ABSTRACT
BACKGROUND: The benefit of complete revascularization in older patients (≥75 years of age) with myocardial infarction and multivessel disease remains unclear. METHODS: In this multicenter, randomized trial, we assigned older patients with myocardial infarction and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion to receive either physiology-guided complete revascularization of nonculprit lesions or to receive no further revascularization. Functionally significant nonculprit lesions were identified either by pressure wire or angiography. The primary outcome was a composite of death, myocardial infarction, stroke, or any revascularization at 1 year. The key secondary outcome was a composite of cardiovascular death or myocardial infarction. Safety was assessed as a composite of contrast-associated acute kidney injury, stroke, or bleeding. RESULTS: A total of 1445 patients underwent randomization (720 to receive complete revascularization and 725 to receive culprit-only revascularization). The median age of the patients was 80 years (interquartile range, 77 to 84); 528 patients (36.5%) were women, and 509 (35.2%) were admitted for ST-segment elevation myocardial infarction. A primary-outcome event occurred in 113 patients (15.7%) in the complete-revascularization group and in 152 patients (21.0%) in the culprit-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = 0.01). Cardiovascular death or myocardial infarction occurred in 64 patients (8.9%) in the complete-revascularization group and in 98 patients (13.5%) in the culprit-only group (hazard ratio, 0.64; 95% CI, 0.47 to 0.88). The safety outcome did not appear to differ between the groups (22.5% vs. 20.4%; P = 0.37). CONCLUSIONS: Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. (Funded by Consorzio Futuro in Ricerca and others; FIRE ClinicalTrials.gov number, NCT03772743.).
Subject(s)
Myocardial Infarction , Percutaneous Coronary Intervention , Aged , Aged, 80 and over , Female , Humans , Male , Acute Kidney Injury/etiology , Myocardial Infarction/surgery , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/surgery , ST Elevation Myocardial Infarction/therapy , Stroke/etiologyABSTRACT
BACKGROUND: The J-chronic total occlusion (CTO) channel score can predict guidewire tracking of the collateral channels (CCs), but its efficacy in predicting microcatheter tracking has never been tested in the setting of retrograde CTO-percutaneous coronary intervention (PCI). AIMS: Predicting microcatheter collateral tracking during retrograde CTO-PCIs. METHODS: A total of 189 patients undergoing retrograde CTO-PCI from April 2017 to August 2021 were screened. The primary outcome of interest was a correlation between J-CTO channel score and microcatheter tracking failure (MTF) after successful CC tracking by the guidewire. The independent association between anatomical features of the J-CTO channel score and the primary outcome of interest was explored. RESULTS: After adjustment, only small size (adjusted OR: 12.70, 95% confidence interval [CI]: 1.79-89.82; p = 0.01) and continuous bends (adjusted OR: 14.15, 95% CI: 2.77-72.34; p < 0.001) remained significantly associated with an increased risk of MTF for septal collaterals. The small size was the only predictor of the MTF for epicardial collaterals (OR: 6.39, 95% CI: 1.13-35.96; p = 0.020) at univariate analysis. Patients in the MTF group had a lower incidence of procedural success compared with patients in the microcatheter tracking success (MTS) group (40.0% vs. 93.9%, p < 0.001) and had a higher incidence of collateral perforations (20.0% vs. 3.0%, p < 0.001). CONCLUSION: Small and tortuous septal collaterals, identified by a score ≥3, are associated with an increased risk of MTF, lower incidence of procedural success, and higher risk of procedural complications driven by collateral perforations.
Subject(s)
Coronary Occlusion , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Treatment Outcome , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/therapy , Coronary Occlusion/etiology , Coronary Angiography , Chronic Disease , Collateral Circulation , Registries , Risk FactorsABSTRACT
Very elderly population constitutes an increasingly larger proportion of patients admitted for acute coronary syndromes (ACS). Notably, age represents both a proxy of frailty and an exclusion criterion in clinical randomized trials, which probably contributes to lack of data and undertreatment of real-world elderly patients. The aim of the study is to describe patterns of treatment and outcome of very elderly patients with ACS. All consecutive patients aged ≥ 80 years old (yo) admitted between January 2017 and December 2019 with ACS were included. The primary endpoint was in-hospital occurrence of major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, new onset cardiogenic shock, definite/probable stent thrombosis, and ischemic stroke. The secondary endpoints were in-hospital incidence of Thrombolysis in Myocardial Infarction (TIMI) major/minor bleedings, contrast-induced nephropathy (CIN), six-month all-cause mortality, and unplanned readmission. One hundred ninety-three patients (mean age 84.1 ± 3.5 yo, 46% females) were included, of whom 86 (44.6%), 79 (40.9%), and 28 (14.5%) presented with ST elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina (UA), respectively. The vast majority of patients received an invasive strategy, with 92.7% undergoing coronary angiography and 84.4% to percutaneous coronary intervention (PCI). Aspirin was administered to 180 (93.3%) patients, clopidogrel to 89 (46.1%) patients, and ticagrelor to 85 (44%) patients. In-hospital MACE occurred in 29 patients (15.0%), whereas 3 (1.6%) and 12 patients (7.2%) experienced in-hospital TIMI major and TIMI minor bleeding, respectively. Of the overall population, 177 (91.7%) were discharged alive. After discharge, 11 patients (6.2%) died of all-cause death, whereas 42 patients (23.7%) required a new hospitalization within six months. Invasive strategy of ACS in elderly patients seems safe and effective. Six-month new hospitalization appears inevitably related to age.
Subject(s)
Acute Coronary Syndrome , Myocardial Infarction , Non-ST Elevated Myocardial Infarction , Percutaneous Coronary Intervention , Female , Humans , Aged , Aged, 80 and over , Male , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy , Acute Coronary Syndrome/complications , Percutaneous Coronary Intervention/adverse effects , Myocardial Infarction/complications , Clopidogrel/adverse effects , Aspirin/adverse effects , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Non-ST Elevated Myocardial Infarction/diagnosis , Non-ST Elevated Myocardial Infarction/therapy , Treatment Outcome , Platelet Aggregation Inhibitors/adverse effectsABSTRACT
Background and Objectives: Percutaneous left-atrial appendage (LAA) occlusion is an important therapeutic option for preventing cardioembolic stroke in patients with non-valvular atrial fibrillation (AF) at high risk of thromboembolic events and with contraindications for oral anticoagulation (OAC). It is usually performed with transesophageal echocardiography (TOE) guidance under general anesthesia (GA). In this retrospective study, we present a multicenter experience of LAA occlusion performed with conscious sedation (CS) without an anesthesiologist on site. Materials and Methods: All the patients on the waiting list for LAA occlusion procedure at Infermi Hospital, Rivoli, and San Luigi Gonzaga University Hospital, Orbassano, from October 2018 to October 2022 were analyzed. All the procedures were performed with a Watchman/FLX LAA closure device under TOE and fluoroscopic guidance without an anesthesiologist on site. CS was performed with a combination of midazolam and fentanyl as needed. Results: One-hundred fifteen patients were included (age 76.4 ± 7.6 years, median CHA2DS2Vasc 4.4 ± 1.4). CS was performed using midazolam (mean dose 5.9 ± 2.1 mg), adding fentanyl for thirty-nine (33.9%) patients in case of poor tolerance for the procedure despite midazolam. The acute procedural success rate was 99.1%. We observed seven acute severe complications. No patients needed anesthesiological assistance during the procedure, and no cases of respiratory failure necessitating ventilation were reported. In a follow-up after 10 ± 9 months, one case of stroke (0.9%) and one case (0.9%) of transient ischemic attack (TIA) occurred. Conclusions: LAA occlusion performed under CS and without the presence of an anesthesiologist on site appears to be safe and effective. It can be an attractive alternative to general anesthesia (GA), as fewer resources are required.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Humans , Aged , Aged, 80 and over , Atrial Appendage/surgery , Treatment Outcome , Conscious Sedation/adverse effects , Retrospective Studies , Anesthesiologists , Midazolam/therapeutic use , Stroke/etiology , Stroke/prevention & control , Atrial Fibrillation/complications , Atrial Fibrillation/surgery , FentanylABSTRACT
BACKGROUND: Carotid artery stenting (CAS) is an attractive option in order to treat carotid artery stenosis. However, its safety in elderly patients is questioned. Aim of this single-center retrospective study was to assess data of elderly patients undergoing CAS, and to compare them with those of the younger (< 75 years). METHODS: We collected data of 580 consecutive patients undergoing CAS between December 2007 and June 2020 and compared clinical and procedural characteristics as well as in-hospital major adverse events (MACCE) and long-term mortality between patients < 75 years and patients ≥ 75 years old. RESULTS: There were 272 patients (46.9%) with age ≥ 75 years and 308 patients (53.1%) with age < 75 years. The median follow-up was 48 months (range 2-144). There was no significant difference about in-hospital MACCE between the two groups (4.7% in the older vs. 3.5% in the younger group, p = 0.9), but a higher rate of cerebral hemorrhage occurred in the older group (1.8% vs. = 0.3%, p = 0.07), even if not significant. Long-term mortality was significantly higher in the older group (27.9 vs. 20.1%, p = 0.027). Multivariate predictors of 12-months mortality were neurologic symptoms within 6 months (OR: 4.83; 95% CI: 2.04-11.42; p ≤ 0.001), smoking status (OR: 2.84; 95% CI: 1.17-6.86; p = 0.02) and age ≥ 75 years (OR: 2.78; 95% CI: 1.14-6.76; p = 0.024). CONCLUSIONS: In elderly patients, CAS can be carried out efficaciously with acceptable procedural risks, if performed by expert operators and after a correct selection by a multidisciplinary team.
Subject(s)
Cardiology , Carotid Stenosis , Endarterectomy, Carotid , Stroke , Aged , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/etiology , Carotid Stenosis/therapy , Endarterectomy, Carotid/adverse effects , Humans , Retrospective Studies , Risk Assessment , Risk Factors , Stents , Stroke/etiology , Time Factors , Treatment OutcomeABSTRACT
AIM: The impact of Grade III coronary perforations (G3-CP) in the setting of CTO-PCI is not well assessed. METHODS AND RESULTS: We reviewed 7773 CTO-PCI and 98,819 non CTO-PCI performed in 10 European centers: G3 perforation occurred in 87 patients (1.1%) during CTO PCI and 224 patients (0.22%) during non CTO-PCI (p < 0.001). G3-CP involved the CTO segment in 68% of patients and the retrograde channels in 14% of cases. In the CTO PCI group, wire induced G3-CP (50.5% vs. 32.5%, p = 0.02) occurred predominantly when dedicated CTO tapered and highly penetrative wires were used. Intra-procedural and in-hospital death rates were 4.6% vs. 5.8% and 3.6% vs. 7.5% respectively for CTO PCI and non-CTO PCI groups (p = NS). At a median follow up of 24 months, the overall mortality and MAE were respectively 7.8% and MAE 19% without difference among groups. CONCLUSIONS: We showed similar in-hospital and long-term outcomes when G3 perforations occurred during CTO PCI and non CTO-PCI.
Subject(s)
Coronary Artery Disease , Coronary Occlusion , Heart Injuries , Percutaneous Coronary Intervention , Vascular System Injuries , Chronic Disease , Coronary Angiography , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/therapy , Heart Injuries/diagnostic imaging , Heart Injuries/etiology , Heart Injuries/therapy , Hospital Mortality , Humans , Registries , Risk Factors , Treatment Outcome , Vascular System Injuries/diagnostic imaging , Vascular System Injuries/etiology , Vascular System Injuries/therapyABSTRACT
OBJECTIVES: To investigate the outcomes of deferred coronary revascularization in patients with non-significant in-stent restenosis (ISR) by physiological assessment. BACKGROUND: The pathophysiology and natural history of ISR is markedly different from de-novo stenoses. There is a paucity of data on the safety of deferral of revascularization of ISR using physiological assessment. METHODS: In this single centre study, using a propensity-score matched analysis, we compared the long-term clinical outcomes of patients with ISR and de-novo disease deferred based on intracoronary physiology. Matching was on a 1:2 basis of ISR to de-novo stenosis. The primary end point was major adverse cardiovascular events (MACE) a composite of all-cause mortality, target lesion revascularization or target vessel myocardial infarction at 36 months. RESULTS: Matched cohorts of 56 ISR and 112 de-novo stenoses were analyzed. The median percentage stenosis was 50% in both groups (p = 0.403). Deferral was based on fractional flow reserve (FFR). The mean FFR was 0.86 across both groups (p = 0.942). At 36-months, freedom from MACE was similar between groups; 86.2% versus 92.8% log rank p=0.180 for ISR and de-novo lesions, respectively. Neither were there differences in the individual components of MACE. CONCLUSIONS: Deferral of coronary revascularization in patients with ISR based on its functional impact is associated to similar long-term safety as in de-novo coronary stenosis.
Subject(s)
Coronary Restenosis , Coronary Stenosis , Fractional Flow Reserve, Myocardial , Constriction, Pathologic/complications , Coronary Angiography/adverse effects , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Coronary Restenosis/therapy , Coronary Stenosis/complications , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/therapy , Fractional Flow Reserve, Myocardial/physiology , Humans , Myocardial Revascularization/adverse effects , Treatment OutcomeABSTRACT
PURPOSE: Left ventricular thrombus (LVT) after ST-elevation myocardial infarction still presents diagnostic and therapeutic challenges. The LEVITATION survey was designed to take a picture of LVT management in current clinical practice. METHODS: The survey covered diagnostic, therapeutic, and prophylactic issues and was completed by 104 European cardiac centers. Most of them (59%) were university or tertiary centers. RESULTS: The survey showed anterior apical a-/dyskinesia, large MI, spontaneous echo-contrast, late presentation with delayed PCI, and TIMI flow 0-1 as the most important perceived risk factors for LVT formation. Serial ultrasound imaging is the most used tool to diagnose LVT (88% of the centers), with contrast-enhanced ultrasound and cardiac MR performed in case of poor apex visualization or spontaneous echo-contrast. One third (34%) of the centers uses prophylactic anticoagulation to prevent LVT formation. In the presence of LVT, low molecular weight heparin is the most used in-hospital therapy. At discharge, vitamin K antagonist and direct oral anticoagulants are used in 67 and 32% of the cases, respectively. Triple antithrombotic therapy with aspirin plus clopidogrel and VKA is the most used strategy at discharge (55%), whereas a single antiplatelet therapy is preferred only in the case of moderate-to-high risk of bleeding. To assess LVT total regression, half of the centers use contrast-enhanced ultrasound and/or cardiac-MR. The duration of anticoagulation is usually 3-6 months (55%), with long-term prolongation in case of LVT persistence or recurrence. CONCLUSION: The survey has depicted for the first time the current real-world management of this neglected topic and has highlighted several grey zones that are still present and not supported by evidence.
ABSTRACT
PURPOSE: Wire-based coronary physiology pullback performed before percutaneous coronary intervention (PCI) discriminates coronary artery disease (CAD) distribution and extent, and is able to predict functional PCI result. No research investigated if quantitative flow ratio (QFR)-based physiology assessment is able to provide similar information. METHODS: In 111 patients (120 vessels) treated with PCI, QFR was measured both before and after PCI. Pre-PCI QFR trace was used to discriminate functional patterns of CAD (focal, serial lesions, diffuse disease, combination). Functional CAD patterns were identified analyzing changes in the QFR virtual pullback trace (qualitative method) or after computation of the QFR virtual pullback index (QVPindex) (quantitative method). QVPindex calculation was based on the maximal QFR drop over 20 mm and the length of epicardial coronary segment with QFR most relevant drop. Then, the ability of the different functional patterns of CAD to predict post-PCI QFR value was tested. RESULTS: By qualitative method, 51 (43%), 20 (17%), 15 (12%), and 34 (28%) vessels were classified as focal, serial focal lesions, diffuse disease, and combination, respectively. QVPindex values >0.71 and ≤0.51 predicted focal and diffuse patterns, respectively. Suboptimal PCI result (post-PCI QFR value ≤0.89) was present in 22 (18%) vessels. Its occurrence differed across functional patterns of CAD (focal 8% vs. serial lesions 15% vs. diffuse disease 33% vs. combination 29%, p=0.03). Similarly, QVPindex was correlated with post-PCI QFR value (r=0.62, 95% CI 0.50-0.72). CONCLUSION: Our results suggest that functional patterns of CAD based on pre-PCI QFR trace can predict the functional outcome after PCI. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , number NCT02811796. Date of registration: June 23, 2016.
Subject(s)
Coronary Artery Disease , Fractional Flow Reserve, Myocardial , Percutaneous Coronary Intervention , Coronary Angiography/methods , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Vessels/diagnostic imaging , Coronary Vessels/surgery , Fractional Flow Reserve, Myocardial/physiology , Humans , Percutaneous Coronary Intervention/adverse effects , Predictive Value of Tests , Treatment OutcomeABSTRACT
Background: Most evidence regarding anticoagulation and COVID-19 refers to the hospitalization setting, but the role of oral anticoagulation (OAC) before hospital admission has not been well explored. We compared clinical outcomes and short-term prognosis between patients with and without prior OAC therapy who were hospitalized for COVID-19. Methods: Analysis of the whole cohort of the HOPE COVID-19 Registry which included patients discharged (deceased or alive) after hospital admission for COVID-19 in 9 countries. All-cause mortality was the primary endpoint. Study outcomes were compared after adjusting variables using propensity score matching (PSM) analyses. Results: 7698 patients were suitable for the present analysis (675 (8.8%) on OAC at admission: 427 (5.6%) on VKAs and 248 (3.2%) on DOACs). After PSM, 1276 patients were analyzed (638 with OAC; 638 without OAC), without significant differences regarding the risk of thromboembolic events (OR 1.11, 95% CI 0.59-2.08). The risk of clinically relevant bleeding (OR 3.04, 95% CI 1.92-4.83), as well as the risk of mortality (HR 1.22, 95% CI 1.01-1.47; log-rank p value = 0.041), was significantly increased in previous OAC users. Amongst patients on prior OAC only, there were no differences in the risk of clinically relevant bleeding, thromboembolic events, or mortality when comparing previous VKA or DOAC users, after PSM. Conclusion: Hospitalized COVID-19 patients on prior OAC therapy had a higher risk of mortality and worse clinical outcomes compared to patients without prior OAC therapy, even after adjusting for comorbidities using a PSM. There were no differences in clinical outcomes in patients previously taking VKAs or DOACs. This trial is registered with NCT04334291/EUPAS34399.
Subject(s)
Atrial Fibrillation , COVID-19 Drug Treatment , Thromboembolism , Administration, Oral , Anticoagulants/adverse effects , Atrial Fibrillation/drug therapy , Hemorrhage/chemically induced , Hospitalization , Hospitals , Humans , Prognosis , Registries , Thromboembolism/prevention & controlABSTRACT
Despite the important advancements in the stent technology for the treatment of diseased coronary arteries, major complications still affect the postoperative long-term outcome. The stent-induced flow disturbances, and especially the altered wall shear stress (WSS) profile at the strut level, play an important role in the pathophysiological mechanisms leading to stent thrombosis (ST) and in-stent restenosis (ISR). In this context, the analysis of the WSS topological skeleton is gaining more and more interest by extending the current understanding of the association between local hemodynamics and vascular diseases. This study aims to analyze the impact that a deployed coronary stent has on the WSS topological skeleton. Computational fluid dynamics (CFD) simulations were performed in three stented human coronary artery geometries reconstructed from clinical images. The selected cases presented stents with different designs (i.e., two contemporary drug-eluting stents and one bioresorbable scaffold) and included regions with stent malapposition or overlapping. A recently proposed Eulerian-based approach was applied to analyze the WSS topological skeleton features. The results highlighted that the presence of single or multiple stents within a coronary artery markedly impacts the WSS topological skeleton. In particular, repetitive patterns of WSS divergence were observed at the luminal surface, highlighting a WSS contraction action exerted proximal to the stent struts and a WSS expansion action distal to the stent struts. This WSS action pattern was independent from the stent design. In conclusion, these findings could contribute to a deeper understanding of the hemodynamics-driven processes underlying ST and ISR.
Subject(s)
Coronary Vessels , Models, Cardiovascular , Computer Simulation , Coronary Vessels/physiology , Hemodynamics/physiology , Humans , Skeleton , Stents , Stress, MechanicalABSTRACT
AIMS: The role of antiplatelet therapy in patients with spontaneous coronary artery dissection (SCAD) undergoing initial conservative management is still a matter of debate, with theoretical arguments in favour and against its use. The aims of this article are to assess the use of antiplatelet drugs in medically treated SCAD patients and to investigate the relationship between single (SAPT) and dual (DAPT) antiplatelet regimens and 1-year patient outcomes. METHODS AND RESULTS: We investigated the 1-year outcome of patients with SCAD managed with initial conservative treatment included in the DIssezioni Spontanee COronariche (DISCO) multicentre international registry. Patients were divided into two groups according to SAPT or DAPT prescription. Primary endpoint was 12-month incidence of major adverse cardiovascular events (MACE) defined as the composite of all-cause death, non-fatal myocardial infarction (MI), and any unplanned percutaneous coronary intervention (PCI). Out of 314 patients included in the DISCO registry, we investigated 199 patients in whom SCAD was managed conservatively. Most patients were female (89%), presented with acute coronary syndrome (92%) and mean age was 52.3 ± 9.3 years. Sixty-seven (33.7%) were given SAPT whereas 132 (66.3%) with DAPT. Aspirin plus either clopidogrel or ticagrelor were prescribed in 62.9% and 36.4% of DAPT patients, respectively. Overall, a 14.6% MACE rate was observed at 12 months of follow-up. Patients treated with DAPT had a significantly higher MACE rate than those with SAPT [18.9% vs. 6.0% hazard ratios (HR) 2.62; 95% confidence intervals (CI) 1.22-5.61; P = 0.013], driven by an early excess of non-fatal MI or unplanned PCI. At multiple regression analysis, type 2a SCAD (OR: 3.69; 95% CI 1.41-9.61; P = 0.007) and DAPT regimen (OR: 4.54; 95% CI 1.31-14.28; P = 0.016) resulted independently associated with a higher risk of 12-month MACE. CONCLUSIONS: In this European registry, most patients with SCAD undergoing initial conservative management received DAPT. Yet, at 1-year follow-up, DAPT, as compared with SAPT, was independently associated with a higher rate of adverse cardiovascular events (ClinicalTrial.gov id: NCT04415762).
Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , Acute Coronary Syndrome/drug therapy , Adult , Coronary Vessels , Dissection , Drug Therapy, Combination , Female , Humans , Middle Aged , Platelet Aggregation Inhibitors/therapeutic use , Registries , Treatment OutcomeABSTRACT
BACKGROUND: The use of Renin-Angiotensin system inhibitors (RASi) in patients with coronavirus disease 2019 (COVID-19) has been questioned because both share a target receptor site. METHODS: HOPE-COVID-19 (NCT04334291) is an international investigator-initiated registry. Patients are eligible when discharged after an in-hospital stay with COVID-19, dead or alive. Here, we analyze the impact of previous and continued in-hospital treatment with RASi in all-cause mortality and the development of in-stay complications. RESULTS: We included 6503 patients, over 18 years, from Spain and Italy with data on their RASi status. Of those, 36.8% were receiving any RASi before admission. RASi patients were older, more frequently male, with more comorbidities and frailer. Their probability of death and ICU admission was higher. However, after adjustment, these differences disappeared. Regarding RASi in-hospital use, those who continued the treatment were younger, with balanced comorbidities but with less severe COVID19. Raw mortality and secondary events were less frequent in RASi. After adjustment, patients receiving RASi still presented significantly better outcomes, with less mortality, ICU admissions, respiratory insufficiency, need for mechanical ventilation or prone, sepsis, SIRS and renal failure (p<0.05 for all). However, we did not find differences regarding the hospital use of RASi and the development of heart failure. CONCLUSION: RASi historic use, at admission, is not related to an adjusted worse prognosis in hospitalized COVID-19 patients, although it points out a high-risk population. In this setting, the in-hospital prescription of RASi is associated with improved survival and fewer short-term complications.
Subject(s)
Angiotensin-Converting Enzyme Inhibitors/therapeutic use , COVID-19 , Heart Failure , Hospitalization/statistics & numerical data , COVID-19/complications , COVID-19/mortality , COVID-19/therapy , Comorbidity , Female , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/etiology , Humans , Italy/epidemiology , Male , Middle Aged , Outcome Assessment, Health Care , Prognosis , Registries , Respiration, Artificial/statistics & numerical data , Risk Factors , SARS-CoV-2 , Severity of Illness Index , Spain/epidemiologyABSTRACT
OBJECTIVES: No standard therapy, including anticoagulation regimens, is currently recommended for coronavirus disease 2019. Aim of this study was to evaluate the efficacy of anticoagulation in coronavirus disease 2019 hospitalized patients and its impact on survival. DESIGN: Multicenter international prospective registry (Health Outcome Predictive Evaluation for Corona Virus Disease 2019). SETTING: Hospitalized patients with coronavirus disease 2019. PATIENTS: Five thousand eight hundred thirty-eight consecutive coronavirus disease 2019 patients. INTERVENTIONS: Anticoagulation therapy, including prophylactic and therapeutic regimens, was obtained for each patient. MEASUREMENTS AND MAIN RESULTS: Five thousand four hundred eighty patients (94%) did not receive any anticoagulation before hospitalization. Two-thousand six-hundred one patients (44%) during hospitalization received anticoagulation therapy and it was not associated with better survival rate (81% vs 81%; p = 0.94) but with higher risk of bleeding (2.7% vs 1.8%; p = 0.03). Among patients admitted with respiratory failure (49%, n = 2,859, including 391 and 583 patients requiring invasive and noninvasive ventilation, respectively), anticoagulation started during hospitalization was associated with lower mortality rates (32% vs 42%; p < 0.01) and nonsignificant higher risk of bleeding (3.4% vs 2.7%; p = 0.3). Anticoagulation therapy was associated with lower mortality rates in patients treated with invasive ventilation (53% vs 64%; p = 0.05) without increased rates of bleeding (9% vs 8%; p = 0.88) but not in those with noninvasive ventilation (35% vs 38%; p = 0.40). At multivariate Cox' analysis mortality relative risk with anticoagulation was 0.58 (95% CI, 0.49-0.67) in patients admitted with respiratory failure, 0.50 (95% CI, 0.49-0.67) in those requiring invasive ventilation, 0.72 (95% CI, 0.51-1.01) in noninvasive ventilation. CONCLUSIONS: Anticoagulation therapy in general population with coronavirus disease 2019 was not associated with better survival rates but with higher bleeding risk. Better results were observed in patients admitted with respiratory failure and requiring invasive ventilation.
Subject(s)
Anticoagulants/therapeutic use , COVID-19 Drug Treatment , Outcome Assessment, Health Care , Registries , COVID-19/mortality , Case-Control Studies , Correlation of Data , Cross-Cultural Comparison , Hemorrhage/chemically induced , Hemorrhage/mortality , Hospitalization , Humans , Multicenter Studies as Topic , Prospective Studies , Respiration, Artificial , Respiratory Insufficiency/drug therapy , Respiratory Insufficiency/mortality , Risk , Survival Rate , Treatment OutcomeABSTRACT
BACKGROUND: A systematic analysis of concomitant arterial hypertension in COVID-19 patients and the impact of angiotensin-converting-enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARBs) have not been studied in a large multicentre cohort yet. We conducted a subanalysis from the international HOPE Registry (https://hopeprojectmd.com, NCT04334291) comparing COVID-19 in presence and absence of arterial hypertension. MATERIALS AND METHODS: Out of 5837 COVID-19 patients, 2850 (48.8%) patients had the diagnosis arterial hypertension. 1978/2813 (70.3%) patients were already treated with ACEI or ARBs. The clinical outcome of the present subanalysis included all-cause mortality over 40 days of follow-up. RESULTS: Patients with arterial hypertension suffered significantly more from different complications including respiratory insufficiency (60.8% vs 39.5%), heart failure (9.9% vs 3.1%), acute kidney injury (25.3% vs 7.3%), pneumonia (90.6% vs 86%), sepsis (14.7% vs 7.5%), and bleeding events (3.6% vs 1.6%). The mortality rate was 29.6% in patients with concomitant arterial hypertension and 11.3% without arterial hypertension (P < .001). Invasive and non-invasive respiratory supports were significantly more required in presence of arterial hypertension as compared without it. In the multivariate cox regression analysis, while age≥65, benzodiazepine, antidepressant at admission, elevated LDH or creatinine, respiratory insufficiency and sepsis might be a positive independent predictors of mortality, antiviral drugs, interferon treatment, ACEI or ARBs at discharge or oral anticoagulation at discharge might be an independent negative predictor of the mortality. CONCLUSIONS: The mortality rate and in-hospital complications might be increased in COVID-19 patients with a concomitant history of arterial hypertension. The history of ACEI or ARBs treatments does not seem to impact the outcome of these patients.
Subject(s)
Acute Kidney Injury/epidemiology , COVID-19/epidemiology , Heart Failure/epidemiology , Hypertension/epidemiology , Pneumonia/epidemiology , Respiratory Insufficiency/epidemiology , Sepsis/epidemiology , Age Factors , Aged , Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/metabolism , COVID-19/therapy , Creatinine/metabolism , Female , Germany/epidemiology , Hospital Mortality , Humans , Hypertension/drug therapy , Italy/epidemiology , L-Lactate Dehydrogenase/metabolism , Male , Middle Aged , Multivariate Analysis , Noninvasive Ventilation , Proportional Hazards Models , Registries , Respiration, Artificial , SARS-CoV-2 , Severity of Illness Index , Spain/epidemiologyABSTRACT
BACKGROUND: No data are currently available on the process of vessel healing and long-term physiological results after implantation of resorbable magnesium-made scaffold (RMS) in human coronary arteries. OBJECTIVES: To investigate after percutaneous coronary intervention (PCI) and at 12 months follow-up (a) RMS resorption process and vessel healing, as judged by optical coherence tomography (OCT) imaging; and (b) physiological result of RMS implantation evaluated by quantitative flow ratio (QFR). METHODS: All patients successfully treated with at least one RMS from July 2016 to August 2018 at 2 Italian centers were evaluated. All cases with OCT pullback and/or coronary angiography suitable for QFR analysis performed after PCI and at 12 months were included. Resorption process was analyzed at OCT in each frame reporting presence of residual struts in the vessel. RESULTS: Forty-four patients/forty-nine lesions were included. 12-months mean lumen area (LA; 7.54 ± 3.04 mm2 ) significantly decreased compared to mean LA recorded immediately after PCI (8.12 ± 1.89 mm2 ; p < .01). However, LA changes did not affect the functional result of PCI with a non-ischemic QFR value (>0.80) in 98% of cases at 12-months follow-up. Protruding struts were detectable in more than half of cases and their presence was correlated with an increase in mean LA (+0.73mm2 [95% CI 0.51-0.94], p < .001). CONCLUSIONS: RMS implantation in a real-world population lead to significant decrease in mean LA without significant functional impairment. Two different patterns of RMS resorption were recorded, whose clinical significance remains to be investigated.
Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Absorbable Implants , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Coronary Vessels/diagnostic imaging , Coronary Vessels/surgery , Humans , Magnesium , Predictive Value of Tests , Tomography, Optical Coherence , Treatment OutcomeABSTRACT
OBJECTIVES: To assess the Usefulness of oral anticoagulation therapy (OAT) in patients with coronary artery aneurysm (CAA). BACKGROUND: Data on the most adequate antithrombotic CAA management is lacking. METHODS: Patients included in CAAR (Coronary Artery Aneurysm Registry, Clinical Trials.gov: NCT02563626) were selected. Patients were divided in OAT and non-OAT groups, according to anticoagulation status at discharge and 2:1 propensity score matching with replacement was performed. The primary endpoint of the analysis was a composite and mutual exclusive endpoint of myocardial infarction, unstable angina (UA), and aneurysm thrombosis (coronary ischemic endpoint). Net adverse clinical events, major adverse cardiovascular events, their single components, cardiovascular death, re-hospitalizations for heart failure, stroke, aneurysm thrombosis, and bleeding were the secondary ones. RESULTS: One thousand three hundred thirty-one patients were discharged without OAT and 211 with OAT. In the propensity-matched sample (390 patients in the non-OAT group, 195 patients in the OAT group), after 3 years of median follow-up (interquartile range 1-6 years), the rate of the primary endpoint (coronary ischemic endpoint) was significantly less in the OAT group as compared to non-OAT group (8.7 vs. 17.2%, respectively; p = .01), driven by a significant reduction in UA (4.6 vs. 10%, p < .01) and aneurysm thrombosis (0 vs. 3.1%, p = .03), along with a non-significant reduction in MI (4.1 vs. 7.7%, p = .13). A non-significant increase in bleedings, mainly BARC type 1 (55%), was found in the OAT-group (10.3% in the non-OAT vs. 6.2% in the OAT group, p = .08). CONCLUSION: OAT decreases the composite endpoint of UA, myocardial infarction, and aneurysm thrombosis in patients with CAA, despite a non-significant higher risk of bleeding.
Subject(s)
Coronary Aneurysm , Percutaneous Coronary Intervention , Anticoagulants/adverse effects , Coronary Aneurysm/diagnostic imaging , Humans , Platelet Aggregation Inhibitors , Registries , Treatment OutcomeABSTRACT
BACKGROUND: The PARIS risk score (PARIS-rs) and percutaneous coronary intervention complexity (PCI-c) predict clinical and procedural residual ischemic risk following PCI. Their accuracy in patients undergoing unprotected left main (ULM) or bifurcation PCI has not been assessed. METHODS: The predictive performances of the PARIS-rs (categorized as low, intermediate, and high) and PCI-c (according to guideline-endorsed criteria) were evaluated in 3,002 patients undergoing ULM/bifurcation PCI with very thin strut stents. RESULTS: After 16 (12-22) months, increasing PARIS-rs (8.8% vs. 14.1% vs. 27.4%, p < .001) and PCI-c (15.2% vs. 11%, p = .025) were associated with higher rates of major adverse cardiac events ([MACE], a composite of death, myocardial infarction [MI], and target vessel revascularization), driven by MI/death for PARIS-rs and target lesion revascularization/stent thrombosis for PCI-c (area under the curves for MACE: PARIS-rs 0.60 vs. PCI-c 0.52, p-for-difference < .001). PCI-c accuracy for MACE was higher in low-clinical-risk patients; while PARIS-rs was more accurate in low-procedural-risk patients. ≥12-month dual antiplatelet therapy (DAPT) was associated with a lower MACE rate in high PARIS-rs patients, (adjusted-hazard ratio 0.42 [95% CI: 0.22-0.83], p = .012), with no benefit in low to intermediate PARIS-rs patients. No incremental benefit with longer DAPT was observed in complex PCI. CONCLUSIONS: In the setting of ULM/bifurcation PCI, the residual ischemic risk is better predicted by a clinical risk estimator than by PCI complexity, which rather appears to reflect stent/procedure-related events. Careful procedural risk estimation is warranted in patients at low clinical risk, where PCI complexity may substantially contribute to the overall residual ischemic risk.
Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Humans , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Risk Factors , Stents , Treatment OutcomeABSTRACT
Olfactory and gustatory dysfunctions (OGD) are a frequent symptom of coronavirus disease 2019 (COVID-19). It has been proposed that the neuroinvasive potential of the novel SARS-CoV-2 could be due to olfactory bulb invasion, conversely studies suggest it could be a good prognostic factor. The aim of the current study was to investigate the prognosis value of OGD in COVID-19. These symptoms were recorded on admission from a cohort study of 5868 patients with confirmed or highly suspected COVID-19 infection included in the multicenter international HOPE Registry (NCT04334291). There was statistical relation in multivariate analysis for OGD in gender, more frequent in female 12.41% vs 8.67% in male, related to age, more frequent under 65 years, presence of hypertension, dyslipidemia, diabetes, smoke, renal insufficiency, lung, heart, cancer and neurological disease. We did not find statistical differences in pregnant (p = 0.505), patient suffering cognitive (p = 0.484), liver (p = 0.1) or immune disease (p = 0.32). There was inverse relation (protective) between OGD and prone positioning (0.005) and death (< 0.0001), but no with ICU (0.165) or mechanical ventilation (0.292). On univariable logistic regression, OGD was found to be inversely related to death in COVID-19 patients. The odds ratio was 0.26 (0.15-0.44) (p < 0.001) and Z was - 5.05. The presence of anosmia is fundamental in the diagnosis of SARS.CoV-2 infection, but also could be important in classifying patients and in therapeutic decisions. Even more knowing that it is an early symptom of the disease. Knowing that other situations as being Afro-American or Latino-American, hypertension, renal insufficiency, or increase of C-reactive protein (CRP) imply a worse prognosis we can make a clinical score to estimate the vital prognosis of the patient. The exact pathogenesis of SARS-CoV-2 that causes olfactory and gustative disorders remains unknown but seems related to the prognosis. This point is fundamental, insomuch as could be a plausible way to find a treatment.
Subject(s)
Anosmia/etiology , COVID-19/complications , SARS-CoV-2 , Taste Disorders/etiology , Aged , Anosmia/epidemiology , Cohort Studies , Female , Humans , Male , Middle Aged , Multivariate Analysis , Prognosis , Registries , Risk Factors , Taste Disorders/epidemiologyABSTRACT
PURPOSE: Higher risk of bleeding with ticagrelor over clopidogrel in elderly patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) has been suggested. We assessed the incidence of major bleedings (MB), reinfarction (re-MI), and all-cause death to evaluate safety and efficacy of ticagrelor versus clopidogrel in such population. METHODS: Real-world registries RENAMI and BleeMACS were merged. The pooled cohort was divided into two groups, clopidogrel versus ticagrelor. Statistical analysis considered patients <75 versus ≥75 years old. Endpoints were BARC 3-5 MB, re-MI, and all-cause death at 1-year follow-up. The study included 16,653 patients (13,153 < 75 and 3500 ≥ 75 years). Ticagrelor was underused in elderly patients (16.3% versus 20.8%, P < 0.001). Using propensity score matching (PSM), two treatment groups of 1566 patients were included in the final analysis. RESULTS: Ticagrelor was able to prevent re-MI (hazard ratio [HR], 0.31; 95% confidence interval [CI], 0.2-0.6; P < 0.001) and all-cause death (HR, 0.60; 95% CI, 0.4-0.9; P = 0.026) irrespective of age. In patients ≥75 years, ticagrelor reduced all-cause death (HR, 0.32; 95% CI, 0.1-0.8; P = 0.012) and re-MI (HR, 0.25; 95% CI, 0.1-1.1, P = 0.072). Moreover, even with the limit of the low number of events, ticagrelor did not significantly increase the incidence of MB (HR, 1.49; 95% CI, 0.70-3.0; P = 0.257). At multiple Cox regression, age (HR, 1.03; 95% CI, 1.02-1.05; P < 0.001) resulted an independent risk factor for bleeding. CONCLUSION: In our study, reflecting the results from two large retrospective, real-world registries, Ticagrelor did not significantly increase MB compared with clopidogrel in elderly patients with ACS treated with PCI, while significantly improving 1-year survival. Further studies on elderly patients are suggested.