High medium-term incidence of major cardiovascular events in discharged patients with unstable angina.

The introduction of high-sensitivity troponin (hsTn) assays has reduced the diagnosis of unstable angina (UA) in favor of non-ST elevation myocardial infarction (NSTEMI) in the context of non-ST elevation acute coronary syndrome (NSTEACS). It is unclear whether the detection of these hsTn levels affects the prognosis and therefore whether a different therapeutic approach is warranted. This study aims to determine whether using hsTn results in medium-term prognostic differences in patients with UA and NSTEMI. Methods: This multicenter, prospective registry study included consecutive patients who underwent hsTn assays and were discharged with a diagnosis of NSTEACS. Patients were followed for two years. Outcomes were the occurrence of major adverse cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke), major bleeding, and all-cause mortality. Results: Patients with UA and NSTEMI did not show differences in terms of the invasive interventions received, the coronary artery disease diagnosed, the type of revascularization performed, or the proportion presenting MACE (UA 18.1% vs. NSTEMI 18.9%; p = 0.79). However, patients with NSTEMI had higher cardiovascular mortality at two years (UA 4% vs. NSTEMI 9.2%; p = 0.012), as well as, all-cause mortality (UA vs. 7.9% vs. NSTEMI 16.4%; p = 0.002). Conclusions: Medium-term incidence of MACE was similar in patients with UA and NSTEMI, but cardiovascular and all-cause mortality in NSTEMI patients was over twice that of patients with UA.

Impact of operators experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry.

BACKGROUND: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. METHODS: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. RESULTS: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centers previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. CONCLUSIONS: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operators experience with its previous device iteration or the number of Watchman FLX devices implanted.

Lifestyle and cardiovascular mortality in menopausal women: a population-based cohort study.

INTRODUCTION AND OBJECTIVES: There are models for cardiovascular risk prediction in the general population, but the prediction of risk in postmenopausal women has not been specifically studied. This study aimed to determine the association of lifestyle habits and chronic diseases with cardiovascular risk in menopausal women, as well as to build a risk scale. METHODS: Retrospective population-based cohort study using data from the 2011 National Health Survey of Spain as a data source, Women ≥ 50 years were included. The characteristics that best defined the life habits of the study women were collected, as well as their health status and self-reported medical history at the time of the survey. Follow-up data on all-cause mortality were obtained from participants from 2011 to 2017. RESULTS: A total of 5953 women ≥ 50 years of age were included, with a mean age of 66.4 ± 11.4 years. The incidence of cardiovascular mortality in the follow-up period was 4%. Vegetable consumption less than 1 time/week (HR, 1.758), smoking (HR, 1.816) or excess hours of sleep (≥ 9h/day, HR, 1.809), or o have main daily activity sitting most of the time (HR, 2.757) were related to cardiovascular mortality. The predictive model presents an honest C-index in test sample of 0.8407 (95%CI, 0.8025-0.8789). CONCLUSIONS: Life habits such as the consumption of vegetables, daily main activity, sleeping hours or smoking are risk factors for cardiovascular mortality of great relevance among menopausal women. A simple 6-year self-reported risk scale with high predictive capacity is provided.

Prognosis Impact of Diabetes in Elderly Women and Men with Non-ST Elevation Acute Coronary Syndrome.

Few studies have addressed to date the interaction between sex and diabetes mellitus (DM) in the prognosis of elderly patients with non-ST-segment elevation acute coronary syndrome (NSTEACS). Our aim was to address the role of DM in the prognosis of non-selected elderly patients with NSTEACS according to sex. A retrospective analysis from 11 Spanish NSTEACS registries was conducted, including patients aged ≥70 years. The primary end point was one-year all-cause mortality. A total of 7211 patients were included, 2,770 (38.4%) were women, and 39.9% had DM. Compared with the men, the women were older (79.95 ± 5.75 vs. 78.45 ± 5.43 years, p < 0.001) and more often had a history of hypertension (77% vs. 83.1%, p < 0.01). Anemia and chronic kidney disease were both more common in women. On the other hand, they less frequently had a prior history of arteriosclerotic cardiovascular disease or comorbidities such as peripheral artery disease and chronic pulmonary disease. Women showed a worse clinical profile on admission, though an invasive approach and in-hospital revascularization were both more often performed in men (p < 0.001). At a one-year follow-up, 1090 patients (15%) had died, without a difference between sexes. Male sex was an independent predictor of mortality (HR = 1.15, 95% CI 1.01 to 1.32, p = 0.035), and there was a significant interaction between sex and DM (p = 0.002). DM was strongly associated with mortality in women (HR: 1.45, 95% CI = 1.18-1.78; p < 0.001), but not in men (HR: 0.98, 95% CI = 0.84-1.14; p = 0.787). In conclusion, DM is associated with mortality in older women with NSTEACS, but not in men.

Direct Oral Anticoagulants Versus Vitamin-K Antagonist After PCIs in Patients With AF: A Meta-analysis of Cardiac Ischemic Events.

BACKGROUND: Clinical trials have assessed the effect of direct oral antagonists (DOACs) in patients with atrial fibrillation (AF) after percutaneous coronary interventions (PCI). Studies were designed to test the effect on bleeding incidence, but concerns related to safety on ischemic events remain. METHODS: We performed a meta-analysis with currently available studies involving DOACs versus Vitamin-K antagonist (VKA) in patients with AF after PCI. The primary endpoint was the incidence of cardiac ischemic events, including myocardial infarction and stent thrombosis. Secondary endpoints were the incidence of stroke, all-cause mortality, and major bleeding. RESULTS: Eleven thousand twenty-three patients were included in the analysis: 5510 receiving DOACs and 5513 VKA. A total of 190 cases of myocardial infarction were registered in patients treated with DOACs and 177 in patients on VKA, and no statistical difference was noted [relative risk (RR): 1.07 95% confidence interval (CI) 0.88-1.31]. The incidence of stent thrombosis was very low with no differences between both treatment strategies (RR: 1.14 95% CI 0.76-1.71). The incidence of cardiac ischemic events was the same in patients receiving DOACs or VKA (HR 1.09 95% CI 0.91-1.30). No differences were observed in the incidence of stroke (RR: 0.86 95% CI 0.61-1.23) or mortality (RR: 1.09, 95% CI 0.90-1.31). Treatment with DOACs was associated with 34% reduction in major bleeding (RR: 0.66, 95% CI 0.54-0.81). CONCLUSIONS: Treatment with DOACs in patients with AF after a PCI do not increase the risk of cardiac ischemic events, stroke, or death and reduce the incidence of major bleeding by 34% as compared with VKA.

Comorbidity burden and revascularization benefit in elderly patients with acute coronary syndrome.

INTRODUCTION AND OBJECTIVES: To evaluate the interaction between comorbidity burden and the benefits of in-hospital revascularization in elderly patients with non-ST-segment elevation acute coronary syndrome (NSTEACS). METHODS: This retrospective study included 7211 patients aged ≥ 70 years from 11 Spanish NSTEACS registries. Six comorbidities were evaluated: diabetes, peripheral artery disease, cerebrovascular disease, chronic pulmonary disease, renal failure, and anemia. A propensity score was estimated to enable an adjusted comparison of in-hospital revascularization and conservative management. The end point was 1-year all-cause mortality. RESULTS: In total, 1090 patients (15%) died. The in-hospital revascularization rate was 60%. Revascularization was associated with lower 1-year mortality; the strength of the association was unchanged by the addition of comorbidities to the model (HR, 0.61; 95%CI, 0.53-0.69; P=.0001). However, the effects of revascularization were attenuated in patients with renal failure, peripheral artery disease, and chronic pulmonary disease (P for interaction=.004, .007, and .03, respectively) but were not modified by diabetes, anemia, and previous stroke (P=.74, .51, and .28, respectively). Revascularization benefits gradually decreased as the number of comorbidities increased (from a HR of 0.48 [95%CI, 0.39-0.61] with 0 comorbidities to 0.83 [95%CI, 0.62-1.12] with ≥ 5 comorbidities; omnibus P=.016). The results were similar for the propensity score model. The same findings were obtained when invasive management was considered the exposure variable. CONCLUSIONS: In-hospital revascularization improves 1-year mortality regardless of comorbidities in elderly patients with NSTEACS. However, the revascularization benefit is progressively reduced with an increased comorbidity burden. Renal failure, peripheral artery disease, and chronic lung disease were the comorbidities with the most detrimental effects on revascularization benefits.

Safety and efficacy of drug eluting stents vs bare metal stents in patients with atrial fibrillation: A systematic review and meta-analysis.

OBJECTIVE: A systematic review and meta-analysis was performed to evaluate the safety and efficacy of drug-eluting stents (DES) vs bare-metal stents (BMS) in atrial fibrillation (AF) patients. METHODS: We systematically searched 5 engines until May 2019 for cohort studies and randomized controlled trials (RCTs). Primary outcomes were major bleeding and major adverse cardiac events (MACE) including cardiac death, myocardial infarction, target vessel revascularization (TVR) or stent thrombosis. Effects of inverse variance random meta-analyses were described with relative risks (RR) and their 95% confidence intervals (CI). We also stratified analyses by type (triple [TAT] vs dual [DAT]) and duration (short-vs long-term) of antithrombotic therapy. RESULTS: Ten studies (3 RCTs; 7 cohorts) including 10,353 patients (DES: 59.6%) were identified. DES did not show higher risk of major bleeding than BMS (5.6% vs 6.9%, RR 1.07; 95%CI, 0.89-1.28, p = 0.47; I2 = 0%) or MACE (12% vs 13.6%; RR 0.96; 95%CI 0.81-1.13, p = 0.60; I2 = 44%). Although, DES almost decreased TVR risk (6.4% vs 8.4%, RR 0.78; 95%CI, 0.61-1.01, p = 0.06; I2 = 15%). Stratified analyses by type and duration of antithrombotic therapy showed no differences in major bleeding or MACE between both types of stents. In DES, long-term TAT showed higher major bleeding risk than long-term DAT (7.7% vs 4.7%, RR 1.48, 95%CI 1.08-2.03, p = 0.01; I2 = 12%). For both types of stents, MACE risk was similar between TAT and DAT. CONCLUSIONS: In patients with AF undergoing PCI, DES had similar rate of major bleeding and MACE than BMS. DAT seems to be a safer antithrombotic therapy compared with TAT.

Pacientes con alto riesgo hemorrágico sometidos a intervención coronaria: seguimos teniendo mucho margen de mejora / High bleeding risk patients undergoing percutaneous coronary intervention: still a large margin left for improvement

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Cierre de orejuela con dos dispositivos distintos / Left atrial appendage closure with 2 different devices

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Under-prescription of novel antiplatelet drugs in patients with acute coronary syndrome and previous cardiovascular disease.

BACKGROUND: Patients with acute coronary syndrome (ACS) and previous cardiovascular disease (CVD) (stroke, peripheral arterial disease [PAD] or coronary artery disease [CAD]) are at high risk of serious events and mortality. Current clinical guidelines recommend new antiplatelet drugs (NADs) for high cardiovascular risk patients with ACS; however, these drugs are underused in different scenarios. METHODS: This study included 1717 ACS patients from 3 tertiary hospitals. Of them, 641 (37.33%) suffered from previous CVD: 149 patients with stroke, 154 patients with PAD and 541 patients with CAD. Bleeding, mortality and major adverse cardiac events (MACE) at 1 year of follow-up after hospital discharge were analyzed. RESULTS: NADs administration during hospital stay and at discharge was less frequent in patients with previous CVDs (P<0.001, for both). Cox analysis in this cohort of patients showed that clopidogrel prescription at discharge was independently associated with MACEs (HR: 1.59 [95% CI: 1.03-2.45]; P=0.036) and with death (HR: 1.99 [95% CI: 1.00-3.98]; P=0.049) in multivariate analysis. More specifically, when ticagrelor prescription at discharge was compared with clopidogrel, a significant death reduction was found in both, the univariate and the multivariate Cox analysis (HR: 4.54 [95% CI: 2.26-9.13]; P<0.001 and HR: 2.61 [95% CI: 1.16-5.90]; P=0.021, respectively). CONCLUSIONS: New antiplatelet drugs, especially ticagrelor, showed lower rates of mortality in patients with CVD without differences for bleeding. Despite the recommendations of current clinical guidelines for high risk patients with ACS, the use of NADs is very low in "real-life" patients with previous CVD.

Switching of Oral P2Y12 Inhibitor Treatment in Patients with Acute Coronary Syndrome: Prevalence, Predictors, and Prognosis.

BACKGROUND AND OBJECTIVE: Dual antiplatelet therapy is one of the main treatments in acute coronary syndrome (ACS). Switching antiplatelet agents may be necessary in some patients to improve efficacy or safety. The objective of this study was to determine the prevalence, predictors, and implications of clinical switching in patients during hospital admission and 1-year follow-up at discharge. METHODS: Observational, prospective, multicenter registry study in patients discharged following an admission for ACS and followed up for 1 year. We analyzed ischemic and bleeding events as well as treatment changes. RESULTS: We recruited 1717 patients; in-hospital switching occurred in 425 (24.8%): 15.1% to clopidogrel and 84.9% to newer antiplatelet drugs (prasugrel or ticagrelor). Those switched to newer antiplatelets were younger, with lower scores on the GRACE and CRUSADE scales, admitted more frequently for ST-elevation myocardial infarction and underwent more invasive management and percutaneous revascularization. The clinical cardiologist was responsible for most in-hospital switching to newer antiplatelets (79.6%). The loading dose of the second antiplatelet did not affect incidence of bleeding events. Post-discharge switching was infrequent (2%) and depended mainly on clinical indications; only 30% was related to a new ACS. CONCLUSIONS: In a contemporary registry with ACS, in-hospital switching of antiplatelet drugs was frequent. Those switched to newer antiplatelets were younger and admitted more frequently for ST-elevation myocardial infarction. Post-discharge switching was infrequent.

Intervención coronaria percutánea y anticoagulantes orales / Percutaneous coronary intervention and oral anticoagulation

Los pacientes con anticoagulación oral crónica sometidos a intervención coronaria percutánea constituyen una población con alto riesgo y gran comorbilidad. Se trata de una población en crecimiento y con un pronóstico complejo por los eventos isquémicos y hemorrágicos que pueden padecer en el corto, medio y largo plazo. El tratamiento antitrombótico es sin duda uno de los aspectos fundamentales que considerar en esta población y el que más impacto pronóstico puede generar. El mantenimiento de la anticoagulación oral es el aspecto prioritario en esta población. En los últimos años se han estudiado diferentes regímenes antitrombóticos buscando fundamentalmente una reducción de eventos hemorrágicos, sin penalizar la eficacia. Para ello se ha estudiado sobre todo acortar la duración de la doble antiagregación añadida a la anticoagulación y el uso de antiagregantes plaquetarios en monoterapia, fundamentalmente el clopidogrel, además del anticoagulante oral. Actualmente la llegada de los anticoagulantes orales de acción directa ha generado una gran expectación e ilusión. Estos fármacos, con un mejor perfil de seguridad que los anticoagulantes dicumarínicos, pueden aportar en este contexto importantes mejoras pronósticas. Hay 3 ensayos clínicos con anticoagulantes orales de acción directa en este paciente tan complejo y, junto con otro que se encuentra en fase de seguimiento, es posible que contribuyan a modificar la práctica clínica habitual de forma relevante en los próximos años. Información sobre el suplemento: este artículo forma parte del suplemento titulado «Actualización en el tratamiento de los pacientes con fibrilación auricular sometidos a intervención coronaria», que ha sido patrocinado por Boehringer Ingelheim

Patients on long-term oral anticoagulation therapy who are scheduled to undergo a percutaneous coronary intervention are a high-risk population with a large number of comorbid conditions. This is a growing population that has a complicated prognosis because ischemic and bleeding events can occur over the short, medium and long term. Antithrombotic therapy, without doubt a key consideration in these patients, could have a substantial impact on prognosis. Maintenance therapy with oral anticoagulants is also a priority. Over the last few years, several antithrombotic regimens have been investigated with the principle aim of reducing hemorrhagic events while maintaining efficacy. To this end, studies have focused on: (i) shortening the duration of the dual antiplatelet therapy added to anticoagulation; and (ii) the use of antiplatelet monotherapy, particularly clopidogrel, along with an oral anticoagulant. Recently, the emergence of direct oral anticoagulants has generated great hope and excitement. These new drugs, which have a better safety profile than dicoumarinic anticoagulants, could produce substantial prognostic improvements in this context. The results of three clinical trials of direct oral anticoagulants in these highly complex patients are currently available. Their findings, together with another trial that is now in the follow-up phase, have the potential to substantially modify our usual clinical practice in coming years. Supplement information: this article is part of a supplement entitled "Treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention: an update", which is sponsored by Boehringer Ingelheim

Impact of anemia as risk factor for major bleeding and mortality in patients with acute coronary syndrome.

BACKGROUND: Anemia is frequent in acute coronary syndrome (ACS) patients and is associated with worse clinical outcomes. We aimed to investigate the therapeutic strategies, the use of novel P2Y12 inhibitors, and the prognostic implication of anemia in a "real world" cohort of ACS patients. METHODS: This is an observational and prospective registry including 1717 ACS patients from three tertiary hospitals. During hospitalization we recorded the clinical management and the antiplatelet therapy at discharge. Patients were divided into 2 groups according to the baseline hemoglobin level, i.e. anemic (hemoglobin < 13 g/dL in men and <12 g/dL in women) and non-anemic patients. Bleeding events, mortality and major adverse cardiovascular events (MACEs) were recorded during 1-year of follow-up. RESULTS: Anemia was present in 445 (25.9%) patients. Cardiac catheterization (83.8% vs. 94.5%, p < .001), and revascularization by percutaneous coronary intervention (53.5% vs. 70.5%, p < .001) were less frequent in these patients. Excluding anticoagulated patients, novel P2Y12 inhibitors were less prescribed in anemic patients (OR 2.80 [95% CI 2.13-3.67], p < .001). Anemia was independently associated with major bleeding (HR 2.26 [95% CI 1.07-4.78], p = .033) and all-cause mortality (HR 1.62 [95% CI 1.03-2.56], p = .038), but not with MACE. At 1-year of follow-up, the risk of mortality in anemic patients taking clopidogrel was higher (HR 2.38 [95% CI 1.01-5.67]; p = .049). CONCLUSIONS: In this registry involving ACS patients, anemia had influence on clinical management and antiplatelet therapy. Patients suffering from anemia had higher risk for major bleeding and mortality. In particular, anemic patients treated with clopidogrel had even more mortality events.

Conservatively managed patients with non-ST-segment elevation acute coronary syndrome are undertreated with indicated medicines.

INTRODUCTION AND AIMS: Patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) are often managed conservatively. Clinical practice guidelines recommend treating these patients with the same pharmacological drugs as those who receive invasive treatment. We analyze the use of new antiplatelet drugs (NADs) and other recommended treatments in people discharged following an NSTE-ACS according to the treatment strategy used, comparing the medium-term prognosis between groups. METHODS: Prospective observational multicenter registry study in 1717 patients discharged from hospital following an ACS; 1143 patients had experienced an NSTE-ACS. We analyzed groups receiving the following treatment: No cardiac catheterization (NO CATH): n = 134; 11.7%; Cardiac catheterization without revascularization (CATH-NO REVASC): n = 256; 22.4%; percutaneous coronary intervention (PCI): n = 629; 55.0%; and coronary artery bypass graft (CABG): n = 124; 10.8%. We assessed major adverse cardiovascular events (MACE), all-cause mortality, and hemorrhagic complications at one year. RESULTS: NO CATH was the oldest, had the most comorbidities, and was at the highest risk for ischemic and hemorrhagic events. Few patients who were not revascularized with PCI received NADs (NO CATH: 3.7%; CATH-NO REVASC: 10.6%; PCI: 43.2%; CABG: 3.2%; p<0.001). Non-revascularized patients also received fewer beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARB), and statins (p<0.001). At one year, MACE incidence in NO CATH group was three times that of the other groups (30.1%, p<0.001), and all-cause mortality was also much higher (26.3%, p<0.001). There were no significant differences in hemorrhagic events. Belonging to NO CATH group was an independent predictor for MACE at one year in the multivariate analysis (HR 2.72, 95% CI 1.29-5.73; p = 0.008). CONCLUSIONS: Despite current invasive management of NSTE-ACS, patients not receiving catheterization are at very high risk for under treatment with recommended drugs, including NADs. Their medium-term prognosis is poor, with high mortality. Patients treated with PCI receive better pharmacological management, with high use of NADs.

Therapeutic management and one-year outcomes in elderly patients with acute coronary syndrome.

BACKGROUND: Elderly represents a subgroup of high-risk ACS patients due to their advanced age and other comorbidities. Unfortunately, they are also often under-represented in many studies and clinical trials. Furthermore, cardiologists commonly find difficulties in the choice of the antiplatelet treatment and even on whether invasive revascularization should be used. In this study, the management of elderly ACS patients regarding antiplatelet therapy and revascularization procedures will be analyzed. METHODS: 1717 ACS patients were consecutively included in this study from 3 tertiary Hospitals in the Southeast of Spain. Of them, 529 (30.8%) were ≥ 75 years. They were mainly male (60.7%) with a mean age of 81.4±4.7 years. Clinical characteristics, treatment received (antiaplatelet therapy, revascularization) and outcome were analyzed. RESULTS: Regression analysis showed that being ≥ 75 years is independently associated with neither performing catheterization (79.6% vs 97.1%), nor revascularization (51.8% vs 72.5%), being the medical conservative treatment the election in these elderly patients (40.6% vs 18.9%) (p < 0.001 for all). Furthermore, ticagrelor prescription were significantly decreased in older patients (11.5% vs 19.6%; p < 0.001). Regarding patients outcome after one-year of follow-up, being ≥ 75 years was associated with death, major adverse cardiac events (MACE) and major bleeding (all of them p < 0.001). Importantly, nor performing catheterization was independently associated with MACE and death in Cox multivariate analysis in elderly patients. CONCLUSIONS: Elderly patients with ACS are undertreated both invasively and pharmacologically, and this fact might be associated with the observed worse outcomes.