Granulocyte-colony stimulating factor for large anterior ST-elevation myocardial infarction: rationale and design of the prospective randomized phase III STEM-AMI OUTCOME trial.

BACKGROUND: Granulocyte-colony stimulating factor (G-CSF) has been clinically tested in ST-elevation myocardial infarction (STEMI) with mixed results. Our 3-year follow-up data from STEM-AMI trial documented a sustained benefit of G-CSF on adverse ventricular remodeling after large anterior STEMI, when administered early and at a high-dose in patients with left ventricular (LV) dysfunction. The Aim of the present trial is to establish whether G-CSF improves hard clinical long-term outcomes. METHODS: The STEM-AMI OUTCOME is a prospective, multicenter, randomized, open-label, phase III trial. It will include 1,530 patients with anterior STEMI undergoing primary percutaneous coronary intervention 2 to 24 hours after symptoms onset and with LV ejection fraction ≤45% after successful reperfusion. Patients will be randomized 1:1 to G-CSF and/or standard treatment. The primary end point is a reduced occurrence of all-cause death, recurrence of myocardial infarction, or hospitalization due to heart failure in G-CSF-treated patients. Left ventricular remodeling will be assessed via cardiac ultrasound and a substudy with cardiac magnetic resonance will be carried out in 120 subjects. Accrual and follow-up periods will last 3 and 2 years, respectively. CONCLUSIONS: The STEM-AMI OUTCOME study is designed to be a rigorous controlled phase III trial with adequate statistical power to conclusively assess efficacy of G-CSF treatment in STEMI.

[Thrombotic storm in a teenager with previously diagnosed ulcerative colitis: a rare case of left ventricular thrombosis]. / Un raro caso di trombosi ventricolare sinistra in adolescente affetto da rettocolite ulcerosa.

Left ventricular thrombi usually occur in the setting of an acute myocardial infarction, left ventricular aneurysm, or dilated cardiomyopathy. In the absence of ventricular wall motion abnormalities, they are rare. We report the case of a patient with ulcerative colitis in whom two-dimensional echocardiography revealed a left intraventricular mass. Thrombosis in ulcerative colitis is a serious condition and can occur in a very young population. This case report also shows that left ventricular thrombi can occur in the active setting of ulcerative colitis.

[Myocardial infarction as the first manifestation of an atrial myxoma: the bomb in the heart. Case report and literature review]. / Infarto miocardico come prima manifestazione di un mixoma atriale: la bomba nel cuore. Caso clinico e revisione della letteratura.

Atrial myxoma is a cardiac tumor often histologically benign but very insidious for its mechanical complications. Among these, myocardial infarction can be an expression of coronary embolism. Imaging techniques are essential for the diagnosis and the therapeutic steps. We describe the clinical case of a 52-year-old woman with acute myocardial infarction and normal coronary arteries with left atrial myxoma. We conducted a review of published case reports over the last 45 years on the rare association between atrial myxoma and acute myocardial infarction, to obtain pathogenic and epidemiological information from the real world.

[Sequential spontaneous coronary artery dissection in a female patient on oral ephedrine]. / Dissezione coronarica spontanea sequenziale in donna in terapia con efedrina.

Spontaneous coronary artery dissection (SCAD) is an infrequent, but not rare, cause of acute coronary syndrome. It mainly affects young women, often with few or no traditional cardiovascular risk factors. In the case described, a 57-year-old woman experienced a first episode of SCAD involving a distal branch of the circumflex coronary artery--treated conservatively--followed, after a few hours, by a second episode of SCAD involving the left anterior descending coronary artery, complicated by hemodynamic instability and treated with emergency angioplasty. During the previous months, the patient was taking a slimming drug containing ephedrine. Dual spontaneous coronary dissection of different type and involving two different vessels, which occurred in the same patient within a few hours, testifies the heterogeneity of the clinical picture of this syndrome and of the therapeutic approach.

In-hospital management and outcome of patients on warfarin undergoing coronary stent implantation: results of the multicenter, prospective WARfarin and coronary STENTing (WAR-STENT) registry.

The in-hospital management of patients on warfarin undergoing coronary stent implantation (PCI-S) is variable, and the in-hospital outcome incompletely defined. To determine the adherence to the current recommendations, and the incidence of adverse events, we carried out the prospective, multicenter, observational WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319). All consecutive patients on warfarin undergoing PCI-S at 37 Italian centers were enrolled and followed for 12 months. Outcome measures were: major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, need for urgent revascularization, stroke, and venous thromboembolism, and major and minor bleeding. In this paper, we report the in-hospital findings. Out of the 411 patients enrolled, 92% were at non-low (ie, moderate or high) thromboembolic risk. The radial approach and bare-metal stents were used in 61% and 60% of cases, respectively. Drug-eluting stents were essentially reserved to patients with diabetes, which in turn, significantly predicted the implantation of drug-eluting stents (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.29-3.17; P=.002). The in-hospital MACE and major bleeding rates were 2.7% and 2.1%, respectively. At discharge, triple therapy (TT) of warfarin, aspirin, and clopidogrel was prescribed to 76% of patients. Prescription of TT was significantly more frequent in the non-low thromboembolic risk group. Non-low thromboembolic risk, in turn, was a significant predictor of TT prescription (OR, 11.2; 95% CI, 4.83-26.3; P<.0001). In conclusion, real-world warfarin patients undergoing PCI-S are largely managed according to the current recommendations. As a consequence, the risk of in-hospital MACE and major bleedings appears limited and acceptable.