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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.

Background: Sepsis patients with a concomitant Coronavirus (COVID-19) infection are related to a high morbidity and mortality rate. We investigated a large cohort of sepsis patients with a concomitant COVID-19 to determine clinical characteristics, laboratory and radiological findings, and predictors of mortality. We developed a risk score for the estimation of sepsis risk in patients with COVID-19. Methods: In the present study, we conducted a sub-analysis from the international Health Outcome Predictive Evaluation Registry for COVID-19 (HOPE-COVID-19-Registry). Out of 5,837 patients with COVID-19, 624 patients were diagnosed with sepsis according to the Sepsis-3 International Consensus. Findings: In multivariable analysis, the following risk factors were identified as independent predictors for developing sepsis: current smoking, tachypnoea (>22 breath per minute), haemoptysis, peripheral oxygen saturation (SpO2) 1.5 mg/dl. By assigning odds ratio weighted points to these variables, the following three risk categories were defined to develop sepsis during admission: low-risk group (probability of sepsis 3.1-11.8%); intermediate-risk group (24.8-53.8%); high-risk-group (58.3-100%). A score of 1 was assigned to current smoking, tachypnoea, decreased SpO2, decreased blood pressure, decreased GCS, elevated PCT, TnI, and creatinine, whereas a score of 2 was assigned to haemoptysis. Interpretation: The HOPE Sepsis Score including 9 parameters is useful in identifying high-risk COVID-19 patients to develop sepsis. Sepsis in COVID-19 is associated with a high mortality rate. Funding Statement: Non-conditioned grant (FUNDACION INTERHOSPITALARIA PARA LA INVESTIGACION CARDIOVASCULAR, FIC. Madrid, Spain) Declaration of Interests: We declare no competing interests. Ethics Approval Statement: The study was approved by the Ethics Committee in all involved centres.

Background: Although numerous patient specific co-factors have been shown to be associated with worse outcomes in COVID-19, the prognostic value of thalasemic syndromes in COVID-19 patients remains poorly understood. Aims: We studied the outcomes of 137 COVID-19 patients with a history of Transfusion Dependent Thalassemia (TDT) and non-Transfusion Dependent Thalassemia (NTDT) extracted from a large international cohort and compared them with the outcomes from a matched cohort of COVID-19 patients with no history of thalasemia. Results: The mean age of thalassemia patients included in our study was 41±16 years (48.9% male). Almost 81% of these patients suffered from TDT requiring blood transfusions on a regular basis. 38.7% of patients were blood group O. Cardiac iron overload was documented in 6.8% of study patients, whereas liver iron overload was documented in 35% of study patients. 25% of thalassemia patients had a history of splenectomy. 27.7% of study patients required hospitalization due to COVID-19 infection. Amongst the hospitalized patients, one patient died (0.7%) and one patient required intubation. Continuous positive airway pressure (CPAP) was required in almost 5% of study patients. After adjustment for age-, sex- and other known risk factors (cardiac disease, kidney disease and pulmonary disease), the rate of in-hospital complications (supplemental oxygen use, admission to the an intensive care unit for CPAP therapy or intubation) and all-cause mortality was significantly lower in the thalassemia group compared to the matched cohort with no history of thalassemia. Amongst thalassemia patients in general, the NTDT group exhibited a higher rate of hospitalization compared to the TDT group (p=0.001). In addition, the rate of complications such as acute kidney injury and need for supplemental oxygen was significantly higher in the NTDT group compared to the TDT group. In the multivariable logistic regression analysis, age and history of heart or kidney disease were all found to be independent risk factors for increased in-hospital, all-cause mortality, whereas the presence of thalassemia (either TDT or NTDT) was found to be independently associated with reduced all-cause mortality. Conclusions: The presence of thalassemia in COVID-19 patients was independently associated with lower in-hospital, all-cause mortality and few in-hospital complications in in our study. The pathophysiology of this is unclear and needs to be studied in vitro and in animal models. Trial Registration for sources of data extraction: NCT: 04334291, 04746066 Funding Statement: This study was funded by a non-conditioned grant from FUNDACION INTERHOSPITALARIA PARA LA INVESTIGACION CARDIOVASCULAR, FIC. (Madrid, Spain). This nonprofit institution had no role in the study design, the collection, analysis and interpretation of data, the writing of the report, or the decision to submit the paper for publication. Declaration of Interests: The authors declare no conflicts of interest. Ethics Approval Statement: The study was approved by the Ethics Committees in all of the centers involved (Banjarmasin, Bari, Cagliari, Catania, Ferrara, Gela, Genoa, Getafe, Guadalajara, Legan, Madrid, Mannheim, Milan, Monza, Naples, Olbia, Padua, Pavia, Ragusa, Rome, Salerno, Turin, Valladolid and Verona).

Objective We carried out a meta-analysis summarizing the efficacy and safety of direct factor Xa inhibitor (DXI) in patients receiving guideline-based antiplatelet therapy (GBAT) after an acute coronary syndrome. Background Randomized-controlled trials have shown that the addition of a DXI to GBAT after acute coronary syndrome can reduce ischemic events, the trade-off being an increase in major bleeding complications. Methods PubMed, Central, Embase, The Cochrane Register, Google Scholar databases, and the scientific session abstracts were searched for eligible randomized trials from 1 January 1990 through 31 December 2016. Results Nine randomized-controlled trials were included in this meta-analysis enrolling a total of 45651 patients. There was a significant reduction in major adverse cardiovascular events with DXIs/GBAT compared with GBAT alone [odds ratio (OR): 0.88; 95% confidence interval (CI): 0.82-0.94, number needed to treat=52]. There were also significant reductions in two individual components of major adverse cardiovascular events: myocardial infarction (OR: 0.89; 95% CI: 0.81-0.98) and stent thrombosis (OR: 0.73; 95% CI: 0.59-0.90), favoring the DXI/GBAT group. There was an increased risk of major bleeding (OR: 2.51; 95% CI: 1.82-3.46) and intracranial hemorrhage (OR: 3.47; 95% CI: 1.76-6.86) compared with GBAT. Conclusion In acute coronary syndromes, the addition of a DXI to GBAT results in a significant reduction of major adverse cardiovascular events, myocardial infarction, and stent thrombosis, offset by an increased risk of bleeding.