February 2024 | Issue 72
Featured in this issue:
www.cardiovascularnews.com
6 Alain Cribier obituary
Remembering the TAVI pioneer
10 Renal denervation Device approvals expand horizons
14 Profile
Ajay Kirtane
19 Cerebral protection
BHF PROTECTTAVI trial update
Trial results “change the orbit” of PCI for stable angina
Jad Malas at STS 2024, picture courtesy of: Dominic Emerson
STS 2024: Data point to shift towards TAVI in patients aged under 60 New data, shared at the annual meeting of the Society of Thoracic Surgeons (STS 2024; 27–29 January, San Antonio, USA), point towards a shift in the proportion of surgery-eligible patients with severe aortic stenosis aged under 60 years receiving a transcatheter procedure.
T
he data, taken from a registry of patients from the US state of California spanning 2013 to 2021, constituted one of several papers presented at the STS meeting to assess changing trends in the treatment of aortic stenosis, weighing up both transcatheter and surgical approaches. Researchers from the Department of Cardiac Surgery in the Smidt Heart Institute at Cedars-Sinai in Los Angeles and the Department of Population Health Science and Policy at Mount Sinai New York compared outcomes for patients undergoing surgery and those undergoing transcatheter aortic valve implantation (TAVI). From a pool of 37,011 patients, the study identified 2,360 patients under the age of 60 years who underwent these
procedures, with 22% receiving TAVI and 78% surgical aortic valve replacement (SAVR). By 2021 almost half of patients younger than 60 years were receiving TAVI rather than SAVR. The research team followed these patients for a median time of 2.4 years after TAVI and 4.9 years after SAVR to assess their outcomes. The primary focus was on five-year survival rates. Secondary outcomes included rates of reoperation, infective endocarditis, stroke, and hospital admissions for heart failure. Propensity score matching ensured a fair comparison of 358 pairs of patients, balancing factors such as age, major health conditions, hospital volume, and urgency. The researchers reported that the 30-day mortality rates were similar (0.2% for SAVR vs. 0.4% for TAVI), but found that the five-year survival rate was better after surgery compared to TAVI (98% vs. 86%, p<0.001). For secondary outcomes, there was no significant difference between the two groups. “While we expected that the volume of transcatheter therapy would increase over the study period in this young patient cohort, we were surprised there appears to be near equipoise in terms of procedure selection, with patients and clinicians opting for procedures against the 2020 guidelines,” said study co-author
We were surprised there appears to be near equipoise in terms of procedure selection, with patients and clinicians opting for procedures against the 2020 guidelines.”
RESULTS OF THE ORBITA-2 trial have, for the first time, provided evidence that percutaneous coronary intervention (PCI) with minimal or no use of antianginal medications reduces symptoms in patients with stable angina. The findings should prompt a change in guidelines regarding the treatment of stable angina, commentators have suggested, with an editorial in the New England Journal of Medicine (NEJM) published in light of the new evidence declaring: “The orbit around PCI for stable angina has been changed.” A predecessor trial—ORBITA— published in 2017, had shown that PCI did not improve exercise tolerance or chest pain any more than a placebo procedure, a finding that had prompted a degree of controversy among proponents of PCI. “However, it is possible that the effect of stenting in ORBITA was diminished by high levels of guideline-directed background, antianginal medication, which are difficult to achieve in clinical practice,” said Rasha AlLamee (Imperial College London and Imperial College Healthcare NHS Trust, London, UK), the chief investigator in both the ORBITA and ORBITA-2 trials. ORBITA-2 enrolled 301 patients with both single and multivessel disease who were randomised either to undergo either PCI or a placebo procedure. Unlike the prior study, patients stopped all antianginal medications and underwent a twoweek symptom assessment phase before randomisation. Throughout the trial, they then reported whether they were experiencing chest pain every day using a dedicated smartphone app. The daily symptom reports and the need for chest pain medication were used to calculate an angina symptom score, the trial’s primary endpoint. Investigators found that patients Continued on page 5
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