Sustained Efficacy, Safety and High Adherence Rate of Onabotulinum Toxin Type A in Chronic Migraine Patients: A Multicentric Prospective Real-Life Study

Guidelines regarding long-term use with onabotulinumtoxinA (onaBT-A) in chronic migraine (CM) prophylaxis are lacking. This multicentric prospective real-life study aimed to assess the efficacy and safety of a long-term treatment. A total of 195 chronic migraine patients were treated with onaBT-A, every 3 months for 5 cycles (Phase 1). In the Phase 2 of the study, depending on response rate, patients were divided into “responders” (R), “partially responders” (PR) and “non-responders” (NR). Then, we proposed to R and PR patients to continue with an additional 12 months of treatment (additional 4 sessions). Response to treatment and adverse events were collected for the entire duration of the study. Of the 195 patients included (females 82.1%, mean age 47.4 ± 12.4), at the end of Phase 1 there were 52.3% of R patients, 17.9% of PR patients, 15.4% of NR patients and 14.4% drop-outs. During Phase 2 of treatment, R patients presented a maintenance of the improvement achieved during the first year of treatment, as well as PR patients. Except for three serious adverse events not related to treatment, all other adverse events were mild or moderate in severity and resolved without sequelae. In the literature, adherence to oral migraine-preventive medications among patients with CM was found to be less than 25%. The results of this prospective real-life multicenter study show efficacy, safety and adherence to a long-term treatment with onaBT-A

sj-pdf-1-eso-10.1177_23969873231186863 – Supplemental material for Anticoagulation in acute ischemic stroke patients with mechanical heart valves: To bridge or not with heparin. The ESTREM study

Supplemental material, sj-pdf-1-eso-10.1177_23969873231186863 for Anticoagulation in acute ischemic stroke patients with mechanical heart valves: To bridge or not with heparin. The ESTREM study by Maurizio Paciaroni, Valeria Caso, Michele Romoli, Cecilia Becattini, Alexander Salerno, Costanza Rapillo, Fanny Simonnet, Davide Strambo, Isabella Canavero, Marialuisa Zedde, Rosario Pascarella, Sung-Il Sohn, Simona Sacco, Raffaele Ornello, Kristian Barlinn, Daniela Schoene, Jan Rahmig, Maria Giulia Mosconi, Ilaria Leone De Magistris, Andrea Alberti, Michele Venti, Giorgio Silvestrelli, Alfonso Ciccone, Marina Padroni, Michele Laudisi, Andrea Zini, Luana Gentile, Odysseas Kargiotis, Georgios Tsivgoulis, Rossana Tassi, Francesca Guideri, Maurizio Acampa, Luca Masotti, Elisa Grifoni, Alessandro Rocco, Marina Diomedi, Theodore Karapanayiotides, Stefan T Engelter, Alexandros A Polymeris, Annaelle Zietz, Fabio Bandini, Pietro Caliandro, Giuseppe Reale, Marco Moci, Aurelia Zauli, Manuel Cappellari, Andrea Emiliani, Antonio Gasparro, Valeria Terruso, Marina Mannino, Elisa Giorli, Danilo Toni, Marco Andrighetti, Anne Falcou, Lina Palaiodimou, George Ntaios, Dimitrios Sagris, Efstathia Karagkiozi, Anastasia Adamou, Panagiotis Halvatsiotis, Yuriy Flomin, Umberto Scoditti, Antonio Genovese, Nemanja Popovic, Leonardo Pantoni, Francesco Mele, Nicola Molitierno, Piergiorgio Lochner, Alessandro Pezzini, Massimo Del Sette, Davide Sassos, Sotirios Giannopoulos, Maria Kosmidou, Evangelos Ntais, Enrico Maria Lotti, Vincenzo Mastrangelo, Alberto Chiti, Andrea Naldi, Peter Vanacker, Mario Ferrante, Vera Volodina, Michelangelo Mancuso, Nicola Giannini, Marco Baldini, Kostantinos Vadikolias, Sofia Kitmeridou, Carlo Emanuele Saggese, Tiziana Tassinari, Valentina Saia and Patrik Michel in European Stroke Journal</p

Risk of recurrent stroke in patients with atrial fibrillation treated with oral anticoagulants alone or in combination with anti-platelet therapy

Introduction: Ischaemic stroke patients with atrial fibrillation (AF) are at high risk of stroke recurrence despite oral anticoagulation therapy. Patients with cardiovascular comorbidities may take both antiplatelet and oral anticoagulation therapy (OAC/AP). Our study aims to evaluate the safety and efficacy of OAC/AP therapy as secondary prevention in people with AF and ischaemic stroke. Patients and methods: We performed a post-hoc analysis of pooled individual data from multicenter prospective cohort studies and compared outcomes in the OAC/AP cohort and patients on DOAC/VKA anticoagulation alone (OAC cohort). Primary outcome was a composite of ischaemic stroke, systemic embolism, intracranial bleeding, and major extracranial bleeding, while secondary outcomes were ischaemic and haemorrhagic events considered separately. A multivariable logistic regression analysis was performed to identify independent predictors for outcome events. To compare the risk of outcome events between the two cohorts, the relation between the survival function and the set of explanatory variables were calculated by Cox proportional hazard models and the results were reported as adjusted hazard ratios (HR). Finally another analysis was performed to compare the overall risk of outcome events in both OAC/AP and OAC cohorts after propensity score matching (PSM). Results: During a mean follow-up time of 7.5 ± 9.1 months (median follow-up time 3.5 months, interquartile range ±3), 2284 stroke patients were on oral anticoagulants and 215 were on combined therapy. The multivariable model demonstrated that the composite outcome is associated with age (OR: 1.03, 95% CI: 1.01-1.04 for each year increase) and concomitant antiplatelet therapy (OR: 2.2, 95% CI: 1.48-3.27), the ischaemic outcome with congestive heart failure (OR: 1.55, 95% CI: 1.02-2.36) and concomitant antiplatelet therapy (OR: 1.93, 95% CI: 1.19-3.13) and the haemorrhagic outcome with age (OR: 1.03, 95% CI: 1.01-1.06 for each year increase), alcoholism (OR: 2.15, 95% CI: 1.06-4.39) and concomitant antiplatelet therapy (OR: 2.22, 95% CI: 1.23-4.02). Cox regression demonstrated a higher rate of the composite outcome (hazard ratio of 1.93 [95% CI, 1.35-2.76]), ischaemic events (HR: 2.05 [95% CI: 1.45-2.87]) and bleeding outcomes (HR: 1.90 [95% CI, 1.06-3.40]) in OAC/AP cohort. After PSM analysis, the composite outcome remained more frequent in people treated with OAC + AP (RR: 1.70 [95% CI, 1.05-2.74]). Discussion: Secondary prevention with combination of oral anticoagulant and antiplatelet therapy after ischaemic stroke was associated with worse outcomes in our cohort. Conclusion: Further research is needed to improve secondary prevention by investigating the mechanisms of recurrent ischaemic stroke in patients with atrial fibrillation