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There are scarce data on the optimal duration and prognostic impact of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with second-generation drug-eluting stents for left main coronary artery (LMCA) disease. The aim of this study was to investigate the practice pattern and long-term prognostic effect of DAPT duration in patients undergoing PCI with second-generation drug-eluting stents for LMCA disease.Using individual patient-level data from the IRIS-MAIN and KOMATE registries, 1827 patients undergoing PCI with second-generation drug-eluting stents for LMCA disease with valid information on DAPT duration were included. The efficacy outcome was major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, and stent thrombosis) and the safety outcome was TIMI major bleeding.DAPT duration was6 months (n=273), 6 to 12 months (n=477), 12 to 24 months (n=637), and ≥ 24 months (n=440). The median follow-up duration was 3.9 [interquartile range, 3.01-5.00] years. Prolonged DAPT duration was associated with lower incidences of MACE. In multigroup propensity score analysis, adjusted HR for MACE were significantly higher for DAPT6 months and DAPT 6 to 12 months than for DAPT 12 to 24 months (HR, 4.51; 95%CI, 2.96-6.88 and HR 1.92; 95%CI, 1.23-3.00). There was no difference in HR for major bleeding among the assessed groups.DAPT duration following PCI for LMCA disease is highly variable. Although the duration of DAPT should be considered in the context of the clinical situation of each patient,12 months of DAPT was associated with higher incidence of MACE. Registration identifiers: NCT01341327; NCT03908463.

Author's summary Myocardial ischemia plays a central role in the pathophysiology of angina pectoris. Percutaneous coronary intervention (PCI) guidance has evolved from anatomic stenosis to physiologic evidence of flow limitation. However, there is no evidence that one guidance is superior to another in improving clinical outcomes after PCI. Hallmarks of inducible ischemia such as electrocardiographic changes and wall motion abnormalities may be more clinically relevant as the reference standard to define ischemia-inducing lesions. Considering all available evidence, PCI should be considered as symptomatic therapy without altering the atherosclerotic process, and reserved for patients with inducible ischemia who are non-responsive to medical therapy., 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.

OBJECTIVES We aimed to assess the advantages of using the retrograde approach as an initial strategy rather than as a rescue strategy for complex chronic total occlusions (CTOs). BACKGROUND Even for complex CTOs where a retrograde approach is deemed necessary, an antegrade approach is frequently used as an initial strategy in real-world practice. METHODS We evaluated 352 retrograde procedures for CTO conducted at our high-volume center between January 2007 and January 2019. Procedural efficiency and safety was assessed based on the guidewire manipulation time (GWMT) and the occurrence of procedure-related adverse events for the primary retrograde approach (PRA) and the rescue retrograde approach (RRA). RESULTS PRA and RRA were used in 191 (54.3%) and 161 (45.7%) of the CTO procedures, respectively. The complexity of the CTO lesion was significantly higher in the PRA group than in the RRA group (Japanese-CTO score, 2.62 ± 1.07 vs. 2.38 ± 1.06, p = 0.037). The technical success rate of two groups was similar (p = 0.47). The median GWMT required for PRA was significantly shorter than that for RRA (85 [interquartile range, 55-126] vs. 120 [85-157] min, p

BACKGROUND: Few studies have evaluated intravascular ultrasound (IVUS) use in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: In CTO-PCI, we aimed to (1) evaluate the clinical benefits of performing post-stent IVUS in preventing adverse clinical events, and (2) identify IVUS parameters and cut-off values for prediction of target lesion revascularisation (TLR)/reocclusion. METHODS: A total of 1,077 patients with 1,077 CTO lesions treated with drug-eluting stents (DES) were included. Clinical outcomes during a median follow-up of 6.3 years were compared between subjects with and those without post-stent IVUS using the inverse probability weighting method. RESULTS: Of 1,077 patients, post-stent IVUS was performed in 838 (77.8%) cases while in the remaining 239 (22.2%) cases it was not. In the weighted population, the risk of TLR/reocclusion was significantly lower in subjects with post-stent IVUS (9.6% vs 18.9%, hazard ratio [HR] 0.54, 95% confidence interval [CI]: 0.34-0.86, p=0.01), compared with those without post-stent IVUS. Cox regression analysis showed that minimal stent area (MSA) measured by IVUS was the only parameter independently associated with TLR/reocclusion (HR 0.78, 95% CI: 0.64-0.95; p=0.01) and the optimal MSA cut-off value was 4.9 mm2 for prediction of TLR/reocclusion (area under the curve=0.632, p=0.001). CONCLUSIONS: In CTO-PCI with DES, post-stent IVUS evaluation was associated with a lower risk of TLR/reocclusion. The final MSA was independently associated with TLR/reocclusion with a cut-off value of 4.9 mm(2).

BACKGROUND Pre-treatment prediction of individual blood pressure (BP) response to anti-hypertensive drugs is important to select and optimize medication for promptly and safely achieving a target BP. However, it is challenging to predict individually variable BP responses to a specific regimen. OBJECTIVE This study aimed to develop supervised machine learning (ML) models for predicting patient-specific treatment effects using 24-hour ambulatory BP monitoring (ABPM) data. METHODS A total of 1,129 patients who had both baseline and follow-up ABPM data were randomly assigned into training, validation and test sets in a 3:1:1 ratio. Utilizing the features including clinical and laboratory findings, initial ABPM data, and anti-hypertensive medication at baseline and at follow-up, ML models were developed to predict post-treatment individual BP response. Each case was labeled by the mean 24-hour and daytime BPs derived from the follow-up ABPM. RESULTS At baseline, 616 (55%) patients had been treated using mono or combination therapy with 45 anti-hypertensive drugs. By using CatBoost, the difference between predicted vs. measured mean 24-hour systolic BP at follow-up was 8.4 ± 7.0 mm Hg (% difference of 6.6% ± 5.7%). The difference between predicted vs. measured mean 24-hour diastolic BP was 5.3 ± 4.3 mm Hg (% difference of 6.8% ± 5.5%). There were significant correlations between the CatBoost-predicted vs. the ABPM-measured changes in the mean 24-hour Systolic (r=0.74) and diastolic (r=0.68) BPs from baseline to follow-up. Even in the patients with renal insufficiency or diabetes, the correlations between CatBoost-predicted vs. ABPM-measured BP changes were significant. CONCLUSIONS ML algorithms accurately predict the post-treatment ambulatory BP levels, which may assist clinicians in personalizing anti-hypertensive treatment. CLINICALTRIAL not-applicable

Objectives This study evaluated the association between elevated levels of lipoprotein(a) [Lp(a)] and risk of recurrent ischemic events in patients who underwent percutaneous coronary intervention (PCI). Background Elevated levels of Lp(a) have been identified as an independent, possibly causal, risk factor for atherosclerotic cardiovascular disease in a general population study. Methods A prospective single-center registry was used to identify 12,064 patients with baseline Lp(a) measurements who underwent PCI between 2003 and 2013. The primary outcomes were a composite of cardiovascular death, spontaneous myocardial infarction, and ischemic stroke. Results From the registry, 3,747 (31.1%) patients had high Lp(a) (>30 mg/dL) and 8,317 (68.9%) patients had low Lp(a) (≤30 mg/dL). During a median follow-up of 7.4 years, primary outcomes occurred in 1,490 patients, and the incidence rates of primary outcomes were 2.0 per 100 person-years in the high-Lp(a) group and 1.6 per 100 person-years in the low-Lp(a) group (adjusted hazard ratio [aHR]: 1.17; 95% confidence interval [CI]: 1.05-1.30; P = 0.004). Increased risk of recurrent ischemic cardiovascular events in the high-Lp(a) group was consistent in various subgroups including patients receiving statin treatment at discharge (aHR: 1.18; 95% CI: 1.03-1.34; P = 0.011). In addition, the risk of repeated revascularization was significantly higher in the high-Lp(a) group (aHR: 1.13; 95% CI: 1.02-1.25; P = 0.022). Conclusions Elevated levels of Lp(a) were significantly associated with the recurrent ischemic events in patients who underwent PCI. This study provides a rationale for outcome trials to test Lp(a)-lowering therapy for secondary prevention in patients undergoing PCI.

PURPOSE We investigated whether the combination therapy of low-intensity rosuvastatin and ezetimibe is an useful alternative to moderate-intensity rosuvastatin monotherapy in patients requiring cholesterol-lowering therapy. METHODS This was a multicenter randomized, double-blind study to investigate the safety and efficacy of a fixed-dose combination of rosuvastatin 2.5 mg and ezetimibe 10 mg (R2.5+E10) compared to those of ezetimibe 10 mg monotherapy (E10), rosuvastatin 2.5 mg (R2.5), and rosuvastatin 5 mg monotherapy (R5) in patients with hypercholesterolemia. A total of 348 patients at 15 centers in Korea were screened, and 279 patients were randomized to different groups in the study. Clinical and laboratory examinations were performed at baseline and 4 and 8 weeks after intervention. The primary endpoint was the percentage change of low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up. FINDINGS Baseline characteristics were similar among the four groups. There were significant changes in lipid profiles at the 8-week follow-up. A greater decrease in the LDL cholesterol levels (primary endpoint) were found in the R2.5+E10 group (-45.7±18.6%) than in the E10 group (-16.7±14.7%, p

BACKGROUND Sodium-glucose co-transporter 2 inhibitors reduce the risk of cardiovascular events in type 2 diabetic patients with coronary artery disease (CAD); however, the underlying mechanisms remain unclear. OBJECTIVES We compared the effects of empagliflozin vs. sitagliptin therapy on myocardial perfusion reserve (MPR) using dynamic single-photon emission computed tomography (SPECT) imaging. METHODS In total, 100 patients with type 2 diabetes, CAD and an MPR

Background and aims Although plaque characterization by intravascular ultrasound (IVUS) is important for risk stratification, frame-by-frame analysis of a whole vascular segment is time-consuming. The aim was to develop IVUS-based algorithms for classifying attenuation and calcified plaques. Methods IVUS image sets of 598 coronary arteries from 598 patients were randomized into training and test sets with 5:1 ratio. Each IVUS frame at a 0.4-mm interval was circumferentially labeled as one of three classes: attenuated plaque, calcified plaque, or plaque without attenuation or calcification. The model was trained on multi-class classification with 5-fold cross validation. By converting from Cartesian to polar coordinate images, the class corresponding to each array from 0 to 360° was plotted. Results At the angle-level, Dice similarity coefficients for identifying calcification vs. attenuation vs. none by using ensemble model were 0.79, 0.74 and 0.99, respectively. Also, the maximal accuracy was 98% to classify those groups in the test set. At the frame-level, the model identified the presence of attenuation with 80% sensitivity, 96% specificity, and 93% overall accuracy, and the presence of calcium with 86% sensitivity, 97% specificity, and 96% overall accuracy. In the per-vessel analysis, the attenuation and calcification burden index closely correlated with human measurements (r = 0.89 and r = 0.95, respectively), as did the maximal attenuation and calcification burden index over 4 mm (r = 0.82 and r = 0.91, respectively). The inference times were 0.05 s per frame and 7.8 s per vessel. Conclusions Our deep learning algorithms for plaque characterization may assist clinicians in recognizing high-risk coronary lesions.

Objectives The aim of this study was to develop pre-procedural intravascular ultrasound (IVUS)–based models for predicting the occurrence of stent underexpansion. Background Although post-stenting IVUS has been used to optimize percutaneous coronary intervention, there are no pre-procedural guidelines to estimate the degree of stent expansion and provide preemptive management before stent deployment. Methods A total of 618 coronary lesions in 618 patients undergoing percutaneous coronary intervention were randomized into training and test sets in a 5:1 ratio. Following the coregistration of pre- and post-stenting IVUS images, the pre-procedural images and clinical information (stent diameter, length, and inflation pressure; balloon diameter; and maximal balloon pressure) were used to develop a regression model using a convolutional neural network to predict post-stenting stent area. To separate the frames with from those without the occurrence of underexpansion (stent area Results Overall, the frequency of stent underexpansion was 15% (5,209 of 34,736 frames). At the frame level, stent areas predicted by the pre-procedural IVUS-based regression model significantly correlated with those measured on post-stenting IVUS (r = 0.802). To predict stent underexpansion, maximal accuracy of 94% (area under the curve = 0.94) was achieved when the convolutional neural network– and mask image–derived features were used for the classification model. At the lesion level, there were significant correlations between predicted and measured minimal stent area (r = 0.832) and between predicted and measured total stent volume (r = 0.958). Conclusions Deep-learning algorithms accurately predicted incomplete stent expansion. A data-driven approach may assist clinicians in making treatment decisions to avoid stent underexpansion as a preventable cause of stent failure.

Background Excess vascular deaths in the PLATO trial comparing ticagrelor to clopidogrel have been repeatedly challenged by the Food and Drug Administration (FDA) reviewers and academia. Based on the Freedom of Information Act, BuzzFeed won a court order and shared with us the complete list of reported deaths for the ticagrelor FDA New Drug Application (NDA) 22-433. This dataset was matched against local patient-level records from PLATO sites monitored by the sponsor. Study question Whether FDA death data in the PLATO trial matched the local site records. Study design The NDA spreadsheet contains 938 precisely detailed PLATO deaths. We obtained and validated local evidence for 52 deaths among 861 PLATO patients from 14 enrolling sites in 8 countries and matched those with the official NDA dataset submitted to the FDA. Measures and outcomes Existence, precise time, and primary cause of deaths in PLATO. Results Discrepant to the NDA document, sites confirmed 2 extra unreported deaths (Poland and Korea) and failed to confirm 4 deaths (Malaysia). Of the remaining 46 deaths, dates were reported correctly for 42 patients, earlier (2 clopidogrel), or later (2 ticagrelor) than the actual occurrence of death. In 12 clopidogrel patients, cause of death was changed to "vascular," whereas 6 NDA ticagrelor "nonvascular" or "unknown" deaths were site-reported as of "vascular" origin. Sudden death was incorrectly reported in 4 clopidogrel patients, but omitted in 4 ticagrelor patients directly affecting the primary efficacy PLATO endpoint. Conclusions Many deaths were inaccurately reported in PLATO favoring ticagrelor. The full extent of mortality misreporting is currently unclear, while especially worrisome is a mismatch in identifying primary death cause. Because all PLATO events are kept in the cloud electronic Medidata Rave capture system, securing the database content, examining the dataset changes or/and repeated entries, identifying potential interference origin, and assessing full magnitude of the problem are warranted.

Aims The aim of this study was to compare percutaneous coronary intervention (PCI) outcomes in relation to stent optimisation profiles between in-stent chronic total occlusions (CTOs) and de novo CTOs. Methods and results We evaluated 1,516 consecutive patients who underwent PCI for 147 in-stent CTOs (9.3%) and 1,439 de novo CTOs between 2007 and 2018. The primary endpoint was target vessel failure (TVF) consisting of a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation. The final post-stenting intravascular ultrasound (IVUS) images were analysed. Target lesion complexity reflected by the Japanese CTO score was similar, albeit calcification was more prevalent in de novo CTOs, whereas occlusion length >20 mm was more frequent in in-stent CTOs. The technical success (88.4% vs 87.5%, p=0.84) and in-hospital adverse event (1.4% vs 3.6%, p=0.26) rates were similar between CTO types. Among those who received drug-eluting stents, the five-year TVF (11.0% vs 10.7%, p=0.99) and target vessel revascularisation (4.2% vs 3.7%, p=0.81) rates were similar between groups. Total stent length, minimum stent area (5.4±1.8 vs 5.5±1.8 mm2, p=0.77), and maximal plaque burden of the reference segments were largely comparable between groups. Conclusions In-stent CTO PCI with drug-eluting stents optimised by IVUS guidance offers as acceptable long-term clinical results as those achieved in de novo CTOs.

AIMS The aim of this study was to develop a deep learning model for classifying frames with versus without optical coherence tomography (OCT)-derived thin-cap fibroatheroma (TCFA). METHODS AND RESULTS A total of 602 coronary lesions from 602 angina patients were randomised into training and test sets in a 4:1 ratio. A DenseNet model was developed to classify OCT frames with or without OCT-derived TCFA. Gradient-weighted class activation mapping was used to visualise the area of attention. In the training sample (35,678 frames of 480 lesions), the model with fivefold cross-validation had an overall accuracy of 91.6±1.7%, sensitivity of 88.7±3.4%, and specificity of 91.8±2.0% (averaged AUC=0.96±0.01) in predicting the presence of TCFA. In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback. The correlation between the %TCFA burden per vessel predicted by the model compared with that identified by experts was significant (r=0.87, p

Objectives This study compared the 3-year outcomes of intracoronary imaging–guided pre-dilation, stent sizing, and post-dilation (iPSP) for patients with complex coronary artery lesions. Background The long-term effects of the optimal drug-eluting stent implantation technique in complex coronary artery disease have not been evaluated. Methods From the IRIS-DES (Interventional Cardiology Research In-cooperation Society-Drug-Eluting Stents) registry, the study evaluated 9,525 patients who underwent percutaneous coronary intervention for left main, bifurcation, long or diffuse (>30 mm), or angiographically severely calcified lesions. The primary outcome was a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The inverse probability of treatment weighting method was used to adjust for confounding factors. Results At the index procedure, intravascular ultrasound assessment PSP were performed in 8,522 (89.5%) patients, 5,141 (54.0%) patients, and 5,531 (58.1%) patients, respectively; overall, 3,374 (35.4%) patients underwent stent implantation using all 3 parts of the iPSP strategy and were defined as the iPSP group. At 3 years, the adjusted rate of the primary outcome was significantly lower in iPSP group (5.6% vs 7.9%; adjusted hazard ratio: 0.71; 95% confidence interval: 0.63 to 0.81; p Conclusions Among patients undergoing drug-eluting stent implantation in complex coronary artery stenosis, iPSP was associated with a lower risk of cardiac events at 3 years. Therefore, physicians should apply iPSP more actively for the treatment of complex coronary artery stenoses, even in the current era. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)

We compared the effects of ezetimibe/rosuvastatin 10/5 mg versus rosuvastatin 20 mg on carotid atherosclerotic plaque inflammation measured by 18FDG PET/CT. Fifty patients with acute coronary syndrome (ACS) were randomly assigned to the ezetimibe/rosuvastatin 10/5 mg and rosuvastatin 20 mg groups. The primary outcome was the percent change in the target-to-background ratio (TBR) of the index vessel in the most diseased segment (MDS), as assessed by 18FDG PET/CT at baseline and at 6 months. Forty-eight patients completed follow-up PET/CT. MDS TBR was − 6.2 ± 13.9% for patients in the ezetimibe/rosuvastatin group and − 10.8 ± 17.7% for those in the rosuvastatin group (difference, 4.6 percentage points; upper limitation of one-sided confidence interval = 13.8; p = 0.60 for noninferiority). In conclusion, combination therapy with ezetimibe 10 mg and rosuvastatin 5 mg compared with rosuvastatin 20 mg did not meet the criterion for non-inferiority for primary outcome, and the present study was not conclusive on whether the former was non-inferior to the latter.

AIMS Outcomes according to the status of renal insufficiency have not been fully evaluated in left main coronary artery disease (LMCAD). In the present study therefore, we sought to evaluate clinical outcomes in patients with significant LMCAD stratified by the degree of renal insufficiency and the relative clinical outcomes after PCI and CABG stratified by the differential levels of renal function using data from the large multinational "all-comers" Interventional Research Incorporation Society-Left MAIN Revascularization (IRIS-MAIN) registry. METHODS AND RESULTS Among 4,894 patients with LMCAD, renal insufficiency was graded according to the estimated glomerular filtration rate (eGFR). The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), defined as death, myocardial infarction, stroke, or any revascularisation. The patients were stratified into three groups according to eGFR: 3,824 (78%) in group 1 (eGFR ≥60 ml·min-1·1.73 m2), 838 (17%) in group 2 (eGFR ≥30 and

The aim of this study was to investigate the practice pattern and long-term prognostic effect of dual antiplatelet therapy (DAPT) duration in patients undergoing percutaneous coronary intervention (PCI) with second-generation drug-eluting stent (DES) for left main coronary artery (LMCA) disease. Using individual patient-level data from the IRIS-MAIN and KOMATE registries, 1,827 patients undergoing PCI with second-generation DES for LMCA disease with valid information on the DAPT duration were included. The primary outcome was major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, stent thrombosis) and the safety outcome was major bleeding. The DAPT duration was

IntroductionAngiography remains the gold standard for guiding percutaneous coronary intervention (PCI). However, it is prone to suboptimal stent results due to the visual estimation of coronary measurements. Although the benefit of intravascular ultrasound (IVUS)-guided PCI is becoming increasingly recognised, IVUS is not affordable for many catheterisation laboratories. Thus, a more practical and standardised angiography-based approach is necessary to support stent implantation.Methods and analysisThe Quantitative Coronary Angiography versus Intravascular Ultrasound Guidance for Drug-Eluting Stent Implantation trial is a randomised, investigator-initiated, multicentre, open-label, non-inferiority trial comparing the quantitative coronary angiography (QCA)-guided PCI strategy with IVUS-guided PCI in all-comer patients with significant coronary artery disease. A novel, standardised, QCA-based PCI protocol for the QCA-guided group will be provided to all participating operators, while the PCI optimisation criteria will be predefined for both strategies. A total of 1528 patients will be randomised to either group at a 1:1 ratio. The primary endpoint is the 12-month cumulative incidence of target-lesion failure defined as a composite of cardiac death, target-vessel myocardial infarction or ischaemia-driven target-lesion revascularisation. Clinical follow-up assessments are scheduled at 1, 6 and 12 months for all patients enrolled in the study.Ethics and disseminationEthics approval for this study was granted by the Institutional Review Board of Asan Medical Center (no. 2017-0060). Informed consent will be obtained from every participant. The study findings will be published in peer-reviewed journal articles and disseminated through public forums and academic conference presentations. Cost-effectiveness and secondary imaging analyses will be shared in secondary papers.Trial registration numberNCT02978456.

Background: Myocardial viability test to guide revascularization remains uncertain in patients with ischemic cardiomyopathy. We aimed to evaluate the different impacts of revascularization on cardiac mortality according to the extent of myocardial scar assessed by cardiac magnetic resonance with late gadolinium enhancement (LGE-CMR) in patients with ischemic cardiomyopathy. Methods: 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. Results: During a median follow-up of 6.3 years, cardiac death occurred in 158 (39.1%) patients. 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], 0.19-0.45; P < 0.001). There was a significant interaction between the number of segments with 76%-100% transmural LGE and revascularization on the risk of cardiac death (P = 0.037 for interaction). In patients with limited myocardial scar (< 6 segments with 76%-100% transmural LGE, N = 354), revascularization had a significantly lower risk of cardiac death than medical treatment alone (aHR, 0.24; 95% CI, 0.15-0.37; P < 0.001); in patients with extensive myocardial scar (≥ 6 segments with 76-100% 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, 0.46-3.80; P = 0.60). Conclusions: Assessment of myocardial scar by LGE-CMR may be helpful in the decision-making process for revascularization in patients with ischemic cardiomyopathy.

Background The long‐term impact of newly discovered, asymptomatic abnormal ankle–brachial index (ABI) in patients with significant coronary artery disease is limited. Methods and Results Between January 2006 and December 2009, ABI was evaluated in 2424 consecutive patients with no history of claudication or peripheral artery disease who had significant coronary artery disease. We previously reported a 3‐year result; therefore, the follow‐up period was extended. The primary end point was a composite of all‐cause death, myocardial infarction (MI), and stroke over 7 years. Of the 2424 patients with significant coronary artery disease, 385 had an abnormal ABI (ABI ≤0.9 or ≥1.4). During the follow‐up period, the rate of the primary outcome was significantly higher in the abnormal ABI group than in the normal ABI group ( P P P Conclusions Among patients with significant coronary artery disease, asymptomatic abnormal ABI was associated with sustained and increased incidence of composite of all‐cause death/MI/stroke, all‐cause death, MI, and stroke during extended follow‐up over 7 years.

AIMS We aimed to evaluate the contribution of the retrograde approach to real-world practice over time and its long-term outcomes in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS AND RESULTS We evaluated 1,635 CTO procedures conducted at our high-volume centre between 2003 and 2015. The retrograde approach has been actively adopted in practice since January 2007. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation/reocclusion. The technical success rate of CTO-PCI has increased from 79.5% to 87.1% since 2007, although the complexity of the CTOs has also significantly increased in that time (J-CTO scores: from 1.8±1.2 to 2.0±1.1, p=0.03). The incidence of in-hospital MACCE using the retrograde approach was 4.5%, which was comparable to the antegrade-only approach rate of 4.1% (p=0.58). The retrograde approach showed a higher four-year TVF rate after successful stenting compared with the antegrade-only approach (17.1% vs 9.4%, p=0.01), but this difference was mainly driven by a higher target vessel revascularisation/reocclusion rate. Multivariable analysis revealed that renal dysfunction (hazard ratio [HR] 3.33, 95% confidence interval [CI]: 1.42-7.83), acute coronary syndrome (HR 1.99, 95% CI: 1.26-3.14), the J-CTO score (per 1, HR 1.23, 95% CI: 1.00-1.51), and the smallest stent diameter (per 1 mm, HR 0.39, 95% CI: 0.21-0.74) (all p

Data on the comparative effectiveness of contemporary drug-eluting stents (DES) in the unrestricted, real-world setting are limited. We investigated the long-term effectiveness and safety of contemporary different drug-eluting stents by means of multiple treatment propensity score weighting.From seven stent-specific, prospective DES registries conducted between July 2007 and July 2015, we evaluated 17 196 patients who received several contemporary DES and first-generation DES: 3053 treated with cobalt-chromium everolimus-eluting stents (CoCr-EES), 2985 with platinum-chromium EES (PtCr-EES), 2922 with Resolute zotarolimus-eluting stents (Re-ZES), 789 with Biomatrix biolimus-eluting stents (Bi-BES), 1907 with Nobori biolimus-eluting stents (No-BES), 1970 with Xience Prime cobalt-chromium everolimus-eluting stents (Pr-CoCr-EES), and 3570 with sirolimus-eluting stents (SES). The primary outcome was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization) at 3 years of follow-up and major cardiovascular adverse events (a composite of all-cause death, any myocardial infarction, or any revascularization) was also evaluated.The observed 3-year rates of target-vessel failure were not significantly different among different second-generation DES and SES (CoCr-EES 9.8%, PtCr-EES 9.5%, Re-ZES 9.3%, Bi-BES 9.8%, No-BES 7.7%, Pr-CoCr-EES 10.4%, SES 10.2%; overall P=0.07). In multiple treatment propensity score analysis, adjusted hazard ratios for target-vessel failure were similar in between-group comparisons of several contemporary DES. In addition, no significant differences were observed with respect of the adjusted risk of major adverse cardiac events.In this comparative effectiveness research using stent-specific, clinical practice registries involving unrestricted use of several contemporary DES, there were no significant between-group differences in the 3-year rates of target-vessel failure.

Background: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. Methods: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. Results: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P =0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P =0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. Conclusions: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

Objectives This study examined the incremental value of subtended myocardial mass (Vsub) as assessed by coronary computed tomography angiography (CTA) for identifying lesion-specific ischemia verified by invasive fractional flow reserve (FFR) in quantitative coronary CTA. Background FFR is determined not only by coronary stenosis severity, but also by Vsub. One-step evaluation of combined Vsub and coronary lesion morphology may improve the accuracy of coronary CTA for identifying ischemia-producing lesions. Methods A total of 246 intermediate coronary artery lesions (30% to 80% diameter stenosis) in 220 patients (mean age 61.7 years, 168 men) interrogated by FFR were retrospectively studied. Coronary CTA data were used to assess the Vsub by coronary artery stenosis, minimal lumen area (MLA), percentage of aggregated plaque volume (%APV), positive remodeling, and low-attenuation plaque. The ability of Vsub/MLA2 to discriminate lesions with FFR ≤0.80 was examined. Diagnostic performance, odds ratios, and category-less net reclassification improvements of coronary CTA parameters for FFR-verified (≤0.80) ischemia were evaluated. On-site computed tomography (CT) derived–FFR (CT-FFR) and quantitative coronary angiography (QCA) data were also compared. Results Of 246 lesions, 84 (34.1%) showed an FFR ≤0.80. Vsub was independently associated with an FFR ≤0.80 (odds ratio: 1.04/1 cm3; p = 0.032) and showed incremental value over MLA. Vsub/MLA2 >4.16 was the best single parameter for discriminating an FFR ≤0.80 with 83.3% sensitivity and 67.9% specificity. The area under the curve (AUC) of Vsub/MLA2 >4.16 (0.80 [95% confidence interval: 0.75 to 0.85]) was better than that of MLA (change in [Δ]AUC: 0.069; p Conclusions Vsub is an independent determinant of an FFR ≤0.80. The mathematical index of Vsub/MLA2 >4.16 assessed by coronary CTA shows better diagnostic performance for the detection of ischemia-producing lesions than CT-derived MLA alone or %APV and QCA parameters and was comparable to that of on-site CT-FFR.

Invasive coronary angiography is a primary imaging modality that visualizes the lumen area of coronary arteries for the diagnosis of coronary artery diseases and guidance for interventional devices. In the current practice of quantitative coronary analysis (QCA), semi-automatic segmentation tools require labor-intensive and time-consuming manual correction; this limits their application in the catheterization room. For a more automated QCA, it is necessary to minimize operator intervention through robust segmentation methods with improved predictability. In this study, we introduced two selective ensemble methods that integrated the weighted ensemble approach with per-image quality estimation. In our selective ensemble methods, the segmentation outcomes from five base models with different loss functions were ranked by mask morphology or estimated dice similarity coefficient (DSC). The final output was determined by imposing different weights according to the ranking. The ranking criteria based on mask morphology were determined empirically to avoid frequent types of segmentation errors, whereas the estimation of DSCs was performed by comparing the pseudo-ground truth generated from a meta-learner. In the assessment with 7,426 frames from 2,924 patients, the selective ensemble methods improved segmentation performance with DSCs of up to 93.11% and provided a better delineation of lumen boundaries near the coronary lesion with local DSCs of up to 94.04%, outperforming all individual models and hard voting ensembles. The probability of mask disconnection at the most narrowed region could be minimized to

Background Several trials reported differential outcomes after percutaneous coronary intervention with drug‐eluting stents (DES) and coronary‐artery bypass grafting (CABG) for multivessel coronary disease according to the presence of diabetes mellitus (DM). However, it is not well recognized how DM status affects very‐long‐term (10‐year) outcomes after DES and CABG for left main coronary artery disease. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty using Sirolimus‐Eluting Stent in Patients with Left Main Coronary Artery Disease) trial, patients with LMCA were randomly assigned to undergo PCI with sirolimus‐eluting stents (n=300) or CABG (n=300). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE; a composite of death from any cause, myocardial infarction, stroke, or ischemia‐driven target‐vessel revascularization). Outcomes were examined in patients with (n=192) and without (n=408) medically treated diabetes. The follow‐up was extended to at least 10 years for all patients (median, 11.3 years). The 10‐year rates of MACCE were not significantly different between DES and CABG in patients with DM (36.3% versus 26.7%, respectively; hazard ratio [HR], 1.35; 95% CI, 0.83–2.19; P =0.23) and without DM (25.3% versus 22.9%, respectively; HR, 1.15; 95% CI, 0.79–1.67; P =0.48) ( P ‐for‐interaction=0.48). There were no significant between‐group differences in composite of death, MI, or stroke, and all‐cause mortality, regardless of DM status. TVR rates were consistently higher after DES than CABG. Conclusions In this 10‐year extended follow‐up of PRECOMBAT, we found no significant difference between DES and CABG with respect to the incidences of MACCE, serious composite outcome, and all‐cause mortality in patients with and without DM with LMCA disease. However, owing to the limited number of patients and no adjustment for multiple testing, overall findings should be considered hypothesis‐generating, highlighting the need for further research. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03871127 and NCT00422968.

The unique characteristics of patients with acute coronary syndrome in the Asia-Pacific region mean that international guidelines on the use of dual antiplatelet therapy (DAPT) cannot be routinely applied to these populations. Newer generation P2Y12 inhibitors (i.e. ticagrelor and prasugrel) have demonstrated improved clinical outcomes compared with clopidogrel. However, low numbers of Asian patients participated in pivotal studies and few regional studies comparing DAPTs have been conducted. This article aims to summarise current evidence on the use of newer generation P2Y12 inhibitors in Asian patients with acute coronary syndrome and provide recommendations to assist clinicians, especially cardiologists, in selecting a DAPT regimen. Guidance is provided on the management of ischaemic and bleeding risks, including duration of therapy, switching strategies and the management of patients with ST-elevation and non-ST-elevation MI or those requiring surgery. In particular, the need for an individualised DAPT regimen and considerations relating to switching, de-escalating, stopping or continuing DAPT beyond 12 months are discussed.

BACKGROUND Although there is a growing interest in prediction models based on electronic medical records (EMRs) to identify patients at risk of adverse cardiac events following invasive coronary treatment, robust models fully utilizing EMR data are limited. OBJECTIVE We aimed to develop and validate machine learning (ML) models by using diverse fields of EMR to predict the risk of 30-day adverse cardiac events after percutaneous intervention or bypass surgery. METHODS EMR data of 5,184,565 records of 16,793 patients at a quaternary hospital between 2006 and 2016 were categorized into static basic (eg, demographics), dynamic time-series (eg, laboratory values), and cardiac-specific data (eg, coronary angiography). The data were randomly split into training, tuning, and testing sets in a ratio of 3:1:1. Each model was evaluated with 5-fold cross-validation and with an external EMR-based cohort at a tertiary hospital. Logistic regression (LR), random forest (RF), gradient boosting machine (GBM), and feedforward neural network (FNN) algorithms were applied. The primary outcome was 30-day mortality following invasive treatment. RESULTS GBM showed the best performance with area under the receiver operating characteristic curve (AUROC) of 0.99; RF had a similar AUROC of 0.98. AUROCs of FNN and LR were 0.96 and 0.93, respectively. GBM had the highest area under the precision-recall curve (AUPRC) of 0.80, and the AUPRCs of RF, LR, and FNN were 0.73, 0.68, and 0.63, respectively. All models showed low Brier scores of 0.95, contributing majorly to the excellent results. CONCLUSIONS Exploiting the diverse fields of the EMR data set, the ML-based 30-day adverse cardiac event prediction models demonstrated outstanding results, and the applied framework could be generalized for various health care prediction models.

Background Although there is a growing interest in prediction models based on electronic medical records (EMRs) to identify patients at risk of adverse cardiac events following invasive coronary treatment, robust models fully utilizing EMR data are limited. Objective We aimed to develop and validate machine learning (ML) models by using diverse fields of EMR to predict the risk of 30-day adverse cardiac events after percutaneous intervention or bypass surgery. Methods EMR data of 5,184,565 records of 16,793 patients at a quaternary hospital between 2006 and 2016 were categorized into static basic (eg, demographics), dynamic time-series (eg, laboratory values), and cardiac-specific data (eg, coronary angiography). The data were randomly split into training, tuning, and testing sets in a ratio of 3:1:1. Each model was evaluated with 5-fold cross-validation and with an external EMR-based cohort at a tertiary hospital. Logistic regression (LR), random forest (RF), gradient boosting machine (GBM), and feedforward neural network (FNN) algorithms were applied. The primary outcome was 30-day mortality following invasive treatment. Results GBM showed the best performance with area under the receiver operating characteristic curve (AUROC) of 0.99; RF had a similar AUROC of 0.98. AUROCs of FNN and LR were 0.96 and 0.93, respectively. GBM had the highest area under the precision-recall curve (AUPRC) of 0.80, and the AUPRCs of RF, LR, and FNN were 0.73, 0.68, and 0.63, respectively. All models showed low Brier scores of 0.95, contributing majorly to the excellent results. Conclusions Exploiting the diverse fields of the EMR data set, the ML-based 30-day adverse cardiac event prediction models demonstrated outstanding results, and the applied framework could be generalized for various health care prediction models.