Adam Sukiennik

Meta-Analysis of Impact of Different Types and Doses of Statins on New-Onset Diabetes Mellitus

Recent reports indicate that statins are associated with an increased risk for new-onset diabetes mellitus (DM) compared with placebo and that this relation is dose dependent. The aim of this study was to perform a comprehensive network meta-analysis of randomized controlled trials (RCTs) investigating the impact of different types and doses of statins on new-onset DM. RCTs comparing different types and doses of statins with placebo were searched for using the MEDLINE, Embase, and Cochrane databases. A search of RCTs pertinent to this meta-analysis covering the period from November 1994 to October 2012 was conducted by 2 independent investigators using the MEDLINE, Cochrane, Google Scholar, and Embase databases as well as abstracts and presentations from major cardiovascular meetings. Seventeen RCTs reporting the incidence of new-onset DM during statin treatment and including a total of 113,394 patients were identified. The RCTs compared either a statin versus placebo or high-dose versus moderate-dose statin therapy. Among different statins, pravastatin 40 mg/day was associated with the lowest risk for new-onset DM compared with placebo (odds ratio 1.07, 95% credible interval 0.86 to 1.30). Conversely, rosuvastatin 20 mg/day was numerically associated with 25% increased risk for DM compared with placebo (odds ratio 1.25, 95% credible interval 0.82 to 1.90). The impact on DM appeared to be intermediate with atorvastatin 80 mg/day compared with placebo (odds ratio 1.15, 95% credible interval 0.90 to 1.50). These findings were replicated at moderate doses. In conclusion, different types and doses of statins show different potential to increase the incidence of DM.

Low-molecular-weight heparins vs. unfractionated heparin in the setting of percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis

Summary.  Background: The aim of the current study was to perform two separate meta‐analyses of available studies comparing low‐molecular‐weight heparins (LMWHs) vs. unfractionated heparin (UFH) in ST‐elevation myocardial infarction (STEMI) patients treated (i) with primary percutaneous coronary intervention (pPCI) or (ii) with PCI after thrombolysis. Methods: All‐cause mortality was the pre‐specified primary endpoint and major bleeding complications were recorded as the secondary endpoints. Relative risk (RR) with a 95% confidence interval (CI) and absolute risk reduction (ARR) were chosen as the effect measure. Results: Ten studies comprising 16 286 patients were included. The median follow‐up was 2 months for the primary endpoint. Among LMWHs, enoxaparin was the compound most frequently used. In the pPCI group, LMWHs were associated with a reduction in mortality [RR (95% CI) = 0.51 (0.41–0.64), P < 0.001, ARR = 3%] and major bleeding [RR (95% CI) = 0.68 (0.49–0.94), P = 0.02, ARR = 2.0%] as compared with UFH. Conversely, no clear evidence of benefits with LWMHs was observed in the PCI group after thrombolysis. Meta‐regression showed that patients with a higher baseline risk had greater benefits from LMWHs (r = 0.72, P = 0.02). Conclusions: LMWHs were associated with greater efficacy and safety than UFH in STEMI patients treated with pPCI, with a significant relationship between risk profile and clinical benefits. Based on this meta‐analysis, LMWHs may be considered as a preferred anticoagulant among STEMI patients undergoing pPCI.

Percutaneous coronary intervention triggers a systemic inflammatory response in patients treated for in-stent restenosis – comparison with stable and unstable angina

Abstract.Objective and design: It is believed that the magnitude of the systemic inflammatory response induced by percutaneous coronary intervention (PCI) impacts on the long-term outcomes in patients with stable angina (SA) and unstable angina (UA). We aimed to determine whether an inflammatory response appears in in-stent restenosis (ISR) patients undergoing balloon angioplasty and to assess its pattern and magnitude in relation to SA and UA subjects.Subjects: 80 patients (59 with SA, 10 with UA, 11 with ISR) were enrolled into the prospective study.Treatment: SA and UA patients undergoing single vessel coronary balloon angioplasty followed by stenting versus ISR subjects in whom only balloon angioplasty was performed.Methods: C-reactive protein (CRP), serum amyloid A (SAA), tumor necrosis factor α (TNF-α) and interleukin 10 (IL-10) were measured in blood samples collected before and 6, 24 h and 1 month after the procedure.Results: A comparable pattern of inflammatory response in terms of CRP and SAA concentrations in subjects undergoing PCI due to ISR and SA was discovered while in unstable patients its magnitude was substantially higher. CRP and SAA levels increased significantly in each group with the peak value at 24 h and the baseline levels remarkably correlated with the highest markers’ concentrations. In contrast, preprocedural TNF-α concentrations were higher in ISR group when compared with SA and UA patients. Additionally, in ISR group a twofold increase in their values of borderline significance at 6 h was noted. SA and UA subjects were found to have significantly lower TNF-α levels at 6 and 24 h after the intervention though the marker concentrations markedly increased with peak values at 1 month. The levels of IL-10 did not differ at any time point between the groups.Conclusions: We suggest that PCI triggers a systemic inflammatory response in patients with ISR and considerable differences in its pattern when compared with SA and UA patients were demonstrated. Moreover, a high preprocedural TNF-α level and its increase provoked by PCI in the ISR group warrant the need for further investigation of its possible involvement in the restenosis process.

Reliability of heart rate variability measurements in patients with a history of myocardial infarction

Despite a well-established prognostic value in cardiac patients, HRV (heart rate variability) indexes have been used little in the clinical setting. Poor reliability of the measurements might be a possible explanation for this. In the present study, we assessed the reliability of short-term HRV indexes in post-MI (myocardial infarction) patients. We studied 61 MI patients [50 males; age, 59+/-8 years; and LVEF (left ventricular ejection fraction), 46+/-6%; values are means +/-S.D.],who underwent a 5+5 min ECG recording during spontaneous and paced breathing on two consecutive days. Standard time-domain [SDNN (S.D. of RR interval values) and RMSSD (root- mean-square of successive RR interval differences)] and frequency-domain [LF (low-frequency) and HF (high-frequency) power, and LF/HF] indexes of HRV were computed. Absolute and relative reliability were assessed by the 95% limits of random variation and by the ICC (intra-class correlation coefficient). The agreement between the two measurements in classifying patients at low or high risk, according to different cut-points, and the sample size needed to detect a clinically relevant change, were also assessed. During spontaneous breathing, individual changes in test-retest measurements ranged from -41 to + 61% (SDNN; best case) and from -76 to + 316% (LF/HF; worst case). The ICC ranged from 0.72 to 0.81. Most patients (79-90 %) were assigned to the same class by the two measurements. Paced breathing did not improve reliability. In conclusion, short-term HRV parameters in MI patients may have large day-to-day variations, making the detection of treatment effects in individual patients difficult; however, the ICC values and the analysis of the consistency of classification between repeated tests indicate that HRV measurements fulfill the criteria required to be used for diagnostic or classification purposes.

Day-by-day variability of spontaneous baroreflex sensitivity measurements: implications for their reliability in clinical and research applications

Objective To assess day-by-day variability of spontaneous baroreflex sensitivity (BRS) measurements, providing implications for their reliability in clinical and research studies. Methods Forty-four healthy volunteers and 57 patients with previous myocardial infarction (MI) underwent an 8 + 8 min (spontaneous + paced breathing) recording of ECG and noninvasive arterial pressure on two consecutive days. BRS was computed according to the sequence method (BRS_seq), the original and modified transfer function method (BRS_TF and BRS_TFmod) and the alpha method (BRS_αLF and BRS_αHF). Absolute and relative reliability were assessed by the 95% limits of random variation (LoV) and by the intraclass correlation coefficient (ICC), respectively. The sample size needed to detect a clinically relevant change was also estimated. Results In healthy volunteers during spontaneous breathing, BRS_seq, BRS_TF, BRS_αLF and BRS_αHF could not be measured in 18, 3, 2 and 2% of recordings, respectively. By definition, BRS_TFmod could always be measured. The 95% LoV indicated that individual day-by-day changes may range from −50% to +101% for BRS_TFmod (best case) and from −58% to +135% for BRS_αHF (worst case). The ICC ranged from 0.70 (BRS_seq) to 0.76 (BRS_TFmod). The sample size varied from 56 (BRS_TFmod) to 80 (BRS_seq). In MI patients, measurability was lower whereas reliability indexes were similar. Results during paced breathing were similar. Conclusion Day-by-day variability should be taken into account when using spontaneous BRS measurements to detect treatment effects in individual patients. The observed substantial to good relative reliability, as assessed by the ICC, indicates that spontaneous BRS measurements are suitable to detect differences between individuals, which is a prerequisite for proper diagnosis and prognosis.

Value of C-reactive protein in predicting left ventricular remodelling in patients with a first ST-segment elevation myocardial infarction.

Objective. To assess the value of C-reactive protein (CRP) in predicting postinfarct left ventricular remodelling (LVR). Methods. We measured in-hospital plasma CRP concentrations in patients with a first ST-segment elevation myocardial infarction (STEMI). Results. LVR was present at 6 months in 27.8% of 198 patients. CRP concentration rose during the first 24 h, mainly in LVR group. The prevalence of LVR was higher in patients from the highest quartile of CRP concentrations at 24 h as compared to those from any other quartile (odds ratio (OR) 3.48, 95% confidence interval (95% CI) 1.76–6.88). Multivariate analysis identified CRP concentration at 24 h (OR for a 10 mg/L increase 1.29, 95% CI 1.04–1.60), B-type natriuretic peptide at discharge (OR for a 100 pg/mL increase 1.21, 95% CI 1.05–1.39), body mass index (OR for a 1 kg/m2 increase 1.10, 95% CI 1.01–1.21), and left ventricular end-diastolic volume (OR for a 1 mL increase 0.98, 95% CI 0.96-0.99) as independent predictors of LVR. The ROC analysis revealed a limited discriminative value of CRP (area under the curve 0.61; 95% CI 0.54–0.68) in terms of LVR prediction. Conclusions. Measurement of CRP concentration at 24 h after admission possesses a significant but modest value in predicting LVR after a first STEMI.

Stress hyperglycaemia in patients with first myocardial infarction

Objective:  To investigate the incidence of stress hyperglycaemia at first acute myocardial infarction (MI) with ST‐segment elevation, occurrence of stress hyperglycaemia as a manifestation of previously undiagnosed abnormal glucose tolerance (AGT), and its relation to stress hormone levels.

Value of oral glucose tolerance test in the acute phase of myocardial infarction

BackgroundAlthough European guidelines advise oral glucose tolerance test (OGTT) in patients with acute myocardial infarction (AMI) before or shortly after hospital discharge, data supporting this recommendation are inconclusive. We aimed to analyze whether disturbances in glucose metabolism diagnosed before hospital discharge in AMI patients represents a latent pre-existing condition or rather temporary finding. Additionally, we planned to investigate the value of pre-selected glycemic control parameters as predictors of long-term glucometabolic state.MethodsWe assessed admission glycemia, glycated hemoglobin, mean blood glucose concentration on days 1 and 2 in 200 patients with a first AMI but without overt disturbances of glucose metabolism. We also performed OGTT at discharge and 3 months after discharge.ResultsThe prevalence of disturbances in glucose metabolism (as assessed by OGTT) at 3 months was significantly lower than at discharge (29% vs. 48%, p = 0.0001). Disturbances in glucose metabolism were not confirmed in 63% of patients with impaired glucose tolerance and in 36% of patients with diabetes mellitus diagnosed during the acute phase of AMI. Age >77 years, glucose ≥12.06 mmol/l at 120 minutes during OGTT before discharge and mean blood glucose level on day 2 >7.5 mmol/l were identified as independent predictors of disturbances in glucose metabolism at the 3-month follow-up.ConclusionsDisturbances in glucose metabolism observed in patients with a first AMI are predominantly transient. Elderly age, high plasma glucose concentration at 120 minutes during OGTT at discharge and elevated mean blood glucose level on day 2 were associated with sustained disturbances in glucose metabolism.

Circulatory support with Impella CP device during high-risk percutaneous coronary interventions: initial experience in Poland

Coronary revascularization is an important part of the treatment of patients with coronary artery disease. However, a significant proportion of patients are characterized by high-risk features. Many of these patients are referred for high-risk percutaneous coronary interventions (PCIs) due to the extremely high risk of surgery. To support such procedures and to facilitate the care of high-risk patients, percutaneous left ventricular assist devices (pLVAD) were developed. Due to confounding data and downgraded guidelines for use of the intra-aortic balloon pump (IABP), especially in cardiogenic shock caused by myocardial infarction (MI), there is currently growing interest in pLVAD [1, 2]. The use of pLVAD during high-risk PCI in Europe varies from country to country mainly due to different reimbursement policies.

Left atrial appendage occlusion: consensus document of Association of Cardiovascular Interventions and Heart Rhythm Section of Polish Cardiac Society

Left atrial appendage (LAA) occlusion devices have the potential to influence the clinical approach to stroke prevention in patients with atrial fibrillation. A number of percutaneous techniques have been proposed, including various intracardiac plugs and also external ligation. Several devices have been already used in Poland. One of them has been evaluated in randomised controlled trials compared with the current standard of care. Others are less well studied but quite commonly used in Eu-rope. It is anticipated that the use of LAA occlusion technologies in clinical practice will expand. This Consensus Document prepared jointly by Association of Cardiovascular Interventions (AISN) and Heart Rhythm Section (HRS) of Polish Cardiac Society seeks to highlight the critical issues surrounding LAA occlusion therapies and to facilitate the alignment of multiple interests, including those of primary care physicians, general cardiologists and procedural specialists (electrophysiologists and interventional cardiologists) but also other medical professionals. The article summarises current evidence and provides spe-cific recommendations on organisation and conduct of LAA therapy in patients with atrial fibrillation in Poland and defines also operator and institutional requirements fundamental to the establishment of successful LAA occlusion programmme.