Aims The aim of the present study was to establish the safety and efficacy profile of prasugrel and ticagrelor in real-life acute coronary syndrome (ACS) patients with renal dysfunction. Methods and results All consecutive patients from RENAMI (REgistry of New Antiplatelets in patients with Myocardial Infarction) and BLEEMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registries were stratified according to estimated glomerular filtration rate (eGFR) lower or greater than 60 mL/min/1.73 m2. Death and myocardial infarction (MI) were the primary efficacy endpoints. Major bleedings (MBs), defined as Bleeding Academic Research Consortium bleeding types 3 to 5, constituted the safety endpoint. A total of 19 255 patients were enrolled. Mean age was 63 ± 12; 14 892 (77.3%) were males. A total of 2490 (12.9%) patients had chronic kidney disease (CKD), defined as eGFR <60 mL/min/1.73 m2. Mean follow-up was 13 ± 5 months. Mortality was significantly higher in CKD patients (9.4% vs. 2.6%, P < 0.0001), as well as the incidence of reinfarction (5.8% vs. 2.9%, P < 0.0001) and MB (5.7% vs. 3%, P < 0.0001). At Cox multivariable analysis, potent P2Y12 inhibitors significantly reduced the mortality rate [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.54–0.96; P = 0.006] and the risk of reinfarction (HR 0.53, 95% CI 0.30–0.95; P = 0.033) in CKD patients as compared to clopidogrel. The reduction of risk of reinfarction was confirmed in patients with preserved renal function. Potent P2Y12 inhibitors did not increase the risk of MB in CKD patients (HR 1.00, 95% CI 0.59–1.68; P = 0.985). Conclusion In ACS patients with CKD, prasugrel and ticagrelor are associated with lower risk of death and recurrent MI without increasing the risk of MB.
Background Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue. Aim To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real‐world patient with persistent LAA thrombus. Methods and results The study retrospectively enrolled consecutive patients with non‐valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high‐volume centres. Twenty‐seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA2DS2‐VASc and HAS‐BLEED scores 3 [2–5] and 3 [2.75–4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra‐aortic trunks dissection was recorded. Conclusions In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.
Introduction. The risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the firstyear of follow-up according to clinical presentation, medical and interventional strategies.Methods. BleeMACS and Renami are two multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary endpoints. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup.Results. 19,826 patients were included. Overall, in the first year after PCI the ADBR was 0.008085%, while ADIR was 0.008017% (p=0.886). In the first 2 weeks ADIR was higher than ADBR (p=0.013), especially in patients with STEMI or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the 3 rd month, while ADBR became higher, although not significantly, afterwards. Patients with incomplete revascularization had an excess in ischemic risk (p=0.003), while non-STelevation-ACS patients (NSTE-ACS) and those on ticagrelor had an excess of bleeding (p=0.012 and p=0.022 respectively). Conclusions.In unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in STEMI patients and those with incomplete revascularization. In the first year ADIR was higher than ADBR in patients with incomplete revascularization, while ADBR was higher in NSTE-ACS patients and in those discharged on ticagrelor.
Introduction: The safety and efficacy of prasugrel and ticagrelor in patients with diabetes mellitus presenting with acute coronary syndrome and treated with percutaneous coronary intervention remain to be assessed. Methods: All diabetes patients admitted for acute coronary syndrome and enrolled in the REgistry of New Antiplatelets in patients with Myocardial Infarction (RENAMI) were compared before and after propensity score matching. Net adverse cardiovascular events (composite of death, stroke, myocardial infarction and BARC 3–5 bleedings) and major adverse cardiovascular events (composite of death, stroke and myocardial infarction) were the co-primary endpoints. Single components of primary endpoints were secondary endpoints. Results: Among 4424 patients enrolled in RENAMI, 462 and 862 diabetes patients treated with prasugrel and ticagrelor, respectively, were considered. After propensity score matching, 386 patients from each group were selected. At 19±5 months, major adverse cardiovascular events and net adverse cardiovascular events were similar in the prasugrel and ticagrelor groups (5.4% vs. 3.4%, P=0.16 and 6.7% vs. 4.1%, P=0.11, respectively). Ticagrelor was associated with a lower risk of death and BARC 2–5 bleeding when compared to prasugrel (2.8% vs. 0.8%, P=0.031 and 6.0% vs. 2.6%, P=0.02, respectively) and a clear but not significant trend for a reduction of BARC 3–5 bleeding (2.3% vs. 0.8%, P=0.08). There were no significant differences in myocardial infarction recurrence and stent thrombosis. Conclusion: Diabetes patients admitted for acute coronary syndrome seem to benefit equally in terms of major adverse cardiovascular events from ticagrelor or prasugrel use. Ticagrelor was associated with a significant reduction in all-cause death and bleedings, without differences in recurrent ischaemic events, which should be confirmed in dedicated randomised controlled trials.
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