Jarosław Wasilewski

Temporal Trends in the Treatment and Outcomes of Patients With Non-ST-Segment Elevation Myocardial Infarction in Poland from 2004–2010 (from the Polish Registry of Acute Coronary Syndromes)

The aim of this work was to analyze temporal trends in clinical presentation, treatment methods, and outcomes of patients in Poland with non-ST-segment elevation myocardial infarction (NSTEMI) from 2004 to 2010. A total of 90,153 patients with NSTEMI enrolled in the Polish Registry of Acute Coronary Syndromes (PL-ACS) from 2004 to 2010 were analyzed. The main outcome measure was all-cause mortality after 12 months, identified from official mortality records. The percentage of admissions for NSTEMI among all acute coronary syndromes increased from 24% in 2004 to 38% in 2010 (p < 0.0001). From 2004 to 2010, the percentage of invasive treatment for NSTEMI increased significantly, almost threefold, to 83% (p < 0.0001). The frequency of recurrent myocardial infarction and stroke during hospitalization decreased significantly over the years, while the frequency of major bleeding increased. Twelve-month mortality decreased significantly throughout the time period, from 19.1% to 14.5%, but was stable in patients treated invasively and slightly higher in the last years in patients treated noninvasively. The invasive treatment of NSTEMI (relative risk 0.62, 95% confidence interval 0.57 to 0.67, p < 0.0001), together with the pharmacotherapy recommended by the guidelines, had a significant impact on reducing 12-month mortality in a multifactor analysis. In conclusion, the distinct improvement in the short- and long-term prognoses of patients with NSTEMI may be in part the result of the popularization of invasive treatment and the optimization of pharmacotherapy.

The Prognostic Role of Red Blood Cell Distribution Width in Coronary Artery Disease: A Review of the Pathophysiology.

Red blood cell distribution width (RDW) is a measure of red blood cell volume variations (anisocytosis) and is reported as part of a standard complete blood count. In recent years, numerous studies have noted the importance of RDW as a predictor of poor clinical outcomes in the settings of various diseases, including coronary artery disease (CAD). In this paper, we discuss the prognostic value of RDW in CAD and describe the pathophysiological connection between RDW and acute coronary syndrome. In our opinion, the negative prognostic effects of elevated RDW levels may be attributed to the adverse effects of independent risk factors such as inflammation, oxidative stress, and vitamin D3 and iron deficiency on bone marrow function (erythropoiesis). Elevated RDW values may reflect the intensity of these phenomena and their unfavorable impacts on bone marrow erythropoiesis. Furthermore, decreased red blood cell deformability among patients with higher RDW values impairs blood flow through the microcirculation, resulting in the diminution of oxygen supply at the tissue level, particularly among patients suffering from myocardial infarction treated with urgent revascularization.

Quality-of-Life Outcomes With Coronary Artery Bypass Graft Surgery in Ischemic Left Ventricular Dysfunction: A Randomized Trial

Context A randomized, controlled trial of patients with high-risk coronary artery disease and heart failure previously reported no significant difference between medical therapy alone and medical therapy plus coronary artery bypass grafting when the outcome was death from any cause. Contribution This study from the same trial reports that medical therapy plus coronary artery bypass grafting is better than medical therapy alone when the outcome is quality of life. Caution The type of therapy was not concealed from patients or investigators. Implication This is the first study to examine how these therapies affect quality of life in patients who have coronary artery disease and heart failure. The Editors Clinical trials performed during the 1970s and 1980s defined several major coronary artery disease (CAD) subgroups for which coronary artery bypass grafting (CABG) provided incremental survival, angina relief, or both relative to medical therapy. These early trials formed the foundation for current practice patterns and guideline recommendations on the use of CABG (13). However, patients with severe left ventricular dysfunction (ejection fraction 0.35) were not represented. Thus, management decisions for these patients have largely relied on clinical judgment to extrapolate from those trials and a small group of observational studies(4, 5). The challenges in using this evidence to select treatment for contemporary patients is further complicated by the substantial improvement in medical therapies for both CAD and heart failure over those used in the earlier trials. The STICH (Surgical Treatment for Ischemic Heart Failure) trial was funded by the National Heart, Lung, and Blood Institute in 2002 to provide a comprehensive evaluation of the incremental therapeutic benefits of routine CABG over contemporary guideline-based medical therapy in patients with severe systolic dysfunction due to CAD (6). A major prespecified secondary end point of the trial was health-related quality of life (QOL), which is an outcome that complements the major clinical end points by assessing the patients experience of, and satisfaction with, the 2 therapeutic strategies compared (7, 8). Methods Patient Population and Primary Clinical Results To test the STICH trials surgical revascularization hypothesis, we randomly assigned 1212 patients with site-defined left ventricular ejection fraction of 0.35 or less and CAD suitable for revascularization to CABG or medical therapy (6). Rationale, trial design, and complete inclusion and exclusion criteria have been described previously (7). Patients were enrolled at 99 clinical sites in 22 countries between July 2002 and May 2007. All patients provided informed consent, and study protocol was approved by each sites institutional review board or ethics committee. Median follow-up was 56 months. The primary intention-to-treat comparison showed that 35.7% of patients assigned to CABG and 40.5% of those assigned to medical therapy died (primary analysis: unadjusted hazard ratio for all-cause mortality, 0.86 [95% CI, 0.72 to 1.04]; P= 0.123; secondary analysis: adjusted hazard ratio for all-cause mortality, 0.82 [CI, 0.68 to 0.99]; P= 0.039). Patients assigned to CABG had lower rates of the 2 major secondary clinical end points: death from cardiovascular causes (hazard ratio, 0.81; P= 0.050) and the composite of all-cause mortality and hospitalization for cardiovascular causes (hazard ratio, 0.74; P< 0.001). Health-Related QOL Data Collection We collected QOL data using structured interviews at baseline and 4, 12, 24, and 36 months after randomization. Site coordinators were specially trained by the Duke Clinical Research Institute Outcomes Research Group to conduct baseline interviews. The original research plan called for all patients to be enrolled in North America and all English- and Spanish-language follow-up QOL interviews to be completed via telephone by the Duke Clinical Research Institute. The few patients expected to require French-language interviews were to be interviewed by site coordinators. When enrollment was expanded outside of North America, the plan was modified to have those site coordinators do all QOL interviews in the patients native language. For nonEnglish-speaking participants, translations of the QOL instruments were obtained from the instrument developers or a translation service was used to create validated translations. The New York Heart Association (NYHA) class and Canadian Cardiovascular Society (CCS) angina class were collected on the clinical case report form at baseline and each follow-up interval. QOL Measures A battery of validated measures was used to provide a comprehensive but efficient assessment of QOL. The principal prespecified QOL measure was the Kansas City Cardiomyopathy Questionnaire (KCCQ), which is a 23-item instrument that measures the effect of heart failure symptoms on QOL (9). We used 3 scales from the Seattle Angina Questionnaire to assess the effect of angina symptoms on QOL outcomes (10), the Short Form-12 Survey to provide a brief overall generic measure of health status (11), and 5 individual scales from the Short Form-36 Health Survey to provide a more detailed assessment of areas of functioning and well-being from a generic perspective (12). Depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale (13). The Cardiac Self-Efficacy Questionnaire was used to measure patient confidence in controlling disease symptoms and maintaining physical functioning (14). Finally, we used the EuroQol-5D, which is a generic instrument consisting of a 5-dimension single summary health status index and a self-rated visual analogue scale (0 to 100) of current health-related QOL (15). Statistical Analysis All primary comparisons were performed with the treatment group defined according to the intention-to-treat principle. Descriptive statistics included percentages for discrete variables and medians with 25th to 75th percentiles plus means with SDs for continuous variables. The chi-square test was used for discrete variable comparisons. Treatment comparisons of continuous variables were done by using a linear mixed model to account for repeated measures within a patient. The baseline QOL measure was used as one of the repeated measures. In PROC MIXED in SAS, version 9.2 (SAS Institute), the baseline, 4-, 12-, 24-, and 36-month measurements within a patient were fitted using maximum likelihood methods with unstructured covariance matrix (16). At each time point, estimated treatment differences, 95% CIs, and P values were obtained using the model estimates. Finally, the proportion of patients who achieved a clinically important improvement of 5 points or more in KCCQ overall summary scores were compared by treatment group using the chi-square test (17). All analyses were conducted using SAS, version 8 or higher. All reported P values were 2-sided. No adjustment was made in significance levels for multiple comparisons. Benchmarks for clinically significant changes in QOL scores for individual patients were used informally to assess the magnitude of the mean difference between the 2 groups. However, a QOL difference between groups at or exceeding the benchmark was not used as a formal decision rule to define clinical significance. Subgroup Analysis Regional effects were tested as interactions between the 5 regions used in the clinical analyses (Asia, Australia and New Zealand, Europe, North America, and South America) and the KCCQ overall summary score. Other interactions tested from those prespecified in the clinical analysis plan included age, sex, race, current NYHA class, left ventricular ejection fraction, baseline diabetes, CCS angina class, and myocardium viability. Sensitivity Analysis Some QOL data were missing because a small proportion of living patients did not complete a scheduled QOL assessment and a larger proportion of patients died before 1 or more of the scheduled assessments could be done. Almost all cases of missing data among living patients were attributed to administrative reasons rather than their state of health (Supplement 1), which supports the assumption of missing at random and the use of multiple imputation techniques. Supplement 1. Data Collection in the Surgical Treatment of Ischemic Heart Disease (STICH) Trial Quality of Life Substudy The STICH trial had a high overall mortality rate and a treatment-related mortality difference, as noted previously. These deaths produced a nonrandom group of survivors who provided the follow-up QOL data. No consensus exists in the statistical literature about how best to analyze intermediate end points, such as QOL, when death prevents complete data collection. The primary concern this issue raises in a treatment comparison is that a therapy more effective at preventing death may also preserve more patients with poor QOL than the comparison therapy. Thus, when comparing QOL in such a situation using all survivors, the therapy with the worse survival might have an artifactual improvement in QOL measurements. Rubin has proposed that because QOL data that are censored due to death do not exist even in theory and should be regarded as undefined, the most meaningful analysis is to compare QOL for patients in the 2 treatment groups who would have survived with either therapy (18). To accomplish this, we performed a survival average causal effect (SACE) analysis (1821). The SACE estimates of QOL are calculated from weighted averages of the QOL data multiplied by survival probability estimates (from survival models developed in the parent STICH study cohort) specific to the study group. The 95% CIs for the SACE were calculated using 200 repetitions of a nonparametric bootstrap procedure (22). These sensitivity analyses are helpful as supplements to the primary analysis but have their own difficulties, not the least of which are the important but untestable assumptioClinical trials performed during the 1970s and 1980s defined several major coronary artery disease (CAD) subgroups for which coronary artery bypass grafting (CABG) provided incremental survival, angina relief, or both relative to medical therapy, which formed the foundation for current practice patterns and guideline recommendations on the use of CABG (1-3). However, patients with severe left ventricular dysfunction (ejection fraction ≤0.35) were not represented in these early trials. Thus, management decisions for these patients have largely relied on clinical judgment to extrapolate from those trials and a small group of observational studies (4, 5). The challenges in using this evidence to select treatment for contemporary patients is further complicated in that medical therapies for both CAD and heart failure have improved substantially over those used in the earlier trials. The STICH (Surgical Treatment for Ischemic Heart Failure) trial was funded by the National Heart, Lung, and Blood Institute in 2002 to provide a comprehensive evaluation of the incremental therapeutic benefits of routine CABG over contemporary guideline-based medical therapy in patients with severe systolic dysfunction due to CAD (6). A major prespecified secondary end point of the trial was health-related quality of life (QOL), which is an outcome that complements the major clinical end points by assessing the patient’s experience of, and satisfaction with, the 2 therapeutic strategies compared (7, 8).

Outcomes of primary coronary angioplasty and angioplasty after initial thrombolysis in the treatment of 374 consecutive patients with acute myocardial infarction

BACKGROUND In patients with acute myocardial infarction (MI), the efficacy of thrombolysis is low. Angioplasty after failed thrombolysis (rescue percutaneous coronary angioplasty [PTCA]) has been associated with an increase in the incidence of inhospital complications. It has been proposed that these complications result from the procedure itself. Thus, the aim of this study was to compare the efficacy, inhospital complications, and mortality rate of patients with MI who are treated with primary PTCA and PTCA after initial thrombolysis (rescue or immediate rescue) in an experienced clinical center specializing in percutaneous coronary interventions. METHODS AND RESULTS The study group consisted of consecutive patients with MI treated with primary PTCA (n = 195) or PTCA after initial thrombolysis (n = 179). The study was performed in a referral center with a 24-hour catheter-laboratory service. The success rate of the procedure was 90.5% and 88.2% in the PTCA after initial thrombolysis group and primary PTCA group, respectively. The groups did not differ in the frequency of reocclusion, emergency surgical revascularization (coronary artery bypass grafting), or stroke. In patients without cardiogenic shock, the inhospital mortality rates were 3.2% and 0.6% in the rescue and immediate rescue group and primary PTCA group, respectively (not significant). In a subgroup of patients with cardiogenic shock, the mortality rate was 36.0% in the initial thrombolysis PTCA group and 30.8% in the primary PTCA group. However, after successful PTCA in this subgroup, the mortality rate dropped to 18% and 10%, respectively. CONCLUSIONS After initial thrombolysis, PTCA is safe, effective, and likely to restore grade 3 Thrombolysis In Myocardial Infarction flow in about 90% of patients. When available, immediate rescue PTCA should be performed in all patients, including patients with cardiogenic shock.

The platelet-to-lymphocyte ratio as a predictor of all-cause mortality in patients with coronary artery disease undergoing elective percutaneous coronary intervention and stent implantation

Background There is no data regarding the association between the platelet-to-lymphocyte ratio (PLR) and long-term mortality in patients with stable coronary artery disease (SCAD). The aim of this study is to evaluate the utility of the pre-procedural PLR for predicting long-term, all-cause mortality in patients with SCAD undergoing percutaneous coronary intervention (PCI) and stent implantation. Methods We analyzed a total of 2959 consecutive patients with SCAD who underwent PCI (balloon angioplasty followed by stent implantation or direct stenting) between July 2006 and December 2011 at our institution. The patients were stratified into tertiles according to their admission PLR. The association between the PLR value and the outcomes was assessed using Cox proportional regression analysis after adjusting for clinical angiographic and laboratory data. Results During median follow-up of 1124 days, mortality was highest in patients with PLR within the 3rd tertile as compared to the 2nd and the 1st tertile (11.0% vs 8.7% vs. 9.6%, respectively, p = 0.03). PLR remained associated with mortality in multivariable analysis including clinical variables, ejection fraction and angiographic parameters HR (per 10 units increase) = 1.02 [95%CI,1.01 ÷ 1.04, p = 0.006]. After adjustment for the eGFR and hemoglobin levels, PLR was however no longer significantly associated with mortality. Conclusion PLR has potential predictive value in patients with SCAD, which has not been reported previously, but statistical significance disappears after adjusting for estimated glomerular filtration rate (eGFR) and hemoglobin levels as a potential confounding variable.

Invasive and non-invasive fractional flow reserve index in validation of hemodynamic severity of intracoronary lesions.

This review discusses visual and functional evaluation of the hemodynamic significance of the degree of stenosis in coronary angiography, with respect to the indications for revascularization. The concept of the coronary flow reserve is defined, and the theoretical assumptions of the invasive measurement of the fractional flow reserve (FFR) are presented. In the following part, the publication describes the basic steps of numerical stimulations in terms of computational fluid dynamics (CFD) in calculating the fractional flow reserve based on computed tomography (CT) coronary angiography (FFRCT). The numerical FFRCT estimation in correlation with invasive measurements, as well as benefits deriving from FFRCT in the diagnosis of coronary artery disease, is presented in the example of the multicentre prospective DISCOVER-FLOW trial and the DeFACTO project. The CDF method enables to obtain hemodynamic significance of stenosis solely from the coronary anatomy vizualized by CT angiography. The calculation of FFRCT increases the diagnostic reliability of coronary flow reserve estimations. It contributes to the improvement in patients’ qualification for contrast coronarography. If the accuracy of FFRCT is confirmed in clinical practice, and the time required for computational processing is shortened, it may turn out that the algorithms of coronary heart disease diagnosis will be verified and it will be to a greater extent based on the CT results.

Prognostic implications of mean platelet volume on short- and long-term outcomes among patients with non-ST-segment elevation myocardial infarction treated with percutaneous coronary intervention: A single-center large observational study

Abstract Background: Mean platelet volume (MPV) is a simple and reliable indicator of platelet size that correlates with platelet activation and their ability to aggregate. We studied the predictive value of MPV in patients with non-ST-segment elevation myocardial infarction (NSTEMI) treated with percutaneous coronary intervention (PCI). Methods: We analyzed the consecutive records of 1001 patients who were hospitalized due to NSTEMI at our center. The primary end point was a composite end point that included the rates of all-cause death, non-fatal myocardial infarction, and acute coronary syndrome (ACS) driven revascularization at 12 months. The enrolled patients were stratified according to the quartile of the MPV level at admission. Results: Along with the increasing quartile of MPV, the 12-month composite end point increased significantly (p = 0.010), and this association remained significant after the risk-adjusted analyses (per 1 fL higher MPV; adjusted hazard ratio [HR] 1.13; 95% confidence interval [CI] 1.02–1.27; p = 0.026). In the multivariate analysis, the MPV was also an independent factor of all-cause mortality (per 1 fL increase; adjusted HR 1.34; 95% CI 1.12–1.61; p = 0.0014) and death or non-fatal myocardial infarction (per 1 fL increase; adjusted HR 1.16; 95% CI 1.03–1.31; p = 0.017). Conclusion: In patients with NSTEMI treated with PCI, a high MPV value was associated with a significantly increased incidence of long-term adverse events, particularly for all-cause mortality.

Functional polymorphism rs710218 in the gene coding GLUT1 protein is associated with in-stent restenosis

AIM To analyze the association between in-stent restenosis (ISR) and polymorphisms in genes coding IGF-1, IGFBP3, ITGB3 and GLUT1, which play an important role in the smooth muscle cell proliferation and extracellular matrix synthesis - the main components of neointima. MATERIALS & METHODS We analyzed 265 patients who underwent bare metal stent implantation. RESULTS The differences in the occurrence of ISR between genotypes of the analyzed polymorphisms in the IGF-1, IGFBP3 and ITGB3 were not statistically significant. The T/T genotype of the rs710218 polymorphism in the GLUT1 (SLC2A1) gene was more common in the ISR group compared with non-ISR patients (81.1 vs 64.8%; p = 0.02). In a multivariable model the A/A and A/T genotype remained correlated with lower occurrence of ISR (odds ratio: 0.45; 95% CI: 0.21-0.97; p = 0.03). CONCLUSION The rs710218 polymorphism in the gene coding GLUT1 protein is a novel risk factor for ISR.

Not at random location of atherosclerotic lesions in thoracic aorta and their prognostic significance in relation to the risk of cardiovascular events.

Summary Thoracic aortic calcium deposits are frequently detected on tomography of the chest, and in other imaging modalities. Numerous studies indicated the correlation of hemodynamic parameters such as wall shear stress in relation to distribution aortic calcifications. This publication discusses similarities and differences of two distinct pathomechanisms of arterial calcifications: intimal associated with atherosclerosis and medial knows as Mönckeberg’s arteriosclerosis. This review also analyzes the frequent coexistence of aortic calcification and coronary artery disease in terms of risk of cardiovascular events.

Comparison of early and long-term results of percutaneous coronary interventions in patients with ST elevation myocardial infarction, complicated or not by cardiogenic shock.

ObjectivesCardiogenic shock (CS) still remains one of the most important factors affecting the mortality rate of patients with ST segment elevation myocardial infarction (STEMI). However, the data with follow-up longer than 1 year are limited. The aim of this study was to evaluate the early and long-term treatment results of patients with STEMI, complicated or not by CS, who underwent percutaneus coronary interventions. MethodsA retrospective registry included data of all patients with STEMI admitted to our centre from January 1999 to December 2001. ResultsOne thousand three hundred and eighty-five patients with STEMI were hospitalized and 1237 of them were treated with immediate percutaneus coronary interventions. Among this subpopulation, 117 (9.5%) patients were with STEMI complicated with CS on admission (group I) and 1120 (90.5%) patients were with STEMI without complications from CS on admission (group II). The groups differed significantly with regard to baseline clinical characteristics, angiographic picture, and in-hospital course. A total of 38.5% of patients with myocardial infarction complicated by CS and 2.5% of patients without shock (P<0.001) died during hospitalization. At the 5-year follow-up, 58.1% of group I patients and 14.8% of group II patients (P<0.001) died. A significant difference in the 5-year mortality rate was also observed in patients who survived the in-hospital period (31.9 vs. 12.6%; P<0.001). ConclusionCS continues to be closely connected with a very high mortality rate both in the hospital and in the long-term, also among patients who survived the in-hospital period.