Grochowski Hospital

Warsaw, Poland

Grochowski Hospital

Warsaw, Poland

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Swahn E.,Linköping University | Alfredsson J.,Linköping University | Afzal R.,McMaster University | Budaj A.,Grochowski Hospital | And 5 more authors.
European Heart Journal | Year: 2012

Aims: The aim of this study was to compare benefits and risks of a routine invasive compared with a selective invasive strategy in women with non-ST-elevation acute coronary syndromes. Methods and results: We randomly assigned 184 women, either to a routine or to a selective invasive strategy as a substudy to the OASIS 5 trial, who were followed for 2 years. Meta-analysis of data from previous randomized trials was also done. There were no significant differences between the two treatment strategies in the primary outcome death/myocardial infarction (MI)/stroke [21.0 vs. 15.4%, HR = 1.46, 95% CI (0.73-2.94)], in the secondary outcome death/MI [18.8 vs. 14.3%, HR = 1.39, 95% CI (0.67-2.88)], or separately analysed outcomes MI [12.9 vs. 13.3%, HR = 0.95, 95% CI (0.42-2.19)] or stroke [2.3 vs. 4.4%, HR = 0.67, 95% CI (0.12-3.70)]. However, there were significantly more deaths after 1 year (8.8 vs. 1.1%, HR = 9.01, 95% CI (1.11-72.90) and a higher rate of major bleeding at 30 days [8.8 vs. 1.1%, HR = 11.45, 95% CI (1.43-91.96)] in the routine invasive strategy group. A meta-analysis including 2692 women in previous randomized trials, with a gender perspective, showed no significant difference in the composite outcome death/MI, OR = 1.18, 95% CI (0.92-1.53) but a higher mortality with a routine invasive strategy for women, OR = 1.51, 95% CI (1.00-2.29). Conclusion: The rate of death, MI, or stroke in women was not different in patients treated with a routine invasive strategy compared with a selective invasive strategy, but there was a concerning trend towards higher mortality. When combined with data from previous trials, there does not appear to be a benefit of an early invasive strategy in women with ACS, which differs from the results in men. These data emphasize the lack of clear evidence in favour of an invasive strategy in women and suggest caution in extrapolating the results from men to women. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009.


Jolly S.S.,Hamilton Health Sciences | Jolly S.S.,Hamilton General Hospital | Yusuf S.,Hamilton Health Sciences | Cairns J.,University of British Columbia | And 14 more authors.
The Lancet | Year: 2011

Background: Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention. Methods: The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT01014273. Findings: Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7) of 3507 patients in the radial access group compared with 139 (4·0) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95 CI 0·72-1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95 CI 0·28-0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38-0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2) of 3507 patients in the radial group compared with 114 (3·2) of 3514 in the femoral group (HR 0·98, 95 CI 0·76-1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7) of 3507 patients in the radial group compared with 33 (0·9) of 3514 patients in the femoral group (HR 0·73, 95 CI 0·43-1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, 95 CI 0·28-0·57; p<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95 CI 0·13-0·71; p=0·006). Interpretation: Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach. Funding: Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research. © 2011 Elsevier Ltd. All Rights Reserved.


Mehta S.R.,Hamilton Health Sciences | Jolly S.S.,Hamilton Health Sciences | Cairns J.,University of British Columbia | Niemela K.,University of Tampere | And 10 more authors.
Journal of the American College of Cardiology | Year: 2012

Objectives: The purpose of this study was to determine the consistency of the effects of radial artery access in patients with ST-segment elevation myocardial infarction (STEMI) and in those with non-ST-segment elevation acute coronary syndrome (NSTEACS). Background: The safety associated with radial access may translate into mortality benefit in higher-risk patients, such as those with STEMI. Methods: We compared efficacy and bleeding outcomes in patients randomized to radial versus femoral access in RIVAL (RadIal Vs femorAL access for coronary intervention trial) (N = 7,021) separately in those with STEMI (n = 1,958) and NSTEACS (n = 5,063). Interaction tests between access site and acute coronary syndrome type were performed. Results: Baseline characteristics were well matched between radial and femoral groups. There were significant interactions for the primary outcome of death/myocardial infarction/stroke/non-coronary artery bypass graft-related major bleeding (p = 0.025), the secondary outcome of death/myocardial infarction/stroke (p = 0.011) and mortality (p = 0.001). In STEMI patients, radial access reduced the primary outcome compared with femoral access (3.1% vs. 5.2%; hazard ratio [HR]: 0.60; p = 0.026). For NSTEACS, the rates were 3.8% and 3.5%, respectively (p = 0.49). In STEMI patients, death/myocardial infarction/stroke were also reduced with radial access (2.7% vs. 4.6%; HR 0.59; p = 0.031), as was all-cause mortality (1.3% vs. 3.2%; HR: 0.39; p = 0.006), with no difference in NSTEACS patients. Operator radial experience was greater in STEMI versus NSTEACS patients (400 vs. 326 cases/year, p < 0.0001). In primary PCI, mortality was reduced with radial access (1.4% vs. 3.1%; HR: 0.46; p = 0.041). Conclusions: In patients with STEMI, radial artery access reduced the primary outcome and mortality. No such benefit was observed in patients with NSTEACS. The radial approach may be preferred in STEMI patients when the operator has considerable radial experience. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [RIVAL]; NCT01014273) © 2012 American College of Cardiology Foundation.


Baran J.,Grochowski Hospital | Stec S.,Grochowski Hospital | Pilichowska-Paszkiet E.,Grochowski Hospital | Zaborska B.,Grochowski Hospital | And 5 more authors.
Circulation: Arrhythmia and Electrophysiology | Year: 2013

Background-Transesophageal echocardiography (TEE) is the gold standard for the exclusion of thrombi in the left atrial appendage (LAA) before ablation for atrial fibrillation. Intracardiac echocardiography (ICE) is used to assist atrial fibrillation ablation; however, it can also be used for LAA imaging. The aim of our study was to determine whether ICE could replace TEE and to identify the optimal ICE placement for LAA visualization. Methods and Results-Seventy-six consecutive patients (56 men; mean age, 55±9.6 years) scheduled for atrial fibrillation ablation underwent TEE before the procedure and LAA assessment by ICE. An 8F AcuNav probe was introduced into right atrium, pulmonary artery, and coronary sinus. LAA structure was analyzed by the echocardiographer and electrophysiologist who were blinded to the results of TEE. ICE probe was positioned in the right atrium in all patients, in the pulmonary artery in 64 of 74 (86%) patients, and in the coronary sinus in 49 of 74 (66%) patients. The LAA was properly visualized in 56 of 64 (87.5%) patients from the pulmonary artery versus 13 of 49 (26%) patients from the coronary sinus (P<0.001). From the right atrium, the whole LAA cavity could not be seen in any patient. In those patients in whom LAA was visualized properly by ICE, a perfect agreement between ICE and TEE was obtained (both techniques detected LAA thrombus in 2 patients and excluded LAA thrombus in the remaining patients). Conclusions-ICE can be used safely and effectively for the evaluation of LAA in patients undergoing atrial fibrillation ablation. ICE imaging from pulmonary artery is accurate for LAA visualization. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01371279. © 2013 American Heart Association, Inc.


Bonaca M.P.,Brigham and Women's Hospital | Bhatt D.L.,Brigham and Women's Hospital | Cohen M.,Newark Beth Israel Medical Center | Steg P.G.,University Paris Diderot | And 22 more authors.
New England Journal of Medicine | Year: 2015

BACKGROUND: The potential benefit of dual antiplatelet therapy beyond 1 year after a myocardial infarction has not been established. We investigated the efficacy and safety of ticagrelor, a P2Y12 receptor antagonist with established efficacy after an acute coronary syndrome, in this context. METHODS: We randomly assigned, in a double-blind 1:1:1 fashion, 21,162 patients who had had a myocardial infarction 1 to 3 years earlier to ticagrelor at a dose of 90 mg twice daily, ticagrelor at a dose of 60 mg twice daily, or placebo. All the patients were to receive low-dose aspirin and were followed for a median of 33 months. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The primary safety end point was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. RESULTS: The two ticagrelor doses each reduced, as compared with placebo, the rate of the primary efficacy end point, with Kaplan-Meier rates at 3 years of 7.85% in the group that received 90 mg of ticagrelor twice daily, 7.77% in the group that received 60 mg of ticagrelor twice daily, and 9.04% in the placebo group (hazard ratio for 90 mg of ticagrelor vs. placebo, 0.85; 95% confidence interval [CI], 0.75 to 0.96; P = 0.008; hazard ratio for 60 mg of ticagrelor vs. placebo, 0.84; 95% CI, 0.74 to 0.95; P = 0.004). Rates of TIMI major bleeding were higher with ticagrelor (2.60% with 90 mg and 2.30% with 60 mg) than with placebo (1.06%) (P<0.001 for each dose vs. placebo); the rates of intracranial hemorrhage or fatal bleeding in the three groups were 0.63%, 0.71%, and 0.60%, respectively. CONCLUSIONS: In patients with a myocardial infarction more than 1 year previously, treatment with ticagrelor significantly reduced the risk of cardiovascular death, myocardial infarction, or stroke and increased the risk of major bleeding. Copyright © 2015 Massachusetts Medical Society.


Kowey P.R.,Lankenau Hospital | Kowey P.R.,Jefferson Medical College | Crijns H.J.G.M.,Academisch Ziekenhuis Maastricht | Aliot E.M.,Nancy University Hospital Center | And 6 more authors.
Circulation | Year: 2011

Background-: Celivarone is a new antiarrhythmic agent developed for the treatment of ventricular arrhythmias. This study investigated the efficacy and safety of celivarone in preventing implantable cardioverter-defibrillator (ICD) interventions or death. Methods and Results-: Celivarone (50, 100, or 300 mg/d) was assessed compared with placebo in this randomized, double-blind, placebo-controlled, parallel-group study. Amiodarone (200 mg/d after loading dose of 600 mg/d for 10 days) was used as a calibrator. A total of 486 patients with a left ventricular ejection fraction ≤40% and at least 1 ICD intervention for ventricular tachycardia or ventricular fibrillation in the previous month or ICD implantation in the previous month for documented ventricular tachycardia/ventricular fibrillation were randomized. Median treatment duration was 9 months. The primary efficacy end point was occurrence of ventricular tachycardia/ventricular fibrillation-triggered ICD interventions (shocks or antitachycardia pacing) or sudden death. The proportion of patients experiencing an appropriate ICD intervention or sudden death was 61.5% in the placebo group; 67.0%, 58.8%, and 54.9% in the celivarone 50-, 100-, and 300-mg groups, respectively; and 45.3% in the amiodarone group. Hazard ratios versus placebo for the primary end point ranged from 0.860 for celivarone 300 mg to 1.199 for celivarone 50 mg. None of the comparisons versus placebo were statistically significant. Celivarone had an acceptable safety profile. CONCLUSIONS-: Celivarone was not effective for the prevention of ICD interventions or sudden death. Clinical Trial Registration-: http://www.clinicaltrials.gov. Unique identifier: NCT00993382. © 2011 American Heart Association, Inc.


De Caterina R.,University G.O.C. | Connolly S.J.,Hamilton Health Sciences | Pogue J.,Hamilton Health Sciences | Chrolavicius S.,Hamilton Health Sciences | And 4 more authors.
European Heart Journal | Year: 2010

Aims:To assess the risk of death after the occurrence of different types of non-fatal events in patients with atrial fibrillation (AF). Antithrombotic therapies in AF have primarily focused on stroke prevention and bleeding. However, strokes and bleeds differ in severity, and the level of severity may differently impact mortality.Methods and results: We analysed the risk of subsequent mortality after the occurrence of non-fatal vascular and bleeding events in the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE)-W trial. In the 3371 patients randomized to vitamin K antagonists and the 3335 patients randomized to clopidogrel plus aspirin in ACTIVE-W, the hazard ratio (HR) and 95 confidence intervals (95 CIs) for subsequent death associated with the occurrence of non-fatal stroke was 5.58 (95 CI 3.84-8.10, P < 0.0001). Both ischaemic (HR 5.29, 95 CI 3.53-7.93, P < 0.0001) and haemorrhagic strokes (HR 7.38, 95 CI 2.74-19.9, P < 0.0001) increased mortality, but transient ischaemic attacks did not. Disabling strokes (Rankin's score ≥3) increased mortality (HR 9.54; 95 CI 6.42-14.2, P< 0.0001), but non-disabling strokes did not. Severe bleeding increased mortality (HR 3.35, 95 CI 2.12-5.27, P < 0.0001), but major bleeding that was not severe according to the study definitions did not.Conclusion: Non-fatal strokes increased mortality in ACTIVE-W, but non-disabling strokes did not. Among major bleeding events, only those also classified as severe increased mortality. Future research should emphasize the prevention of disabling strokes and severe bleeds and place less emphasis on non-disabling stroke or major bleeds that are not severe. © European Society of Cardiology The Author 2010. All rights reserved.


Oldgren J.,Uppsala University | Budaj A.,Grochowski Hospital | Granger C.B.,Duke Clinical Research Institute | Khder Y.,Boehringer Ingelheim | And 5 more authors.
European Heart Journal | Year: 2011

AimAfter an acute coronary syndrome, patients remain at risk of recurrent ischaemic events, despite contemporary treatment, including aspirin and clopidogrel. We evaluated the safety and indicators of efficacy of the novel oral direct thrombin inhibitor dabigatran. Methods and resultsIn this double-blind, placebo-controlled, dose-escalation trial, 1861 patients (99.2 on dual antiplatelet treatment) in 161 centres were enrolled at mean 7.5 days (SD 3.8) after an ST-elevation (60) or non-ST-elevation (40) myocardial infarction and randomized to twice daily treatment with dabigatran 50 mg (n 369), 75 mg (n 368), 110 mg (n 406), 150 mg (n 347), or placebo (n 371). Primary outcome was the composite of major or clinically relevant minor bleeding during the 6-month treatment period. There were 96 primary outcome events and, compared with placebo, a dose-dependent increase with dabigatran, hazard ratio (HR) 1.77 (95 confidence intervals 0.70, 4.50) for 50 mg; HR 2.17 (0.88, 5.31) for 75 mg; HR 3.92 (1.72, 8.95) for 110 mg; and HR 4.27 (1.86, 9.81) for 150 mg. Compared with placebo, D-dimer concentrations were reduced in all dabigatran dose groups by an average of 37 and 45 at weeks 1 and 4, respectively (P< 0.001). Fourteen (3.8) patients died, had a myocardial infarction or stroke in the placebo group compared with 17 (4.6) in 50 mg, 18 (4.9) in 75 mg, 12 (3.0) in 110 mg, and 12 (3.5) in the 150 mg dabigatran groups. ConclusionsDabigatran, in addition to dual antiplatelet therapy, was associated with a dose-dependent increase in bleeding events and significantly reduced coagulation activity in patients with a recent myocardial infarction. © 2011 The Author.


James S.,Uppsala Clinical Research Center | Budaj A.,Grochowski Hospital | Aylward P.,Flinders Medical Center | Buck K.K.,Astrazeneca | And 12 more authors.
Circulation | Year: 2010

Background-: Reduced renal function is associated with a poorer prognosis and increased bleeding risk in patients with acute coronary syndromes and may therefore alter the risk-benefit ratio with antiplatelet therapies. In the Platelet Inhibition and Patient Outcomes (PLATO) trial, ticagrelor compared with clopidogrel reduced the primary composite end point of cardiovascular death, myocardial infarction, and stroke at 12 months but with similar major bleeding rates. Methods and Results-: Central laboratory serum creatinine levels were available in 15 202 (81.9%) acute coronary syndrome patients at baseline, and creatinine clearance, estimated by the Cockcroft Gault equation, was calculated. In patients with chronic kidney disease (creatinine clearance <60 mL/min; n=3237), ticagrelor versus clopidogrel significantly reduced the primary end point to 17.3% from 22.0% (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.65 to 0.90) with an absolute risk reduction greater than that of patients with normal renal function (n=11 965): 7.9% versus 8.9% (HR, 0.90; 95% CI, 0.79 to 1.02). In patients with chronic kidney disease, ticagrelor reduced total mortality (10.0% versus 14.0%; HR, 0.72; 95% CI, 0.58 to 0.89). Major bleeding rates, fatal bleedings, and non-coronary bypass-related major bleedings were not significantly different between the 2 randomized groups (15.1% versus 14.3%; HR, 1.07; 95% CI, 0.88 to 1.30; 0.34% versus 0.77%; HR, 0.48; 95% CI, 0.15 to 1.54; and 8.5% versus 7.3%; HR, 1.28; 95% CI, 0.97 to 1.68). The interactions between creatinine clearance and randomized treatment on any of the outcome variables were nonsignificant. Conclusions-: In acute coronary syndrome patients with chronic kidney disease, ticagrelor compared with clopidogrel significantly reduces ischemic end points and mortality without a significant increase in major bleeding but with numerically more non-procedure-related bleeding. © 2010 American Heart Association, Inc.


Stec S.,Grochowski Hospital | Zaborska B.,Grochowski Hospital | Sikora-Frc M.,Grochowski Hospital | Kryski T.,Grochowski Hospital | Kuakowski P.,Grochowski Hospital
Europace | Year: 2011

AimsImaging of the left atrium (LA) is mandatory during catheter ablation of atrial fibrillation (AF) and may be achieved by echocardiography. The aim of the present study was to assess the feasibility of using a recently released transoesophageal echocardiography (TEE) microprobe (micro-TEE) in non-sedated adult patients undergoing AF ablation and to directly compare this new technique with intracardiac echocardiography (ICE).Methods and resultsThe study group consisted of 12 consecutive patients (8 males, mean age 49 ± 14 years) who underwent first radiofrequency AF ablation. All patients underwent standard TEE, computed tomography, intraprocedural micro-TEE, and ICE. The easiness of introducing the microprobe in the supine position in non-sedated patients in the electrophysiology laboratory, its tolerability, and quality of obtained images were assessed using a five-point scale. There were no problems with microprobe introduction and obtaining images for a mean of 54 ± 17 min. The microprobe was significantly better tolerated than the standard TEE probe (4.3 ± 0.5 vs. 3.4 ± 0.6 points, P< 0.01). The micro-TEE was scored as significantly better than ICE in the assessment of the LA and LA appendage (LAA) anatomy and function. Both techniques were very useful in guiding transseptal puncture, although micro-TEE images were ranked higher by an echocardiographer than by an electrophysiologist (tenting 4.8 ± 0.6 vs. 4.0 ± 0.6 points, P< 0.01), whereas ICE images were ranked equally excellent by both observers.ConclusionIn non-sedated patients undergoing AF ablation, the micro-TEE can be used for the assessment of the LA, LAA, and pulmonary veins anatomy as well as the guidance of transseptal puncture. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2010.

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