We performed a pooled analysis of three trials comparing titanium-nitride-oxide-coated bioactive ... more We performed a pooled analysis of three trials comparing titanium-nitride-oxide-coated bioactive stents (BAS) with paclitaxel-eluting stents (PES) in 1,774 patients. All patients were followed for 12 months. The primary outcomes of interest were recurrent myocardial infarction (MI), death and target lesion revascularization (TLR). Secondary endpoints were stent thrombosis (ST) and major adverse cardiac events (MACE) including MI, death and TLR. There were 922 patients in the BAS group and 852 in the PES group. BAS significantly reduced the risk of recurrent MI (2.7% vs. 5.6%; risk ratio 0.50, 95% CI 0.31-0.81; p = 0.004) and MACE (8.9% vs. 12.6%; risk ratio 0.71, 95% CI 0.54-0.94; p = 0.02) during the 12 months of follow up. In contrast, the differences between BAS and PES were not statistically significant with respect to TLR (risk ratio 0.98, 95% CI 0.68-1.41), death (risk ratio 0.96, 95% CI 0.61-1.51) and definite ST (risk ratio 0.28, 95% CI 0.05-1.47). In conclusion, the results of this analysis suggest that BAS is effective in reducing TLR and improves clinical outcomes by reducing MI and MACE compared with PES.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 26, 2015
We explored the 12-month clinical outcome of the titanium-nitride-oxide-coated OPTIMAX stent base... more We explored the 12-month clinical outcome of the titanium-nitride-oxide-coated OPTIMAX stent based on cobalt-chromium platform. The OPTIMAX stent demonstrated a satisfactory 6-month clinical outcome in de novo coronary lesions. We enrolled 224 consecutive symptomatic patients with significant (50%) stenosis in de novo coronary lesions, who were treated with OPTIMAX stent implantation. The primary endpoint was major adverse cardiac events at 12-month follow-up, defined as a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Stent thrombosis was adjudicated according to the definition of the Academic Research Consortium. The mean age of the cohort was 67 ± 8 years (75% males). Patients presented with acute coronary syndrome in 62.1%. Radial access was used in 92%; complex (type B and C) lesions were treated in 79.9%. Both procedural and clinical success occurred in 100% of the cases. The mean follow-up period was...
Adequate antiplatelet therapy in patients with myocardial infarction with ST-elevation (STEMI) is... more Adequate antiplatelet therapy in patients with myocardial infarction with ST-elevation (STEMI) is vital in order to avoid ischemic complications. However, especially with the novel potent oral drugs, bleeding is a major concern. We aimed to investigate whether STEMI patients switched to novel ADP receptor inhibitors due to high platelet reactivity (HPR) on clopidogrel have similar outcomes compared to patients with adequate response to clopidogrel. A prospective cohort of 175 STEMI patients (mean age 62.3years) undergoing primary PCI were included in the PASTOR study. Patients were loaded with 600mg clopidogrel before the index PCI procedure. Bedside VerifyNow P2Y12 platelet function testing was performed the following morning. 46 patients (26.3%) were found to have HPR on clopidogrel (PRU>235) and were switched to novel ADP receptor antagonists. The remaining 129 patients were treated with clopidogrel. The mean duration of dual antiplatelet therapy (DAPT) was 6.7months. Duration of entire follow-up of patients was approximately 2years. Major adverse cardiac events (MACE) while patients were on DAPT occurred in 7.0% in the clopidogrel group compared to 8.7% in the novel ADP receptor antagonist group (p=0.70). No differences were observed between groups off-DAPT either. Following primary PCI for STEMI, patients with adequate response to clopidogrel show similar outcomes compared to patients switched to novel ADP receptor antagonists due to HPR on clopidogrel. Platelet reactivity testing can be used to guide the choice of antiplatelet therapy in patients with STEMI treated by primary PCI.
A major concern in cardioversion of newly detected atrial fibrillation is the risk of thromboembo... more A major concern in cardioversion of newly detected atrial fibrillation is the risk of thromboembolic events. The vast majority of these events occur in the first week following cardioversion. Transesophageal echocardiography has demonstrated that thrombus and dense spontaneous echo contrast may occur in the left atrium and left atrial appendage in patients with acute atrial fibrillation (<48 hours) scheduled for cardioversion. Moreover, atrial function may become impaired immediately following successful cardioversion. The risk of thromboembolic events increases with the presence of stroke risk factors, such as heart failure, hypertension, diabetes, prior stroke, female sex and age above 65-75 years. Thus, the current guidelines of the ESC and ACC/AHA/Heart Rhythm Society recommend that patients with acute atrial fibrillation should undergo cardioversion under cover of unfractionated or low-molecular weight heparin followed by oral anticoagulation for at least 4 weeks in patients...
The efficacy and safety of titanium-nitride-oxide-coated bioactive stents (BASs) were demonstrate... more The efficacy and safety of titanium-nitride-oxide-coated bioactive stents (BASs) were demonstrated in prior studies. In a prospective registry, we sought to explore the extent of neointimal coverage of stent struts by optical coherence tomography (OCT) at 30 days following the implantation of BASs in an unselected non-diabetic population. We enrolled 20 consecutive nondiabetic patients who underwent BAS implantation. OCT images were obtained at 30-day follow-up. Binary stent strut coverage was defined as the number of covered struts as a percentage of all analyzed struts. Patients underwent OCT examination at an average of 30.5 ± 5.7 days following stent implantation. In these, 411 cross-sections were analyzed, including 3780 struts. Binary stent strut coverage was 97.2%, and the prevalence of malapposed struts was 3.2%. Mean neointimal thickness was 109.7 ± 83.6 μm. In the current evaluation by OCT at 30-day follow-up after BAS implantation in an unselected non-diabetic cohort, bin...
In a prospective study, we explored the extent of neointimal coverage of stent struts by optical ... more In a prospective study, we explored the extent of neointimal coverage of stent struts by optical coherence tomography 14 days following the implantation of bioactive stents in an unselected cohort. We enrolled 15 consecutive patients who underwent bioactive stent implantation. Optical coherence tomography images were obtained at 14-day follow-up. Morphometric analysis, strut coverage, strut apposition, neointimal hyperplasia and possible thrombosis were evaluated at 1-mm intervals. Binary stent strut coverage was defined as the percentage of covered struts of all analyzed struts. Patients underwent optical coherence tomography examination at an average of 14.5 ± 2.3 days following stent implantation. Mean age was 62 ± 11 years; 86.7% were males; 26.7% diabetic. Three-hundred eighteen cross-sections were analysed, including 2935 struts, an average of 9.2 ± 3 struts per cross-section. Binary stent strut coverage was 96.3%; the prevalence of malapposed struts 1.8%. No thrombi were detected. Mean neointimal hyperplasia thickness was 71.5 ± 53.7 µm. In the current evaluation by optical coherence tomography at 14-day follow-up after bioactive stent implantation in an unselected cohort, binary stent strut coverage was fairly adequate, and the prevalence of malapposed struts was low.
Central vein leads are known to predispose to venous obstruction. Although usually asymptomatic, ... more Central vein leads are known to predispose to venous obstruction. Although usually asymptomatic, obstruction may render electrode removal difficult. This study aimed at quantifying changes in venous calibers in a prospective fashion by intravenous contrast venography (ICV) before and after pacemaker (PM) or cardioverter-defibrillator implantation. One hundred and fifty (mean age 67; 61% male) consecutive patients were enrolled, and followed for 6 months. A successful ICV was done at baseline prior to implantation and at 6-month follow-up in 136 (91%) patients. Minimum (D(min)) and maximum (D(max)) vessel diameters were obtained from both ICVs. A new stenosis was defined as a 50% diameter reduction in a venous segment when compared to baseline. We implanted a total of 230 electrodes: 47 (34.6%) single lead, 84 (61.8%) 2-lead, and 5 (3.7%) 3-lead systems. At baseline ICV, 10 patients (7%) were found to have venous anomalies, including 8 patients with obstructive lesions, 1 patient wit...
Venous lesions, including obstruction and thromboembolism (VTE), are not uncommon after pacemaker... more Venous lesions, including obstruction and thromboembolism (VTE), are not uncommon after pacemaker implantation. The purpose of this prospective study was to assess the role of various patient and procedure-related risk factors in the development of these complications. A prospective venography-based study of 150 consecutive pacemaker implantations with a 6-month follow-up was conducted. Current case-control study included all cases (n = 47) with a new venous lesion, and their matched controls. Several surgical and technical factors, i.e. lead burden, choice of venous access, operator experience and procedure duration, as well as patient-related classic risk factors of VTE were assessed. Plasma markers of coagulation and endothelial activation [prothrombin fragment 1 + 2 (F1 + 2), D-dimer (DD), von Willebrand factor (vWF), thrombomodulin (Tm)] were used to evaluate the extent of acute surgical trauma. All cases with venous lesions were also screened for thrombophilia. None of the pro...
The Journal of thoracic and cardiovascular surgery, Jan 21, 2015
Postpericardiotomy syndrome is a well-known complication after cardiac surgery. Nevertheless, lit... more Postpericardiotomy syndrome is a well-known complication after cardiac surgery. Nevertheless, little is known about the incidence and predictors of postpericardiotomy syndrome requiring medical attention or hospitalization in a contemporary set of patients undergoing isolated coronary bypass. This retrospective analysis included 688 patients from 2008 to 2010. The median follow-up time was 5.3 [4.5-6.0] years. The incidence of postpericardiotomy syndrome was 61 of 688 patients (8.9%), and the median time to diagnosis was 21 [11-52] days, but only 13 patients (22%) required pleural drainage and 3 patients (4.9%) required pericardiocentesis. Patients with postpericardiotomy syndrome more often had 1 or more red blood cell units transfused (61% vs 43%, P = .008) after surgery and less often had diabetes (12% vs 31% P = .002) or metformin medication (3.3% vs 20%, P = .001) compared with those without postpericardiotomy syndrome. In multivariable Cox regression model, renal insufficiency...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2006
The aim of the Titan PORI Registry was to evaluate the safety and efficacy of a stainless steel s... more The aim of the Titan PORI Registry was to evaluate the safety and efficacy of a stainless steel stent coated with titanium nitride oxide (Titan(R), Hexacath, France) in routine clinical practice. We report a prospective single-centre experience in treating patients with the Titan(R) stent. All consecutive patients receiving Titan(R) stent(s) were enrolled. The choice of a stent was at the discretion of the operator with no exclusion criteria. The primary end point of the registry was Major Adverse Cardiac Events (MACE) at 6 and 9 months. A total of 210 lesions were treated in 193 enrolled patients (mean age 67+/-10; men 71%; diabetes 17%). Lesions were of type B in 64% and type C in 23%. The indications for PCI were unstable angina or non-Q-wave MI in 36% and acute STEMI in 30% of the patients. Mean reference diameter was 2.9+/-0.3 mm and mean lesion length 12.9+/-3.0 mm. Mean stent size was 2.98 mm (range 2-3.5 mm) and length 15.5 mm (range 7-28 mm). Stent delivery was successful i...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 20, 2012
Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when ... more Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when compared with paclitaxel-eluting stents in patients with acute myocardial infarction (MI). In a prospective randomised non-inferiority study design, we compared the safety and efficacy of BAS versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). We randomised 827 patients with ACS (1:1) to either BAS (417) or EES (410). The primary endpoint was a composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) at 12-month follow-up. Analyses were performed by intention to treat. At 12-month follow-up, the primary composite endpoint occurred in 9.6% of patients in the BAS group and 9.0% of those in the EES group (HR [hazard ratio] 1.04, 95% CI [confidence interval] 0.81-1.32, p=0.81, p for non-inferiority =0.001). Non-fatal MI was significantly less frequent in the BAS as compared with the EES group (2.2% vs. 5.9%, p=0.007...
We performed a pooled analysis of three trials comparing titanium-nitride-oxide-coated bioactive ... more We performed a pooled analysis of three trials comparing titanium-nitride-oxide-coated bioactive stents (BAS) with paclitaxel-eluting stents (PES) in 1,774 patients. All patients were followed for 12 months. The primary outcomes of interest were recurrent myocardial infarction (MI), death and target lesion revascularization (TLR). Secondary endpoints were stent thrombosis (ST) and major adverse cardiac events (MACE) including MI, death and TLR. There were 922 patients in the BAS group and 852 in the PES group. BAS significantly reduced the risk of recurrent MI (2.7% vs. 5.6%; risk ratio 0.50, 95% CI 0.31-0.81; p = 0.004) and MACE (8.9% vs. 12.6%; risk ratio 0.71, 95% CI 0.54-0.94; p = 0.02) during the 12 months of follow up. In contrast, the differences between BAS and PES were not statistically significant with respect to TLR (risk ratio 0.98, 95% CI 0.68-1.41), death (risk ratio 0.96, 95% CI 0.61-1.51) and definite ST (risk ratio 0.28, 95% CI 0.05-1.47). In conclusion, the results of this analysis suggest that BAS is effective in reducing TLR and improves clinical outcomes by reducing MI and MACE compared with PES.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 26, 2015
We explored the 12-month clinical outcome of the titanium-nitride-oxide-coated OPTIMAX stent base... more We explored the 12-month clinical outcome of the titanium-nitride-oxide-coated OPTIMAX stent based on cobalt-chromium platform. The OPTIMAX stent demonstrated a satisfactory 6-month clinical outcome in de novo coronary lesions. We enrolled 224 consecutive symptomatic patients with significant (50%) stenosis in de novo coronary lesions, who were treated with OPTIMAX stent implantation. The primary endpoint was major adverse cardiac events at 12-month follow-up, defined as a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Stent thrombosis was adjudicated according to the definition of the Academic Research Consortium. The mean age of the cohort was 67 ± 8 years (75% males). Patients presented with acute coronary syndrome in 62.1%. Radial access was used in 92%; complex (type B and C) lesions were treated in 79.9%. Both procedural and clinical success occurred in 100% of the cases. The mean follow-up period was...
Adequate antiplatelet therapy in patients with myocardial infarction with ST-elevation (STEMI) is... more Adequate antiplatelet therapy in patients with myocardial infarction with ST-elevation (STEMI) is vital in order to avoid ischemic complications. However, especially with the novel potent oral drugs, bleeding is a major concern. We aimed to investigate whether STEMI patients switched to novel ADP receptor inhibitors due to high platelet reactivity (HPR) on clopidogrel have similar outcomes compared to patients with adequate response to clopidogrel. A prospective cohort of 175 STEMI patients (mean age 62.3years) undergoing primary PCI were included in the PASTOR study. Patients were loaded with 600mg clopidogrel before the index PCI procedure. Bedside VerifyNow P2Y12 platelet function testing was performed the following morning. 46 patients (26.3%) were found to have HPR on clopidogrel (PRU&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;235) and were switched to novel ADP receptor antagonists. The remaining 129 patients were treated with clopidogrel. The mean duration of dual antiplatelet therapy (DAPT) was 6.7months. Duration of entire follow-up of patients was approximately 2years. Major adverse cardiac events (MACE) while patients were on DAPT occurred in 7.0% in the clopidogrel group compared to 8.7% in the novel ADP receptor antagonist group (p=0.70). No differences were observed between groups off-DAPT either. Following primary PCI for STEMI, patients with adequate response to clopidogrel show similar outcomes compared to patients switched to novel ADP receptor antagonists due to HPR on clopidogrel. Platelet reactivity testing can be used to guide the choice of antiplatelet therapy in patients with STEMI treated by primary PCI.
A major concern in cardioversion of newly detected atrial fibrillation is the risk of thromboembo... more A major concern in cardioversion of newly detected atrial fibrillation is the risk of thromboembolic events. The vast majority of these events occur in the first week following cardioversion. Transesophageal echocardiography has demonstrated that thrombus and dense spontaneous echo contrast may occur in the left atrium and left atrial appendage in patients with acute atrial fibrillation (<48 hours) scheduled for cardioversion. Moreover, atrial function may become impaired immediately following successful cardioversion. The risk of thromboembolic events increases with the presence of stroke risk factors, such as heart failure, hypertension, diabetes, prior stroke, female sex and age above 65-75 years. Thus, the current guidelines of the ESC and ACC/AHA/Heart Rhythm Society recommend that patients with acute atrial fibrillation should undergo cardioversion under cover of unfractionated or low-molecular weight heparin followed by oral anticoagulation for at least 4 weeks in patients...
The efficacy and safety of titanium-nitride-oxide-coated bioactive stents (BASs) were demonstrate... more The efficacy and safety of titanium-nitride-oxide-coated bioactive stents (BASs) were demonstrated in prior studies. In a prospective registry, we sought to explore the extent of neointimal coverage of stent struts by optical coherence tomography (OCT) at 30 days following the implantation of BASs in an unselected non-diabetic population. We enrolled 20 consecutive nondiabetic patients who underwent BAS implantation. OCT images were obtained at 30-day follow-up. Binary stent strut coverage was defined as the number of covered struts as a percentage of all analyzed struts. Patients underwent OCT examination at an average of 30.5 ± 5.7 days following stent implantation. In these, 411 cross-sections were analyzed, including 3780 struts. Binary stent strut coverage was 97.2%, and the prevalence of malapposed struts was 3.2%. Mean neointimal thickness was 109.7 ± 83.6 μm. In the current evaluation by OCT at 30-day follow-up after BAS implantation in an unselected non-diabetic cohort, bin...
In a prospective study, we explored the extent of neointimal coverage of stent struts by optical ... more In a prospective study, we explored the extent of neointimal coverage of stent struts by optical coherence tomography 14 days following the implantation of bioactive stents in an unselected cohort. We enrolled 15 consecutive patients who underwent bioactive stent implantation. Optical coherence tomography images were obtained at 14-day follow-up. Morphometric analysis, strut coverage, strut apposition, neointimal hyperplasia and possible thrombosis were evaluated at 1-mm intervals. Binary stent strut coverage was defined as the percentage of covered struts of all analyzed struts. Patients underwent optical coherence tomography examination at an average of 14.5 ± 2.3 days following stent implantation. Mean age was 62 ± 11 years; 86.7% were males; 26.7% diabetic. Three-hundred eighteen cross-sections were analysed, including 2935 struts, an average of 9.2 ± 3 struts per cross-section. Binary stent strut coverage was 96.3%; the prevalence of malapposed struts 1.8%. No thrombi were detected. Mean neointimal hyperplasia thickness was 71.5 ± 53.7 µm. In the current evaluation by optical coherence tomography at 14-day follow-up after bioactive stent implantation in an unselected cohort, binary stent strut coverage was fairly adequate, and the prevalence of malapposed struts was low.
Central vein leads are known to predispose to venous obstruction. Although usually asymptomatic, ... more Central vein leads are known to predispose to venous obstruction. Although usually asymptomatic, obstruction may render electrode removal difficult. This study aimed at quantifying changes in venous calibers in a prospective fashion by intravenous contrast venography (ICV) before and after pacemaker (PM) or cardioverter-defibrillator implantation. One hundred and fifty (mean age 67; 61% male) consecutive patients were enrolled, and followed for 6 months. A successful ICV was done at baseline prior to implantation and at 6-month follow-up in 136 (91%) patients. Minimum (D(min)) and maximum (D(max)) vessel diameters were obtained from both ICVs. A new stenosis was defined as a 50% diameter reduction in a venous segment when compared to baseline. We implanted a total of 230 electrodes: 47 (34.6%) single lead, 84 (61.8%) 2-lead, and 5 (3.7%) 3-lead systems. At baseline ICV, 10 patients (7%) were found to have venous anomalies, including 8 patients with obstructive lesions, 1 patient wit...
Venous lesions, including obstruction and thromboembolism (VTE), are not uncommon after pacemaker... more Venous lesions, including obstruction and thromboembolism (VTE), are not uncommon after pacemaker implantation. The purpose of this prospective study was to assess the role of various patient and procedure-related risk factors in the development of these complications. A prospective venography-based study of 150 consecutive pacemaker implantations with a 6-month follow-up was conducted. Current case-control study included all cases (n = 47) with a new venous lesion, and their matched controls. Several surgical and technical factors, i.e. lead burden, choice of venous access, operator experience and procedure duration, as well as patient-related classic risk factors of VTE were assessed. Plasma markers of coagulation and endothelial activation [prothrombin fragment 1 + 2 (F1 + 2), D-dimer (DD), von Willebrand factor (vWF), thrombomodulin (Tm)] were used to evaluate the extent of acute surgical trauma. All cases with venous lesions were also screened for thrombophilia. None of the pro...
The Journal of thoracic and cardiovascular surgery, Jan 21, 2015
Postpericardiotomy syndrome is a well-known complication after cardiac surgery. Nevertheless, lit... more Postpericardiotomy syndrome is a well-known complication after cardiac surgery. Nevertheless, little is known about the incidence and predictors of postpericardiotomy syndrome requiring medical attention or hospitalization in a contemporary set of patients undergoing isolated coronary bypass. This retrospective analysis included 688 patients from 2008 to 2010. The median follow-up time was 5.3 [4.5-6.0] years. The incidence of postpericardiotomy syndrome was 61 of 688 patients (8.9%), and the median time to diagnosis was 21 [11-52] days, but only 13 patients (22%) required pleural drainage and 3 patients (4.9%) required pericardiocentesis. Patients with postpericardiotomy syndrome more often had 1 or more red blood cell units transfused (61% vs 43%, P = .008) after surgery and less often had diabetes (12% vs 31% P = .002) or metformin medication (3.3% vs 20%, P = .001) compared with those without postpericardiotomy syndrome. In multivariable Cox regression model, renal insufficiency...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2006
The aim of the Titan PORI Registry was to evaluate the safety and efficacy of a stainless steel s... more The aim of the Titan PORI Registry was to evaluate the safety and efficacy of a stainless steel stent coated with titanium nitride oxide (Titan(R), Hexacath, France) in routine clinical practice. We report a prospective single-centre experience in treating patients with the Titan(R) stent. All consecutive patients receiving Titan(R) stent(s) were enrolled. The choice of a stent was at the discretion of the operator with no exclusion criteria. The primary end point of the registry was Major Adverse Cardiac Events (MACE) at 6 and 9 months. A total of 210 lesions were treated in 193 enrolled patients (mean age 67+/-10; men 71%; diabetes 17%). Lesions were of type B in 64% and type C in 23%. The indications for PCI were unstable angina or non-Q-wave MI in 36% and acute STEMI in 30% of the patients. Mean reference diameter was 2.9+/-0.3 mm and mean lesion length 12.9+/-3.0 mm. Mean stent size was 2.98 mm (range 2-3.5 mm) and length 15.5 mm (range 7-28 mm). Stent delivery was successful i...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 20, 2012
Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when ... more Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when compared with paclitaxel-eluting stents in patients with acute myocardial infarction (MI). In a prospective randomised non-inferiority study design, we compared the safety and efficacy of BAS versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). We randomised 827 patients with ACS (1:1) to either BAS (417) or EES (410). The primary endpoint was a composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) at 12-month follow-up. Analyses were performed by intention to treat. At 12-month follow-up, the primary composite endpoint occurred in 9.6% of patients in the BAS group and 9.0% of those in the EES group (HR [hazard ratio] 1.04, 95% CI [confidence interval] 0.81-1.32, p=0.81, p for non-inferiority =0.001). Non-fatal MI was significantly less frequent in the BAS as compared with the EES group (2.2% vs. 5.9%, p=0.007...
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