden of ischemia, that is just as important as the bleeding risk. Making sure to do those evaluations in a good way ensures you will not be rationing therapy in patients who need it for ischemic protection, or exposing patients to undue bleeding risk where there is a lower ischemic burden. It is very important to make those assessments. Have a good conversation with patients. Do good follow-ups to assess the risk of ischemia versus bleeding. Then you can make these important choices. In patients on an oral anticoagulant, there is good evidence that a novel oral anticoagulant is better than the vitamin K antagonists in most cases for stroke protection and reduced bleeding. I also think that when patients undergo PCI, the aspirin can be dropped as soon as possible. That is an important new finding, and hopefully we can get that into the guidelines as well.

International Circulation: When ACS encounters HBR, what impact does it have on emergency PCI strategy? What is the support evidence?

Prof.Roxana Mehran: Emergency PCI is a different story. At that time, we are there to save a patient’s life. Once the procedure is complete and the patient has been saved, then thought needs to go to strategy. In the periprocedural setting, anybody who is a high bleeding risk should undergo radial access. We should not be using glycoprotein IIb/IIIa inhibitors unless needed. These are the kinds of things to take into account with an emergency procedure in an elderly patient who is on an oral anticoagulant with atrial fibrillation, for example. So there are important procedural things that can be done to protect the patient.