Indirect impact of the war in Ukraine on primary percutaneous coronary interventions for ST-elevation myocardial infarction in Poland.

INTRODUCTION: The Russian invasion of Ukraine in February 2022 resulted in the displacement of approximately 12.5 million refugees to adjacent countries including Poland, that may have strained healthcare service delivery. OBJECTIVES: Using the ST-elevation myocardial infarction (STEMI) data, we aimed to evaluate whether the Russian invasion of Ukraine has indirectly impacted the delivery of acute cardiovascular care in Poland. PATIENTS AND METHODS: We analyzed all adult patients undergoing percutaneous coronary interventions (PCI) for STEMI across Poland between 25th February 2017 to 24th May 2022. Centers were allocated to regions of <100km and >100km of the Polish-Ukraine border. Mixed effect generalized linear regression models with random effects per hospital were used to explore the associations between the war in Ukraine starting with several outcomes of interest, and whether these associations differed across regions of 100km from the Polish-Ukraine border. RESULTS: A total of 90,115 procedures were included in the analysis. The average number of procedures per-month was similar to predicted volume for centers in the >100km region, while the average number of PCI was higher than expected (by an estimated 15 (11-19)) for the <100km region. There was no difference in adjusted fatality rate or quality of care outcomes pre- vs. during-war in both <100 and >100 km regions, with no evidence of a difference-in-difference across regions. CONCLUSIONS: Following the Russian invasion of Ukraine, there was only a modest and temporary increase in primary PCI predominantly in centers situated within 100km of the border, although no significant impact on in-hospital fatality rate.

Association of myocardial injury with adverse long-term survival among cancer patients.

AIMS: Over time, cardiovascular disease (CVD) deaths increasingly exceed those from malignancy among cancer survivors. However, the association of myocardial injury with long-term survival (beyond three years) in cancer patients has not been previously described. METHODS: The National Health and Nutrition Examination Survey high-sensitivity cardiac troponin (hs-cTn) and morbidities databases (1999-2004) were linked with the latest mortality dataset isolating records were respondents reported cancer diagnosis by a healthcare professional. Myocardial injury was then determined by elevated hs-cTn. RESULTS: 16,225,560 weighted records (1,058 unweighted) were included in this observational study, with myocardial injury identified in 14·2%. Those with myocardial injury had progressively worse survival at 5 (51·6% vs. 89·5%), 10 (28·3% vs. 76·0%), and 15 years (12·6% vs. 61·4%) compared to those without myocardial injury. After adjusting for baseline characteristics, those with myocardial injury had an adjusted hazard ratio (aHR) of 2·10 (95% CI 2·09-2·10, p<0·001) for all-cause mortality, 2·23 (2·22-2·24, p<0·001) for cardiovascular mortality, and 1·59 (95% CI 1·59-1·60, p<0·001) for cancer mortality compared to those without myocardial injury. Among patients with no pre-existing CVD, the hs-cTn I Ortho assay was a strong independent predictor of all cause (aHR 6·29, 95% CI 6·25-6·33, p<0·001), CVD (aHR 11·38, 95% CI 11·23-11·54, p<0·001), and cancer (aHR 5·02, 95% CI 4·96-5·07, p<0·001) mortality. CONCLUSIONS: As a marker for myocardial injury, hs-cTn/s were independently associated with worse long-term survival among cancer patients with a stronger relationship with all-cause, cardiovascular, and cancer mortality using hs-cTn I ortho assay.

We conducted an observational analysis using the Unites States' National Health and Nutrition Examination Survey (NHANES) database to examine the association of myocardial injury, as defined by elevated cardiac biomarkers in the form of four different high sensitivity cardiac troponins, with long-term outcome among cancer survivors. Cancer survivors with myocardial injury had progressively worse survival at 5 (51·6% vs. 89·5%), 10 (28·3% vs. 76·0%), and 15 years (12·6% vs. 61·4%) compared to those without myocardial injury.After adjusting for population characteristics including cancer type, the risk of death from any cause among cancer survivors with myocardial injury were more than double that of those without myocardial injury (adjusted hazard ratio of 2·10 (95% CI 2·09­2·10, p<0·001).

Complex percutaneous coronary intervention in patients unable to undergo coronary artery bypass grafting during the COVID-19 pandemic: insights from the UK-ReVasc Registry.

OBJECTIVES: Cardiac surgery for coronary artery disease was dramatically reduced during the first wave of the COVID-19 pandemic. Many patients with disease ordinarily treated with coronary artery bypass grafting (CABG) instead underwent percutaneous coronary intervention (PCI). We sought to describe 12-month outcomes following PCI in patients who would typically have undergone CABG. METHODS: Between March 1 and July 31, 2020, patients who received revascularization with PCI when CABG would have been the primary choice of revascularization were enrolled in the prospective, multicenter UK-ReVasc Registry. We evaluated the following major adverse cardiovascular events at 12 months: all-cause mortality, myocardial infarction, repeat revascularization, stroke, major bleeding, and stent thrombosis. RESULTS: A total of 215 patients were enrolled across 45 PCI centers in the United Kingdom. Twelve-month follow up data were obtained for 97% of the cases. There were 9 deaths (4.3%), 5 myocardial infarctions (2.4%), 12 repeat revascularizations (5.7%), 1 stroke (0.5%), 3 major bleeds (1.4%), and no cases of stent thrombosis. No difference in the primary endpoint was observed between patients who received complete vs incomplete revascularization (residual SYNTAX score £ 8 vs > 8) (P = .22). CONCLUSIONS: In patients with patterns of coronary disease in whom CABG would have been the primary therapeutic choice outside of the pandemic, PCI was associated with acceptable outcomes at 12 months of follow-up. Contemporary randomized trials that compare PCI to CABG in such patient cohorts may be warranted.

Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the CHIP-BCIS3 Randomized Controlled Trial.

INTRODUCTION: Percutaneous coronary intervention for complex coronary disease is associated with a high risk of cardiogenic shock. This can cause harm and limit the quality of revascularization achieved, especially when left ventricular function is impaired at the outset. Elective percutaneous left ventricular unloading is increasingly used to mitigate adverse events in patients undergoing high-risk percutaneous coronary intervention, but this strategy has fiscal and clinical costs and is not supported by robust evidence. METHODS: CHIP-BCIS3 (Controlled Trial of High-Risk Coronary Intervention With Percutaneous Left Ventricular Unloading) is a prospective, multicenter, open-label randomized controlled trial that aims to determine whether a strategy of elective percutaneous left ventricular unloading is superior to standard care (no planned mechanical circulatory support) in patients undergoing nonemergent high-risk percutaneous coronary intervention. Patients are eligible for recruitment if they have severe left ventricular systolic dysfunction, extensive coronary artery disease, and are due to undergo complex percutaneous coronary intervention (to the left main stem with calcium modification or to a chronic total occlusion with a retrograde approach). Cardiogenic shock and acute ST-segment-elevation myocardial infarction are exclusions. The primary outcome is a hierarchical composite of all-cause death, stroke, spontaneous myocardial infarction, cardiovascular hospitalization, and periprocedural myocardial infarction, analyzed using the win ratio. Secondary outcomes include completeness of revascularization, major bleeding, vascular complications, health economic analyses, and health-related quality of life. A sample size of 250 patients will have in excess of 80% power to detect a hazard ratio of 0.62 at a minimum of 12 months, assuming 150 patients experience an event across all follow-up. CONCLUSIONS: To date, 169 patients have been recruited from 21 National Health Service hospitals in the United Kingdom, with recruitment expected to complete in 2024. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05003817.

Complex High-Risk Percutaneous Coronary Intervention Types, Trends, and Outcomes in Nonsurgical Centres.

BACKGROUND: Limited data are available on complex high-risk percutaneous coronary intervention (CHiP) trends and outcomes in nonsurgical centres (NSCs), particularly in health care systems where most centres are NSCs. METHODS: Using data from a national registry, we studied the characteristics and outcomes of CHiP procedures performed for stable angina from 2006 to 2017 according to the presence or absence of on-site surgical cover. Multivariate regression analyses and propensity score matching were used to determine risks for in-hospital death, major bleeding, and major cardiovascular or cerebral events (MACCE). RESULTS: Out of 134,730 CHiP procedures, 42,433 (31.5%) were performed in NSCs, increasing from 12.5% in 2006 to 42% in 2017. Compared with surgical centres (SCs), patients who had a CHiP procedure undertaken in NSCs were, on average, 2.4 years older and had a greater prevalence of cardiovascular risks. Common CHiP procedures performed in NSCs included poor left ventricular function (41.6%), chronic renal failure (38.8%), and chronic total occlusion percutaneous coronary intervention (31.1%). NSC-based CHiP is associated with lower odds of mortality (adjusted odds ratio [aOR] 0.7, 95% confidence interval [CI] 0.5-0.8) and major bleeding (aOR 0.7, 95% CI 0.6-0.8). In both groups, MACCE odds were similar (aOR 1.0, 95% CI 0.9-1.1). CONCLUSIONS: CHiP numbers have steadily increased in NSCs. NSC patients were older and had a higher prevalence of cardiovascular risks than SC patients. Mortality and major bleeding odds were significantly lower in those cases undertaken in NSCs, although MACCE odds were not different between the groups.

Derivation and validation of a novel functional FFRCT score incorporating the burden of coronary stenosis severity and flow impairment to predict clinical events.

BACKGROUND: A score combining the burden of stenosis severity on coronary computed tomography angiography (CCTA) and flow impairment by fractional flow reserve derived from computed tomography (FFRCT) may be a better predictor of clinical events than either parameter alone. METHODS: The Functional FFRCT Score (FFS) combines CCTA and FFRCT parameters in an allocated point-based system. The feasibility of the FFS was assessed in cohort of 72 stable chest pain patients with matched CCTA and FFRCT datasets. Validation was performed using 2 cohorts: (a) 4468 patients from the ADVANCE Registry to define its association with revascularization and major adverse cardiovascular events (MACE); (b) 212 patients from the FORECAST trial to determine predictors of MACE. RESULTS: The median calculation time for the FFS was 10 (interquartile range 6-17) seconds, with strong intra-operator and inter-operator agreement (Cohen's Kappa 0.89 (±0.37, p â€‹< â€‹0.001) and 0.83 (±0.04, p â€‹< â€‹0.001, respectively). The FFS correlated strongly with both the CT-SYNTAX and the Functional CT-SYNTAX scores (rS â€‹= â€‹0.808 for both, p â€‹< â€‹0.001). In the ADVANCE cohort the FFS had good discriminatory abilities for revascularization with an area under the curve of 0.82, 95 â€‹% confidence interval (CI) 0.81-0.84, p â€‹< â€‹0.001. Patients in the highest FFS tertile had significantly higher rates of revascularization (61 â€‹% vs 5 â€‹%, p â€‹< â€‹0.001) and MACE (1.9 â€‹% vs 0.5 â€‹%, p â€‹= â€‹0.001) compared with the lowest FFS tertile. In the FORECAST cohort the FFS was an independent predictor of MACE at 9-month follow-up (hazard ratio 1.04, 95 â€‹% CI 1.01-1.08, p â€‹< â€‹0.01). CONCLUSION: The FFS is a quick-to-calculate and reproducible score, associated with revascularization and MACE in two distinct populations of stable symptomatic patients.

Very early invasive strategy in higher risk non-ST-elevation acute coronary syndrome: the RAPID NSTEMI trial.

OBJECTIVE: To investigate whether a very early invasive strategy (IS)±revascularisation improves clinical outcomes compared with standard care IS in higher risk patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). METHODS: Multicentre, randomised, controlled, pragmatic strategy trial of higher risk patients with NSTE-ACS, defined by Global Registry of Acute Coronary Events 2.0 score of ≥118, or ≥90 with at least one additional high-risk feature. Participants were randomly assigned to very early IS±revascularisation (<90 min from randomisation) or standard care IS±revascularisation (<72 hours). The primary outcome was a composite of all-cause mortality, new myocardial infarction or hospitalisation for heart failure at 12 months. RESULTS: The trial was discontinued early by the funder due to slow recruitment during the COVID-19 pandemic. 425 patients were randomised, of whom 413 underwent an IS: 204 to very early IS (median time from randomisation: 1.5 hours (IQR: 0.9-2.0)) and 209 to standard care IS (median: 44.0 hours (IQR: 22.9-72.6)). At 12 months, there was no significant difference in the primary outcome between the early IS (5.9%) and standard IS (6.7%) groups (OR 0.93, 95% CI 0.42 to 2.09; p=0.86). The incidence of stroke and major bleeding was similar. The length of hospital stay was reduced with a very early IS (3.9 days (SD 6.5) vs 6.3 days (SD 7.6), p<0.01). CONCLUSIONS: A strategy of very early IS did not improve clinical outcomes compared with a standard care IS in higher risk patients with NSTE-ACS. However, the primary outcome rate was low and the trial was underpowered to detect such a difference. TRIAL REGISTRATION NUMBER: NCT03707314.

Cost-effectiveness of intravascular ultrasound-guided percutaneous intervention in patients with acute coronary syndromes: A UK perspective.

BACKGROUND: Use of intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI) is associated with improved clinical outcomes over angiography alone. Despite this, the adoption of IVUS in clinical practice remains low. AIMS: To examine the cost-effectiveness of IVUS-guided PCI compared to angiography alone in patients with acute coronary syndromes (ACS). METHODS: A one-year decision tree and lifetime Markov model were constructed to compare the cost-effectiveness of IVUS-guided PCI to angiography alone for two hypothetical adult populations consisting of 1,000 individuals: ST-elevation myocardial infarction (STEMI) and unstable angina/ non-ST-elevation myocardial infarction (UA/NSTEMI) patients undergoing drug-eluting stent (DES) implantation. The UK healthcare system perspective was applied using 2019/20 costs. All-cause death, myocardial infarction (MI), repeat PCI, lifetime costs, life expectancy and quality-adjusted life-years (QALYs) were assessed. RESULTS: Over a lifetime horizon, IVUS-guided PCI was cost-effective compared to angiography alone in both populations, yielding an incremental cost-effectiveness ratio of £3,649 and £5,706 per-patient in STEMI and UA/NSTEMI patients, respectively. In the one-year time horizon, the model suggested that IVUS was associated with reductions in mortality, MI and repeat PCI by 51%, 33% and 52% in STEMI and by 50%, 29% and 57% in UA/NSTEMI patients, respectively. Sensitivity analyses demonstrated the robustness of the model with IVUS being 100% cost-effective at a willingness-to-pay (WTP) threshold of £20,000 per QALY-gained. CONCLUSIONS: From a UK healthcare perspective, an IVUS-guided PCI strategy was highly cost-effective over angiography alone amongst ACS patients undergoing DES implantation due to the medium- and long-term reduction in repeat PCI, death, and MI.

A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina.

BACKGROUND: Percutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina. RESULTS: A total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group. CONCLUSIONS: Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.).

The Relationship Between Cardiac Troponin in People Hospitalised for Exacerbation of COPD and Major Adverse Cardiac Events (MACE) and COPD Readmissions.

Background: No single biomarker currently risk stratifies chronic obstructive pulmonary disease (COPD) patients at the time of an exacerbation, though previous studies have suggested that patients with elevated troponin at exacerbation have worse outcomes. This study evaluated the relationship between peak cardiac troponin and subsequent major adverse cardiac events (MACE) including all-cause mortality and COPD hospital readmission, among patients admitted with COPD exacerbation. Methods: Data from five cross-regional hospitals in England were analysed using the National Institute of Health Research Health Informatics Collaborative (NIHR-HIC) acute coronary syndrome database (2008-2017). People hospitalised with a COPD exacerbation were included, and peak troponin levels were standardised relative to the 99th percentile (upper limit of normal). We used Cox Proportional Hazard models adjusting for age, sex, laboratory results and clinical risk factors, and implemented logarithmic transformation (base-10 logarithm). The primary outcome was risk of MACE within 90 days from peak troponin measurement. Secondary outcome was risk of COPD readmission within 90 days from peak troponin measurement. Results: There were 2487 patients included. Of these, 377 (15.2%) patients had a MACE event and 203 (8.2%) were readmitted within 90 days from peak troponin measurement. A total of 1107 (44.5%) patients had an elevated troponin level. Of 1107 patients with elevated troponin at exacerbation, 256 (22.8%) had a MACE event and 101 (9.0%) a COPD readmission within 90 days from peak troponin measurement. Patients with troponin above the upper limit of normal had a higher risk of MACE (adjusted HR 2.20, 95% CI 1.75-2.77) and COPD hospital readmission (adjusted HR 1.37, 95% CI 1.02-1.83) when compared with patients without elevated troponin. Conclusion: An elevated troponin level at the time of COPD exacerbation may be a useful tool for predicting MACE in COPD patients. The relationship between degree of troponin elevation and risk of future events is complex and requires further investigation.

Impact of Social Vulnerability on Diabetes-Related Cardiovascular Mortality in the United States.

Background Social vulnerability impacts the natural history of diabetes as well as cardiovascular disease (CVD). However, there are little data regarding the social vulnerability association with diabetes-related CVD mortality. Methods and Results County-level mortality data (where CVD was the underlying cause of death with diabetes among the multiple causes) extracted from the Centers for Disease Control multiple cause of death (2015-2019) and the 2018 Social Vulnerability Index databases were aggregated into quartiles based on their Social Vulnerability Index ranking from the least (first quartile) to the most vulnerable (fourth quartile). Stratified by demographic groups, the data were analyzed for overall CVD, as well as for ischemic heart disease, hypertensive disease, heart failure, and cerebrovascular disease. In the 5-year study period, 387 139 crude diabetes-related cardiovascular mortality records were identified. The age-adjusted mortality rate for CVD was higher in the fourth quartile compared with the first quartile (relative risk [RR], 1.66 [95% CI, 1.64-1.67]) with an estimated 39 328 excess deaths. Among the youngest age group (<55 years), those with the highest social vulnerability had 2 to 4 times the rate of cardiovascular mortality compared with the first quartile: ischemic heart disease (RR, 2.07 [95% CI, 1.97-2.17]; heart failure (RR, 3.03 [95% CI, 2.62-3.52]); hypertensive disease (RR, 3.79 [95% CI, 3.45-4.17]; and cerebrovascular disease (RR, 4.39 [95% CI, 3.75-5.13]). Conclusions Counties with greater social vulnerability had higher diabetes-related CVD mortality, especially among younger adults. Targeted health policies that are designed to reduce these disparities are warranted.

Is high sensitivity troponin, taken regardless of a clinical indication, associated with 1 year mortality in critical care patients?

The aim of this study was to assess whether high sensitivity troponin (hs-cTnI) is associated with 1 year mortality in critical care (CC). One year mortality data were obtained from NHS Digital for a consecutive cohort of patients admitted to general CC unit (GCCU) and neuroscience CC unit (NCCU) who had hs-cTnI tests performed throughout their CC admission, regardless of whether the test was clinically indicated. Cox proportional hazards were used to estimate the risk of 1-year mortality. A landmark analysis was undertaken to assess whether any relationship at 1 year was driven by mortality within the first 30 days. A total of 1033 consecutive patients were included. At 1 year 254 (24.6%) patients had died. The admission log(10)hs-cTnI concentration in the entire cohort (HR 1.35 (95% CI 1.05-1.75) p = 0.009 with a bootstrap of 1000 samples) was independently associated with 1 year mortality. On landmark analysis the association with 1 year mortality was driven by 30 day mortality. These results indicate that admission hs-cTnI concentration is independently associated with 1 year mortality in CC and this relationship may be driven by differences in mortality at 30 days.

Early computed tomography coronary angiography and preventative treatment in patients with suspected acute coronary syndrome: A secondary analysis of the RAPID-CTCA trial.

BACKGROUND: Computed tomography coronary angiography (CTCA) offers detailed assessment of the presence of coronary atherosclerosis and helps guide patient management. We investigated influences of early CTCA on the subsequent use of preventative treatment in patients with suspected acute coronary syndrome. METHODS: In this secondary analysis of a multicenter randomized controlled trial of early CTCA in intermediate-risk patients with suspected acute coronary syndrome, prescription of aspirin, P2Y12 receptor antagonist, statin, renin-angiotensin system blocker, and beta-blocker therapies from randomization to discharge were compared within then between those randomized to early CTCA or to standard of care only. Effects of CTCA findings on adjustment of these therapies were further examined. RESULTS: In 1,743 patients (874 randomized to early CTCA and 869 to standard of care only), prescription of P2Y12 receptor antagonist, dual antiplatelet, and statin therapies increased more in the early CTCA group (between-group difference: 4.6% [95% confidence interval, 0.3-8.9], 4.5% [95% confidence interval, 0.2-8.7], and 4.3% [95% confidence interval, 0.2-8.5], respectively), whereas prescription of other preventative therapies increased by similar extent in both study groups. Among patients randomized to early CTCA, there were additional increments of preventative treatment in those with obstructive coronary artery disease and higher rates of reductions in antiplatelet and beta-blocker therapies in those with normal coronary arteries. CONCLUSIONS: Prescription patterns of preventative treatment varied during index hospitalization in patients with suspected acute coronary syndrome. Early CTCA facilitated targeted individualization of these therapies based on the extent of coronary artery disease.

'Pill-in-the-pocket' Oral Anticoagulation Guided by Daily Rhythm Monitoring for Stroke Prevention in Patients with AF: A Systematic Review and Meta-analysis.

Aims: In patients with a low AF burden and long periods of sinus rhythm, 'pill-in-the-pocket' oral anticoagulation (OAC) may, taken as needed in response to AF episodes, offer the same thromboembolic protection as continuous, life-long OAC, while reducing bleeding complications at the same time. The purpose of this study is to systematically summarise available evidence pertaining to the feasibility, safety and efficacy of pill-in-the-pocket OAC. Methods: Medline and Embase were searched from inception to July 2022 for studies adopting a pill-in-the-pocket OAC strategy in AF patients guided by daily rhythm monitoring (PROSPERO/CRD42020209564). Outcomes of interest were extracted and event rates per patient-years of follow-up were calculated. A random effects model was used for pooled estimates. Results: Eight studies were included (711 patients). Daily rhythm monitoring was continuous in six studies and intermittent in two (pulse checks or smartphone single-lead electrocardiograms were used). Anticoagulation criteria varied across studies, reflecting the uncertainty regarding the AF burden that warrants anticoagulation. The mean time from AF meeting OAC criteria to its initiation was not reported. Adopting pill-in-the-pocket OAC led to 390 (54.7%) patients stopping OAC, 85 (12.0%) patients taking pill-in-the-pocket OAC and 237 (33.3%) patients remaining on or returning to continuous OAC. Overall, annualised ischaemic stroke and major bleeding rates per patient-year of follow-up were low at 0.005 (95% CI [0.002-0.012]) and 0.024 (95% CI [0.013-0.043]), respectively. Conclusion: Current evidence, although encouraging, is insufficient to inform practice. Additional studies are required to improve our understanding of the relationships between AF burden and thromboembolic risk to help define anticoagulation criteria and appropriate monitoring strategies.

Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected Coronary Artery Disease: The PRECISE Randomized Clinical Trial.

Importance: Trials showing equivalent or better outcomes with initial evaluation using coronary computed tomography angiography (cCTA) compared with stress testing in patients with stable chest pain have informed guidelines but raise questions about overtesting and excess catheterization. Objective: To test a modified initial cCTA strategy designed to improve clinical efficiency vs usual testing (UT). Design, Setting, and Participants: This was a pragmatic randomized clinical trial enrolling participants from December 3, 2018, to May 18, 2021, with a median of 11.8 months of follow-up. Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy (PS) or UT. Interventions: PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care. Main Outcomes and Measures: Outcomes were clinical efficiency (invasive catheterization without obstructive CAD) and safety (death or nonfatal myocardial infarction [MI]) combined into a composite primary end point. Secondary end points included safety components of the primary outcome and medication use. Results: A total of 2103 participants (mean [SD] age, 58.4 [11.5] years; 1056 male [50.2%]) were included in the study, and 422 [20.1%] were classified as minimal risk. The primary end point occurred in 44 of 1057 participants (4.2%) in the PS group and in 118 of 1046 participants (11.3%) in the UT group (hazard ratio [HR], 0.35; 95% CI, 0.25-0.50). Clinical efficiency was higher with PS, with lower rates of catheterization without obstructive disease (27 [2.6%]) vs UT participants (107 [10.2%]; HR, 0.24; 95% CI, 0.16-0.36). The safety composite of death/MI was similar (HR, 1.52; 95% CI, 0.73-3.15). Death occurred in 5 individuals (0.5%) in the PS group vs 7 (0.7%) in the UT group (HR, 0.71; 95% CI, 0.23-2.23), and nonfatal MI occurred in 13 individuals (1.2%) in the PS group vs 5 (0.5%) in the UT group (HR, 2.65; 95% CI, 0.96-7.36). Use of lipid-lowering (450 of 900 [50.0%] vs 365 of 873 [41.8%]) and antiplatelet (321 of 900 [35.7%] vs 237 of 873 [27.1%]) medications at 1 year was higher in the PS group compared with the UT group (both P < .001). Conclusions and Relevance: An initial diagnostic approach to stable chest pain starting with quantitative risk stratification and deferred testing for minimal-risk patients and cCTA with selective FFR-CT in all others increased clinical efficiency relative to UT at 1 year. Additional randomized clinical trials are needed to verify these findings, including safety. Trial Registration: ClinicalTrials.gov Identifier: NCT03702244.

Deferred Testing in Stable Outpatients With Suspected Coronary Artery Disease: A Prespecified Secondary Analysis of the PRECISE Randomized Clinical Trial.

Importance: Guidelines recommend deferral of testing for symptomatic people with suspected coronary artery disease (CAD) and low pretest probability. To our knowledge, no randomized trial has prospectively evaluated such a strategy. Objective: To assess process of care and health outcomes in people identified as minimal risk for CAD when testing is deferred. Design, Setting, and Participants: This randomized, pragmatic effectiveness trial included prespecified subgroup analysis of the PRECISE trial at 65 North American and European sites. Participants identified as minimal risk by the validated PROMISE minimal risk score (PMRS) were included. Intervention: Randomization to a precision strategy using the PMRS to assign those with minimal risk to deferred testing and others to coronary computed tomography angiography with selective computed tomography-derived fractional flow reserve, or to usual testing (stress testing or catheterization with PMRS masked). Randomization was stratified by PMRS risk. Main Outcome: Composite of all-cause death, nonfatal myocardial infarction (MI), or catheterization without obstructive CAD through 12 months. Results: Among 2103 participants, 422 were identified as minimal risk (20%) and randomized to deferred testing (n = 214) or usual testing (n = 208). Mean age (SD) was 46 (8.6) years; 304 were women (72%). During follow-up, 138 of those randomized to deferred testing never had testing (64%), whereas 76 had a downstream test (36%) (at median [IQR] 48 [15-78] days) for worsening (30%), uncontrolled (10%), or new symptoms (6%), or changing clinician preference (19%) or participant preference (10%). Results were normal for 96% of these tests. The primary end point occurred in 2 deferred testing (0.9%) and 13 usual testing participants (6.3%) (hazard ratio, 0.15; 95% CI, 0.03-0.66; P = .01). No death or MI was observed in the deferred testing participants, while 1 noncardiovascular death and 1 MI occurred in the usual testing group. Two participants (0.9%) had catheterizations without obstructive CAD in the deferred testing group and 12 (5.8%) with usual testing (P = .02). At baseline, 70% of participants had frequent angina and there was similar reduction of frequent angina to less than 20% at 12 months in both groups. Conclusion and Relevance: In symptomatic participants with suspected CAD, identification of minimal risk by the PMRS guided a strategy of initially deferred testing. The strategy was safe with no observed adverse outcome events, fewer catheterizations without obstructive CAD, and similar symptom relief compared with usual testing. Trial Registration: ClinicalTrials.gov Identifier: NCT03702244.

Association between troponin level and medium-term mortality in 20 000 hospital patients.

INTRODUCTION: Cardiac troponin (cTn) concentrations above the manufacturer recommended upper limit of normal (ULN) are frequently seen in hospital patients without a clinical presentation consistent with type 1 myocardial infarction, and the significance of this is uncertain. The aim of this study was to assess the relationship between medium-term mortality and cTn concentration in a large consecutive hospital population, regardless of whether there was a clinical indication for performing the test. METHOD: This prospective observational study included 20 000 consecutive in-hospital and outpatient patients who had a blood test for any reason at a large teaching hospital, and in whom a hs-cTnI assay was measured, regardless of the original clinical indication. Mortality was obtained via NHS Digital. RESULTS: A total of 20 000 patients were included in the analysis and 18 282 of these (91.4%) did not have a clinical indication for cardiac troponin I (cTnI) testing. Overall, 2825 (14.1%) patients died at a median of 809 days. The mortality was significantly higher if the cTnI concentration was above the ULN (45.3% vs 12.3% p<0.001 log rank). Multivariable Cox analysis demonstrated that the log10 cTnI concentration was independently associated with mortality (HR 1.76 (95% CI 1.65 to 1.88)). Landmark analysis, excluding deaths within 30 days, showed the relationship between cTnI concentration and mortality persisted. CONCLUSION: In a large, unselected hospital population, in 91.4% of whom there was no clinical indication for testing, cTnI concentration was independently associated with medium-term cardiovascular and non-cardiovascular mortality in the statistical model tested.

Characteristics and Outcomes of Patients Who Underwent Coronary Atherectomy in Centers With and Without On-Site Cardiac Surgery.

We aimed to describe the clinical characteristics and outcomes of patients who underwent atherectomy at the time of percutaneous coronary intervention in centers with on-site surgical centers (SCs) versus nonsurgical centers (NSCs). Patients treated with coronary atherectomy between January 1, 2006, to December 31, 2019, from the British Cardiovascular Society Intervention (BCIS) registry were included. Primary outcomes were in-hospital all-cause mortality and major adverse cardiovascular and cerebrovascular events. A total of 20,833 patients were treated with coronary atherectomy, of which 7,983 (38%) were performed at NSC. The proportion of coronary atherectomies performed in NSC increased from 12.5% in 2006 to 42% in 2019. Compared with patients treated at SC, patients treated in NSC were older (mean age 75.1 ± SD years vs 74.2 ± SD, p <0.001), but had comparable prevalence of hypertension (NSC 73.9% vs SC 72.8%, p = 0.085), diabetes mellitus (NSC 32.2% vs SC 31.6%, p = 0.43) and renal disease (NSC 6.0% vs SC 6.0%, p = 0.99). Intracoronary imaging was used more often in NSC than SC (22.3% vs 19.4%, p <0.001). After adjustment, the odds of in-hospital mortality (odds ratios [OR] 0.76, 95% confidence intervals [CI] 0.50 to 1.16), major adverse cardiovascular and cerebrovascular events (OR 0.80, 95% CI 0.53 to 1.21), emergency coronary artery bypass graft (OR 0.49, 95% CI 0.15 to 1.57), major bleeding (OR 0.67, 95% CI 0.36 to 1.24) and coronary perforation (OR 1.07, 95% CI 0.97 to 1.43) in NSC were comparable with SC. In conclusion, coronary atherectomy in hospitals with off-site surgical cover has become more frequent, with no association with poorer outcomes, compared with hospitals with on-site surgical cover.

Is It Really Safe to Discontinue Antiplatelet Therapy 12 Months After Percutaneous Coronary Intervention in Patients with Atrial Fibrillation?

The prevalence of AF in patients with coronary artery disease is high. The guidelines from many professional groups, including the European Society of Cardiology, American College of Cardiology/American Heart Association and Heart Rhythm Society, recommend a maximum duration of 12 months of combination single antiplatelet and anticoagulation therapy in patients who undergo percutaneous coronary intervention and who have concurrent AF, followed by anticoagulation alone beyond 1 year. However, the evidence that anticoagulation alone without antiplatelet therapy adequately reduces the well-documented attritional risk of stent thrombosis after coronary stent implantation is relatively sparse, particularly given that very late stent thrombosis (>1 year from stent implantation) is the commonest type. By contrast, the elevated risk of bleeding from combined anticoagulation and antiplatelet therapy is clinically important. The aim of this review is to assess the evidence for long-term anticoagulation alone without antiplatelet therapy 1 year post-percutaneous coronary intervention in patients with AF.