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IMPORTANCE: Risk stratification strategies in primary prevention of coronary events lack precision.

OBJECTIVE: To determine whether prediction of first coronary events is improved by adding information on coronary atherosclerosis from coronary computed tomography angiography (CCTA) to a model using the pooled cohort equation (PCE) risk score tool and the coronary artery calcification score (CACS).

DESIGN, SETTING, AND PARTICIPANTS: Observational cohort study including individuals aged 50 to 64 years randomly recruited from the general population and examined at 6 university hospitals in Sweden from 2013 to 2018, with a median follow-up of 7.8 years. A sample of 30 154 individuals underwent cardiopulmonary imaging, physical examinations, routine laboratory tests, questionnaires, and/or functional tests. This study included 24 791 individuals without previous cardiovascular disease for whom high-quality CCTA images were available. Events were followed up via registers until September 2024.

EXPOSURES: The information used from the CCTA images was the extent of coronary atherosclerosis (segment involvement score), presence of noncalcified atherosclerosis, and presence of coronary obstructive disease (stenosis ≥50%).

MAIN OUTCOMES AND MEASURES: The outcome was a composite of first occurrence of nonfatal myocardial infarction or death from coronary heart disease.

RESULTS: During follow-up, 304 coronary events occurred. Segment involvement scores of 3 to 4 and greater than 4 and presence of noncalcified atherosclerosis were associated with hazard ratios of 2.71 (95% CI, 1.34-5.44), 5.27 (95% CI, 2.50-11.07), and 1.66 (95% CI, 1.23-2.22), respectively. In a model based on the PCE and CACS, CCTA-derived data improved risk discrimination (C statistic improved from 0.764 to 0.779; P = .004) and risk reclassification (net reclassification improvement of 0.133 [95% CI, 0.031-0.165]), conferred a net correct upward reclassification of 14.2% in those with events and incorrectly classified 1.6% of participants not experiencing an event into a higher-risk category. Because of the low event rate in the cohort, reclassification mainly occurred in the group classified as at low risk (<5%) according to the PCE.

CONCLUSIONS AND RELEVANCE: Information on coronary atherosclerosis from CCTA modestly improved risk prediction beyond traditional risk factors and CACS in identifying individuals at risk of coronary events and in need of primary prevention.

Background: The ORBITA and ORBITA-2 trials have valuable insights into the effects of coronary revascularization in chronic coronary syndrome (CCS). However, uncertainties remain regarding the efficacy of revascularization on symptoms in large real-world populations. To evaluate the efficacy of revascularization, we used dispensed long-acting nitrates as a proxy for the presence of angina.

Methods: The Swedish Coronary Angiography and Angioplasty Registry (SCAAR) was used to identify all patients with CCS and at least one stenosis >= 50% undergoing angiography between the 1st of January 2014 and the 16th of January 2020. Four groups were defined based on treatment strategy: coronary artery bypass graft (CABG) surgery, complete revascularization with percutaneous coronary intervention (PCI), incomplete revascularization with PCI, and no revascularization. As patients in these treatment arms are inherently different, we employed a case-crossover design where each patient served as their own control with data collected during two periods: 1 year before up until angiography and 1-2 years after. This study design inherently controls for time-invariant confounding. The primary outcome was the use of long-acting nitrates defined as a dispensed prescription during the studied periods. Conditional Poisson regression was used to analyse the data.

Findings: For this study, 15,955 patients were eligible. CABG, complete revascularization with PCI, and incomplete revascularization with PCI were associated with a decrease in dispensed prescriptions of long-acting nitrates (from 989/2218 [30.8%] to 156/3207 [4.9%]; risk-ratio (RR): 0.16 [95% confidence interval (CI): 0.13-0.19]), (from 1676/ 7525 [22.3%] to 966/7525 [12.8%]; RR: 0.58 [95% CI: 0.53-0.62]), and (from 601/2180 [27.6%] to 495/2180 [22.7%]; RR: 0.82 [95% CI: 0.73-0.93]), respectively. No difference was observed for no revascularization (from 864/3043 [28.4%] to 856/3043 [28.1%]; RR: 0.99 [95% CI: 0.90-1.09]).

Interpretation: Revascularization reduces the use of long-acting nitrates in patients with CCS, suggesting angina symptom improvement. CABG appears to provide a more significant effect than PCI, with complete PCI demonstrating greater effectiveness than incomplete revascularization.

Funding: This work was supported by The Swedish Heart and Lung Foundation, ALF, Skane University Hospital funds, the Crafoord Foundation and the Swedish Medical Association. Copyright (c) 2025 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

BACKGROUND: Management of severe aortic stenosis (AS) has evolved over the past decade, driven by the widespread adoption of transcatheter aortic valve implantation (TAVI). This study aims to assess trends in procedural volumes, patient characteristics, and outcomes for patients undergoing TAVI or surgical aortic valve replacement (SAVR) in Sweden.

METHODS: This was a descriptive, non-comparative, nationwide cohort study using the SWEDEHEART registry. We included 21,383 patients who underwent TAVI or SAVR between 2013 and 2023 (11,366 TAVI and 10,017 SAVR). Trends in patient characteristics, preoperative risk, complications and mortality were examined.

FINDINGS: TAVI procedures increased from 307 (26.1%, n = 307/1174) in 2013 to 1851 (71.2%, n = 1851/2601) in 2023, while SAVR volumes declined from ∼1000 annually before 2018 to roughly 750 procedures annually. Median age of TAVI patients were 81 (IQR 77, 85) years and 71 (IQR 65, 76) years for SAVR patients. The median EuroSCORE II for TAVI decreased from 5.6 (IQR 3.3, 10.2) to 2.7 (IQR 1.7, 4.6) (p = 0.002), and STS-PROM from 3.3 (IQR 1.9, 4.1) to 1.6 (IQR 1.1, 2.8) (p = 0.0021). Among SAVR patients, EuroSCORE II decreased from 1.5 (IQR 1.0, 2.3) to 1.3 (IQR 0.9, 2.1) (p = 0.022) and STS-PROM from 1.8 (IQR 1.2, 3.0) to 1.6 (IQR 1.1, 2.6) (p = 0.0082). Any in-hospital complications declined significantly for TAVI (29.2%, n = 210/719 to 13.2%, n = 244/1851), while SAVR complication rates increased slightly (18.4%, n = 354/1921 to 18.7%, n = 140/750). In-hospital mortality for TAVI declined from 3.6% (n = 26/719) to 1.0% (n = 18/1851), and 1-year mortality from 11.1% to 6.9% (p = 0.019). SAVR in-hospital all-cause death decreased from 1.6% to 0.4% (n = 3/750) and 5.0% to 2.2% for 1-year mortality (p = 0.013).

INTERPRETATION: TAVI has become the predominant treatment strategy for AS in Sweden expanding access within the treated cohort. Despite this, current 2023 SAVR results demonstrate similar in-hospital complication rates compared to TAVI (18.7% vs 13.2%), but lower in-hospital (0.4% vs 1.0%) and 1-year mortality rates (2.2% vs 6.9%).

FUNDING: This study was supported by ALF and national research funding bodies.

Background

Accurate assessment of mortality, bleeding, and atherothrombotic risk in patients with cancer and acute coronary syndrome could inform novel personalised treatment strategies, but no standardised tools for this purpose exist. We aimed to develop and validate a clinically applicable risk score for mortality, bleeding, and ischaemic events in patients with cancer and acute coronary syndrome.

Methods

In this model development and validation study, we obtained data for 1 017 759 patients who presented with acute coronary syndrome in England, UK (n=815 170; 36 771 with cancer), Sweden (n=194 059; 10 262 with cancer), and Switzerland (n=8530; 203 with cancer) between Jan 1, 2004, and Aug 8, 2023. Machine learning models were developed to predict all-cause mortality, major bleeding events, and ischaemic events, defined as a composite of cardiovascular death, myocardial infarction, and ischaemic stroke, in patients with cancer and acute coronary syndrome from England in a competing risks framework with a prediction horizon of 6 months. Final models (the ONCO-ACS score) were externally validated in geographically distinct held out datasets from the English Midlands, Sweden, and Switzerland.

Findings

Patients with cancer and with acute coronary syndrome were characterised by high rates of mortality (cumulative incidence 27·8% [95% CI 27·3–28·3]), major bleeding (7·3% [7·0–7·5]), and ischaemic events (16·1% [15·7–16·4]) and had a distinct risk profile. The ONCO-ACS score was informed by a single set of variables: tumour type, time since cancer diagnosis, metastatic disease, age, haemoglobin, heart rate, estimated glomerular filtration rate, BMI, Killip class, cardiac arrest, and major bleed within 6 months. Accounting for traditional and cancer-related risk factors, ONCO-ACS showed a time-dependent area under the receiver operating characteristic curve (tAUC) at 6 months of 0·84 (0·83–0·85) for all-cause mortality, 0·70 (0·68–0·73) for major bleeding, and 0·79 (0·78–0·81) for ischaemic events on internal validation. On external validation, ONCO-ACS achieved similar performance for all-cause mortality (tAUC at 6 months 0·84 [0·82–0·85] for the English Midlands, 0·80 [0·79–0·82] for Sweden, and 0·83 [0·76–0·91] for Switzerland), major bleeding events (0·70 [0·67–0·74] for the English Midlands, 0·67 [0·65–0·70] for Sweden, and 0·74 [0·57–0·91] for Switzerland), and ischaemic events (0·76 [0·74–0·78] for the English Midlands, 0·70 [0·69–0·72] for Sweden, and 0·73 [0·61–0·86] for Switzerland). ONCO-ACS was well calibrated and decision curve analyses suggested favourable clinical utility. Applying ONCO-ACS to current guidelines suggests that most patients with cancer and acute coronary syndrome qualify for invasive management and long dual antiplatelet therapy using clopidogrel.

Interpretation

The ONCO-ACS score provides a validated practical tool for predicting mortality, bleeding, and ischaemic risk in patients with cancer and acute coronary syndrome. Combined assessment of competing outcome risks could facilitate balancing treatment benefits and harms.

The level of evidence (LOE) grading system for ESC Clinical Practice Guidelines classifies the quality of the evidence supporting a recommendation. However, the current taxonomy does not fully consider the optimal study design necessary to establish evidence for such recommendations. Therefore, two separate taskforces of clinical and methodological experts were appointed by the Clinical Practice Guidelines Committee, with the first tasked with updating the LOE grading system for therapy and prevention, and the second responsible for developing a LOE grading system for diagnosis and prediction. The updated system for therapy and prevention presented here maintains the three-level grading structure but uses revised definitions. Level of evidence A represents conclusive evidence usually from ≥2 adequately powered randomized controlled trials (RCTs) free from major bias, with substantial evidence against the play of chance when combined in a meta-analysis (e.g. P < .005 for superiority). Additional criteria are specified to define substantial evidence against the play of chance in case of non-inferiority, equivalence, and harm. Level of evidence B is now subdivided into B1 and B2. Level of evidence B1 represents suggestive evidence usually from ≥1 adequately powered RCT free from major bias, or a meta-analysis of such RCTs, with some evidence against the play of chance (e.g. P < .05 for superiority). Level of evidence B2 represents limited evidence from ≥2 adequately powered non-randomized studies with careful control of major sources of bias or from a meta-analysis of small, underpowered RCTs. Level of evidence C represents preliminary evidence from either non-randomized studies without careful control of major sources of bias, a single small, underpowered RCT, or expert consensus.

Background Optimal antithrombotic therapy and its duration, whether triple therapy with dual antiplatelets plus oral anticoagulant (OAC), or dual antithrombotic therapy with an antiplatelet plus OAC, is uncertain for patients with myocardial infarction (MI) and atrial fibrillation (AF).

Methods Patients registered in SWEDEHEART (Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies) for their first MI between 2011 and 2021 with a history or new-onset AF were included (n=26 574). Linkage between SWEDEHEART and Swedish administrative health databases was performed, and pseudonymised data analysed.

Results Over time, OAC use at discharge after MI tripled from 27% in 2011 to 77% in 2021, with direct OACs (DOACs) largely replacing warfarin, predominantly in combination with a single antiplatelet. The strongest factors for initiating OAC therapy were the performance of coronary angiography (OR 1.53 (1.40-1.68)), and percutaneous coronary intervention (OR 1.49 (1.39-1.61)). However, the year of the MI was the most predictive variable associated with OAC initiation, with an OR of 9.31 (7.92-10.95) in 2021 compared with 2011. The clinical factors associated with lower likelihood of OAC initiation were dementia, liver disease, cancer and ST-elevation MI (STEMI) versus non-STEMI.

Conclusions Use of OAC has increased over the years in patients with MI and concurrent AF, primarily driven by the increased adoption of DOACs. Additionally, there has been a shift in antithrombotic combinations, with most patients in recent years receiving DOAC in combination with a single antiplatelet, reflecting the nationwide implementation of recent evidence and guidelines. However, significant variation in antithrombotic therapy strategies remains.

BACKGROUND Hemodynamically obstructive coronary plaques may contain more vulnerable plaque characteristics than nonobstructive lesions. OBJECTIVES The authors aimed to assess whether pressure-wire-based physiologic indices in nonculprit lesions are associated with vulnerable plaque characteristics. METHODS In the PROSPECT II study, patients with recent myocardial infarction underwent coronary angiography and culprit lesion percutaneous coronary intervention plus combined near-infrared spectroscopy and intravascular ultrasound assessment of all 3 coronary arteries. Instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements were performed in intermediate lesions with angiographic stenosis >40%. RESULTS Among 898 patients, 319 angiographically intermediate lesions in 275 patients had matched intravascular ultrasound/near-infrared spectroscopy and FFR/iFR measurements; 96 (30.1%) lesions were physiologically significant (FFR <= 0.80 or iFR <= 0.89) and 223 (69.9%) were not. Physiologically significant lesions, compared with those that were not, more likely had a minimal lumen area <= 4.0 mm(2) (96.9% vs 83.9%), plaque burden >= 70% (92.7% vs 71.3%) and maximum lipid core burden index in any 4 mm segment of the lesion >= 324.7 (57.0% vs 45.4%). By multivariable analysis, lesion location in the left anterior descending artery, small minimal lumen area, and larger plaque burden were independently associated with physiologic significance, whereas maximum lipid core burden index in any 4 mm segment of the lesion was not. CONCLUSIONS In patients with recent myocardial infarction, angiographically intermediate but physiologically significant coronary lesions were more likely to have high-risk vulnerable plaque features compared with nonphysiologically significant stenoses. However, coronary lesions without physiological significance also had a moderate-to-high prevalence of high-risk plaque characteristics, which may explain the residual risk associated with conservative noninterventional management of these lesions.

BACKGROUND AND AIMS: The European Society of Cardiology (ESC) has developed quality indicators (QIs) specifically for evaluating the care and outcomes for patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to evaluate TAVI care in all patients undergoing such procedures in Sweden using the ESC 2023 QIs for TAVI.

METHODS: We used the Swedish Transcatheter Cardiac Intervention Registry to identify all TAVI procedures performed in Swedish centres (n=8) between 2008-2021.

RESULTS: 8524 patients (median 82 years, 52.8% male) were included. In total, 24 (88.8%) of the 27 QIs could be captured from the available registry data. The attainment levels were generally high (median 97.8%, interquartile range [IQR] 91.3-100%) with small variations in attainment levels between centres. The greatest variations were observed in the QIs related to patients undergoing TAVI through transfemoral route (median 90.3%, IQR 85.6-96.9%), and in the proportion undergoing transfemoral TAVI without general anaesthesia (median 87.6%, IQR 57.1-94.4%). In total, 80% of the QIs were associated with one-year all-cause mortality, and 85% with one-year cardiovascular mortality. The QIs with greatest impact on one-year mortality were the absence of coronary obstruction (adjusted HR 0.12; 95% CI 0.07-0.22), in-hospital stroke (adjusted HR 0.25; 95% CI 0.18-0.33) and no new dialysis (adjusted HR 0.25; 95% CI 0.15-0.41).

CONCLUSION: In this study, the majority of the QIs were associated with both all-cause and cardiovascular mortality. Hence, the ESC 2023 QIs for TAVI may serve as a valuable tool for evaluating TAVI care, benchmarking performance, and improving patient outcomes.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly used in patients with bicuspid aortic valve (BAV) stenosis, but there is limited comparative data on balloon-expandable (BEV) versus self-expanding valves (SEV) in this population.

AIM: To compare clinical and hemodynamic outcomes between BEVs and SEVs in patients with BAV stenosis.

METHODS: This observational cohort included all patients who underwent TAVR in Sweden between 2016 and 2022. Exclusion criteria included procedures for pure aortic insufficiency and valve-in-valve interventions. The analysis focused on Evolut, Sapien, Acurate, and Portico/Navitor valve families. A doubly robust approach was applied combining inverse probability of treatment weighting and multivariable regression. Sensitivity analyses were also conducted.

RESULTS: Of 577 patients, 274 (47.5%) received a BEV. The majority in the SEV group received an Evolut valve (62%). The mean EUROSCORE II-predicted mortality risk was 4.1% for BEV and 3.6% for SEV. BEVs were used more in patients with reduced ejection fraction (EF ≤ 40%) and larger aortic annuli. There were no significant differences between groups in periprocedural mortality, all-cause mortality at a median follow-up of 675 days, or device success. However, SEVs had higher technical success (aOR: 2.21, p = 0.006), lower postprocedural gradients (adjusted coefficient: -3.72, p < 0.001), and reduced risk of prosthesis-patient mismatch (aOR: 0.10, p = 0.02). SEVs, though, had a higher incidence of paravalvular leakage (aOR: 7.5, p < 0.01).

CONCLUSION: Both BEVs and SEVs were feasible with similar clinical outcomes in BAV stenosis. SEVs had better hemodynamic outcomes but more paravalvular leakage. Randomized trials are needed to determine the optimal valve choice.