P208 THE TREATMENT WITH BETA–BLOCKERS AFTER MYOCARDIAL INFARCTION WITHOUT REDUCED EJECTION FRACTION (REBOOT) TRIAL. CURRENT STATUS

Background There is a lack of evidence regarding the benefits of maintenance β–blocker (BB) treatment in post–acute AMI patients (pts) without reduced LVEF in the era of invasive management. Design and Trial Status REBOOT is an independent multinational pragmatic, controlled, randomized, open–label, with blinded endpoint adjudication clinical trial testing the benefits of BB maintenance therapy in post–AMI pts (either with or without ST segment elevation) discharged with LVEF >40%. Patients ≥18 years (yr) old undergoing invasive management during admission and without history of heart failure (HF) are eligible to participate. At discharge, pts are 1:1 randomized to either receive BB (agent and dose chosen by the treating physician) or no BB therapy. The primary endpoint is a composite of "all–cause death, nonfatal reAMI, or HF hospitalization” over a minimum follow–up period of 2 yr. Key secondary endpoints are: a) the incidence rate of each individual component of the composite endpoint;b) cardiovascular death;c) admission for sustained ventricular tachycardia/ventricular fibrillation;and d) admission for atrial fibrillation. Events will be adjudicated by a blinded committee. A sample size of 8468 pts (728 events) was estimated to provide a power of 85% to detect a relative risk reduction of 20% (incidence of primary endpoint in control 10%) and assuming 5% withdrawals. Statistical analyses will be conducted according to the intention–to–treat principle, although a pre–specified per–protocol analysis will also be performed. The Spanish National Center for Cardiovascular Research (CNIC) is the sponsor of the trial, which has no external funding. CNIC coordinates ≥75 Spanish centers, while Istituto di Ricerche Farmacologiche Mario Negri IRCCS coordinate 33 Cardiology Centers distributed in 10 Italian regions. The first pt was included in Spain in October 2018, in Italy in January 2019. The end of enrollment is anticipated in December 2022. At 09 December 2021, 5669 pts had been enrolled from which 1263 in Italy (Figure). Pts baseline characteristics are described in the Table. Hospital admission data for COVID–19 pre and post randomization were also recorded since June 2020. Conclusions The REBOOT trial (NCT03596385) will fill the existing scientific gap on the efficacy of β–BB after AMI in pts with LVEF > 40% and no HF who are treated according to current standard–of–care. REBOOT trial results might have an impact on clinical practice guidelines.

THE TREATMENT WITH BETA-BLOCKERS AFTER MYOCARDIAL INFARCTION WITHOUT REDUCED EJECTION FRACTION (REBOOT) TRIAL. CURRENT STATUS

Background: There is a lack of evidence regarding the benefits of maintenance β- blocker (BB) treatment in post-acute AMI patients (pts) without reduced LVEF in the era of invasive management. Design and Trial Status: REBOOT is an independent multinational pragmatic, controlled, randomized, open-label, with blinded endpoint adjudication clinical trial testing the benefits of BB maintenance therapy in post-AMI pts (either with or without ST segment elevation) discharged with LVEF >40%. Patients ≥18 years (yr) old undergoing invasive management during admission and without history of heart failure (HF) are eligible to participate. At discharge, pts are 1:1 randomized to either receive BB (agent and dose chosen by the treating physician) or no BB therapy. The primary endpoint is a composite of “all-cause death, nonfatal reAMI, or HF hospitalization” over a minimum follow-up period of 2 yr. Key secondary endpoints are: a) the incidence rate of each individual component of the composite endpoint;b) cardiovascular death;c) admission for sustained ventricular tachycardia/ventricular fibrillation;and d) admission for atrial fibrillation. Events will be adjudicated by a blinded committee. A sample size of 8468 pts (728 events) was estimated to provide a power of 85% to detect a relative risk reduction of 20% (incidence of primary endpoint in control 10%) and assuming 5% withdrawals. Statistical analyses will be conducted according to the intention-to-treat principle, although a pre-specified per-protocol analysis will also be performed. The Spanish National Center for Cardiovascular Research (CNIC) is the sponsor of the trial, which has no external funding. CNIC coordinates ≥75 Spanish centers, while Istituto di Ricerche Farmacologiche Mario Negri IRCCS coordinate 33 Cardiology Centers distributed in 10 Italian regions. The first pt was included in Spain in October 2018, in Italy in January 2019. The end of enrollment is anticipated in December 2022. At 09 December 2021, 5669 pts had been enrolled from which 1263 in Italy (Figure). Pts baseline characteristics are described in the Table. Hospital admission data for COVID-19 pre and post randomization were also recorded since June 2020. Conclusions: The REBOOT trial (NCT03596385) will fill the existing scientific gap on the efficacy of β-BB after AMI in pts with LVEF > 40% and no HF who are treated according to current standard-of-care. REBOOT trial results might have an impact on clinical practice guidelines. (Figure Presented).

A rare and early skin reaction after the third dose of comirnaty vaccine

Introduction: In December 2019, many cases of atypical pneumonia with unknown etiology were reported in China. Later on, a new coronavirus was identified, named SARS-Cov2. In December 2020, FDA, EMA and AIFA issued emergency use authorizations for Pfizer/SARS-Cov2 vaccine (Comirnaty). In this case report we describe a serious early large local reaction after the third dose Comirnaty. Case clinic: A 66 year-old white female with cutaneous reaction after inoculation Comirnaty arrived at the Dermatology Service. She reported six hours ago had received the third dose of the vaccine. The patient was lucid, oriented and cooperative. She reported no history of allergy no medical history and took no drugs. The blood pressure was 125/75 with sinus rhythm with pulse 75 bpm, apyretic, SpO2 98% on ambient air. The physical examination showed a large wheal reaction the left arm at the injection site. She complained of heat pain and difficulty in moving the limb. The chest examination and ABG were normal. She was submitted to therapy based on antihistamine and topical steroids. After a week she presented complete resolution of the symptoms. Conclusions: In many COVID-19 studies the incidence of cutaneous reaction after messenger RNA based COVID-19 vaccines have been reported but are not well characterized. The peculiarity of this case-report is given by the rare (after third dose) serious and early cutaneous manifestation in the absence of history of allergy, drugs smoke tobacco or use recreational drugs. This suggests that others processes not yet defined are involved in the skin reaction.

An early complication in patient with CoViD19 pneumonia

Background: In December 2019, many cases of atypical pneumonia with unknown etiology were reported in China. Later on, a new coronavirus was identified, named SARS-CoV-2. We present a case of SARS-CoV-2 pneumonia complicated by spontaneous pneumomediastinum (SPM), pneumothorax (PNX) and subcutaneous emphysema (SCE) without the use of an invasive or noninvasive positive pressure ventilator. Presentation of the case: A 42-year-old man with moderate dyspnea arrived at the DEA. He reported infection with SARS-CoV-2 from a week. He reported no medical history. At the entrance the patient was lucid, oriented and cooperative. The B.P. was 125/75 with sinus rhythm with pulse 75 bpm, apyretic, SpO2 88% on A.A. To DEA showed examinations: D-Dimer 549, fibrinogen 850, VES 75, PCR 8.33, LDH 295. The EGA (Reservoir 90%) detected: pO2 60.7 mmHg, pCO2 36.3, pH 7.47, SpO2 92% and P/F 67,4. The Rx thorax showed multiple hazy parenchymal opacities in the lower lobar seat bilaterally. He was submitted to therapy based on dexamethasone, fluid therapy, antibiotics, enoxaparin. After 36 hours, he presented progressive deterioration of respiratory function and chest CT showed: SPM, PNX, SCE. After two days he died. Conclusions: In many CoViD-19 studies the incidence of SPM, PNX, SCE is rare. The peculiarity of this case report is given by the serious SPM, PNX, SCE as an early complication in the absence of lung comorbidities, cough, consume alcohol, smoke tobacco or use recreational drugs. This suggests that others processes related to CoViD-19 might be the mechanism of air leak that progress to SPM, PNX, SCE.

Severe thrombocytopenia in patient with SARS-CoV-2 infection

Background: SARS-CoV-2 disease (CoViD-19) is an important pandemic respiratory disease that emerged in China on December 2019 and quickly spread around the world. Many studies on SARSCoV- 2 infection demonstrate its association with an increased incidence of coagulopathy. In this case-report we describe a serious thrombocytopenia as an early manifestation of CoViD-19. Description of the case: A 59-year-old male with moderate dyspnea and rare petechiae spread to the trunk arrived at the DEA. He reported infection with SARS-CoV-2 from a week with the appearance of petechiae 24 hours before the discovery of positivity. He also reported COPD history and hypertension. At the entrance the patient was lucid, oriented and cooperative. The B.P. was 110/75 with sinus rhythm with pulse of 110 bpm, apyretic, SpO2 85% in A.A. To DEA showed examinations: thrombocytopenia (8,000), leukocytosis (15,560), D-Dimer 11727, VES 74, PCR 10.53, ferritin 1592, LDH 365. The EGA (Reservoir 90%) detected pO2 70.0 mmHg, pCO2 36.5 mmHg, pH7.44, SpO2 94% and P/F 78. The X-ray chest showed multiple thickening at the lower lobar seat bilaterally and moderately spread interstitial thickening. He was admitted to the CPAP cycle (FiO2 90% PEEP 7.5 cm H2O) and therapy based on dexamethasone, fluid therapy, cholecalciferol, antibiotics and multiple platelet transfusions. After 12 days the patient died. Conclusions: In many CoViD-19 studies the incidence of thrombocytopenia is about 36%. The peculiarity of this case-report is given by the serious thrombocytopenia as an initial manifestation in the absence of clinical bleeding.

Severe hypernatriemia refractory to therapy in patient with SARS-CoV2 infection

Background: In December 2019, pneumonia-like syndrome with unknown etiology was observed in China. Later on, a new coronavirus was identified, named SARS-CoV-2. We present a case of SARS-CoV-2 pneumonia complicated by severe hypernatriemia refractory to therapy. Description of the case: A 60-year-old man with mild dyspnea came at the DEA. He reported infection with SARS-CoV-2 from a week. He reported no medical history except for prostatic hypertrophy. At the entrance the patient was lucid, oriented and cooperative. The B.P. was 130/75 with pulse 75 bpm, apyretic, SpO2 88% on A.A. To DEA showed examinations: D-Dimer 291, fibrinogen 744, VES 84, PCR 21.4, Ferritin 17347, LDH 532, normal electrolytes. The EGA (Reservoir 60%) detected: pO2 61.8 mmHg, pCO2 42.7, pH 7.45, SpO2 89% and P/F 103. The Rx thorax showed multiple hazy parenchymal opacities in the lower lobar seat bilaterally. He was submitted to therapy based on dexamethasone, fluid therapy, antibiotics, enoxaparin. After 36 hours, he presented progressive deterioration of the cognitive state and blood tests showed hypernatriemia (154 mmol). He undergoing therapy, sodium (168 mmol) worsened . After six days he died. Conclusions: While the multisystem impact of SARS-CoV-2 has been well established only recently been described the incidence of the disruption of sodium homeostasis in patients with CoViD- 19. The peculiarity of this case-report is given by the early and serious hypernatriemia as an uncommon complication. This suggests that others processes related to CoViD-19 might be the mechanism of dysnatremias in hospitalized patients.