Tricuspid valve intervention and intravascular imaging studies among “trials to watch” in 2023

Continued from page 1 that this “incredibly important” study, which is to be presented during a latebreaking trial session on day one of the ACC meeting, may possibly help to “improve and enhance” patient quality of life, as well as benefitting clinical outcomes, if early experience with the device is borne out in a randomised trial setting.

Another eagerly anticipated presentation at ACC 2023 will shed light on the effect of myocardial viability, percutaneous coronary intervention (PCI) and functional recovery as observed in the REVIVEDBCIS2 trial. The first data from the trial were released at the annual congress of the European Society of Cardiology (ESC 2022; 26–29 August, Barcelona, Spain), showing that PCI did not reduce all-cause mortality or heart failure hospitalisation in patients with severe left ventricular dysfunction and extensive coronary artery disease when compared to optimal medical therapy.

Alasnag recalls that the trial results sparked “intense discussions” at ESC 2022 following their initial presentation, and she said it will be “critical to assess the role of myocardial viability in the context of percutaneous revascularisation and functional recovery including clinical outcomes.”

“Teasing out the role of viability will be essential, particularly as we interpret these results in the context of other trials such as the STICH trial,” Alasnag tells Cardiovascular News, referencing the randomised trial comparing coronary artery bypass graft (CABG) surgery to medical therapy in patients with coronary disease and heart failure. Similarly, Mehran says that further findings from REVIVEDBCIS2 randomised clinical trial, will produce “enhanced data” on whether myocardial viability has a role in improving clinical outcomes in patients with heart failure due to coronary artery disease who have been treated with the best medical therapy versus PCI. The issue of myocardial viability is “key” in the context of ischaemic heart disease, said Mehran.

Outside of the ACC meeting, Alasnag identifies the RENOVATECOMPLEX-PCI trial, which is designed to investigate whether PCI under the guidance of intravascular ultrasound (IVUS) or optical coherence tomography (OCT) improves clinical outcomes compared with angiographyguided PCI in patients with complex lesions, as another to watch in 2023.

“This is a prospective, randomised, open label parallel trial where the choice of intravascular imaging devices such as IVUS or OCT are at the operator’s discretion,” explains Alasnag. “Use of intravascular imaging devices is permitted at any step of the PCI (pre-, during, and post-PCI, but intravascular imaging evaluation after in six Chinese hospitals with 1,200 participants enrolled. Subjects are assigned to either the routine clinicallyindicated diagnostic care group or the CTA/CT-FFR care group.

Noting its comparability to recent studies in cardiovascular intervention, Alasnag notes: “[TARGET] would complement results of the previously published FORECAST trial conducted in the UK, where a strategy of FFR-CT compared to usual care of patients with stable chest pain did not lower costs or improve quality-of-life measures.”

Staying in the coronary space, Alasnag highlights the YELLOW III study as one to follow. The study aims to assess the effect of evolocumab on coronary plaque morphology in patients with stable coronary artery disease on maximally tolerated statin therapy. Using multi-modality intravascular imaging, gene expression analysis of peripheral blood mononuclear cells (PBMC) and transcriptomicbased machine learning algorithms, researchers are hoping to uncover the molecular mechanisms responsible for beneficial changes in atherosclerotic lesions of patients treated with evolocumab. This novel study can be ground-breaking in understanding plaque morphology changes in the context of molecular changes in patients treated with PCSK9 inhibitors, Mehran noted.

Valvular heart disease

“Continuing our quest to find less invasive management of patients with severe disease, particularly in ageing populations, is incredibly important,” comments Mehran, pinpointing the significance of trials relating to small aortic annulus.

Mehran is a co-principal investigator in the SMART trial alongside global principal investigator Howard Herman (University of Pennsylvania, Pennsylvania, USA) and co-principal investigator Didier Tchétché (Clinique Pasteur Toulouse, Toulouse, France), which is expected to report results later this year. The trial is investigating safety and performance of the selfexpanding Evolut (Medtronic) versus the balloon-expandable Sapien (Edwards Lifesciences) TAVI systems in patients with a small aortic annulus and symptomatic severe native aortic stenosis.

“A large majority—up to 90% of these patients—as could be associated with small annulus, are women,” Mehran said, concluding the study will be one of the first leading female focused clinical trials.

Anticipating many other trials that are “on the horizon” in 2023, spanning across renal denervation, drug-coated balloons and artificial intelligence (AI), Mehran commented “the field is very bright.” She added: “2023 sparks interest in rebooting clinical trials and forums to reiterate how important evidence-based medicine is to the progression of interventional cardiology.”

“We are moving towards the future. What we have previously learnt and what we are going to learn in 2023, will make a huge impact when treating patients with cardiovascular disease, helping to promote the continued evolution of the interventional cardiology space—to improve health outcomes of our patients in a bigger and better way.” stent implantation will be mandatory.”

With a focus on patients with stable coronary artery disease, Alasnag also pinpointed the TARGET trial, which aims to evaluate whether the availability of computed tomography angiography (CTA) and fractional flow reserve-computed tomography (FFR-CT) might effectively optimise the flow of clinical practice of stable chest pain. This is compared against the conventional clinical pathway in decision making, by avoiding the overuse of invasive procedures, reducing total expenditure and improving outcomes.

The randomised, open label, prospectively designed trial is running

Trials to watch

● TRILUMINATE – Comparing TriClip (Abbott) TEER with medical therapy for patients with severe TR, results from the pivotal trial are eagerly anticipated among structural heart specialists to reinforce interventional options for treating the tricuspid valve.

● REVIVED-BCIS2 – Primary results presented at ESC 2022, showing that PCI did not reduce all-cause mortality or heart failure hospitalisation in patients with severe left ventricular dysfunction, were among the biggest talking points of the year. Investigators follow up in 2023 with the presentation of findings of the effect of myocardial viability and functional recovery on clinical outcomes.

RENOVATE-COMPLEX-PCI

Investigators in Korea hope to offer some answers as to whether PCI under guidance of intravascular imaging devices (IVUS or OCT) improves clinical outcomes compared with angiography-guided PCI in patients with complex lesions.

TARGET – Could the availability of CTA/ CT-FFR procedures avoid the overuse of invasive procedures in evaluating patients with stable chest pain? Over 1,200 patients have been enrolled in the TARGET study in a bid to answer this question.

SMART – This study aims to provide clinical evidence on the performance of self-expanding and balloon-expandable TAVI valves in patients with a small aortic annulus and symptomatic severe native aortic stenosis.