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Gabriel Steg comments on the RHEIA, OCEANIC-AF, ABYSS, SENIOR RITA and HELIOS trials

An update on the results of key studies presented at the European Society of Cardiology congress, with Professor Gabriel Steg.

TRANSCRIPTION

Hello, here is some news from the European Congress of Cardiology (ESC), in London. I am Gabriel Steg, from Bichat Hospital, and I am pleased to share with you a personal selection of some of the most important results that were presented at this congress.

ABYSS: stop or continue with beta-blockers in stable coronary patients?

Discontinuation of beta-blockers did not demonstrate non-inferiority.

Chronologically, on the first day we had the results of the test ABYSS which asked the question: stop or continue with beta-blockers in stable coronary patients, and the answer is quite clear: it seems that stopping beta-blockers is not equivalent to continuing them. And technically, the conclusion of the study is that stopping beta-blockers did not demonstrate non-inferiority compared to continuing beta-blockers. Why? There were not so many fatal events or re-infarctions but there were clearly, significantly, more rehospitalizations for cardiovascular reasons in the group that stopped beta-blockers compared to those who continued them, with symptoms related to a hypertensive surge, tachycardia, angina symptoms or possibly heart failure. So this study does not argue for routinely proposing stopping beta-blockers to the majority of these patients.

This is a slightly different result than what our Swedish colleagues reported with the REDUCE-MI study last year.

OCEANIC-AF: asundexian ineffective against apixaban

Second study, the study OCEANIC OF which is interested in a factor XI inhibitor, asundexian, one of these new anticoagulants which it is hoped will be as effective as conventional anticoagulants, but safer with a reduced risk of bleeding. However, the OCEANIC-AF study, the results of which have been presented and published at the Congress, show that asundexian, one of these 2 anti-factor XI used at a relatively low dose of 50 mg once a day, was not equivalent to apixaban 5 mg twice a day to which it was compared in patients with atrial fibrillation (AF). Certainly, asundexian caused few hemorrhages and less hemorrhages than apixaban, but on the other hand, there was a very clear excess of ischemic events, and in particular cerebral infarction, strokes or systemic embolisms.

So we have the impression that the treatment is not effective. It is safe, but not effective and a number of arguments suggest that this is very likely linked to an insufficient dose, the dose of asundexian that was tested only allowing an inhibition of the order of 90% of the generation of factors XI. And it is likely that to obtain a sufficient clinical anticoagulant effect, it is probably necessary to obtain an inhibition of 95, or even 99% of the generation of factor XI. This raises the question of whether other factor XI inhibitors (such as milvexian) that are currently being tested will be able to show sufficient efficacy. In the trials that are underway, the doses that are used are substantially higher and therefore we can hope to keep the compromise between better safety and maintained efficacy.

RHEIA: TAVI outperformed surgery in women with aortic stenosis

The 3rd test is French, it is about RHEIA which is the first comparison, in women with aortic stenosis, of percutaneous aortic valve replacement by TAVI versus conventional valve surgery. It is a trial on just over 400 patients.

Results: At one year, when we look at the composite between deaths and cardiovascular rehospitalizations, TAVI does better than surgery with a fairly clear and statistically significant reduction which is driven by lower rehospitalizations in the TAVI group than in the surgery group.

SENIOR-RITA: the conservative strategy to favor in elderly subjects after MI

The 4th try is called SENIOR-RITA . This is a British study that looks at an invasive strategy versus a conservative strategy after non-ST elevation infarction in older people ― this trial recruited really old and frail people and in a slightly different way to what has been seen in other trials, such as the FIRE test Italian presented last year. Our British colleagues observed no difference between an invasive and a conservative strategy, suggesting that it is perfectly reasonable to offer these patients a conservative strategy.

HELIOS: a significant hope in transthyretin amyloidosis with cardiomyopathy

Finally, the last trial that I would like to talk about because I think it is an important step forward for patients is the trial HELIOS with vutrisiran (siRNA) which aims to improve the prognosis of patients with ATTR amyloidosis [Transthyretin amyloidosis with cardiomyopathy]This trial showed a net clinical benefit on morbidity and mortality in patients with ATTR amyloidosis.

It’s a additional important hope among all this range of new treatments that are arriving for cardiac amyloidosis in order to improve the prognosis of this formidable disease, which is not as rare as previously thought.

Well, this is a subjective, personal selection, but I hope you found it interesting. Lots of other news on Medscape.fr concerning the results presented at the ESC.

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