In one multicenter and several single-center studies involving 202 cases, new shapes of transradi... more In one multicenter and several single-center studies involving 202 cases, new shapes of transradial access PCI guide catheters were tested following a standardized original protocol. The evaluation included a newly designed score for PCI complexity. Three operators successfully performed the 40 cases of the multicenter study, scoring intermediate to difficult 66% of the cases. New shapes were tested for left and right coronary artery and saphenous vein graft PCIs, with right or left transradial access. The new shapes performed adequately, including in 5F sizing. PCI success and fluoroscopy time were related to the score of complexity.
Journal of the American College of Cardiology, 2021
Background: It remains uncertain whether female sex is itself a strong risk factor for worse outc... more Background: It remains uncertain whether female sex is itself a strong risk factor for worse outcomes in ACS. We hypothesized that sex differences in vulnerability to heart failure after ACS may modify the association between sex and outcomes Methods: Data were drawn from the ISACS-Archives network of registries (NCT04008173). The study population consisted of 87,812 patients with known time from symptom onset to hospital presentation. Participants were stratified by ACS subtypes: STEMI and NSTEACS Data on presenting heart failure symptoms were collected from medical record abstraction. Heart failure was categorized as Killip class >2. Time from symptom onset to hospital presentation was categorized as early ( 64120 minutes) or late (>120 minutes). The primary outcome measure was 30-day mortality. Estimates were performed using a parametric balancing strategy by weighting and compared by test of interaction on the log scale Results: Among the study sample, 30922 (35.2%) patients were women. Patient outcomes varied according to subtype of ACS. The mortality rates at 30-days were significantly higher among women vs men in STEMI (RR:1.65; 95%CI: 1.56-1.73) compared with NSTEACS (RR:1.18; 95%CI: 1.09-1.28; P interaction <0.0001). Similarly, the women vs men RR of heart failure was higher in STEMI (RR: 1.24; 95%CI: 1.20-1.29) compared with NSTE-ACS (RR:1.02; 95%CI: 0.97-1.08; P interaction <0.0001). Sex difference in heart failure rates with STEMI presentation were independent (P<0.0001) of early (34.3% in women vs 24.2 % in men) or late (35.5% in women vs 30.7% in men) hospital presentation. The same finding was not seen in NSTE-ACS patients. Overall, women presenting with heart failure was had higher 30-day mortality than did their male counterparts with heart failure (29.8% vs 25.5%; RR: 1.24; 95%CI: 1.17-1.31) Conclusion: Women exhibit substantially more vulnerability to heart failure in STEMI than men: a greater percentage of women have heart failure, and women with heart failure have higher 30-day mortality than men with heart failure. This finding was not seen in NSTE-ACS. Heart failure on initial assessment is a key feature to explain the sex gap in mortality after AC
Introduction: Previous works have shown that women hospitalized with STEMI have higher short-term... more Introduction: Previous works have shown that women hospitalized with STEMI have higher short-term mortality rates than men. However, it is unclear if these differences persist among patients undergoing contemporary primary PCI. Hypothesis: We sought to investigate whether the risk of in-hospital death after STEMI is higher in women than men and, if so, to assess the role of age, medications and primary PCI in this excess of risk. Methods: From January 2010 to May 2014, a total of 6690 patients have been hospitalized and received medical treatment for STEMI in 57 hospitals, referring data to the International Survey of Acute Coronary Syndromes in Transitional Countries (ISACS-TC) registry (NCT01218776). Logistic regression model was adjusted to covariates significantly different between groups in univariate analysis. The endpoint was in-hospital mortality after STEMI. Results: There were 2070 women and 4620 men. Women were older than man, with a higher prevalence of risk factors and ...
AIMS The use of digitalis has been plagued by controversy since its initial use. We aimed to dete... more AIMS The use of digitalis has been plagued by controversy since its initial use. We aimed to determine the relationship between digoxin use and outcomes in hospitalized patients with acute coronary syndromes (ACSs) complicated by heart failure (HF) accounting for sex difference and prior heart diseases. METHODS AND RESULTS Of the 25,187 patients presenting with acute HF (Killip class ≥ 2) in the International Survey of Acute Coronary Syndromes (ISACS)-Archives (NCT04008173) registry, 4,722 (18.7%) received digoxin on hospital admission. The main outcome measure was all cause 30-day mortality. Estimates were evaluated by inverse probability of treatment weighting models. Women who received digoxin had a higher rate of death than women who did not receive it (33.8% vs. 29.2%; relative risk [RR] ratio:1.24;95% confidence interval [CI]: 1.12-1.37). Similar odds for mortality with digoxin were observed in men (28.5% vs. 24.9%; RR ratio 1.20; 95% CI:1.10-1.32). Comparable results were obt...
TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy vs. percutaneous coronary i... more TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction, showed no difference in the primary efficacy outcome but a significant increase in stroke. We sought to understand these findings. A detailed analysis of stroke timing, stroke severity, and stroke subtype was performed. Strokes were adjudicated by neurologists blinded to treatment assignment. Stroke within 30 days, the primary safety outcome, was increased [33 (0.7%) vs. 16 (0.3%), hazard ratio (HR) 2.06; 95% confidence interval (CI) 1.13-3.75]. The difference in stroke was apparent within 48 h [15 (0.3%) vs. 5 (0.1%), HR 3.00; 95% CI 1.09-8.25]. There was an increase in strokes within 180 days with minor or no disability (Rankin 0-2) [18 (0.4%) vs. 13 (0.3%) HR 1.38; 95% CI 0.68-2.82] and in strokes with major disability or fatal (Rankin 3-6) [35 (0.7%) vs. 13 (0.3%), HR 2.69; 95% CI 1.42-5.08]. Most of the absolute difference was...
Purpose Endovascular carotid artery stenosis treatment is associated with a higher peri- and earl... more Purpose Endovascular carotid artery stenosis treatment is associated with a higher peri- and early post-procedural stroke risk relative to surgery. Dual-layer micromesh carotid stents were specifically designed for improved plaque coverage to reduce the cerebral embolization risk and related ischemic events. ROADSAVER study aims to further confirm the safety and efficacy of the Roadsaver™ dual-layer micromesh stent for the treatment of elective patients with carotid artery stenosis. Materials and Methods ROADSAVER is a prospective, multi-center, observational study. Between January 2018 and February 2021, a total of 1967 patients featuring asymptomatic or symptomatic, non-occlusive and non-thrombotic carotid stenosis eligible for an elective stenting procedure were enrolled across 13 European countries (52 centers). Follow-up visits are scheduled at 30 days and at 12 months. The primary outcome measure is the major adverse event rate, i.e., cumulative incidence of any death or strok...
PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text ... more PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text (HTML) versions will be made available soon.
Aim of the study: To investigate the incidence, predictors and prognosis of gastrointestinal blee... more Aim of the study: To investigate the incidence, predictors and prognosis of gastrointestinal bleeding in patients treated for acute coronary syndrome. Materials and Methods: A retrospective study with data gathered from the registry. We analyzed different variables of STEMI, NSTEMI and unstable angina treated patients: clinical, angiographic, treatment type, medications use, in-hospital outcome. Upper gastrointestinal bleeding was defined as hematemesis and/or melena with Hgb reduction, requiring cessation of antiplatelet or anticoagulant therapy and administration of erythrocyte transfusion and, if needed, upper GIT endoscopy. Statistical Analysis: Descriptive, comparative, univariate and multivariate linear and/or binary logistic regression analysis. Statistical significance was determined at a 0,05 level. Results: 874 patients (66,6% males and 33,4% females, mean age 65,7 ± 11,04 y) were analyzed. 75,4% of the patients had STEMI, 12.5% had NSTEMI and 12,1% APNS. The predominant r...
Purpose: To analyze early rehospitalization rate (defined as 90 days after the acute event) in pa... more Purpose: To analyze early rehospitalization rate (defined as 90 days after the acute event) in patients with ACS, and to identify predictors of risk for readmission. Methods:463 randomly selected patients with ACS,were retrospectively analyzed.Analyzed variables:type of ACS(STEMI/NSTEMI/APNS),location of MI,gender,age,risk factors:HTA,HLP,DM,COPD,CAD,PVD,CVD,EF,type of treatment(PCI vs. noninvasive),extensiveness of coronary disease,GRACE and TIMI risk score, type of morbidity,and reason for rehospitalization.Comparative analysis was performed between patients with early rehospitalisation and others.Statistical analysis:t-test,Chi square,univariate and multivariate linear regression. Results:463 patients were enrolled:68.9% males mean age 60.4±10.9, and 31.1% females mean age 64.94±12.0(p 0.000).MI type:STEMI 75.8%,NSTEMI 11.2%,APNS 13%; MI location:40.2% anterior,39,7% inferior,3% lateral and 3.7% multiple locations(p 0.000).Risk profile:15.3% HCAD,27% HF,62% HTA,28.1% DM,5.8% PVD,...
Introduction: Little is known regarding gender differences in coronary flow and 30 day mortality ... more Introduction: Little is known regarding gender differences in coronary flow and 30 day mortality after primary PCI in STEMI, despite blood flow is a major determinant of patients’ prognosis. Hypoth...
Цел: Целта на иследувањето беше да се процени влијаните на „acces site‟, те. местото на пристап п... more Цел: Целта на иследувањето беше да се процени влијаните на „acces site‟, те. местото на пристап при изведување на перкутани коронарни интервентни процедури (ПКИ), врз краткорочниот клинички тек и исход кај пациентите со СТЕМИ миокарден инфаркт. Метод: Во иследувањето беа вклучени 206 пациенти со дијагностициран СТЕМИ во периодот од јануари 2008 до декември 2010, од источниот регион на Р. Македонија. Пациентите беа третирани со пПКИ со радијален (ТРА) или трансфеморален (ТФА) пристап. Пациентите беа поделени во две споредувани групи во зависност од пристапот на пункција (ТРА вис а вис ТФА). Беше следена појавата на перипроцедурални компликации од типот на: крварење на местото на пристапот, време на флуороскопија, должина на болничкото лекување и рана интрахоспитална смртност. Статистичката обработка беше направена со дескриптивна и споредбена статистика. За континуираните обележја t-test, додека за категориските Chi square. Статистичката значајност беше дефинирана на ниво 0.05. Резул...
OBJECTIVE The multicenter proximal upper limb artery (PULA) Registry was created to study the opt... more OBJECTIVE The multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries. BACKGROUND Little is known about the optimal vascular access for PULA interventions, despite the well-known technical complexity of these procedures. METHODS We performed the retrospective analysis of consecutive patients treated for symptomatic steno-occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high-volume centers. Acute thrombotic occlusions were excluded from the study. RESULTS Two hundred and seventy-two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient's characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255/272) versus 86.11% (93/108) p = 0.0230, while the procedure length 27 min (8; 133) versus 46 min (7; 140) p = 0.0001 and fluoroscopy times 439 s (92; 2993) versus 864 s (86; 4176) p = 0.0001 were higher in the occlusion group. The main adverse event rate was similarly low. Dual access was used more often to treat occlusions (60.19% (65/108) vs. 11.40% (31/272) p = 0.0001) without significantly increasing the complication rate. The safest access was ultrasound-guided distal radial artery puncture, significantly better than conventional radial access with 0% (0/31) versus 13.6% (18/131) p = 0.0253 complication. CONCLUSIONS The percutaneous revascularization of proximal upper limb arteries is a safe and effective. Dual access can be applied to increase treatment efficacy, without significantly compromising safety.
In one multicenter and several single-center studies involving 202 cases, new shapes of transradi... more In one multicenter and several single-center studies involving 202 cases, new shapes of transradial access PCI guide catheters were tested following a standardized original protocol. The evaluation included a newly designed score for PCI complexity. Three operators successfully performed the 40 cases of the multicenter study, scoring intermediate to difficult 66% of the cases. New shapes were tested for left and right coronary artery and saphenous vein graft PCIs, with right or left transradial access. The new shapes performed adequately, including in 5F sizing. PCI success and fluoroscopy time were related to the score of complexity.
Journal of the American College of Cardiology, 2021
Background: It remains uncertain whether female sex is itself a strong risk factor for worse outc... more Background: It remains uncertain whether female sex is itself a strong risk factor for worse outcomes in ACS. We hypothesized that sex differences in vulnerability to heart failure after ACS may modify the association between sex and outcomes Methods: Data were drawn from the ISACS-Archives network of registries (NCT04008173). The study population consisted of 87,812 patients with known time from symptom onset to hospital presentation. Participants were stratified by ACS subtypes: STEMI and NSTEACS Data on presenting heart failure symptoms were collected from medical record abstraction. Heart failure was categorized as Killip class >2. Time from symptom onset to hospital presentation was categorized as early ( 64120 minutes) or late (>120 minutes). The primary outcome measure was 30-day mortality. Estimates were performed using a parametric balancing strategy by weighting and compared by test of interaction on the log scale Results: Among the study sample, 30922 (35.2%) patients were women. Patient outcomes varied according to subtype of ACS. The mortality rates at 30-days were significantly higher among women vs men in STEMI (RR:1.65; 95%CI: 1.56-1.73) compared with NSTEACS (RR:1.18; 95%CI: 1.09-1.28; P interaction <0.0001). Similarly, the women vs men RR of heart failure was higher in STEMI (RR: 1.24; 95%CI: 1.20-1.29) compared with NSTE-ACS (RR:1.02; 95%CI: 0.97-1.08; P interaction <0.0001). Sex difference in heart failure rates with STEMI presentation were independent (P<0.0001) of early (34.3% in women vs 24.2 % in men) or late (35.5% in women vs 30.7% in men) hospital presentation. The same finding was not seen in NSTE-ACS patients. Overall, women presenting with heart failure was had higher 30-day mortality than did their male counterparts with heart failure (29.8% vs 25.5%; RR: 1.24; 95%CI: 1.17-1.31) Conclusion: Women exhibit substantially more vulnerability to heart failure in STEMI than men: a greater percentage of women have heart failure, and women with heart failure have higher 30-day mortality than men with heart failure. This finding was not seen in NSTE-ACS. Heart failure on initial assessment is a key feature to explain the sex gap in mortality after AC
Introduction: Previous works have shown that women hospitalized with STEMI have higher short-term... more Introduction: Previous works have shown that women hospitalized with STEMI have higher short-term mortality rates than men. However, it is unclear if these differences persist among patients undergoing contemporary primary PCI. Hypothesis: We sought to investigate whether the risk of in-hospital death after STEMI is higher in women than men and, if so, to assess the role of age, medications and primary PCI in this excess of risk. Methods: From January 2010 to May 2014, a total of 6690 patients have been hospitalized and received medical treatment for STEMI in 57 hospitals, referring data to the International Survey of Acute Coronary Syndromes in Transitional Countries (ISACS-TC) registry (NCT01218776). Logistic regression model was adjusted to covariates significantly different between groups in univariate analysis. The endpoint was in-hospital mortality after STEMI. Results: There were 2070 women and 4620 men. Women were older than man, with a higher prevalence of risk factors and ...
AIMS The use of digitalis has been plagued by controversy since its initial use. We aimed to dete... more AIMS The use of digitalis has been plagued by controversy since its initial use. We aimed to determine the relationship between digoxin use and outcomes in hospitalized patients with acute coronary syndromes (ACSs) complicated by heart failure (HF) accounting for sex difference and prior heart diseases. METHODS AND RESULTS Of the 25,187 patients presenting with acute HF (Killip class ≥ 2) in the International Survey of Acute Coronary Syndromes (ISACS)-Archives (NCT04008173) registry, 4,722 (18.7%) received digoxin on hospital admission. The main outcome measure was all cause 30-day mortality. Estimates were evaluated by inverse probability of treatment weighting models. Women who received digoxin had a higher rate of death than women who did not receive it (33.8% vs. 29.2%; relative risk [RR] ratio:1.24;95% confidence interval [CI]: 1.12-1.37). Similar odds for mortality with digoxin were observed in men (28.5% vs. 24.9%; RR ratio 1.20; 95% CI:1.10-1.32). Comparable results were obt...
TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy vs. percutaneous coronary i... more TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction, showed no difference in the primary efficacy outcome but a significant increase in stroke. We sought to understand these findings. A detailed analysis of stroke timing, stroke severity, and stroke subtype was performed. Strokes were adjudicated by neurologists blinded to treatment assignment. Stroke within 30 days, the primary safety outcome, was increased [33 (0.7%) vs. 16 (0.3%), hazard ratio (HR) 2.06; 95% confidence interval (CI) 1.13-3.75]. The difference in stroke was apparent within 48 h [15 (0.3%) vs. 5 (0.1%), HR 3.00; 95% CI 1.09-8.25]. There was an increase in strokes within 180 days with minor or no disability (Rankin 0-2) [18 (0.4%) vs. 13 (0.3%) HR 1.38; 95% CI 0.68-2.82] and in strokes with major disability or fatal (Rankin 3-6) [35 (0.7%) vs. 13 (0.3%), HR 2.69; 95% CI 1.42-5.08]. Most of the absolute difference was...
Purpose Endovascular carotid artery stenosis treatment is associated with a higher peri- and earl... more Purpose Endovascular carotid artery stenosis treatment is associated with a higher peri- and early post-procedural stroke risk relative to surgery. Dual-layer micromesh carotid stents were specifically designed for improved plaque coverage to reduce the cerebral embolization risk and related ischemic events. ROADSAVER study aims to further confirm the safety and efficacy of the Roadsaver™ dual-layer micromesh stent for the treatment of elective patients with carotid artery stenosis. Materials and Methods ROADSAVER is a prospective, multi-center, observational study. Between January 2018 and February 2021, a total of 1967 patients featuring asymptomatic or symptomatic, non-occlusive and non-thrombotic carotid stenosis eligible for an elective stenting procedure were enrolled across 13 European countries (52 centers). Follow-up visits are scheduled at 30 days and at 12 months. The primary outcome measure is the major adverse event rate, i.e., cumulative incidence of any death or strok...
PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text ... more PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text (HTML) versions will be made available soon.
Aim of the study: To investigate the incidence, predictors and prognosis of gastrointestinal blee... more Aim of the study: To investigate the incidence, predictors and prognosis of gastrointestinal bleeding in patients treated for acute coronary syndrome. Materials and Methods: A retrospective study with data gathered from the registry. We analyzed different variables of STEMI, NSTEMI and unstable angina treated patients: clinical, angiographic, treatment type, medications use, in-hospital outcome. Upper gastrointestinal bleeding was defined as hematemesis and/or melena with Hgb reduction, requiring cessation of antiplatelet or anticoagulant therapy and administration of erythrocyte transfusion and, if needed, upper GIT endoscopy. Statistical Analysis: Descriptive, comparative, univariate and multivariate linear and/or binary logistic regression analysis. Statistical significance was determined at a 0,05 level. Results: 874 patients (66,6% males and 33,4% females, mean age 65,7 ± 11,04 y) were analyzed. 75,4% of the patients had STEMI, 12.5% had NSTEMI and 12,1% APNS. The predominant r...
Purpose: To analyze early rehospitalization rate (defined as 90 days after the acute event) in pa... more Purpose: To analyze early rehospitalization rate (defined as 90 days after the acute event) in patients with ACS, and to identify predictors of risk for readmission. Methods:463 randomly selected patients with ACS,were retrospectively analyzed.Analyzed variables:type of ACS(STEMI/NSTEMI/APNS),location of MI,gender,age,risk factors:HTA,HLP,DM,COPD,CAD,PVD,CVD,EF,type of treatment(PCI vs. noninvasive),extensiveness of coronary disease,GRACE and TIMI risk score, type of morbidity,and reason for rehospitalization.Comparative analysis was performed between patients with early rehospitalisation and others.Statistical analysis:t-test,Chi square,univariate and multivariate linear regression. Results:463 patients were enrolled:68.9% males mean age 60.4±10.9, and 31.1% females mean age 64.94±12.0(p 0.000).MI type:STEMI 75.8%,NSTEMI 11.2%,APNS 13%; MI location:40.2% anterior,39,7% inferior,3% lateral and 3.7% multiple locations(p 0.000).Risk profile:15.3% HCAD,27% HF,62% HTA,28.1% DM,5.8% PVD,...
Introduction: Little is known regarding gender differences in coronary flow and 30 day mortality ... more Introduction: Little is known regarding gender differences in coronary flow and 30 day mortality after primary PCI in STEMI, despite blood flow is a major determinant of patients’ prognosis. Hypoth...
Цел: Целта на иследувањето беше да се процени влијаните на „acces site‟, те. местото на пристап п... more Цел: Целта на иследувањето беше да се процени влијаните на „acces site‟, те. местото на пристап при изведување на перкутани коронарни интервентни процедури (ПКИ), врз краткорочниот клинички тек и исход кај пациентите со СТЕМИ миокарден инфаркт. Метод: Во иследувањето беа вклучени 206 пациенти со дијагностициран СТЕМИ во периодот од јануари 2008 до декември 2010, од источниот регион на Р. Македонија. Пациентите беа третирани со пПКИ со радијален (ТРА) или трансфеморален (ТФА) пристап. Пациентите беа поделени во две споредувани групи во зависност од пристапот на пункција (ТРА вис а вис ТФА). Беше следена појавата на перипроцедурални компликации од типот на: крварење на местото на пристапот, време на флуороскопија, должина на болничкото лекување и рана интрахоспитална смртност. Статистичката обработка беше направена со дескриптивна и споредбена статистика. За континуираните обележја t-test, додека за категориските Chi square. Статистичката значајност беше дефинирана на ниво 0.05. Резул...
OBJECTIVE The multicenter proximal upper limb artery (PULA) Registry was created to study the opt... more OBJECTIVE The multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries. BACKGROUND Little is known about the optimal vascular access for PULA interventions, despite the well-known technical complexity of these procedures. METHODS We performed the retrospective analysis of consecutive patients treated for symptomatic steno-occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high-volume centers. Acute thrombotic occlusions were excluded from the study. RESULTS Two hundred and seventy-two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient's characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255/272) versus 86.11% (93/108) p = 0.0230, while the procedure length 27 min (8; 133) versus 46 min (7; 140) p = 0.0001 and fluoroscopy times 439 s (92; 2993) versus 864 s (86; 4176) p = 0.0001 were higher in the occlusion group. The main adverse event rate was similarly low. Dual access was used more often to treat occlusions (60.19% (65/108) vs. 11.40% (31/272) p = 0.0001) without significantly increasing the complication rate. The safest access was ultrasound-guided distal radial artery puncture, significantly better than conventional radial access with 0% (0/31) versus 13.6% (18/131) p = 0.0253 complication. CONCLUSIONS The percutaneous revascularization of proximal upper limb arteries is a safe and effective. Dual access can be applied to increase treatment efficacy, without significantly compromising safety.
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