Comprehensive imaging-based cardiovascular screening in men aged 65-74 did not significantly reduce all-cause mortality in a new Danish study, although there were strong suggestions of benefit for some cardiovascular parameters in the group as a whole and also for mortality in elderly people younger than 70.
The DANCAVAS study was presented today at the European Society of Cardiology (ESC) Congress 2022 taking place in Barcelona, Spain. It was also simultaneously published online in The New England Journal of Medicine.
“I believe there is something to this study,” said lead investigator Axel Diederichsen, PhD, Odense University Hospital, Odense, Denmark. lecoeur.org | Medscape Cardiology.
“We can reduce all-cause mortality by screening men under 70. It’s amazing, I think. And across the whole group, the composite endpoint of all-cause mortality/MI/stroke was significantly reduced by 7%.
He pointed out that only 63% of the testing group actually attended the tests. “So 63% had to take into account the 100% difference of the screening group, with an endpoint of all-cause mortality. That’s very ambitious. But even so, we were very close to reaching the primary endpoint for all-cause mortality.”
Diederichsen thinks the data could support such cardiovascular screening in men under 70. “In Denmark, I think it would be feasible and our study suggests it would be cost effective compared to cancer screening,” he said.
Noting that Denmark has a relatively healthy population with good routine care, he added: “In other countries where it may be more difficult to access care or where cardiovascular health is not so good , such a screening program would likely have a greater effect.”
The population-based DANCAVAS trial randomly assigned 46,611 Danish men aged 65-74 in a 1:2 ratio to be screened (invited group) or not screened (control group) for diseases subclinical cardiovascular events.
Screening included CT with non-contrast electrocardiography to determine coronary artery calcium score and to detect aneurysms and atrial fibrillation; ankle-arm blood pressure measurements to detect peripheral arterial disease and hypertension; and a blood sample to detect diabetes and high cholesterol. Of the 16,736 men who were invited to the screening group, 10,471 (62.6%) actually attended the screening.
In intention-to-treat analyses, after a median follow-up of 5.6 years, the primary endpoint (all-cause death) occurred in 2106 men (12.6%) in the invited group and 3 915 men (13.1%) in the control group. (relative risk, 0.95; 95% CI, 0.90 – 1.00; P = 0.06).
The risk ratio of stroke in the invited group, compared to the control group, was 0.93 (95% CI, 0.86, 0.99); for IM 0.91 (95% CI, 0.81, 1.03); for aortic dissection, 0.95 (95% CI, 0.61, 1.49); and for aortic rupture, 0.81 (95% CI, 0.49, 1.35).
The post-hoc composite endpoint of all-cause mortality/stroke/MI was reduced by 7%, with a hazard ratio of 0.93 (95% CI 0.89, 0.97).
There were no significant differences between groups in safety outcomes.
Subgroup analysis showed that the primary outcome of all-cause mortality was significantly reduced in men invited to screening aged 65–69 years (RR, 0.89; 95% CI 0.83, 0 .96), with no effect in men aged 70 to 74.
Other results showed that in the group invited to screening, there was a large increase in the use of antiplatelet agents (HR, 3.12) and lipid-lowering agents (HR, 2.54), but no difference in the use of anticoagulants, antihypertensives and drugs for diabetes or in the event of coronary or aortic revascularization.
In terms of cost-effectiveness, the total cost of additional health care was €207 (US$206) per person in the invited group, which included screening, medications, and all doctor and clinic visits. ‘hospital.
The quality-adjusted life year (QALY) gained per person was 0.023, with an incremental cost-effectiveness ratio of €9,075 ($9,043) per QALY across the entire cohort and €3,860 ( $3,846) in men aged 65 to 69.
Diederichsen said those numbers compared favorably to cancer screening, with breast cancer screening having a cost-effectiveness of €22,000 ($21,923) per QALY.
“This study is a step in the right direction,” Diederichsen said. lecoeur.org | Medscape Cardiology. But governments will have to decide if they want to spend public money on this kind of screening. I would like that to happen. We can prove it with this data.”
He said the study also collected data on younger men – aged 60 to 64 – and a small group of women, which have not yet been analysed. “We would like to look at that to help us come up with recommendations,” he added.
Increased medical therapy
Designated discussant of the study at the ESC session, Harriette Van Spall, MD, McMaster University, Hamilton, Canada, praised the DANCAVAS investigators for the trial, which she said was “perfectly implemented. work”.
“It’s the kind of trial that is very difficult to conduct but comes from a lot of research from this remarkable group,” she commented.
Van Spall pointed out that it seemed likely that the benefits of the screening approach were driven by increased use of medical therapy alone (antiplatelet and lipid-lowering drugs). She added that the lack of an active screening comparison group made it unclear whether full CT imaging was more effective than active screening for traditional risk factors or assessment of global cardiovascular risk scores. , and that there was a missed opportunity to screen for and treat smoking in the intervention group.
“Aspects of screening such as a full CT scan might be considered resource-intensive and unfeasible in some healthcare systems. The strength of restricting iliac abdominal aorta screening to an enriched risk group – perhaps smokers cigarettes – could have conserved additional resources,” she suggested.
Given that 37% of the invited group did not attend screening and that at baseline these non-participants had more comorbidities, this may have caused a bias in the intention-to-treat analysis towards the group control, thereby underestimating the benefit of screening. So there is a role for secondary analysis during treatment, she noted.
Van Spall also pointed out that due to the population involved in this study, inferences can only be made for Danish men aged 65-74.
Noting that cardiovascular disease affects everyone, accounting for 24% of deaths among Danish women and 25% of deaths among Danish men, she asked researchers to consider eliminating gender-based eligibility criteria in their next big trial in cardiovascular prevention.
Susanna Price, MD, Royal Brompton Hospital, London, UK, and co-chair of the ESC session at which DANCAVAS was presented, described the study as “really interesting” and useful for planning future screening approaches.
“While the primary endpoint is neutral and the results may not change practice at this time, it should promote consideration of different predefined endpoints in a broader population, including both men and women, to see what would be the best screening interventions,” she commented. lecoeur.org | Medscape Cardiology.
“What’s interesting is that we see huge amounts of money being spent on acute heart patients after an event, but here we are starting to focus on how to prevent cardiovascular morbidity and mortality. This is starting to be the trend in cardiovascular medicine.”
Also commenting for lecoeur.org | Medscape Cardiology, Dipti Itchhaporia, MD, University of California, Irvine, and past president of the American College of Cardiology, said, “This study raises the important question of whether comprehensive cardiovascular screening is necessary, but I don’t think it has fully given the answer, although there seems to be some advantage in the under 70s.”
Itchhaporia questioned whether the 5-year follow-up was long enough to show the true benefit of screening, and she suggested that a different approach with a longer follow-up period might have been better for detecting AF.
The DANCAVAS study was supported by Denmark’s Southern Region, the Danish Heart Foundation and the Danish Independent Research Councils.
European Society of Cardiology (ESC) Congress 2022. Presented August 27, 2022.
N English J med. Published online August 27. Full Text
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