RNA Therapeutics for the Cardiovascular System.

RNA therapeutics hold significant promise in the treatment of cardiovascular diseases. RNAs are biologically diverse and functionally specific and can be used for gain- or loss-of-function purposes. The effectiveness of mRNA-based vaccines in the recent COVID-19 pandemic has undoubtedly proven the benefits of an RNA-based approach. RNA-based therapies are becoming more common as a treatment modality for cardiovascular disease. This is most evident in hypertension where several small interfering RNA-based drugs have proven to be effective in managing high blood pressure in several clinical trials. As befits a rapidly burgeoning field, there is significant interest in other classes of RNA. Revascularization of the infarcted heart through an mRNA drug is under clinical investigation. mRNA technology may provide the platform for the expression of paracrine factors for myocardial protection and regeneration. Emergent technologies on the basis of microRNAs and gene editing are tackling complex diseases in a novel fashion. RNA-based gene editing offers hope of permanent cures for monogenic cardiovascular diseases, and long-term control of complex diseases such as essential hypertension, as well. Likewise, microRNAs are proving effective in regenerating cardiac muscle. The aim of this review is to provide an overview of the current landscape of RNA-based therapies for the treatment of cardiovascular disease. The review describes the large number of RNA molecules that exist with a discussion of the clinical development of each RNA type. In addition, the review also presents a number of avenues for future development.

Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial.

BACKGROUND: Ventricular arrhythmia is an important cause of mortality in patients with ischemic left ventricular dysfunction. Revascularization with coronary artery bypass graft or percutaneous coronary intervention is often recommended for these patients before implantation of a cardiac defibrillator because it is assumed that this may reduce the incidence of fatal and potentially fatal ventricular arrhythmias, although this premise has not been evaluated in a randomized trial to date. METHODS: Patients with severe left ventricular dysfunction, extensive coronary disease, and viable myocardium were randomly assigned to receive either percutaneous coronary intervention (PCI) plus optimal medical and device therapy (OMT) or OMT alone. The composite primary outcome was all-cause death or aborted sudden death (defined as an appropriate implantable cardioverter defibrillator therapy or a resuscitated cardiac arrest) at a minimum of 24 months, analyzed as time to first event on an intention-to-treat basis. Secondary outcomes included cardiovascular death or aborted sudden death, appropriate implantable cardioverter defibrillator (ICD) therapy or sustained ventricular arrhythmia, and number of appropriate ICD therapies. RESULTS: Between August 28, 2013, and March 19, 2020, 700 patients were enrolled across 40 centers in the United Kingdom. A total of 347 patients were assigned to the PCI+OMT group and 353 to the OMT alone group. The mean age of participants was 69 years; 88% were male; 56% had hypertension; 41% had diabetes; and 53% had a clinical history of myocardial infarction. The median left ventricular ejection fraction was 28%; 53.1% had an implantable defibrillator inserted before randomization or during follow-up. All-cause death or aborted sudden death occurred in 144 patients (41.6%) in the PCI group and 142 patients (40.2%) in the OMT group (hazard ratio, 1.03 [95% CI, 0.82-1.30]; P=0.80). There was no between-group difference in the occurrence of any of the secondary outcomes. CONCLUSIONS: PCI was not associated with a reduction in all-cause mortality or aborted sudden death. In patients with ischemic cardiomyopathy, PCI is not beneficial solely for the purpose of reducing potentially fatal ventricular arrhythmias. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01920048.

Stent-specific fat attenuation index is associated with target vessel revascularization after PCI.

OBJECTIVES: To explore the clinical relevance of stent-specific perivascular fat attenuation index (FAI) in patients with stent implantation. METHODS: A total of 162 consecutive patients who underwent coronary computed tomography angiography (CCTA) following stent implantation were retrospectively included. The stent-specific FAI at 2 cm adjacent to the stent edge was calculated. The endpoints were defined as target vessel revascularization (TVR) on the stented vessel after CCTA and readmission times due to chest pain after stent implantation. Binary logistic regression analysis for TVR and ordinal regression models were conducted to identify readmission times (0, 1, and ≥ 2) with generalized estimating equations on a per-stent basis. RESULTS: On a per-stent basis, 9 stents (4.5%) experienced TVR after PCI at a median 30 months' follow-up duration. Stent-specific FAI differed significantly among subgroups of patients with stent implantation and different readmission times (p = 0.002); patients with at least one readmission had higher stent-specific FAI than those without readmission (p < 0.001). Bifurcated stents (odds ratio [OR]: 11.192, p = 0.001) and stent-specific FAI (OR: 1.189, p = 0.04) were independently associated with TVR. With no readmission as a reference, stent-specific FAI (OR: 0.984, p = 0.007) was an independent predictor for hospital readmission times ≥ 2 (p = 0.003). CONCLUSION: Non-invasive stent-specific FAI derived from CCTA was found to be associated with TVR, which was a promising imaging marker for functional assessment in patients who underwent stent implantation. CLINICAL RELEVANCE STATEMENT: Noninvasive fat attenuation index adjacent to the stents edge derived from CCTA, an imaging marker reflecting the presence of inflammation acting on the neointimal tissue at the sites of coronary stenting, might be relevant clinically with target vessel revascularization. KEY POINTS: • Non-invasive stent-specific FAI derived from CCTA was associated with TVR (OR: 1.189 [95% CI: 1.007-1.043], p = 0.04) in patients who underwent stent implantation. • Stent-specific FAI significantly differed among a subgroup of patients with chest pain after stent implantation and with different readmission times (p = 0.002); the patients with at least one readmission had higher stent-specific FAI than those without readmission (p < 0.001). • Non-invasive stent-specific FAI derived from CCTA could be used as an imaging maker for the functional assessment of patients following stent implantation.

Autoimmune blistering disorders and cardiovascular risks: A population-based cohort study.

BACKGROUND: Autoimmune blistering disorders (ABDs) might elevate cardiovascular risk, but studies are lacking. OBJECTIVE: The objective of this study was to examine if ABDs elevate the risk of atherosclerotic cardiovascular disease, heart failure, arrhythmia, venous thromboembolism, and cardiovascular death. METHODS: A population-based cohort of Danish patients with ABD (≥18 years of age) diagnosed during 1996-2021 (n = 3322) was compared with an age- and sex-matched comparison cohort from the general population (n = 33,195). RESULTS: Compared with the general population, patients with ABDs had higher 1-year risks of atherosclerotic cardiovascular disease (3.4% vs 1.6%), heart failure (1.9% vs 0.7%), arrhythmia (3.8% vs 1.3%), venous thromboembolism (1.9% vs 0.3%), and cardiovascular death (3.3% vs 0.9%). The elevated risk persisted after 10 years for all outcomes but arrhythmia. The hazard ratios associating ABDs with the outcomes during the entire follow-up were 1.24 (1.09-1.40) for atherosclerotic cardiovascular disease, 1.48 (1.24-1.77) for heart failure, 1.16 (1.02-1.32) for arrhythmia, 1.87 (1.50-2.34) for venous thromboembolism, and 2.01 (1.76-2.29) for cardiovascular death. The elevated cardiovascular risk was observed for both pemphigus and pemphigoid. LIMITATIONS: Our findings might only generalize to patients with ABDs without prevalent cardiovascular diseases. CONCLUSION: Patients with ABDs had an elevated cardiovascular risk compared with age- and sex-matched controls.

Performance of machine learning-based coronary computed tomography angiography for selecting revascularization candidates.

BACKGROUND: Limited studies have investigated the accuracy of therapeutic decision-making using machine learning-based coronary computed tomography angiography (ML-CCTA) compared with CCTA. PURPOSE: To investigate the performance of ML-CCTA for therapeutic decision compared with CCTA. MATERIAL AND METHODS: The study population consisted of 322 consecutive patients with stable coronary artery disease. The SYNTAX score was calculated with an online calculator based on ML-CCTA results. Therapeutic decision-making was determined by ML-CCTA results and the ML-CCTA-based SYNTAX score. The therapeutic strategy and the appropriate revascularization procedure were selected using ML-CCTA, CCTA, and invasive coronary angiography (ICA) independently. RESULTS: The sensitivity, specificity, positive predictive value, negative predictive value, accuracy of ML-CCTA and CCTA for selecting revascularization candidates were 87.01%, 96.43%, 95.71%, 89.01%, 91.93%, and 85.71%, 87.50%, 86.27%, 86.98%, 86.65%, respectively, using ICA as the standard reference. The area under the receiver operating characteristic curve (AUC) of ML-CCTA for selecting revascularization candidates was significantly higher than CCTA (0.917 vs. 0.866, P = 0.016). Subgroup analysis showed the AUC of ML-CCTA for selecting percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) candidates was significantly higher than CCTA (0.883 vs. 0.777, P < 0.001, 0.912 vs. 0.826, P = 0.003, respectively). CONCLUSION: ML-CCTA could distinguish between patients who need revascularization and those who do not. In addition, ML-CCTA showed a slightly superior to CCTA in making an appropriate decision for patients and selecting a suitable revascularization strategy.

Systematic Review of Literature Citing the ISCHEMIA Trial.

PURPOSE OF REVIEW: Optimal therapy for patients with chronic coronary artery disease (CCD) has long been a topic under investigation and a subject of debate. Seeking to clarify appropriate management, the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial compared medical management versus coronary angiography for patients with stable ischemic heart disease. Its reception in the medical community has been met with both acclaim and criticism. In light of such disparate views of this trial, a systematic review of the literature citing the ISCHEMIA trial was performed. RECENT FINDINGS: All articles citing the ISCHEMIA trial on PubMed as of July 21, 2023, were compiled and underwent qualitative analysis. A total of 430 articles were evaluated; 109 (25.3%) did not offer substantial commentary on ISCHEMIA and cite it as background evidence for further study. Of the commentary articles, the majority (224, 52.1%) gave balanced, honest appraisals of the ISCHEMIA trial. A total of 46 (10.7%) strongly praised the trial while another 39 (9.1%) were strongly critical of the results. Almost three-quarters of the literature citing the ISCHEMIA trial was commentary in nature, with roughly equal distribution across the spectrum of praise and criticism. Despite being one of the largest studies on CCD and coronary revascularization ever conducted, the impact of ISCHEMIA on the cardiology community appears to be mixed.

2022 Joint ESC/EACTS review of the 2018 guideline recommendations on the revascularization of left main coronary artery disease in patients at low surgical risk and anatomy suitable for PCI or CABG.

In October 2021, the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) jointly agreed to establish a Task Force (TF) to review recommendations of the 2018 ESC/EACTS Guidelines on myocardial revascularization as they apply to patients with left main (LM) disease with low-to-intermediate SYNTAX score (0-32). This followed the withdrawal of support by the EACTS in 2019 for the recommendations about the management of LM disease of the previous guideline. The TF was asked to review all new relevant data since the 2018 guidelines including updated aggregated data from the four randomized trials comparing percutaneous coronary intervention (PCI) with drug-eluting stents vs. coronary artery bypass grafting (CABG) in patients with LM disease. This document represents a summary of the work of the TF; suggested updated recommendations for the choice of revascularization modality in patients undergoing myocardial revascularization for LM disease are included. In stable patients with an indication for revascularization for LM disease, with coronary anatomy suitable for both procedures and a low predicted surgical mortality, the TF concludes that both treatment options are clinically reasonable based on patient preference, available expertise, and local operator volumes. The suggested recommendations for revascularization with CABG are Class I, Level of Evidence A. The recommendations for PCI are Class IIa, Level of Evidence A. The TF recognized several important gaps in knowledge related to revascularization in patients with LM disease and recognizes that aggregated data from the four randomized trials were still only large enough to exclude large differences in mortality.

Postoperative Pain Management in Coronary Artery Bypass Grafting: An Integrative Review.

PURPOSE: To identify pharmacological and nonpharmacological interventions adopted for pain relief in the postoperative period of coronary artery bypass graft surgery. DESIGN: Integrative review. METHODS: Studies published in English, Spanish, and Portuguese from January 2010 to December 2019 in Cumulative Index to Nursing and Allied Health Literature (CINAHL), Latin American and Caribbean Literature on Health Science, PubMed, and Web of Science. Two hundred studies were identified and eleven were included. Methodological analysis was performed using the Medical Education Research Study Quality Instrument. FINDINGS: The studies found were organized into three thematic categories: pharmacological interventions (methadone, morphine, lidocaine gel, remifentanil, sufentanil, and nefopam), nonpharmacological interventions (low-level laser therapy, light-emitting diode, Class IV laser, and transcutaneous nerve stimulation) and anesthetic techniques (dexmedetomidine, ultrasound-guided pectoral nerve block, high thoracic epidural analgesia, and perioperative parasternal block with levobupivacaine). CONCLUSIONS: A greater tendency to use drug strategies for postoperative pain relief was identified. The drugs used demonstrated efficacy and safety in the treatment of pain, with the exception of nefopam, which showed little benefit in this population. Nonpharmacological interventions, used as adjuvants to drug treatment, were shown to be safe, effective, and well tolerated by the patients.

[Functional status of patients after myocardial revascularization combined with chronic low back pain at the sanatorium-resort stage of medical rehabilitation]. / Funktsional'nyi status patsientov posle revaskulyarizatsii miokarda v sochetanii s khronicheskoi bol'yu v nizhnei chasti spiny na sanatorno-kurortnom etape meditsinskoi reabilitatsii.

Chronic ischemic heart disease (CIHD) is the leading cause of morbidity and mortality, increasing in proportion to the growth of the older population. Rehabilitative measures in patients who have undergone the myocardial revascularization, with back pain currently have insufficient evidence base. The differentiated program of medical rehabilitation (MR) at the stage of sanatorium-resort treatment is not regulated. A description of the comorbid patients' functional status will create a differentiated system of individual rehabilitation program set up. OBJECTIVE: To develop an algorithm for assessing the functional status of patients after myocardial revascularization with chronic low back pain. MATERIAL AND METHODS: The single-center cross-sectional cohort study (September 2021 - May 2022 yrs) included 50 patients after a myocardial revascularization with chronic low back pain (36 women, 14 men; median age 63.5 [55.5; 67.5] years), who were the study group and 10 patients with CIHD (5 women, 5 men; median age 65.0 [62.0; 68.0] years) who joined the control group. All patients underwent clinical (neurological and therapeutic examination), functional (clinical tests, echocardiography) and laboratory (general and biochemical blood analysis, blood cytokine levels) investigations, the functional class of impairment was defined. RESULTS: There are 4 groups with combined pain syndrome (cardiogenic and vertebrogenic) in different ratios due to different functional and laboratory status among patients after the myocardial revascularization with chronic back pain. The presence of cardiogenic pain syndrome was associated with an increase in leukocyte and peripheral blood glucose levels, interleukin-6, myocardial mass enlargement, while vertebrogenic pain syndrome correlated with personal anxiety. CONCLUSION: The evaluation of the functional status of patients according to the degree of severity of cardiogenic and vertebrogenic pain syndrome has revealed a simple method of pathogenetically based differentiation selection for individual rehabilitation program of patient development.

Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA.

BACKGROUND: ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy. METHODS: In 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index). RESULTS: Median age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2-2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (95% CI, 1.6-5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI, 0.2-6.1), Angina Frequency 3.2 points (95% CI, 1.2-5.1), Quality of Life/Health Perceptions 5.3 points (95% CI, 2.8-7.8). For the Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index scores were higher for INV (3.2 points [95% CI, 0.6-5.7]), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5%-12.8%) and was unaffected by treatment assignment. CONCLUSIONS: In the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01471522.

2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use. METHODS: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline.

The Association of Serum Immunoglobulins with Risk of Cardiovascular Disease and Mortality: the Rotterdam Study.

PURPOSE: Inflammation is implicated in cardiovascular disease (CVD), but the association of total serum immunoglobulin (Ig) A, G, and M with CVD across the whole spectrum of atherosclerosis in community-dwelling elderly is unknown. METHODS: This study was embedded in the Rotterdam Study, an ongoing population-based cohort study. We performed Cox regression for the associations of Igs with incident atherosclerotic CVD (ACVD; composite of myocardial infarction, revascularization, and stroke), cardiovascular mortality, and all-cause mortality, and multinomial logistic regression for the association between Igs and coronary artery calcification (CAC) scores. We adjusted for age, sex, lifestyle, and cardiovascular risk factors and presented results per standard deviation increase. RESULTS: We included 8767 participants (median age 62.2 years, 57% women). Higher IgG was associated with an increased ACVD risk (hazard ratio [HR]: 1.08; 95% confidence interval [95% CI]: 1.01-1.15). Higher IgA and IgG were associated with an increased cardiovascular mortality risk, mainly within Ig reference ranges, and with an increased all-cause mortality risk, although less marked. Higher IgA was associated with severe atherosclerosis, i.e., CAC score > 400 (odds ratio: 1.29; 95% CI: 1.03-1.62), while for higher IgG a trend was seen with severe atherosclerosis. CONCLUSION: In middle-aged and older individuals from the general population, higher serum IgA and IgG, but not IgM, are associated with CVD, cardiovascular mortality, and severe atherosclerosis, particularly within Ig reference ranges and independent of serum C-reactive protein. Future studies are needed to elucidate potential causality of the reported associations.

Myocardial revascularization failure among patients requiring cardiac catheterization and secondary revascularization in contemporary clinical practice: Results of the REVASEC multicenter registry.

BACKGROUND: Myocardial revascularization failure (MRF) and Secondary revascularization (SR) are contemporary interventional cardiology challenges. AIM: To investigate the characteristics, management, and prognosis of patients with myocardial revascularization failure (MRF) and need for secondary revascularization (SR) in contemporary practice. METHODS: The REVASEC study is a prospective registry (NCT03349385), which recruited patients with prior revascularization referred for coronary angiography at 19 centers. The primary endpoint is a patient-oriented composite (POCE) at 1 year, including death, myocardial infarction, or repeat revascularization. RESULTS: A total of 869 patients previously revascularized by percutaneous intervention (83%) or surgery (17%) were recruited. MRF was found in 83.7% (41.1% stent/graft failure, 32.1% progression of coronary disease, and 10.5% residual disease). SR was performed in 70.1%, preferably by percutaneous intervention (95%). The POCE rate at 1 year was 14% in the overall cohort, with 6.4% all-cause death. In the multivariate analysis, lower POCE rates were found in the groups without MRF (9.4%) and with disease progression (11%) compared with graft/stent failure (17%) and residual disease (18%), hazard ratio 0.67 (95% confidence interval: 0.45-0.99), p = 0.043. At 1 year, the SR group had less chronic persistent angina (19% vs. 34%, p < 0.001), but a higher rate of repeat revascularization (9% vs. 2.9%, p < 0.001). CONCLUSION: MRF was found in 84% of patients with prior revascularization referred for coronary angiography. Stent/graft failure and residual coronary disease were associated with a worse prognosis. SR provided better symptom control at the expense of a higher rate of new revascularization.

Coronary Artery Bypass Surgery: Comparing the Long-Term Impact of Total Arterial Grafting With Multiarterial Plus Saphenous Vein Grafting.

INTRODUCTION: This study aimed to compare the long-term outcomes in a propensity matched population receiving total arterial grafting (TAG) and multiple arterial grafts (MAG) in addition to saphenous vein graft (SVG) following multivessel coronary artery bypass grafting requiring at least three distal anastomoses. METHODS: In this retrospective study, 655 patients from two centers met the inclusion criteria and were divided into two groups: TAG group (n = 231) and MAG + SVG group (n = 424). Propensity score matching was performed resulting in 231 pairs. RESULTS: No significant differences were observed between both groups in terms of early outcomes. Survival probabilities at 5, 10, and 15 y were 89.1% versus 94.2%, 76.2% versus 76.1%, and 66.7% versus 69.8% in the TAG and MAG + SVG groups, respectively (hazard ratio stratified on matched pairs: 0.90; 95% confidence interval [0.45-1.77]; P = 0.754). Freedom from major adverse cardiac and cerebral events (MACCE) in the matched cohort did not show any significant difference between both groups. Probabilities at 5, 10, and 15 y were 82.7% versus 85.6%, 62.2% versus 75.3%, and 48.8% versus 59.5% in the TAG and MAG + SVG groups, respectively (hazard ratio stratified on matched pairs: 1.12; 95% confidence interval [0.65-1.92]; P = 0.679). Subgroup analyses of the matched cohort showed no significant difference between TAR with three arterial conduits compared to TAR with two arterial conduits with sequential grafting and MAG + SVG in terms of long-term survival and freedom from MACCE. CONCLUSIONS: Multiple arterial revascularizations in addition to SVG may yield comparable long-term outcomes in terms of survival and freedom from MACCE compared to total arterial revascularization.

Patient's learning needs and self-efficacy level after percutaneous coronary intervention: A descriptive study.

AIMS AND OBJECTIVES: Identify and compare learning needs, levels of self-efficacy and their association among inpatients and outpatients of a cardiac care unit with coronary heart disease who have undergone percutaneous coronary intervention (PCI) in a Swiss university hospital. BACKGROUND: After primary PCI, 42% of patients will suffer a recurrent ischemic cardiovascular event. Although adherence to therapeutic regimen contributes to prevent recurrence, patient adherence remains low. To strengthen it, learning needs and self-efficacy must be considered when developing effective therapeutic patient education (TPE). METHODS: Learning needs and self-efficacy were assessed using the Cardiac Patient Learning Needs Inventory (CPLNI) and the Cardiac Self-Efficacy Scale among inpatients and outpatients. The STROBE checklist for cross-sectional studies was used in reporting this study. RESULTS: Ninety-three patients participated in the study with a participation rate of 73.9%. The CPLNI median total score was significantly higher in inpatients than in outpatients: 4.23 (3.82, 4.64) versus 3.67 (3.33, 4.09), p < .001. In both units, participants declared that the most important need was related to 'anatomy and physiology' of the heart. Despite the high score, the least important need was about 'physical activity' for inpatients and 'miscellaneous information' for outpatients. No statistically significant differences were found among patients from both units regarding their self-efficacy level. CONCLUSIONS: This study shows that after PCI, patients have high learning needs and moderate levels of self-efficacy that require addressing. RELEVANCE TO CLINICAL PRACTICE: Patient's individual learning needs and self-efficacy level must be assessed prior/after PCI. A tailored TPE that considers individual learning needs and self-efficacy is recommended as a preventative measure to reduce recurrent ischemic cardiovascular events. Nurses can play a key role in this process. NO PATIENT OR PUBLIC CONTRIBUTION: For feasibility reasons, patients and public were not involved in the design, conduct, reporting or dissemination plans of this research.

Coronary artery lesions in Takayasu arteritis.

Introduction: Takayasu arteritis (TAK) is a granulomatous inflammation of vessels of large diameter, mainly affecting the aorta and its proximal branches, which is more common in young women. The incidence of coronary artery disease in TAK is unknown and not sufficiently studied. Material and methods: A literature review was performed for the period 2003 to 2023 using a search of the PubMed and Scopus scientific databases. We used the following key words to search the academic journal databases: "Takayasu arteritis", "coronary angiography", "myocardial revascularization", "coronary artery disease", "angina pectoris", and "myocardial infarction". Results: The analysis of studies showed that coronary artery lesions (CAL) in TAK are not uncommon, being identified particularly in children and young individuals. Pathology of the coronary arteries increases the morbidity and mortality of TAK patients. In TAK, the ostia and proximal segments of the coronary arteries are more frequently affected, presenting as stenosis or occlusion with the development of stable coronary artery disease, unstable coronary artery disease, acute myocardial infarction, and sudden death. The diagnosis of TAK and coronary artery pathology is often complicated due to nonspecific manifestations and frequently the absence of symptoms. The treatment of patients with TAK with CAL is challenging and requires both pharmacological therapy and interventional or surgical methods of myocardial revascularization. Conclusions: Takayasu arteritis is a more prevalent cause of CAL development, especially in young patients, than previously believed, and cardiovascular death due to CAL is not rare. Early diagnosis of TAK with CAL, particularly occlusion or hemodynamically significant stenosis, and the prompt initiation of appropriate treatment prevent dangerous complications, reduce mortality, and improve prognosis.

Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses.

BACKGROUND: Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. METHODS: REDUCE-IT (The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial), a multicenter, double-blind, placebo-controlled trial, randomly assigned statin-treated patients with elevated triglycerides (135-499 mg/dL), controlled low-density lipoprotein (41-100 mg/dL), and either established cardiovascular disease or diabetes plus other risk factors to receive icosapent ethyl 4 g/d or placebo. The primary and key secondary composite end points were significantly reduced. Prespecified analyses examined all coronary revascularizations, recurrent revascularizations, and revascularization subtypes. RESULTS: A total of 8179 randomly assigned patients were followed for 4.9 years (median). First revascularizations were reduced to 9.2% (22.5/1000 patient-years) with icosapent ethyl versus 13.3% (33.7/1000 patient-years) with placebo (hazard ratio, 0.66 [95% CI, 0.58-0.76]; P<0.0001; number needed to treat for 4.9 years=24); similar reductions were observed in total (first and subsequent) revascularizations (negative binomial rate ratio, 0.64 [95% CI, 0.56-0.74]; P<0.0001), and across elective, urgent, and emergent revascularizations. Icosapent ethyl significantly reduced percutaneous coronary intervention (hazard ratio, 0.68 [95% CI, 0.59-0.79]; P<0.0001) and coronary artery bypass grafting (hazard ratio, 0.61 [95% CI, 0.45-0.81]; P=0.0005). CONCLUSIONS: Icosapent ethyl reduced the need for first and subsequent coronary revascularizations in statin-treated patients with elevated triglycerides and increased cardiovascular risk. To our knowledge, icosapent ethyl is the first non-low-density lipoprotein-lowering treatment that has been shown to reduce coronary artery bypass grafting in a blinded, randomized trial. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.

Outcomes in the ISCHEMIA Trial Based on Coronary Artery Disease and Ischemia Severity.

BACKGROUND: The ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) postulated that patients with stable coronary artery disease (CAD) and moderate or severe ischemia would benefit from revascularization. We investigated the relationship between severity of CAD and ischemia and trial outcomes, overall and by management strategy. METHODS: In total, 5179 patients with moderate or severe ischemia were randomized to an initial invasive or conservative management strategy. Blinded, core laboratory-interpreted coronary computed tomographic angiography was used to assess anatomic eligibility for randomization. Extent and severity of CAD were classified with the modified Duke Prognostic Index (n=2475, 48%). Ischemia severity was interpreted by independent core laboratories (nuclear, echocardiography, magnetic resonance imaging, exercise tolerance testing, n=5105, 99%). We compared 4-year event rates across subgroups defined by severity of ischemia and CAD. The primary end point for this analysis was all-cause mortality. Secondary end points were myocardial infarction (MI), cardiovascular death or MI, and the trial primary end point (cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest). RESULTS: Relative to mild/no ischemia, neither moderate ischemia nor severe ischemia was associated with increased mortality (moderate ischemia hazard ratio [HR], 0.89 [95% CI, 0.61-1.30]; severe ischemia HR, 0.83 [95% CI, 0.57-1.21]; P=0.33). Nonfatal MI rates increased with worsening ischemia severity (HR for moderate ischemia, 1.20 [95% CI, 0.86-1.69] versus mild/no ischemia; HR for severe ischemia, 1.37 [95% CI, 0.98-1.91]; P=0.04 for trend, P=NS after adjustment for CAD). Increasing CAD severity was associated with death (HR, 2.72 [95% CI, 1.06-6.98]) and MI (HR, 3.78 [95% CI, 1.63-8.78]) for the most versus least severe CAD subgroup. Ischemia severity did not identify a subgroup with treatment benefit on mortality, MI, the trial primary end point, or cardiovascular death or MI. In the most severe CAD subgroup (n=659), the 4-year rate of cardiovascular death or MI was lower in the invasive strategy group (difference, 6.3% [95% CI, 0.2%-12.4%]), but 4-year all-cause mortality was similar. CONCLUSIONS: Ischemia severity was not associated with increased risk after adjustment for CAD severity. More severe CAD was associated with increased risk. Invasive management did not lower all-cause mortality at 4 years in any ischemia or CAD subgroup. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01471522.

Ten-Year All-Cause Death According to Completeness of Revascularization in Patients With Three-Vessel Disease or Left Main Coronary Artery Disease: Insights From the SYNTAX Extended Survival Study.

BACKGROUND: Ten-year all-cause death according to incomplete (IR) versus complete revascularization (CR) has not been fully investigated in patients with 3-vessel disease and left main coronary artery disease undergoing percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). METHODS: The SYNTAX Extended Survival study (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]) evaluated vital status up to 10 years in patients who were originally enrolled in the SYNTAX trial. In the present substudy, outcomes of the CABG CR group were compared with the CABG IR, PCI CR, and PCI IR groups. In addition, in the PCI cohort, the residual SYNTAX score (rSS) was used to quantify the extent of IR and to assess its association with fatal late outcome. The rSS of 0 suggests CR, whereas a rSS>0 identifies the degree of IR. RESULTS: IR was more frequently observed in patients with PCI versus CABG (56.6% versus 36.8%) and more common in those with 3-vessel disease than left main coronary artery disease in both the PCI arm (58.5% versus 53.8%) and the CABG arm (42.8% versus 27.5%). Patients undergoing PCI with CR had no significant difference in 10-year all-cause death compared with those undergoing CABG (22.2% for PCI with CR versus 24.3% for CABG with IR versus 23.8% for CABG with CR). In contrast, those with PCI and IR had a significantly higher risk of all-cause death at 10 years compared with CABG and CR (33.5% versus 23.7%; adjusted hazard ratio, 1.48 [95% CI, 1.15-1.91]). When patients with PCI were stratified according to the rSS, those with a rSS≤8 had no significant difference in all-cause death at 10 years as the other terciles (22.2% for rSS=0 versus 23.9% for rSS>0-4 versus 28.9% for rSS>4-8), whereas a rSS>8 had a significantly higher risk of 10-year all-cause death than those undergoing PCI with CR (50.1% versus 22.2%; adjusted hazard ratio, 3.40 [95% CI, 2.13-5.43]). CONCLUSIONS: IR is common after PCI, and the degree of incompleteness was associated with 10-year mortality. If it is unlikely that complete (or nearly complete; rSS<8) revascularization can be achieved with PCI in patients with 3-vessel disease, CABG should be considered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00114972. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03417050.

Myocardial Infarction in the ISCHEMIA Trial: Impact of Different Definitions on Incidence, Prognosis, and Treatment Comparisons.

BACKGROUND: In the ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy did not significantly reduce rates of cardiovascular events or all-cause mortality in comparison with a conservative strategy in patients with stable ischemic heart disease and moderate/severe myocardial ischemia. The most frequent component of composite cardiovascular end points was myocardial infarction (MI). METHODS: ISCHEMIA prespecified that the primary and major secondary composite end points of the trial be analyzed using 2 MI definitions. For procedural MI, the primary MI definition used creatine kinase-MB as the preferred biomarker, whereas the secondary definition used cardiac troponin. Procedural thresholds were >5 times the upper reference level for percutaneous coronary intervention and >10 times for coronary artery bypass grafting. Procedural MI definitions included (1) a category of elevated biomarker only events with much higher biomarker thresholds, (2) new ST-segment depression of ≥1 mm for the primary and ≥0.5 mm for the secondary definition, and (3) new coronary dissections >National Heart, Lung, and Blood Institute grade 3. We compared MI type, frequency, and prognosis by treatment assignment using both MI definitions. RESULTS: Procedural MIs accounted for 20.1% of all MI events with the primary definition and 40.6% of all MI events with the secondary definition. Four-year MI rates in patients undergoing revascularization were more frequent with the invasive versus conservative strategy using the primary (2.7% versus 1.1%; adjusted hazard ratio [HR], 2.98 [95% CI, 1.87-4.73]) and secondary (8.2% versus 2.0%; adjusted HR, 5.04 [95% CI, 3.64-6.97]) MI definitions. Type 1 MIs were less frequent with the invasive versus conservative strategy using the primary (3.40% versus 6.89%; adjusted HR, 0.53 [95% CI, 0.41-0.69]; P<0.0001) and secondary (3.48% versus 6.89%; adjusted HR, 0.53 [95% CI, 0.41-0.69]; P<0.0001) definitions. The risk of subsequent cardiovascular death was higher after a type 1 MI than after no MI using the primary (adjusted HR, 3.38 [95% CI, 2.03-5.61]; P<0.001) or secondary MI definition (adjusted HR, 3.52 [2.11-5.88]; P<0.001). CONCLUSIONS: In ISCHEMIA, type 1 MI events using the primary and secondary definitions during 5-year follow-up were more frequent with an initial conservative strategy and associated with subsequent cardiovascular death. Procedural MI rates were greater in the invasive strategy and with the use of the secondary MI definition. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.