Treatment with SGLT2 Inhibitors in Patients with Diabetes Mellitus and Extensive Coronary Artery Disease: Mortality and Cardiovascular Outcomes.

INTRODUCTION: Sodium-glucose type 2 cotransporter inhibitors (SGLT2-I) have shown solid benefits in reducing cardiovascular mortality and admissions for heart failure in patients with type 2 diabetes mellitus (T2DM) and cardiovascular disease. However, no specific studies exist in patients with high-risk coronary artery disease (CAD). METHODS: Single-center, retrospective, observational study including patients with T2DM and a new diagnosis of extensive CAD (defined as left main disease or three main coronary vessel disease). Patients were recruited from 2015 until 2020, with a follow-up of at least 12 months. The primary outcome was to compare all-cause mortality in patients treated with or without SGLT2-I at discharge and adjusted by inverse probability of treatment weighting (IPTW) propensity score. RESULTS: A total of 420 patients were included: 104 (24.7%) were treated with SGLT2-I and 316 (75.3%) were not (non-SGLT2-I group). The presentation was acute coronary syndrome in 44.3%. The mean age was 71.2 ± 10.5 years. The mean left ventricular ejection fraction was 51.5 ± 12.5%, and the mean estimated glomerular filtration rate was 73.9 ± 22 ml/min. After a mean follow-up of 3 ± 1.6 years, all-cause mortality was 16.4%, and cardiovascular mortality was 9.5%. After IPTW, the risk of all-cause death was lower in the SGLT2-I group with a hazard ratio of 0.32 (95% confidence interval 0.12-0.81), p = 0.016. With regard to secondary outcomes, patients in the SGLT2-I group were associated with less renal function deterioration but an increase in unplanned revascularizations. CONCLUSIONS: In patients with T2DM and extensive CAD, treatment with SGLT2-I after discharge was associated with a reduced risk of all-cause death.

Duration and clinical outcomes of dual antiplatelet therapy following percutaneous coronary intervention for acute coronary syndrome: A multicentre "real-world practice" registry-based study.

Background: The optimal duration of dual antiplatelet therapy (DAPT) ought to be determined taking into account individual ischaemic or bleeding events risks. To date, studies have provided inconclusive evidence on the effects of prolonged DAPT. We sought to evaluate the long-term outcomes of this strategy following percutaneous revascularization in the context of acute coronary syndrome (ACS). Methods: Retrospectively from four centers in Madrid, we identified 750 consecutive ACS patients, divided in two groups of DAPT duration: <13 months and >13 months, with a mean follow-up of 48 months. Results: Patients with DAPT > 13 months had a higher non-adjusted incidence of Major Adverse Cardiovascular Events (11.6% vs. 17.3%) and new revascularization (3.7% vs. 8.7%). Differences in all-cause death, cardiac death, myocardial infarction, stent thrombosis and stroke were non-significant. There was no difference in the incidence of major bleeding (7.4% vs. 6.3%). Multivariable Cox regression analysis showed that the independent risk predictors of MACE were age (HR: 1.04, 95% CI: 1.02-1.06, p < 0.001) and multivessel disease (HR: 2.29, 95% CI: 1.32-3.95, p = 0.003), whereas the independent protective predictor was normal hemoglobin (HR: 0.88, 95% CI: 0.78-0.98, p = 0.022). Conclusions: In this real-world registry cohort of ACS patients treated with PCI and 1 year of DAPT in Spain, we report a trend of increased rate of MACE and new revascularization not associated with TVR in patients with longer DAPT. Our findings support the need for future randomized controlled trials to confirm or refute these results.

Extended use of dual antiplatelet therapy among older adults with acute coronary syndromes and associated variables: a cohort study.

BACKGROUND: Current guidelines recommend extending the use of dual antiplatelet therapy (DAPT) beyond 1 year in patients with an acute coronary syndrome (ACS) and a high risk of ischaemia and low risk of bleeding. No data exist about the implementation of this strategy in older adults from routine clinical practice. METHODS: We conducted a Spanish multicentre, retrospective, observational registry-based study that included patients with ACS but no thrombotic or bleeding events during the first year of DAPT after discharge and no indication for oral anticoagulants. High bleeding risk was defined according to the Academic Research Consortium definition. We assessed the proportion of cases of extended DAPT among patients 65 ≥ years that went beyond 1 year after hospitalisation for ACS and the variables associated with the strategy. RESULTS: We found that 48.1% (928/1,928) of patients were aged ≥ 65 years. DAPT was continued beyond 1 year in 32.1% (298/928) of patients ≥ 65; which was a similar proportion as with their younger counterparts. There was no significant correlation between a high bleeding risk and DAPT duration. Contrastingly, there was a strong correlation between the extent of coronary disease and DAPT duration (p < 0.001). Other variables associated with extended DAPT were a higher left ventricle ejection fraction, a history of heart failure and a prior stent thrombosis. CONCLUSION: There was no correlation between age and extended use of DAPT beyond 1 year in older patients with ACS. DAPT was extended in about one-third of patients ≥ 65 years. The severity of the coronary disease, prior heart failure, left ventricle ejection fraction and prior stent thrombosis all correlated with extended DAPT.

Evaluation of the Use of Dual Antiplatelet Therapy beyond the First Year after Acute Coronary Syndrome.

Clinical practice guidelines recommend extending dual antiplatelet therapy (DAPT) beyond 1 year after acute coronary syndrome (ACS) in patients with high ischemic risk and without high bleeding risk. The aim of this study was to identify variables associated with DAPT prolongation in a cohort of 1967 consecutive patients discharged after ACS without thrombotic or hemorrhagic events during the following year. The sample was stratified according to whether DAPT was extended beyond 1 year, and the factors associated with this strategy were analyzed. In 32.2% of the patients, DAPT was extended beyond 1 year. Overall, 770 patients (39.1%) were considered candidates for extended treatment based on PEGASUS criteria and absence of high bleeding risk, and DAPT was extended in 34.4% of them. The presence of a PEGASUS criterion was associated with extended DAPT in the univariate analysis, but not history of bleeding or a high bleeding risk. In the multivariate analysis, a history of percutaneous coronary intervention (odds ratio (OR) = 1.8, 95% confidence interval (CI) 1.4-2.4), stent thrombosis (OR = 3.8, 95% CI 1.7-8.9), coronary artery disease complexity (OR = 1.3, 95% CI 1.1-1.5), reinfarction (OR = 4.1, 95% CI 1.6-10.4), and clopidogrel use (OR = 1.3, 95% CI 1.1-1.6) were significantly associated with extended use. DAPT was extended in 32.2% of patients who survived ACS without thrombotic or hemorrhagic events. This percentage was 34.4% when the candidates were analyzed according to clinical guidelines. Neither the PEGASUS criteria nor the bleeding risk was independently associated with this strategy.

Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction.

AIMS: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. METHODS AND RESULTS: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01). CONCLUSIONS: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

Safety and Feasibility of MitraClip Implantation in Patients with Acute Mitral Regurgitation after Recent Myocardial Infarction and Severe Left Ventricle Dysfunction.

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)-35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF < 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded.

Influence of Baseline Physical Activity as a Modifying Factor on COVID-19 Mortality: A Single-Center, Retrospective Study.

INTRODUCTION: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection causes a severe respiratory disease with a 3% global mortality. In the absence of effective treatment, controlling of risk factors that predispose to severe disease is essential to reduce coronavirus disease 2019 (COVID-19) mortality. Large observational studies suggest that exercise can reduce the risk of all-cause and disease-specific mortality. The aim of this study was to analyze the influence of the baseline physical activity level on COVID-19 mortality METHODS: This is a retrospective cohort study that included patients between 18 and 70 years old, diagnosed with COVID-19 and hospitalized in our center between February 15 and April 15, 2020. After discharge all the patients included in the study were contacted by telephone. Baseline physical activity level was estimated using the Rapid Assessment of Physical Activity Scale questionnaire and patients were divided into two groups for comparison: sedentary patients (group 1) and active patients (group 2). RESULTS: During the study period 552 patients were admitted to our hospital and met the inclusion criteria. Global mortality in group 1 was significantly higher than in group 2 (13.8% vs 1.8%; p < 0.001). Patients with a sedentary lifestyle had increased COVID-19 mortality independently of other risk factors previously described (hazard ratio 5.91 (1.80-19.41); p = 0.003). CONCLUSION: A baseline sedentary lifestyle increases the mortality of hospitalized patients with COVID-19. This finding may be of great utility in the prevention of severe COVID-19 disease.

Clinical Profile and 30-Day Mortality of Invasively Managed Patients with Suspected Acute Coronary Syndrome During the COVID-19 Outbreak.

The COVID-19 pandemic severely disrupted cardiovascular care during the spring of 2020 in Europe. Our study analyzed the clinical profile, COVID-19 impact, and 30-day prognosis of invasively managed patients with acute coronary syndrome (ACS) compared to a historical cohort.All invasively managed ACS patients from March 1st to April 30th, 2020 were compared to a cohort from the same timeframe of 2019 (n = 316). COVID-19 confirmed cases were defined by a positive SARS-CoV-2 polymerase chain reaction (PCR) test (CoV+). The primary outcome was all-cause 30-day mortality and multivariable predictors of this outcome.A 40.4% reduction in ACS patients was noted (198 cases in 2019 to 118 in 2020), and 11% of 2020 ACS patients were CoV+. Baseline characteristics were similar between groups. There were significantly more in-hospital patients with ACS (15.3% versus 6.1%, P = 0.007), and fewer patients were found to have a culprit lesion (58.5% versus 74.2%, P = 0.004) in 2020 compared to 2019. Thirty-day mortality in 2020 (7%) was not different from that in 2019 (4.2%), P = 0.294, but it was significantly higher in CoV+ patients (23.1%) compared to that in negative SARS-CoV-2 PCR test (CoV-) patients (5%), P = 0.047, in the 2020 group. In the multivariate analysis, CoV+ was an independent mortality predictor (OR = 9.8, 95% CI = 1.48-64.78), along with the left ventricular ejection fraction (LVEF) (OR = 0.91, 95% CI = 0.86-0.97), P = 0.0006.This study found increased 30-day mortality of invasively managed CoV+ ACS patients compared to that of CoV- patients during the 2020 COVID-19 spring outbreak. In the multivariable analysis, a SARS-CoV-2 positive test was independently associated with 30-day mortality. Further investigations of the underlying physiopathological relations between COVID-19 and ACS are warranted.

Quantitative flow ratio as a new tool for angiography-based physiological evaluation of coronary artery disease: a review.

The functional evaluation of coronary stenoses has obtained important clinical results in recent years, resulting in strong guideline recommendations. Nonetheless, the use of coronary wire-based functional evaluation has not yet become part of the routine in catheterization laboratories for several reasons, including the need to advance a wire into the coronary vessel to interrogate the stenosis. Angiography-derived indexes have been introduced to expand the current use of physiology to estimate the functional meaning of a stenosis on the basis of angiographic data only. The most studied and validated angiography-derived index is certainly the quantitative flow ratio. This article will summarize the basics of the quantitative flow ratio, the related validation studies and its current and future applications.

Lay abstract Coronary arteries are the main vessels that carry blood and oxygen to the heart muscle, ensuring its functionality. In cardiology, coronary stenoses are defined as pathological narrowing of one or more of these vessels, which can lead to a critical reduction in blood flow, ischemic problems and myocardial infarction. Currently, percutaneous coronary intervention is considered the first-line treatment of myocardial infarction. This technique consists of a procedure in which the stenosis is resolved and proper blood flow is restored thanks to balloon inflation and stent implantation through a percutaneous procedure performed under local anesthesia. Coronary angiography was, for many years, the only available tool to diagnose and assess the consequences of coronary atherosclerosis, becoming the standard reference in the study of ischemic heart disease, allowing us to routinely describe the severity of coronary stenosis or the severity of the disease based on the number of vessels affected. Subsequently, the introduction of invasive methods to assess coronary physiology allowed us to obtain a precise assessment regarding the physiological impact of stenoses located in main vessels while demonstrating the poor diagnostic performance of angiography to assess the functional impact of these stenoses. Among these coronary physiology techniques, quantitative flow ratio has recently been the object of many investigations. In contrast to invasive techniques that can be performed only by advancing a wire into the coronary artery, quantitative flow ratio allows us to perform a functional evaluation of coronary stenoses on the basis of angiographic data only. Given its potential, this work will summarize the basics of quantitative flow ratio, the main validation studies and its current and future applications in interventional cardiology.

Anomalous origin of coronary arteries from pulmonary artery in adults: a case series.

BACKGROUND: Anomalous origin of a coronary artery from the pulmonary trunk is a small group of rare congenital anomalies present in up to 1% of the population. These patients, in absence of an adequate collateral supply, may present with congestive heart failure secondary to ischaemia, arrhythmia, or sudden cardiac death in up to 90% of cases within the first months of life. CASE SUMMARY: We present four cases diagnosed in adulthood over 10 years in two high-volume centres. The first patient presented with dyspnoea and orthopnoea. The second with chest pain and episodes of non-sustained ventricular tachycardia. The third patient presented during her third pregnancy with chest pain, palpitations, and arrhythmia (non-sustained ventricular tachycardia). The fourth patient presented with sudden cardiac death. DISCUSSION: In all cases with anomalous origin of coronary arteries, it is recommendable to consider surgical correction to avoid the progression of ischaemia, congestive heart failure, arrhythmia, and sudden death.

Health Outcome Predictive Evaluation for COVID 19 international registry (HOPE COVID-19), rationale and design.

The disease produced by the new coronavirus known as SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), named COVID-19 (Coronavirus Disease-2019) has recently been classified as a pandemic by the World Health Organization (WHO). However, scarce clinical data is available and generally limited to the Chinese population due to the first cases were identified in Wuhan (Hubei, China).This article describes the rationale and design of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) registry (ClinicalTrials.gov Identifier: NCT04334291). With an ambispective cohort design, eligible patients are those discharged, deceased or alive, from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion. With a current recruitment of more than 7000 cases, in 46 hospitals in 8 countries, since it is not possible to estimate the sample size based on literature reports, the investigators will try to get the maximum numbers of patients possible. The study primary objective is all cause mortality and aims to characterize the clinical profile of patients infected in order to develop a prognostic clinical score allowing, rapid logistic decision making. As secondary objectives, the analysis of other clinical events, the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed.The results of HOPE COVID-19 will contribute to a better understanding of this condition. We aim to describe the management of this condition as well as the outcomes in relation to the therapy chosen, in order to gain insight into improving patient care in the coming months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov. Unique identifier: NCT04334291.