Background: Appropriate use criteria (AUC) for coronary revascularization were developed to deliv... more Background: Appropriate use criteria (AUC) for coronary revascularization were developed to deliver high-quality care; however, the prognostic impact of these criteria remains unclear. We sought to assess the outcomes of patients treated with second-generation drug-eluting stent (DES) classified according to the updated American College of Cardiology Foundation/American Heart Association/Society for Cardiac Angiography and Intervention AUC for percutaneous coronary intervention (PCI). Methods: Between January 2012 and December 2013, a total of 1108 consecutive patients treated only with second-generation DES were categorized according to the AUC in three groups, using the new proposed terminology: appropriate ("A"); uncertain ("U"); and inappropriate ("I"). Major adverse cardiac event (MACE, defined as cardiac death, non-fatal myocardial infarction, and ischemia-driven target-lesion revascularization) and stent thrombosis up to 3 years were compared. Results: PCI was categorized as A in 33.8%, U in 46.8%, and I in 19.4% of all cases. PCI-A patients had a higher prevalence of acute coronary syndromes, while PCI-I involved the treatment of more diabetics and patients with stable coronary disease. There were no differences in procedural complications among the three groups, with comparable rates of in-hospital MACE (9.3% for A vs 9.0% for U vs 7.0% for I; P=.70) and 2-year MACE (13.9% for A vs 9.0% for U vs 8.6% for I; P=.40). In the multivariable analysis, AUC classification was not associated with adverse outcomes. Conclusions: In this contemporary cohort of patients treated with second-generation DES implantation, AUC did not impact 3-year clinical follow-up.
Background: We sought to develop a risk score to estimate the risk of major adverse cardiac event... more Background: We sought to develop a risk score to estimate the risk of major adverse cardiac event (MACE) occurrence during the in-hospital and long-term follow-up periods after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Methods: This score was developed and validated in a single-center database encompassing all consecutive patients treated with DES between 2007 and 2014 (n = 4061). For the development of the score, we analyzed all patients treated between January 2007 and December 2012 (n = 2863) while the validation was conducted in a cohort treated between January 2013 and December 2014 (n = 1198). MACE was defined as the combination of cardiovascular death, myocardial infarction, and ischemia- driven target-lesion revascularization. Different stratification models were developed for the in-hospital (logistic regression) and late follow-up score (Cox model). Results: In-hospital scores ranged from 0 to 37 points and comprised: (a) age; (b) previous coronary artery bypass grafting (CABG); (c) acute coronary syndrome; (d) peripheral vascular disease; (e) treatment of saphenous vein graft; (f) long lesions; (g) small vessels; (h) multivessel disease; and (i) thrombus. The late scores ranged from 0 to 45 points and comprised: (a) previous CABG; (b) diabetes mellitus; (c) acute coronary syndrome; (d) multivessel disease; (e) small vessels; (f) ejection fraction <40%; and (g) treatment of saphenous vein graft. Patients were stratified into low-risk, moderate-risk, and high-risk groups. Both scores had close to 70% accuracy for predicting MACE. Conclusion: The present score was developed and validated based on contemporary models for assessing periprocedural and long-term MACE risk post PCI, throughout the full spectrum of patient risk, and important patient subgroups.
Journal of the American College of Cardiology, Sep 1, 2014
imbalances between trials confirmed non-significant differences between stent type and stent thro... more imbalances between trials confirmed non-significant differences between stent type and stent thrombosis rates. The trend for a higher definite stent thrombosis rate in the BES group was by multivariate analysis less prominent (HR 2.05 [CI95% 0.75-5.60]; p¼0.16). Conclusions: At 1-year follow-up the biodegradable polymer-coated BES has similar stent thrombosis rates as the durable polymer-coated EES. However, incidence of definite stent thrombosis is numerically higher in the BES group without reaching statistical significance. Longer follow-up is needed to determine the safety profile of biodegradable polymer-coated BES in real world clinical practice.
Journal of the American College of Cardiology, Apr 1, 2014
background: Despite the extensive knowledge accrued on DES in the past years, there is still lack... more background: Despite the extensive knowledge accrued on DES in the past years, there is still lack of consistent data on the very late outcomes of these devices, especially after the use of 2nd generation DES.
Journal of the American College of Cardiology, Apr 1, 2014
background: Stent thrombosis (ST) has been described as a rare event in current drug-eluting sten... more background: Stent thrombosis (ST) has been described as a rare event in current drug-eluting stent (DES) era; however, its occurrence has been associated with relatively high morbimortality. Our objective was to investigate the impact of second generation DES on the occurrence of ST in daily clinical practice. Methods: A total of 4,790 pts (7,530 lesions) undergoing elective for emergency PCI solely with DES as a default strategy were enrolled between May/02-Mar/13. Clinical follow-up (FU) was performed at 1, 6 and 12 months and yearly up to 10 years (97.3%). Overall, a total of 8,058 DES were implanted including 1st generation (Cypher/Taxus) in 69% and 2nd generation (Xience/Promus/Resolute/Endeavor/BioMatrix) in 31%, given that mean FU for pts treated with 1st vs. 2nd generation DES were 5.3±2.6 vs. 1.1±1.0, respectively. results: Overall, mean age was 64 years, 31% had diabetes, 23% had previous MI and 41% presented with acute coronary syndrome. Compared to pts treated with 1st generation DES, those treated with 2nd generation DES had more diabetes (p<0.001), multivessel disease (p<0.001), and multiple DES implanted (p<0.001), but angiographic success was similar in both groups (>99%). The occurrence curve for ST (ARC) up to 2 years FU with landmark analysis at 1 year is shown in the Figure. conclusions: Compared to 1st generation DES, 2nd generation DES was associated with a non-significant trend towards less ST up to 2 years FU, given that there was no very late ST found with 2nd generation DES.
Background Nosocomial sepsis is a major healthcare issue, but there are few data on estimates of ... more Background Nosocomial sepsis is a major healthcare issue, but there are few data on estimates of its attributable mortality. We aimed to estimate attributable mortality fraction (AF) due to nosocomial sepsis. Methods Matched 1:1 case–control study in 37 hospitals in Brazil. Hospitalized patients in participating hospitals were included. Cases were hospital non-survivors and controls were hospital survivors, which were matched by admission type and date of discharge. Exposure was defined as occurrence of nosocomial sepsis, defined as antibiotic prescription plus presence of organ dysfunction attributed to sepsis without an alternative reason for organ failure; alternative definitions were explored. Main outcome measurement was nosocomial sepsis-attributable fractions, estimated using inversed-weight probabilities methods using generalized mixed model considering time-dependency of sepsis occurrence. Results 3588 patients from 37 hospitals were included. Mean age was 63 years and 48.8...
Background There is limited prospective real-world evidence of patients with atrial fibrillation ... more Background There is limited prospective real-world evidence of patients with atrial fibrillation (AF) in Latin America. Methods The rationale and design of the study were previously published (1). Briefly, RECALL was the first nationwide prospective study of patients in Brazil with known atrial fibrillation. A total of 4,585 patients were included among 89 sites from April 2012 to August 2019. All patients were followed for one year by the protocol. Patient characteristics, medications under use and clinical outcomes during the follow-up were collected. Results From the total of patients enrolled, 41 were excluded from the analysis since they did not have a confirmed diagnosis of atrial fibrillation. The median age was 70 (61–78) years, 46% were women and the majority of the cases were permanent AF (53,8%). The mean CHA2DS2VASc was 3.2±1.6 and the median HASBLED was 2 [2–3]. The most common risk factor was arterial hypertension (77.9%). The median heart rate was 74 [65–85] and the m...
Aims To evaluate whether a strategy of double-dose influenza vaccination during hospitalization f... more Aims To evaluate whether a strategy of double-dose influenza vaccination during hospitalization for an acute coronary syndrome (ACS) compared with standard-dose outpatient vaccination (as recommended by current guidelines) would further reduce the risk of major cardiopulmonary events. Methods and results Vaccination against Influenza to Prevent cardiovascular events after Acute Coronary Syndromes (VIP-ACS) was a pragmatic, randomized, multicentre, active-comparator, open-label trial with blinded outcome adjudication comparing two strategies of influenza vaccination following an ACS: double-dose quadrivalent inactivated vaccine before hospital discharge vs. standard-dose quadrivalent inactivated vaccine administered in the outpatient setting 30 days after randomization. The primary outcome was a hierarchical composite of all-cause death, myocardial infarction, stroke, unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respir...
IMPORTANCE The effect of high-flow oxygen therapy vs conventional oxygen therapy has not been est... more IMPORTANCE The effect of high-flow oxygen therapy vs conventional oxygen therapy has not been established in the setting of severe COVID-19. OBJECTIVE To determine the effect of high-flow oxygen therapy through a nasal cannula compared with conventional oxygen therapy on need for endotracheal intubation and clinical recovery in severe COVID-19. DESIGN, SETTING, AND PARTICIPANTS Randomized, open-label clinical trial conducted in emergency and intensive care units in 3 hospitals in Colombia. A total of 220 adults with respiratory distress and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of less than 200 due to COVID-19 were randomized from August 2020 to January 2021, with last follow-up on February 10, 2021. INTERVENTIONS Patients were randomly assigned to receive high-flow oxygen through a nasal cannula (n = 109) or conventional oxygen therapy (n = 111). MAIN OUTCOMES AND MEASURES The co-primary outcomes were need for intubation and time to clinical recovery until day 28 as assessed by a 7-category ordinal scale (range, 1-7, with higher scores indicating a worse condition). Effects of treatments were calculated with a Cox proportional hazards model adjusted for hypoxemia severity, age, and comorbidities. RESULTS Among 220 randomized patients, 199 were included in the analysis (median age, 60 years; n = 65 women [32.7%]). Intubation occurred in 34 (34.3%) randomized to high-flow oxygen therapy and in 51 (51.0%) randomized to conventional oxygen therapy (hazard ratio, 0.62; 95% CI, 0.39-0.96; P = .03). The median time to clinical recovery within 28 days was 11 (IQR, 9-14) days in patients randomized to high-flow oxygen therapy vs 14 (IQR, 11-19) days in those randomized to conventional oxygen therapy (hazard ratio, 1.39; 95% CI, 1.00-1.92; P = .047). Suspected bacterial pneumonia occurred in 13 patients (13.1%) randomized to high-flow oxygen and in 17 (17.0%) of those randomized to conventional oxygen therapy, while bacteremia was detected in 7 (7.1%) vs 11 (11.0%), respectively. CONCLUSIONS AND RELEVANCE Among patients with severe COVID-19, use of high-flow oxygen through a nasal cannula significantly decreased need for mechanical ventilation support and time to clinical recovery compared with conventional low-flow oxygen therapy.
BACKGROUND: The best way to offer non-invasive respiratory support across several aetiologies of ... more BACKGROUND: The best way to offer non-invasive respiratory support across several aetiologies of acute respiratory failure (ARF) is presently unclear. Both high flow nasal catheter (HFNC) therapy and non-invasive positive pressure ventilation (NIPPV) may improve outcomes in critically ill patients by avoiding the need for invasive mechanical ventilation (IMV). OBJECTIVE: Describe the details of the protocol and statistical analysis plan designed to test whether HFNC therapy is non-inferior or even superior to NIPPV in patients with ARF due to different aetiologies. METHODS: RENOVATE is a multicentre adaptive randomised controlled trial that is recruiting patients from adult emergency departments, wards and intensive care units (ICUs). It takes advantage of an adaptive Bayesian framework to assess the effectiveness of HFNC therapy versus NIPPV in four subgroups of ARF (hypoxaemic non-immunocompromised, hypoxaemic immunocompromised, chronic obstructive pulmonary disease exacerbations,...
Background The 2019 coronavirus disease (COVID-19) pandemic continues to spread and affects large... more Background The 2019 coronavirus disease (COVID-19) pandemic continues to spread and affects large numbers of people with unprecedented impacts. To date, there is no consensus on a specific treatment. Experimental evidence has already been obtained for use of the standardized extract of Brazilian green propolis (EPP-AF) against viral targets, and clinical rationality has been demonstrated for testing this extract as an adjunct to treatment in patients affected by COVID-19. The BeeCovid2 study is once again assessing EPP-AF in hospitalized patients with coronavirus infection. Methods BeeCovid2 is a randomized, double-blinded, placebo-controlled clinical study being conducted in Brazil to provide further evidence on the effectiveness of standardized green propolis extract as an adjunctive treatment for adults hospitalized with COVID-19. Adults hospitalized with COVID-19 with respiratory symptoms for less than 14 days who are not on invasive oxygen therapy are eligible. Enrolled patient...
ABSTRACT: Feline injection site sarcoma is a malignant neoplasm with digitiform projections into ... more ABSTRACT: Feline injection site sarcoma is a malignant neoplasm with digitiform projections into muscular planes that are ill recognized during physical examination and may compromise tumor margin demarcation. This study compared tumoral size of 32 cats measured by different methods, and evaluated the CT density of 10 tumoral tissues (Hounsfield unit) based on histograms. Tumor axes were measured by physical examination and CT images. Larger craniocaudal axis measurements were obtained following multiplanar reconstruction of pre- and post-contrast CT images (p=0.049 and p=0.041 respectively); dorsoventral axis measurements taken from post-contrast CT images were also larger (p=0.010). Tumor volume estimates increased following contrast-enhancement. Histograms tended to produce two peaks: one in the fat and another in the soft tissue attenuation range. Multiplanar reconstructed post-contrast CT images provided clearer definition of tumor margins and more judicious determination of tu...
This is a PDF file of an article that has undergone enhancements after acceptance, such as the ad... more This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group IMPORTANCE Clinical... more The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group IMPORTANCE Clinical trials assessing the efficacy of IL-6 antagonists in patients hospitalized for COVID-19 have variously reported benefit, no effect, and harm. OBJECTIVE To estimate the association between administration of IL-6 antagonists compared with usual care or placebo and 28-day all-cause mortality and other outcomes. DATA SOURCES Trials were identified through systematic searches of electronic databases between October 2020 and January 2021. Searches were not restricted by trial status or language. Additional trials were identified through contact with experts. STUDY SELECTION Eligible trials randomly assigned patients hospitalized for COVID-19 to a group in whom IL-6 antagonists were administered and to a group in whom neither IL-6 antagonists nor any other immunomodulators except corticosteroids were administered. Among 72 potentially eligible trials, 27 (37.5%) met study selection criteria. DATA EXTRACTION AND SYNTHESIS In this prospective meta-analysis, risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I 2 statistic. The primary analysis was an inverse variance-weighted fixed-effects meta-analysis of odds ratios (ORs) for 28-day all-cause mortality. MAIN OUTCOMES AND MEASURES The primary outcome measure was all-cause mortality at 28 days after randomization. There were 9 secondary outcomes including progression to invasive mechanical ventilation or death and risk of secondary infection by 28 days. RESULTS A total of 10 930 patients (median age, 61 years [range of medians, 52-68 years]; 3560 [33%] were women) participating in 27 trials were included. By 28 days, there were 1407 deaths among 6449 patients randomized to IL-6 antagonists and 1158 deaths among 4481 patients randomized to usual care or placebo (summary OR, 0.86 [95% CI, 0.79-0.95]; P = .003 based on a fixed-effects meta-analysis). This corresponds to an absolute mortality risk of 22% for IL-6 antagonists compared with an assumed mortality risk of 25% for usual care or placebo. The corresponding summary ORs were 0.83 (95% CI, 0.74-0.92; P < .001) for tocilizumab and 1.08 (95% CI, 0.86-1.36; P = .52) for sarilumab. The summary ORs for the association with mortality compared with usual care or placebo in those receiving corticosteroids were 0.77 (95% CI, 0.68-0.87) for tocilizumab and 0.92 (95% CI, 0.61-1.38) for sarilumab. The ORs for the association with progression to invasive mechanical ventilation or death, compared with usual care or placebo, were 0.77 (95% CI, 0.70-0.85) for all IL-6 antagonists, 0.74 (95% CI, 0.66-0.82) for tocilizumab, and 1.00 (95% CI, 0.74-1.34) for sarilumab. Secondary infections by 28 days occurred in 21.9% of patients treated with IL-6 antagonists vs 17.6% of patients treated with usual care or placebo (OR accounting for trial sample sizes, 0.99; 95% CI, 0.85-1.16). CONCLUSIONS AND RELEVANCE In this prospective meta-analysis of clinical trials of patients hospitalized for COVID-19, administration of IL-6 antagonists, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.
; for the BaSICS investigators and the BRICNet members IMPORTANCE Intravenous fluids are used for... more ; for the BaSICS investigators and the BRICNet members IMPORTANCE Intravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury. OBJECTIVE To determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients. DESIGN, SETTING, AND PARTICIPANTS Double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately). INTERVENTIONS Patients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids. MAIN OUTCOMES AND MEASURES The primary outcome was 90-day survival. RESULTS Among 11 052 patients who were randomized, 10 520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed; P = .98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05]; P = .47). There were no unexpected treatment-related severe adverse events in either group. CONCLUSION AND RELEVANCE Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution.
Background: Appropriate use criteria (AUC) for coronary revascularization were developed to deliv... more Background: Appropriate use criteria (AUC) for coronary revascularization were developed to deliver high-quality care; however, the prognostic impact of these criteria remains unclear. We sought to assess the outcomes of patients treated with second-generation drug-eluting stent (DES) classified according to the updated American College of Cardiology Foundation/American Heart Association/Society for Cardiac Angiography and Intervention AUC for percutaneous coronary intervention (PCI). Methods: Between January 2012 and December 2013, a total of 1108 consecutive patients treated only with second-generation DES were categorized according to the AUC in three groups, using the new proposed terminology: appropriate ("A"); uncertain ("U"); and inappropriate ("I"). Major adverse cardiac event (MACE, defined as cardiac death, non-fatal myocardial infarction, and ischemia-driven target-lesion revascularization) and stent thrombosis up to 3 years were compared. Results: PCI was categorized as A in 33.8%, U in 46.8%, and I in 19.4% of all cases. PCI-A patients had a higher prevalence of acute coronary syndromes, while PCI-I involved the treatment of more diabetics and patients with stable coronary disease. There were no differences in procedural complications among the three groups, with comparable rates of in-hospital MACE (9.3% for A vs 9.0% for U vs 7.0% for I; P=.70) and 2-year MACE (13.9% for A vs 9.0% for U vs 8.6% for I; P=.40). In the multivariable analysis, AUC classification was not associated with adverse outcomes. Conclusions: In this contemporary cohort of patients treated with second-generation DES implantation, AUC did not impact 3-year clinical follow-up.
Background: We sought to develop a risk score to estimate the risk of major adverse cardiac event... more Background: We sought to develop a risk score to estimate the risk of major adverse cardiac event (MACE) occurrence during the in-hospital and long-term follow-up periods after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Methods: This score was developed and validated in a single-center database encompassing all consecutive patients treated with DES between 2007 and 2014 (n = 4061). For the development of the score, we analyzed all patients treated between January 2007 and December 2012 (n = 2863) while the validation was conducted in a cohort treated between January 2013 and December 2014 (n = 1198). MACE was defined as the combination of cardiovascular death, myocardial infarction, and ischemia- driven target-lesion revascularization. Different stratification models were developed for the in-hospital (logistic regression) and late follow-up score (Cox model). Results: In-hospital scores ranged from 0 to 37 points and comprised: (a) age; (b) previous coronary artery bypass grafting (CABG); (c) acute coronary syndrome; (d) peripheral vascular disease; (e) treatment of saphenous vein graft; (f) long lesions; (g) small vessels; (h) multivessel disease; and (i) thrombus. The late scores ranged from 0 to 45 points and comprised: (a) previous CABG; (b) diabetes mellitus; (c) acute coronary syndrome; (d) multivessel disease; (e) small vessels; (f) ejection fraction <40%; and (g) treatment of saphenous vein graft. Patients were stratified into low-risk, moderate-risk, and high-risk groups. Both scores had close to 70% accuracy for predicting MACE. Conclusion: The present score was developed and validated based on contemporary models for assessing periprocedural and long-term MACE risk post PCI, throughout the full spectrum of patient risk, and important patient subgroups.
Journal of the American College of Cardiology, Sep 1, 2014
imbalances between trials confirmed non-significant differences between stent type and stent thro... more imbalances between trials confirmed non-significant differences between stent type and stent thrombosis rates. The trend for a higher definite stent thrombosis rate in the BES group was by multivariate analysis less prominent (HR 2.05 [CI95% 0.75-5.60]; p¼0.16). Conclusions: At 1-year follow-up the biodegradable polymer-coated BES has similar stent thrombosis rates as the durable polymer-coated EES. However, incidence of definite stent thrombosis is numerically higher in the BES group without reaching statistical significance. Longer follow-up is needed to determine the safety profile of biodegradable polymer-coated BES in real world clinical practice.
Journal of the American College of Cardiology, Apr 1, 2014
background: Despite the extensive knowledge accrued on DES in the past years, there is still lack... more background: Despite the extensive knowledge accrued on DES in the past years, there is still lack of consistent data on the very late outcomes of these devices, especially after the use of 2nd generation DES.
Journal of the American College of Cardiology, Apr 1, 2014
background: Stent thrombosis (ST) has been described as a rare event in current drug-eluting sten... more background: Stent thrombosis (ST) has been described as a rare event in current drug-eluting stent (DES) era; however, its occurrence has been associated with relatively high morbimortality. Our objective was to investigate the impact of second generation DES on the occurrence of ST in daily clinical practice. Methods: A total of 4,790 pts (7,530 lesions) undergoing elective for emergency PCI solely with DES as a default strategy were enrolled between May/02-Mar/13. Clinical follow-up (FU) was performed at 1, 6 and 12 months and yearly up to 10 years (97.3%). Overall, a total of 8,058 DES were implanted including 1st generation (Cypher/Taxus) in 69% and 2nd generation (Xience/Promus/Resolute/Endeavor/BioMatrix) in 31%, given that mean FU for pts treated with 1st vs. 2nd generation DES were 5.3±2.6 vs. 1.1±1.0, respectively. results: Overall, mean age was 64 years, 31% had diabetes, 23% had previous MI and 41% presented with acute coronary syndrome. Compared to pts treated with 1st generation DES, those treated with 2nd generation DES had more diabetes (p<0.001), multivessel disease (p<0.001), and multiple DES implanted (p<0.001), but angiographic success was similar in both groups (>99%). The occurrence curve for ST (ARC) up to 2 years FU with landmark analysis at 1 year is shown in the Figure. conclusions: Compared to 1st generation DES, 2nd generation DES was associated with a non-significant trend towards less ST up to 2 years FU, given that there was no very late ST found with 2nd generation DES.
Background Nosocomial sepsis is a major healthcare issue, but there are few data on estimates of ... more Background Nosocomial sepsis is a major healthcare issue, but there are few data on estimates of its attributable mortality. We aimed to estimate attributable mortality fraction (AF) due to nosocomial sepsis. Methods Matched 1:1 case–control study in 37 hospitals in Brazil. Hospitalized patients in participating hospitals were included. Cases were hospital non-survivors and controls were hospital survivors, which were matched by admission type and date of discharge. Exposure was defined as occurrence of nosocomial sepsis, defined as antibiotic prescription plus presence of organ dysfunction attributed to sepsis without an alternative reason for organ failure; alternative definitions were explored. Main outcome measurement was nosocomial sepsis-attributable fractions, estimated using inversed-weight probabilities methods using generalized mixed model considering time-dependency of sepsis occurrence. Results 3588 patients from 37 hospitals were included. Mean age was 63 years and 48.8...
Background There is limited prospective real-world evidence of patients with atrial fibrillation ... more Background There is limited prospective real-world evidence of patients with atrial fibrillation (AF) in Latin America. Methods The rationale and design of the study were previously published (1). Briefly, RECALL was the first nationwide prospective study of patients in Brazil with known atrial fibrillation. A total of 4,585 patients were included among 89 sites from April 2012 to August 2019. All patients were followed for one year by the protocol. Patient characteristics, medications under use and clinical outcomes during the follow-up were collected. Results From the total of patients enrolled, 41 were excluded from the analysis since they did not have a confirmed diagnosis of atrial fibrillation. The median age was 70 (61–78) years, 46% were women and the majority of the cases were permanent AF (53,8%). The mean CHA2DS2VASc was 3.2±1.6 and the median HASBLED was 2 [2–3]. The most common risk factor was arterial hypertension (77.9%). The median heart rate was 74 [65–85] and the m...
Aims To evaluate whether a strategy of double-dose influenza vaccination during hospitalization f... more Aims To evaluate whether a strategy of double-dose influenza vaccination during hospitalization for an acute coronary syndrome (ACS) compared with standard-dose outpatient vaccination (as recommended by current guidelines) would further reduce the risk of major cardiopulmonary events. Methods and results Vaccination against Influenza to Prevent cardiovascular events after Acute Coronary Syndromes (VIP-ACS) was a pragmatic, randomized, multicentre, active-comparator, open-label trial with blinded outcome adjudication comparing two strategies of influenza vaccination following an ACS: double-dose quadrivalent inactivated vaccine before hospital discharge vs. standard-dose quadrivalent inactivated vaccine administered in the outpatient setting 30 days after randomization. The primary outcome was a hierarchical composite of all-cause death, myocardial infarction, stroke, unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respir...
IMPORTANCE The effect of high-flow oxygen therapy vs conventional oxygen therapy has not been est... more IMPORTANCE The effect of high-flow oxygen therapy vs conventional oxygen therapy has not been established in the setting of severe COVID-19. OBJECTIVE To determine the effect of high-flow oxygen therapy through a nasal cannula compared with conventional oxygen therapy on need for endotracheal intubation and clinical recovery in severe COVID-19. DESIGN, SETTING, AND PARTICIPANTS Randomized, open-label clinical trial conducted in emergency and intensive care units in 3 hospitals in Colombia. A total of 220 adults with respiratory distress and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of less than 200 due to COVID-19 were randomized from August 2020 to January 2021, with last follow-up on February 10, 2021. INTERVENTIONS Patients were randomly assigned to receive high-flow oxygen through a nasal cannula (n = 109) or conventional oxygen therapy (n = 111). MAIN OUTCOMES AND MEASURES The co-primary outcomes were need for intubation and time to clinical recovery until day 28 as assessed by a 7-category ordinal scale (range, 1-7, with higher scores indicating a worse condition). Effects of treatments were calculated with a Cox proportional hazards model adjusted for hypoxemia severity, age, and comorbidities. RESULTS Among 220 randomized patients, 199 were included in the analysis (median age, 60 years; n = 65 women [32.7%]). Intubation occurred in 34 (34.3%) randomized to high-flow oxygen therapy and in 51 (51.0%) randomized to conventional oxygen therapy (hazard ratio, 0.62; 95% CI, 0.39-0.96; P = .03). The median time to clinical recovery within 28 days was 11 (IQR, 9-14) days in patients randomized to high-flow oxygen therapy vs 14 (IQR, 11-19) days in those randomized to conventional oxygen therapy (hazard ratio, 1.39; 95% CI, 1.00-1.92; P = .047). Suspected bacterial pneumonia occurred in 13 patients (13.1%) randomized to high-flow oxygen and in 17 (17.0%) of those randomized to conventional oxygen therapy, while bacteremia was detected in 7 (7.1%) vs 11 (11.0%), respectively. CONCLUSIONS AND RELEVANCE Among patients with severe COVID-19, use of high-flow oxygen through a nasal cannula significantly decreased need for mechanical ventilation support and time to clinical recovery compared with conventional low-flow oxygen therapy.
BACKGROUND: The best way to offer non-invasive respiratory support across several aetiologies of ... more BACKGROUND: The best way to offer non-invasive respiratory support across several aetiologies of acute respiratory failure (ARF) is presently unclear. Both high flow nasal catheter (HFNC) therapy and non-invasive positive pressure ventilation (NIPPV) may improve outcomes in critically ill patients by avoiding the need for invasive mechanical ventilation (IMV). OBJECTIVE: Describe the details of the protocol and statistical analysis plan designed to test whether HFNC therapy is non-inferior or even superior to NIPPV in patients with ARF due to different aetiologies. METHODS: RENOVATE is a multicentre adaptive randomised controlled trial that is recruiting patients from adult emergency departments, wards and intensive care units (ICUs). It takes advantage of an adaptive Bayesian framework to assess the effectiveness of HFNC therapy versus NIPPV in four subgroups of ARF (hypoxaemic non-immunocompromised, hypoxaemic immunocompromised, chronic obstructive pulmonary disease exacerbations,...
Background The 2019 coronavirus disease (COVID-19) pandemic continues to spread and affects large... more Background The 2019 coronavirus disease (COVID-19) pandemic continues to spread and affects large numbers of people with unprecedented impacts. To date, there is no consensus on a specific treatment. Experimental evidence has already been obtained for use of the standardized extract of Brazilian green propolis (EPP-AF) against viral targets, and clinical rationality has been demonstrated for testing this extract as an adjunct to treatment in patients affected by COVID-19. The BeeCovid2 study is once again assessing EPP-AF in hospitalized patients with coronavirus infection. Methods BeeCovid2 is a randomized, double-blinded, placebo-controlled clinical study being conducted in Brazil to provide further evidence on the effectiveness of standardized green propolis extract as an adjunctive treatment for adults hospitalized with COVID-19. Adults hospitalized with COVID-19 with respiratory symptoms for less than 14 days who are not on invasive oxygen therapy are eligible. Enrolled patient...
ABSTRACT: Feline injection site sarcoma is a malignant neoplasm with digitiform projections into ... more ABSTRACT: Feline injection site sarcoma is a malignant neoplasm with digitiform projections into muscular planes that are ill recognized during physical examination and may compromise tumor margin demarcation. This study compared tumoral size of 32 cats measured by different methods, and evaluated the CT density of 10 tumoral tissues (Hounsfield unit) based on histograms. Tumor axes were measured by physical examination and CT images. Larger craniocaudal axis measurements were obtained following multiplanar reconstruction of pre- and post-contrast CT images (p=0.049 and p=0.041 respectively); dorsoventral axis measurements taken from post-contrast CT images were also larger (p=0.010). Tumor volume estimates increased following contrast-enhancement. Histograms tended to produce two peaks: one in the fat and another in the soft tissue attenuation range. Multiplanar reconstructed post-contrast CT images provided clearer definition of tumor margins and more judicious determination of tu...
This is a PDF file of an article that has undergone enhancements after acceptance, such as the ad... more This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group IMPORTANCE Clinical... more The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group IMPORTANCE Clinical trials assessing the efficacy of IL-6 antagonists in patients hospitalized for COVID-19 have variously reported benefit, no effect, and harm. OBJECTIVE To estimate the association between administration of IL-6 antagonists compared with usual care or placebo and 28-day all-cause mortality and other outcomes. DATA SOURCES Trials were identified through systematic searches of electronic databases between October 2020 and January 2021. Searches were not restricted by trial status or language. Additional trials were identified through contact with experts. STUDY SELECTION Eligible trials randomly assigned patients hospitalized for COVID-19 to a group in whom IL-6 antagonists were administered and to a group in whom neither IL-6 antagonists nor any other immunomodulators except corticosteroids were administered. Among 72 potentially eligible trials, 27 (37.5%) met study selection criteria. DATA EXTRACTION AND SYNTHESIS In this prospective meta-analysis, risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I 2 statistic. The primary analysis was an inverse variance-weighted fixed-effects meta-analysis of odds ratios (ORs) for 28-day all-cause mortality. MAIN OUTCOMES AND MEASURES The primary outcome measure was all-cause mortality at 28 days after randomization. There were 9 secondary outcomes including progression to invasive mechanical ventilation or death and risk of secondary infection by 28 days. RESULTS A total of 10 930 patients (median age, 61 years [range of medians, 52-68 years]; 3560 [33%] were women) participating in 27 trials were included. By 28 days, there were 1407 deaths among 6449 patients randomized to IL-6 antagonists and 1158 deaths among 4481 patients randomized to usual care or placebo (summary OR, 0.86 [95% CI, 0.79-0.95]; P = .003 based on a fixed-effects meta-analysis). This corresponds to an absolute mortality risk of 22% for IL-6 antagonists compared with an assumed mortality risk of 25% for usual care or placebo. The corresponding summary ORs were 0.83 (95% CI, 0.74-0.92; P < .001) for tocilizumab and 1.08 (95% CI, 0.86-1.36; P = .52) for sarilumab. The summary ORs for the association with mortality compared with usual care or placebo in those receiving corticosteroids were 0.77 (95% CI, 0.68-0.87) for tocilizumab and 0.92 (95% CI, 0.61-1.38) for sarilumab. The ORs for the association with progression to invasive mechanical ventilation or death, compared with usual care or placebo, were 0.77 (95% CI, 0.70-0.85) for all IL-6 antagonists, 0.74 (95% CI, 0.66-0.82) for tocilizumab, and 1.00 (95% CI, 0.74-1.34) for sarilumab. Secondary infections by 28 days occurred in 21.9% of patients treated with IL-6 antagonists vs 17.6% of patients treated with usual care or placebo (OR accounting for trial sample sizes, 0.99; 95% CI, 0.85-1.16). CONCLUSIONS AND RELEVANCE In this prospective meta-analysis of clinical trials of patients hospitalized for COVID-19, administration of IL-6 antagonists, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.
; for the BaSICS investigators and the BRICNet members IMPORTANCE Intravenous fluids are used for... more ; for the BaSICS investigators and the BRICNet members IMPORTANCE Intravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury. OBJECTIVE To determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients. DESIGN, SETTING, AND PARTICIPANTS Double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately). INTERVENTIONS Patients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids. MAIN OUTCOMES AND MEASURES The primary outcome was 90-day survival. RESULTS Among 11 052 patients who were randomized, 10 520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed; P = .98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05]; P = .47). There were no unexpected treatment-related severe adverse events in either group. CONCLUSION AND RELEVANCE Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution.
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