6-year results of BiOSS stents in coronary bifurcation treatment.

BACKGROUND: The wide variation in bifurcation anatomy has generated an ongoing search for stents explicitly designed for coronary bifurcations, and to date, results have been underachieved. METHODS: The POLBOS I and POLBOS II were international, multicentre, randomized, open-label, controlled trials. Patients were randomly assigned to BiOSS Expert (in POLBOS I, biodegradable polymer eluting paclitaxel)/BiOSS LIM (in POLBOS II, biodegradable polymer eluting sirolimus) stent implantation or regular drug-eluting stent (rDES) deployment. A provisional T-stenting strategy was the default treatment option. The primary endpoint of this pooled data study was the cumulative rate of major adverse cardiovascular events (MACE) consisting of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Telephone follow-up was performed annually up to 72 months. (ClinicalTrials.gov Identifier: POLBOS I-NCT02192840, POLBOS II-NCT02198300). RESULTS: The total study population consisted of 445 patients, 222 patients in the BiOSS group and 223 patients in the rDES group. The follow-up rate was 93.7% in the BiOSS group and 91.9% in the rDES group. At 72 months, there was no significant difference between BiOSS and rDES groups regarding MACE (25.7% vs 25.1%, HR 1.06, 95% CI 0.73-1.52), cardiac death (3.1% vs 4.0%, HR 0.94, 95% CI 0.43-2.34), MI (3.6% vs 4.9%, HR 0.76, 95% CI 0.32-2.89), TLR (18.9% vs 16.1%, HR 1.17, 95% CI 0.75-1.83) and stent thrombosis rates (0.9% vs 0.5%, HR 1.21, 95CI 0.75-2.09). CONCLUSIONS: At the 6-year follow-up, clinically significant clinical events did not differ between BiOSS stents and rDES.

The vicious cycle: a history of obesity and COVID-19.

Recently, we face a surge in the fast-forward Coronavirus Disease 2019 (COVID-19) pandemic with nearly 170 million confirmed cases and almost 3.5 million confirmed deaths at the end of May 2021. Obesity, also known as the pandemic of the 21st century, has been evolving as an adverse prognostic marker. Obesity is associated with a higher risk of being SARS-CoV-2-positive (46%), as well as hospitalization (113%) and death (48%) due to COVID-19. It is especially true for subjects with morbid obesity. Also, observational studies suggest that in the case of COVID-19, no favorable "obesity paradox" is observed. Therefore, it is postulated to introduce a new entity, i.e., coronavirus disease-related cardiometabolic syndrome (CIRCS). In theory, it applies to all stages of COVID-19, i.e., prevention, acute proceedings (from COVID-19 diagnosis to resolution or three months), and long-term outcomes. Consequently, lifestyle changes, glycemic control, and regulation of the renin-angiotensin-aldosterone pathway have crucial implications for preventing and managing subjects with COVID-19. Finally, it is crucial to use cardioprotective drugs such as angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers and statins. Nevertheless, there is the need to conduct prospective studies and registries better to evaluate the issue of obesity in COVID-19 patients.

BALLOON AORTIC VALVULOPLASTY WITH VALVER BALLOON CATHETER IN ADULTS WITH SEVERE AORTIC STENOSIS AS A BRIDGE OR PALLIATIVE TREATMENT.

OBJECTIVE: The aim: We aimed to assess the feasibility and safety of performing balloon aortic valvuloplasty (BAV) with Valver balloon catheter (Balton, Poland) in adults with severe aortic stenosis as a bridge or palliative treatment. PATIENTS AND METHODS: Materials and methods: We identified consecutive patients who underwent BAV procedures between May 2019 and March 2020 using Valver balloon catheters. Demographic data, medical history, and clinical characteristics were retrospectively collected in all study patients together with periprocedural data as well as 12-month follow-up data. RESULTS: Results: We included 18 patients. The mean population age was 78.1±8.9 years, and women were 61.1%. The most common co-morbidities were arterial hypertension (88.9%), dyslipidemia (83.3%), and coronary artery disease (72.2%). The baseline mean aortic valve pressure gradient was 49.94±27.02 mmHg and the mean aortic valve area (AVA) was 0.65±0.20 cm2. In all cases, the procedure was performed from the femoral access via the 8F sheath. Two Valver balloon catheter sizes were used 18x40mm (33.3%) and 20x40mm (66.7%). Three periprocedural complications were observed, and none was associated with the Valver balloon catheter per se. The transthoracic echocardiography after the procedure revealed a decrease in the mean pressure gradient of 11.1±8.85 mmHg, and an increase in AVA of 0.21±0.19 cm2. At 12-month follow-up, the mortality rate was 38.9%. CONCLUSION: Conclusions: BAV is a procedure increasingly performed in catheterization laboratories worldwide. This paper confirmed the relative safety of BAV with Valver balloon catheters in the modern era, showing a low incidence of valve and vascular complications.

THE ROLE OF INVASIVE AND NON-INVASIVE MEASUREMENTS OF HVPG IN DECISION MAKING IN PATIENTS WITH PORTAL HYPERTENSIONAND ESOPHAGEAL VARICES.

Many researchers and clinicians have taken the value of hepatic venous pressure gradient (HVPG) as an essential prognostic factor in subjects with chronic liver disorders. And HVPG alterations characterize a predictive value in subjects at the beginning of the disease (HVPG 6 - 10 mmHg) as well as in subjects in whom hemodynamically significant portal hypertension has developed (HVPG ≥ 10 mmHg). Our review aims to present the feasibility and applicability of HVPG in modern clinical practice in patients with liver cirrhosis, including invasive and non-invasive methods. HVPG measurement is a feasible method with a favorable safety profile. However, hemodynamically significant portal hypertension also might be determined using non-invasive options as elastography, magnetic resonance imaging, and indices derived from laboratory parameters, e.g., aspartate aminotransferase-to-platelet ratio, platelet count/spleen diameter ratio, or VITRO score. Hepatic vein catheterization with the evaluation of HVPG is the current gold standard for determining portal pressure; however, new non-invasive techniques are nowadays more frequently used.

Non-st-elevation acute coronary syndrome due to a totally occluded coronary artery: a history of two twin brothers.

We present the image of two twin brothers aged 53. Within 18 months they both underwent acute coronary syndrome treated with percutaneous coronary intervention (PCI). This story shows that both twins had similar comorbidities (hypercholesterolemia and hypothyroidism) as well as the course of the acute coronary syndrome. Although in both cases the coronary artery was totally occluded (in one case - fresh occlusion, in the other - CTO), no STEMI presentation was observed. Therefore, thorough investigation is warranted in twins after the acute coronary syndrome in of them, even in case of no evident ischemia symptoms.

Conservative treatment as a therapeutic option for penetrating aortic ulcer of the aortic arch in a patient with bicuspid aortic valve.

Penetrating aortic ulcer (PAU) is ulceration of an aortic atherosclerotic plaque penetrating through the internal lamina into the media. PAU is a rare condition and occurs in 2% - 7% of acute aortic syndromes (AAS); however, the actual incidence is unknown because of asymptomatic patients. One may treat it conservatively as well as surgically. We present a case of a 54-year-old man, who was admitted to hospital due to the exaggeration of exertional chest pain and persistent headaches. During coronary angiography, the suspicion of PAU was raised. Contrast-enhanced computed tomography confirmed the diagnosis. Transesophageal echocardiography showed bicuspid aortic valve with minimal calcification, the dilated ascending aorta, large atherosclerotic plaques in the aortic arch with ulceration (thickness: 5.0 - 5.5mm, diameter: 5 - 6 mm, depth: 3 - 4 mm), without intramural hematoma. Conservative treatment was chosen with uneventful 2-year follow-up. Although surgical management is advocated for patients with PAU type A, we demonstrated that type A PAU can be successfully treated conservatively as well.

Rational and design of the INtentional COronary revascularization versus conservative therapy in patients undergOing successful peripheRAl arTEry revascularization due to critical limb ischemia trial (INCORPORATE trial).

Critical limb ischemia is associated with excessively high risk for cardiovascular events, including myocardial infarction and death. Additionally, in this patient population non-invasive evaluation of coronary artery disease is limited due to (1) inability of exercise testing, (2) frequent occurrence of balanced ischemia and (3) frequent occurrence of diffuse coronary calcification. Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia trial (INCORPORATE trial) is a multicentric international randomized open label clinical trial. Trial will recruit patients, who underwent successful peripheral artery revascularization due to critical limb ischemia and randomize 1:1 to conservative medical therapy versus an immediate invasive strategy to investigate and treat coronary artery disease. The objective is to evaluate whether intentional invasive strategy with ischemia targeted reasonably complete coronary revascularization is superior as compared to conventional primarily conservative approach in terms of spontaneous myocardial infarction and overall survival at 12 months follow-up. The trial is registered at clinicaltrials.gov (NCT03712644).

The influence of calcium-phosphate metabolism abnormalities on the quality of life in patients with hemodynamically significant mitral regurgitation.

BACKGROUND: In recent years, studies have indicated that vitamin D [25(OH)D3] and other calcium-phosphate (Ca-P) metabolism parameters and their disturbances might be potential new factors that may influence health-related quality of life (HRQoL). The aim of our study was to assess the extent of Ca-P metabolism abnormalities in patients with significant mitral regurgitation (MR) and their effect on patients' HRQoL. METHODS: We included 99 patients with significant MR (median age, 75 years [Q1-Q3, 66.0-81.5], 35.4% females). Hemodynamically significant MR was assessed using transthoracic echocardiography (vena contracta > 3 mm, effective orifice area > 0.2 cm2, and MR volume > 30 mL/s). HRQoL was evaluated using a cardiac-specific (MacNew) tool. RESULTS: A significant negative correlation between parathormone (PTH) levels and HRQoL was demonstrated (r = - 0.242, - 0.243, and - 0.255; p = 0.018, 0.018, and 0.013 for Global Scores, and physical and social domains, respectively). Additionally, we confirmed that patients with higher NT-proBNP levels, NYHA heart failure (HF) class, and larger left ventricles had poorer HRQoL. Moreover, patients with poorer HRQoL walked a shorter distance in a 6-min walking test. CONCLUSIONS: To the best of our knowledge, this report is the first to show that Ca-P abnormalities resulted in significantly worse HRQoL, especially in the physical domain, in a population of patients with hemodynamically significant MR.

Statins use and cancer: an update.

After initial concerns regarding the association of statins with increased incidences of cancer and elevated cancer-related mortality, there are now plenty of data on the antitumor, cytostatic and cytotoxic effectiveness of this class of drugs. Here, we present a short review of possible mechanisms of antineoplastic activity obtained from preclinical research and the influence of statins on cancer treatment. In the second part of the article, we focus on the most recent data from observational clinical trials, as well as meta-analyses regarding cancer incidence and mortality in patients treated with statins.

Platelet distribution width as the prognostic marker in coronary bifurcation treatment.

BACKGROUND: Mean platelet volume (MPV) was proved to be a reliable prognostic factor in cardiac patients. However, platelet distribution width (PDW) was disclosed to be more specific marker of platelet reactivity. The aim of study was to evaluate whether baseline PDW value can predict the outcome in patients undergoing percutaneous coronary interventions (PCI) with drug-eluting stent implantation within coronary bifurcation lesions. MATERIALS AND METHODS: It was a two-centre observational study, which included patients who underwent PCI within bifurcation lesions between January 2014 and December 2014. Thrombocytopenia below 100 000/µL and STEMI were the exclusion criteria. Analysed data came entirely from in-hospital records and information obtained from the 12-month telephone follow-up. RESULTS: We included 269 patients. Mean PDW value was 13·4 ± 2·5 fL, whereas median was 13 (Q1 < 11·6 fL, Q2 11·6-13 fL, Q3 13-14·8 fL and Q4 > 14·8 fL). We found strong correlation between PDW and MPV (r = 0·96, P < 0·001), but no correlation was revealed between red blood cell distribution width (RDW) and PDW (r = 0·003, P = 0·95) as well as RDW and MPV (r = 0·0018, P = 0·98). Receiver operating characteristics (ROC) curve showed that PDW for cutoff 15·8% can predict MACE rate with sensitivity of 79% and specificity of 47% (area under curve - AUC 0·654; P = 0·01). A ROC curve for PDW categorized by 1-year TLR rate was described by optimal cutoff 16·3%, with sensitivity 69% and specificity 54% (AUC 0·697; P = 0·0015). CONCLUSIONS: PDW is an affordable and reliable predictor of 1-year MACE and TLR rate after PCI within coronary bifurcation lesions.

[The influence of drugs used in the treatment of diabetes type 2 on the cardio-vascular risk].

With the obesity epidemic, we observe increase in the number of people suffering from diabetes mellitus type 2. This illness is considered cardiovascular disease equivalent, so influence of drugs used to manage diabetes on cardiovascular outcomes is important. Below we present review of main class of drugs used in diabetes treatment and summingup of trials conducted with their use to evaluate cardiovascular risk during treatment.

First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM® Registry.

OBJECTIVES: The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM® (Balton, Poland) in 12-month Registry. BACKGROUND: The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions. METHODS: This was the international, 3-center registry, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months. RESULTS: A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE-ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug-eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow-up (11 ± 1 months) there was 1 non-cardiac death (1.7%), 1 non-ST-elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in-stent thrombosis. Overall TLR was 8.3% (clinically driven TLR - 1.7%, angiographically driven - 6.6%). Mean late lumen loss was as follows: In main vessel - 0.35 ± 0.33 mm, in main branch - 0.34 ± 0.27 mm and in side branch - 0.18 ± 0.38 mm. CONCLUSION: Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long-term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis.

Novel sirolimus-eluting stent Prolim® with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis.

BACKGROUND: The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population. METHODS: We prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15 % of patients (randomly chosen) underwent optical coherence tomography imaging. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization at 12 months. RESULTS: There were 204 patients enrolled, in whom 238 Prolim® stents were deployed (1.17 stent per patient). The mean age was 68 ± 10 years and 32.8 % were females. The examined stent was implanted in 5.9 % in STEMI patients, in 21.6 % - in NSTE-ACS and in 72.5 % - in patients with stable coronary artery disease. The Prolim® stent was most frequently implanted in right coronary artery (38.2 %) followed by left anterior descending artery (34.0 %). The cumulative major adverse cardiovascular events rate at 12 months was 6.9 %, and the clinically-driven target lesion revascularization rate - 5.4 %. At 12 months in quantitative coronary angiography the late lumen loss was 0.21 ± 0.18 mm, and in optical coherence tomography the mean neointima burden was 24.6 ± 8.6 %. CONCLUSIONS: Sirolimus-eluting Prolim® stent with a biodegradable polymer is a feasible device with a very good safety profile and long-term clinical effectiveness. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02545985 .

Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® in the treatment of distal left main stem stenosis.

OBJECTIVES: The aim of this study was to assess prospectively the effectiveness and safety profile of distal left main stem (LMS) stenosis treatment with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®. BACKGROUND: Angioplasty of distal LMS stenosis is always a high-risk procedure, and optimal treatment is uncertain. METHODS: This was a prospective international 2-center study, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) or stable angina with distal left main stenosis. All patients were treated with the dedicated bifurcation stent BiOSS Expert®. Provisional T-stenting was the obligatory strategy. Angiographic control was performed after 12 months. The primary end-point was cumulative rate of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months. Angiographic end-points included late lumen loss, percent diameter stenosis, and binary restenosis rate. RESULTS: A total of 54 patients with distal LMS stenosis were enrolled. Seven patients (13%) were enrolled during NSTE-ACS, 77.8% were hypertensive, 27.8% were diabetic, 51.9% had previous MI, 53.7% underwent prior percutaneous coronary intervention, and 16.7% coronary artery bypass graft. The mean SYNTAX score was 21.52 ± 6.50. The device success rate was 100%. The mean BiOSS Expert stent parameters were as follows: 4.07 ± 0.26 mm × 3.36 ± 0.26 mm × 16.61 ± 1.72 mm and in side branch the other stent (classical drug-eluting stent) was implanted in 25.9% of cases. The overall TLR was 9.3%. There were no death, stent thrombosis, or acute MI. In the univariate regression analysis, the only factor associated with higher risk for TLR was the SYNTAX score value. CONCLUSIONS: The dedicated bifurcation stent BiOSS Expert® proved to be a feasible device, with promising safety and long-term clinical effectiveness in the treatment of distal LMS stenosis.

Percutaneous Coronary Interventions with Sirolimus-Eluting Alex Plus Stents in Patients with or without Diabetes: 4-Year Results.

We characterized the performance, as well as the safety, of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), implanted in patients with type 2 diabetes (DM) with a 4-year follow-up. We defined the primary endpoint as the 48-month rate of major cardiovascular adverse events (MACE), including cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were all-cause death, cardiac death, MI, and TLR rates at 12, 24, 36, and 48 months. We enrolled 232 patients in whom 282 stents were implanted, including 97 DM and 135 non-DM patients. The mean age of the DM patients was 69.5 ± 10.1 years and females accounted for 30% of the patients. DM patients had higher rates of arterial hypertension (97% vs. 88%, p = 0.016), dyslipidemia (86% vs. 70%, p = 0.005), prior MI (61% vs. 40%, p = 0.002), prior PCI (65% vs. 50%, p = 0.020), and prior CABG (14% vs. 5.9%, p = 0.029). We recorded statistically significant differences for MACE (HR 1.85, 95% CI 1.01-3.41, p = 0.046), cardiac death (HR 4.46, 95% CI 1.44-13.8, p = 0.010), and MI (HR 3.17, 95% CI 1.10-9.12, p = 0.033), but not for TLR, between DM and non-DM patients in terms of the analyzed endpoints at 4 years. Our study showed that Alex Plus was efficient and safe in a contemporary cohort of real-world DM patients undergoing percutaneous revascularization.

The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results.

This multicenter, randomized study aimed to compare the sirolimus-eluting BiOSS LIM C dedicated coronary bifurcation stent with second-generation -limus drug-eluting stents (rDESs) in the treatment of non-left main (non-LM) coronary bifurcation. The deployment of a single stent in the main vessel-main branch across a side branch was the default strategy in all patients. The primary endpoint was the rate of major cardiovascular events (cardiac death, myocardial infarction, and target lesion revascularization) at 48 months. We enrolled 230 patients, allocating 116 patients to the BiOSS LIM C group and 114 patients to the rDES group. Most procedures were elective (BiOSS vs. rDES: 48.3% vs. 59.6%, p = 0.09) and performed in bifurcations within the left anterior descending/diagonal branch (BiOSS vs. rDES: 51.7% vs. 61.4%, p = 0.15). At 48 months, there were no statistically significant differences between the BiOSS and rDES groups in terms of major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) as follows: MACEs-18.1% vs. 14.9%, HR 1.36, 95% CI 0.62-2.22, and p = 0.33; cardiac death-4.3% vs. 3.5%, HR 1.23, 95% CI 0.33-4.56, and p = 0.75; MI-2.6% vs. 3.5%, HR 0.73, 95% CI 0.17-3.23, and p = 0.68; and TLR-11.2% vs. 7.9%, HR 1.66, 95% CI 0.75-3.71, and p = 0.21. The implantation success rate of the BiOSS LIM C stent was very high, and the cumulative MACE rates were promising. The POLBOS 3 trial sets an important benchmark for treating non-LM coronary bifurcations (ClinicalTrials.gov NCT03548272).

Clinical characteristics and predictors of in-hospital mortality of patients hospitalized with myocardial infarction before and during COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has impacted many acute coronary syndrome (ACS) care aspects. The aim was to compare the patient profile, ACS characteristics, and the outcomes in patients referred to the invasive cardiology department before (March 2019 - February 2020) and during the COVID-19 pandemic (March 2020 - February 2021). MATERIAL AND METHODS: Clinical and demographic features, comorbidities, laboratory parameters at admission, and periprocedural data were recorded. The relationship of these parameters with in-hospital mortality was assessed. RESULTS: Before the COVID-19 pandemic, 664 patients were admitted due to ACS (mean age 67.16 ± 11.94 years, females 32.1%), and during the COVID-19 pandemic 545 ACS patients were recorded [mean age 66.02 ± 12.02 years (p = 0.463), females 31% (p = 0.706)]. A 17.8% decrease in the ACS rate was observed. During the pandemic, there were more STEMI patients (44.3% vs. 52.1%, p < 0.001) and fewer patients treated conservatively (24.9% vs. 8%, p < 0.001). Most lesions were located in the left anterior descending artery (53.4% vs. 54.7%), but post-percutaneous coronary intervention TIMI 3 was observed more frequently before the pandemic (83.9% vs. 75.1%, p < 0.001). Periprocedural complication rates did not differ between the groups. In-hospital outcomes did not differ between analyzed periods regarding all-cause death nor cardiac death rates, 5.3% vs. 4.6% (p = 0.598) and 4.5% vs. 3.7% (p = 0.473), respectively. CONCLUSIONS: Based on the analysis of 1209 patients, a decrease in ACS patients admitted during the pandemic was recorded, but in-hospital mortality remained similar.

Predicting Short- and Long-Term Functional Outcomes Based on Serum S100B Protein Levels in Patients with Ischemic Stroke.

BACKGROUND: Ischemic stroke is one of the leading causes of mortality and disability. The neuroimaging methods are the gold standard for diagnostics. Biomarkers of cerebral ischemia are considered to be potentially helpful in the determination of the etiology and prognosis of patients with ischemic stroke. AIM: This study aimed to investigate the usefulness of serum S100B protein levels as a short- and long-term prognostic factor in patients with ischemic stroke. STUDY DESIGN AND METHODS: The study group comprised 65 patients with ischemic stroke. S100B protein levels were measured by immunoenzymatic assay. Short-term functional outcome was determined by the NIHSS score on day 1 and the difference in the NIHSS scores between day 1 and day 9 (delta NIHSS). Long-term outcome was assessed by the modified Rankin Scale (MRS) at 3 months after the stroke. At the end of the study, patients were divided into groups based on the NIHSS score on day 9 (0-8 "good" and >8 "poor"), the delta NIHSS ("no improvement" ≤0 and >0 "improvement"), and the MRS ("good" 0-2 and >2 "poor"). Differences in S100B levels between groups were analyzed with the ROC curve to establish the optimal cut-off point for S100B. The odds ratio was calculated to determine the strength of association. Correlations between S100B levels at three time points and these variables were evaluated. RESULTS: We revealed a statistically significant correlation between S100B levels at each measurement point (<24 h, 24-48 H, 48-72 h) and the NIHSS score on day 9 (R Spearman 0.534, 0.631, and 0.517, respectively) and the MRS score after 3 months (R Spearman 0.620, 0.657, and 0.617, respectively). No statistically significant correlation was found between S100B levels and the delta NIHSS. Analysis of the ROC curve confirmed a high sensitivity and specificity for S100B. The calculated AUC for the NIHSS on day 9 were 90.2%, 95.0%, and 82.2%, respectively, and for the MRS, 83.5%, 83.4%, and 84.0%, respectively. After determining the S100B cut-off, the odds ratio for beneficial effect (NIHSS ≤ 8 at day 9 or MRS 0-2 after 3 months) was determined for each sampling point. CONCLUSION: S100B is a useful marker for predicting short- and long-term functional outcomes in patients with ischemic stroke.

Ten-Year Outcomes in Patients Undergoing Simultaneous Coronary and Renal Angiography-Does Renal Artery Stenosis Matter?

Background: We aimed to characterize the population of consecutive patients undergoing coronary angiography with simultaneous renal artery angiography and assess prognostic factors at a 10 year follow-up. Methods: The KORONEF study was a prospective, single-center, observational, and descriptive study with 492 patients included. We analyzed several baseline demographics, clinical and periprocedural characteristics, and laboratory data, and we assessed the results of coronary angiography and renal artery angiography. Results: The study population consisted of 37.2% women, and the mean age was 64.4 ± 9.9 years (min. 30 years, max. 89 years). Angiography revealed significant renal artery stenosis (RAS) in 35 (7.1%) patients. Among patients with significant RAS (≥50%), we observed more women (57.1% vs. 35.7%, p = 0.011), and patients were older (69.1 ± 10.4 years vs. 64.0 ± 9.7 years, p = 0.005). In the whole population, all-cause death was reported in 29.9% of patients, myocardial infarction (MI) rate-in 11.8%, and stroke-in 4.9%. In the multivariable analysis, independent predictors of death were age 65-75 years (HR 2.88), age > 75 years (HR 8.07), diabetes (HR 1.59), previous MI (HR 1.64), chronic kidney disease (HR 2.22), unstable angina (HR 0.37), and left ventricular ejection fraction > 60% (HR 0.43). Conclusions: Over a 10 year follow-up, the all-cause death rate was 29.9%, showing no statistically significant differences between patients with and without significant RAS.

Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.

OBJECTIVES: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018. BACKGROUND: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes. METHODS: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality. RESULTS: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]). CONCLUSION: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.