Effectiveness of low-intensity atorvastatin 5 mg and ezetimibe 10 mg combination therapy compared with moderate-intensity atorvastatin 10 mg monotherapy: A randomized, double-blinded, multi-center, phase III study.

BACKGROUND: We compared the efficacy and safety of low-intensity atorvastatin and ezetimibe combination therapy with moderate-intensity atorvastatin monotherapy in patients requiring cholesterol-lowering therapy. METHODS: At 19 centers in Korea, 290 patients were randomized to 4 groups: atorvastatin 5 mg and ezetimibe 10 mg (A5E), ezetimibe 10 mg (E), atorvastatin 5 mg (A5), and atorvastatin 10 mg (A10). Clinical and laboratory examinations were performed at baseline, and at 4-week and 8-week follow-ups. The primary endpoint was percentage change from baseline in low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up. Secondary endpoints included percentage changes from baseline in additional lipid parameters. RESULTS: Baseline characteristics were similar among the study groups. At the 8-week follow-up, percentage changes in LDL cholesterol levels were significantly greater in the A5E group (49.2%) than in the E (18.7%), A5 (27.9%), and A10 (36.4%) groups. Similar findings were observed regarding the percentage changes in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B levels. Triglyceride levels were also significantly decreased in the A5E group than in the E group, whereas high-density lipoprotein levels substantially increased in the A5E group than in the E group. In patients with low- and intermediate-cardiovascular risk, 93.3% achieved the target LDL cholesterol levels in the A5E group, 40.0% in the E group, 66.7% in the A5 group, and 92.9% in the A10 group. In addition, 31.4% of patients in the A5E group, 8.1% in E, 9.7% in A5, and 7.3% in the A10 group reached the target levels of both LDL cholesterol < 70 mg/dL and reduction of LDL ≥ 50% from baseline. CONCLUSIONS: The addition of ezetimibe to low-intensity atorvastatin had a greater effect on lowering LDL cholesterol than moderate-intensity atorvastatin alone, offering an effective treatment option for cholesterol management, especially in patients with low and intermediate risks.

Associations of cardiovascular and diabetes-related risk factors with myocardial perfusion reserve assessed by 201Tl/99mTc-tetrofosmin single-photon emission computed tomography in patients with diabetes mellitus and stable coronary artery disease.

We aimed to examine the associations of cardiovascular risk factors with myocardial perfusion reserve (MPR) in patients with type 2 diabetes and stable coronary artery disease. The study patients were retrospectively identified from a database of patients with diabetes and stable coronary artery disease at Asan Medical Center (Seoul, Republic of Korea), covering the period from 2017 to 2019. The primary outcome variable was MPR assessed by dynamic stress 201Tl/rest 99mTc-tetrofosmin SPECT. Univariable and stepwise multivariable analyses were performed to assess the associations of cardiovascular risk factors with MPR. A total of 276 patients (236 men and 40 women) were included. The median global MPR was 2.4 (interquartile range 1.9-3.0). Seventy-five (27.2%) patients had an MPR < 2.0. Multivariable linear regression showed that smoking (ß = - 0.44, 95% confidence interval - 0.68 to - 0.21, P < 0.001), hypertension (ß = - 0.24, 95% confidence interval - 0.47 to - 0.02, P = 0.033), and summed difference score (ß = - 0.05, 95% confidence interval - 0.07 to - 0.03, P < 0.001) were independently associated with MPR. Abnormal MPR (< 2.0) was associated with a higher incidence of cardiac death or myocardial infarction (P = 0.034). MPR assessed by dynamic stress 201Tl/rest 99mTc-tetrofosmin SPECT was impaired in a large cohort of patients with diabetes. After adjusting for risk variables, including standard myocardial perfusion imaging characteristics, smoking, and hypertension were associated with MPR. Our results may aid in identifying patients with impaired MPR and stratifying patients with type 2 diabetes.

Incidence and predictors of intracranial bleeding after coronary artery bypass graft surgery.

Background: There is a paucity of direct data on the incidence and predictors of intracranial bleeding (ICB) after coronary artery bypass graft surgery (CABG). Methods: The Korean National Health Insurance database was used to identify patients without prior ICB who underwent CABG. The outcomes of interest were the time-dependent incidence rates of ICB and the associated mortality. Results: Among 35,021 patients who underwent CABG between 2007 and 2018, 895 (2.6%) experienced an ICB during a median follow-up of 6.0 years. The 1-year cumulative incidence of ICB was 0.76%, with a relatively high incidence rate (9.93 cases per 1,000 person-years) within the first 1-30 days. Subsequent incidence rates showed a sharp decline until 3 years, followed by a steady decrease up to 10 years. The 1-year mortality rate after ICB was 38.1%, with most deaths occurring within 30 days (23.6%). The predictors of ICB after CABG were age ≥ 75 years, hypertension, pre-existing dementia, history of ischemic stroke or transient ischemic attack, and end-stage renal disease. Conclusions: In an unselected nationwide population undergoing CABG, the incidence of ICB was non-negligible and showed a relatively high incidence rate during the early postoperative period. Post-CABG ICB was associated with a high risk of premature death. Further research is needed to stratify high-risk patients and personalize therapeutic decisions for preventing ICB after CABG.

Electronic Medical Record-Based Machine Learning Approach to Predict the Risk of 30-Day Adverse Cardiac Events After Invasive Coronary Treatment: Machine Learning Model Development and Validation.

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 <0.1 as well as highly fitted calibration plots, indicating a good fit of the ML-based models. On external validation, the GBM model demonstrated maximal performance with an AUROC of 0.90, while FNN had an AUROC of 0.85. The AUROCs of LR and RF were slightly lower at 0.80 and 0.79, respectively. The AUPRCs of GBM, LR, and FNN were similar at 0.47, 0.43, and 0.41, respectively, while that of RF was lower at 0.33. Among the categories in the GBM model, time-series dynamic data demonstrated a high AUROC 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.

Ten-year Outcomes After Drug-Eluting Stents or Bypass Surgery for Left Main Coronary Disease in Patients With and Without Diabetes Mellitus: The PRECOMBAT Extended Follow-Up Study.

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.

2020 Asian Pacific Society of Cardiology Consensus Recommendations on the Use of P2Y12 Receptor Antagonists in the Asia-Pacific Region.

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.

Comparative effectiveness analysis of percutaneous coronary intervention versus coronary artery bypass grafting in patients with chronic kidney disease and unprotected left main coronary artery disease.

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 <60), and 232 (5%) in group 3 (eGFR <30). At two years, after adjustment, compared with group 1, the risk of MACCE was significantly higher in group 2 (hazard ratio [HR] 1.46, 95% confidence interval [CI]: 1.18-1.79) and in group 3 (HR 3.39, 95% CI: 2.61-4.40). The p interaction for MACCE across groups was 0.20. The adjusted risk of MACCE was similar between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in groups 1 and 2. However, PCI was associated with a significantly higher risk of MACCE compared to CABG (HR 1.88, 95% CI: 1.08-3.25) in group 3. CONCLUSIONS: The degree of renal insufficiency was proportionately associated with unfavourable outcomes in patients with LMCAD. In group 3, PCI was associated with a higher risk of MACCE compared with CABG. Also, the effect of PCI versus CABG on MACCE was consistent, with PCI being associated with less bleeding and CABG being associated with less repeat revascularisation.

Meta-Analysis Comparing the Risk of Myocardial Infarction Following Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention in Patients With Multivessel or Left Main Coronary Artery Disease.

There is insufficient data regarding the comparative efficacy of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) regarding myocardial infarction (MI). Our systematic review included randomized controlled trials that compared CABG versus PCI with stents in patients with multivessel or left main coronary artery disease (CAD). Included trials should have had reported event number of MI and a clinical follow-up of one or more years. Data were pooled using a random-effects model. The primary end point was MI at the longest available follow-up in the intention-to-treat population. Fifteen trials with a total of 13,592 patients treated with either CABG (n = 6,596) or PCI (n = 6,996) were included. After a weighted follow-up of 4.5 years, patients treated with CABG had a significantly lower risk of MI than those treated with PCI (risk ratio [RR] 0.75, 95% confidence interval [CI] 0.58 to 0.96, p = 0.024). The lower risk of MI with CABG as compared with PCI was more evident during a longer duration of follow-up (≥3 years, RR 0.69, 95% CI 0.52 to 0.91, p = 0.008; ≥5 years, RR 0.64, 95% CI 0.48 to 0.86, p = 0.003) and in the diabetic population (RR 0.55, 95% CI 0.44 to 0.70, p <0.001). The magnitude of risk reduction was similar across patients with multivessel (RR 0.72, 95% CI 0.53 to 0.99) and left main CAD (RR 0.74, 95% CI 0.47 to 1.15). In conclusion, the present meta-analysis of studies involving patients with multivessel or left main CAD suggests a significant benefit of CABG over PCI concerning the risk of future MI.

Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion.

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.

Fate of Grafts Bypassing Nonischemic Versus Ischemic Inducing Coronary Stenosis.

There is a lack of evidence regarding the efficacy of ischemia-guided coronary artery bypass grafting. We compared the incidence of graft failure between grafts bypassing ischemia-inducing and nonischemia-inducing stenoses. Between 1997 and 2011, 2,304 patients for whom baseline coronary angiography and myocardial perfusion imaging were available were identified from a single-center coronary artery bypass grafting registry. According to baseline myocardial perfusion imaging, each graft was assigned to either graft bypassing ischemia-inducing or nonischemia-inducing stenoses (ischemia-related grafts, n = 4,904; ischemia-unrelated grafts, n = 2,709). Graft failure was defined as total occlusion on coronary computed tomography angiography, performed at the discretion of the treating physician. The incidence of graft failure was compared on a per-graft basis. At 5 years, the incidence of graft failure was significantly higher in the ischemia-unrelated grafts (4.2% vs 2.9% in ischemia-related grafts; p = 0.003). Ischemia-related graft was an independent determinant of graft patency (adjusted hazard ratio 0.61; 95% confidence interval 0.44 to 0.84; p = 0.002). Increased risk of graft failure associated with ischemia-unrelated graft was observed only in the internal thoracic artery (3.3% vs 2.0%, p = 0.021) and arterial grafts (6.5% vs 4.3%, p = 0.020), but not in the venous grafts (2.7% vs 2.7%; p = 0.99). In terms of major adverse cardiac and cerebrovascular events, 5-year incidences were comparable between the patients with and without ischemia-unrelated grafts (219, 19.3% vs 160, 18.0%; p = 0.61). In conclusion, ischemia-unrelated grafts became dysfunctional more frequently than ischemia-related grafts, and were not preventive of adverse events.

Safety and Effectiveness of Second-Generation Drug-Eluting Stents in Patients With Left Main Coronary Artery Disease.

BACKGROUND: Limited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD). OBJECTIVES: This study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice. METHODS: Among 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents] registry, the IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization] registry, and the PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease] study) treated between July 2007 and July 2015, the authors identified 2,692 patients with significant LMCAD who received second-generation DES; 1,254 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 232 with biodegradable polymer biolimus-eluting stents (BP-BES), 616 with platinum-chromium EES (PtCr-EES), and 590 with Resolute zotarolimus-eluting stent (Re-ZES). The primary outcome was target-vessel failure. RESULTS: The observed 3-year rates of target-vessel failure were not significantly different for the different types of DES (16.7% for the CoCr-EES, 13.2% for the BP-BES, 18.7% for the PtCr-EES, and 14.7% for the Re-ZES; p = 0.15). In multiple treatment propensity score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were similar in between-group comparisons of the different DES, except for the PtCr-EES versus the BP-BES (reference; HR: 1.60; 95% confidence interval: 1.01 to 2.54; p = 0.046). There were no significant differences in risk of composite of all-cause death, any myocardial infarction, or any revascularization and its individual components according to the different types of DES. Although the 3-year incidence of stent thrombosis was considerably low (≤1.0%) for all types of DES, between-group differences were observed, generally favoring the EES platforms. CONCLUSIONS: In this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Comparison of a Simple Angiographic Approach With a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery Score-Based Approach for Left Main Coronary Artery Stenting: A Pooled Analysis of Serial PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) Studies.

BACKGROUND: The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making. METHODS AND RESULTS: We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94; P<0.001). The risk for a composite outcome of death or myocardial infarction was also higher with extensive left main CAD (adjusted hazard ratio, 1.75; 95% confidence interval, 1.08-2.85; P=0.02). However, Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score tertiles did not effectively stratify these 2 outcome measures. CONCLUSIONS: Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation.

Coronary CT angiography characteristics of OCT-defined thin-cap fibroatheroma: a section-to-section comparison study.

OBJECTIVES: To evaluate whether plaque characteristics as assessed by coronary computed tomography angiography (CCTA) were associated with the presence of a thin-cap fibroatheroma (TCFA)-a precursor of plaque rupture-defined by optical coherence tomography (OCT) in a section-to-section-level comparison. METHODS: From 28 symptomatic patients, 31 coronary lesions were evaluated on 727 cross-sections co-registered by both CCTA and OCT. CCTA plaque characteristics included low attenuation plaque (LAP, <30 HU), napkin ring sign (NRS), positive remodelling (PR, remodelling index ≥1.10), and spotty calcification and plaque area and plaque burden. By OCT, presence of TCFA, lumen area and arc of lipid were determined. RESULTS: OCT revealed a TCFA in 69 (9.4%) sections from 19 (61.2 %) lesions. In per-section analysis, OCT-TCFA showed higher frequency of CCTA-detected LAP (58.0% vs. 18.5%), NRS (31.9% vs. 8.8%) and PR (68.1% vs. 48.0%) and greater plaque burden (70.6% vs. 61.9%) as compared to sections without OCT-TCFA (all p < 0.05). In multivariable analysis, LAP (odds ratio [OR] 4.05, p < 0.001) and NRS (OR 2.47, p = 0.005) were associated with OCT-TCFA. CCTA-measured lumen area correlated well with OCT-measured lumen area (R = 0.859, limits of agreement -0.5 ± 3.7 mm2). CONCLUSIONS: LAP and NRS in CCTA were associated with the presence of OCT-defined TCFA in a section-to-section comparison. KEY POINTS: • CT-defined LAP and NRS were associated with OCT-defined TCFA • OCT-TCFA showed higher frequency of LAP, NRS, PR and greater plaque burden • Non-calcified plaque area was correlated with OCT-measured lipid arc.

Comparative effectiveness of coronary screening in heart valve surgery: Computed tomography versus conventional coronary angiography.

BACKGROUND: Although conventional coronary angiography (CAG) is considered the gold standard for coronary artery disease (CAD) screening in the setting of heart valve surgery, coronary artery computed tomography angiography (CCTA) has emerged as an alternative modality. This study was conducted to evaluate the clinical outcomes of CCTA compared with conventional CAG for CAD screening in patients undergoing heart valve surgery. METHODS: A total of 3150 consecutive patients aged >40 years or with coronary risk factors undergoing elective valve operations between 2001 and 2015 were evaluated. Of these, 1402 patients underwent CCTA (CT group) and 1748 patients underwent conventional CAG (CAG group) for CAD screening. RESULTS: The 30-day mortality rates were similar in the 2 groups (2.1% in the CT group vs 1.7% in the CAG group; P = .463); however, the incidence of low cardiac output syndrome was higher in the CT group (2.3% vs 1.0%; P = .008). The final rate of detection of significant CAD (≥50% stenosis) (4.9% vs 9.7%; P < .001) and proportion of receiving coronary bypass grafting (CABG) (2.9% vs 4.3%; P = .041) were lower in the CT group. After adjustment by propensity score matching (563 pairs), the main findings of our crude analyses did not change, with lower rates of CAD detection (odds ratio [OR], 0.56; 95% confidence interval [CI], 0.36-0.85) and CABG (OR, 0.47; 95% CI, 0.26-0.81), a similar risk of early mortality (OR, 1.51; 95% CI, 0.54-4.52), but a higher risk of low cardiac output syndrome (OR, 3.30; 95% CI, 1.16-11.78) in the CT group compared with the CAG group. CONCLUSIONS: The detection of significant CAD and identification of candidates for CABG were inferior with CCTA compared with conventional CAG in patients scheduled for elective heart valve operations.

Long-term outcomes of bypass grafting versus drug-eluting stenting for left main coronary artery disease: Results from the IRIS-MAIN registry.

There are limited data on comparative outcomes and its determinants following coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for left main coronary artery disease (LMCAD) in a real-world setting. METHODS: A total of 3,504 consecutive patients with LMCAD treated with CABG (n=1,301) or PCI with DES (n=2,203) from the IRIS-MAIN registry were analyzed. The relative treatment effect of one strategy over another was assessed by propensity-score matching method. The primary outcome was a composite of death, myocardial infarction, or stroke. RESULTS: Median follow-up duration was 4.7 years. In the matched cohort, both groups demonstrated a similar risk for the primary outcome (adjusted hazard ratio [HR]: 0.94; 95% CI: 0.77-1.15; P=.54). Compared with CABG, PCI exhibited higher risks of myocardial infarction (HR: 2.11; 95% CI: 1.16-3.83; P=.01) and repeated revascularization (HR: 5.95; 95% CI: 3.94-8.98; P<.001). In the overall population, age, presence of chronic kidney disease, and low ejection fraction (<40%) were key clinical predictors of primary outcome regardless of the treatment strategy. However, factors deemed to be associated with perioperative morbidity were determinants of primary outcome in the CABG group, whereas those generally associated with the severity of atherosclerotic coronary artery disease were strong predictors in the PCI group. CONCLUSIONS: Among patients with significant LMCAD, the long-term risk of the composite outcome of death, myocardial infarction, or stroke was similar between CABG and PCI. Clinical variables that differentially predict adverse outcomes might be useful in triaging appropriate revascularization strategy.

Differential Rates and Clinical Significance of Periprocedural Myocardial Infarction After Stenting or Bypass Surgery for Multivessel Coronary Disease According to Various Definitions.

OBJECTIVES: This study sought to estimate the differential incidence and prognostic significance of periprocedural myocardial infarction (MI) according to various definitions. BACKGROUND: In trials comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), the primary composite endpoint is very sensitive to the definition of MI. Especially, the definition of periprocedural MI has considerably varied, and uniform criteria are still unsettled. METHODS: We evaluated 7,697 patients with multivessel disease who received PCI (n = 4,514) or underwent CABG (n = 3,183) between 2003 and 2013, and for whom serial measurement of creatine kinase-MB was available. According to various MI definitions (second and third universal definitions and the Society for Cardiovascular Angiography and Interventions definition), we assessed the prevalence and prognostic significance of periprocedural MI after both PCI and CABG. Patients were followed for major cardiovascular events (death from cardiovascular causes and spontaneous MI) and death for a median of 4.7 years. RESULTS: According to various definitions of MI, there was a substantial difference in the rates of periprocedural MI after PCI and CABG (18.7% vs. 2.9% by second universal; 3.2% vs. 1.9% by third universal; and 5.5% vs. 18.3% by Society for Cardiovascular Angiography and Interventions definition). The presence of periprocedural MI was associated with increased risks of major cardiovascular events after both PCI and CABG regardless of MI definition. The risk-adjusted 5-year rates of future major cardiovascular events after occurrence of periprocedural MI were similar after PCI and CABG in second and third universal definition. However, using Society for Cardiovascular Angiography and Interventions definition, the rates of major cardiovascular events were significantly higher after PCI than after CABG (24.3% vs. 20.4%; hazard ratio: 1.61; 95% confidence interval: 1.07 to 2.41; p = 0.02). CONCLUSIONS: There were substantial differences in incidence and clinical relevance of periprocedural MI according to various contemporary, widely used definitions of MI.

Generalizability of EXCEL and NOBLE results to a large registry population with unprotected left main coronary artery disease.

OBJECTIVE: The aim of this study was to determine how trial-based findings of EXCEL and NOBLE might be interpreted and generalizable in 'real-world' settings with comparison of data from the large-scaled, all-comer Interventional Research Incorporation Society-Left MAIN Revascularization (IRIS-MAIN) registry. PATIENTS AND METHODS: We compared baseline clinical and procedural characteristics and also determined how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) was different in EXCEL and NOBLE, compared with those of the multicenter, IRIS-MAIN registry (n=2481). The primary outcome for between-study comparison was a composite of death, myocardial infarction (MI), or stroke. RESULTS: There were between-study differences in patient risk profiles (age, BMI, diabetes, and clinical presentation), lesion complexities, and procedural characteristics (stent type, the use of off-pump surgery, and radial artery); the proportion of diabetes and acute coronary syndrome was particularly lower in NOBLE than in other studies. Although there was interstudy heterogeneity for the protocol definition of MI, the risks for serious composite outcome of death, MI, or stroke were similar between PCI and CABG in EXCEL [hazard ratio (HR): 1.00; 95% confidence interval (CI): 0.79-1.26; P=0.98] and in the matched cohort of IRIS-MAIN (HR: 1.08; 95%CI: 0.85-1.38; P=0.53), whereas it was significantly higher after PCI than after CABG in NOBLE (HR: 1.47; 95%CI: 1.06-2.05; P=0.02), which was driven by more common MI and stroke after PCI. CONCLUSION: In the comparison of a large-sized, all-comer registry, the EXCEL trial might represent better generalizability with respect to baseline characteristics and observed clinical outcomes compared with the NOBLE trial.

Comparative determinants of 5-year cardiovascular event rates in patients with unprotected left main coronary artery disease.

BACKGROUND: Diabetes mellitus (DM), low ejection fraction (EF), and the extent of coronary artery disease (CAD) have all been identified as predictors of cardiovascular events in multivessel disease, but their comparative contributions to future risk remain unclear in patients with unprotected left main coronary artery (ULMCA) disease. Through this study we aimed to categorize the risk for cardiovascular events in patients with ULMCA disease using simple clinical descriptors. PATIENTS AND METHODS: Our study included a total of 5975 patients with ULMCA disease from the Interventional Research Incorporation Society-Left MAIN Revascularization registry who were treated with percutaneous coronary intervention (n=2850), coronary artery bypass grafting (n=2337), or medical therapy alone (n=608). We categorized the risk for cardiovascular events using simple clinical descriptors (DM, low EF, and the extent of CAD). The primary outcome was a major adverse cardiac or cerebrovascular event (MACCE) (i.e. death from any cause, stroke, myocardial infarction, or repeat revascularization). RESULTS: Overall, the 5-year rate of MACCE was highest in the medical group, lower in the percutaneous coronary intervention group, and lowest in the coronary artery bypass grafting group (42.5, 25.7, and 19.9%, respectively; P<0.001). In multivariable modeling, the presence of DM [hazard ratio (HR): 1.25; 95% confidence interval (CI): 1.12-1.40; P<0.001], low EF of 40% or less (HR: 1.83; 95% CI: 1.56-2.15; P<0.001), and the extent of CAD (HR: 1.14; 95% CI: 1.08-1.21; P<0.001) were independent predictors of MACCE; in addition, these factors were consistently associated with a significantly higher risk for MACCE, regardless of index treatment strategies. CONCLUSION: Simple clinical descriptors can assist clinicians in identifying high-risk patients and in predicting future cardiovascular events within the broad range of risk factors for ULMCA disease.

Differential Event Rates and Independent Predictors of Long-Term Major Cardiovascular Events and Death in 5795 Patients With Unprotected Left Main Coronary Artery Disease Treated With Stents, Bypass Surgery, or Medication: Insights From a Large International Multicenter Registry.

BACKGROUND: Identifying predictive factors for major cardiovascular events and death in patients with unprotected left main coronary artery disease is of great clinical value for risk stratification and possible guidance for tailored preventive strategies. METHODS AND RESULTS: The Interventional Research Incorporation Society-Left MAIN Revascularization registry included 5795 patients with unprotected left main coronary artery disease (percutaneous coronary intervention, n=2850; coronary-artery bypass grafting, n=2337; medication alone, n=608). We analyzed the incidence and independent predictors of major adverse cardiac and cerebrovascular events (MACCE; a composite of death, MI, stroke, or repeat revascularization) and all-cause mortality in each treatment stratum. During follow-up (median, 4.3 years), the rates of MACCE and death were substantially higher in the medical group than in the percutaneous coronary intervention and coronary-artery bypass grafting groups (P<0.001). In the percutaneous coronary intervention group, the 3 strongest predictors for MACCE were chronic renal failure, old age (≥65 years), and previous heart failure; those for all-cause mortality were chronic renal failure, old age, and low ejection fraction. In the coronary-artery bypass grafting group, old age, chronic renal failure, and low ejection fraction were the 3 strongest predictors of MACCE and death. In the medication group, old age, low ejection fraction, and diabetes mellitus were the 3 strongest predictors of MACCE and death. CONCLUSIONS: Among patients with unprotected left main coronary artery disease, the key clinical predictors for MACCE and death were generally similar regardless of index treatment. This study provides effect estimates for clinically relevant predictors of long-term clinical outcomes in real-world left main coronary artery patients, providing possible guidance for tailored preventive strategies. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01341327.

Comparison of Stenting Versus Bypass Surgery According to the Completeness of Revascularization in Severe Coronary Artery Disease: Patient-Level Pooled Analysis of the SYNTAX, PRECOMBAT, and BEST Trials.

OBJECTIVES: The aim of this study was to compare long-term survival between patients with severe coronary artery disease undergoing coronary artery bypass grafting (CABG) and those undergoing percutaneous coronary intervention (PCI) achieving complete revascularization (CR) or incomplete revascularization. BACKGROUND: The importance of CR in decision making regarding revascularization strategy in patients with severe coronary artery disease is unknown. METHODS: Data were pooled from the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trials. The primary outcome was death from any cause and was compared in an as-treated analysis. RESULTS: The rate of CR was 61.7% (57.2% with PCI and 66.8% with CABG). During a median 4.9-year follow-up period (interquartile range: 4.5 to 5.0 years), compared with patients undergoing CABG with CR, those undergoing PCI with incomplete revascularization had a higher risk for death from any cause (adjusted hazard ratio [aHR]: 1.43; 95% confidence interval [CI]: 1.03 to 2.00; p = 0.036) and the composite of death, myocardial infarction, and stroke (aHR: 1.48; 95% CI: 1.14 to 1.92; p = 0.003). However, there was no significant difference between patients undergoing CABG with CR and those undergoing PCI with CR regarding the risk for death from any cause (aHR: 1.16; 95% CI: 0.83 to 1.63; p = 0.39) and the composite of death, myocardial infarction, and stroke (aHR: 1.14; 95% CI: 0.87 to 1.48; p = 0.35). Subgroup analysis of multivessel coronary disease, high SYNTAX score (>32), and diabetes showed consistent findings. CONCLUSIONS: For the treatment of left main or multivessel coronary artery disease, PCI resulting in CR was associated with a similar long-term survival rate to CABG resulting in CR. Therefore, the ability to achieve CR should enter into the decision algorithm for choice of revascularization strategy.