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The momentum of cardiovascular drug development has slowed dramatically. Use of validated cardiac biomarkers in clinical trials could accelerate development of much-needed therapies, but biomarkers have been used less for cardiovascular drug development than in therapeutic areas such as oncology. Moreover, there are inconsistences in biomarker use in clinical trials, such as sample type, collection times, analytical methods, and storage for future research. With these needs in mind, participants in a Cardiac Safety Research Consortium Think Tank proposed the development of international guidance in this area, together with improved quality assurance and analytical methods, to determine what biomarkers can reliably show. Participants recommended the development of systematic methods for sample collection, and the archiving of samples in all cardiovascular clinical trials (including creation of a biobank or repository). The academic and regulatory communities also agreed to work together to ensure that published information is fully and clearly expressed.
The increasing proportion of elderly patients being treated for abdominal aortic aneurysm (AAA) in the endovascular era is controversial.
This study compared 30-day outcomes of endovascular aortic repair (EVAR) in nonagenarians (NAs) with non-nonagenarians (NNAs).
This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program database included EVAR procedures performed from 2011 to 2017. Multivariate logistic regression in the unadjusted cohort, followed by propensity-score matching (PSM), was performed. Primary outcomes were 30-day mortality and 30-day major adverse events.
A total of 12,267 patients were included (365 NAs). Ruptured aneurysms accounted for 6.7% (n=819) 15.7% (n=57) in NAs versus 6.5% (n=762) in NNAs (p<0.001). Mean aneurysm diameter was 6.5 ± 1.8cm in NAs versus 5.8 ± 1.7cm in NNAs (p<0.001). The unadjusted 30-day mortality was 9.9% in NA versus 2.2% in NNAs (p<0.001). Multivariate analysis revealed age≥90 years (odds ratio [ORte analysis. However, no differences were found after PSM, suggesting that being ≥90 years of age but with similar comorbidities to younger patients is not associated with a higher short-term mortality after EVAR. Age ≥90 years alone should not exclude patients from EVAR, and tailored indications and carefully balanced risk assessment are advised.
Recent population-based studies have revealed that the use of fluoroquinolones (FQs) is associated with an increased risk of aortic dissection (AD) and aneurysm (AA). However, no evidence is available on whether FQs increase adverse events in patients who had been diagnosed with AD or AA.
This study investigated whether the use of FQs increases the risk of aortic-related adverse events and death in this high-risk population.
A retrospective cohort study was conducted by using the Taiwan National Health Insurance Research Database. A total of 31,570 adult patients who survived after admission for AD or AA between 2001 and 2013 were identified. We divided each calendar year into 6 data units (2months) for each patient and each year during follow-up. Covariates and exposure of interest (FQs) were reassessed every 2months. ASN-002 research buy We used another common antibiotic, amoxicillin, as a negative control exposure.
Exposure to FQs was associated with a higher risk of all-cause death (adjusted hazard ratio 1.61; 95% confidence interval 1.50 to 1.73), aortic death (adjusted hazard ratio 1.80; 95% confidence interval 1.50 to 2.15), and later aortic surgery. However, amoxicillin exposure was not significantly associated with risk of any of the outcomes. A subgroup analysis revealed that the effect of FQs was not significantly different between the AD and AA groups.
Relative to amoxicillin use, FQ exposure in patients with AD or AA was associated with a higher risk of adverse outcomes. FQs should not be used by high-risk patients unless no other treatment options are available.
Relative to amoxicillin use, FQ exposure in patients with AD or AA was associated with a higher risk of adverse outcomes. FQs should not be used by high-risk patients unless no other treatment options are available.
Real-world data on baseline characteristics, clinical practice, and outcomes of late presentation (12 to 48h of symptom onset) in patients with ST-segment elevation myocardial infarction (STEMI) are limited.
This study aimed to investigate real-world features of STEMI late presenters in the contemporary percutaneous coronary intervention (PCI) era.
Of 13,707 patients from the Korea Acute Myocardial Infarction Registry-National Institutes of Health database, 5,826 consecutive patients diagnosed with STEMI within 48h of symptom onset during 2011 to 2015 were categorized as late (12 to 48 h; n=624) or early (<12 h; n=5,202) presenters. Coprimary outcomes were 180-day and 3-year all-cause mortality.
Late presenters had remarkably worse clinical outcomes than early presenters (180-day mortality 10.7% vs. 6.8%; 3-year mortality 16.2% vs. 10.6%; both log-rank p<0.001), whereas presentation at≥12h of symptom onset was not independently associated with increased mortality after STEMI. The use of invasiventers after STEMI. A multidisciplinary approach is required in identifying late presenters of STEMI who can benefit from invasive interventional procedures until further studied.
Prompt myocardial revascularization with percutaneous coronary intervention (PCI) reduces infarct size and improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI). However, as much as 50% of the loss of viable myocardium may be attributed to the reperfusion injury and the associated inflammatory response.
This study sought to evaluate the effect of the interleukin-6 receptor inhibitor tocilizumab on myocardial salvage in acute STEMI.
The ASSAIL-MI trial was a randomized, double-blind, placebo-controlled trial conducted at 3 high-volume PCI centers in Norway. Patients admitted with STEMI within 6h of symptom onset were eligible. Consenting patients were randomized in a 11 fashion to promptly receive a single infusion of 280mg tocilizumab or placebo. The primary endpoint was the myocardial salvage index as measured by magnetic resonance imaging after 3 to 7days.
We randomized 101 patients to tocilizumab and 98 patients to placebo. The myocardial salvage index was larger in the tocilizumab group than in the placebo group (adjusted between-group difference 5.
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