Patterns of left ventricular remodeling post-myocardial infarction, determinants, and outcome.

AIM: Left ventricular remodeling (LVR) after myocardial infarction (MI) can lead to heart failure, arrhythmia, and death. We aim to describe adverse LVR patterns at 6 months post-MI and their relationships with subsequent outcomes and to determine baseline. METHODS AND RESULTS: A multicenter cohort of 410 patients (median age 57 years, 87% male) with reperfused MI and at least 3 akinetic LV segments on admission was analyzed. All patients had transthoracic echocardiography performed 4 days and 6 months post-MI, and 214 also had cardiac magnetic resonance imaging performed on day 4. To predict LVR, machine learning methods were employed in order to handle many variables, some of which may have complex interactions. Six months post-MI, echocardiographic increases in LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), and LV ejection fraction (LVEF) were 14.1% [interquartile range 0.0, 32.0], 5.0% [- 14.0, 25.8], and 8.7% [0.0, 19.4], respectively. At 6 months, ≥ 15% or 20% increases in LVEDV were observed in 49% and 42% of patients, respectively, and 37% had an LVEF < 50%. The rate of death or new-onset HF at the end of 5-year follow-up was 8.8%. Baseline variables associated with adverse LVR were determined best by random forest analysis and included stroke volume, stroke work, necrosis size, LVEDV, LVEF, and LV afterload, the latter assessed by Ea or Ea/Ees. In contrast, baseline clinical and biological characteristics were poorly predictive of LVR. After adjustment for predictive baseline variables, LV dilation > 20% and 6-month LVEF < 50% were significantly associated with the risk of death and/or heart failure: hazard ratio (HR) 2.12 (95% confidence interval (CI) 1.05-4.43; p = 0.04) and HR 2.68 (95% CI 1.20-6.00; p = 0.016) respectively. CONCLUSION: Despite early reperfusion and cardioprotective therapy, adverse LVR remains frequent after acute MI and is associated with a risk of death and HF. A machine learning approach identified and prioritized early variables that are associated with adverse LVR and which were mainly hemodynamic, combining LV volumes, estimates of systolic function, and afterload.

Establishing a multi-specialty consensus in the clinical need for hypercholesterolemia management and its implication for patients access to innovative therapies.

BACKGROUND: Increased level of blood LDL-C has a causal and cumulative effect on advancing atherosclerotic cardiovascular diseases (ASCVD). European guidelines for treating high LDL-C levels have been recently updated. However, in France, several challenges (e.g., physician and patient awareness, healthcare management) limit the application of management guidelines. The aim of this study was to understand the current opinions and perceived unmet clinical needs in recognising and managing hypercholesterolemia as an ASCVD risk factor, and to explore consensus around factors that support the effective management of elevated LDL-C. METHODS: An expert group of cardiologists, endocrinologists, biology/genetics researchers, and a health technology assessments expert, from France was convened. The current management of hypercholesterolemia and barriers to achieving LDL-C goals in France were discussed and 44 statements were developed. Wider consensus was assessed by sending the statements as a 4-point Likert Scale questionnaire to cardiologists and endocrinologists across France. The consensus threshold was defined as ≥75%. RESULTS: A total of 101 responses were received. Consensus was very high (>90%) in 25 (57%) statements, high (≥75%) in 18 (41%) statements and was not achieved (<75%) only in 1 (2%) of statements. Overall, 43 statements achieved consensus. CONCLUSIONS: Based on consensus levels, key recommendations for improving current guidelines and approaches to care have been developed. Implementation of these recommendations will lead to better concordance with international treatment guidelines and increase levels of education for healthcare practitioners and patients. In turn, this will improve the available treatment pathways for cardiovascular diseases, potentially creating improved patient outcomes in the future.

Long-term heart function in cardiac-arrest survivors.

Purpose: To assess outcomes and predictors of long-term myocardial dysfunction after cardiac arrest (CA) of cardiac origin. Methods: We retrospectively included consecutive, single-center, prospective-registry patients who survived to hospital discharge for adult out-of-hospital and in-hospital CA of cardiac origin in 2005-2019. The primary objective was to collect the 1-year New York Heart Association Functional Class (NYHA-FC) and major adverse cardiovascular events (MACE). Results: Of 135 patients, 94 (72%) had their NYHA-FC determined after 1 year, including 75 (75/94, 80%) who were I, 17 (17/94, 18%) II, 2 (2/94, 2%) III, and none IV. The echocardiographic left ventricular ejection fraction was abnormal in 87/130 (67%) patients on day 1, 52/123 (42%) at hospital discharge, and 17/52 (33%) at 6 months. During the median follow-up of 796 [283-1975] days, 38/119 (32%) patients experienced a MACE. These events were predominantly related to acute heart failure (13/38) or ischemic cardiovascular events (16/38), with acute coronary syndrome being the most prevalent among them (8/16). Pre-CA cardiovascular disease was a risk factor for 1-year NYHA-FC > I (P = 0.01), absence of bystander cardiopulmonary resuscitation was significantly associated with NYHA-FC > I at 1 year. Conclusion: Most patients had no heart-failure symptoms a year after adult out-of hospital or in-hospital CA of cardiac origin, and absence of bystander cardiopulmonary resuscitation was the only treatment component significantly associated with NYHA-FC > I at 1 year. Nearly a third experienced MACE and the most common types of MACE were ischemic cardiovascular events and acute heart failure. Early left ventricular dysfunction recovered within 6 months in half the patients with available values.

Acute myocardial damage after electrical injury assessed by MRI.

Electrical injuries are not uncommon, and electrical shock-induced cardiac damage can be life-threatening. We present the case of a young patient who suffered from acute myocardial damage due to an occupational electric shock. Myocardial damage was assessed by very early (day 4) and repeated (up to month 18) MRI. Clinical management and patient risk estimation in such a setting are challenging because data on similar non-lethal cases and practice recommendations are scarce in the literature.

[Cardiac sarcoidosis revealed by recurrent ventricular tachycardia]. / Tachycardie ventriculaire récidivante révélant une sarcoïdose cardiaque.

Sarcoidosis is an inflammatory disease whose diagnosis is suggested by clinical and paraclinical signs and confirmed by histological evidence showing granulomatosis without caseous necrosis. The clinical presentation is sometimes misleading and the diagnosis difficult to confirm. We report here the case of a young woman with cardiac sarcoidosis of difficult diagnosis, revealed by a myocardial infarction with normal coronary angiography and recurrent ventricular tachycardia. Multimodal imaging, combined with left ventricular endomyocardial biopsies guided by electrophysiological analysis and endocavitary mapping, finally confirmed the diagnosis, and allowed effective medical treatment.

Factors Influencing Anti-Xa Assays: A Multicenter Prospective Study in Critically Ill and Noncritically Ill Patients Receiving Unfractionated Heparin.

BACKGROUND: The presence of dextran sulfate (DS) in reagents and the type of blood collection tube (citrate/citrated-theophylline-adenosine-dipyridamole [CTAD]) can lead to discrepancies between unfractionated heparin (UFH) anti-Xa levels. OBJECTIVES: To evaluate the extent of the effect (1) of different reagents containing or not containing DS and (2) of the blood collection tubes, on UFH anti-Xa levels, in various clinical situations (NCT04700670). METHODS: We prospectively included patients from eight centers: group (G)1, cardiopulmonary bypass (CPB) after heparin neutralization (n = 39); G2, cardiothoracic intensive care unit (ICU) after CPB (n = 35); G3, medical ICU (n = 53); G4, other medical inpatients (n = 38). Blood was collected into citrated and CTAD tubes. Chromogenic anti-Xa assays were centrally performed, using seven reagent/analyzer combinations including two without DS. The association between anti-Xa levels and covariates was tested using a linear mixed-effects model. RESULTS: We analyzed 4,546 anti-Xa values from 165 patients. Median anti-Xa levels were systematically higher with reagents containing DS, whatever the patient group, with the greatest effect observed in G1 (0.32 vs. 0.05 IU/mL). Anti-Xa levels were slightly higher in CTAD than in citrate samples, irrespective of the assay. The model showed: (1) a significant dextran-patient group interaction (p < 0.0001), the effect of DS on anti-Xa levels varying from 30.9% in G4 to 296% in G1, and (2) a significant effect of CTAD, varying between patient groups (p = 0.0302). CONCLUSION: The variability of anti-Xa levels with a great overestimation of the values, using a reagent containing DS, can lead to different treatment decisions, especially after heparin neutralization by protamine. Clinical consequences of these differences remain to be demonstrated.

Incidence of deep venous thrombosis in COVID-19 critically ill patients treated with intermediate-dose of heparin for thromboprophylaxis: The COVIDOP-DVT observational study.

INTRODUCTION: The high prevalence of deep vein thrombosis (DVT) in patients admitted to intensive care unit (ICU) for COVID-19-related acute respiratory distress syndrome (ARDS) would justify systematic screening of these patients or higher therapeutic dose of heparin for thromboprophylaxis. MATERIAL AND METHOD: We performed a systematic echo-Doppler of the lower limb proximal veins during the first 48 h (visit 1) and from 7 to 9 days after visit 1 (visit 2) in consecutive patients admitted to the ICU of a university-affiliated tertiary hospital for severe proven COVID-19 during the second wave. All patients received intermediate-dose heparin (IDH). The primary objective was to determine DVT incidence on venous Doppler ultrasound. Secondary objectives were to determine whether the presence of DVT modifies the anticoagulation regimen, the incidence of major bleeding according to International Society on Thrombosis and Haemostasis (ISTH) criteria, and the mortality rate of patients with and without DVT. RESULTS: We included 48 patients (30 [62.5%] men) with a median age of 63 years [IQR, 54-70]. The prevalence of proximal deep vein thrombosis was 4.2% (2/48). In these two patients, after DVT diagnosis, anticoagulation was changed from intermediate to curative dose. Two patients (4.2%) had a major bleeding complication according to ISTH criteria. Among the 48 patients, 9 (18.8%) died before hospital discharge. No DVT or pulmonary embolism was diagnosed in these deceased patients during their hospital stay. CONCLUSION: In critically ill patients with COVID-19, management with IDH results in a low incidence of DVT. Although our study is not designed to demonstrate any difference in outcome, our results do not suggest any signal of harm when using intermediate-dose heparin (IDH) COVID-19 with a frequency of major bleeding complications less than 5%.

[Management of congestive heart failure in the elderly after hospitalization for acute decompensation Interest of a dedicated territorial geriatric network ; the GERICCO-78 study]. / Prise en charge de l'insuffisance cardiaque chronique chez le sujet âgé fragile après hospitalisation pour décompensation aiguë ; apport d'une cellule de coordination ville-hôpital ; étude GERICCO-78.

AIMS: Heart failure (HF) is the leading cause of hospitalisation in the elderly in France. Early rehospitalisations are common, often through an emergency department. The aim of this study was to assess the impact of a primary care-hospital coordination network, with interventions by coordination nurses (IDEC), on the rehospitalisations after a first hospitalisation for acute decompensation in frail elderly HF patients. METHODS: From 01/10/2019 to 01/10/2021, 237 patients aged > 75 years with frailty criteria, hospitalised in 8 departments of 5 private or public hospitals in the Yvelines Sud health territory were followed by an IDEC (hospital visit, telephone contacts, home visit(s)) within 3 months of their return home. This prospective observational study analysed the rate of consultations to the emergency room, rehospitalisations (total and for acute HF), and the number of events avoided at 90 days after discharge. RESULTS: The mean age of the patients was 87 years, 54% were women, 68% had a left ventricular ejection fraction > 40%, and 70% had atrial fibrillation. Non-cardiac comorbidities were very frequent. At 3-month follow-up, mortality was 9.3% (22/237), only 27 patients (11.3%) consulted the emergency room for acute HF, and the rehospitalisation rate for HF was 19.8%, without difference according to left ventricular ejection fraction. A consultation to the emergency room or a rehospitalisation for heart failure could be avoided for 10% of patients. CONCLUSION: This study suggests that a primary care-hospital coordination network with dedicated coordination nurses is useful for the management of very elderly frail patients following hospitalisation for heart failure, limiting visits to the emergency room and rehospitalisations.

[Home treatment of low-risk pulmonary embolism patients : Efficacy and safety of an outpatient program including the general practitioner]. / Prise en charge ambulatoire des embolies pulmonaires à risque faible ; expérience d'une filière centrée sur le lien ville-hôpital.

AIM: Outpatient treatment (OT) of patients with low-risk pulmonary embolisms (PE) is recommended. A multidisciplinary OT program including the general practitioner (GP) has been implemented at Versailles hospital in 2019. The objectives of the study were to assess the feasibility, safety and acceptability of the program. MATERIAL AND METHODS: The feasibility of, and the inclusion criteria for OT were defined from a retrospective cohort study of PE patients carried out in 2018. In the prospective study, consecutive patients consulting in the emergency department between 2019 and 2021 with confirmed PE were eligible for OT if they had sPESI and HESTIA scores equal to 0, normal troponin and NT-pro-BNP levels, and no right ventricular dilation on imaging. PEs associated with COVID were excluded. The OT program included 4 appointments within 3 months, including 2 with the GP. Events (death, recurrence of PE or venous thromboembolism, bleeding, rehospitalisation) were collected at 3-month follow-up. RESULTS: In the retrospective study, 19% of the 138 PE patients seen in the emergency department were eligible for OT. No complication occurred at Day 90. In the prospective study, 313 consecutive patients with confirmed PE in the emergency department were included, 66 (21%) were eligible for OT. Overall, 43 patients (14%) received OT (39 eligible) and 27 patients eligible for OT were hospitalised (92% because of pulmonary infarction). At 3-month follow-up, there were no death, no recurrence of thromboembolism, and one patient has been early hospitalised for COVID; 3 female patients treated with rivaroxaban had minor bleeding (heavy menstrual bleeding). The satisfaction rate of general practitioner was 95%. CONCLUSIONS: This study confirms the feasibility and safety of our OT program for low-risk EP patients, centered on the general practitioner. It reduces the time spent in the emergency department, reduces hospitalisations and strengthens the city-hospital link for care.

Impact of chronic coronary syndromes on cardiovascular hospitalization and mortality: the ESC-EORP CICD-LT registry.

AIMS: In Europe, global data on guideline adherence, geographic variations, and determinants of clinical events in patients with chronic coronary syndrome (CCS) remain suboptimal. The European Society of Cardiology (ESC) EURObservational Research Programme (EORP) Chronic Ischemic Cardiovascular Disease Long-Term (CICD-LT) registry is a prospective European registry, and was designed to describe the profile, management, and outcomes of patients with CCS across the ESC countries. METHODS AND RESULTS: We aimed to investigate clinical events at 1-year follow-up from the ESC EORP CICD-LT registry.One-year outcomes of 6655 patients from the 9174 recruited in this European registry were analysed. Overall, 168 patients (2.5%) died, mostly from cardiovascular (CV) causes (n = 97, 1.5%). Northern Europe had the lowest CV mortality rate, while southern Europe had the highest (0.5 vs. 2.0%, P = 0.04). Women had a higher rate of CV mortality compared with men (2.0 vs. 1.3%, P = 0.02). During follow-up, 1606 patients (27.1%) were hospitalized at least once, predominantly for CV indications (n = 1220, 20.6%). Among the population with measured low-density lipoprotein-cholesterol level at 1 year, 1434 patients (66.5%) were above the recommended target. Age, history of atrial fibrillation, previous stroke, liver disease, chronic obstructive pulmonary disease or asthma, increased serum creatinine, and impaired left ventricular function were associated with an increased risk of CV death or hospitalization. CONCLUSION: In the CICD registry, the majority of patients with CCS have uncontrolled CV-risk factors. The 1-year mortality rate is low, but these patients are frequently hospitalized for CV causes. Early identification of comorbidities may represent an opportunity for enhanced care and better outcomes.

Characteristics and Prognosis of Patients With Fibromuscular Dysplasia in a Population of Spontaneous Coronary Artery Dissections (from the French Registry of Spontaneous Coronary Artery Dissections "DISCO").

Spontaneous coronary artery dissection (SCAD) and fibromuscular dysplasia (FMD) are pathologies that appear to be closely related. This study compares the characteristics of the FMD population to the non-FMD population in a SCAD cohort. It thus assesses the involvement of the FMD phenotype in a SCAD population. From the data of the French DISCO registry, we included patients with a diagnosis of SCAD and in whom a search for FMD was performed. We collected the following characteristics of this population: the clinical and angiographic presentation, the data concerning the management, and the events occurring during the follow-up. In the 373 SCADs confirmed in the DISCO registry, we obtained imaging data for 340 of them. FMD was found in 45% of cases. The mean age was higher in the FMD group, 53.2 ± 8.8 years, versus 50.1 ± 11 years in the non-FMD group. High blood pressure and postmenopausal status were significantly higher in the FMD group. Clinical presentation, angiographic data, and management were comparable. The major adverse cardiac event rate and recurrence rate were not different between the 2 groups after 1 year of follow-up. In conclusion, we confirmed a 45% prevalence of FMD in the SCAD population. The median age was higher in the FMD group, suggesting that FMD may develop over time. The rate of major adverse cardiac events and recurrence were similar in the FMD group versus the non-FMD group after 1 year of follow-up.

Economic evaluation of fractional flow reserve-guided versus angiography-guided multivessel revascularisation in ST-segment elevation myocardial infarction patients in the FLOWER-MI randomised trial.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) who have multivessel disease, the FLOWER-MI trial found no significant clinical benefit to fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared to angiography-guided PCI. AIMS: Our aim was to estimate the cost-effectiveness and cost-utility of FFR-guided PCI, the secondary endpoint of the FLOWER-MI trial. METHODS: Costs, major adverse cardiovascular events (composite of all-cause death, non-fatal myocardial infarction [MI], and unplanned hospitalisation leading to urgent revascularisation), and quality-adjusted life years were calculated in both groups. The incremental cost-effectiveness and cost-utility ratios were estimated. Uncertainty was explored by probabilistic bootstrapping. The analysis was conducted from the perspective of the health care provider with a time horizon of one year. RESULTS: At one year, the average cost per patient was 7,560€ (±2,218) in the FFR-guided group and 7,089€ (±1,991) in the angiography-guided group (p-value<0.01). The point estimates for the incremental cost-effectiveness and cost-utility ratios found that the angiography-guided strategy was cost saving and improved outcomes, with a probabilistic sensitivity analysis confirming dominance. CONCLUSIONS: The FFR-guided strategy at one year is unlikely to be cost effective compared to the angiography-guided strategy on both clinical and quality of life outcomes.

INCREASED EXPOSURE TO X-RAYS DURING CORONARY ANGIOGRAPHY AND PERCUTANEOUS CORONARY INTERVENTIONS ASSOCIATED WITH FRACTIONAL FLOW RESERVE MEASUREMENT AND ENDOCORONARY IMAGING TECHNIQUES.

Growing use of fractional flow reserve (FFR) and intracoronary imaging techniques by optical coherence tomography or intravascular ultrasound has raised concerns about additional exposure during coronary angiography and percutaneous coronary interventions (PCIs). Using data from the prospective CRAC-France PCI Prospective Multicentre registry, we sought to evaluate the effect of these new techniques on the radiation dose to patients undergoing coronary procedures. Data on Kerma Area Product (PKA), total air kerma (KAr) and fluoroscopy time from 42 182 coronary procedures were retrospectively compared, using multivariable linear regression, according to whether they included FFR and intracoronary imaging. In coronary angiography, FFR was associated with longer fluoroscopy time and higher PKA (21.0 vs. 18.9 Gy.cm2) and KAr (372 vs. 299 mGy) (all p < 0.001). Intracoronary imaging was associated with longer fluoroscopy time, higher contrast volume (both p < 0.001), lower PKA (18.3 vs. 19.0 Gy.cm2, p = 0.02) and similar KAr. In PCI, FFR was associated with a moderate increase in KAr (682 vs. 626 mGy, p < 0.01) but not PKA (35.9 vs. 33.7 Gy.cm2, p = 0.34). For intracoronary imaging, there were no differences between groups, except for contrast volume. Increased patient exposure associated with FFR and intracoronary imaging is moderate in diagnostic coronary angiography and minimal or none in PCI, provided optimization techniques are used. It should not be a limitation on the use of these techniques given the important additional information they provide.

Use of ADAM-C and CHA2DS2-VASc scores to predict complex aortic atheroma after brain ischemia: A prospective observational study.

BACKGROUND AND AIMS: Complex aortic atheroma (CAA) is a common cause of acute brain ischemia (BI), including ischemic stroke (IS) and transient ischemic attack (TIA), and is associated with recurrence. The CHA2DS2-VASc score is a useful tool for predicting stroke in patients with atrial fibrillation (AF), and can also predict cardiovascular events in other populations, including non-AF populations. The ADAM-C score is a new risk score for predicting the diagnostic yield of transesophageal echocardiography (TEE) after BI. We aimed to evaluate the ability of CHA2DS2-VASc and ADAM-C scores to predict CAA after BI. METHODS: This prospective, multicenter, observational study included 1479 patients aged over 18 years who were hospitalized for BI. CAA was defined as the presence of one or more of the following criteria: thrombus, ulcerated plaque, or plaque thickening ≥ 4 mm. RESULTS: CAA was diagnosed in 216 patients (14.6%). CHA2DS2-VASc and ADAM-C scores were significantly higher in the CAA group versus the non-CAA group (P < .0001 for both). The CHA2DS2-VASc and ADAM-C scores appear to be good predictors of CAA (AUC 0.699 [0.635, 0.761] and 0.759 [0.702, 0.814], respectively). The sensitivity, specificity, predictive positive value (PPV), and negative predictive value (NPV) of the scores for detecting CAA were 94%, 22%, 17%, and 96%, respectively, for a CHA2DS2-VASc score < 2, and 90%, 46%, 22%, and 96%, respectively, for an ADAM-C score < 3 CONCLUSIONS: CHA2DS2-VASc and ADAM-C scores are able to predict CAA after BI. CHA2DS2-VASc < 2 and ADAM-C < 3 both have an interesting NPV of 96%.

Positive association of angiotensin II receptor blockers, not angiotensin-converting enzyme inhibitors, with an increased vulnerability to SARS-CoV-2 infection in patients hospitalized for suspected COVID-19 pneumonia.

BACKGROUND: Angiotensin-converting enzyme 2 is the receptor that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses for entry into lung cells. Because ACE-2 may be modulated by angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), there is concern that patients treated with ACEIs and ARBs are at higher risk of coronavirus disease 2019 (COVID-19) pneumonia. AIM: This study sought to analyze the association of COVID-19 pneumonia with previous treatment with ACEIs and ARBs. MATERIALS AND METHODS: We retrospectively reviewed 684 consecutive patients hospitalized for suspected COVID-19 pneumonia and tested by polymerase chain reaction assay. Patients were split into two groups, according to whether (group 1, n = 484) or not (group 2, n = 250) COVID-19 was confirmed. Multivariable adjusted comparisons included a propensity score analysis. RESULTS: The mean age was 63.6 ± 18.7 years, and 302 patients (44%) were female. Hypertension was present in 42.6% and 38.4% of patients in groups 1 and 2, respectively (P = 0.28). Treatment with ARBs was more frequent in group 1 than group 2 (20.7% vs. 12.0%, respectively; odds ratio [OR] 1.92, 95% confidence interval [CI] 1.23-2.98; P = 0.004). No difference was found for treatment with ACEIs (12.7% vs. 15.7%, respectively; OR 0.81, 95% CI 0.52-1.26; P = 0.35). Propensity score-matched multivariable logistic regression confirmed a significant association between COVID-19 and previous treatment with ARBs (adjusted OR 2.36, 95% CI 1.38-4.04; P = 0.002). Significant interaction between ARBs and ACEIs for the risk of COVID-19 was observed in patients aged > 60 years, women, and hypertensive patients. CONCLUSIONS: This study suggests that ACEIs and ARBs are not similarly associated with COVID-19. In this retrospective series, patients with COVID-19 pneumonia more frequently had previous treatment with ARBs compared with patients without COVID-19.

Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.

BACKGROUND: Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y12 receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting. METHODS: Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier). CONCLUSION: ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.

Duration of dual antiplatelet therapy in patients with CKD and drug-eluting stents: a meta analysis

Background and objectives Whether prolonged dual antiplatelet therapy (DAPT) is more protective in patients with CKD and drug elutings tents compared with shorter DAPT isuncertain.The purposeofthismeta-analysis was to examine whether shorter DAPT in patients with drug-eluting stents and CKD is associated with lower mortality or major adverse cardiovascular event rates compared with longer DAPT. Design, setting, participants, & measurements A Medline literature research was conducted to identify randomized trials in patients with drug-eluting stents comparing different DAPT duration strategies.Inclusionof patients with CKD was alsorequired. The primary outcome was acomposite of all-cause mortality, myocardial infarction,stroke,orstent thrombosis (definiteorprobable).Major bleeding was the secondary outcome.Therisk ratio (RR) was estimated using a random-effects model. Results Five randomized trials were included (1902 patient swith CKD).Short DAPT (#6months) was associated with a similar incidence of the primary outcome, compared with 12-month DAPT among patients with CKD (48 versus 50 events; RR, 0.93; 95% confidence interval [95% CI], 0.64 to 1.36; P=0.72). Twelve-month DAPT was also associated with a similar incidence of the primary outcome compared with extended DAPT ($30 months) in the CKD subgroup (35 versus 35 events; RR, 1.04; 95% CI, 0.67 to 1.62; P=0.87). Numerically lower major bleeding eventrates were detected with shorter versus 12-monthDAPT(9versus13events;RR,0.69;95%CI,0.30 to1.60;P=0.39)and12-month versus extended DAPT( 9 versus 12 events;RR,0.83;95%CI,0.35to1.93;P=0.66)in patients with CKD.Conclusions Short DAPT does not appear to be inferior to longer DAPT in patients with CKD and drug-eluting stents.Because of imprecisioninestimates (feweventsandwide confidence intervals),nodefinite conclusion scan be drawn with respect to stent thrombosis. (AU)