In 7213 patients with an acute coronary syndrome, the rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin. Post-PCI bivalirudin infusion did not ...reduce the risk of stent thrombosis.
The most effective antithrombotic regimen for preventing ischemic complications while limiting bleeding risk in patients with an acute coronary syndrome who are undergoing invasive treatment remains unknown.
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Two of the most commonly used antithrombotic regimens worldwide
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are unfractionated heparin, an indirect thrombin inhibitor, with or without the concomitant use of a glycoprotein IIb/IIIa inhibitor, and bivalirudin, a direct thrombin inhibitor, with a glycoprotein IIb/IIIa inhibitor added only for periprocedural ischemic complications. Previous studies that have compared these two options among patients who were undergoing invasive treatment for an acute coronary syndrome have provided conflicting results with respect to . . .
The optimal management and short- and long-term prognoses of spontaneous coronary artery dissection (SCAD) remain not well defined. The aim of this observational multicenter study was to assess ...long-term clinical outcomes in patients with SCAD. In-hospital and long-term outcomes were assessed in 134 patients with documented SCAD, as well as the clinical impact and predictors of a conservative rather than a revascularization strategy of treatment. The mean age was 52 ± 11, years and 81% of patients were female. SCAD presented as an acute coronary syndromes in 93% of patients. A conservative strategy was performed in 58% of patients and revascularization in 42%. On multivariate analysis, distal versus proximal or mid location of dissection (odds ratio 9.27) and basal Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 or 3 versus 0 or 1 (odds ratio 0.20) were independent predictors of conservative versus revascularization strategy. A conservative strategy was associated with better in-hospital outcomes compared with revascularization (rates of major adverse cardiac events 3.8% and 16.1%, respectively, p = 0.028); however, no significant differences were observed in the long-term outcomes. In conclusion, in this large observational study of patients with SCAD, angiographic features significantly influenced the treatment strategy, providing an excellent short- and long-term prognosis.
Background: PFO (Patent foramen ovale) is a common defect that affects about 25% of the population. Although its presence is asymptomatic in the majority of the cases, the remaining part becomes ...overt with different symptoms, including cryptogenic stroke. PFO closure is currently a widely available procedure in complex anatomy, with Amplatzer PFO Occluder (APO) being the most commonly used tool. However, the performance of another device, the GORE Septal Occluder (GSO), has not been completely explored with regard to different septal anatomies. Methods: From March 2012 to June 2020, 118 consecutive patients with an indication of PFO closure were treated using the GSO system, included in a prospective analysis, and followed. After 12 months, every patient underwent transcranial Doppler ultrasound to evaluate the effectiveness of treatment. Results: Of 111 patients evaluated, 107 showed effective PFO closure (96.4%), and 4 showed a residual shunt (3.6%). To better evaluate the device performance, the overall population was sorted into two clusters based on the echocardiographic characteristics. The main difference between groups was for PFO width (4.85 ± 1.8 vs. 2.9 ± 1 mm, p < 0.001) and PFO tunnel length (12.6 ± 3.8 vs. 7.2 ± 2, p < 0.001), allowing complex and simple anatomies to be identified, respectively. Regardless of the aforementioned cluster, the GSO performance required to reach an effective closure was independent of anatomy type and the chosen device size. Conclusion: The GSO device showed a high closure rate at 1-year follow-up in patients, with at least one anatomical factor of complexity of PFO irrespective of the level of complexity itself.
Abstract Background Elderly patients display higher on clopidogrel platelet reactivity as compared to younger patients. Treatment with prasugrel 5 mg has been shown to provide more predictable and ...homogenous antiplatelet effect, as compared to clopidogrel, suggesting the possibility of reducing ischemic events after an acute coronary syndrome (ACS) without increasing bleeding. Study design The Elderly-ACS 2 study is a multicenter, randomized, parallel-group, open-label trial designed to demonstrate the superiority of a strategy of dual antiplatelet treatment using a reduced 5 mg daily dose of prasugrel over a standard strategy with a daily clopidogrel dose of 75 mg in patients >74 years of age with ACS (either ST- or non ST-elevation myocardial infarction) undergoing early percutaneous revascularization. The primary endpoint is the composite of all-cause mortality, myocardial re-infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year. Taking advantage of the planned size of 2000 patients, the secondary objective is to assess the prognostic impact of selected pre-randomization variables (age, sex, diabetic status, serum creatinine level, ECG changes, abnormal troponin levels, basal and residual SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery SYNTAX score). Conclusion The Elderly-ACS 2 study is a multicenter, randomized trial comparing a strategy of dual antiplatelet therapy with a reduced dose of prasugrel with a standard dose of clopidogrel in elderly patients with ACS undergoing percutaneous revascularization. (The Elderly ACS 2 trial: NCT01777503 )
Cyclosporine A in Reperfused Myocardial Infarction Ottani, Filippo, MD; Latini, Roberto, MD; Staszewsky, Lidia, MD ...
Journal of the American College of Cardiology,
02/2016, Letnik:
67, Številka:
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Journal Article
Recenzirano
Odprti dostop
Abstract Background Whether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated. Objectives This study investigated whether CsA improved ST-segment ...resolution in a randomized, multicenter phase II study. Methods The authors randomly assigned 410 patients from 31 cardiac care units, age 63 ± 12 years, with large ST-segment elevation MI within 6 h of symptom onset, Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1 in the infarct-related artery, and committed to primary percutaneous coronary intervention, to 2.5 mg/kg intravenous CsA (n = 207) or control (n = 203) groups. The primary endpoint was incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3. Secondary endpoints included high-sensitivity cardiac troponin T (hs-cTnT) on day 4, left ventricular (LV) remodeling, and clinical events at 6-month follow-up. Results Time from symptom onset to first antegrade flow was 180 ± 67 min; a median of 5 electrocardiography leads showed ST-segment deviation (quartile Q1 to Q3: 4 to 6); 49.8% of MIs were anterior. ST-segment resolution ≥70% was found in 52.0% of CsA patients and 49.0% of controls (p = 0.55). Median hs-cTnT on day 4 was 2,160 (Q1 to Q3: 1,087 to 3,274) ng/l in CsA and 2,068 (1,117 to 3,690) ng/l in controls (p = 0.85). The 2 groups did not differ in LV ejection fraction on day 4 and at 6 months. Infarct site did not influence CsA efficacy. There were no acute allergic reactions or nonsignificant excesses of 6-month mortality (5.7% CsA vs. 3.2% controls, p = 0.17) or cardiogenic shock (2.4% CsA vs. 1.5% controls, p = 0.33). Conclusions In the CYCLE (CYCLosporinE A in Reperfused Acute Myocardial Infarction) trial, a single intravenous CsA bolus just before primary percutaneous coronary intervention had no effect on ST-segment resolution or hs-cTnT, and did not improve clinical outcomes or LV remodeling up to 6 months. (CYCLosporinE A in Reperfused Acute Myocardial Infarction CYCLE; NCT01650662 ; EudraCT number 2011-002876-18 )
Sudden cardiac death (SCD) is a potentially fatal event usually caused by a cardiac arrhythmia, which is often the result of coronary artery disease (CAD). Up to 80% of patients suffering from SCD ...have concomitant CAD. Arrhythmic complications may occur in patients with acute coronary syndrome (ACS) before admission, during revascularization procedures, and in hospital intensive care monitoring. In addition, about 20% of patients who survive cardiac arrest develop a transmural myocardial infarction (MI). Prevention of ACS can be evaluated in selected patients using cardiac computed tomography angiography (CCTA), while diagnosis can be depicted using electrocardiography (ECG), and complications can be evaluated with cardiac magnetic resonance (CMR) and echocardiography. CCTA can evaluate plaque, burden of disease, stenosis, and adverse plaque characteristics, in patients with chest pain. ECG and echocardiography are the first-line tests for ACS and are affordable and useful for diagnosis. CMR can evaluate function and the presence of complications after ACS, such as development of ventricular thrombus and presence of myocardial tissue characterization abnormalities that can be the substrate of ventricular arrhythmias.
Abstract Background Carotid occlusive disease is the most common determinant of thromboembolic stroke. However, limited insights in vivo into the pathophysiology and pathology of carotid plaques are ...available. We designed a prospective multicenter registry to appraise the safety and feasibility of intravascular ultrasound (IVUS) and IVUS–virtual histology (IVUS–VH) imaging before and immediately after carotid stenting. Methods Symptomatic and asymptomatic patients scheduled for carotid stenting were included. IVUS–VH pullbacks were performed before and after stenting. Angiographic, IVUS and IVUS–VH analyses were performed. The primary objective was to appraise feasibility and safety of IVUS–VH, and secondary objectives were to correlate plaque composition and plaque type derived from IVUS–VH with acute and 30-day complications. Results A total of 119 patients were enrolled. IVUS–VH could be performed in all cases (100%), with additional runs after completion of the stenting procedure in 85%. Most plaques were stable by IVUS–VH, with vulnerable ones at minimum lumen area in 7%. Conversely, vulnerable plaques were significantly more common elsewhere in the internal carotid artery (ICA, 24% of patients, p < 0.001). Acute and 30-day adverse events were uncommon (2 strokes, 1 transient ischemic attack), with no significant association between these and IVUS–VH features. Conclusions IVUS and IVUS–VH examinations during carotid interventions are feasible and safe, and provide important insights on qualitative and quantitative compositions of carotid plaques. Whether carotid IVUS–VH can predict clinical events remains uncertain, awaiting long-term follow-up of the VICTORY study and additional clinical trials.
Venous (VTEs) and arterial thromboembolic events (ATEs) are causes of morbidity, disability, mortality, and increase in treatment costs in cancer patients. The risk associated with immune checkpoint ...inhibitors (ICIs) has not yet been clarified. The primary objective of this systematic review was to evaluate the incidence of VTEs and ATEs in patients treated with ICIs as single agents or in combination with other treatments.
Data from retrospective and prospective studies were selected from PubMed, EMBASE, SCOPUS, and The Cochrane Library from inception up to May up to 21st May 2020. All studies had to be in English and use human study participants. The studies were eligible if they provided a number (or rate) of VTEs and ATEs and the size of the population included. The PRISMA guidelines were followed. The data on the incidence of VTEs and ATEs were extracted for each arm, analyzed using random-effects models, and reported as weighted measures.
A total of 20,273 patients from 68 studies were included (median follow-up ranged from a few months up to three years). Overall, there were 390 VTEs and 59 ATEs, with incidence rates of 2.7% (95%CI 1.8%–4%) and 1.1% (95%CI 0.5%–2.1%), respectively. The rate of pulmonary embolism was 1.6% (95%CI 0.7%–3.2%) and deep venous thrombosis was 2.7% (95%CI 1.4%–5.4%). In studies where ICIs were administered with chemotherapy, rates of VTEs were similar to ICI alone arms (2.8% vs 2.5%). The rate of stroke and myocardial infarction were 1.1% (95%CI 0.65%–1.45%) and 0.7% (95%CI 0.15%–1.15%), respectively. In randomized trials, compared with non-ICIs containing arms (e.g. chemotherapy), the relative risk (RR) of VTEs due to ICIs was similar (RR 1.08, 95%CI 0.6–1.9; P = .79).
Thromboembolic events associated with ICIs are relatively rare in cancer patients with an advanced stage of the disease. However, in randomized studies, their incidence is similar to control arms, suggesting that the contributory role of ICIs to the thromboembolic risk in many cancer settings is small.
•We systematically evaluated the risk of vascular thrombosis with immune check point inhibitors (ICIs)•We found that venous and artherial thrombotic or thromboembolic events were 2.7% and 1.1% respectively.•Thromboembolic events are rare but not negligible vascular events treated with ICIs alone or in combination.•Higher rates are observed in genitourinary, sarcoma and pancreatic cancers.
to assess costs and safety of insulin pen devices and safety needles as compared to vial/syringes in hospitalized patients requiring insulin therapy in a General Hospital in Northern Italy.
in a ...prospective 9-month study, consecutive patients admitted to three Hospital Units received insulin therapy through either a traditional disposable syringe method, or pen/safety needles with dual-ended protection, or disposable safety syringes. We compared the median direct (insulin and devices) and indirect (insulin supply at discharge, insulin wastage) costs of a 10-day in-hospital insulin treatment in the 3 study groups, additionally accounting for the costs related to the observed needlestick injury rate. Patients' safety during in-hospital stay (hypo- and hyperglycemia episodes) and satisfaction were also assessed.
N=360 patients (55% men, mean age 75.6 years, 57% with DM since ≥10 years) were recruited in the study. Insulin pens had higher median direct cost than both traditional syringes (43 vs. 18 ε/patient, p<.0001) and safety syringes (21.5 ε/patient, p<.0001). However, when also indirect and injuries costs were taken into account, the estimated savings for using pens over traditional syringes were as high as 32 ε/patient (45.8 vs. 77.6 ε/patient, p-value <.0001). No differences in patients' safety were observed. 74% and 12% of patients using pens and syringes would like to continue the method at home, respectively (p<0.0001).
A selective use of individual pre-filled pens/safety needles for patients who are likely to continue insulin therapy at home may strongly reduce hospital diabetes treatment related costs.
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