Design of the PERSEO Registry on the management of patients treated with oral anticoagulants and coronary stent.

AIM: Percutaneous coronary intervention with stent implantation (PCI-S) in patients requiring chronic oral anticoagulant therapy (OAC) is associated with an increased risk of bleeding and ischemic complications. Different randomized studies showed a significant advantage of a double antithrombotic therapy and superiority of direct oral anticoagulant (DOAC) compared with warfarin, but real-world data are limited. Aim is to evaluate the antithrombotic management and clinical outcome of patients with an indication for OAC who undergo PCI-S in a 'real-world' setting. METHODS: The multicentre prospective observational PERSEO (PERcutaneouS coronary intErventions in patients treated with Oral anticoagulant therapy) Registry (ClinicalTrials.gov Identifier: NCT03392948) has been designed to enrol patients requiring OAC treated by PCI-S in 25 Italian centres. A target of at least 1080 patients will be followed for 1 year and data on thromboembolic and bleeding events and changes in antithrombotic therapy will be registered. The primary end point is a combined measure of efficacy and safety outcome (NACE), including major bleeding events and major adverse cardiac and cerebral events at 1-year follow-up in patients treated with DOAC (and dual or triple antiplatelet therapy) compared with the corresponding strategies with vitamin K antagonists. A secondary prespecified analysis has been defined to evaluate NACE in dual versus triple antithrombotic therapy after hospital discharge at 1-year follow-up. CONCLUSION: The PERSEO Registry will investigate in a 'real world' setting the safety and efficacy of DOAC versus warfarin and dual versus triple antithrombotic therapy in patients with indication for oral anticoagulant therapy who undergo PCI-S.

Anomalous right coronary artery origin from pulmonary artery associated with aortic stenosis, mitral regurgitation, and Vieussens' arterial ring: a very rare association and case.

We report a very rare case of anomalous origin of the right coronary artery from the pulmonary artery associated with severe aortic stenosis, severe mitral regurgitation, and Vieussens' arterial ring (VAR). Diagnosis was made accidentally during preoperative coronary angiography and confirmed by multidetector computed tomography. Surgery was performed with aortic valve replacement, mitral valve annuloplasty, right coronary artery reimplantation into the ascending aorta, and VAR resection. .

[Periprocedural management of anticoagulation therapy and in-hospital outcomes in patients with warfarin indication undergoing percutaneous coronary intervention. Data from the WAR-STENT registry]. / Gestione periprocedurale della terapia anticoagulante ed esiti intraospedalieri nei pazienti con indicazione a warfarin sottoposti ad angioplastica coronarica. Informazioni dal registro WAR-STENT.

BACKGROUND: In patients with an indication for oral anticoagulation (OAC) with warfarin, the management of OAC peri-procedure of percutaneous coronary intervention (PCI) is still not fully defined. To investigate clinical practice and outcomes associated with continuation vs interruption of OAC, with or without bridging with low-molecular-weight heparin (LMWH), we examined the database of the observational, prospective, multicenter Italian WAR-STENT registry. METHODS: The WAR-STENT registry was conducted in 2008-2010 in 37 Italian centers and included 411 consecutive patients in 157 of whom the peri-procedural international normalized ratio (INR) value was available. In relation to the continuation vs interruption of OAC, patients were divided into group 1 (n = 106) and group 2 (n = 51) respectively, and compared. RESULTS: The basal characteristics of the two groups were similar. The most frequent indication for OAC was atrial fibrillation and for PCI acute coronary syndromes, respectively. The pre-procedural mean value of INR was significantly different in group 1 vs group 2 (2.3 ± 0.4 vs 1.5 ± 0.2; p <0.001), while the use of antithrombotic drugs did not differ, except for LMWH which, albeit limited to only 14% of cases, was used significantly more frequently in group 2 (14% vs 2%; p=0.006). The radial approach was used significantly more often in group 1 vs group 2 (72% vs 45%; p=0.002). The in-hospital incidence of major bleeding complications was similar in groups 1 and 2 (4% vs 8%; p=0.27), as well as the occurrence of major adverse cardio-cerebrovascular events, including cardiovascular death, non-fatal myocardial infarction, re-revascularization of the treated vessel, stent thrombosis, stroke and venous thromboembolism (6% vs 6%; p=0.95). There was a tendency towards a higher incidence of minor access-site bleeding complications in group 1 patients treated by the femoral route. CONCLUSIONS: In unselected patients with an indication for OAC with warfarin and undergoing PCI, the continuation vs interruption of OAC (essentially without LMWH bridging) strategies appears similar in terms of efficacy and safety. In consideration of the superior convenience, peri-procedural continuation of OAC should therefore generally be preferred, with the possible exception of patients in whom the femoral approach is required for the procedure.

Outcome of patients on oral anticoagulation undergoing coronary artery stenting: data from discharge to 12 months in the Warfarin and Coronary Stenting (WAR-STENT) Registry.

OBJECTIVES: To obtain further, and more focused, information on the efficacy and safety of the antithrombotic regimens, including triple therapy (TT) of warfarin, aspirin, and clopidogrel; dual therapy (DT) of warfarin and single antiplatelet agent (aspirin or clopidogrel); and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, prescribed to patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S). BACKGROUND: The true efficacy and safety of TT, DT, and DAPT in OAC patients undergoing PCI-S is largely undefined. METHODS: We analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319), only including the post-discharge period. RESULTS: Of the 401 patients discharged alive from index hospitalization, 339 (85%), 20 (5%), and 42 (10%) were prescribed TT, DT, and DAPT, respectively. Throughout a mean follow-up of 368.3 ± 22.8 days, major adverse cardiovascular events (MACE) (including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism), total bleeding, major bleeding, and combination of MACE plus total bleeding were comparable across the three treatment groups. The absolute rate of major bleeding with TT was 4%. The antithrombotic treatment actually ongoing at major bleeding was TT in 44%, DT in 50%, and DAPT in 6% of cases. CONCLUSION: In the real-world population of OAC patients undergoing PCI-S in the WAR-STENT registry, the three antithrombotic regimens of TT, DT, and DAPT showed comparable efficacy and safety. Due to several limitations, our data cannot be considered conclusive in confuting the current recommendations to prescribe TT. Further properly designed and sized studies are warranted.

Echocardiographic evolution of pulmonary artery pressure after acute pulmonary embolism. Results from IPER registry.

AIMS: The aim of the study is to describe the course of the echocardiographically measured pulmonary artery systolic pressure (PAsP) in a series of patients included in the Italian Pulmonary Embolism Registry (IPER). METHODS: Patients with confirmed PE received an echo-Doppler evaluation within 24 hours from hospital admission and after one year. Pulmonary hypertension (PH) was considered "likely" , "possible" or "unlikely" with a right ventricular-right atrial (RV-RA) pressure gradient>45 mm Hg, between 32 and 45 mm Hg and ≤31 mm Hg and no additional echocardiographic variables suggestive of PH, respectively. RESULTS: We studied 286 patients (169 females and 117 males, mean age 67 ± 15; mean follow-up 387 ± 45 days): 240 had a baseline tricuspid regurgitation (TR) and a RV-RA gradient of variable degree. PH was considered likely, unlikely and possible in 97, 93 and 50 patients respectively. At FU echocardiography, 6 patients (2.1%) had a likely PH and all of them were part of the group of 97 patients with a baseline likely PH; 24 patients (8.4%) had a possible PH, and 67% of them had an initial likely PH. No patients with a baseline unlikely PH or without TR developed a follow-up PH (both likely or possible). The probability to show a likely PH at FU echocardiography for patients with a baseline RV-RA gradient>45 mm Hg was 6.2%, while the probability not to have a likely PH for patients with a baseline RV-RA gradient ≤ 45 mm Hg was 100%. CONCLUSION: In our study population of patients with acute PE, we observed that those presenting with a baseline echocardiographic RV-RA pressure gradient ≤ 45 mm Hg were completely free from a likely PH after 1-year.

Acute pulmonary embolism: external validation of an integrated risk stratification model.

BACKGROUND: In hemodynamically stable patients with acute pulmonary embolism, risk stratification is essential to drive clinical management. In these patients, risk stratification for in-hospital adverse outcomes based on markers of right ventricular dysfunction and injury has been proposed. METHODS: The aim of this study was to validate a model based on the incremental prognostic value of right ventricular dysfunction and injury in hemodynamically stable patients with acute pulmonary embolism. Patients from the prospective Italian Pulmonary Embolism Registry were included in the study. Study outcomes were in-hospital death and the composite of in-hospital death or clinical deterioration. RESULTS: Among 1,515 hemodynamically stable patients, 869 had both echocardiography and troponin assessments. The risk for in-hospital death or clinical deterioration was higher in patients with right ventricular dysfunction and elevated troponin level (8.8%; hazard ratio [HR], 14.2 [95% CI, 1.94-104.16]; P < .01) and with either right ventricular dysfunction or elevated troponin level (4.7%; HR, 7.9 [95% CI, 1.1-59.9]; P < .05) compared with patients without dysfunction and normal troponin levels. The negative predictive value of the model was 100% for in-hospital death and 99% for death or clinical deterioration. C statistics showed an improvement of the discriminatory power for in-hospital death or clinical deterioration by using the overall model (0.66; 95% CI, 0.60-0.73) over either echocardiography (0.59; 95% CI, 0.53-0.67) or troponin level (0.61; 95% CI, 0.53-0.69) alone. CONCLUSIONS: A model that includes both dysfunction and injury of the right ventricle has an incremental prognostic value for risk stratification in hemodynamically stable patients with acute pulmonary embolism. Patients with no dysfunction or injury have a favorable outcome. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01604538; URL: www.clinicaltrials.gov.

Pheochromocytoma mimicking a non-ST elevation acute myocardial infarction.

We report a 57 year-old male patient admitted with a diagnosis of non-ST elevation acute myocardial infarction. He had suffered from chest pain, diaphoresis and intense asthenia for three days. The electrocardiogram on admission showed a high frequency sinus tachycardia. Troponin T levels were elevated. An echocardiogram suggested an antero-lateral myocardial infarction. Eventually, a left adrenal pheochromocytoma was discovered. Left ventricular function, severely depressed, returned to normal after medical and surgical therapy.

Electrocardiographic abnormalities mimicking myocardial infarction in a patient with intracranial haemorrhage: a possible pitfall for prehospital thrombolysis.

The electrocardiogram, when applied in the prehospital setting, has a significant effect on a patient with chest pain. The potential effect includes both diagnostic and therapeutic issues, including the diagnosis of acute myocardial infarction and the indication for thrombolysis or invasive procedures. We report the case of a man who suffered from a syncope, with a prehospital electrocardiogram showing prominent ST-segment elevation. Out-of-hospital thrombolytic therapy was planned by the emergency department. Fortunately, thrombolysis did not start because the patient fared worse. He was taken to the emergency department and, because of mental status impairment, it was decided to perform a cranial computed tomographic scan. The diagnosis shifted to a haemorrhagic stroke. According to the guidelines, prehospital thrombolysis would have been inappropriate in this case because the patient did not have any chest discomfort. The pathophysiological mechanisms of electrocardiographic abnormalities in the setting of intracranial haemorrhage are reviewed, as well as the issue of thrombolysis administered or planned only on the basis of an electrocardiogram.

[Type A acute aortic dissection presenting as mental status confusion: is it an atypically really uncommon presentation?]. / Dissezione aortica acuta tipo A esordita con stato confusionale: una presentazione atipica davvero infrequente?

The most common initial symptom of acute aortic dissection is chest or abdominal pain. Nevertheless, in a minority of cases, it may have an atypical presentation, making the diagnosis clinically challenging. This article reports on a case of acute type A aortic dissection presenting as mental status confusion. The diagnostic suspicion for a cerebrovascular accident may have catastrophic consequences in a clinical condition, which is associated with a high mortality during the first 48 hours after the onset of symptoms if untreated. The right diagnosis was made by combining a careful physical examination, echocardiography, and computed tomography. The available literature about neurologic manifestations, their pathophysiology and prevalence as the initial symptom of acute type A aortic dissection is reviewed.

Successful treatment of post-exertion acute myocardial infarction by primary angioplasty and stenting in a patient with antiphospholipid antibody syndrome.

Antiphospholipid syndrome is a disorder characterized by arterial and venous thromboses, thrombocytopaenia and stroke. Acute myocardial infarction is rarely associated with this syndrome. The treatment of these patients is a clinical challenge. This report is about a patient with antiphospholipid syndrome presenting with an acute myocardial infarction after an exercise test. The infarct-related coronary artery was successfully revascularized by primary angioplasty and stenting without any major bleeding complications. We think that the physical exertion could have favoured acute coronary thrombosis in this particular setting.

A rare cause of cardiogenic shock: catecholamine cardiomyopathy of pheochromocytoma.

Pheochromocytoma is a rare catecholamine secreting tumor that accounts for about 0.04% of cases of hypertension. Other less common cardiovascular manifestations such as arrhythmias, angina pectoris, acute myocardial infarction, dilated cardiomyopathy, acute heart failure, and cardiogenic shock have occasionally been reported. We describe the case of a 32-year-old previously healthy male patient who died of cardiogenic shock within 10 hours of admission. Postmortem examination showed a catecholamine cardiomyopathy and a pheochromocytoma of the right adrenal gland. Pheochromocytoma with predominant epinephrine or dopamine secretion may take a hypotensive course. Sudden excessive catecholamine release can, as in the described case, cause cardiogenic shock.

[Transesophageal echocardiography diagnosis of ruptured aneurysm of the Valsalva sinus associated with aneurysm of the interatrial septum]. / Diagnosi ecocardiografica transesofagea di rottura di aneurisma del seno di Valsalva associato ad aneurisma del setto interatriale.

Aneurysms of the sinus of Valsalva are uncommon heart defects that often remain undetected unless rupture occurs. They have been reported in association with other cardiac anomalies. The present case report deals with a 51-year-old man who was referred to our division with a diagnosis of recent-onset progressive heart failure. Echocardiographic evaluation, both transthoracic and transesophageal, disclosed rupture of an aneurysm of the non-coronary sinus of Valsalva into the right atrium. This anomaly was associated with an aneurysm of the atrial septum.