Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial.

BACKGROUND: Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intraobserver variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories. METHODS: The FLASH (fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, noninferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 1:1 ratio. The primary endpoint is the minimal stent area (mm2), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study. RESULTS: Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024. CONCLUSION: The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT05388357.

Edoxaban Versus Dual Antiplatelet Therapy for Leaflet Thrombosis and Cerebral Thromboembolism After TAVR: The ADAPT-TAVR Randomized Clinical Trial.

BACKGROUND: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. METHODS: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. RESULTS: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, -8.5% [95% CI, -17.8% to 0.8%]; P=0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, -6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. CONCLUSIONS: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT03284827.

Ten-Year Outcomes After Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Disease: Extended Follow-Up of the PRECOMBAT Trial.

BACKGROUND: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents and coronary-artery bypass grafting (CABG) for left main coronary artery disease are highly debated. METHODS: In the PRECOMBAT trial (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease), patients with unprotected left main coronary artery disease were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300) in 13 hospitals in Korea from April 2004 to August 2009. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). RESULTS: At 10 years, a primary outcome event occurred in 29.8% of the PCI group and in 24.7% of the CABG group (hazard ratio [HR] with PCI vs CABG, 1.25 [95% CI, 0.93-1.69]). The 10-year incidence of the composite of death, myocardial infarction, or stroke (18.2% vs 17.5%; HR 1.00 [95% CI, 0.70-1.44]) and all-cause mortality (14.5% vs 13.8%; HR 1.13 [95% CI, 0.75-1.70]) were not significantly different between the PCI and CABG groups. Ischemia-driven target-vessel revascularization was more frequent after PCI than after CABG (16.1% vs 8.0%; HR 1.98 [95% CI, 1.21-3.21). CONCLUSIONS: Ten-year follow-up of the PRECOMBAT trial of patients with left main coronary artery disease randomized to PCI or CABG did not demonstrate significant difference in the incidence of major adverse cardiac or cerebrovascular events. Because the study was underpowered, the results should be considered hypothesis-generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03871127 and NCT00422968.

Comparison of simple versus complex stenting in patients with true distal left main bifurcation lesions.

INTRODUCTION: Distal left main (LM) bifurcation disease is one of the most challenging lesion subsets for percutaneous coronary intervention (PCI) and optimal stenting strategy for such complex lesions is still debated. This study aimed to compare clinical outcomes following single versus dual stenting for true distal LM bifurcation lesions. METHODS: Patients with true distal LM bifurcation lesions (type 1,1,1 or 0,1,1: both left anterior descending and circumflex artery >2.5 mm diameter) receiving PCI with drug-eluting stents (DES) from two large clinical registries were evaluated. The primary outcome was target-lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (MI), or target-lesion revascularization (TLR). Outcomes were compared with the use of propensity scores and inverse probability-weighting adjustment to reduce treatment selection bias. RESULTS: Among 1,002 patients undergoing true distal LM PCI, 440 (43.9%) and 562 (56.1%) were treated with single and dual stents, respectively. The TLF rates at 3 year was 20.3% in the single-stent group and 24.1% in the dual-stenting group (log-rank p = 0.18). The adjusted risk for TLF did not differ significantly between two groups (hazard ratio [HR] with dual-stent vs. single-stent: 1.27, 95% confidence interval [CI]: 0.95-1.71). The adjusted risks for death, MI, repeat revascularization, or stent thrombosis were also similar between the single- and dual-stenting groups. CONCLUSIONS: In patients undergoing PCI for true distal LM disease, single- and dual-stent strategies showed a similar adjusted risk of TLF at 3 years. Our findings should be confirmed or refuted through large, randomized clinical trials.

Ten-year outcomes of early generation sirolimus- versus paclitaxel-eluting stents in patients with left main coronary artery disease.

To compare 10-year outcomes after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) for left main coronary artery (LMCA) stenosis. Very long-term outcome data of patients with LMCA disease treated with drug-eluting stents (DES) have not been well described. In 10-year extended follow-up of the MAINCOMPARE registry, we evaluated 778 patients with unprotected LMCA stenosis who were treated with SES (n = 607) or PES (n = 171) between January 2000 and June 2006. The primary composite outcome (a composite of death, myocardial infarction [MI] or target-vessel revascularization [TVR]) was compared with an inverse-probability-of-treatment-weighting (IPTW) adjustment. Clinical events have linearly accumulated over 10 years. At 10 years, there were no significant differences between SES and PES in the observed rates of the primary composite outcome (42.0% vs. 47.4%; hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.66-1.10), and definite stent thrombosis (ST) (1.9% vs. 1.8%; HR 1.02, 95% CI 0.28-3.64). In the IPTW-adjusted analyses, there were no significant differences between SES and PES in the risks for the primary composite outcome (HR 0.89, 95% CI 0.65-1.14) or definite ST (adjusted HR 1.05, 95% CI 0.29-3.90). In patients who underwent DES implantation, high overall adverse clinical event rates (with a linearly increasing event rate over time) were observed during extended follow-up. At 10 years, there were no measurable differences in outcomes between patients treated with SES vs. PES for LMCA disease. The incidence of stent thrombosis was quite low and comparable between the groups.

Outcomes of left ventricular unloading with a transseptal cannula during extracorporeal membrane oxygenation in adults.

We evaluated the benefit of left ventricular (LV) unloading using a percutaneous transseptal left atrial (LA) drain catheter via femoral vein incorporated into the ECMO venous circuit. This single-center retrospective observational study analyzed clinical outcomes of the LA venting group (N = 62) who underwent percutaneous transseptal LA drain placement comparing with the conventionally treated control group (N = 62) with an arterial pulse pressure below 10 mm Hg for at least 24 hours from December 2012 to August 2018. The ECMO weaning rate (61.3% vs. 38.7%, P = .012) and cardiac transplantation rate (29.0% vs. 11.3%, P = .014) were higher in the LA venting group than in the control group. Inhospital mortality was not significantly different (56.5% vs. 69.4%, P = .191). Pulmonary congestion mostly improved after LA decompression (61.3%, P = .003). A serum lactate level at 24 hours after LA venting of more than 2.2 mmol/L was associated with poor outcomes. LA venting via transseptal cannula reduced pulmonary venous congestion and achieved higher rates of successful ECMO weaning and cardiac transplantation. Placement of a transseptal venous drain cannula should be considered in patients with uncontrolled pulmonary edema secondary to severe LV loading undergoing VA-ECMO.

Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial.

BACKGROUND: Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain. METHODS: In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months. RESULTS: At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P=0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P=0.04) and fatal bleeding (1% [4/400] vs 0%, P=0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P=0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups. CONCLUSIONS: In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02094963.

Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial.

BACKGROUND: The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown. METHODS AND DESIGN: The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year. RESULTS: Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023. CONCLUSION: This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.

Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial.

BACKGROUND: Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. METHODS: The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. RESULTS: More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. CONCLUSION: This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.

Long-term (10-year) outcomes of stenting or bypass surgery for acute coronary syndromes and stable ischemic heart disease with unprotected left main coronary artery disease.

BACKGROUND: Acuity of clinical presentation may influence decision making of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease. However, it is undetermined whether clinical indication for myocardial revascularization may affect the relative long-term effect after PCI and CABG. METHODS: In the MAIN-COMPARE study including 2,240 patients with LMCA disease treated with PCI (n = 1102) or CABG (n = 1138), we examined interaction between acuity of clinical presentation (acute coronary syndromes [ACS] or non-ACS) and revascularization strategy on 10-year outcomes. Primary outcome was a composite of all-cause death, Q-wave myocardial infarction, or stroke. Secondary outcomes were all-cause death or target vessel revascularization. RESULTS: In overall patients, 1,603 patients (71.6%) presented with ACS and 637 patients (28.4%) presented with non-ACS. The 10-year adjusted risks for primary composite outcome were similar after PCI and CABG among patients who presented with non-ACS (hazard ratio [HR] 1.07; 95% CI 0.71-1.61) and those who presented with ACS (HR 1.00; 95% CI 0.81-1.24) (P for interaction = .29). The adjusted risks of death were also similar between 2 groups in non-ACS (HR 0.98; 95% CI 0.63-1.51) and ACS (HR 1.02; 95% CI 0.81-1.28) patients (P for interaction = .62). The adjusted risks of target vessel revascularization were consistently higher after PCI in non-ACS (HR 6.38; 95% CI 3.14-12.96) and ACS (HR 3.96; 95% CI 2.80-5.60) patients (P for interaction = .39). CONCLUSIONS: In patients with LMCA disease, we have identified no significant interaction between the acuity of clinical indication and the relative treatment effect of PCI versus CABG on 10-year clinical outcomes.

Long-term trends of treatment effect of stenting or bypass surgery in patients with ostial or shaft left main coronary artery disease.

BACKGROUND: Little is known about how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG) on clinical outcomes in ostial or shaft left main coronary artery (LMCA) disease has evolved over time. METHODS: This study included 2,112 patients with ostial or shaft LMCA disease from IRIS-MAIN registry who underwent PCI (n = 1,329) or CABG (n = 783). Patients were stratified by time period based on stent type availability: wave 1 (1995-2002, bare-metal stent [BMS] era); wave 2 (2003-2006, first-generation drug-eluting stent [DES] era); and wave 3 (2007-2014, second-generation DES era). RESULTS: Compared to CABG, PCI has been used more frequently from wave 1 to wave 3. PCI showed substantial improvements over time with respect to death (P for trend = 0.012); the composite of death, myocardial infarction (MI), or stroke (P for trend = 0.047); repeat revascularization (P for trend < 0.001); and major adverse cardiac and cerebrovascular events (MACCE; a composite of death, MI, stroke, or repeat revascularization) (P for trend < 0.001). By contrast, outcomes of CABG remained relatively stable over time. The gap between the treatment effects of CABG vs PCI for MACCE has narrowed over time; the adjusted hazard ratios for CABG compared to PCI during wave 1, 2, and 3 were 0.41 (95% confidence interval [CI]: 0.22-0.76), 0.47 (95% CI: 0.31-0.71), and 0.78 (95% CI: 0.50-1.20), respectively. CONCLUSIONS: In patients with ostial or shaft LMCA disease, significant improvements in PCI outcomes resulted in a progressive decline in the gap between the outcomes of CABG and PCI.

Synthesis of Ultra-Small Palladium Nanoparticles Deposited on CdS Nanorods by Pulsed Laser Ablation in Liquid: Role of Metal Nanocrystal Size in the Photocatalytic Hydrogen Production.

It is imperative to suppress the rate of recombination of photogenerated carriers to improve the semiconductor-catalyzed solar-driven production of hydrogen. To this end, photocatalysts comprising active sunlight-harvesting photo-absorbers and stable metal co-catalysts have attracted significant attention. However, the size, clean surface, and highly dispersed nature of the metal co-catalysts are crucial factors affecting catalyst performance and reaction rate. Nevertheless, most of the available metal nanocrystals have been synthesized by complex procedures using harmful organic templates and stabilizers, affording high-purity compounds with difficulty and high cost. To overcome these problems, in this study, the pulsed laser ablation in liquid approach was utilized to generate palladium and bimetallic palladium-platinum nanoparticles with an average size and distribution by adjusting the laser wavelength and fluence. A high rate of evolution of hydrogen of 130.33 mmol g-1 h-1 was obtained by using the optimized CdS-PdPt catalyst under simulated sunlight irradiation. This value is 51.31 times greater than that observed for bare CdS nanostructures. Furthermore, the amount of hydrogen evolved was significantly better than that obtained by using several other noble-metal co-catalysts deposited on CdS. This proposed strategy is thought to open new avenues for the design of advanced photocatalytic materials for efficient solar-driven production of hydrogen.

Early left atrial venting versus conventional treatment for left ventricular decompression during venoarterial extracorporeal membrane oxygenation support: The EVOLVE-ECMO randomized clinical trial.

AIMS: Few studies have reported data on the optimal timing of left ventricular (LV) unloading during venoarterial extracorporeal membrane oxygenation (VA-ECMO) for cardiac arrest or shock. This study evaluated the feasibility of an early LV unloading strategy compared with a conventional strategy in VA-ECMO. METHODS AND RESULTS: Between December 2018 and August 2022, 60 patients at two institutions were randomized in a 1:1 ratio to receive early (n = 30) or conventional (n = 30) LV unloading strategies. The early LV unloading strategy was defined as LV unloading performed at the time of VA-ECMO insertion. LV unloading was performed using a percutaneous transseptal left atrial cannulation via the femoral vein incorporated into the ECMO venous circuit. The early and conventional LV unloading groups included 29 (96.7%) and 23 (76.7%) patients, respectively (median time from VA-ECMO insertion to LV unloading: 48.4 h, interquartile range 47.8-96.5 h). The groups showed no significant differences in the rate of VA-ECMO weaning as the primary endpoint (70.0% vs. 76.7%; relative risk 0.91; 95% confidence interval 0.67-1.24; p = 0.386) and survival to discharge (53.3% vs. 50.0%, p = 0.796). However, the pulmonary congestion score index at 48 h after LV unloading was significantly improved only in the early LV unloading group (2.0 ± 0.7 vs. 1.7 ± 0.6 at baseline vs. at 48 h; p = 0.008). CONCLUSIONS: Compared with the conventional approach, early LV unloading did not improve the VA-ECMO weaning rate, despite the rapid improvement in pulmonary congestion. Therefore, the results of this study do not support the application of this strategy after VA-ECMO insertion.

Myocardial Scar and Revascularization on Mortality in Ischemic Cardiomyopathy (from the Late Gadolinium Enhancement Cardiac Magnetic Resonance Study).

Myocardial viability test to guide revascularization remains uncertain in patients with ischemic cardiomyopathy. We evaluated the different impacts of revascularization on cardiac mortality according to the extent of myocardial scar assessed by cardiac magnetic resonance (CMR) with late gadolinium enhancement (LGE) in patients with ischemic cardiomyopathy. A total of 404 consecutive patients with significant coronary artery disease and an ejection fraction ≤35% were assessed by LGE-CMR before revascularization. Of them, 306 patients underwent revascularization and 98 patients received medical treatment alone. The primary outcome was cardiac death. During a median follow-up of 6.3 years, cardiac death occurred in 158 patients (39.1%). Revascularization was associated with a significantly lower risk of cardiac death than medical treatment alone in the overall population (adjusted hazard ratio [aHR] 0.29, 95% confidence interval (CI) 0.19 to 0.45, p <0.001). There was a significant interaction between the number of segments with >75% transmural LGE and revascularization on the risk of cardiac death (p = 0.037 for interaction). In patients with limited myocardial scar (<6 segments with >75% transmural LGE, n = 354), revascularization had a significantly lower risk of cardiac death than medical treatment alone (aHR 0.24, 95% CI 0.15 to 0.37, p <0.001); in patients with extensive myocardial scar (≥6 segments with >75% transmural LGE, n = 50), there was no significant difference between revascularization and medical treatment alone regarding the risk of cardiac death (aHR 1.33, 95% CI 0.46 to 3.80, p = 0.60). In conclusion, the assessment of myocardial scar by LGE-CMR may be helpful in the decision-making process for revascularization in patients with ischemic cardiomyopathy.

Effect of Edoxaban Versus Antiplatelet Therapy on Leaflet Thrombosis and Cerebral Thromboembolism After TAVI According to Major Clinical and Anatomic Factors in Prespecified Subgroup Analysis from the ADAPT-TAVR Trial.

It is unknown whether edoxaban versus dual antiplatelet therapy (DAPT) has differential treatment effects on leaflet thrombosis, cerebral thromboembolism, and neurologic or neurocognitive dysfunction according to clinical and anatomic factors after transcatheter aortic valve implantation. To investigate the relative effects of edoxaban and DAPT on leaflet and cerebral thromboembolism in patients with major risk factors. The primary end point of this study was the incidence of leaflet thrombosis on computed tomography at 6 months. The secondary end points were new cerebral lesions on brain magnetic resonance imaging and neurologic and neurocognitive dysfunction between baseline and 6-month follow-up. Cox regression models assessed the consistency of the treatment effects in the prespecified subgroups. The favorable effect of edoxaban versus DAPT on the leaflet thrombosis was consistent across multiple clinical or anatomic subgroups, without significant interaction between the drug effect and each subgroup (p for interaction for age = 0.597, gender = 0.557, body mass index = 0.866, Society of Thoracic Surgeons score = 0.307, valve type = 0.702, edoxaban reduction criteria = 0.604, and valve morphology = 0.688). However, the incidence of new cerebral lesions on brain magnetic resonance imaging and worsening of neurologic and neurocognitive function were not significantly different between the groups among the various key subgroups. The relative effects of edoxaban and DAPT on the risk of leaflet thrombosis, cerebral thromboembolism, and neurologic dysfunction were consistent across a diverse spectrum of clinical or anatomical factors. Further studies are required to define tailored antithrombotic therapy for high-risk groups with specific clinical or anatomic characteristics.

Functional Angioplasty: Definitions, Historical Overview, and Future Perspectives.

Percutaneous coronary intervention (PCI) is used to treat obstructive coronary artery disease (CAD). The role of PCI is well defined in acute coronary syndrome, but that for stable CAD remains debatable. Although PCI generally relieves angina in patients with stable CAD, it may not change its prognosis. The extent and severity of CAD are major determinants of prognosis, and complete revascularization (CR) of all ischemia-causing lesions might improve outcomes. Several studies have shown better outcomes with CR than with incomplete revascularization, emphasizing the importance of functional angioplasty. However, different definitions of inducible myocardial ischemia have been used across studies, making their comparison difficult. Various diagnostic tools have been used to estimate the presence, extent, and severity of inducible myocardial ischemia. However, to date, there are no agreed reference standards of inducible myocardial ischemia. The hallmarks of inducible myocardial ischemia such as electrocardiographic changes and regional wall motion abnormalities may be more clinically relevant as the reference standard to define ischemia-causing lesions. In this review, we summarize studies regarding myocardial ischemia, PCI guidance, and possible explanations for similar findings across studies. Also, we provide some insights into the ideal definition of inducible myocardial ischemia and highlight the appropriate PCI strategy.

Time-Dependent Impact of Sex on the Long-Term Outcomes After Left Main Revascularization.

Background There are still limited data about the differential effect of sex on long-term outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease. This extended follow-up study of the MAIN-COMPARE (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease) registry evaluated clinical outcomes beyond 10 years. Methods and Results Of 2240 patients with unprotected left main coronary artery disease (PCI=1102 and CABG=1138), all-cause mortality, the composite of death, Q-wave myocardial infarction, or stroke, and target vessel revascularization were separately evaluated in both sexes. Of 2240 patients, 631 (28.2%) were women and 1609 (71.8%) were men. Women had lower 10-year incidences of death and serious composite outcomes than men. The adjusted 10-year risks of adverse outcomes were similar in men. However, the adjusted 10-year risks were different according to a prespecified period in women. In the short-term (0-1 year) period, PCI had a significantly lower risk for serious composite outcomes (adjusted hazard ratio [HR], 0.41; 95% CI, 0.19-0.91; P=0.03) compared with CABG. The adjusted risks for death and serious composite outcomes were significantly higher after PCI than after CABG, during the midterm (1-5 years) period (death; adjusted HR, 3.99; 95% CI, 2.01-7.92; P<0.001 and composite outcome; adjusted HR, 2.93; 95% CI, 1.59-5.39; P=0.001). Beyond 5 years, adjusted risks were similar after PCI and CABG in women. Conclusions In this 10-year extended follow-up study of patients undergoing left main coronary artery revascularization, we observed a time-dependent impact of sex on the long-term outcomes after PCI and CABG, especially in women, with significant interactions. However, these results warrant confirmation on larger series of studies. Registration URl: https://www.clinicaltrials.gov; Unique identifier: NCT02791412.

Comparison of Contemporary Drug-Eluting Stents in Patients Undergoing Complex High-Risk Indicated Procedures.

Background: Limited data are available on the relative performances of diverse contemporary drug-eluting stents (DES) in patients undergoing complex high-risk indicated procedures (CHIP). Objectives: The purpose of this study was to evaluate the comparative effectiveness of contemporary second-generation DES for CHIP patients in "real-world" settings. Methods: Of 28,843 patients enrolled in the IRIS-DES registry, a total of 6,645 patients with CHIP characteristics who received 5 different types of contemporary DES were finally included: 3,752 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 1,258 with Resolute zotarolimus-eluting stents (Re-ZES), 864 with platinum-chromium EES (PtCr-EES), 437 with ultrathin strut biodegradable-polymer sirolimus-eluting stents (UT-SES), and 334 with bioresorbable polymer SES (BP-SES). The primary outcome was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 12 months. Results: At 12 months, the rate of target-vessel failure was highest in the CoCr-EES (7.1%) group; intermediate in the Re-ZES (5.0%), PtCr-EES (4.6%), and BP-SES (4.2%) groups; and lowest in the UT-SES (3.8%) group (overall long-rank P = 0.001). In multiple-treatment propensity-score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were significantly lower in the Re-ZES (HR: 0.71; 95% confidence interval [CI]: 0.52-0.97), the UT-SES (HR: 0.52; 95% CI: 0.29-0.95), and BP-SES (HR: 0.33; 95% CI: 0.16-0.70) groups than in the CoCr-EES group (referent). Conclusions: In this contemporary PCI registry, we observed the differential risks of target-vessel failure according to various types of contemporary DES in patients with CHIP characteristics. However, owing to inherent selection bias, the results should be considered hypothesis-generating, highlighting the need for further randomized trials. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Inter-racial differences in patients undergoing transcatheter aortic valve implantation.

OBJECTIVE: Little information exists about inter-racial differences in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). We investigated whether differences in baseline characteristics between Asian and non-Asian population may contribute to disparities in clinical outcomes after TAVI. METHODS: We performed a registry-based, multinational cohort study of patients with severe AS who underwent TAVI at two centres in the USA and one centre in South Korea. The primary outcome was a composite of death, stroke or rehospitalisation at 1 year. RESULTS: Of 1412 patients, 581 patients were Asian and 831 were non-Asian (87.5% white, 1.7% black, 6.1% Hispanic or 4.7% others). There were substantial differences in baseline characteristics between two racial groups. The primary composite outcome was significantly lower in the Asian group than in the non-Asian group (26.0% vs 35.0%; HR 0.73; 95% CI 0.59 to 0.89; p=0.003). However, after adjustment of baseline covariates, the risk of primary composite outcome was not significantly different (HR 0.79; 95% CI 0.60 to 1.03; p=0.08). The all-cause mortality at 1 year was significantly lower in the Asian group than the non-Asian group (7.4% vs 12.5%; HR 0.60; 95% CI 0.41 to 0.88; p=0.009). After multivariable adjustment, the risk of all-cause mortality was also similar (HR 1.17; 95% CI 0.73 to 1.88; p=0.52). CONCLUSIONS: There were significant differences in baseline and procedural factors among Asian and non-Asian patients who underwent TAVI. Observed inter-racial differences in clinical outcomes were largely explained by baseline differences in clinical, anatomical and procedural factors. TRIAL REGISTRATION NUMBER: NCT03826264 (https://wwwclinicaltrialsgov).

Incidence, Predictors, and Prognostic Impact of Immediate Improvement in Left Ventricular Systolic Function After Transcatheter Aortic Valve Implantation.

Immediate improvement in left ventricular ejection fraction (LVEF) following transcatheter aortic valve implantation (TAVI) is common; however, data on the pattern and prognostic value of this improvement are limited. To evaluate the incidence, predictors, and clinical impact of immediate improvement in LVEF, we studied 694 consecutive patient who had underwent successful TAVI for severe aortic stenosis (AS) between March 2010 and December 2019. We defined immediate improvement of LVEF as an absolute increase of ≥5% in LVEF at post-procedure echocardiogram. The primary outcome was major adverse cardiac or cerebrovascular event (MACCE), defined as a composite of death from cardiovascular cause, myocardial infarction, stroke, or rehospitalization from cardiovascular cause. Among them, 160 patients showed immediate improvement in LVEF. The independent predictors of immediate LVEF improvement were absence of hypertension and baseline significant aortic regurgitation, and greater baseline LV mass index. Immediate improvement in LVEF was significantly associated with a lower risk of MACCE (adjusted hazard ratio, 0.48; 95% confidence interval, 0.28-0.81; p = 0.01). In conclusion, approximately one-fourth of patients with severe AS who underwent TAVI showed immediate improvement in LVEF during index hospitalization. Immediate LVEF recovery was associated with a lower risk of MACCE during follow-up.