Maciej Niewada

Influence of Gender on Baseline Features and Clinical Outcomes among 17,370 Patients with Confirmed Ischaemic Stroke in the International Stroke Trial

Aim: We sought to determine whether there were differences between men and women with acute stroke in their baseline characteristics and outcome in a large cohort of patients randomized in the International Stroke Trial (IST). Methods: Of the 19,435 patients randomized in the IST, 17,370 had an ischemic stroke confirmed by CT scan or autopsy (8,003 female and 9,367 male). In males and females, we compared baseline characteristics (age, frequency of atrial fibrillation, pre-stroke administration of aspirin and systolic blood pressure, conscious level, stroke syndrome) and outcome at 14 days and 6 months (death, complications, dependency, recovery, place of residence). We developed a specific logistic regression model to adjust for case-mix in order to evaluate the separate influence of gender on outcome. Results: Female patients were older, suffered more frequently from atrial fibrillation, had higher systolic blood pressure at randomization and generally had more severe strokes (a higher proportion were unconscious or drowsy or had a total anterior circulation syndrome). Females had higher 14-day and 6-month case fatality and were more likely to be dead or dependent at six months (and consequently more likely to require institutional or residential care). Gender was an independent predictor of death or dependency at 6 months. Conclusions: The adverse effect of female gender on outcome indicates that further research to explore the underlying biological mechanism is justified, and that more intensive acute and long-term treatment may be needed to improve outcome among female patients with stroke.

Valuation of EQ‐5D Health States in Poland: First TTO‐Based Social Value Set in Central and Eastern Europe

OBJECTIVE Currently, there is no EQ-5D value set for Poland. The primary objective of this study was to elicit EQ-5D Polish values using the time trade-off (TTO) method. METHODS Face-to-face interviews with visitors of inpatients in eight medical centers in Warsaw, Skierniewice, and Puławy were carried out by trained interviewers. Quota sampling was used to achieve a representative sample of the Polish population with regard to age and sex. Modified protocol from the Measurement and Value of Health study was used. Each respondent ranked 10 health states and valued 4 health states using the visual analog scale and 23 using the TTO. Mean and variance stability tests were performed to determine whether using a larger number of health states per respondent would yield credible results. Modeling included random effects and random parameters models. RESULTS Between February and May 2008, 321 interviews were performed. Modeling based on 6777 valuations resulted in an additive model with all coefficients statistically significant, R(2) equal to 0.45, and value -0.523 for the worst possible health state. Means and variance did not differ significantly for states valued in the middle and at the end of the TTO exercise. CONCLUSIONS This is the first EQ-5D value set based on TTO in Central and Eastern Europe so far. Because the values differ considerably from those elicited in Western European countries, its use should be recommended for studies in Poland. Increasing the number of health states that each respondent is asked to value using TTO seems feasible and justifiable.

The International Stroke Trial database

BackgroundWe aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.MethodsFor each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point (14-days after randomisation or prior discharge) and at 6-months and provide them as an analysable database.ResultsThe IST dataset includes data on 19 435 patients with acute stroke, with 99% complete follow-up. Over 26.4% patients were aged over 80 years at study entry. Background stroke care was limited and none of the patients received thrombolytic therapy.ConclusionsThe IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Given the age distribution and nature of the background treatment given, the data may be of value in planning trials in older patients and in resource-poor settings.

Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria

This paper describes and discusses the development and use of health technology assessment (HTA) in five Central and Eastern European countries (CEE): Poland, the Czech Republic, Hungary, Romania and Bulgaria. It provides a general snapshot of HTA policies in the selected CEE countries to date by focusing on country case-studies based on document analysis and expert opinion. It offers an overview of similarities and differences between the individual CEE countries and discusses in detail the role of HTA by assessing its formalization and institutionalization, standardization of methodology, the use of HTA in practice and the degree of professionalization of HTA in the region. It finds that HTA has been to some extent implemented in all five countries studied, with methodologies in accordance with international standards, but that challenges remain when it comes to the role of HTA in health care decision-making as well as to human resource capacities of the countries. This paper suggests that coming years will show whether CEE countries develop adequate national analytical capacity to assess and appraise technologies in the context of local need and affordability, instead of using HTA as a mere administrative procedure to fulfill (inter)national requirements. Finally, suggestions are provided to strengthen HTA in CEE countries through cooperation, mutual learning, a common accreditation of HTA bodies and increased network building among CEE HTA experts.

Impact of diabetes on survival in patients with ST-segment elevation myocardial infarction treated by primary angioplasty: Insights from the POLISH STEMI registry

BACKGROUND It has been shown that, among patients with ST-segment elevation myocardial infarction (STEMI), diabetes is associated with a significantly higher mortality. The aim of this study was to investigate in a large cohort of patients the impact of diabetes on mortality in a large cohort of patients with STEMI treated with primary angioplasty. METHODS Our population is represented by consecutive patients with STEMI treated by primary angioplasty and enrolled in the POLISH registry in 2003. All clinical, angiographic, and follow-up data were prospectively collected. Diagnosis of diabetes was based on history of diabetes at admission. RESULTS Among 7193 patients, 877 (12.2%) had diabetes at admission. Diabetes was associated with more advanced age (p<0.0001), higher prevalence of female gender (p<0.0001), hyperlipidemia (p<0.0001), shock at presentation (p<0.0001), renal failure (p<0.0001), previous myocardial infarction (p<0.0001), more often treated after 6h from symptom onset (p<0.0001). Diabetes was associated with more extensive coronary artery disease (p<0.0001), less often treated with stenting (p<0.0001). Diabetes was significantly associated with impaired epicardial reperfusion (TIMI 0-2: OR [95% CI]=1.81 [1.5-2.18], p<0.0001), that persisted after correction for baseline confounding factors (OR [95% CI]=1.33 [1.075-1.64], p=0.009). At a mean follow-up of 524+/-194 days, diabetes was associated with higher mortality (unadjusted cumulative mortality: 23.5% vs. 12.6%, unadjusted HR=1.95 [1.66-2.3], p<0.0001), that persisted after correction for confounding factors (adjusted cumulative mortality: 13.3% vs. 10.7%, adjusted HR=1.23 [1.04-1.46], p=0.013). CONCLUSIONS This study shows that among STEMI treated by primary angioplasty diabetes is independently associated with impaired epicardial reperfusion and higher mortality.

Acute Ischemic Stroke Care and Outcome in Centers Participating in the Polish National Stroke Prevention and Treatment Registry

Background and Purpose— Significant intercenter variability in quality of care and stroke outcomes was found in many countries. The aim of the study was to compare the acute ischemic stroke care and outcomes in centers participating in the Polish National Stroke Prevention and Treatment Registry. Methods— The World Health Organization Stepwise Approach to Stroke Surveillance–based questionnaire was used to collect data on patients admitted to participating centers between December 1, 2001, and July 31, 2002. To ensure data quality, only centers reporting representative sample of patients were analyzed. Ischemic stroke patient characteristics, in-hospital care, and early outcomes (adjusted for case mix) were compared for participating centers. Results— There were 26 of 48 centers that met inclusion criteria, with a total of 8736 patients (52% women; mean age 71 years, with a range among institutions from 68 to 75 years). Significant differences between centers were observed for distribution of risk factors and in-hospital care. The rates for death and poor outcome (defined as a Rankin score ≥3 or death) ranged from 8.0% to 31.8% and from 44.2% to 74.7%, respectively. After adjusting for case mix, the death or poor outcome prognoses remained significantly different between centers. Conclusions— The observed significant differences between Polish stroke centers indicate the need for improvement of patient education, effective stroke risk factor control, and standardized in-hospital care.

Eligibility of stroke units in Poland for administration of intravenous thrombolysis

Systemic thrombolysis treatment was approved in Poland in 2003 and should be performed in specialist stroke units (SU). We performed a survey to determine stroke service preparedness for thrombolysis treatment in Poland. We sent a questionnaire evaluating the neurological departments in Poland, where stroke patients are treated. We divided them into four categories: (i) class A SU (fulfilling criteria of the National Program for Stroke Prevention and Therapy and European Stroke Initiative guidelines), (ii) class B (conditionally fulfilling criteria), (iii) class C (not fulfilling criteria), and (iv) departments without SU. Only class A units are eligible for implementing thrombolysis. We obtained response from 194 of 222 (87.4%) departments; 90 (46.4%) declared having an SU. According to criteria, 20 class A, 56 class B, 14 class C. During one year, 71 208 patients were admitted to hospitals; 69 982 (98.2%) to neurological departments. A total of 10 959 (15.4%) were treated in class A SU, 23 650 (33.2%) in class B, 5153 (7.2%) in class C, whereas 30 220 (42.4%) in neurological departments without SU. Our survey showed that only 15.4% stroke patients in Poland are admitted to high‐quality SU, where thrombolysis may potentially be administered. Improvement of SU quality in Poland is necessary for wide implementation of new methods of stroke therapy.

High early case fatality after ischaemic stroke in Poland: Exploration of possible explanations in the International Stroke Trial

PURPOSE To determine why Polish patients included in the International Stroke Trial (IST) had a higher early case fatality than patients from other countries. METHODS Of 19,435 patients randomised to IST, 17,370 had CT or autopsy-confirmed ischaemic stroke. We compared the baseline clinical state and 14-day case fatality of patients randomised in Polish centres with those from all other IST countries. We examined: age, gender, presence of atrial fibrillation (AF), conscious level, neurological deficit, cause of death and aspirin use in the 3 days before stroke. RESULTS In Poland, the 14-day case fatality rate was significantly higher than in other IST countries (13% vs. 9.6%; odds ratio, OR, 1.5, 95% confidence interval, CI, 1.2-1.9). In Poland, a significantly higher proportion of deaths was attributed to coronary heart disease (2.5% vs. 0.7%) and pulmonary embolism (1.0% vs. 0.4%). Polish patients had higher percentage of AF and drowsiness, but were younger. When these factors were adjusted for, Polish patients still had approximately a 57% higher risk of death within 14 days compared with other countries. A logistic regression analysis revealed that an increased risk of death within 14 days in Poland compared to other IST patients was present among patients younger than 75 years (OR 1.7; 95% CI 1.3-2.4), females (OR 1.8; 95% CI 1.3-2.5), patients who were alert at onset (OR 2.4; 95% CI 1.7-3.4), with partial anterior circulation syndrome (PACS) (OR 2.0; 95% CI 1.4-2.8) or lacunar syndrome (LACS) (OR 2.4; 95% CI 1.1-5.0) and without AF (OR 1.8; 95% CI 1.3-2.4). Polish patients were less likely to have been on aspirin before their stroke than other countries (7.6% vs. 20.8%). CONCLUSION The 14-day case fatality was significantly higher in Poland than in other countries in IST. Part of the increase was due to greater stroke severity in the Polish patients. However, differences persisted even after adjustment for baseline stroke severity. Several factors may have contributed the excess: poor attention to treatment of cardiovascular disease, less attention to treatment of secondary complications of stroke and some other--as yet unidentified--factor specific to Poland.

Incidence and case fatality rates of first-ever stroke – comparison of data from two prospective population-based studies conducted in Warsaw

BACKGROUND AND PURPOSE According to official statistics, the stroke mortality rate has remained high in Eastern European countries for a few decades. It has been shown that also in Poland stroke mortality failed to decline in the period 1984 to 1992. Since that time, stroke management in our country has changed, especially in the cities, where stroke units have been developed. The aim of the present study was to compare incidence and case fatality rates, estimated on the basis of two prospective population-based studies performed in Warsaw in 1991/1992 and 2005. MATERIAL AND METHODS Incidence rates and case fatality rates for the first-ever-in-a-lifetime stroke have been estimated on the basis of two population-based studies: the Warsaw Stroke Registry (population 182 649) conducted in 1991 and 1992, and the European Register of Stroke (population 120 186) - registration in 2005. In both studies data were standardized to the European population by the direct methods. RESULTS Contrary to the incidence rates, which did not change significantly between 1991/1992 and 2005, 30-day and 1-year case fatality rates decreased significantly from 43% to 14.9% and from 59.7% to 33.1%, respectively. CONCLUSIONS Comparison of data from two population-based prospective stroke registries showed that stroke case fatality and mortality significantly decreased. This may be associated with the better management of patients in the acute phase of stroke and implementation of secondary prevention strategies for stroke.

Influence of different antiplatelet treatment regimens for primary percutaneous coronary intervention on all-cause mortality

AIMS The aim of this analysis was to examine the influence of different in-cath-lab antiplatelet regimens for the primary percutaneous coronary intervention (PCI) on all-cause mortality. METHODS AND RESULTS The study group consisted of 7193 patients (pts) undergoing primary PCI in 38 centres in 2003 in Poland. All patients received pretreatment with 300 mg of aspirin, 992 pts (14%) received glycoprotein (GP) IIb/IIIa inhibitors, 2690 pts (37%) were treated with 300 mg loading dose of clopidogrel, and 1566 (22%) received combined antiplatelet treatment with both GP IIb/IIIa inhibitors and clopidogrel. Remaining 1945 patients (27%) did not receive GP IIb/IIIa inhibitors or clopidogrel. Primary endpoint of the study was all-cause mortality up to 1 year from ST-segment elevation myocardial infarction (STEMI). One year mortality rates in the four groups were: 10.4%, 9.0%, 9.7%, and 15.3%, respectively. Propensity-adjusted survival analysis showed significant reduction of mortality for combination therapy with GP IIb/IIIa inhibitors and clopidogrel, clopidogrel alone, and GP IIb/IIIa inhibitors alone over aspirin alone. No additive effect on survival was seen for a combination therapy with GP IIb/IIIa inhibitors and clopidogrel in comparison to treatment with clopidogrel alone. CONCLUSION In this large cohort, multicentre STEMI registry in-cath-lab use of GP IIb/IIIa inhibitors and clopidogrel alone or in combination was associated with the reduction of 1 year all-cause mortality in the setting of primary PCI in comparison with aspirin only. However, the use of GP IIb/IIIa inhibitors on top of 300 mg loading dose of clopidogrel did not further reduce mortality.