Arterial Stiffness and Heart Failure With Preserved Ejection Fraction.

Heart failure with preserved ejection fraction (HFpEF) is prevalent and associated with a poor prognosis, imposing a significant burden on society. Arterial stiffness is increasingly recognized as a crucial factor in the pathophysiology of HFpEF, affecting diagnosis, management, and prognosis. As a hallmark of vascular aging, arterial stiffness contributes to increased afterload on the left ventricle (LV), leading to diastolic dysfunction, a key feature of HFpEF. Elevated arterial stiffness is linked with common cardiovascular risk factors in HFpEF, such as hypertension, diabetes and obesity, exacerbating the progression of disease. Studies have demonstrated that patients with HFpEF exhibit significantly higher levels of arterial stiffness compared to those without HFpEF, highlighting the value of arterial stiffness measurements as both diagnostic and prognostic tools. Moreover, interventions aimed at reducing arterial stiffness, whether through pharmacological therapies or lifestyle modifications, have shown potential in improving LV diastolic function and patient outcomes. Despite these advancements, the precise mechanisms by which arterial stiffness contributes to HFpEF are still not fully understood, necessitating the need for further research.

Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Data are limited regarding the effects of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) in patients with diabetes. Objective: To compare the clinical outcomes of intravascular imaging-guided vs angiography-guided complex PCI in patients with or without diabetes. Design, Setting, and Participants: This prespecified secondary analysis of a subgroup of patients in RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention), an investigator-initiated, open-label multicenter trial, analyzed enrolled patients who underwent complex PCI at 20 sites in Korea from May 2018 through May 2021. Eligible patients were randomly assigned in a 2:1 ratio to undergo either the intravascular imaging-guided PCI or angiography-guided PCI. Data analyses were performed from June 2023 to April 2024. Interventions: Percutaneous coronary intervention was performed either under the guidance of intravascular imaging or angiography alone. Main Outcomes and Measures: The primary end point was target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Results: Among the 1639 patients included in the analysis (mean [SD] age, 65.6 [10.2] years; 1300 males [79.3%]), 617 (37.6%) had diabetes. The incidence of TVF was significantly higher in patients with diabetes than patients without diabetes (hazard ratio [HR], 1.86; 95% CI, 1.33-2.60; P < .001). Among patients without diabetes, the intravascular imaging-guided PCI group had a significantly lower incidence of TVF compared with the angiography-guided PCI group (4.7% vs 12.2%; HR, 0.41 [95% CI, 0.25-0.67]; P < .001). Conversely, in patients with diabetes, the risk of TVF was not significantly different between the 2 groups (12.9% vs 12.3%; HR, 0.97 [95% CI, 0.60-1.57]; P = .90). There was a significant interaction between the use of intravascular imaging and diabetes for the risk of TVF (P for interaction = .02). Among patients with diabetes, only those with good glycemic control (hemoglobin A1c level ≤7.5%) and who achieved stent optimization by intravascular imaging showed a lower risk of future ischemic events (HR, 0.31; 95% CI, 0.12-0.82; P = .02). Conclusions and Relevance: In this secondary analysis of a subgroup of patients in the RENOVATE-COMPLEX-PCI trial, intravascular imaging guidance reduced the risk of TVF compared with angiography guidance in patients without diabetes (but not in patients with diabetes) during complex PCI. In patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging and glycemic control to improve outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872.

The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan Monotherapy.

PURPOSE: This study aimed to evaluate the efficacy and tolerability of irbesartan (IRB) and amlodipine (AML) combination therapy in patients with essential hypertension whose blood pressure (BP) was not controlled by IRB monotherapy. METHODS: Two multicenter, randomized, double-blind, placebo-controlled, phase III studies were conducted in Korea (the I-DUO 301 study and the I-DUO 302 study). After a 4-week run-in period with either 150 mg IRB (I-DUO 301 study) or 300 mg IRB (I-DUO 302 study), patients with uncontrolled BP (ie, mean sitting systolic BP [MSSBP] ≥140 mmHg to <180 mmHg and mean sitting diastolic BP <110 mmHg) were randomized to the placebo, AML 5 mg, or AML 10 mg group. A total of 428 participants were enrolled in the 2 I-DUO studies. In the I-DUO 301 study, 271 participants were randomized in a 1:1:1 ratio to receive either IRB/AML 150/5 mg, IRB/AML 150/10 mg, or IRB 150 mg/placebo. In the I-DUO 302 study, 157 participants were randomized in a 1:1 ratio to receive IRB/AML 300/5 mg or IRB 300 mg/placebo. The primary endpoint was the change in MSSBP from baseline to week 8. Tolerability was assessed according to the development of treatment-emergent adverse events (TEAEs) and clinically significant changes in physical examination, laboratory tests, pulse, and 12-lead electrocardiography. FINDINGS: In I-DUO 301, the mean (SD) changes of MSSBP at week 8 from baseline were -14.78 (12.35) mmHg, -21.47 (12.78) mmHg, and -8.61 (12.19) mmHg in the IRB/AML 150/5 mg, IRB/AML 150/10 mg, and IRB 150 mg/placebo groups, respectively. In I-DUO 302, the mean (SD) changes of MSSBP at week 8 from baseline were -13.30 (12.47) mmHg and -7.19 (15.37) mmHg in the IRB/AML 300/5 mg and IRB 300 mg/placebo groups, respectively. In both studies, all combination groups showed a significantly higher reduction in MSSBP than the IRB monotherapy groups (P < 0.001 for both). TEAEs occurred in 10.00%, 10.99%, and 12.22% of participants in the IRB/AML 150/5 mg, IRB/AML 150/10 mg, and IRB 150 mg/placebo groups, respectively, in I-DUO 301 and in 6.33% and 10.67% of participants in the IRB/AML 300/5 mg and IRB 300 mg/placebo groups, respectively, in I-DUO 302, with no significant between-group differences. Overall, there was one serious adverse event throughout I-DUO study. IMPLICATIONS: The combination of IRB and AML has superior antihypertensive effects compared with IRB alone over an 8-week treatment period, with placebo-like tolerability. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05476354 (I-DUO 301), NCT05475665 (I-DUO 302).

Impact of Intravascular Imaging-Guided Stent Optimization According to Clinical Presentation in Patients Undergoing Complex PCI.

BACKGROUND: It is unclear whether the beneficial effects of intravascular imaging-guided stent optimization vary by clinical presentation during complex percutaneous coronary intervention (PCI). OBJECTIVES: In this prespecified, stratified subgroup analysis from RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex PCI), we sought to compare the outcomes between intravascular imaging vs angiography guidance according to clinical presentation. METHODS: Patients with complex coronary artery lesions were randomly assigned to undergo either intravascular imaging-guided PCI or angiography-guided PCI in a 2:1 ratio. The primary endpoint was target vessel failure (TVF), which is a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. RESULTS: Of 1,639 patients, 832 (50.8%) presented with acute coronary syndrome (ACS) and 807 (49.2%) with chronic coronary syndrome. During a median follow-up of 2.1 years (Q1-Q3: 1.4-3.0 years), there was no significant interaction between the treatment effect of intravascular imaging and clinical presentation (P for interaction = 0.19). Among patients with ACS, the incidences of TVF were 10.4% in the intravascular imaging group and 14.6% in the angiography group (HR: 0.74; 95% CI: 0.48-1.15; P = 0.18). Among patients with CCS, the incidences of TVF were 5.0% in the intravascular imaging group and 10.4% in the angiography group (HR: 0.46; 95% CI: 0.27-0.80; P = 0.006). Achieving stent optimization by intravascular imaging resulted in a reduced risk of TVF among patients with ACS who were randomly assigned to intravascular imaging-guided PCI for complex coronary lesions (optimized vs unoptimized, 6.5% vs 14.1%; HR: 0.49; 95% CI: 0.27-0.87; P = 0.02) but not those with CCS (5.4% vs 4.7%, HR: 1.18; 95% CI: 0.53-2.59; P = 0.69). CONCLUSIONS: No significant interaction was observed between the benefits of intravascular imaging and clinical presentation in the risk of TVF. Stent optimization by intravascular imaging was particularly important for ACS patients. (Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease [RENOVATE]; NCT03381872).

Intravascular Imaging-Guided Optimization of Complex Percutaneous Coronary Intervention by Sex: A Subgroup Analysis of the RENOVATE-COMPLEX-PCI Trial.

Importance: There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions. Objective: To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men. Design, Setting, and Participants: This prespecified substudy evaluates the interaction of sex in the investigator-initiated, open-label, multicenter RENOVATE-COMPLEX-PCI randomized clinical trial, which demonstrated the superiority of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. The trial was conducted at 20 sites in Korea. Patients with complex coronary artery lesions undergoing PCI were enrolled between May 2018 and May 2021, and the median (IQR) follow-up period was 2.1 (1.4-3.0) years. Data were analyzed from December 2022 to December 2023. Interventions: After diagnostic coronary angiography, eligible patients were randomly assigned in a 2:1 ratio to receive intravascular imaging-guided PCI or angiography-guided PCI. The choice and timing of the intravascular imaging device were left to the operators' discretion. Main Outcomes and Measures: The primary end point was target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Secondary end points included individual components of the primary end point. Results: Of 1639 included patients, 339 (20.7%) were women, and the mean (SD) age was 65.6 (10.2) years. There was no difference in the risk of the primary end point between women and men (9.4% vs 8.3%; adjusted hazard ratio [HR], 1.39; 95% CI, 0.89-2.18; P = .15). Intravascular imaging-guided PCI tended to have lower incidence of the primary end point than angiography-guided PCI in both women (5.2% vs 14.5%; adjusted HR, 0.34; 95% CI, 0.15-0.78; P = .01) and men (8.3% vs 11.7%; adjusted HR, 0.72; 95% CI, 0.49-1.05; P = .09) without significant interaction (P for interaction = .86). Conclusions and Relevance: In patients undergoing complex PCI, compared with angiographic guidance, intravascular imaging guidance was associated with similar reduction in the risk of target vessel failure among women and men. The treatment benefit of intravascular imaging-guided PCI showed no significant interaction between treatment strategy and sex. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872.

Evidence-Based Guideline for the Treatment of Smoking Cessation Provided by the National Health Insurance Service in Korea.

Although major countries, such as South Korea, have developed and disseminated national smoking cessation guidelines, these efforts have been limited to developing individual societies or specialized institution-based recommendations. Therefore, evidence-based clinical guidelines are essential for developing smoking cessation interventions and promoting effective smoking cessation treatments. This guideline targets frontline clinical practitioners involved in a smoking cessation treatment support program implemented in 2015 with the support of the National Health Insurance Service. The Guideline Development Group of 10 multidisciplinary smoking cessation experts employed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE)-ADOLOPMENT approach to review recent domestic and international research and guidelines and to determine evidence levels using the GRADE methodology. The guideline panel formulated six strong recommendations and one conditional recommendation regarding pharmacotherapy choices among general and special populations (mental disorders and chronic obstructive lung disease [COPD]). Strong recommendations favor varenicline rather than a nicotine patch or bupropion, using varenicline even if they are not ready to quit, using extended pharmacotherapy (>12 weeks) rather than standard treatment (8-12 weeks), or using pharmacotherapy for individuals with mental disorders or COPD. The conditional recommendation suggests combining varenicline with a nicotine patch instead of using varenicline alone. Aligned with the Korean Society of Medicine's clinical guideline development process, this is South Korea's first domestic smoking cessation treatment guideline that follows standardized guidelines. Primarily focusing on pharmacotherapy, it can serve as a foundation for comprehensive future smoking cessation clinical guidelines, encompassing broader treatment topics beyond medications.

Percutaneous coronary intervention versus medical therapy in stable angina: a matched cohort study.

OBJECTIVE: It is uncertain whether percutaneous coronary intervention (PCI) in addition to optimal medical therapy (OMT) can reduce adverse clinical events in the long term as compared with OMT alone in patients with pure stable angina. METHODS: We enrolled patients from 2006 to 2010 using the Korean national insurance data. 58 742 patients with pure stable angina with no history of myocardial infarction (MI) nor PCI were candidate, and finally, 5673 patients in the PCI plus OMT group and 5673 in the OMT alone group were selected with 1:1 propensity matching. They were followed up for 9.3 years. RESULTS: Primary endpoint, a composite of MI, stroke and cardiac death rate was significantly higher in the PCI group than in the OMT group, 13.5/1000 vs 11.5/1000 person-year with HR of 1.18 (95% CI 1.06 to 1.32, p=0.003). Individual event rate of MI and cardiac death rate was higher in the PCI group than in the OMT group at 9.3 years, 2.9 vs 2.1 (HR 1.38, 95% CI 1.09 to 1.7, p=0.009) and 4.8 vs 3.4/1000 person-year (HR 1.40, 95% CI 1.16 to 1.69, p=0.001), respectively. Revascularisation and total death occurred more in the PCI group as compared with the OMT group, 30.3 vs 8.2 (HR 3.64, 95% CI 3.27 to 4.05, p<0.001) and 13.5 vs 10.6/1000 person-year (HR 1.23, 95% CI 1.12 to 1.40, p<0.001), respectively. In subgroup analysis, the same trend of more event in the PCI group was detected. CONCLUSIONS: PCI plus OMT was associated with higher rate of primary endpoint of MI, stroke, cardiac death as compared with OMT alone in patients with pure stable angina at 9.3-year follow-up in large population.

Nighttime administration of antihypertensive medication: a review of chronotherapy in hypertension.

Hypertension remains a global health concern because of suboptimal blood pressure control despite advancements in antihypertensive treatments. Chronotherapy, defined as evening or bedtime administration of medication based on biological rhythms, is emerging as a potential strategy to improve blood pressure control and treatment outcomes. Clinical trials have investigated the potential effects of nighttime administration of antihypertensive medication in the improvement of 24 hours blood pressure control and reduction of cardiovascular risk. Implementing chronotherapy in clinical practice could have significant implications in enhancing blood pressure control and improving clinical outcomes in patients with hypertension, particularly those with resistant hypertension. However, recent trials have reported contradictory results, causing confusion in real-world practice. Herein we review, analyze, and critique the current evidence and propose suggestions regarding the clinical application and future directions of chronotherapy.

Clinical Benefit of Intravascular Imaging Compared With Conventional Angiography in Left Main Coronary Artery Intervention.

BACKGROUND: The RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) demonstrated that intravascular imaging-guided percutaneous coronary intervention (PCI) improved clinical outcome compared with angiography-guided PCI for patients with complex coronary artery lesions. This study aims to assess whether the prognostic benefit of intravascular imaging-guided procedural optimization persists in patients undergoing PCI for left main coronary artery disease. METHODS: Of 1639 patients enrolled in the RENOVATE-COMPLEX-PCI, 192 patients with left main coronary artery disease were selected for the current prespecified substudy. Selected patients were randomly assigned to either the intravascular imaging-guided PCI group (n=138) or the angiography-guided PCI group (n=54). The primary end point was target vessel failure defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. RESULTS: At a median follow-up of 2.1 years (interquartile range 1.1 to 3.0 years), intravascular imaging-guided PCI was associated with lower incidence of primary end point compared with angiography-guided PCI (6.8% versus 25.1%; hazard ratio, 0.31 [95% CI, 0.13-0.76]; P=0.010). This significant reduction in primary end point was mainly driven by a lower risk of cardiac death or spontaneous target vessel-related myocardial infarction (1.6% versus 12.7%; hazard ratio, 0.16 [95% CI, 0.03-0.82]; P=0.028). Intravascular imaging-guided PCI was independently associated with a lower risk of primary end point, even after adjusting for various clinical factors (hazard ratio, 0.29 [95% CI, 0.12-0.72]; P=0.007). CONCLUSIONS: Intravascular imaging-guided PCI showed clinical benefit over angiography-guided PCI for left main coronary artery disease in reducing the risk of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.

Intravascular Imaging in Patients With Complex Coronary Lesions and Chronic Kidney Disease.

Importance: As patients with chronic kidney disease (CKD) are more likely to have complex coronary lesions, intravascular imaging guidance in percutaneous coronary intervention (PCI) for this population could be potentially beneficial. Objectives: To investigate whether the outcomes of intravascular imaging-guided procedural optimization would be different according to the presence of CKD. Design, Setting, and Participants: This was a prespecified substudy of RENOVATE-COMPLEX-PCI, a recently published multicenter randomized clinical trial in Korea studying the benefits of intravascular imaging for complex coronary lesions. Patients with complex coronary lesions, with or without CKD, were enrolled between May 2018 and May 2021. Data were analyzed from January to June 2023. Interventions: PCI in each group was done either under the guidance of intravascular imaging or angiography alone. Main Outcomes and Measures: The primary end point was target vessel failure (TVF) at the 3-year point, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Results: A total of 1639 patients (1300 male [79.3%]) treated with PCI for complex coronary lesions were stratified into CKD (296 participants) and non-CKD (1343 participants) groups. The mean (SD) age of each group was 70.3 (9.4) and 64.5 (10.1) years, and mean (SD) estimated serum creatinine was 2.9 (5.3) and 0.8 (0.2) mg/dL for CKD and non-CKD groups, respectively. Intravascular imaging-guided revascularization was associated with significantly lower incidence of the primary end point compared with angiography-guided revascularization in both CKD (13.3% vs 23.3%; hazard ratio [HR], 0.51; 95% CI, 0.27-0.93; P = .03) and non-CKD (6.4% vs 9.9%; HR, 0.66; 95% CI, 0.44-0.99; P = .05) groups. The significantly lower incidence of the primary end point was mainly associated with the lower risk of cardiac death or target vessel-related myocardial infarction (9.4% vs 22.2%; HR, 0.39; 95% CI, 0.20-0.76; P = .006) in the CKD group and by target vessel revascularization (3.0% vs 5.5%; HR, 0.55; 95% CI, 0.30-0.99; P = .05) in the non-CKD group. Those with a glomerular filtration rate of at least 30 mL/min/1.73m2 and less than 60 ml/kg/1.73m2 showed the greatest benefit from imaging-guided complex PCI (8.8% vs 21.2%; HR, 0.28; 95% CI, 0.11-0.68; P = .02). Conclusions and Relevance: In this prespecified cohort substudy of the Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention trial, intravascular imaging guidance showed clinical benefit over angiography guidance in reducing the risk of TVF, regardless of the presence of CKD. The greatest benefits of imaging-guided complex PCI were observed in stage 3 CKD. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872.

Comparison of Antiplatelet Monotherapies After Percutaneous Coronary Intervention According to Clinical, Ischemic, and Bleeding Risks.

BACKGROUND: Clopidogrel was superior to aspirin monotherapy in secondary prevention after percutaneous coronary intervention (PCI). OBJECTIVES: The purpose of this study was to evaluate the benefits of clopidogrel across high-risk subgroups METHODS: This was a post hoc analysis of the HOST-EXAM (Harmonizing Optimal Strategy for Treatment of coronary artery diseases-EXtended Antiplatelet Monotherapy) trial that randomly assigned patients who were event free for 6 to 18 months post-PCI on dual antiplatelet therapy (DAPT) to clopidogrel or aspirin monotherapy. Two clinical risk scores were used for risk stratification: the DAPT score and the Thrombolysis In Myocardial Infarction Risk Score for Secondary Prevention (TRS 2°P) (the sum of age ≥75 years, diabetes, hypertension, current smoking, peripheral artery disease, stroke, coronary artery bypass grafting, heart failure, and renal dysfunction). The primary composite endpoint was a composite of all-cause death, nonfatal myocardial infarction, stroke, readmission because of acute coronary syndrome, and major bleeding (Bleeding Academic Research Consortium type ≥3) at 2 years after randomization. RESULTS: Among 5,403 patients, clopidogrel monotherapy showed a lower rate of the primary composite endpoint than aspirin monotherapy (HR: 0.73; 95% CI: 0.59-0.90). The benefit of clopidogrel over aspirin was consistent regardless of TRS 2°P (high TRS 2°P [≥3] group: HR: 0.65 [95% CI: 0.44-0.96]; and low TRS 2°P [<3] group: HR: 0.77 [95% CI: 0.60-0.99]) (P for interaction = 0.454) and regardless of DAPT score (high DAPT score [≥2] group: HR: 0.68 [95% CI: 0.46-1.00]; and low DAPT score [<2] group: HR: 0.75 [95% CI: 0.59-0.96]) (P for interaction = 0.662). The association was similar for the individual outcomes. CONCLUSIONS: The beneficial effect of clopidogrel over aspirin monotherapy was consistent regardless of clinical risk or relative ischemic and bleeding risks compared with aspirin monotherapy. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy [HOST-EXAM]; NCT02044250).

Triglyceride-Rich Lipoproteins and Remnant Cholesterol in Cardiovascular Disease.

Despite the well-established benefits of statin treatments in lowering low-density lipoprotein cholesterol (LDL-C), a significant residual risk for atherosclerotic cardiovascular disease (ASCVD) remains. Triglycerides (TGs) have long been recognized as potential residual risk factors in this context, but recent studies now disclose the substantial role of TG-rich lipoproteins (TRLs) and cholesterol components of metabolized TRLs (commonly referred to as remnant cholesterol) in atherogenesis, not just TGs alone. Evidence derived through diverse sources, including preclinical studies of pathogenic mechanisms, epidemiologic investigations, and genetic research, has consistently supported the considerable contribution of TRLs and remnant cholesterol in predicting occurrences of ASCVD. As emerging biomarkers for predicting atherosclerosis, they have thus become prioritized therapeutic targets, meant to augment LDL-C lowering efforts in individuals at high risk of ASCVD. However, routine clinical testing for remnant cholesterol and TRLs is still in question, necessitating further research into appropriate treatment plans if levels are elevated. New therapies targeting proteins in TG metabolic pathways, particularly angiopoietin-like protein 3 and apolipoprotein C-III, have shown potential advantages in patients with mild-to-moderate hypertriglyceridemia by reducing blood levels of TGs and remnant cholesterol. The aim of this review is to summarize existing evidence linking elevated TRLs and remnant cholesterol with development of ASCVD and to explore additional guidance for clinical therapy.

Intravascular Imaging-Guided or Angiography-Guided Complex PCI.

BACKGROUND: Data regarding clinical outcomes after intravascular imaging-guided percutaneous coronary intervention (PCI) for complex coronary-artery lesions, as compared with outcomes after angiography-guided PCI, are limited. METHODS: In this prospective, multicenter, open-label trial in South Korea, we randomly assigned patients with complex coronary-artery lesions in a 2:1 ratio to undergo either intravascular imaging-guided PCI or angiography-guided PCI. In the intravascular imaging group, the choice between intravascular ultrasonography and optical coherence tomography was at the operators' discretion. The primary end point was a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization. Safety was also assessed. RESULTS: A total of 1639 patients underwent randomization, with 1092 assigned to undergo intravascular imaging-guided PCI and 547 assigned to undergo angiography-guided PCI. At a median follow-up of 2.1 years (interquartile range, 1.4 to 3.0), a primary end-point event had occurred in 76 patients (cumulative incidence, 7.7%) in the intravascular imaging group and in 60 patients (cumulative incidence, 12.3%) in the angiography group (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P = 0.008). Death from cardiac causes occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group; target-vessel-related myocardial infarction occurred in 38 (cumulative incidence, 3.7%) and 30 (cumulative incidence, 5.6%), respectively; and clinically driven target-vessel revascularization in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively. There were no apparent between-group differences in the incidence of procedure-related safety events. CONCLUSIONS: Among patients with complex coronary-artery lesions, intravascular imaging-guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI. (Supported by Abbott Vascular and Boston Scientific; RENOVATE-COMPLEX-PCI ClinicalTrials.gov number, NCT03381872).

Omega-3 fatty acids and atrial fibrillation.

Although some clinical trials have demonstrated reduced incidence of cardiovascular disease with the use of omega-3 fatty acids, others have found an increased risk of atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia worldwide. It is associated with high morbidity and mortality rates and significant public health burden. Previous studies of the effect of omega-3 fatty acids on AF occurrence have reported contradictory results. Here we reviewed the effect of omega-3 fatty acids on the risk of AF.

A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.

PURPOSE: Pitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-blind, multicenter, randomized, Phase III study was to compare the efficacy and safety of pitavastatin and ezetimibe combination therapy with those of pitavastatin monotherapy in Korean patients with primary hypercholesterolemia. METHODS: Korean men and women aged >19 and <80 years with primary hypercholesterolemia requiring medical treatment were included in this study. During the 8-week screening period, all patients were instructed to make therapeutic lifestyle changes. The screening period consisted of a 4-week washout period and a placebo run-in period (4-8 weeks). During treatment period I, patients were randomly assigned to receive 1 of 4 treatments: pitavastatin 2 mg plus ezetimibe 10 mg, pitavastatin 2 mg, pitavastatin 4 mg plus ezetimibe 10 mg, or pitavastatin 4 mg. The 8-week double-blind treatment period then commenced. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients. FINDINGS: The percentages in LDL-C from baseline after 8 weeks of double-blind treatment decreased significantly in the pooled pitavastatin/ezetimibe (-52.8% [11.2%]) and pooled pitavastatin (-37.1% [14.1%]) groups. Treatment with pitavastatin/ezetimibe resulted in a significantly greater LDL-C-lowering effect than that with pitavastatin (difference, -15.8 mg/dL; 95% CI, -18.7 to -12.9; P < 0.001). The precentages of achieving LDL-C goal in pooled pitavastatin/ezetimibe and pooled pitavastatin groups were 94.2% and 69.1%, respectively (P < 0.001). There were no significant differences in the incidence of overall AEs and adverse drug reactions. Serious AEs were comparable between the groups. IMPLICATIONS: Pitavastatin and ezetimibe combinations effectively and safely decreased LDL-C levels by >50% in patients with dyslipidemia. The safety and tolerability of pitavastatin and ezetimibe combination therapy were comparable with those of pitavastatin monotherapy. CLINICALTRIALS: gov identifier: NCT04584736.

Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial.

BACKGROUND AND OBJECTIVES: Self-monitoring of blood pressure (SMBP) is a reliable method used to assess BP accurately. However, patients do not often know how to respond to the measured BP value. We developed a mobile application-based feed-back algorithm (SMBP-App) for tailored recommendations. In this study, we aim to evaluate whether SMBP-App is superior to SMBP alone in terms of BP reduction and drug adherence improvement in patients with hypertension. METHODS: Self-Monitoring of blood pressure and Feed-back using APP in TReatment of UnconTrolled Hypertension (SMART-BP) is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App compared with SMBP alone. Patients with uncomplicated essential hypertension will be randomly assigned to the SMBP-App (90 patients) and SMBP alone (90 patients) groups. In the SMBP group, the patients will perform home BP measurement and receive the standard care, whereas in the SMBP-App group, the patients will receive additional recommendations from the application in response to the obtained BP value. Follow-up visits will be scheduled at 12 and 24 weeks after randomization. The primary endpoint of the study is the mean home systolic BP. The secondary endpoints include the drug adherence, the home diastolic BP, home and office BP. CONCLUSIONS: SMART-BP is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App. If we can confirm its efficacy, SMBP-App may be scaled-up to improve the treatment of hypertension. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04470284.

Durable polymer versus biodegradable polymer drug-eluting stents in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial.

BACKGROUND: Comparative data of durable polymer (DP) versus biodegradable polymer (BP) drug-eluting stents (DES) are limited in patients presenting with acute coronary syndrome (ACS) undergoing complex percutaneous coronary intervention (PCI). AIMS: We sought to evaluate the efficacy and safety of DP-DES and BP-DES in ACS patients receiving complex PCI. METHODS: This study was a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomly assigned 1:1 to DP-DES or BP-DES in the HOST-REDUCE-POLYTECH-ACS trial. Complex PCI was defined as having at least 1 of the following features: ≥3 stents implanted, ≥3 lesions treated, total stent length ≥60 mm, bifurcation PCI with 2 stents, left main PCI, or heavy calcification. Patient-oriented (POCO, a composite of all-cause death, non-fatal myocardial infarction, and any repeat revascularisation) and device-oriented composite outcomes (DOCO, a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularisation) were evaluated at 12 months. RESULTS: Among 3,301 patients for whom full procedural data were available, 1,140 patients received complex PCI. Complex PCI was associated with higher risks of POCO and DOCO. The risks of POCO were comparable between DP-DES and BP-DES in both the complex (HR 0.87, 95% confidence interval [CI]: 0.57-1.33; p=0.522) and non-complex (HR 0.83, 95% CI: 0.56-1.24; p=0.368; p for interaction=0.884) PCI groups. DOCO was also not significantly different between DP-DES and BP-DES in both the complex (HR 0.74, 95% CI: 0.43-1.27; p=0.278) and non-complex (HR 0.67, 95% CI: 0.38-1.19; p=0.175; p for interaction=0.814) PCI groups. CONCLUSIONS: In ACS patients, DP-DES and BP-DES showed similar clinical outcomes irrespective of PCI complexity.

Nitrates vs. Other Types of Vasodilators and Clinical Outcomes in Patients with Vasospastic Angina: A Propensity Score-Matched Analysis.

Although vasodilators are widely used in patients with vasospastic angina (VA), few studies have compared the long-term prognostic effects of different types of vasodilators. We investigated the long-term effects of vasodilators on clinical outcomes in VA patients according to the type of vasodilator used. Study data were obtained from a prospective multicenter registry that included patients who had symptoms suggestive of VA. Patients were classified into two groups according to use of nitrates (n = 239) or other vasodilators (n = 809) at discharge. The composite clinical events rate, including acute coronary syndrome (ACS), cardiac death, new-onset arrhythmia (including ventricular tachycardia and ventricular fibrillation), and atrioventricular block, was significantly higher in the nitrates group (5.3% vs. 2.2%, p = 0.026) during one year of follow-up. Specifically, the prevalence of ACS was significantly more frequent in the nitrates group (4.3% vs. 1.5%, p = 0.024). After propensity score matching, the adverse effects of nitrates remained. In addition, the use of nitrates at discharge was independently associated with a 2.69-fold increased risk of ACS in VA patients. In conclusion, using nitrates as a vasodilator at discharge can increase the adverse clinical outcomes in VA patients at one year of follow-up. Clinicians need to be aware of the prognostic value and consider prescribing other vasodilators.