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.

Significance of S100B Protein as a Rapid Diagnostic Tool in Emergency Departments for Traumatic Brain Injury Patients.

Traumatic brain injuries (TBIs) are not only the leading cause of death among people below 44 years of age, but also one of the biggest diagnostic challenges in the emergency set up. We believe that the use of serum biomarkers in diagnosis can help to improve patient care in TBI. One of them is the S100B protein, which is currently proposed as a promising diagnostic tool for TBI and its consequences. In our study, we analyzed serum biomarker S100B in 136 patients admitted to the Emergency Department of the Regional Specialist Hospital in Olsztyn. Participants were divided into three groups: patients with head trauma and alcohol intoxication, patients with head trauma with no alcohol intoxication and a control group of patients with no trauma or with injury in locations other than the head. In our study, as compared to the control group, patients with TBI had a significantly higher S100B level (both with and without intoxication). Moreover, in both groups, the mean S100B protein level was significantly higher in patients with pathological changes in CT. According to our study results, the S100B protein is a promising diagnostic tool, and we propose including its evaluation in routine regimens in patients with TBI.

48-Month Clinical Outcomes and Prognostic Factors in an All-Comers Population with Acute Coronary Syndrome and Chronic Coronary Syndrome Undergoing Percutaneous Coronary Intervention with a Sirolimus-Eluting Stent.

We characterized the performance as well as safety of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), deployed in the acute coronary syndrome (ACS) setting. We enrolled patients who were subjected to percutaneous coronary intervention (PCI) between July 2015 and March 2016 and took into consideration demographics, clinical and laboratory data, and clinical outcomes. 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 88 ACS and 144 chronic coronary syndrome (CCS) patients. The mean age of the ACS population was 67 ± 13 years old, and 32% of it consisted of females. Patients with ACS were characterized by lower rates of arterial hypertension (85.2% vs. 95.8%, p = 0.004), dyslipidemia (67% vs. 81.9%, p = 0.01), prior MI (34.1% vs. 57.6%, p < 0.001), and prior PCI (35.2% vs. 68.8%, p < 0.001). At 48 months, among the ACS patients, the rates of MACE, death, cardiac death, MI, and TLR were 23.9%, 11.4%, 7.9%, 9.1%, and 10.2%, respectively. No stent thrombosis cases were reported. Multivariable Cox regression revealed that the statistically significant MACE predictors were massive calcifications in coronary arteries (HR 9.0, 95% CI 1.75-46.3, p = 0.009), post-dilatation (HR 3.78, 95% CI 1.28-11.2, p = 0.016), prior CABG (HR 6.64, 95% CI 1.62-27.1, p = 0.008), vitamin K antagonist use (HR 5.99, 95% CI 1.29-27.8, p = 0.022), and rivaroxaban use (HR 51.7, 95% CI 4.48-596, p = 0.002). The study findings show that Alex Plus was effective and safe in a contemporary cohort of real-world ACS patients undergoing primary PCI. The outcomes were comparable between the ACS and chronic coronary syndrome patients, with a trend of lower TLR in ACS patients at 4 years.

Clinical Outcomes and Prognostic Factors in Complex, High-Risk Indicated Procedure (CHIP) and High-Bleeding-Risk (HBR) Patients Undergoing Percutaneous Coronary Intervention with Sirolimus-Eluting Stent Implantation: 4-Year Results.

We aimed to characterize the performance and safety of percutaneous coronary intervention (PCI) in complex, high-risk indicated procedure (CHIP) and high-bleeding-risk (HBR) patients at a 4-year follow up. We included all consecutive patients who underwent PCI with the sirolimus-eluting coronary stent Alex Plus (Balton, Poland) between July 2015 and March 2016. We analyzed various baseline demographic and clinical characteristics, laboratory data, and clinical outcomes. We enrolled 232 patients in whom 282 stents were implanted, including 81 patients meeting the CHIP criteria and 76 patients meeting the HBR criteria. In the whole population, the mean age was 68 ± 11 years, and 23.7% were females. Most procedures were performed from radial access (83.2%) using a 6F guiding catheter (95.7%). The lesions were mostly predilated (61.6%), and postdilatation was performed in 37.9%. The device success was 99.6% (in one case, a second stent was required due to heavy calcifications). Additional stents were deployed in 39% of cases due to edge dissection (6.9%), side branch stenting (5.2%), or diffuse disease (26.9%). Myocardial infarction (MI) type 4a was revealed in 2.2% of cases. At 4 years, the MACE rates for the whole population and for CHIP and HBR patients were 23.3%, 29.6%, and 27.6%, respectively. CHIP patients had a higher risk of MACEs (29.6% vs. 19.9%, HR 1.69, p = 0.032) and cardiac death (11.1% vs. 4.6%, HR 2.50, p = 0.048). There were no differences for MI (7.4% vs. 6.6%, p = 0.826) and TLR (18.5% vs. 12.6%, p = 0.150). HBR patients were also characterized by a higher risk of MACEs (27.6% vs. 21.2%, HR 1.84, p = 0.049) and cardiac death (17.1% vs. 1.9%, HR 9.61, p < 0.001). There were no differences for MI (7.9% vs. 6.4%, p = 0.669) and TLR (11.8% vs. 16.0%, p = 0.991). PCI in CHIP and HBR patients is feasible with a low rate of periprocedural complications. Nevertheless, CHIP and HBR patients are at a high risk of future adverse events and require strict surveillance to improve outcomes.

The Comparison of Predicting Factors and Outcomes of MINOCA and STEMI Patients in the 5-Year Follow-Up.

The long-term outcomes of patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) are still not well known. This study aimed to compare the characteristics and outcomes between MINOCA and STEMI patients in a 5-year follow-up. Between 2010 and 2015 we identified 3171 coronary angiography procedures performed due to acute coronary syndrome, from which 153 had a working MINOCA diagnosis, and the final diagnosis of MINOCA was ascribed to 112 (5.8%) patients. Additionally, we matched 166 patients with STEMI and obstructive coronary arteries as the reference group. In MINOCA patients (mean age of 63 years), there were more females (60% vs. 26%, p < 0.001), and patients presented most frequently with NSTEMI (83.9%). Patients with MINOCA had more frequent atrial fibrillation (22% vs. 5.4%, p < 0.001) and higher left ventricular ejection fraction (59 ± 10% vs. 54 ± 10%, p < 0.001) compared to STEMI patients. We observed only a trend for a higher rate of MACE in STEMI patients at 5 years (11.6% vs. 18.7%, HR 1.82, 95% CI 0.91-3.63, p = 0.09). In multivariable Cox regression, only beta-blocker use was a protective factor (a trend observed), with HR 0.33, 95% CI 0.10-1.15, p = 0.082 of future MACE. The outcomes of MINOCA and STEMI patients were comparable in the 5-year follow-up.

Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry.

Introduction: Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-in-man registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods: In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results: The study population consisted of 95 patients (mean age: 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in 4 (4.2%) cases. At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions: Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.

Clinical characteristics and 12-month outcomes of patients with myocardial infarction with nonobstructive coronary arteries before and during the COVID-19 pandemic.

INTRODUCTION: SARS­CoV­2 infection is associated with an increased risk of thromboembolic complications. Thromboembolism is one of the possible causes of myocardial infarction with nonobstructive coronary arteries (MINOCA). OBJECTIVES: We aimed to compare the characteristics and 12­month clinical outcomes of patients with MINOCA treated before and during the COVID­19 pandemic. PATIENTS AND METHODS: We retrospectively analyzed data of 51 734 patients with acute myocardial infarction registered in the nationwide Polish Registry of Acute Coronary Syndromes database in 2019 and 2020. The final study group included 3178 patients with MINOCA. We compared the baseline characteristics, management strategies, and 12­month clinical outcomes of the MINOCA patients treated before (2019) and during the COVID­19 pandemic (2020). RESULTS: The rate of MINOCA was higher in 2019 than in 2020 (6.3% vs 5.9%; P = 0.03). The only difference between the groups was a higher hypercholesterolemia rate before the pandemic (33.9% vs 28.2%; P <0.001). In­hospital stroke was observed more frequently during the pandemic (0% vs 0.3%; P = 0.01), whereas other in­hospital complications were similar between the groups. Most patients were discharged on aspirin (85.6%), a ß­blocker (73.1%), an angiotensin­converting enzyme inhibitor / angiotensin receptor blocker (70.2%), and a statin (62.7%), but only 50.6% of the participants received a P2Y12 inhibitor. There was no difference in 12­month all­cause mortality between the patients with MINOCA treated before and during the pandemic (9.2% vs 11%; P = 0.09). CONCLUSIONS: We observed a lower percentage of MINOCA cases and higher in­hospital stroke rates in the MINOCA patients treated during the COVID­19 pandemic (2020). The possible association between worse clinical outcomes of the MINOCA patients treated during the pandemic and the increased risk for thromboembolic complications of SARS­CoV­2 infection needs further evaluation.

Complete Blood Count-Derived Indices as Prognostic Factors of 5-Year Outcomes in Patients With Confirmed Coronary Microvascular Spasm.

Background: Coronary microcirculatory dysfunction is a meaningful factor in the development of ischemic heart disease. We investigated the relationship between coronary microvascular spasm and complete blood count indices. Methods: Between 2010 and 2013, we performed acetylcholine test (AChT) in subjects with suspicion of angina evoked by epicardial coronary spasm or coronary microvascular spasm according to COVADIS criteria. We administered acetylcholine in increasing doses of 25, 50, and 75 µg into the right coronary artery and 25, 50, and 100 µg into the left coronary artery. Patients were followed up for 60 months. Results: In total, 211 patients (60.5 ± 7.8 years, 67.8% women) were included in the study. The AChT revealed angina due to epicardial coronary spasm in 99 patients (46.9%) and coronary microvascular spasm in 72 (34.1%). White blood cell (WBC), red blood cell distribution width (RDW), platelets (PLT), mean platelet volume (MPV), and platelet distribution width (PDW) values were significantly higher in patients with coronary microvascular spasm than in patients from the other two groups, i.e., epicardial coronary spasm and negative AChT. PDW showed the highest sensitivity (65%) and specificity (72%) at the cutoff value of 15.32% [area under the curve, 0.723; 95% confidence interval (CI) 0.64-0.83; P < 0.001]. Independent risk factors for coronary microvascular spasm diagnosis using AChT were as follows: female sex (OR, 1.199), PDW (OR, 2.891), and RDW (OR, 1.567). Conclusion: PDW and RDW are significantly associated with the diagnosis of coronary microvascular spasm in patients undergoing AChT as well as with poor prognosis in such patients at 5 years.

Cost comparison of intra-detrusor injection of botulinum toxin versus augmentation cystoplasty for refractory neurogenic detrusor overactivity in children.

INTRODUCTION: Treatment options for refractory neurogenic detrusor overactivity (NDO) in children include botulinum toxin type A (BTX-A) and augmentation cystoplasty (AC). Although BTX-A is accepted in contemporary pediatric urologic practice, cost and long-term outcomes data for BTX-A are limited relative to the gold standard, AC. The purpose of this study was to compare the projected 10-year costs of AC versus BTX-A. METHODS: We performed a cost analysis from the payer perspective by computationally modeling treatment sequences by a Markov model. In the model, we used probabilities derived from published sources, and costs obtained at a tertiary medical center. The base case was a pediatric patient with refractory NDO. In the model, we assumed biannual BTX-A treatments. Treatment costs over 10 years were compared between immediate AC versus bridging therapy with BTX-A. Using the computational model, we simulated 100,000 instances of 10-year treatment cost for each of the two treatment modalities. The costs for the two treatment approaches were then compared using t-test and Wilcoxon test. RESULTS: The projected median and mean 10-year cost of immediately AC were $51,798.72 (95% CI [$51,798.72, $327,483.80]) and $123,473.4 (SD: $98,085.23) respectfully, while the projected median and mean 10-year cost of bridging therapy with BTX-A prior to proceeding to AC as needed were $74,552.46 (95% CI [$53,188.56, $309,913.07]) and $124,858.80 (SD: $84,495.35) (p < 0.001). CONCLUSIONS: For a typical index pediatric patient with NDO, bridging therapy with intravesical BTX-A is associated with an increased cost compared to immediate AC over a ten-year period.

Clinical Characteristics and Predictors of In-Hospital Mortality of Patients Hospitalized with COVID-19 Infection.

Background: The identification of parameters that would serve as predictors of prognosis in COVID-19 patients is very important. In this study, we assessed independent factors of in-hospital mortality of COVID-19 patients during the second wave of the pandemic. Material and methods: The study group consisted of patients admitted to two hospitals and diagnosed with COVID-19 between October 2020 and May 2021. Clinical and demographic features, the presence of comorbidities, laboratory parameters, and radiological findings at admission were recorded. The relationship of these parameters with in-hospital mortality was evaluated. Results: A total of 1040 COVID-19 patients (553 men and 487 women) qualified for the study. The in-hospital mortality rate was 26% across all patients. In multiple logistic regression analysis, age ≥ 70 years with OR = 7.8 (95% CI 3.17−19.32), p < 0.001, saturation at admission without oxygen ≤ 87% with OR = 3.6 (95% CI 1.49−8.64), p = 0.004, the presence of typical COVID-19-related lung abnormalities visualized in chest computed tomography ≥40% with OR = 2.5 (95% CI 1.05−6.23), p = 0.037, and a concomitant diagnosis of coronary artery disease with OR = 3.5 (95% CI 1.38−9.10), p = 0.009 were evaluated as independent risk factors for in-hospital mortality. Conclusion: The relationship between clinical and laboratory markers, as well as the advancement of lung involvement by typical COVID-19-related abnormalities in computed tomography of the chest, and mortality is very important for the prognosis of these patients and the determination of treatment strategies during the COVID-19 pandemic.

A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study.

The risk of ischemic events gradually decreases after acute coronary syndrome (ACS), reaching a stable level after 1 month, while the risk of bleeding remains steady during the whole period of dual antiplatelet treatment (DAPT). Several de-escalation strategies of antiplatelet treatment aiming to enhance safety of DAPT without depriving it of its efficacy have been evaluated so far. We hypothesized that reduction of the ticagrelor maintenance dose 1 month after ACS and its continuation until 12 months after ACS may improve adherence to antiplatelet treatment due to better tolerability compared with the standard dose of ticagrelor. Moreover, improved safety of treatment and preserved anti-ischemic benefit may also be expected with additional acetylsalicylic acid (ASA) withdrawal. To evaluate these hypotheses, we designed the Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome - a randomized clinical trial (ELECTRA-SIRIO 2), to assess the influence of ticagrelor dose reduction with or without continuation of ASA versus DAPT with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients. The study was designed as a phase III, randomized, multicenter, double-blind, investigator-initiated clinical study with a 12-month follow-up (ClinicalTrials.gov Identifier: NCT04718025; EudraCT number: 2020-005130-15).

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.

The Impact of Sclerostin Levels on Long-Term Prognosis in Patients Undergoing Coronary Angiography: A Personalized Approach with 9-Year Follow-Up.

Sclerostin might play a role in atherosclerosis development. This study aimed to analyze the impact of baseline sclerostin levels on 9-year outcomes in patients without significant renal function impairment and undergoing coronary angiography. The primary study endpoint was the rate of major cardiovascular events (MACE), defined as a combined rate of myocardial infarction (MI), stroke, or death at 9 years. We included 205 patients with a mean age of 62.9 ± 0.6 years and 70.2% male. Median serum sclerostin concentration was 133.22 pg/mL (IQR 64.0-276.17). At 9 years, in the whole population, the rate of MACE was 34.1% (n = 70), MI: 11.2% (n = 23), stroke: 2.4% (n = 5), and death: 20.5% (n = 42). In the high sclerostin (>median) group, we observed statistically significant higher rates of MACE and death: 25.2% vs. 43.1% (HR 1.75, 95% CI 1.1-2.10, p = 0.02) and 14.6% vs. 26.5% (HR 1.86, 95% CI 1.02-3.41, p = 0.049), respectively. Similar relationships were observed in patients with chronic coronary syndrome and SYNTAX 0-22 subgroups. Our results suggest that sclerostin assessment might be useful in risk stratification, and subjects with higher sclerostin levels might have a worse prognosis.

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.