Faculty of Medicine

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    Age and sex differences in the efficacy of early invasive strategy for non-ST-elevation acute coronary syndrome: A comparative analysis in stable patients
    (Elsevier BV, 2025-06)
    Cenko, Edina
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    Bergami, Maria
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    Yoon, Jinsung
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    Vadalà, Giuseppe
    ;
    Objective: Previous works have struggled to clearly define sex-specific outcomes based on initial management in NSTE-ACS patients. We examined whether early revascularization (<24 h) versus conservative strategy impacts differently based on sex and age in stable NSTE-ACS patients upon hospital admission. Methods: We identified 8905 patients with diagnosis of non-ST elevation acute coronary syndromes (NSTE-ACS) in the ISACS-TC database. Patients with cardiac arrest, hemodynamic instability, and serious ventricular arrhythmias were excluded. The final cohort consisted of 7589 patients. The characteristics between groups were adjusted using inverse probability of treatment weighting models. Primary outcome measure was all-cause 30-day mortality. Risk ratios (RRs) with their 95 % CIs were employed. Results: Of the 7589 NSTE-ACS patients identified, 2450 (32.3 %) were women. The data show a notable reduction in mortality for the older women (aged 65 years and older) undergoing early invasive strategy compared to those receiving an initial conservative (3.0 % versus 5.1 %; RR: 0.57; 95 % CI: 0.32 - 0.99) Conversely, younger women did not exhibit a significant association between early invasive strategy and mortality reduction (2.0 % versus 0.9 %; RR: 2.27; 95 % CI: 0.73 - 7.04). For men, age stratification did not markedly alter the observed benefits of an early invasive strategy over a conservative approach in the overall population, with reduced death rates in both older (3.1 % versus 5.7 %; RR: 0.52; 95 % CI: 0.34 - 0.80) and younger age groups (0.8 % versus 1.7 %; RR: 0.46; 95 % CI: 0.22 - 0.94). These age and sex-specific mortality patterns did not significantly change within subgroups stratified by the presence of NSTEMI or a GRACE risk score>140. Conclusion: Early coronary revascularization is associated with improved 30-day survival in older men and women and younger men who present to the hospital in stable conditions after NSTE-ACS. It does not confer a survival advantage in young women. Further studies are needed to more accurately risk-stratify young women to guide treatment strategies.
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    Outcomes of digoxin vs. beta blocker in atrial fibrillation: report from ESC–EHRA EORP AF Long-Term General Registry
    (Oxford University Press (OUP), 2021-10-19)
    Ding, Wern Yew
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    Boriani, Giuseppe
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    Marin, Francisco
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    Blomström-Lundqvist, Carina
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    Potpara, Tatjana S
    Aims The safety of digoxin therapy in atrial fibrillation (AF) remains ill-defined. We aimed to evaluate the effects of digoxin over beta-blocker therapy in AF. Methods and results Patients with AF who were treated with either digoxin or a beta blocker from the ESC–EHRA EORP AF (European Society of Cardiology–European Heart Rhythm Association EURObservational Research Programme Atrial Fibrillation) General Long-Term Registry were included. Outcomes of interest were all-cause mortality, cardiovascular (CV) mortality, non-CV mortality, quality of life, and number of patients with unplanned hospitalizations. Of 6377 patients, 549 (8.6%) were treated with digoxin. Over 24 months, there were 550 (8.6%) all-cause mortality events and 1304 (23.6%) patients with unplanned emergency hospitalizations. Compared to beta blocker, digoxin therapy was associated with increased all-cause mortality [hazard ratio (HR) 1.90 (95% confidence interval, CI, 1.48–2.44)], CV mortality [HR 2.18 (95% CI 1.47–3.21)], and non-CV mortality [HR 1.68 (95% CI 1.02–2.75)] with reduced quality of life [health utility score 0.555 (±0.406) vs. 0.705 (±0.346), P < 0.001] but no differences in emergency hospitalizations [HR 1.00 (95% CI 0.56–1.80)] or AF-related hospitalizations [HR 0.95 (95% CI 0.60–1.52)]. On multivariable analysis, there were no differences in any of the outcomes between both groups, after accounting for potential confounders. Similar results were obtained in the subgroups of patients with permanent AF and coexisting heart failure. There were no differences in outcomes between AF patients receiving digoxin with and without chronic kidney disease. Conclusion Poor outcomes related to the use of digoxin over beta-blocker therapy in terms of excess mortality and reduced quality of life are associated with the presence of other risk factors rather than digoxin per se. The choice of digoxin or beta-blocker therapy had no influence on the incidence of unplanned hospitalizations.
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    The no-reflow phenomenon in the young and in the elderly
    (Elsevier BV, 2016-11-01)
    Cenko, Edina
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    Ricci, Beatrice
    ;
    ;
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    Câlmâc, Lucian
    Background The objectives of this study were to evaluate the incidence of no-reflow as independent predictor of adverse events and to assess whether baseline pre-procedural treatment options may affect clinical outcomes. Methods Data were derived from the ISACS-TC registry (NCT01218776) from October 2010 to January 2015. No-reflow was defined as post-PCI TIMI flow grades 0–1, in the absence of post-procedural significant (≥25%) residual stenosis, abrupt vessel closure, dissection, perforation, thrombus of the original target lesion, or epicardial spasm. The outcome measure was in-hospital mortality. Results No-reflow was identified in 128 of 5997 patients who have undergone PCI (2.1%). On multivariate analysis, patients with no-reflow were more likely to be older (OR: 1.20, 95% CI: 1.01–1.44), to have a history of hypercholesterolemia (OR: 1.95, 95% CI: 1.31–2.91) and to be admitted with a diagnosis of STEMI (OR: 2.96, 95% CI: 1.85–4.72). Angiographic characteristics associated with no-reflow phenomenon were: stenosis ≥50% of the right coronary artery, presence of multivessel disease and pre-procedural TIMI blood flow grades 0–1. No-reflow was highly predictive of in-hospital mortality (17.2% vs. 4.2%; adjusted OR: 4.60, 95% CI: 2.61–8.09). Administration of pre-procedural unfractioned heparin or 600mg clopidogrel loading dose was associated with less incidence of no-reflow (OR: 0.65, 95% CI: 0.43–0.99 and 0.61, 95% CI: 0.37–1.00, respectively). Aspirin, enoxaparin, and 300mg clopidogrel loading dose, did not significantly impact the occurrence of the no-reflow. Conclusions We found that pre-procedural administration of 600mg loading dose of clopidogrel and/or unfractioned heparin is associated with reduced incidence of no-reflow.
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    Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study
    (Springer Science and Business Media LLC, 2020-10-09)
    Labeau, Sonia O.
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    Afonso, Elsa
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    Benbenishty, Julie
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    Blackwood, Bronagh
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    Boulanger, Carole
    Purpose: Intensive care unit (ICU) patients are particularly susceptible to developing pressure injuries. Epidemiologic data is however unavailable. We aimed to provide an international picture of the extent of pressure injuries and factors associated with ICU-acquired pressure injuries in adult ICU patients. Methods: International 1-day point-prevalence study; follow-up for outcome assessment until hospital discharge (maximum 12 weeks). Factors associated with ICU-acquired pressure injury and hospital mortality were assessed by generalised linear mixed-effects regression analysis. Results: Data from 13,254 patients in 1117 ICUs (90 countries) revealed 6747 pressure injuries; 3997 (59.2%) were ICU acquired. Overall prevalence was 26.6% (95% confidence interval [CI] 25.9–27.3). ICU-acquired prevalence was 16.2% (95% CI 15.6–16.8). Sacrum (37%) and heels (19.5%) were most affected. Factors independently associated with ICU-acquired pressure injuries were older age, male sex, being underweight, emergency surgery, higher Simplified Acute Physiology Score II, Braden score < 19, ICU stay > 3 days, comorbidities (chronic obstructive pulmonary disease, immunodeficiency), organ support (renal replacement, mechanical ventilation on ICU admission), and being in a low or lower-middle income-economy. Gradually increasing associations with mortality were identified for increasing severity of pressure injury: stage I (odds ratio [OR] 1.5; 95% CI 1.2–1.8), stage II (OR 1.6; 95% CI 1.4–1.9), and stage III or worse (OR 2.8; 95% CI 2.3–3.3). Conclusion: Pressure injuries are common in adult ICU patients. ICU-acquired pressure injuries are associated with mainly intrinsic factors and mortality. Optimal care standards, increased awareness, appropriate resource allocation, and further research into optimal prevention are pivotal to tackle this important patient safety threat.
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    Outcome of patients with acute symptomatic pulmonary embolism and psychiatric disorders
    (Elsevier, 2020)
    Diurbis Velasco,
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    David Jiménez,
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    Behnood Bikdeli,
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    Alfonso Muriel,
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    Pablo Javier Marchena,
    Objective: To address the association between psychiatric disorders and short-term outcomes after acute symptomatic pulmonary embolism (PE). Methods: We identified adults with PE enrolled in the RIETE registry between December 1, 2013, and January 31, 2019. Using multinomial regression, we assessed the association between a history of psychiatric disorders and the outcomes of all-cause mortality, PE-related mortality, and venous thromboembolism recurrence and bleeding rates through 30 days after initiation of treatment. We also examined the impact of depression on all-cause and PE-specific mortality. Results: Among 13,120 patients diagnosed with acute PE, 16.1% (2115) had psychiatric disorders and 4.2% died within the first 30-days of follow-up. Patients with psychiatric disorders had increased odds for all-cause (adjusted odds ratio [OR] 1.50; 95% CI, 1.21 to 1.86; P < 0.001) and PE-related mortality (adjusted OR 1.64; 95% CI, 1.09 to 2.48; P = 0.02) compared to those without psychiatric disorders. Multinomial logistic regression showed a non-significant trend toward lower risk of recurrences for patients with psychiatric disorders (adjusted OR 0.49; 95% CI, 0.21 to 1.15; P = 0.10). Psychiatric disorders were not significantly associated with increased odds for major bleeds during follow-up (adjusted OR 1.09; 95% CI, 0.85 to 1.40; P = 0.49). Results were consistent in a sensitivity analysis that only considered patients with a diagnosis of depression. Conclusions: In patients with acute PE, history of psychiatric disorders might predict all-cause and PE-related death in the ensuing month after diagnosis.
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    Systolic blood pressure and mortality in acute symptomatic pulmonary embolism
    (Elsevier, 2020)
    Quezada A,
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    Jiménez D,
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    Bikdeli B,
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    Moores L,
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    Porres-Aguilar M,
    Background: The optimal cutoff for systolic blood pressure (SBP) level to define high-risk pulmonary embolism (PE) remains to be defined. Methods: To evaluate the relationship between SBP levels on admission and mortality in patients with acute symptomatic PE, the current study included 39,257 consecutive patients with acute symptomatic PE from the RIETE registry between 2001 and 2018. Primary outcomes included all-cause and PE-specific 30-day mortality. Secondary outcomes included major bleeding and recurrent venous thromboembolism (VTE). Results: There was a linear inverse relationship between admission SBP and 30-day all-cause and PE-related mortality that persisted after multivariable adjustment. Patients in the lower SBP strata had higher rates of all-cause death (reference: SBP 110-129 mmHg) (adjusted odds ratio [OR] 2.9; 95% confidence interval [CI], 2.0-4.2 for SBP <70 mmHg; and OR 1.7; 95% CI, 1.4-2.1 for SBP 70-89 mmHg). The findings for 30-day PE-related mortality were similar (adjusted OR 4.4; 95% CI, 2.7-7.2 for SBP <70 mmHg; and OR 2.6; 95% CI, 1.9-3.4 for SBP 70-89 mmHg). Patients in the higher strata of SBP had significantly lower rates of 30-day all-cause mortality compared with the same reference group (adjusted OR 0.7; 95% CI, 0.5-0.9 for SBP 170-190 mmHg; and OR 0.6; 95% CI, 0.4-0.9 for SBP >190 mmHg). Consistent findings were also observed for 30-day PE-related death. Conclusions: In patients with acute symptomatic PE, a low SBP portends an increased risk of all-cause and PE-related mortality. The highest mortality was observed in patients with SBP <70 mmHg.
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    Frequency and prognostic impact of acute kidney injury in patients with acute pulmonary embolism. Data from the RIETE registry
    (2019)
    Martin Murgier,
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    Laurent Bertoletti,
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    Michael Darmon,
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    Fabrice Zeni,
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    Reina Valle,
    Rationale: Acute kidney injury (AKI) is associated with a poor outcome. Although pulmonary embolism (PE) may promote AKI through renal congestion and/or hemodynamic instability, its frequency and influence on outcome in patients with acute PE have been poorly studied. Methods: The frequency of AKI (defined according to the "Kidney Disease: Improving Global Outcomes" definition) at baseline and its influence on the 30-day mortality was evaluated in patients with acute PE from the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry. We used multivariate analysis to assess whether the presence of AKI influenced the risk for 30-day death. Results: The study included 21,131 patients, of whom 6222 (29.5%) had AKI at baseline: 4385 patients (21%) in stage 1, 1385 (6.5%) in stage 2 and 452 (2%) in stage 3. The proportion of patients with high-risk PE in those with no AKI, AKI stage 1, AKI stage 2 or AKI stage 3 was: 2.8%, 5.3%, 8.8% and 12%, respectively (p < 0.001). After 30 days, 1236 patients (5.9%) died. Overall mortality was 4% in patients with no AKI, 8.4% in AKI stage 1, 14% in AKI stage 2 and 17% in AKI stage 3 (all p < 0.001). AKI was independently associated with an increased risk of all-cause death at 30 days (odds ratio = 1.25; 95%CI: 1.02-1.54). Conclusions: One in every 3-4 patients with acute PE had AKI at baseline. The presence of AKI independently predicted 30-day mortality. This study suggests that AKI may deserve to be evaluated as a prognostic factor in patients with acute PE.
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    Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism.
    (Springer, 2019)
    Mellado M,
    ;
    Trujillo-Santos J,
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    Bikdeli B,
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    Jiménez D,
    ;
    Núñez MJ,
    The association between inferior vena cava filter (IVC) use and outcome in patients presenting with major bleeding during anticoagulation for venous thromboembolism (VTE) has not been thoroughly investigated. We used the RIETE registry to compare the 30-day outcomes (death, major re-bleeding or VTE recurrences) in VTE patients who bled during the first 3 months of therapy, regarding the insertion of an IVC filter. A propensity score matched (PSM) analysis was performed to adjust for potential confounders. From January 2001 to September 2016, 1065 VTE patients had major bleeding during the first 3 months of anticoagulation (gastrointestinal 370; intracranial 124). Of these, 122 patients (11%) received an IVC filter. Patients receiving a filter restarted anticoagulation later (median, 4 vs. 2 days) and at lower doses (95 ± 52 IU/kg/day vs. 104 ± 55 of low-molecular-weight heparin) than those not receiving a filter. During the first 30 days after bleeding (after excluding 246 patients who died within the first 24 h), 283 patients (27%) died, 63 (5.9%) had non-fatal re-bleeding and 19 (1.8%) had recurrent pulmonary embolism (PE). In PSM analysis, patients receiving an IVC filter (n = 122) had a lower risk for all-cause death (HR 0.49; 95% CI 0.31-0.77) or fatal bleeding (HR 0.16; 95% CI 0.07-0.49) and a similar risk for re-bleeding (HR 0.55; 95% CI 0.23-1.40) or PE recurrences (HR 1.57; 95% CI 0.38-6.36) than those not receiving a filter (n = 429). In VTE patients experiencing major bleeding during the first 3 months, use of an IVC filter was associated with reduced mortality rates.Clinical Trial Registration NCT02832245.
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    The Clinical Course of Venous Thromboembolism May Differ According to Cancer Site.
    (Elsevier, 2016)
    Mahé I
    ;
    Chidiac J
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    Bertoletti L
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    Font C
    ;
    Trujillo-Santos J
    Background: We hypothesized that the clinical course of venous thromboembolism in patients with active cancer may differ according to the specificities of primary tumor site. Aim and methods: We used data from RIETE (international registry of patients with venous thromboembolism) to compare the clinical venous thromboembolism-related outcomes during the course of anticoagulation in patients with one of the 4 more frequent cancers (breast, prostate, colorectal, or lung cancer). Results: As of September 2014, 3947 cancer patients were recruited, of whom 938 had breast, 629 prostate, 1189 colorectal, and 1191 lung cancer. Overall, 55% had metastatic disease (42%, 36%, 53%, and 72%, respectively). During the course of anticoagulant therapy (mean duration, 139 days), the rate of thromboembolic recurrences was similar to the rate of major bleeding in patients with breast (5.6 [95% confidence interval (CI), 3.8-8.1] vs 4.1 [95% CI, 2.7-5.9] events per 100 patient-years) or colorectal cancer (10 [95% CI, 7.6-13] vs 12 [95% CI, 9.4-15] per 100 patient-years). In contrast, in patients with prostate cancer, the rate of venous thromboembolic recurrences was half the rate of major bleeding (6.9 [95% CI, 4.4-10] vs 13 [95% CI, 9.2-17] events per 100 patient-years), whereas in those with lung cancer, the rate of thromboembolic recurrences was twofold higher than the rate of major bleeding (27 [95% CI, 22-23] vs 11 [95% CI, 8.6-15] per 100 patient-years). Conclusions: Significant differences in the clinical profile of venous thromboembolic-related outcomes were observed according to the site of cancer. These findings suggest the development of cancer-specific anticoagulant strategies as an area for further research.