Browsing by Author "Ameriso, Sebastian"
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Publication Risk and impact of stroke across 38 countries and territories of the Americas from 1990 to 2021: a population-based trends analysis from the Global Burden of Disease Study 2021(2025) Martinez, Ramón; Munoz Venturelli, Paula; Ordunez, Pero; Fregni, Felipe; Abanto, Carlos; Alet, Matias; Alvarez, Tony; Amaya, Pablo; Ameriso, Sebastian; Arauz, Antonio; Barboza, Miguel; Bayona, Hernán; Ortiz, Antonio; Calleja, Juan; Cano, Vanessa; Carbonera, Leonardo; Carrillo, Rodrigo; Corredor, Angel; De Souza, Ana; Jimenez, Claudio; Lanas, Fernando; Martins, Sheila; Navia, Víctor; Novarro, Nelson; Olavarría, Verónica V.; Ovbiagele, Bruce; Pachecho, Kevin; Pontes, Octavio; Pujol, Virginia; Rabinstein, Alejandro; Rosales, Julieta; Rosende, Andrés; Sampaio, Gisele; Saposnik, Gustavo; Sen, Souvik; Testai, Fernando; Urrutia, Victor; Anderson, Craig; Lavados, PabloBackground: Despite substantial declines in burden over time, stroke remains a public health threat in the Americas. This study aimed to assess the current magnitude, trends, and disparities in the estimates of stroke burden by sex and age in the Americas from 1990 to 2021. Methods: Estimates from the Global Burden of Disease, Injuries and Risk Factors Study 2021 were used to analyze incidence, prevalence, mortality, years of life lost due to premature death, years lived with disabilities, and disability-adjusted life years (DALYs) caused by stroke and its major subtypes stratified by age, and sex in the Americas from 1990 to 2021. We used Joinpoint regression analysis to estimate the average annual percent change (AAPC) of stroke mortality and disease burden outcomes and assessed trends. Findings: In 2021, there were 1.1 million (95% uncertainty interval: 1.0-1.2) new cases, 12.9 million (12.3-13.7) prevalent cases, 0.5 million (0.5-0.6) deaths, and 11.4 million (10.6-12.1) DALYs due to stroke in the Americas. The absolute number of stroke burden outcomes increased from 1990 to 2021, but their corresponding age-standardized rates significantly declined. A deceleration in reduction rates of burden outcomes for all strokes and most stroke subtypes occurred over the last decade, with pronounced difference between sexes mainly in incidence among younger groups. From 2015 to 2021, trends in incidence rates from all stroke and stroke subtypes reversed to increase in most age groups, and strikingly, trends in mortality and DALY rates from ischemic stroke among younger populations reversed to upward with AAPC over 1.4%. A substantial number of countries contributed to these increasing trends. Interpretation: Regionally, the annual number of stroke cases and deaths significantly increased from 1990 to 2021, despite reductions in age-standardized rates. The declining pace in age-standardized stroke rates has decelerated in recent years, while trends in incidence, and ischemic stroke mortality and DALY among middle-aged adults and adults, reversed towards upward in the period 2015-2021. Further studies are needed to understand the determinants of this recent pattern and identify the most cost-effective interventions to stem this alarming trend. Funding: There was no funding source for this study.Item Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial(Sage Publications, 2016) Hart, Robert; Sharma, Mukul; Mundl, Hardi; Shoamanesh, Ashkan; Kasner, Scott; Berkowitz, Scott; Pare, Guillaume; Kirsch, Bodo; Pogue, Janice; Pater, Calin; Peters, Gary; Davalos, Antoni; Lang, Wilfried; Wang, Yongjun; Wang, Yilong; Cunha, Luis; Eckstein, Jens; Tatlisumak, Turgut; Shamalov, Nikolay; Mikulik, Robert; Lavados, Pablo; Hankey, Graeme; Czlonkowska, Anna; Toni, Danilo; Ameriso, Sebastian; Gagliardi, Rubens; Amarenco, Pierre; Bereczki, Daniel; Uchiyama, Shinichiro; Lindgren, Arne; Endres, Matthias; Brouns, Raf; Yoon, Byung-Woo; Ntaios, George; Veltkamp, Roland; Muir, Keith; Ozturk, Serefnur; Arauz, Antonio; Bornstein, Natan; Bryer, Alan; O’Donnell, Martin; Weitz, Jeffrey; Peacock, Frank; Themeles, Ellison; Connolly, StuartBackground: Embolic strokes of undetermined source comprise up to 20% of ischemic strokes. The stroke recurrence rate is substantial with aspirin, widely used for secondary prevention. The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source international trial will compare the efficacy and safety of rivaroxaban, an oral factor Xa inhibitor, versus aspirin for secondary prevention in patients with recent embolic strokes of undetermined source. Main hypothesis: In patients with recent embolic strokes of undetermined source, rivaroxaban 15 mg once daily will reduce the risk of recurrent stroke (both ischemic and hemorrhagic) and systemic embolism (primary efficacy outcome) compared with aspirin 100 mg once daily. Design: Double-blind, randomized trial in patients with embolic strokes of undetermined source, defined as nonlacunar cryptogenic ischemic stroke, enrolled between seven days and six months from the qualifying stroke. The planned sample size of 7000 participants will be recruited from approximately 480 sites in 31 countries between 2014 and 2017 and followed for a mean of about two years until at least 450 primary efficacy outcome events have occurred. The primary safety outcome is major bleeding. Two substudies assess (1) the relative effect of treatments on MRIdetermined covert brain infarcts and (2) the biological underpinnings of embolic strokes of undetermined source using genomic and biomarker approaches. Summary: The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source trial is evaluating the benefits and risks of rivaroxaban for secondary stroke prevention in embolic strokes of undetermined source patients. Main results are anticipated in 2018.Item Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial(2018) Kasner, Scott; Swaminathan, Balakumar; Lavados, Pablo; Sharma, Mukul; Muir, Keith; Veltkamp, Roland; Ameriso, Sebastian; Endres, Matthias; Lutsep, Helmi; Messé, Steven; Spence, John; Nedeltechev, Krassen; Perera, Kanjana; Santo, Gustavo; Olavarria, Veronica; Lindgren, Arne; Bangdiwala, Shrikant; Shoamanesh, Ashkan; Berkowitz, Scott; Mundl, Hardi; Connolly, Stuart; Hart, Robert; NAVIGATE ESUS InvestigatorsBackground: Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from previous studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesised that anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, would reduce the risk of recurrent ischaemic stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE ESUS trial. Methods: NAVIGATE ESUS was a double-blinded, randomised, phase 3 trial done at 459 centres in 31 countries that assessed the efficacy and safety of rivaroxaban versus aspirin for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined on the basis of transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE). The primary efficacy outcome was time to recurrent ischaemic stroke between treatment groups. The primary safety outcome was major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis. The primary analyses were based on the intention-to-treat population. Additionally, we did a systematic review and random-effects meta-analysis of studies in which patients with cryptogenic stroke and PFO were randomly assigned to receive anticoagulant or antiplatelet therapy. Findings: Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive rivaroxaban (n=3609) or aspirin (n=3604). Patients were followed up for a mean of 11 months because of early trial termination. PFO was reported as present in 534 (7·4%) patients on the basis of either TTE or TOE. Patients with PFO assigned to receive aspirin had a recurrent ischaemic stroke rate of 4·8 events per 100 person-years compared with 2·6 events per 100 person-years in those treated with rivaroxaban. Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22-1·36), and the risk was similar for those without known PFO (1·06; 0·84-1·33; pinteraction=0·18). The risks of major bleeding with rivaroxaban versus aspirin were similar in patients with PFO detected (HR 2·05; 95% CI 0·51-8·18) and in those without PFO detected (HR 2·82; 95% CI 1·69-4·70; pinteraction=0·68). The random-effects meta-analysis combined data from NAVIGATE ESUS with data from two previous trials (PICSS and CLOSE) and yielded a summary odds ratio of 0·48 (95% CI 0·24-0·96; p=0·04) for ischaemic stroke in favour of anticoagulation, without evidence of heterogeneity. Interpretation: Among patients with ESUS who have PFO, anticoagulation might reduce the risk of recurrent stroke by about half, although substantial imprecision remains. Dedicated trials of anticoagulation versus antiplatelet therapy or PFO closure, or both, are warranted. Funding: Bayer and Janssen.