Browsing by Author "Ameriso, Sebastián"
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Item COVID-19 Lockdown Effects on Acute Stroke Care in Latin America(2021) Pujol-Lereis, Virginia A.; Flores, Alan; Barboza, Miguel A.; Abanto-Argomedo, Carlos; Amaya, Pablo; Bayona, Hernán; Bonardo, Pablo; Díaz-Escobar, Luis; Gómez-Schneider, Maia; Góngora-Rivera, Fernando; Lavados, Pablo; León, Carolina; Luraschi, Adriana; Márquez-Romero, Juan Manuel; Ouriques-Martins, Sheila C.; Navia, Víctor; Ruiz-Franco, Angélica; Vences, Miguel Angel; Zurru, María Cristina; Arauz, Antonio; Ameriso, Sebastián; Latin American Stroke rEgistry (LASE) COVID-19 Collaborators.Objectives: COVID-19 pandemic has forced important changes in health care worldwide. Stroke care networks have been affected, especially during peak periods. We assessed the impact of the pandemic and lockdowns in stroke admissions and care in Latin America. Materials and Methods: A multinational study (7 countries, 18 centers) of patients admitted during the pandemic outbreak (March-June 2020). Comparisons were made with the same period in 2019. Numbers of cases, stroke etiology and severity, acute care and hospitalization outcomes were assessed. Results: Most countries reported mild decreases in stroke admissions compared to the same period of 2019 (1187 vs. 1166, p = 0.03). Among stroke subtypes, there was a reduction in ischemic strokes (IS) admissions (78.3% vs. 73.9%, p = 0.01) compared with 2019, especially in IS with NIHSS 0 5 (50.1% vs. 44.9%, p = 0.03). A substantial increase in the proportion of stroke admissions beyond 48 h from symptoms onset was observed (13.8% vs. 20.5%, p < 0.001). Nevertheless, no differences in total reperfusion treatment rates were observed, with similar door-to-needle, door-toCT, and door-to-groin times in both periods. Other stroke outcomes, as all-type mortality during hospitalization (4.9% vs. 9.7%, p < 0.001), length of stay (IQR 1 5 days vs. 0 9 days, p < 0.001), and likelihood to be discharged home (91.6% vs. 83.0%, p < 0.001), were compromised during COVID-19 lockdown period. Conclusions: In this Latin America survey, there was a mild decrease in admissions of IS during the COVID-19 lockdown period, with a significant delay in time to consultations and worse hospitalization outcomes.Item Fighting Against Stroke in Latin America: A Joint Effort of Medical Professional Societies and Governments(2021) Ouriques Martins, Sheila Cristina; Lavados, Pablo; Secchi, Thaís Leite; Brainin, Michael; Ameriso, Sebastián; Gongora-Rivera, Fernando; Sacks, Claudio; Cantú-Brito, Carlos; Álvarez Guzmán, Tony Fabián; Pérez-Romero, Germán Enrique; Muñoz Collazos, Mario; Barboza, Miguel A.; Arauz, Antonio; Abanto Argomedo, Carlos; Novarro-Escudero, Nelson; Amorin Costabile, Héctor Ignacio; Crosa, Roberto; Camejo, Claudia; Mernes, Ricardo; Maldonado, Nelson; Mora Cuervo, Daissy Liliana; Pontes Neto, Octávio Marques; Sampaio Silva, Gisele; Carbonera, Leonardo Augusto,; Souza, Ana Claudia; Gomes de Sousa, Eduardo David; Flores, Alan; Melgarejo, Donoban; Santos Carquín, Irving R.; Hoppe, Arnold; Freitas de Carvalho, João José; Mont'Alverne, Francisco; Amaya, Pablo; Bayona, Hernán; Navia, Víctor; Duran, Juan Carlos; Urrutia, Víctor C.; Vianna Araujo, Denizar; Feigin, Valery L.; Nogueira, Raúl G.Introduction: Stroke is one of the leading causes of death in Latin America, a region with countless gaps to be addressed to decrease its burden. In 2018, at the first Latin American Stroke Ministerial Meeting, stroke physician and healthcare manager representatives from 13 countries signed the Declaration of Gramado with the priorities to improve the region, with the commitment to implement all evidence-based strategies for stroke care. The second meeting in March 2020 reviewed the achievements in 2 years and discussed new objectives. This paper will review the 2-year advances and future plans of the Latin American alliance for stroke. Method: In March 2020, a survey based on the Declaration of Gramado items was sent to the neurologists participants of the Stroke Ministerial Meetings. The results were confirmed with representatives of the Ministries of Health and leaders from the countries at the second Latin American Stroke Ministerial Meeting. Results: In 2 years, public stroke awareness initiatives increased from 25 to 75% of countries. All countries have started programs to encourage physical activity, and there has been an increase in the number of countries that implement, at least partially, strategies to identify and treat hypertension, diabetes, and lifestyle risk factors. Programs to identify and treat dyslipidemia and atrial fibrillation still remained poor. The number of stroke centers increased from 322 to 448, all of them providing intravenous thrombolysis, with an increase in countries with stroke units. All countries have mechanical thrombectomy, but mostly restricted to a few private hospitals. Pre-hospital organization remains limited. The utilization of telemedicine has increased but is restricted to a few hospitals and is not widely available throughout the country. Patients have late, if any, access to rehabilitation after hospital discharge. Conclusion: The initiative to collaborate, exchange experiences, and unite societies and governments to improve stroke care in Latin America has yielded good results. Important advances have been made in the region in terms of increasing the number of acute stroke care services, implementing reperfusion treatments and creating programs for the detection and treatment of risk factors. We hope that this approach can reduce inequalities in stroke care in Latin America and serves as a model for other under-resourced environments.Publication Safety and efficacy of factor XIa inhibition with milvexian for secondary stroke prevention (AXIOMATIC-SSP): a phase 2, international, randomised, double-blind, placebo-controlled, dose-finding trial(2024) Sharma, Mukul; Molina, Carlos; Toyoda, Kazunori; Bereczki, Daniel; Bangdiwala, Shrikant; Kasner, Scott; Lutsep, Helmi; Tsivgoulis, Georgios; Ntaios, George; Czlonkowska, Anna; Shuaib, Ashfaq; Amarenco, Pierre; Endres, Matthias; Yoon, Byung-Woo; Tanne, David; Toni, Danilo; Yperzeele, Laetitia; Weitzel, Paul; Sampaio, Gisele; Avezum, Alvaro; Dawson, Jesse; Strbian, Daniel; Tatlisumak, Turgut; Eckstein, Jens; Ameriso, Sebastián; Weber, Joerg; Sandset, Else; Pogosova, Nana; Lavados, Pablo; Arauz, Antonio; Gailani, David; Diener, Hans-Christoph; Bernstein, Richard; Cordonnier, Charlotte; Kahl, Anja; Abelian, Grigor; Donovan, Mark; Pachai, Chahin; Li, Danshi; Hankey, GraemeBackground: People with factor XI deficiency have lower rates of ischaemic stroke than the general population and infrequent spontaneous bleeding, suggesting that factor XI has a more important role in thrombosis than in haemostasis. Milvexian, an oral small-molecule inhibitor of activated factor XI, added to standard antiplatelet therapy, might reduce the risk of non-cardioembolic ischaemic stroke without increasing the risk of bleeding. We aimed to estimate the dose-response of milvexian for recurrent ischaemic cerebral events and major bleeding in patients with recent ischaemic stroke or transient ischaemic attack (TIA). Methods: AXIOMATIC-SSP was a phase 2, randomised, double-blind, placebo-controlled, dose-finding trial done at 367 hospitals in 27 countries. Eligible participants aged 40 years or older, with acute (<48 h) ischaemic stroke or high-risk TIA, were randomly assigned by a web-based interactive response system in a 1:1:1:1:1:2 ratio to receive one of five doses of milvexian (25 mg once daily, 25 mg twice daily, 50 mg twice daily, 100 mg twice daily, or 200 mg twice daily) or matching placebo twice daily for 90 days. All participants received clopidogrel 75 mg daily for the first 21 days and aspirin 100 mg daily for the first 90 days. Investigators, site staff, and participants were masked to treatment assignment. The primary efficacy endpoint was the composite of ischaemic stroke or incident covert brain infarct on MRI at 90 days, assessed in all participants allocated to treatment who completed a follow-up MRI brain scan, and the primary analysis assessed the dose-response relationship with Multiple Comparison Procedure-Modelling (MCP-MOD). The main safety outcome was major bleeding at 90 days, assessed in all participants who received at least one dose of the study drug. This trial is registered with ClinicalTrials.gov (NCT03766581) and the EU Clinical Trials Register (2017-005029-19). Findings: Between Jan 27, 2019, and Dec 24, 2021, 2366 participants were randomly allocated to placebo (n=691); milvexian 25 mg once daily (n=328); or twice-daily doses of milvexian 25 mg (n=318), 50 mg (n=328), 100 mg (n=310), or 200 mg (n=351). The median age of participants was 71 (IQR 62-77) years and 859 (36%) were female. At 90 days, the estimates of the percentage of participants with either symptomatic ischaemic stroke or covert brain infarcts were 16·8 (90·2% CI 14·5-19·1) for placebo, 16·7 (14·8-18·6) for 25 mg milvexian once daily, 16·6 (14·8-18·3) for 25 mg twice daily, 15·6 (13·9-17·5) for 50 mg twice daily, 15·4 (13·4-17·6) for 100 mg twice daily, and 15·3 (12·8-19·7) for 200 mg twice daily. No significant dose-response was observed among the five milvexian doses for the primary composite efficacy outcome. Model-based estimates of the relative risk with milvexian compared with placebo were 0·99 (90·2% CI 0·91-1·05) for 25 mg once daily, 0·99 (0·87-1·11) for 25 mg twice daily, 0·93 (0·78-1·11) for 50 mg twice daily, 0·92 (0·75-1·13) for 100 mg twice daily, and 0·91 (0·72-1·26) for 200 mg twice daily. No apparent dose-response was observed for major bleeding (four [1%] of 682 participants with placebo, two [1%] of 325 with milvexian 25 mg once daily, two [1%] of 313 with 25 mg twice daily, five [2%] of 325 with 50 mg twice daily, five [2%] of 306 with 100 mg twice daily, and five [1%] of 344 with 200 mg twice daily). Five treatment-emergent deaths occurred, four of which were considered unrelated to the study drug by the investigator. Interpretation: Factor XIa inhibition with milvexian, added to dual antiplatelet therapy, did not substantially reduce the composite outcome of symptomatic ischaemic stroke or covert brain infarction and did not meaningfully increase the risk of major bleeding. Findings from our study have informed the design of a phase 3 trial of milvexian for the prevention of ischaemic stroke in patients with acute ischaemic stroke or TIA.