Publications by authors named "Fernando Lozano"

93 Publications

Real world effectiveness of standard of care triple therapy versus two-drug combinations for treatment of people living with HIV.

PLoS One 2021 8;16(4):e0249515. Epub 2021 Apr 8.

Hospital General Universitario Gregorio Marañón, Madrid, Spain.

Background: Since 1996, the standard of care (SOC) therapy for HIV treatment has consisted of a backbone of two nucleoside analogue reverse transcriptase inhibitors (NRTI) paired with a third agent. Use of two-drug combinations (2DC) has been considered for selected patients to avoid toxicities associated with the use of NRTIs. This study aimed to compare the real-world outcomes of integrase strand transfer inhibitor (INSTI)-containing triple therapy (TT) to dolutegravir- (DTG) and/or boosted protease inhibitor (bPI)-based 2DC in a large Spanish cohort of HIV patients.

Methods: A retrospective analysis was performed using data from the VACH cohort, a prospective multicentre Spanish cohort of adult HIV patients. All treatment experienced patients initiating a TT of an INSTI combined with two NRTIs or a 2DC-containing DTG and/or a bPI between 01/01/2012 and 01/06/2017 were included. The unit of analysis was patient-regimens. The overall sample analysis was complemented with two sub-analyses. The first sub-analysis focused on patients treated with a backbone plus DTG compared to those treated with DTG+ one other antiretroviral. The second sub-analysis focused on patients with HIV RNA<50 copies/mL at baseline, irrespective of the regimen used. The following endpoints were assessed: time to discontinuation for any reason, time to switch due to virologic failure, and time to switch due to toxicity (reasons for discontinuation according to clinician report in the database). Time-to-event analyses were conducted using Kaplan-Meier survival curves and Cox regression models.

Results: Overall 7,481 patients were included in the analysis, contributing to 9,243 patient-regimens. Patient characteristics at baseline differed among groups, with the 2DC group being significantly older and having a higher proportion of women, a longer time on ART and a higher number of previous virologic failures. Median (95% Confidence Interval [C.I.]) time to switch was 2.5 years (2.3, 2.7) in 2DC group versus 2.9 years (2.7, 3.0) in TT. Adjusted hazard ratios (95% C.I.) for discontinuation due to any reason, virologic failure and toxicity in the 2DC vs TT group were 1.29 (1.15; 1.44), 2.06 (1.54; 2.77) and 1.18 (0.94; 1.48), respectively. Results were consistent in the two sub-analyses.

Conclusion: In this analysis, time to discontinuation and probability of remaining free of virologic failure were significantly higher in patients on INSTI-based TT compared to DTG- and/or bPI-containing 2DC, with no differences in toxicity.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0249515PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8031389PMC
April 2021

Choice of CTO scores to predict procedural success in clinical practice. A comparison of 4 different CTO PCI scores in a comprehensive national registry including expert and learning CTO operators.

PLoS One 2021 2;16(4):e0245898. Epub 2021 Apr 2.

Servicio de Cardiología, H. Clínico de Valencia. Universidad de Valencia, CIBERCV, Valencia, Spain.

Background: We aimed to compare the performance of the recent CASTLE score to J-CTO, CL and PROGRESS CTO scores in a comprehensive database of percutaneous coronary intervention of chronic total occlusion procedures.

Methods: Scores were calculated using raw data from 1,342 chronic total occlusion procedures included in REBECO Registry that includes learning and expert operators. Calibration, discrimination and reclassification were evaluated and compared.

Results: Mean score values were: CASTLE 1.60±1.10, J-CTO 2.15±1.24, PROGRESS 1.68±0.94 and CL 2.52±1.52 points. The overall percutaneous coronary intervention success rate was 77.8%. Calibration was good for CASTLE and CL, but not for J-CTO or PROGRESS scores. Discrimination: the area under the curve (AUC) of CASTLE (0.633) was significantly higher than PROGRESS (0.557) and similar to J-CTO (0.628) and CL (0.652). Reclassification: CASTLE, as assessed by integrated discrimination improvement, was superior to PROGRESS (integrated discrimination improvement +0.036, p<0.001), similar to J-CTO and slightly inferior to CL score (- 0.011, p = 0.004). Regarding net reclassification improvement, CASTLE reclassified better than PROGRESS (overall continuous net reclassification improvement 0.379, p<0.001) in roughly 20% of cases.

Conclusion: Procedural percutaneous coronary intervention difficulty is not consistently depicted by available chronic total occlusion scores and is influenced by the characteristics of each chronic total occlusion cohort. In our study population, including expert and learning operators, the CASTLE score had slightly better overall performance along with CL score. However, we found only intermediate performance in the c-statistic predicting chronic total occlusion success among all scores.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0245898PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8018648PMC
April 2021

Impact of diabetes in patients waiting for invasive cardiac procedures during COVID-19 pandemic.

Cardiovasc Diabetol 2021 03 23;20(1):69. Epub 2021 Mar 23.

Hospital Vall D´Hebron, Barcelona, Spain.

Background: During COVID-19 pandemic, elective invasive cardiac procedures (ICP) have been frequently cancelled or postponed. Consequences may be more evident in patients with diabetes.

Objectives: The objective was to identify the peculiarities of patients with DM among those in whom ICP were cancelled or postponed due to the COVID-19 pandemic, as well as to identify subgroups in which the influence of DM has higher impact on the clinical outcome.

Methods: We included 2,158 patients in whom an elective ICP was cancelled or postponed during COVID-19 pandemic in 37 hospitals in Spain. Among them, 700 (32.4%) were diabetics. Patients with and without diabetes were compared.

Results: Patients with diabetes were older and had a higher prevalence of other cardiovascular risk factors, previous cardiovascular history and co-morbidities. Diabetics had a higher mortality (3.0% vs. 1.0%; p = 0.001) and cardiovascular mortality (1.9% vs. 0.4%; p = 0.001). Differences were especially important in patients with valvular heart disease (mortality 6.9% vs 1.7% [p < 0.001] and cardiovascular mortality 4.9% vs 0.9% [p = 0.002] in patients with and without diabetes, respectively). In the multivariable analysis, diabetes remained as an independent risk factor both for overall and cardiovascular mortality. No significant interaction was found with other clinical variables.

Conclusion: Among patients in whom an elective invasive cardiac procedure is cancelled or postponed during COVID-19 pandemic, mortality and cardiovascular mortality is higher in patients with diabetes, irrespectively on other clinical conditions. These procedures should not be cancelled in patients with diabetes.
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http://dx.doi.org/10.1186/s12933-021-01261-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986134PMC
March 2021

Dynamics of creatinine estimated glomerular filtration rate using one or more antiretrovirals that inhibit creatinine tubular secretion.

J Antimicrob Chemother 2021 Mar;76(4):1046-1050

Hospital Clinic de Barcelona, Barcelona, Spain.

Background: Cobicistat, dolutegravir and rilpivirine are all modest inhibitors of proximal tubular creatinine secretion (IPTCrS) and hence a moderate and early non-progressive creatinine estimated glomerular filtration rate (Cr-eGFR) reduction has been observed in clinical trials. Data regarding the impact of combination of those drugs on Cr-eGFR, in the clinical practice, are scarcely known.

Methods: Changes in Cr-eGFR after starting darunavir/cobicistat alone or in combination with dolutegravir and/or rilpivirine were studied in a nationwide retrospective cohort study of consecutive HIV-infected patients initiating darunavir/cobicistat. The relationship between Cr-eGFR changes over time and the use of darunavir/cobicistat alone or darunavir/cobicistat plus dolutegravir and/or rilpivirine adjusted by different HIV patient's characteristics, socio-demographics, HIV severity and use of tenofovir concomitant medication other than antiretrovirals was explored through univariate and multivariate analyses.

Results: The analysis included 725 patients. At 48 weeks, the combination of two or more IPTCrS (darunavir/cobicistat with rilpivirine and/or dolutegravir) was associated with higher decreases in Cr-eGFR [adjusted median difference (±SD) -3.5 ± 1.6 (95% CI -6.6 to -0.3), P = 0.047], and a decrease up to or higher than 15 mL/min/1.73 m2 was more frequent [adjusted OR 3.233 (95% CI 1.343-7.782), P = 0.009], with respect to darunavir/cobicistat alone. The Cr-eGFR changes between darunavir/cobicistat and darunavir/cobicistat with rilpivirine and/or dolutegravir showed more significant decreases in patients taking two or more IPTCrS at 12, 24 and 48 weeks. (ClinicalTrials.gov: NCT03042390).

Conclusions: Concomitant use of darunavir/cobicistat plus IPTCrS dolutegravir, rilpivirine, or both produced an additive effect in the expected Cr-eGFR decrease.
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http://dx.doi.org/10.1093/jac/dkaa547DOI Listing
March 2021

A Robot-Assisted Complete Urinary Tract Extirpation in a Patient with Simultaneous Panurothelial Carcinoma: A Case Report.

J Endourol Case Rep 2020 29;6(4):483-486. Epub 2020 Dec 29.

Department of Urology and Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.

Despite concomitant bladder and upper urinary tract cancers are present in 17% of cases, the simultaneous affection of the urethra, bladder, and both upper urinary tracts is extremely rare. Treatment decisions in this setting could be challenging because of the lack of evidence in the literature. A 65-year-old Caucasian man with a history of nine low-grade (LG) and multifocal bladder tumor recurrences during the past 4 years is referred to our department with a newly diagnosed panurothelial carcinoma involving the bladder, urethra, and both upper urinary tracts. Because of the large and recurrent LG bladder tumor, the urethral involvement and the presence of bilateral pyelocaliceal tumors >4 cm the patient underwent a robot-assisted complete urinary tract extirpation (CUTE). Operating time was 360 minutes and blood loss 460 mL. No intraoperative complications were reported and blood transfusion was not required. The patient developed a surgical site infection in the glans that was solved with antibiotics without any other postoperative complication. He started renal replacement therapy and was discharged 6 days after the surgery. Pathologic analysis showed multifocal urothelial carcinomas; pTa LG involving the bladder and the prostatic-bulbar-membranous-penile urethra, pT3 high grade (HG) in right renal pelvis, pT1 HG in left renal pelvis, and pN0 in pelvic lymph node dissection. After a reasonable free-recurrence period of time the patient could be evaluated for a robot-assisted intracorporeal urinary diversion in preparation for a later renal transplantation. Robot-assisted CUTE could be a feasible and safe technique for selected patients with simultaneous panurothelial carcinoma. Further multicentric studies are warranted to determine the safety of this minimally invasive approach in patients with different comorbidities.
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http://dx.doi.org/10.1089/cren.2020.0189DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803193PMC
December 2020

SARS-CoV-2 infection in patients with primary central nervous system lymphoma.

J Neurol 2021 Jan 2. Epub 2021 Jan 2.

Service de Neurologie 2-Mazarin, Sorbonne Université, Inserm, CNRS, UMR S 1127, Institut du Cerveau Et de La Moelle Épinière, ICM, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière - Charles Foix, 47-83 boulevard de l'Hôpital, 75013, Paris, France.

Background: Cancer patients may be at higher risk for severe coronavirus infectious disease-19 (COVID-19); however, the outcome of Primary Central Nervous System Lymphoma (PCNSL) patients with SARS-CoV-2 infection has not been described yet.

Methods: We conducted a retrospective study within the Lymphomes Oculo-Cérébraux national network (LOC) to assess the clinical characteristics and outcome of SARS-CoV-2 infection in PCNSL patients (positive real-time polymerase chain reaction of nasopharyngeal swab or evocative lung computed tomography scan). We compared clinical characteristics between patients with severe (death and/or intensive care unit admission) and mild disease.

Results: Between March and May 2020, 13 PCNSL patients were diagnosed with SARS-CoV-2 infection, 11 (85%) of whom were undergoing chemotherapy at the time of infection. The mortality rate was 23% (3/13), and two additional patients (15%) required mechanical ventilation. Two patients (15%) had no COVID-19 symptoms. History of diabetes mellitus was more common in severe patients (3/5 vs 0/8, p = 0.03). Two patients recovered from COVID-19 after mechanical ventilation during more than two weeks and resumed chemotherapy. In all, chemotherapy was resumed after COVID-19 recovery in nine patients (69%) after a median delay of 16 days (range 3-32), none of whom developed unusual chemotherapy complication nor SARS-Cov2 reactivation.

Conclusion: This preliminary analysis suggests that, while being at higher risk be for severe illness, PCNSL patients with COVID-19 might be treated maximally especially if they achieved oncological response at the time of SARS-CoV-2 infection. Chemotherapy might be resumed without prolonged delay in PCNSL patients with COVID-19.
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http://dx.doi.org/10.1007/s00415-020-10311-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7776286PMC
January 2021

Consequences of canceling elective invasive cardiac procedures during Covid-19 outbreak.

Catheter Cardiovasc Interv 2021 04 17;97(5):927-937. Epub 2020 Dec 17.

Hospital Vall D´Hebron, Barcelona, Spain.

Background: During COVID-19 pandemic in Spain, elective procedures were canceled or postponed, mainly due to health care systems overwhelming.

Objective: The objective of this study was to evaluate the consequences of interrupting invasive procedures in patients with chronic cardiac diseases due to the COVID-19 outbreak in Spain.

Methods: The study population is comprised of 2,158 patients that were pending on elective cardiac invasive procedures in 37 hospitals in Spain on the 14th of March 2020, when a state of alarm and subsequent lockdown was declared in Spain due to the COVID-19 pandemic. These patients were followed-up until April 31th.

Results: Out of the 2,158 patients, 36 (1.7%) died. Mortality was significantly higher in patients pending on structural procedures (4.5% vs. 0.8%, respectively; p < .001), in those >80 year-old (5.1% vs. 0.7%, p < .001), and in presence of diabetes (2.7% vs. 0.9%, p = .001), hypertension (2.0% vs. 0.6%, p = .014), hypercholesterolemia (2.0% vs. 0.9%, p = .026) [Correction added on December 23, 2020, after first online publication: as per Dr. Moreno's request changes in p-values were made after original publication in Abstract.], chronic renal failure (6.0% vs. 1.2%, p < .001), NYHA > II (3.8% vs. 1.2%, p = .001), and CCS > II (4.2% vs. 1.4%, p = .013), whereas was it was significantly lower in smokers (0.5% vs. 1.9%, p = .013). Multivariable analysis identified age > 80, diabetes, renal failure and CCS > II as independent predictors for mortality.

Conclusion: Mortality at 45 days during COVID-19 outbreak in patients with chronic cardiovascular diseases included in a waiting list due to cancellation of invasive elective procedures was 1.7%. Some clinical characteristics may be of help in patient selection for being promptly treated when similar situations happen in the future.
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http://dx.doi.org/10.1002/ccd.29433DOI Listing
April 2021

[Impact of COVID-19 on ST-segment elevation myocardial infarction care. The Spanish experience].

Rev Esp Cardiol 2020 Dec 9;73(12):994-1002. Epub 2020 Oct 9.

Hospital Universitario de Puerto Real.

Introduction And Objectives: The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI management during the COVID-19 outbreak.

Methods: Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19.

Results: Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 [150-375] vs 200 [140-332] minutes,  < .001) but showed no differences in the time from first medical contact to reperfusion. In-hospital mortality was higher during COVID-19 (7.5% vs 5.1%; unadjusted OR, 1.50; 95%CI, 1.07-2.11; < .001); this association remained after adjustment for confounders (risk-adjusted OR, 1.88; 95%CI, 1.12-3.14;  = .017). In the 2020 cohort, there was a 6.3% incidence of confirmed SARS-CoV-2 infection during hospitalization.

Conclusions: The number of STEMI patients treated during the current COVID-19 outbreak fell vs the previous year and there was an increase in the median time from symptom onset to reperfusion and a significant 2-fold increase in the rate of in-hospital mortality. No changes in reperfusion strategy were detected, with primary percutaneous coronary intervention performed for the vast majority of patients. The co-existence of STEMI and SARS-CoV-2 infection was relatively infrequent.
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http://dx.doi.org/10.1016/j.recesp.2020.07.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546233PMC
December 2020

Impact of COVID-19 on ST-segment elevation myocardial infarction care. The Spanish experience.

Rev Esp Cardiol (Engl Ed) 2020 Dec 8;73(12):994-1002. Epub 2020 Sep 8.

Hospital Universitario de Puerto Real.

Introduction And Objectives: The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI management during the COVID-19 outbreak.

Methods: Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19.

Results: Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 [150-375] vs 200 [140-332] minutes, P<.001) but showed no differences in the time from first medical contact to reperfusion. In-hospital mortality was higher during COVID-19 (7.5% vs 5.1%; unadjusted OR, 1.50; 95%CI, 1.07-2.11; P <.001); this association remained after adjustment for confounders (risk-adjusted OR, 1.88; 95%CI, 1.12-3.14; P=.017). In the 2020 cohort, there was a 6.3% incidence of confirmed SARS-CoV-2 infection during hospitalization.

Conclusions: The number of STEMI patients treated during the current COVID-19 outbreak fell vs the previous year and there was an increase in the median time from symptom onset to reperfusion and a significant 2-fold increase in the rate of in-hospital mortality. No changes in reperfusion strategy were detected, with primary percutaneous coronary intervention performed for the vast majority of patients. The co-existence of STEMI and SARS-CoV-2 infection was relatively infrequent.
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http://dx.doi.org/10.1016/j.rec.2020.08.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834732PMC
December 2020

Clinical outcomes after implantation of polyurethane-covered cobalt-chromium stents. Insights from the Papyrus-Spain registry.

Cardiovasc Revasc Med 2020 Aug 12. Epub 2020 Aug 12.

Cardiology Department, La Paz University Hospital, Madrid, Spain.

Background/purpose: The main indication of covered stents (CS) is coronary artery perforation (CAP), but, they have been increasingly used in other scenarios. Data on the long-term follow-up of CS is limited, and no studies have been conducted specifically using new-generation polyurethane-covered cobalt-chromium Papyrus CS.

Purpose: to evaluate the clinical outcomes after hospital discharge of Papyrus CS and to compare their outcome after implantation in CAP or coronary artery aneurysms (CAA).

Methods/materials: We evaluated the baseline clinical characteristics, lesion subsets, procedural features and the outcomes after initial discharge of Papyrus CS implanted in 17 high-PCI-volume centers.

Results: 127 Papyrus CS were implanted in 108 patients (68 ± 1 years; 82.8% male) admitted for stable coronary disease (32.3%), NSTEMI (42.4%) or STEMI (25.3%). The number of CS per patient was 1.2 ± 0.6 (diameter: 3.5 ± 1.7 mm; length: 18.5 ± 3.7 mm). Angiographic success rate was 96%. CS diameter was larger in CAA (CAP:3.04 ± 0.5 mm vs CAA:4.1 ± 2.7 mm; p = .022). Intracoronary imaging techniques were used more frequently in CAA (p < .0001). After a mean follow-up of 22 ± 16 months, the major cardiovascular adverse events (MACE) rate was 7.1% [cardiac death: 2%, Myocardial infarction: 5%, Target Lesion Revascularization: 5% and Stent Thrombosis (ST): 3%]. MACE rate was similar in CAP (7.7%) and CAA (7.1%) (p = .9). However, CAA showed a higher ST rate (CAP: 0% vs CA: 7.1%; p = .04).

Conclusion: After hospital discharge, clinical outcomes after Papyrus CS implantation are acceptable (considering the clinical scenario and compared with other treatment alternatives) with no significant differences in the MACE rate between those implanted in CAA or in CAP. However, CAA group showed a higher ST rate.
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http://dx.doi.org/10.1016/j.carrev.2020.08.017DOI Listing
August 2020

In reply to: "Executive summary of the GeSIDA consensus document on control and monitoring of HIV-infected patients".

Enferm Infecc Microbiol Clin 2020 11 18;38(9):459-460. Epub 2020 Jun 18.

Unidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valme, Sevilla, España.

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http://dx.doi.org/10.1016/j.eimc.2020.05.001DOI Listing
November 2020

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease.

Cardiovasc Drugs Ther 2020 06;34(3):335-344

Centre Hospitalier d'Avignon, Avignon, France.

Objectives: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.

Methods: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel.

Results: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis.

Conclusion: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.
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http://dx.doi.org/10.1007/s10557-020-06963-5DOI Listing
June 2020

Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice.

Medicine (Baltimore) 2020 Feb;99(8):e19119

Städtische Kliniken Esslingen, Esslingen, Germany.

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.
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http://dx.doi.org/10.1097/MD.0000000000019119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034709PMC
February 2020

Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes.

PLoS One 2020 13;15(1):e0226606. Epub 2020 Jan 13.

Gachon University Gil Medical Center, Incheon, South Korea.

Background: The objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe.

Methods: Two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months.

Results: Of the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe.

Conclusions: PF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226606PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6957170PMC
April 2020

Algorithm for antinuclear antibodies in subjects with clinical suspicion of autoimmune diseases.

Clin Exp Rheumatol 2020 Jul-Aug;38(4):633-639. Epub 2019 Oct 17.

Department of Immunology, Hospital Universitario 12 de Octubre, Madrid, Spain.

Objectives: Antinuclear antibodies (ANA) are fundamental in the diagnosis of systemic autoimmune rheumatic diseases (SARDs). Different assays for ANA screening are available, such as indirect immunofluorescence (IIF) on HEp-2 cells and Multiplex fluorescent immunoassay (MFI). This study aimed to clarify the importance of ANA detected only by IIF in the future development of SARDs and to recommend a laboratory algorithm that integrates the available diagnostic approaches to optimise the diagnosis of ANA IIF+MFI- subjects.

Methods: A total of 9,291 subjects with clinical suspicion of SARDs were evaluated for ANA by IIF and MFI. One hundred and ninety-eight subjects (2.1%) were ANA IIF+MFI-, who were followed up for 2 years. ANA were evaluated using IIF on HEp-2 cells and MFI on the BioPlex 2200.

Results: The ANA IIF+MFI- cohort included 106 subjects with SARDs, 26 subject with other autoimmune diseases (not-SARDs) and 66 subjects with minor symptoms or ANA requested in check-ups. Only 94 subjects underwent re-evaluation. After a 2-year follow-up, most re-evaluated subjects (51 patients) became ANA negative for both assays (mainly rheumatoid arthritis, polymyalgia and inflammatory bowel disease patients) and 35 subjects remained ANA IIF+MFI- (principally systemic sclerosis and systemic lupus erythematosus patients). A new algorithm for ANA evaluation was suggested.

Conclusions: According to the proposed algorithm, ANA IIF+MFI- subjects should be screened by an alternative solid-phase assay such as line-immunoassay or ELISA.
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September 2020

Comparison of standard vs. palliative management for bladder cancer in patients older than 85 years: multicenter study of 317 de novo tumors.

Urol Oncol 2020 02 2;38(2):40.e9-40.e15. Epub 2019 Oct 2.

Department of Urology, Hospital of Vall Hebron, Autonomous University of Barcelona, Barcelona, Spain.

Background: The peak incidence of bladder cancer (BCa) occurs at 85 years but data on treatment and outcome are sparse in this age group. We aimed to compare the outcomes of high-grade nonmuscle invasive BCa (HG NMIBC) and muscle invasive BCa (MIBC) treated with standard therapies vs. palliative management in patients >85 years.

Methods: Retrospective multicenter study of 317 patients >85 years who underwent transurethral resection (TURB) for de novo BCa between 2014 and 2016. Standard management consisted in following EAU-guidelines and palliative in monitoring patients without applying oncological treatments after TURB. Low-grade tumors were not compared because all of them were considered to have followed a standard management.

Results: Median age was 87 years (85-97). ASA-score was as follows: II, 34.7%; III, 52.1%; IV, 13.2%. Pathological examination showed: 86 Low-grade NMIBC (27.1%), 156 HG NMIBC (49.2%), and 75 MIBC (23.7%). Median follow-up of the series was 21 months (3-61) and median overall survival (OS) 29 (24-33). Among HG NMIBC, 77 patients (49.4%) received standard treatments (BCG, restaging TURB) and 79 (50.6%) palliative management. Among MIBC, 24 (32%) received standard management (cystectomy, radiotherapy, chemotherapy) and 51 (68%) palliative. Applying standard management in HG NMIBC was an independent prognostic factor of OS (44 months vs. 24, HR 1.95; P = 0.013) and decreased the emergency visit rate (33% vs. 43%). In MIBC, the type of management was not a related to OS (P = 0.439) and did not decrease the emergency visit rate (33% vs. 33%). ASA and Charlson-score were not predictors of OS in HG NMIBC (P = 0.368, P = 0.386) and MIBC (P = 0.511, P = 0.665).

Conclusions: Chronological age should not be a contraindication for applying standard therapies in NMIBC. In MIBC the survival is low regardless of the type of management. The lack of correlation between OS and ASA or Charlson-score raises the necessity of a geriatric assessment for selecting the best treatment strategy.
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http://dx.doi.org/10.1016/j.urolonc.2019.09.007DOI Listing
February 2020

Factors associated with the number of drugs in darunavir/cobicistat regimens.

J Antimicrob Chemother 2020 01;75(1):208-214

Hospital Universitario Ramón y Cajal, Madrid, Spain.

Background: Darunavir/cobicistat can be used as mono, dual, triple or more than triple therapy.

Objectives: To assess factors associated with the number of drugs in darunavir/cobicistat regimens.

Methods: A nationwide retrospective cohort study of consecutive HIV-infected patients initiating darunavir/cobicistat in Spain from July 2015 to May 2017. Baseline characteristics, efficacy and safety at 48 weeks were compared according to the number of drugs used.

Results: There were 761 patients (75% men, 98% were antiretroviral-experienced, 32% had prior AIDS, 84% had HIV RNA <50 copies/mL and 88% had ≥200 CD4 cells/mm3) who initiated darunavir/cobicistat as mono (n=308, 40%), dual (n=173, 23%), triple (n=253, 33%) or four-drug (n=27, 4%) therapy. Relative to monotherapy, triple therapy was more common in men aged <50 years, with prior AIDS and darunavir plus ritonavir use, and with CD4 cells <200/mm3 and with detectable viral load at initiation of darunavir/cobicistat; dual therapy was more common with previous intravenous drug use, detectable viral load at initiation of darunavir/cobicistat and no prior darunavir plus ritonavir; and four-drug therapy was more common with prior AIDS and detectable viral load at initiation of darunavir/cobicistat. Monotherapy and dual therapy showed a trend to better virological responses than triple therapy. CD4 responses and adverse effects did not differ among regimens.

Discussion: Darunavir/cobicistat use in Spain has been tailored according to clinical characteristics of HIV-infected patients. Monotherapy and dual therapy have been common and preferentially addressed to older patients with a better HIV status, suggesting that health issues other than HIV infection may have been strong determinants of its prescription.
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http://dx.doi.org/10.1093/jac/dkz399DOI Listing
January 2020

Performance of the Bladder EpiCheck™ Methylation Test for Patients Under Surveillance for Non-muscle-invasive Bladder Cancer: Results of a Multicenter, Prospective, Blinded Clinical Trial.

Eur Urol Oncol 2018 09 17;1(4):307-313. Epub 2018 Jul 17.

Department of Urology, Meir Medical Center, Kfar Saba, Israel.

Background: The highly frequent strategy of surveillance for non-muscle-invasive bladder cancer (NMIBC) involves cystoscopy and cytology. Urine assays currently available have not shown performance sufficient to replace the current gold standard for follow-up, which would require a very high negative predictive value (NPV), especially for high-grade tumors. Bladder EpiCheck (BE) is a novel urine assay that uses 15 proprietary DNA methylation biomarkers to assess the presence of bladder cancer.

Objective: To assess the performance of BE for NMIBC recurrence.

Design, Setting, And Participants: This was a blinded, single-arm, prospective multicenter study. The inclusion criteria were age ≥22 yr, urothelial carcinoma (UC) being monitored cystoscopically at 3-mo intervals, all UC resected within 12 mo, able to produce 10ml of urine, and able to consent.

Outcome Measurements And Statistical Analysis: The BE test characteristics were calculated and compared to cytology and cystoscopy results confirmed by pathology.

Results And Limitations: Out of 440 patients recruited, 353 were eligible for the performance analysis. Overall sensitivity, specificity, NPV, and positive predictive value were 68.2%, 88.0%, 95.1%, and 44.8%, respectively. Excluding low-grade (LG) Ta recurrences, the sensitivity was 91.7% and NPV was 99.3%. The area under receiver operating characteristic (ROC) curves with and without LG Ta lesions was 0.82 and 0.94, respectively.

Conclusions: In follow-up of NMIBC patients, the BE test showed an overall high NPV of 95.1%, and 99.3% when excluding LG Ta recurrences. With high specificity of 88.0%, the test could be incorporated in NMIBC follow-up since high-grade recurrences would be instantly detected with high confidence. Thus, the current burden of repeat cystoscopies and cytology tests could be reduced.

Patient Summary: The Bladder EpiCheck urine test has a clinically relevant and high negative predictive value. Its use in clinical routine could reduce the number of follow-up cystoscopies, and thus associated patient and financial burdens.
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http://dx.doi.org/10.1016/j.euo.2018.06.011DOI Listing
September 2018

Comparison of Outcomes between Standard and Palliative Management for High Grade Non-Muscle Invasive Bladder Cancer in Patients Older than 85 Years.

Urol Int 2019 7;102(3):277-283. Epub 2019 Mar 7.

Department of Urology, Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.

Objectives: To analyze outcomes of patients > 85 years with de novo bladder cancer (BCa). To compare outcomes of high grade (HG) non-muscle invasive BCa (NMIBC) treated with standard therapies versus palliative management.

Methods: Retrospective revision of 65 patients > 85 years who underwent transurethral resection of the bladder (TURB) for de novo BCa. According to functional status each patient was offered a standard or palliative management after TURB.

Results: Median age was 87.3 years (85.2-95.4) and 51 were men (78.5%). Twenty-eight (43%) were American Society of Anesthesiologists (ASA) II and 37 ASA III-IV (57%). Pathological examination: 29 pTx-pTa (44.6%), 28 pT1 (43.1%) and 8 pT2 (12.3%). Twenty were low grade (30.8%) and 45 HG (69.2%). Among 37 HG NMIBC patients, 43% followed standard therapies (BCG or re-staging TURB + BCG), and 57% a palliative management (no oncological treatments). With a median follow-up of 20 months (3-108), 2 (12.5%) died in standard group compared to 11 (52.4%) in palliative. In univariate analysis, age (p = 0.024), stage (p = 0.009), and standard management (p = 0.019) were related to overall survival (OS). In multivariate, standard management was an independent prognostic factor of OS (hazard ratio 0.164, 95% CI 0.036-0.744, p = 0.048).

Conclusions: Advanced age should not be a contraindication for standard therapies in BCa. A geriatric assessment could identify patients who may benefit from adjuvant therapies after TURB.
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http://dx.doi.org/10.1159/000496802DOI Listing
December 2019

Effectiveness and safety of dual therapy with rilpivirine and boosted darunavir in treatment-experienced patients with advanced HIV infection: a preliminary 24 week analysis (RIDAR study).

BMC Infect Dis 2019 Feb 28;19(1):207. Epub 2019 Feb 28.

Hospital Universitario Virgen de las Nieves, Granada, Spain.

Background: The objective was to analyze the effectiveness and safety of dual therapy with rilpivirine plus boosted-darunavir (RPV + bDRV) in real-life patients.

Methods: Observational, retrospective, multi-center study in HIV+ patients who had received RPV + bDRV for 24 weeks to optimize/simplify their previous antiretroviral treatment. We determined the percentage of patients without virologic failure (2 consecutive viral loads > 50 copies/mL) at 24 weeks of treatment.

Results: The study included 161 patients from 15 hospitals with median age of 49 years; 29.3% had previous AIDS stage and median CD4+ lymphocyte nadir of 170 cells/uL. They had been diagnosed with HIV for a median of 17 years and had received 14 years of ART, with five previous treatment combinations, and 36.6% had a history of virological failure. The reasons for the switch were simplification/optimization (49.7%), toxicity/intolerance (17.4%), or inadequate effectiveness of previous ART (10.6%). Baseline VL of 50-1000 copies/mL was recorded in 25.5% of the patients. In the"intention-to-treat" analysis at 24 weeks, 87.6% of 161 patients continued the study treatment without virologic failure criteria. In the "on treatment" analysis (excluding patients who discontinued treatment with dual therapy for any reason other than virologic failure) the efficacy was 94.6% (141/149 patients).

Conclusions: Dual therapy with RPV + DRVb proved to be effective and safe in patients with advanced HIV infection, long exposure to ART, low CD4 nadir, previous virologic failure, and/or history of ineffective ART.
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http://dx.doi.org/10.1186/s12879-019-3817-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396540PMC
February 2019

Baseline Risk Stratification of Patients Older Than 75 Years With Infarction and Cardiogenic Shock Undergoing Primary Angioplasty.

Rev Esp Cardiol (Engl Ed) 2019 Dec 5;72(12):1005-1011. Epub 2018 Oct 5.

Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital de Galdacano, Bilbao, Spain.

Background And Objectives: Patients older than 75 years with ST-segment elevation myocardial infarction undergoing primary angioplasty in cardiogenic shock have high mortality. Identification of preprocedural predictors of short- and long-term mortality could be useful to guide decision-making and further interventions.

Methods: We analyzed a nationwide registry of primary angioplasty in the elderly (ESTROFA MI+75) comprising 3576 patients. The characteristics and outcomes of the subgroup of patients in cardiogenic shock were analyzed to identify associated factors and prognostic predictors in order to derive a baseline risk prediction score for 1-year mortality. The score was validated in an independent cohort.

Results: A total of 332 patients were included. Baseline independent predictors of mortality were anterior myocardial infarction (HR 2.8, 95%CI, 1.4-6.0 P=.005), ejection fraction<40% (HR 2.3, 95%CI, 1.14-4.50 P=.018), and time from symptom onset to angioplasty >6hours (HR 3.2, 95%CI, 1.6-7.5; P=.001). A score was designed that included these predictive factors (score "6-ANT-40"). Survival at 1 year was 54.5% for patients with score 0, 32.3% for score 1, 27.4% for score 2 and 17% for score 3 (P=.004, c-statistic 0.70). The score was validated in an independent cohort of 124 patients, showing 1-year survival rates of 64.5%, 40.0%, 28.9%, and 22.2%, respectively (P=.008, c-statistic 0.68).

Conclusions: A preprocedural score based on 3 simple clinical variables (anterior location, ejection fraction<40%, and delay time >6 hours) may be used to estimate survival after primary angioplasty in elderly patients with cardiogenic shock and to guide preinterventional decision-making.
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http://dx.doi.org/10.1016/j.rec.2018.09.001DOI Listing
December 2019

Analysis of the costs and cost-effectiveness of the guidelines recommended by the 2018 GESIDA/Spanish National AIDS Plan for initial antiretroviral therapy in HIV-infected adults.

Enferm Infecc Microbiol Clin 2019 03 6;37(3):151-159. Epub 2018 Jun 6.

Servicio de Enfermedades Infecciosas, Hospital Clinic-IDIBAPS, Universidad de Barcelona, Barcelona, Spain.

Background: The GESIDA/National AIDS Plan expert panel recommended preferred regimens (PR), alternative regimens (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2018. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR.

Methods: Economic assessment of costs and efficiency (cost-effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug-resistance studies) over the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting was Spain and the costs correspond to those of 2018. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable.

Results: In the base-case scenario, the cost of initiating treatment ranges from 6788 euros for TAF/FTC/RPV (AR) to 10,649 euros for TAF/FTC+RAL (PR). The effectiveness varies from 0.82 for TAF/FTC+DRV/r (AR) to 0.91 for TAF/FTC+DTG (PR). The efficiency, in terms of cost-effectiveness, ranges from 7814 to 12,412 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TAF/FTC+RAL (PR), respectively.

Conclusion: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TAF/FTC/RPV (AR) and TAF/FTC/EVG/COBI (AR).
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http://dx.doi.org/10.1016/j.eimc.2018.04.010DOI Listing
March 2019

High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial.

PLoS One 2018 12;13(4):e0195068. Epub 2018 Apr 12.

Hospital Universitario Virgen de las Nieves, Infectious Diseases, Granada, Spain.

Trial Design: The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment with a boosted protease inhibitor (TT).

Methods: This was a 24-week, open-label, multicentre study in virologically-suppressed HIV-infected participants (N = 225) with a 2:1 randomization: 146 patients who switched to MT were compared with 79 patients who remained on a TT regimen. The primary endpoint was change in patient-reported outcomes in quality of life as measured by the MOS-HIV and EQ-5D questionnaires. Secondary endpoints included treatment adherence, patient satisfaction, incidence of adverse events and differences in plasma HIV-1 RNA viral load (VL) and CD4 cell counts.

Results: Baseline quality of life, measured with the MOS-HIV score, was very good (overall score of 83 ± 10.5 in the MT arm and 82.3 ± 11.3 in the TT arm) and suffered no change during the study in any of the arms (at week 24, 83.5 ± 12.2 in MT arm and 81.9 ± 12.7 in TT arm), without statistically significant differences when compared. In regards to adherence to therapy and patient satisfaction, some aspects (number of doses forgotten in the last week and satisfaction of treatment measured with the CESTA score, dimension 1) improved significantly with MT. There were also no differences in the incidence and severity of adverse events, even though 22.8% of those in the MT arm switched their treatment when they were included in the study. Moreover, there was also no significant difference between the immunological and virological evolution of MT and TT. In the MT arm, the VL was always undetectable in 83% of patients (vs 90.7% in the TT arm) and there were only 6.7% of virological failures with VL > 50 copies/mL (vs 2.3% in the TT arm), without resistance mutations and with resuppression of VL after switching back to TT.

Conclusions: In a new clinical trial, monotherapy as a treatment simplification strategy in HIV-1 infected patients with sustained viral suppression has demonstrated quality of life, safety and efficacy profiles comparable to those of conventional triple therapy regimens.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0195068PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5896909PMC
July 2018

Multivessel disease in patients over 75years old with ST elevated myocardial infarction. Current management strategies and related clinical outcomes in the ESTROFA MI+75 nation-wide registry.

Cardiovasc Revasc Med 2018 Jul - Aug;19(5 Pt B):580-588. Epub 2017 Dec 6.

Hospital de Galdacano, Servicio de Cardiologia, Bilbao, Spain.

Background: In elderly patients with ST elevated myocardial infarction (STEMI) and multivessel disease (MVD the outcomes related with different revascularization strategies are not well known.

Methods: Subgroup-analysis of a nation-wide registry of primary angioplasty in the elderly (ESTROFA MI+75) with 3576 patients over 75years old from 31 centers. Patients with MVD were analyzed to describe treatment approaches and 2years outcomes.

Results: Of 1830 (51%) with MVD, 847 (46%) underwent multivessel revascularization either in acute (51%), staged (44%) or both procedures (5%). Patients with previous myocardial infarction and those receiving drug-eluting stents or IIb-IIIa inhibitors were more prone to be revascularized, whereas older patients, females and those with Killip III-IV, renal failure and higher ejection fraction were less likely. Survival free of cardiac death and infarction at 2years was better for those undergoing multivessel PCI (85.8% vs. 80.4%, p<0.0008), regardless of Killip class. Multivessel PCI was protective of cardiac death and infarction (HR 0.60, 95% CI 0.40-0.89; p=0.011). Complete revascularization made no difference in outcomes among those patients undergoing multivessel PCI. The best prognosis corresponded to those undergoing multivessel PCI in staged procedures (p<0.001). A propensity score matching analysis (514 patients in each group) yielded similar results.

Conclusions: In elderly patients with STEMI and MVD, multivessel PCI was related with better outcomes especially after staged procedures. Among those undergoing multivessel PCI, anatomically defined completeness of revascularization had not prognostic influence.

Summary: We sought to investigate the revascularization strategies applied and their prognostic implications in patients aged over 75years with ST elevated myocardial infarction showing multivessel disease. Of 1830 patients, 847 (46%) underwent multivessel PCI either in acute (51%), staged (44%) or both procedures (5%). Multivessel PCI was independent predictor of cardiac death and infarction with the best prognosis corresponding to those undergoing staged procedures.
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http://dx.doi.org/10.1016/j.carrev.2017.12.004DOI Listing
July 2019

Executive summary of the consensus document on osteoporosis in HIV-infected individuals.

Enferm Infecc Microbiol Clin 2018 05 31;36(5):312-314. Epub 2017 May 31.

Hospital Clínico San Carlos, IDISSC, Universidad Complutense, Madrid, Spain. Electronic address:

Osteoporosis has become an emerging comorbid condition in people living with HIV (PLWH). The increase in survival and the progressive aging of PLWH will make this complication more frequent in the near future. In addition to the traditional risk factors affecting the general population, factors directly or indirectly associated with HIV infection, including antiretroviral therapy, can increase the risk of osteoporosis. The present article is an executive summary of the document that updates the previous recommendations on the prevention and treatment of osteoporosis in PLWH. This document is intended for all professionals who work in clinical practice in the field of HIV infection.
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http://dx.doi.org/10.1016/j.eimc.2017.03.010DOI Listing
May 2018

Costs and cost-efficacy analysis of the 2017 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

Enferm Infecc Microbiol Clin 2018 05 19;36(5):268-276. Epub 2017 May 19.

Servicio de Enfermedades Infecciosas, Hospital Clinic-IDIBAPS, Universidad de Barcelona, Barcelona, Spain.

Introduction: GESIDA and the Spanish National AIDS Plan panel of experts have recommended preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral therapy (ART) as initial therapy in HIV-infected patients for 2017. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR.

Methods: Economic assessment of costs and efficiency (cost-efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, resistance studies and HLA B*5701 screening. The setting was Spain and the costs correspond to those of 2017. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable.

Results: In the base case scenario, the cost of initiating treatment ranged from 6882 euro for TFV/FTC/RPV (AR) to 10,904 euros for TFV/FTC+RAL (PR). The efficacy varied from 0.82 for TFV/FTC+DRV/p (AR) to 0.92 for TAF/FTC/EVG/COBI (PR). The efficiency, in terms of cost-efficacy, ranged from 7923 to 12,765 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TFV/FTC+RAL (PR), respectively.

Conclusion: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TFV/FTC/RPV (AR) and TAF/FTC/EVG/COBI (PR).
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http://dx.doi.org/10.1016/j.eimc.2017.04.002DOI Listing
May 2018

Low incidence of acute hepatitis C virus infection among Southern Spanish HIV-infected individuals.

J Infect 2017 05 3;74(5):514-517. Epub 2017 Feb 3.

Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Avenida de Bellavista S/N, 41014 Seville, Spain. Electronic address:

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http://dx.doi.org/10.1016/j.jinf.2017.01.013DOI Listing
May 2017

Primary Angioplasty in Patients Older Than 75 Years. Profile of Patients and Procedures, Outcomes, and Predictors of Prognosis in the ESTROFA IM+75 Registry.

Rev Esp Cardiol (Engl Ed) 2017 Feb 11;70(2):81-87. Epub 2016 Nov 11.

Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital de Galdakao, Vizcaya, Spain.

Introduction And Objectives: The proportion of elderly patients undergoing primary angioplasty is growing. The present study describes the clinical profile, procedural characteristics, outcomes, and predictors of outcome.

Methods: A 31-center registry of consecutive patients older than 75 years treated with primary angioplasty. Clinical and procedural data were collected, and the patients underwent clinical follow-up.

Results: The study included 3576 patients (39.3% women, 48.5% with renal failure, 11.5% in Killip III or IV, and 29.8% with>6hours of chest pain). Multivessel disease was present in 55.4% and nonculprit lesions were additionally treated in 24.8%. Radial access was used in 56.4%, bivalirudin in 11.8%, thromboaspiration in 55.9%, and drug-eluting stents in 26.6%. The 1-month and 2-year incidences of cardiovascular death were 10.1% and 14.7%, respectively. The 2-year rates of definite or probable thrombosis, repeat revascularization, and BARC bleeding>2 were 3.1%, 2.3%, and 4.2%, respectively. Predictive factors were diabetes mellitus, renal failure, atrial fibrillation, delay to reperfusion>6hours, ejection fraction<45%, Killip class III-IV, radial access, bivalirudin, drug-eluting stents, final TIMI flow of III, and incomplete revascularization at discharge.

Conclusions: Notable registry findings include frequently delayed presentation and a high prevalence of adverse factors such as renal failure and multivessel disease. Positive procedure-related predictors include shorter delay, use of radial access, bivalirudin, drug-eluting stents, and complete revascularization before discharge.
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http://dx.doi.org/10.1016/j.rec.2016.06.012DOI Listing
February 2017

Costs and cost-efficacy analysis of the 2016 GESIDA/Spanish AIDS National Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

Enferm Infecc Microbiol Clin 2017 Feb 25;35(2):88-99. Epub 2016 Jul 25.

Servicio de Enfermedades Infecciosas, Hospital Clínic-IDIBAPS, Universidad de Barcelona, Barcelona, Spain.

Introduction: GESIDA and the AIDS National Plan panel of experts suggest preferred (PR), alternative (AR), and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for the year 2016. The objective of this study is to evaluate the costs and the efficacy of initiating treatment with these regimens.

Methods: Economic assessment of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48 in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2016. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable, and least favourable.

Results: In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,894 Euros for TDF/FTC+RAL (PR). The efficacy varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/efficacy, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR), and RAL+DRV/r (OR), respectively.

Conclusion: Despite the overall most efficient regimen being 3TC+LPV/r (OR), among the PR and AR, the most efficient regimen was ABC/3TC/DTG (PR). Among the AR regimes, the most efficient was TDF/FTC/RPV.
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http://dx.doi.org/10.1016/j.eimc.2016.06.013DOI Listing
February 2017

Executive summary: Prevention and treatment of opportunistic infections and other coinfections in HIV-infected patients: May 2015.

Enferm Infecc Microbiol Clin 2016 Oct 5;34(8):517-23. Epub 2016 Apr 5.

Opportunistic infections continue to be a cause of morbidity and mortality in HIV-infected patients. They often arise because of severe immunosuppression resulting from poor adherence to antiretroviral therapy, failure of antiretroviral therapy, or unawareness of HIV infection by patients whose first clinical manifestation of AIDS is an opportunistic infection. The present article is an executive summary of the document that updates the previous recommendations on the prevention and treatment of opportunistic infections in HIV-infected patients, namely, infections by parasites, fungi, viruses, mycobacteria, and bacteria, as well as imported infections. The article also addresses immune reconstitution inflammatory syndrome. This document is intended for all professionals who work in clinical practice in the field of HIV infection.
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http://dx.doi.org/10.1016/j.eimc.2016.02.025DOI Listing
October 2016