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 Bleeding is frequent in patients with atrial fibrillation (AF) treated with oral anticoagulant therapy, and may be the first manifestation of underlying cancer. We sought to investigate to what extent bleeding represents the unmasking of an occult cancer in patients with AF treated with oral anticoagulants. Methods and Results Using data from CardioCHUVI‐AF (Retrospective Observational Registry of Patients With Atrial Fibrillation From Vigo's Health Area), 8753 patients with AF aged ≥75 years with a diagnosis of AF between 2014 and 2017 were analyzed. Of them, 2171 (24.8%) experienced any clinically relevant bleeding, and 479 (5.5%) were diagnosed with cancer during a follow‐up of 3 years. Among 2171 patients who experienced bleeding, 198 (9.1%) were subsequently diagnosed with cancer. Patients with bleeding have a 3‐fold higher hazard of being subsequently diagnosed with new cancer compared with those without bleeding (4.7 versus 1.4 per 100 patient‐years; adjusted hazard ratio [HR], 3.2 [95% CI, 2.6–3.9]). Gastrointestinal bleeding was associated with a 13‐fold higher hazard of new gastrointestinal cancer diagnosis (HR, 13.4; 95% CI, 9.1–19.8); genitourinary bleeding was associated with an 18‐fold higher hazard of new genitourinary cancer diagnosis (HR, 18.1; 95% CI, 12.5–26.2); and bronchopulmonary bleeding was associated with a 15‐fold higher hazard of new bronchopulmonary cancer diagnosis (HR, 15.8; 95% CI, 6.0–41.3). For other bleeding (nongastrointestinal, nongenitourinary, nonbronchopulmonary), the HR for cancer was 2.3 (95% CI, 1.5–3.6). Conclusions In patients with AF treated with oral anticoagulant therapy, any gastrointestinal, genitourinary, or bronchopulmonary bleeding was associated with higher rates of new cancer diagnosis. These bleeding events should prompt investigation for cancers at those sites.
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.
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