ABSTRACT Chlorthalidone (CLTD) and hydrochlorothiazide (HCTZ) are widely used thiazide diuretics for hypertension management. This study aimed to evaluate and compare the cardiovascular outcomes of patients treated with CLTD versus HCTZ. This multicenter, retrospective cohort study utilized data from the Korea University Medical Center, derived from electronic health records. A total of 14 257 hypertensive patients treated with either CLTD (n = 1920) or HCTZ (n = 12 337) were identified. Patients were matched 1:1 using propensity scores, resulting in 1606 patients in each treatment group. Demographic and clinical characteristics, incidence of major adverse cardiovascular events (MACE), and safety profiles were analyzed. Baseline characteristics after propensity score matching were well balanced between the two groups. The average age was 61.8 ± 14.6 years for CLTD users, with 59.3% being male. The 3‐year MACE occurred in 1.2% of the CLTD group compared with 1.4% of the HCTZ group (hazard ratio 0.91, p = 0.77). For secondary outcomes, cardiovascular mortality was 0.2% in both groups (p = 0.92). Myocardial infarction occurred in 0.3% of CLTD users and 0.4% of HCTZ users (p = 0.65). The incidence of hypokalemia was 19.2% in the CLTD group versus 16.7% in the HCTZ group (p = 0.07). In conclusion, in hypertensive patients, CLTD and HCTZ showed comparable cardiovascular outcomes and safety profiles.
BACKGROUND:High-intensity statin therapy significantly reduces mortality and cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD). However, moderate-intensity statins are often preferred for elderly patients due to their higher risk of intolerance to high-intensity statins. OBJECTIVE:To compare the incidence of statin-associated muscle symptoms (SAMS) and the effect on low-density lipoprotein cholesterol (LDL-C) levels between elderly ASCVD patients receiving high-intensity statin monotherapy and those receiving moderate-intensity statin with ezetimibe in a combination therapy. METHOD:In a prospective, multicenter, open-label trial conducted in South Korea, 561 patients aged 70 years or above with ASCVD were randomly assigned to receive either moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg) over 6 months. The primary endpoint was the incidence of SAMS, and the key secondary endpoint was the achievement of target LDL-C levels (<70 mg/dL) within 6 months. RESULTS:The primary endpoint showed a lower incidence of SAMS in the combination therapy group (0.7%) compared to the high-intensity statin monotherapy group (5.7%, p = 0.005). Both groups achieved similar LDL-C levels, with 75.4% in the combination therapy group and 68.7% in the monotherapy group reaching target levels. CONCLUSION:Moderate-intensity statin with ezetimibe combination therapy offers a lower risk of SAMS and similar LDL-C reduction in elderly patients with ASCVD, compared to high-intensity statin monotherapy.
Background:Despite advancements in coronary artery disease (CAD) treatment with drug-eluting stent, its morbidity and mortality remain high. In context, intravascular imaging-guided percutaneous coronary intervention (PCI) is increasingly recommended for better clinical outcomes in patient with CAD. Near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), as one of the intravascular imaging methods, is effective in detecting lipid-rich plaques, which is crucial for identifying high-risk or vulnerable plaques employing near-infrared light. High lipid core burden, as identified by NIRS-IVUS, correlates with an increased risk of adverse cardiac events and shows varying degrees of efficacy in plaque management and event prevention.Summary:This article addresses about how NIRS-IVUS can be used to predict event of CAD. The study highlights the crucial role of NIRS-IVUS in predicting future cardiovascular events. Findings indicate that the presence of high lipid core burden is related to increased risks of periprocedural myocardial infarction and reduced coronary flow during PCI. The study also outlines the predictive value of NIRS-IVUS in non-culprit lesions, where plaques with high lipid core burden significantly increase the occurrence of major adverse cardiac events as demonstrated in the PROSPECT II trial. In terms of therapeutic strategies, the study reviews the effectiveness of high-intensity lipid-lowering strategies in stabilizing vulnerable plaques, as evidenced in trials such as the YELLOW and PACMAN AMI trials.Key Messages:NIRS-IVUS emerges as a valuable diagnostic tool in treating CAD. It effectively identifies vulnerable plaques and aids in predicting and preventing future adverse cardiac events. However, to enhance its practicality and promote widespread adoption in clinical settings, further long-term outcome research of NIRS-IVUS-guided PCI is necessary. These efforts can potentially make NIRS-IVUS a more accessible and indispensable tool in cardiovascular disease management.
Abstract Background Concomitant use of clopidogrel and proton pump inhibitor (PPI) is common, but PPI may reduce the antiplatelet effects of clopidogrel in patients undergoing percutaneous coronary intervention (PCI). We evaluated the impact of PPI use on clinical outcomes in post-PCI patients, by incorporating P2Y12 reaction unit (PRU) and CYP2C19 genotyping results. Methods From a multicenter registry of patients who underwent PCI with drug-eluting stent implantation and received clopidogrel-based dual antiplatelet therapy (DAPT), patients who were prescribed a PPI at the time of PCI (PPI users) were compared to those who were not (non-users). The primary outcome included all-cause death, myocardial infarction, stent thrombosis, or cerebrovascular accident at 12 months. Major bleeding (Bleeding Academic Research Consortium [BARC] types 3–5) and gastrointestinal (GI) bleeding (BARC types 3–5) were important secondary outcomes. The adjusted outcomes were compared using a 1:1 propensity-score (PS) matching and competing risk analysis. Results Of 13,160 patients, 2,235 (17.0%) were prescribed PPI, with an average age of 65.4 years. PPI users had higher on-treatment PRU levels than non-users. After PS matching, the primary outcome occurred in 51 patients who were PPI users (cumulative incidence, 4.7%) and 41 patients who were non-users (cumulative incidence, 3.7%; log-rank p = 0.27). In carriers of both CYP2C19 loss-of-function alleles, PPI use was linked to an increased risk of the primary outcome (hazard ratio, 3.22; 95% confidence interval, 1.18–8.78). The incidence of major bleeding and GI bleeding (BARC types 3–5) was comparable between PPI users and non-users in the PS-matched cohort. Conclusions In post-PCI patients receiving clopidogrel-based DAPT, PPI use was not linked to an increased risk of adverse cardiac and cerebrovascular events, but there was a small but significant increase in on-treatment PRU. Future research using a more individualized approach would further elucidate these interactions and guide evidence-based clinical practices.
BACKGROUND Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) have shown comparable outcomes in guiding percutaneous coronary intervention (PCI). However, their comparative effectiveness in complex coronary artery lesions remains unclear. OBJECTIVES This study compared the effectiveness and safety of OCT-guided vs IVUS-guided PCI for complex coronary artery lesions. METHODS This was a prespecified, main subgroup analysis of complex coronary artery lesions in the OCTIVUS (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention) trial, which included unprotected left main disease, bifurcation disease, an aorto-ostial lesion, a chronic total occlusion, a severely calcified lesion, an in-stent restenotic lesion, a diffuse long lesion, or multivessel PCI. The primary endpoint was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization. RESULTS In 2,008 randomized patients, 1,475 (73.5%) underwent imaging -guided PCI for complex coronary artery lesions; 719 (48.7%) received OCT-guided and 756 (51.3%) IVUS-guided PCI. At a median follow-up of 2.0 years, primary endpoint event had occurred in 47 patients (6.5%) in the OCT-guided group and in 56 patients (7.4%) in the IVUS-guided group (HR: 0.87; 95% CI: 0.59-1.29; P = 0.50). These findings were consistent in adjusted analyses. The incidence of contrast -induced nephropathy was similar between the 2 groups (1.9% vs 1.5%; P = 0.46). The incidence of major procedural complications was lower in the OCT-guided group than in the IVUS-guided group (1.7% vs 3.4%; P = 0.03). CONCLUSIONS Among patients with complex coronary artery lesions, OCT-guided PCI showed a similar risk of primary composite event of death from cardiac causes, target vessel-related myocardial infarction, or target vessel revascularization as compared with IVUS-guided PCI. (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention [OCTIVUS]; NCT03394079) (J Am Coll Cardiol 2024;83:401-413) (c) 2024 by the American College of Cardiology Foundation.
Background and Objectives: Lipid lowering therapy is essential to reduce the risk of major cardiovascular events; however, limited evidence exists regarding the use of statin with ezetimibe as primary prevention strategy for middle-aged adults. We aimed to investigate the impact of single pill combination therapy on clinical outcomes in relatively healthy middle-aged patients when compared with statin monotherapy. Methods: Using the Korean National Health Insurance Service database, a propensity score match analysis was performed for baseline characteristics of 92,156 patients categorized into combination therapy (n=46,078) and statin monotherapy (n=46,078) groups. Primary outcome was composite outcomes, including death, coronary artery disease, and ischemic stroke. And secondary outcome was all-cause death. The mean follow-up duration was 2.9 +/- 0.3 years. Results: The 3-year composite outcomes of all-cause death, coronary artery disease, and ischemic stroke demonstrated no significant difference between the 2 groups (10.3% vs. 10.1%; hazard ratio [HR], 1.022; 95% confidence interval [CI], 0.980-1.064; p=0.309). Meanwhile, the 3-year all-cause death rate was lower in the combination therapy group than in the statin monotherapy group (0.2% vs. 0.4%; p<0.001), with a significant HR of 0.595 (95% CI, 0.460-0.769; p<0.001). Single pill combination therapy exhibited consistently lower mortality rates across various subgroups. Conclusions: Compared to the statin monotherapy, the combination therapy for primary prevention showed no difference in composite outcomes but may reduce mortality risk in relatively healthy middle-aged patients. However, since the study was observational, further randomized clinical trials are needed to confirm these findings.
Background:Accurate medical advice is paramount in ensuring optimal patient care, and misinformation can lead to misguided decisions with potentially detrimental health outcomes. The emergence of large language models (LLMs) such as OpenAI's GPT-4 has spurred interest in their potential health care applications, particularly in automated medical consultation. Yet, rigorous investigations comparing their performance to human experts remain sparse. Objective:This study aims to compare the medical accuracy of GPT-4 with human experts in providing medical advice using real-world user-generated queries, with a specific focus on cardiology. It also sought to analyze the performance of GPT-4 and human experts in specific question categories, including drug or medication information and preliminary diagnoses. Methods:We collected 251 pairs of cardiology-specific questions from general users and answers from human experts via an internet portal. GPT-4 was tasked with generating responses to the same questions. Three independent cardiologists (SL, JHK, and JJC) evaluated the answers provided by both human experts and GPT-4. Using a computer interface, each evaluator compared the pairs and determined which answer was superior, and they quantitatively measured the clarity and complexity of the questions as well as the accuracy and appropriateness of the responses, applying a 3-tiered grading scale (low, medium, and high). Furthermore, a linguistic analysis was conducted to compare the length and vocabulary diversity of the responses using word count and type-token ratio. Results:GPT-4 and human experts displayed comparable efficacy in medical accuracy ("GPT-4 is better" at 132/251, 52.6% vs "Human expert is better" at 119/251, 47.4%). In accuracy level categorization, humans had more high-accuracy responses than GPT-4 (50/237, 21.1% vs 30/238, 12.6%) but also a greater proportion of low-accuracy responses (11/237, 4.6% vs 1/238, 0.4%; P=.001). GPT-4 responses were generally longer and used a less diverse vocabulary than those of human experts, potentially enhancing their comprehensibility for general users (sentence count: mean 10.9, SD 4.2 vs mean 5.9, SD 3.7; P<.001; type-token ratio: mean 0.69, SD 0.07 vs mean 0.79, SD 0.09; P<.001). Nevertheless, human experts outperformed GPT-4 in specific question categories, notably those related to drug or medication information and preliminary diagnoses. These findings highlight the limitations of GPT-4 in providing advice based on clinical experience. Conclusions:GPT-4 has shown promising potential in automated medical consultation, with comparable medical accuracy to human experts. However, challenges remain particularly in the realm of nuanced clinical judgment. Future improvements in LLMs may require the integration of specific clinical reasoning pathways and regulatory oversight for safe use. Further research is needed to understand the full potential of LLMs across various medical specialties and conditions.
Parkinson's disease (PD) reports high rates of morbidity and mortality, but the risk of adverse cardiovascular outcomes in patients with PD has not been fully elucidated. This bi-center retrospective cohort study using the electronic health records (EHR) database of two tertiary hospitals screened a total of 327,292 subjects who visited the outpatient clinic, and 1194 patients with PD were propensity score-matched with a control population. The primary outcome was the occurrence of major adverse cardiovascular events (MACE). Key secondary outcomes included all-cause death, cardiovascular (CV) death, stroke, myocardial infarction (MI), heart failure hospitalization and 30-day CV death. After PS matching, MACE occurrence was not significantly different between PD and non-PD groups (18.2% vs. 17.5%, log-rank p = 0.98). Key secondary outcomes were also similar between the two groups. In patients with PD, MACE rate, and also CV risk score, were higher in patients with more severe PD (according to Hoehn and Yahr scale and unified Parkinson's disease rating scale), and after multivariable analysis, PD severity was not an independent predictor of MACE. Patients with PD are at an increased risk of adverse cardiovascular outcomes, but the contribution from other common CV risk factors cannot be ignored. The management of prevalent CV risk factors is therefore important in mitigating adverse outcomes among patients with PD.
Stent thrombosis (ST) is a fatal complication after percutaneous coronary intervention (PCI). The association between P2Y12 reaction unit (PRU) level and stent thrombosis occurrence remains unclear. Based on the multicenter, observational PTRG-DES (Platelet function and genoType-Related long-term proGnosis in DES-treated patients) registry of patients with drug-eluting stents (DES) implantation, a total of 11,714 patients with PRU values were analyzed. We sought to identify the predictors of early stent thrombosis (EST) and compared the primary outcome, a composite of cardiac death, myocardial infarction, and revascularization, between EST and non-EST groups. EST, defined as definite ST within 1 month after index PCI, occurred in 51 patients. PRU values were significantly higher in the EST group (263.5 ± 70.8 vs. 217.5 ± 78.7, p < 0.001). In multivariable analysis, PRU ≥ 252 (OR, 5.10; 95% CI 1.58–16.46; p = 0.006) and aspirin reaction unit ≥ 414 (OR 4.85; 95% CI 1.07–21.97; p = 0.040) were independent predictors of EST. The cumulative incidence of primary composite outcome at one year was significantly higher in the EST group (38.2% vs. 3.9%, Log-rank p < 0.001). In patients treated with clopidogrel after successful DES implantation, EST was associated with higher platelet reactivities, and a greater risk of cardiovascular events. Trial Registration: clinicaltrials.gov Identifier: NCT04734028.
Background Current guidelines recommend that patients with established atherosclerotic cardiovascular disease (ASCVD) use high-intensity statin therapy to lower low-density lipoprotein (LDL)-cholesterol levels by at least 50%, irrespective of age. However, in real-world practice, there is reluctance to maintain statin use in response to side-effects, particularly statin-associated muscle symptoms (SAMS). Moreover, no randomized trial has been conducted on the safety of statin therapy in elderly patients. Trial design This investigator-initiated, multicenter, randomized clinical trial aimed to investigate the incidence of SAMS and its effect on LDL-cholesterol levels in elderly patients with established ASCVD. Eligible patients were aged 70 years or older with established ASCVD. Consecutive patients who met the inclusion criteria were randomized in a 1:1 fashion to receive either intensive statin monotherapy (rosuvastatin 20 mg) or combination therapy (rosuvastatin/ezetimibe, 5/10 mg). The primary endpoint of the study is SAMS at 6 months with regard to treatment strategy. Positive SAMS results are defined as patients with a proposed statin myalgia index score of 7 or higher. The key secondary end-points are target LDL-cholesterol achievement (LDL < 70 mg/dL), incidence of myopathy, rhabdomyolysis, frequency of drug discontinuation, and creatinine kinase, aspartate transaminase, alanine transaminase, total cholesterol, LDL-cholesterol, high-density lipoprotein-cholesterol, triglyceride, and highly sensitive C-reactive protein levels at 6 months. Conclusions The SaveSAMS study is a multicenter, randomized trial that will compare the incidence of SAMS in patients with established ASCVD who are 70 years or older on intensive statin monotherapy to that combination therapy.
Objective: Olmesartan has been linked to numerical imbalances of cardiovascular mortality compared to placebo group. There is a paucity of contemporary data on real world evidence of this agent in different study populations. We sought to investigate clinical outcomes between olmesartan and other anti-hypertensive medications in moderately hypertensive patients. Design and method: This multicenter, retrospective study used the Korea University Medical Center database built on electronic health records from 2017 to 2020. Patients prescribed with at least two antihypertensive drugs as combined therapy were followed up for 3 years. The primary endpoint was a composite of all cause mortality, myocardial infarction, stroke, and heart failure. Adjusted outcome was compared with the use of propensity score matching (PSM). Results: Among 20,835 patients, 3,508 (16.8%) were olmesartan initiators from Jan 2017 to Dec 2017. Average age was 64 years, 45% were men, and 41% had diabetes. Olmesartan group were younger, more often women, and less likely to have diabetes mellitus and chronic kidney disease. The 3 year cumulative incidence of the composite primary endpoint was similar in both groups (4.9% vs. 5.7%, log rank p = 0.06). After PSM, the adjusted 3 year rate of the primary endpoint was similar between two groups (7.4% vs. 7.1%, log rank p = 0.72). In multivariable analysis, olmesartan use was associated with an adjusted hazard for the primary outcome of 0.95 (95% confidence interval, 0.83 to 1.10). Conclusions: Olmesartan combination for moderately hypertensive patients showed similar cardiovascular outcomes in real world practice, and there is no robust signal for harm with olmesartan use.
Background Metabolic abnormalities such as dyslipidemia, glucose and high blood pressure are common in diabetic patients. Visit-to-visit variabilities in these measures have been reported as potential residual cardiovascular risk factors. However, the relationship between these variabilities and their effects on cardiovascular prognosis have not been studied. Methods A total of 22,310 diabetic patients with ≥ 3 measurements of systolic blood pressure (SBP), blood glucose, total cholesterol (TC), and triglyceride (TG) levels during a minimum of three years at three tertiary general hospitals were selected. They were divided into high/low variability groups for each variable based on the coefficient of variation (CV) values. The primary outcome was the incidence of major adverse cardiovascular events (MACE), a composite of cardiovascular death, myocardial infarction, and stroke. Results All high CV groups had a higher incidence of MACE than those with low CV (6.0% vs. 2.5% for SBP-CV groups, 5.5% vs. 3.0% for TC-CV groups, 4.7% vs. 3.8% for TG-CV groups, 5.8% vs. 2.7% for glucose-CV groups). In multivariable Cox regression analysis,, high SBP-CV (HR 1.79 [95% CI 1.54–2.07], p < 0.01), high TC-CV (HR 1.54 [95% CI 1.34–1.77], p < 0.01), high TG-CV (HR 1.15 [95% CI 1.01–1.31], p = 0.040) and high glucose-CV (HR 1.61 [95% CI 1.40–1.86], p < 0.01) were independent predictors of MACE. Conclusion Variability of SBP, TC, TG and glucose are important residual risk factors for cardiovascular events in diabetic patients.
Background No large‐scale study has compared the clinical impact of triple antiplatelet therapy (TAPT: aspirin, clopidogrel, and cilostazol) and dual antiplatelet therapy (DAPT) on adverse limb events in patients with diabetes after endovascular therapy (EVT) for peripheral artery disease. Thus, we investigate the effect of cilostazol added to a DAPT on the clinical outcomes after EVT in patients with diabetes using a nationwide, multicenter, real‐world registry. Methods and Results A total of 990 patients with diabetes who underwent EVT were enrolled from the retrospective cohorts of a Korean multicenter EVT registry and were divided according to the antiplatelet regimen (TAPT [n=350; 35.4%] versus DAPT [n=640; 64.6%]). After propensity score matching based on clinical characteristics, a total of 350 pairs were compared for clinical outcomes. The primary end points were major adverse limb events, a composite of major amputation, minor amputation, and reintervention. For the matched study groups, the lesion length was 125.4±102.0 mm, and severe calcification was observed in 47.4%. The technical success rate (96.9% versus 94.0%; P=0.102) and the complication rate (6.9% versus 6.6%; P>0.999) were similar between the TAPT and DAPT groups. At 2‐year follow‐up, the incidence of major adverse limb events (16.6% versus 19.4%; P=0.260) did not differ between the 2 groups. However, the TAPT group showed less minor amputation than the DAPT group (2.0% versus 6.3%; P=0.004). In multivariate analysis, TAPT was an independent predictor of minor amputation (adjusted hazard ratio, 0.354 [95% CI, 0.158–0.794]; P=0.012). Conclusions In patients with diabetes undergoing EVT for peripheral artery disease, TAPT did not decrease the incidence of major adverse limb events but may be associated with a decreased risk of minor amputation.
Objective: There is limited evidence of the growing population of elderly patients with hypertension, particularly the relationship between blood pressure (BP) and adverse outcomes. We sought to estimate outcomes according to attained BP in elderly patients treated for moderate hypertension. Design and method: This multicenter, retrospective study used the Korea University Medical Center database built on electronic health records from 2017 to 2020. Patients initiated with at least two antihypertensive drugs as combined therapy were followed up for 3 years. The patients were grouped by on treatment systolic BP (SBP) in 10 mmHg increments from less than 120 to 140 mmHg or more. The primary outcome was a composite of all cause mortality, myocardial infarction, and stroke. The relationships between attained BP and outcomes were assessed using adjusted Cox regression analyses and restricted cubic splines. Results: From Jan 2017 to Dec 2017, a total of 4760 patients aged over 75 years (mean age 79.9) were enrolled and grouped into SBP lower 120 mmHg (n = 1188), SBP 120 to 129 mmHg (n = 1221), SBP 130 to 139 mmHg (n = 1194), and SBP over 140 mmHg (n = 1157). After a median follow up of 4.5 years, the incidence of the primary outcome was lowest in individuals with SBP of 120 to 129 mmHg (9.2%, p = 0.087). The age adjusted hazard ratio for the primary outcome showed a J shaped relationship with on treatment SBP and diastolic BP. Conclusions: A J curve relationship between on treatment SBP and the composite outcome was found consistently. In real world practice, on treatment SBP less than 130 mmHg was associated with improved outcomes in the elderly with moderate hypertension.
Background:Older patients who treated by percutaneous coronary intervention (PCI) are at a higher risk of adverse cardiac outcomes. We sought to investigate the clinical impact of bifurcation PCI in older patients from Korea and Italy. Methods:We selected 5,537 patients who underwent bifurcation PCI from the BIFURCAT (comBined Insights from the Unified RAIN and COBIS bifurcAtion regisTries) database. The primary outcome was a composite of target vessel myocardial infarction, clinically driven target lesion revascularization, and stent thrombosis at two years. Results:In patients aged ≥75 years, the mean age was 80.1 ± 4.0 years, 65.2% were men, and 33.7% had diabetes. Older patients more frequently presented with chronic kidney disease (CKD), severe coronary calcification, and left main coronary artery disease (LMCA). During a median follow-up of 2.1 years, older patients showed similar adverse clinical outcomes compared to younger patients (the primary outcome, 5.7% vs. 4.5%; p = 0.21). Advanced age was not an independent predictor of the primary outcome (p = 0.93) in overall patients. Both CKD and LMCA were independent predictors regardless of age group. Conclusions:Older patients (≥75 years) showed similar clinical outcomes to those of younger patients after bifurcation PCI. Advanced age alone should not deter physicians from performing complex PCIs for bifurcation disease.
BACKGROUND:Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared with angiography-guided PCI. However, the comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown. METHODS:In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group compared with the IVUS group. Safety outcomes were also assessed. RESULTS:At 1 year, primary end point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% CI, 0.97 percentage points; P<0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group versus 15 patients [1.5%] in the IVUS group; P=0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] versus 37 [3.7%]; P=0.047), although imaging procedure-related complications were not observed. CONCLUSIONS:In patients with significant coronary artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower-than-expected event rates should be considered in interpreting the trial. REGISTRATION:URL: https://www. CLINICALTRIALS:gov; Unique number: NCT03394079.