Vulnerable plaque features and adverse events in patients with diabetes mellitus: a post hoc analysis of the COMBINE OCT-FFR trial.

BACKGROUND: Thin-cap fibroatheroma (TCFA) lesions are associated with a high risk of future major adverse cardiovascular events. However, the impact of other optical coherence tomography-detected vulnerability features (OCT-VFs) and their interplay with TCFA in predicting adverse events remains unknown. AIMS: We aimed to evaluate the individual as well as the combined prognostic impact of OCT-VFs in predicting the incidence of the lesion-oriented composite endpoint (LOCE) in non-ischaemic lesions in patients with diabetes mellitus (DM). METHODS: COMBINE OCT-FFR (ClinicalTrials.gov: NCT02989740) was a prospective, double-blind, international, natural history study that included DM patients with ≥1 non-culprit lesions with a fractional flow reserve>0.80 undergoing systematic OCT assessment. OCT-VFs included the following: TCFA, reduced minimal lumen area (r-MLA), healed plaque (HP), and complicated plaque (CP). The primary endpoint, LOCE - a composite of cardiac mortality, target vessel myocardial infarction, or clinically driven target lesion revascularisation up to 5 years - was analysed according to the presence of these OCT-VFs, both individually and in combination. RESULTS: TCFA, r-MLA, HP and CP were identified in 98 (25.3%), 190 (49.0%), 87 (22.4%), and 116 (29.9%) patients, respectively. The primary endpoint rate increased progressively from 6.3% to 55.6% (hazard ratio 15.2, 95% confidence interval: 4.53-51.0; p<0.001) in patients without OCT-VFs as compared to patients with concomitant HP, r-MLA, CP, and TCFA. The coexistence of TCFA with other OCT-VFs resulted in an increased risk of the LOCE at 5 years. CONCLUSIONS: In DM patients with non-ischaemic lesions, TCFA was the strongest predictor of future LOCE events. However, lesions that present additional OCT-VFs are associated with a higher risk of adverse events than OCT-detected TCFA alone. Further randomised studies are warranted to confirm these findings and their potential clinical implications.

Implementation of Microcirculation Examination in Clinical Practice-Insights from the Nationwide POL-MKW Registry.

Background and Objectives: The assessment of coronary microcirculation may facilitate risk stratification and treatment adjustment. The aim of this study was to evaluate patients' clinical presentation and treatment following coronary microcirculation assessment, as well as factors associated with an abnormal coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) values. Materials and Results: This retrospective analysis included 223 patients gathered from the national registry of invasive coronary microvascular testing collected between 2018 and 2023. Results: The frequency of coronary microcirculatory assessments in Poland has steadily increased since 2018. Patients with impaired IMR (≥25) were less burdened with comorbidities. Patients with normal IMR underwent revascularisation attempts more frequently (11.9% vs. 29.8%, p = 0.003). After microcirculation testing, calcium channel blockers (CCBs) and angiotensin-converting enzyme inhibitors were added more often for patients with IMR and CFR abnormalities, respectively, as compared to control groups. Moreover, patients with coronary microvascular dysfunction (CMD, defined as CFR and/or IMR abnormality), regardless of treatment choice following microcirculation assessment, were provided with trimetazidine (23.2%) and dihydropyridine CCBs (26.4%) more frequently than those without CMD who were treated conservatively (6.8%) and by revascularisation (4.2% with p = 0.002 and 0% with p < 0.001, respectively). Multivariable analysis revealed no association between angina symptoms and IMR or CFR impairment. Conclusions: The frequency of coronary microcirculatory assessments in Poland has steadily increased. Angina symptoms were not associated with either IMR or CFR impairment. After microcirculation assessment, patients with impaired microcirculation, expressed as either low CFR, high IMR or both, received additional pharmacotherapy treatment more often.

Current role of intravascular imaging in percutaneous treatment of calcified coronary lesions.

Percutaneous treatment of calcified coronary lesions is still a challenge in modern interventional cardiology practice. Coronary angiography is limited to the precise and quantitative assessment of calcium in coronary arteries. Intracoronary imaging (ICI) modalities, including optical coherence tomography (OCT) and intravascular ultrasound (IVUS), produce a very detailed image of calcifications and could help in proper percutaneous treatment. Intracoronary imaging indicates the need to use additional tools and improves the final effect of an intervention. Drawing on the already published literature, the authors focused on the qualification of patients to the procedure, conduct and result of interventional procedures involving calcified lesions supported by ICI. The article shows the advantages and disadvantages of both ICI methods in general and especially in calcified lesions. Currently available tools dedicated to dealing with coronary calcium and helping to meet optimal stent implantation criteria are also described. This article reviews the data on ICI implementation in daily clinical practice to improve the results of percutaneous interventions, and indicates further directions.

The characteristic of acute coronary syndromes of patients with multivessel coronary artery disease in centers with and without cardiac surgery on-site.

BACKGROUND: Multivessel disease (MVD) is diagnosed in a fair number of patients with acute coronary syndrome (ACS). There are 36 cardiac-surgery (CS) centres and 157 catheterization laboratories dedicated to treat ACS in Poland. The aim of the study was to analyze MVD patient outcomes presented with ACS in centers with or without CS on-site. METHODS: The present study is a retrospective analysis (2017-2020) of MVD ACS patients (n = 4618) outcomes between those treated in centers with CS on site (n = 595) and those without CS (n = 4023). RESULTS: Patients in CS centers had a higher prevalence of renal failure (13.3% vs. 8.8%, p ≤ 0.001) and a more frequent history of coronary angioplasty - percutaneous coronary intervention (18.9% vs. 14.4%, p = 0.005). During the coronary angiography a femoral artery access was more often used in CS center patients (47.1% vs. 15.2%, p < 0.001). Percutaneous coronary intervention of MVD was more often performed in CS centers (74.6% vs. 71.0%, p = 0.054). In-hospital death (7.6% vs. 4.6%, p = 0.002), reinfarction (1.1% vs. 0.1%, p < 0.001), hemorrhagic complications (6.4% vs. 1.6%, p < 0.001), recurrent target vessel revascularization (1.8% vs. 0.4%, p ≤ 0.001) and pulmonary edema (3.7% vs. 1.5%, p < 0.001) occurred more often in CS centers. CONCLUSIONS: The safety of ACS treatment in MVD patients in centers without CS on site is non-inferior to their treatment in centers with CS on site. Interestingly, there were more in-hospital adverse events observed in ACS MVD patients treated in centers with CS.

Fractional Flow Reserve-Negative High-Risk Plaques and Clinical Outcomes After Myocardial Infarction.

Importance: Even after fractional flow reserve (FFR)-guided complete revascularization, patients with myocardial infarction (MI) have high rates of recurrent major adverse cardiovascular events (MACE). These recurrences may be caused by FFR-negative high-risk nonculprit lesions. Objective: To assess the association between optical coherence tomography (OCT)-identified high-risk plaques of FFR-negative nonculprit lesions and occurrence of MACE in patients with MI. Design, Setting, and Participants: PECTUS-obs (Identification of Risk Factors for Acute Coronary Events by OCT After STEMI [ST-segment elevation MI] and NSTEMI [non-STEMI] in Patients With Residual Non-flow Limiting Lesions) is an international, multicenter, prospective, observational cohort study. In patients presenting with MI, OCT was performed on all FFR-negative (FFR > 0.80) nonculprit lesions. A high-risk plaque was defined containing at least 2 of the following prespecified criteria: (1) a lipid arc at least 90°, (2) a fibrous cap thickness less than 65 µm, and (3) either plaque rupture or thrombus presence. Patients were enrolled from December 14, 2018, to September 15, 2020. Data were analyzed from December 2, 2022, to June 28, 2023. Main Outcome and Measure: The primary end point of MACE, a composite of all-cause mortality, nonfatal MI, or unplanned revascularization, at 2-year follow-up was compared in patients with and without a high-risk plaque. Results: A total of 438 patients were enrolled, and OCT findings were analyzable in 420. Among included patients, mean (SD) age was 63 (10) years, 340 (81.0) were men, and STEMI and non-STEMI were equally represented (217 [51.7%] and 203 [48.3%]). A mean (SD) of 1.17 (0.42) nonculprit lesions per patient was imaged. Analysis of OCT images revealed at least 1 high-risk plaque in 143 patients (34.0%). The primary end point occurred in 22 patients (15.4%) with a high-risk plaque and 23 of 277 patients (8.3%) without a high-risk plaque (hazard ratio, 1.93 [95% CI, 1.08-3.47]; P = .02), primarily driven by more unplanned revascularizations in patients with a high-risk plaque (14 of 143 [9.8%] vs 12 of 277 [4.3%]; P = .02). Conclusions and Relevance: Among patients with MI and FFR-negative nonculprit lesions, the presence of a high-risk plaque is associated with a worse clinical outcome, which is mainly driven by a higher number of unplanned revascularizations. In a population with a high recurrent event rate despite physiology-guided complete revascularization, these results call for research on additional pharmacological or focal treatment strategies in patients harboring high-risk plaques.

Out-of-hospital cardiac arrest: Do we have to perform coronary angiography?

Out-of-hospital cardiac arrest (OHCA) remains a leading cause of global mortality, while survivors are burdened with long-term neurological and cardiovascular complications. OHCA management at the hospital level remains challenging, due to heterogeneity of OHCA presentation, the critical status of OHCA patients reaching the return of spontaneous circulation (ROSC), and the demands of post ROSC treatment. The validity and optimal timing for coronary angiography is one important, yet not fully defined, component of OHCA management. Guidelines state clear recommendations for coronary angiography in OHCA patients with shockable rhythms, cardiogenic shock, or in patients with ST-segment elevation observed in electrocardiography after ROSC. However, there is no established consensus on the angiographic management in other clinical settings. While coronary angiography may accelerate the diagnostic and therapeutic process (provided OHCA was a consequence of coronary artery disease), it might come at the cost of impaired post-resuscitation care quality due to postponing of intensive care management. The aim of the current statement paper is to discuss clinical strategies for the management of OHCA including the stratification to invasive procedures and the rationale behind the risk-benefit ratio of coronary angiography, especially with patients in critical condition.

Angio-computed tomography reveals differences in the anatomy of renal arteries in resistant hypertension patients qualified for renal denervation versus pseudo-resistant hypertensive subjects.

BACKGROUND: Renal denervation is a novel therapeutic option in resistant hypertension (RHT). The anatomy of renal arteries and the presence of additional renal arteries are important determinants of the effect of the procedure. The aim of this study was to assess the anatomy of renal arteries using angio- -computed tomography in patients with RHT, who were qualified for renal denervation. METHODS: We analyzed angio-computed tomography scans of the renal arteries of 72 patients qualified for renal denervation. We divided the study population into two groups: a resistant hypertension group (RHT) and a pseudo-resistant hypertension group (NRHT). The biochemical and endocrine diagnostic procedures were performed to rule out secondary hypertension. We analyzed the morphology, the diameters, and the number of additional renal arteries. RESULTS: In both groups, we found additional renal arteries (ARN). ARN were more frequent in RHT than in patients with non-resistant hypertension (48.4% vs. 24.3%; p < 0.05). They were present more often on the left side (18 left side vs. 7 right side). The ARNs were longer than main renal artery - left side 41.7 ± 12.1 mm vs. 51.1 ± 11.8 mm, right side 49.2 ± 14.5 mm vs. 60 ± ± 8.6 mm, respectively (p < 0.05). The diameters of ARN were similar in both groups. In the group of patients with RHT the number of ARN was significantly higher (p < 0.04). CONCLUSIONS: The ARNs occur more often in patients with RHT. It seems that there is no connection between the resistance of hypertension and the diameters of renal arteries.

Morphological characteristics of lesions with thin cap fibroatheroma-a substudy from the COMBINE (OCT-FFR) trial.

AIMS: To study if any qualitative or quantitative optical coherence tomography (OCT) variables in combination with thin cap fibroatheroma (TCFA) patients could improve the identification of lesions at risk for future major adverse cardiac events (MACEs). METHODS AND RESULTS: From the combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) trial database (NCT02989740), we performed a detailed assessment OCT qualitative and quantitative variables in TCFA carrying diabetes mellitus (DM) patients with vs. without MACE during follow-up. MACEs were defined as a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, and hospitalization for unstable angina. From the 390 fractional flow reserve (FFR)-negative DM patients, 98 (25.2%) had ≥1 OCT-detected TCFA, of which 13 (13.3%) had MACE and 85 (86.7%) were event-free (non-MACE). The baseline characteristics were similar between both groups; however, a smaller minimal lumen area (MLA) and lower mean FFR value were observed in MACE group (1.80 vs. 2.50 mm2, P = 0.01, and 0.85 vs. 0.89, P = 0.02, respectively). Prevalence of healed plaque (HP) was higher in the MACE group (53.85 vs. 21.18%, P = 0.01). TCFA were predominantly located proximal to the MLA. TCFA area was smaller in the MACE group, while no difference was observed regarding the lesion area. CONCLUSION: Within TCFA carrying patients, a smaller MLA, lower FFR values, and TCFA location adjacent to a HP were associated with future MACE. Carpet-like measured lesion area surface was similar, while the TCFA area was smaller in the MACE arm, and predominantly located proximal to the MLA.

Long-term outcomes of patients with normal fractional flow reserve and thin-cap fibroatheroma.

BACKGROUND: The long-term prognostic implications of fractional flow reserve (FFR)-negative lesions hosting vulnerable plaques remain unsettled. AIMS: The aim of this study was to evaluate the association of non-ischaemic lesions hosting optical coherence tomography (OCT)-detected thin-cap fibroatheromas (TCFA) with first and recurrent cardiovascular events during follow-up up to 5 years in a diabetes mellitus (DM) patient population. METHODS: COMBINE OCT-FFR is a prospective, international, double-blind, natural history study. Patients with DM and with ≥1 FFR-negative lesion were classified into 2 groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint (PE) is a composite of cardiac mortality, target vessel-related myocardial infarction (TV-MI), clinically driven target lesion revascularisation (TLR), or unstable angina (UA) requiring hospitalisation during follow-up up to 5 years. RESULTS: Among 390 DM patients (age 67.5±9 years; 37% female) with ≥1 FFR-negative lesion, 292 (74.9%) were TCFA-negative while 98 (25.1%) were TCFA-positive. The PE occurred more frequently in TCFA-positive than in TCFA-negative patients (21.4% vs 8.2%, hazard ratio [HR] 2.89, 95% confidence interval [CI]: 1.61-5.20; p<0.001; 6.42 vs 2.46 events per 100 patient-years, rate ratio [RR] 2.61, 95% CI: 1.38-4.90; p=0.002). Furthermore, when TV-MI, TLR, and UA were treated as recurrent components of the PE, TCFA-positive patients experienced a higher risk of recurrent events (HR 2.89, 95% CI; 1.74-4.80; p<0.001; 13.45 vs 2.87 events per 100 patient-years, RR 4.69, 95% CI: 2.86-7.83; p<0.001). A multivariable analysis identified the presence of TCFA as an independent predictor of the PE (HR 2.76, 95% CI: 1.53-4.97; p<0.001). CONCLUSIONS: OCT-detected TCFA-positive lesions, although not ischaemia-generating, are associated with an increased risk of adverse events during long-term follow-up. CLINICALTRIALS: gov: NCT02989740.

Human Gut Microbiota in Coronary Artery Disease: A Systematic Review and Meta-Analysis.

In recent years, the importance of the gut microbiome in human health and disease has increased. Growing evidence suggests that gut dysbiosis might be a crucial risk factor for coronary artery disease (CAD). Therefore, we conducted a systematic review and meta-analysis to determine whether or not CAD is associated with specific changes in the gut microbiome. The V3-V4 regions of the 16S rDNA from fecal samples were analyzed to compare the gut microbiome composition between CAD patients and controls. Our search yielded 1181 articles, of which 21 met inclusion criteria for systematic review and 7 for meta-analysis. The alpha-diversity, including observed OTUs, Shannon and Simpson indices, was significantly decreased in CAD, indicating the reduced richness of the gut microbiome. The most consistent results in a systematic review and meta-analysis pointed out the reduced abundance of Bacteroidetes and Lachnospiraceae in CAD patients. Moreover, Enterobacteriaceae, Lactobacillus, and Streptococcus taxa demonstrated an increased trend in CAD patients. The alterations in the gut microbiota composition are associated with qualitative and quantitative changes in bacterial metabolites, many of which have pro-atherogenic effects on endothelial cells, increasing the risk of developing and progressing CAD.

Intracoronary Imaging of Vulnerable Plaque-From Clinical Research to Everyday Practice.

The introduction into clinical practice of intravascular imaging, including intravascular ultrasound (IVUS), optical coherence tomography (OCT) and their derivatives, allowed for the in vivo assessment of coronary atherosclerosis in humans, including insights into plaque evolution and progression process. Intravascular ultrasound, the most commonly used intravascular modality in many countries, due to its low resolution cannot assess many features of vulnerable plaque such as lipid plaque or thin-cap fibroatheroma. Thus, novel methods were introduced to facilitate this problem including virtual histology intravascular ultrasound and later on near-infrared spectroscopy and OCT. Howbeit, none of the currently used modalities can assess all known characteristics of plaque vulnerability; hence, the idea of combining different intravascular imaging methods has emerged including NIRS-IVUS or OCT-IVUS imaging. All of those described methods may allow us to identify the most vulnerable plaques, which are prone to cause acute coronary syndrome, and thus they may allow us to introduce proper treatment before plaque destabilization.

Comparative Appraisal of Intravascular Ultrasound and Optical Coherence Tomography in Invasive Coronary Imaging: 2022 Update.

Although coronary angiography has been well established as a standard modality for percutaneous coronary intervention guidance, recent developments in intravascular imaging techniques, such as intravascular ultrasound and optical coherence tomography, have become increasingly adopted, enabling direct detailed lesion visualization, including lesions beyond the scope of assessment using exclusively angiography. Intravascular imaging modalities have been reported to potentially improve both short- and long-term percutaneous intervention outcomes. This review aims to provide a comparative summary of recent advancements in research regarding the clinical applications and outcomes of intravascular ultrasound and optical coherence tomography.

Thin-Cap Fibroatheroma Rather Than Any Lipid Plaques Increases the Risk of Cardiovascular Events in Diabetic Patients: Insights From the COMBINE OCT-FFR Trial.

BACKGROUND: Autopsy studies have established that thin-cap fibroatheromas (TCFAs) are the most frequent cause of fatal coronary events. In living patients, optical coherence tomography (OCT) has sufficient resolution to accurately differentiate TCFA from thick-cap fibroatheroma (ThCFA) and not lipid rich plaque (non-LRP). However, the impact of OCT-detected plaque phenotype of nonischemic lesions on future adverse events remains unknown. Therefore, we studied the natural history of OCT-detected TCFA, ThCFA, and non-LRP in patients enrolled in the prospective multicenter COMBINE FFR-OCT trial (Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients). METHODS: In the COMBINE FFR-OCT trial, patients with diabetes and ≥1 lesion with a fractional flow reserve >0.80 underwent OCT evaluation and were clinically followed for 18 months. A composite primary end point of cardiac death, target vessel-related myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina was evaluated in relation to OCT-based plaque morphology. RESULTS: A total of 390 patients (age 67.5±9 years; 63% male) with ≥1 nonischemic lesions underwent OCT evaluation: 284 (73%) had ≥1 LRP and 106 (27%) non-LRP lesions. Among LRP patients, 98 (34.5%) had ≥1 TCFA. The primary end point occurred in 7% of LRP patients compared with 1.9% of non-LRP patients (7.0% versus 1.9%; hazard ratio [HR], 3.9 [95% CI, 0.9-16.5]; P=0.068; log rank-P=0.049). However, within LRP patients, TCFA patients had a much higher risk for primary end point compared with ThCFA (13.3% versus 3.8%; HR, 3.8 [95% CI, 1.5-9.5]; P<0.01), and to non-LRP patients (13.3% versus 1.9%; HR, 7.7 [95% CI, 1.7-33.9]; P<0.01), whereas ThCFA patients had risk similar to non-LRP patients (3.8% versus 1.9%; HR, 2.0 [95% CI, 0.42-9.7]; P=0.38). Multivariable analyses identified TCFA as the strongest independent predictor of primary end point (HR, 6.79 [95% CI, 1.50-30.72]; P=0.013). CONCLUSIONS: Among diabetes patients with fractional flow reserve-negative lesions, patients carrying TCFA lesions represent only one-third of LRP patients and are associated with a high risk of future events while patients carrying LRP-ThCFA and non-LRP lesions portend benign outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02989740.

Co-toxicity of Endotoxin and Indoxyl Sulfate, Gut-Derived Bacterial Metabolites, to Vascular Endothelial Cells in Coronary Arterial Disease Accompanied by Gut Dysbiosis.

Gut dysbiosis, alongside a high-fat diet and cigarette smoking, is considered one of the factors promoting coronary arterial disease (CAD) development. The present study aimed to research whether gut dysbiosis can increase bacterial metabolites concentration in the blood of CAD patients and what impact these metabolites can exert on endothelial cells. The gut microbiomes of 15 age-matched CAD patients and healthy controls were analyzed by 16S rRNA sequencing analysis. The in vitro impact of LPS and indoxyl sulfate at concentrations present in patients' sera on endothelial cells was investigated. 16S rRNA sequencing analysis revealed gut dysbiosis in CAD patients, further confirmed by elevated LPS and indoxyl sulfate levels in patients' sera. CAD was associated with depletion of Bacteroidetes and Alistipes. LPS and indoxyl sulfate demonstrated co-toxicity to endothelial cells inducing reactive oxygen species, E-selectin, and monocyte chemoattractant protein-1 (MCP-1) production. Moreover, both of these metabolites promoted thrombogenicity of endothelial cells confirmed by monocyte adherence. The co-toxicity of LPS and indoxyl sulfate was associated with harmful effects on endothelial cells, strongly suggesting that gut dysbiosis-associated increased intestinal permeability can initiate or promote endothelial inflammation and atherosclerosis progression.

Clinical use of intracoronary imaging modalities in Poland. Expert opinion of the Association of Cardiovascular Interventions of the Polish Cardiac Society.

The article presents the most common, current indications for the use of intravascular invasive imag-ing diagnostic techniques, i.e. intravascular ultrasound and optical coherence tomography in Polish invasive cardiology centers. The application of the above-mentioned techniques in the diagnosis of stenosis of the left main coronary artery, optimization of stent implantation procedures, treatment of calcified lesions, and other clinically important issues are discussed.

Sleep-disordered breathing as a risk factor for unnecessary pacemaker implantation.

BACKGROUND: Sleep-disordered breathing (SDB) is a risk factor for bradyarrhythmia, which is reversible with positive airway pressure therapy. AIMS: The study aims to evaluate the occurrence and number of severe sinus bradycardia and advanced atrioventricular block (AVB) in patients with cardiovascular diseases and SDB risk factors. METHODS: The analysis covered 207 patients with cardiovascular diseases aged 59.4 (standard deviation [SD], 10.49) years, including 177 men (85.51%), hospitalized in the Department of Electro-cardiology and the Day Stay Cardiac Rehabilitation Ward Upper-Silesian Medical Centre in Katowice, Poland. The inclusion criterion was a high risk of SDB, in particular obstructive sleep apnea (OSA), in one of the following questionnaires: the Four-Variable Screening Tool, the STOP-Bang Questionnaire, and the Epworth Sleepiness Scale. Both level-3 portable sleep tests and electrocardiogram Holter recordings were made simultaneously. RESULTS: SDB was confirmed in 175 (84.5%) patients, including severe in 74 (35.7%), moderate in 42 (20.3%), and mild in 59 (28.5%) participants. The dominant type of SDB was OSA, which was found in 158 (76.3%) participants. The severe SDB was a predictor of third-degree AVB (odds ratio [OR], 11.61; 95% confidence interval [CI], 1.37-98.60), second-degree AVB type 2 (Mobitz) (OR, 4.51; 95% CI, 1.17-18.08), pauses above 3 seconds (OR, 10.26; 95% CI, 2.18-48.40), and sinus bradycardia below 40 bpm (OR, 3.00; 95% CI, 1.36-6.60) during sleep. CONCLUSIONS: SDB, with particular emphasis on OSA, is a risk factor for sinus bradycardia and advanced AVB during sleep, which may lead to a hasty qualification for pacemaker implantation. The severity of SDB determines the frequency and number of bradyarrhythmic episodes.

Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial.

AIMS: The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. METHODS AND RESULTS: COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001). CONCLUSIONS: Among DM patients with ≥1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients.

Performance of Integrated Near-Infrared Spectroscopy and Intravascular Ultrasound (NIRS-IVUS) System against Quantitative Flow Ratio (QFR).

Quantitative flow ratio (QFR) is a new opportunity to analyze functional stenosis during invasive coronary angiography. Together with a well-known intravascular ultrasound (IVUS) and a new player in the field, near-infrared spectroscopy (NIRS), it is gaining a lot of interest. The aim of the study was to compare QFR results with integrated IVUS-NIRS results acquired simultaneously in the same coronary lesion. We retrospectively enrolled 66 patients in whom 66 coronary lesions were assessed by NIRS-IVUS and QFR. Lesions were divided into two groups based on QFR results as QFR-positive group (QFR ≤ 0.8) or QFR-negative group (QFR > 0.8). Based on ROC curve analysis, the best cut-off values of minimal lumen area (MLA), minimal lumen diameter (MLD) and percent diameter stenosis for predicting QFR ≤ 80 were 2.4 (AUC 0.733, 95%CI 0.61, 0.834), 1.6 (AUC 0.768, 95%CI 0.634, 0.872) and 59.5 (AUC 0.918, 95%CI 0.824, 0.971), respectively. In QFR-positive lesions, the maxLCBI4mm was significantly higher than in QFR-negative lesions (450.12 ± 251.0 vs. 329.47 ± 191.14, p = 0.046). The major finding of the present study is that values of IVUS-MLA, IVUS-MLD and percent diameter stenosis show a good efficiency in predicting QFR ≤ 0.80. Moreover, QFR-positive lesions are characterized by higher maxLCBI4mm as compared to the QFR-negative group.