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2. Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)

Author

Zapata-Arriaza, Elena, Medina-Rodríguez, Manuel, Moniche Álvarez, Francisco, Albóniga‑Chindurza, Asier de, Aguilar-Pérez, Marta, Ainz-Gómez, Leire, Baena-Palomino, Pablo, Zamora, Aynara, Pardo-Galiana, Blanca, Delgado-Acosta, Fernando, Valverde Moyano, Roberto, Jiménez-Gómez, Elvira, Bravo Rey, Isabel, Oteros Fernández, Rafael, Escudero-Martínez, Irene, Vielba-Gómez, Isabel, Morales Caba, Lluis, Díaz Pérez, José, García Molina, Estefanía, Mosteiro, Sonia, Castellanos, María del Mar, Amaya Pascasio, Laura, Hidalgo, Carlos, Freijo Guerrero, María del Mar, González-Díaz, Eva, Ramírez Moreno, José María, Fernández Prudencio, Luis, Terceño Izaga, Mikel, Bashir Viturro, Saima, Gamero-García, Miguel-Ángel, Jiménez Jorge, Silvia, Rosso Fernández, Clara, Montaner, Joan, González García, Alejandro, Zapata-Arriaza, Elena, Medina-Rodríguez, Manuel, Moniche Álvarez, Francisco, Albóniga‑Chindurza, Asier de, Aguilar-Pérez, Marta, Ainz-Gómez, Leire, Baena-Palomino, Pablo, Zamora, Aynara, Pardo-Galiana, Blanca, Delgado-Acosta, Fernando, Valverde Moyano, Roberto, Jiménez-Gómez, Elvira, Bravo Rey, Isabel, Oteros Fernández, Rafael, Escudero-Martínez, Irene, Vielba-Gómez, Isabel, Morales Caba, Lluis, Díaz Pérez, José, García Molina, Estefanía, Mosteiro, Sonia, Castellanos, María del Mar, Amaya Pascasio, Laura, Hidalgo, Carlos, Freijo Guerrero, María del Mar, González-Díaz, Eva, Ramírez Moreno, José María, Fernández Prudencio, Luis, Terceño Izaga, Mikel, Bashir Viturro, Saima, Gamero-García, Miguel-Ángel, Jiménez Jorge, Silvia, Rosso Fernández, Clara, Montaner, Joan, and González García, Alejandro

Abstract

[Abstract] Rationale: In-stent reocclusion after endovascular therapy has a negative impact on outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Optimal antiplatelet therapy approach in these patients to avoid in-stent reocclusion is yet to be elucidated. Aims: To assess efficacy and safety of intravenous tirofiban versus intravenous aspirin in patients undergoing MT plus carotid stenting in the setting of AIS due to TL. Sample size estimates: Two hundred forty patients will be enrolled, 120 in every treatment arm. Methods and design: A multicenter, prospective, randomized, controlled (aspirin group), assessor-blinded clinical trial will be conducted. Patients fulfilling the inclusion criteria will be randomized at MT onset to the experimental or control group (1:1). Intravenous aspirin will be administered at a 500-mg single dose and tirofiban at a 500-mcg bolus followed by a 200-mcg/h infusion during the first 24 h. All patients will be followed for up to 3 months. Study outcomes: Primary efficacy outcome will be the proportion of patients with carotid in-stent thrombosis within the first 24 h after MT. Primary safety outcome will be the rate of symptomatic intracranial hemorrhage. Discussion: This will be the first clinical trial to assess the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL.

Published
2024

3. Additional file 1 of Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)

Author

Instituto de Salud Carlos III, Zapata‐Arriaza, Elena [0000-0002-1730-1999], Medina-Rodríguez, Manuel [0000-0002-2862-9586], Moniche, Francisco [0000-0001-8613-2909], Delgado, Fernando [0000-0003-2180-5273], Escudero-Martínez, Irene [0000-0003-1838-0235], Montaner, Joan [0000-0003-4845-2279], Zapata‐Arriaza, Elena, Medina-Rodríguez, Manuel, Moniche, Francisco, Albóniga-Chindurza, Asier de, Aguilar-Pérez, Marta, Ainz-Gómez, Leire, Baena-Palomino, Pablo, Zamora, Aynara, Pardo‐Galiana, Blanca, Delgado, Fernando, Valverde Moyano, Roberto, Jiménez-Gómez, Elvira, Bravo-Rey, Isabel, Oteros-Fernández, Rafael, Escudero-Martínez, Irene, Vielba-Gómez, Isabel, Morales-Caba, Lluis, Díaz-Pérez, José, García-Molina, Estefanía, Mosteiro, Sonia, Castellanos-Rodrigo, María del Mar, Pascasio, Laura Amaya, Hidalgo, Carlos, Freijo-Guerrero, Maria del Mar, González-Díaz, Eva, Ramírez-Moreno, José M., Fernández-Prudencio, Luis, Terceño Izaga, Mikel, Bashir Viturro, Saima, Gamero-García, Miguel Ángel, Jiménez-Jorge, Silvia, Rosso-Fernández, Clara, Montaner, Joan, González, Alejandro, Instituto de Salud Carlos III, Zapata‐Arriaza, Elena [0000-0002-1730-1999], Medina-Rodríguez, Manuel [0000-0002-2862-9586], Moniche, Francisco [0000-0001-8613-2909], Delgado, Fernando [0000-0003-2180-5273], Escudero-Martínez, Irene [0000-0003-1838-0235], Montaner, Joan [0000-0003-4845-2279], Zapata‐Arriaza, Elena, Medina-Rodríguez, Manuel, Moniche, Francisco, Albóniga-Chindurza, Asier de, Aguilar-Pérez, Marta, Ainz-Gómez, Leire, Baena-Palomino, Pablo, Zamora, Aynara, Pardo‐Galiana, Blanca, Delgado, Fernando, Valverde Moyano, Roberto, Jiménez-Gómez, Elvira, Bravo-Rey, Isabel, Oteros-Fernández, Rafael, Escudero-Martínez, Irene, Vielba-Gómez, Isabel, Morales-Caba, Lluis, Díaz-Pérez, José, García-Molina, Estefanía, Mosteiro, Sonia, Castellanos-Rodrigo, María del Mar, Pascasio, Laura Amaya, Hidalgo, Carlos, Freijo-Guerrero, Maria del Mar, González-Díaz, Eva, Ramírez-Moreno, José M., Fernández-Prudencio, Luis, Terceño Izaga, Mikel, Bashir Viturro, Saima, Gamero-García, Miguel Ángel, Jiménez-Jorge, Silvia, Rosso-Fernández, Clara, Montaner, Joan, and González, Alejandro

Published
2024

4. Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)

Author

Instituto de Salud Carlos III, European Commission, CSIC-JA-USE - Instituto de Biomedicina de Sevilla (IBIS), Zapata‐Arriaza, Elena [0000-0002-1730-1999], Medina-Rodríguez, Manuel [0000-0002-2862-9586], Moniche, Francisco [0000-0001-8613-2909], Delgado, Fernando [0000-0003-2180-5273], Escudero-Martínez, Irene [0000-0003-1838-0235], Montaner, Joan [0000-0003-4845-2279], Zapata‐Arriaza, Elena, Medina-Rodríguez, Manuel, Moniche, Francisco, Albóniga-Chindurza, Asier de, Aguilar-Pérez, Marta, Ainz-Gómez, Leire, Baena-Palomino, Pablo, Zamora, Aynara, Pardo‐Galiana, Blanca, Delgado, Fernando, Valverde Moyano, Roberto, Jiménez-Gómez, Elvira, Bravo-Rey, Isabel, Oteros-Fernández, Rafael, Escudero-Martínez, Irene, Vielba-Gómez, Isabel, Morales-Caba, Lluis, Díaz-Pérez, José, García-Molina, Estefanía, Mosteiro, Sonia, Castellanos-Rodrigo, María del Mar, Pascasio, Laura Amaya, Hidalgo, Carlos, Freijo-Guerrero, Maria del Mar, González-Díaz, Eva, Ramírez-Moreno, José M., Fernández-Prudencio, Luis, Terceño Izaga, Mikel, Bashir Viturro, Saima, Gamero-García, Miguel Ángel, Jiménez-Jorge, Silvia, Rosso-Fernández, Clara, Montaner, Joan, González, Alejandro, Instituto de Salud Carlos III, European Commission, CSIC-JA-USE - Instituto de Biomedicina de Sevilla (IBIS), Zapata‐Arriaza, Elena [0000-0002-1730-1999], Medina-Rodríguez, Manuel [0000-0002-2862-9586], Moniche, Francisco [0000-0001-8613-2909], Delgado, Fernando [0000-0003-2180-5273], Escudero-Martínez, Irene [0000-0003-1838-0235], Montaner, Joan [0000-0003-4845-2279], Zapata‐Arriaza, Elena, Medina-Rodríguez, Manuel, Moniche, Francisco, Albóniga-Chindurza, Asier de, Aguilar-Pérez, Marta, Ainz-Gómez, Leire, Baena-Palomino, Pablo, Zamora, Aynara, Pardo‐Galiana, Blanca, Delgado, Fernando, Valverde Moyano, Roberto, Jiménez-Gómez, Elvira, Bravo-Rey, Isabel, Oteros-Fernández, Rafael, Escudero-Martínez, Irene, Vielba-Gómez, Isabel, Morales-Caba, Lluis, Díaz-Pérez, José, García-Molina, Estefanía, Mosteiro, Sonia, Castellanos-Rodrigo, María del Mar, Pascasio, Laura Amaya, Hidalgo, Carlos, Freijo-Guerrero, Maria del Mar, González-Díaz, Eva, Ramírez-Moreno, José M., Fernández-Prudencio, Luis, Terceño Izaga, Mikel, Bashir Viturro, Saima, Gamero-García, Miguel Ángel, Jiménez-Jorge, Silvia, Rosso-Fernández, Clara, Montaner, Joan, and González, Alejandro

Abstract

[Rationale] In-stent reocclusion after endovascular therapy has a negative impact on outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Optimal antiplatelet therapy approach in these patients to avoid in-stent reocclusion is yet to be elucidated., [Aims] To assess efficacy and safety of intravenous tirofiban versus intravenous aspirin in patients undergoing MT plus carotid stenting in the setting of AIS due to TL., [Sample size estimates] Two hundred forty patients will be enrolled, 120 in every treatment arm., [Methods and design] A multicenter, prospective, randomized, controlled (aspirin group), assessor-blinded clinical trial will be conducted. Patients fulfilling the inclusion criteria will be randomized at MT onset to the experimental or control group (1:1). Intravenous aspirin will be administered at a 500-mg single dose and tirofiban at a 500-mcg bolus followed by a 200-mcg/h infusion during the first 24 h. All patients will be followed for up to 3 months., [Study outcomes] Primary efficacy outcome will be the proportion of patients with carotid in-stent thrombosis within the first 24 h after MT. Primary safety outcome will be the rate of symptomatic intracranial hemorrhage., [Discussion] This will be the first clinical trial to assess the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL., [Trial registration] The trial is registered as NCT05225961. February, 7th, 2022.

Published
2024

5. Safety and efficacy of intra-arterial bone marrow mononuclear cell transplantation in patients with acute ischaemic stroke in Spain (IBIS trial): a phase 2, randomised, open-label, standard-of-care controlled, multicentre trial

Author

Junta de Andalucía, Fundación Progreso y Salud, Instituto de Salud Carlos III, European Commission, Fundación Mutua Madrileña, Servicio Andaluz de Salud, Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla, Moniche, Francisco, Cabezas, Juan A., Valverde, Roberto, Escudero-Martínez, Irene, Lebrato, Lucía, Pardo‐Galiana, Blanca, Ainz-Gómez, Leire, Medina-Rodríguez, Manuel, Torre, Javier de la, Escamilla-Gómez, Virginia, Ortega-Quintanilla, Joaquín, Zapata‐Arriaza, Elena, Albóniga-Chindurza, Asier de, Mancha, Fernando, Gamero-García, Miguel Ángel, Pérez, Soledad, Espinosa-Rosso, Raúl, Forero-Diaz, Lucía, Moya, Miguel, Piñero, Pilar, Calderón-Cabrera, Cristina, Nogueras, Sonia, Jiménez, Rosario, Martin, Vanesa, Delgado, Fernando, Ochoa-Sepúlveda, Juan José, Quijano, Blanca, Mata, Rosario, Santos-González, Mónica, Carmona Sánchez, Gloria, Herrera, Concha, González-García, Alejandro, Montaner, Joan, Junta de Andalucía, Fundación Progreso y Salud, Instituto de Salud Carlos III, European Commission, Fundación Mutua Madrileña, Servicio Andaluz de Salud, Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla, Moniche, Francisco, Cabezas, Juan A., Valverde, Roberto, Escudero-Martínez, Irene, Lebrato, Lucía, Pardo‐Galiana, Blanca, Ainz-Gómez, Leire, Medina-Rodríguez, Manuel, Torre, Javier de la, Escamilla-Gómez, Virginia, Ortega-Quintanilla, Joaquín, Zapata‐Arriaza, Elena, Albóniga-Chindurza, Asier de, Mancha, Fernando, Gamero-García, Miguel Ángel, Pérez, Soledad, Espinosa-Rosso, Raúl, Forero-Diaz, Lucía, Moya, Miguel, Piñero, Pilar, Calderón-Cabrera, Cristina, Nogueras, Sonia, Jiménez, Rosario, Martin, Vanesa, Delgado, Fernando, Ochoa-Sepúlveda, Juan José, Quijano, Blanca, Mata, Rosario, Santos-González, Mónica, Carmona Sánchez, Gloria, Herrera, Concha, González-García, Alejandro, and Montaner, Joan

Abstract

[Background] Pilot clinical trials have shown the safety of intra-arterial bone marrow mononuclear cells (BMMNCs) in stroke. However, the efficacy of different doses of intra-arterial BMMNCs in patients with acute stroke has not been tested in a randomised clinical trial. We aimed to show safety and efficacy of two different doses of autologous intra-arterial BMMNC transplantation in patients with acute stroke., [Methods] The IBIS trial was a multicentre phase 2, randomised, controlled, investigator-initiated, assessor-blinded, clinical trial, in four stroke centres in Spain. We included patients (aged 18–80 years) with a non-lacunar, middle cerebral artery ischaemic stroke within 1–7 days from stroke onset and with a National Institutes of Health Stroke Scale score of 6–20. We randomly assigned patients (2:1:1) with a computer-generated randomisation sequence to standard of care (control group) or intra-arterial injection of autologous BMMNCs at one of two different doses (2 × 106 BMMNCs/kg or 5 × 106 BMMNCs/kg). The primary efficacy outcome was the proportion of patients with modified Rankin Scale scores of 0–2 at 180 days in the intention-to-treat population, comparing each BMMNC dose group and the pooled BMMNC group versus the control group. The primary safety endpoint was the proportion of serious adverse events. This trial was registered at ClinicalTrials.gov, NCT02178657 and is completed., [Findings] Between April 1, 2015, and May 20, 2021, we assessed 114 patients for eligibility. We randomly assigned 77 (68%) patients: 38 (49%) to the control group, 20 (26%) to the low-dose BMMNC group, and 19 (25%) the high-dose BMMNC group. The mean age of participants was 62·4 years (SD 12·7), 46 (60%) were men, 31 (40%) were women, all were White, and 63 (82%) received thrombectomy. The median NIHSS score before randomisation was 12 (IQR 9–15), with intra-arterial BMMNC injection done a median of 6 days (4–7) after stroke onset. The primary efficacy outcome occurred in 14 (39%) patients in the control group versus ten (50%) in the low-dose group (adjusted odds ratio 2·08 [95% CI 0·55–7·85]; p=0·28), eight (44%) in the high-dose group (1·89 [0·52–6·96]; p=0·33), and 18 (47%) in the pooled BMMNC group (2·22 [0·72–6·85]; p=0·16). We found no differences in the proportion of patients who had adverse events or dose-related events, but two patients had a groin haematoma after cell injection in the low-dose BMMNC group., [Interpretation] Intra-arterial BMMNCs were safe in patients with acute ischaemic stroke, but we found no significant improvement at 180 days on the mRS. Further clinical trials are warranted to investigate whether improvements might be possible at different timepoints.

Published
2023

6. Relevance of Carotid Reocclusion in Tandem Lesions

Author

Instituto de Salud Carlos III, European Commission, CSIC-JA-USE - Instituto de Biomedicina de Sevilla (IBIS), Zapata‐Arriaza, Elena, Medina-Rodríguez, Manuel, Ortega-Quintanilla, Joaquín, Albóniga-Chindurza, Asier de, Ainz-Gómez, Leire, Pardo‐Galiana, Blanca, Cabezas, Juan A., Lebrato, Lucía, Barragán-Prieto, Ana, Pérez-Sánchez, Soledad, Zamora, Aynara, Montaner, Joan, González-García, Alejandro, Moniche, Francisco, Instituto de Salud Carlos III, European Commission, CSIC-JA-USE - Instituto de Biomedicina de Sevilla (IBIS), Zapata‐Arriaza, Elena, Medina-Rodríguez, Manuel, Ortega-Quintanilla, Joaquín, Albóniga-Chindurza, Asier de, Ainz-Gómez, Leire, Pardo‐Galiana, Blanca, Cabezas, Juan A., Lebrato, Lucía, Barragán-Prieto, Ana, Pérez-Sánchez, Soledad, Zamora, Aynara, Montaner, Joan, González-García, Alejandro, and Moniche, Francisco

Abstract

Aims: Carotid reocclusion (CRO) after mechanical thrombectomy (MT) in acute ischemic stroke (AIS) due to tandem lesion (TL) or isolated internal carotid occlusion (ICO) is associated with worse clinical outcomes. Our aim was to analyze the predictors and clinical impact of CRO. Methods: A retrospective single-center analysis of all patients with anterior circulation strokes who underwent MT prospectively included in a registry between 2017 and 2020 was performed. ICO and TL as stroke causes were included. Stent deployment was left to the discretion of the interventionist. All patients received at least intravenous aspirin during MT. CRO was assessed using ultrasound within the first 24 h after MT. Efficacy and safety of stenting were assessed. Results: Among 1304 AIS cases, 218 (16.7%) were related to TL or ICO. Of them, 5% (n=11) were associated with internal CRO 24 h after the endovascular procedure. After adjusting per confounders, multivariate analysis showed that the independent variables associated with CRO were the TICI recanalization grade [TICI 2b–3; OR 0.1, 95% confidence interval (CI) 0.01–0.89, p=0.040], pial collateral circulation presence (OR 0.09, 95% CI 0.02–0.45, p=0.03), stent deployment during MT (OR 0.17, 95% CI 0.03–0.84, p=0.030), and general anesthesia use (OR 2.92, 95% CI 1.13–7.90, p=0.034). CRO showed a trend toward worst outcomes (modified Rankin scale 3–6) at 3 months (OR 3.4, 95% CI 0.96–12, p=0.057). After multivariate analysis, variables independently associated with worse outcomes at 90 days were intrastent platelet aggregation phenomena during endovascular therapy, admission National Institute of Health Stroke Scale, and age. Conversely, intravenous thrombolysis and TICI 2b–3 recanalization grade were identified as independent predictors of good outcomes at 90 days. Conclusions: CRO has a relevant clinical impact in our study, associating lower rates of good functional outcomes at 3 months. Independent factors of CRO were the recanal

Published
2023

7. Antithrombotic Treatment after Carotid Stenting in Patients with Concomitant Atrial Fibrillation

Author

Instituto de Salud Carlos III, European Commission, Pardo‐Galiana, Blanca, Medina-Rodríguez, Manuel, Millan-Vazquez, M., Cabezas, Juan A., Lebrato, Lucía, Aínz-Gómez, L., Zapata‐Arriaza, Elena, Ortega, Joaquín, Albóniga-Chindurza, Asier de, Montaner, Joan, González, Alejandro, Moniche, Francisco, Instituto de Salud Carlos III, European Commission, Pardo‐Galiana, Blanca, Medina-Rodríguez, Manuel, Millan-Vazquez, M., Cabezas, Juan A., Lebrato, Lucía, Aínz-Gómez, L., Zapata‐Arriaza, Elena, Ortega, Joaquín, Albóniga-Chindurza, Asier de, Montaner, Joan, González, Alejandro, and Moniche, Francisco

Abstract

[Background and purpose] Antithrombotic therapy following carotid artery stent placement with concomitant atrial fibrillation is not well-established. Our aim was to assess the safety and efficacy of the combination of direct oral anticoagulants and a P2Y12 inhibitor at 30 days after carotid artery stent placement in patients with atrial fibrillation., [Materials and methods] We designed an observational single-center study including patients who underwent carotid artery stent placement with concomitant atrial fibrillation. We studied 3 groups according to antithrombotic therapy: 1) the direct oral anticoagulants plus clopidogrel (DC) group: receiving direct oral anticoagulants plus a P2Y12 inhibitor; 2) the triple therapy group: anticoagulation and dual antiplatelet therapy; and 3) the dual antiplatelet therapy group: following dual antiplatelet therapy alone. The safety outcome was a major or clinically relevant non-major bleeding event at the first month. The efficacy outcomes were the thromboembolic events (myocardial infarction, stroke, systemic embolism, or stent thrombosis)., [Results] Of 959 patients with carotid artery stent placement, 91 met the inclusion criteria, including 24 patients in the DC group, 42 patients in the triple therapy group, and 25 in the dual antiplatelet therapy group. The mean age was 72.27 (SD, 8.1 ) years, with similar baseline characteristics. The median CHA2DS2-VASc score for each group was 6 (interquartile range = 5–6), 5 (interquartile range = 4–6), and 5 (interquartile range = 4–6), respectively. The median HAS-BLED score was 4 in the 3 groups (P = .17). The primary safety end point was 23.8% in the triple therapy group compared with 4% in the dual antiplatelet therapy group (P = .032), with no bleeding events in the DC group (P = .007). There was 1 stent thrombosis in DC group and a cardioembolic stroke in the dual antiplatelet therapy group (P = .41)., [Conclusions] Among patients with carotid artery stent placement with atrial fibrillation, triple therapy confers a high bleeding risk. A regimen of direct oral anticoagulants plus a P2Y12 inhibitor might confer a good safety profile with significantly lower rates of bleeding and optimal efficacy.

Published
2022

8. Intravenous Thrombolysis Guided by Perfusion CT with Alteplase in >4.5 Hours from Stroke Onset

Author

Medina-Rodríguez, Manuel, Millan-Vazquez, M., Zapata‐Arriaza, Elena, Escudero-Martínez, Irene, Pardo‐Galiana, Blanca, Cabezas-Rodriguez, J. A., Lebrato, Lucía, Ortega-Quintanilla, Joaquín, Albóniga-Chindurza, Asier de, Ocete, Rafael F., Jurado Serrano, J., González-García, A., Cayuela, Aurelio, and Moniche, Francisco

Abstract

[Introduction]: The benefit of intravenous thrombolysis (IVT) in wake-up stroke (WUS), stroke of unknown time of onset (SUKO), or when time exceeds 4.5 h from last-seen-normal (LSN) guided by CT perfusion (CTP) or MRI has been recently suggested. However, there is limited information of IVT in those patients in real-world studies. Objective: Our aim was to evaluate safety and efficacy of IVT selected by CTP in patients with WUS, SUKO, or stroke of time onset beyond 4.5 h. [Material and Methods]: We studied a prospective cohort of patients who underwent IVT from January 2010 to December 2017. Two groups were defined: standard of care group (SC) included patients with time onset 4.5 h from LSN with penumbra area in CTP. We evaluated baseline characteristics, functional outcomes according to modified Rankin Scale (mRS) at discharge and at 90 days, and intracranial hemorrhages rates. [Results]: 657 patients were studied: 604 (92%) were treated in the SC group and 53 (8%) in the CTP group. The mean NIHSS score was 9.8 in the CTP group versus 13 in the SC group (p = 0.001). Seventeen patients in the CTP group (32.1%) received bridging therapy with mechanical thrombectomy (MT). Last time seen well-to-needle time was 538 versus 155 min (p < 0.001). The incidence of symptomatic intracranial hemorrhage was equal in both groups (3.8 vs. 3.8%, p = 1). Good functional outcome (mRS < 2) was achieved in both groups (72 vs. 60.4%, p = 0.107). [Conclusions]: IVT in patients with WUS, SUKO, or stroke beyond >4.5 h from LSN, with salvageable brain tissue on CTP, seems to be safe and has similar functional outcomes at 90 days to the standard therapeutic window, even when combined with MT.

Published
2020

9. Sex Differences by Hospital-Level in Performance and Outcomes of Endovascular Treatment for Acute Ischemic Stroke

Author

Pérez-Sánchez, Soledad, Barragán-Prieto, Ana, Ortega-Quintanilla, Joaquín, Domínguez-Mayoral, Ana, Gamero-García, Miguel Ángel, Zapata‐Arriaza, Elena, Torres-Chacón, Reyes de, Albóniga-Chindurza, Asier de, Zapata, Montserrat, Moniche, Francisco, Escudero-Martínez, Irene, Baena, Pablo, Cabezas, Juan A., Oropesa-Ruiz, Juan Manuel, Sanz-Fernández, Gema, González, Alejandro, Montaner, Joan, Pérez-Sánchez, Soledad, Barragán-Prieto, Ana, Ortega-Quintanilla, Joaquín, Domínguez-Mayoral, Ana, Gamero-García, Miguel Ángel, Zapata‐Arriaza, Elena, Torres-Chacón, Reyes de, Albóniga-Chindurza, Asier de, Zapata, Montserrat, Moniche, Francisco, Escudero-Martínez, Irene, Baena, Pablo, Cabezas, Juan A., Oropesa-Ruiz, Juan Manuel, Sanz-Fernández, Gema, González, Alejandro, and Montaner, Joan

Published
2020

10. The Value of Transcranial Doppler Sonography in Hyperperfusion Syndrome after Carotid Artery Stenting: A Nationwide Prospective Study

Author

Instituto de Salud Carlos III, Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares (España), Abbott Laboratories, Grifols, Moniche, Francisco, Escudero-Martínez, Irene, Mancha, Fernando, Tomasello, Alejandro, Ribó, Marc, Delgado-Acosta, Fernando, Ochoa, Juan José, Gil, Joaquín, Gil, Rosario, González-Delgado, Montserrat, Murias, Eduardo, Lunak, Alain, Gil, Alberto, Mosteiro, Sonia, Fernández-Couto, María Dolores, Fernández de Alarcón, Luis, Ramírez-Moreno, José M., Zamarro, Joaquín, Parrilla, Guillermo, Caniego, José Luis, Zapata-Wainberg, Gustavo, González-Mandly, Andrés, Heras, José A. de las, López-Mesonero, L., Ortega, Joaquín, Arenillas, Juan F., García, Ernesto, Alcázar, Pedro P., Zapata‐Arriaza, Elena, Albóniga-Chindurza, Asier de, Cabezas, Juan A., Algaba, Pilar, Cayuela, Aurelio, Montaner, Joan, González-García, Alejandro, Instituto de Salud Carlos III, Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares (España), Abbott Laboratories, Grifols, Moniche, Francisco, Escudero-Martínez, Irene, Mancha, Fernando, Tomasello, Alejandro, Ribó, Marc, Delgado-Acosta, Fernando, Ochoa, Juan José, Gil, Joaquín, Gil, Rosario, González-Delgado, Montserrat, Murias, Eduardo, Lunak, Alain, Gil, Alberto, Mosteiro, Sonia, Fernández-Couto, María Dolores, Fernández de Alarcón, Luis, Ramírez-Moreno, José M., Zamarro, Joaquín, Parrilla, Guillermo, Caniego, José Luis, Zapata-Wainberg, Gustavo, González-Mandly, Andrés, Heras, José A. de las, López-Mesonero, L., Ortega, Joaquín, Arenillas, Juan F., García, Ernesto, Alcázar, Pedro P., Zapata‐Arriaza, Elena, Albóniga-Chindurza, Asier de, Cabezas, Juan A., Algaba, Pilar, Cayuela, Aurelio, Montaner, Joan, and González-García, Alejandro

Published
2020

11. Clinical Outcomes of Mechanical Thrombectomy in Stroke Tandem Lesions According to Intracranial Occlusion Location

Author

Zapata-Arriaza, Elena, primary, Albóniga-Chindurza, Asier de, additional, Ortega-Quintanilla, Joaquin, additional, Escudero-Martínez, Irene, additional, Moniche, Francisco, additional, Medina-Rodríguez, Manuel, additional, Pardo-Galiana, Blanca, additional, Rodríguez, Juan Antonio Cabezas, additional, Hernández, Lucía Lebrato, additional, Ainz, Leire, additional, Pérez-Sánchez, Soledad, additional, Domínguez-Mayoral, Ana, additional, Barragán, Ana, additional, Cayuela, Aurelio, additional, Montaner, Joan, additional, and García, Alejandro González, additional

Published
2021
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12. Sex Differences by Hospital-Level in Performance and Outcomes of Endovascular Treatment for Acute Ischemic Stroke

Author

Pérez-Sánchez, Soledad, primary, Barragán-Prieto, Ana, additional, Ortega-Quintanilla, Joaquín, additional, Domínguez-Mayoral, Ana, additional, Gamero-García, Miguel Ángel, additional, Zapata-Arriaza, Elena, additional, Torres-Chacón, Reyes de, additional, Albóniga-Chindurza, Asier de, additional, Zapata-Hidalgo, Montserrat, additional, Moniche, Francisco, additional, Escudero-Martínez, Irene, additional, Baena, Pablo, additional, Cabezas, Juan Antonio, additional, Oropesa-Ruiz, Juan Miguel, additional, Sanz-Fernández, Gema, additional, González, Alejandro, additional, and Montaner, Joan, additional

Published
2020
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13. The Value of Transcranial Doppler Sonography in Hyperperfusion Syndrome after Carotid Artery Stenting: A Nationwide Prospective Study

Author

Moniche, Francisco, primary, Escudero-Martínez, Irene, additional, Mancha, Fernando, additional, Tomasello, Alejandro, additional, Ribó, Marc, additional, Delgado-Acosta, Fernando, additional, Ochoa, Juán José, additional, Gil, Joaquín, additional, Gil, Rosario, additional, González-Delgado, Montserrat, additional, Murias, Eduardo, additional, Luna, Alain, additional, Gil, Alberto, additional, Mosteiro, Sonia, additional, Fernández-Couto, María Dolores, additional, Alarcón, Luis Fernández de, additional, Ramírez-Moreno, José M., additional, Zamarro, Joaquín, additional, Parrilla, Guillermo, additional, Caniego, José L., additional, Zapata-Wainberg, Gustavo, additional, González-Mandly, Andrés, additional, Heras, José A. de las, additional, López-Mesonero, Luis, additional, Ortega, Joaquín, additional, Arenillas, Juan F., additional, García, Ernesto, additional, Alcázar, Pedro P., additional, Zapata-Arriaza, Elena, additional, Albóniga-Chindurza, Asier de, additional, Cabezas, Juan Antonio, additional, Algaba, Pilar, additional, Cayuela, Aurelio, additional, Montaner, Joan, additional, and García, Alejandro González, additional

Published
2020
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14. Clinical Predictors of Hyperperfusion Syndrome Following Carotid Stenting: Results From a National Prospective Multicenter Study

Author

González-García, Alejandro, Moniche, Francisco, Escudero-Martínez, Irene, Mancha, Fernando, Tomasello, Alejandro, Ribó, Marc, Delgado-Acosta, Fernando, Ochoa, Juan José, Heras, José A. de las, López-Mesonero, L., González-Delgado, Montserrat, Murias, Eduardo, Gil, Joaquín, Gil, Rosario, Zamarro, Joaquín, Parrilla, Guillermo, Mosteiro, Sonia, Fernández-Couto, María Dolores, Fernández de Alarcón, Luis, Ramírez-Moreno, José M., Luna, Alain, Gil, Alberto, González-Mandly, Andrés, Caniego, José Luis, Zapata-Wainberg, Gustavo, García, Ernesto, Alcázar, Pedro P., Ortega, Joaquín, Arenillas, Juan F., Algaba, Pilar, Zapata‐Arriaza, Elena, Alcalde-López, Jesús, Albóniga-Chindurza, Asier de, Instituto de Salud Carlos III, Abbott Fund, Grifols, and Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares (España)

Subjects
integumentary system, Hyperperfusion, hemic and lymphatic diseases, Stent, cardiovascular diseases, equipment and supplies, skin and connective tissue diseases, Carotid
Abstract

[Objectives] The aim of the HISPANIAS (HyperperfusIon Syndrome Post-carotid ANgIoplasty And Stenting) study was to define CHS rates and develop a clinical predictive model for cerebral hyperperfusion syndrome (CHS) after carotid artery stenting (CAS)., [Background] CHS is a severe complication following CAS. The presence of clinical manifestations is estimated on the basis of retrospective reviews and is still uncertain., [Methods] The HISPANIAS study was a national prospective multicenter study with 14 recruiting hospitals. CHS was classified as mild (headache only) and moderate-severe (seizure, impaired level of consciousness, or development of focal neurological signs)., [Results] A total of 757 CAS procedures were performed. CHS occurred in 22 (2.9%) patients, in which 16 (2.1%) had moderate-severe CHS and 6 (0.8%) had mild CHS (only headache). The rate of hemorrhages was 0.7% and was associated with high mortality (20%). Pre-operative predictors of moderate-severe CHS in multivariate analysis were female sex (odds ratio [OR]: 3.24; 95% confidence interval [CI]: 1.11 to 9.47; p = 0.03), older patients (OR: 1.09; 95% CI: 1.01 to 1.17; p = 0.02), left carotid artery treated (OR: 4.13; 95% CI: 1.11 to 15.40; p = 0.03), and chronic renal failure (OR: 6.29; 95% CI: 1.75 to 22.57; p = 0.005). The area under the curve of this clinical and radiological model was 0.86 (95% CI: 0.81 to 0.92; p = 0.001)., [Conclusions] The rate of CHS in the HISPANIAS study was 2.9%, with moderate-severe CHS of 2.1%. CHS was independently associated with female sex, older age, history of chronic kidney disease, and a treated left carotid artery. Although further investigations are needed, the authors propose a model to identify high-risk patients and develop strategies to decrease CHS morbidity and mortality in the future., This study was supported by a Spanish grant from the Instituto de Salud Carlos III (ISCIII-FIS IP14/00971, 2014–2017). The ITRIBIS project has the registration number REGPOT-2013-1. Cooperative Cerebrovascular Disease Research Network (INVICTUS+) (RD16/0019/0015). Dr. Mancha is supported by a Río Hortega contract (CM16/00015). Abbott and Grifols have partial financial supported the conduction of the HISPANIAS project but had no role in the design of the study, interpretation of the data, or manuscript approval.

Published
2019

15. Clinical Predictors of Hyperperfusion Syndrome Following Carotid Stenting: Results From a National Prospective Multicenter Study

Author

Instituto de Salud Carlos III, Abbott Fund, Grifols, Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares (España), González-García, Alejandro, Moniche, Francisco, Escudero-Martínez, Irene, Mancha, Fernando, Tomasello, Alejandro, Ribó, Marc, Delgado-Acosta, Fernando, Ochoa, Juan José, Heras, José A. de las, López-Mesonero, L., González-Delgado, Montserrat, Murias, Eduardo, Gil, Joaquín, Gil, Rosario, Zamarro, Joaquín, Parrilla, Guillermo, Mosteiro, Sonia, Fernández-Couto, María Dolores, Fernández de Alarcón, Luis, Ramírez-Moreno, José M., Luna, Alain, Gil, Alberto, González-Mandly, Andrés, Caniego, José Luis, Zapata-Wainberg, Gustavo, García, Ernesto, Alcázar, Pedro P., Ortega, Joaquín, Arenillas, Juan F., Algaba, Pilar, Zapata‐Arriaza, Elena, Alcalde-López, Jesús, Albóniga-Chindurza, Asier de, Instituto de Salud Carlos III, Abbott Fund, Grifols, Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares (España), González-García, Alejandro, Moniche, Francisco, Escudero-Martínez, Irene, Mancha, Fernando, Tomasello, Alejandro, Ribó, Marc, Delgado-Acosta, Fernando, Ochoa, Juan José, Heras, José A. de las, López-Mesonero, L., González-Delgado, Montserrat, Murias, Eduardo, Gil, Joaquín, Gil, Rosario, Zamarro, Joaquín, Parrilla, Guillermo, Mosteiro, Sonia, Fernández-Couto, María Dolores, Fernández de Alarcón, Luis, Ramírez-Moreno, José M., Luna, Alain, Gil, Alberto, González-Mandly, Andrés, Caniego, José Luis, Zapata-Wainberg, Gustavo, García, Ernesto, Alcázar, Pedro P., Ortega, Joaquín, Arenillas, Juan F., Algaba, Pilar, Zapata‐Arriaza, Elena, Alcalde-López, Jesús, and Albóniga-Chindurza, Asier de

Abstract

[Objectives] The aim of the HISPANIAS (HyperperfusIon Syndrome Post-carotid ANgIoplasty And Stenting) study was to define CHS rates and develop a clinical predictive model for cerebral hyperperfusion syndrome (CHS) after carotid artery stenting (CAS)., [Background] CHS is a severe complication following CAS. The presence of clinical manifestations is estimated on the basis of retrospective reviews and is still uncertain., [Methods] The HISPANIAS study was a national prospective multicenter study with 14 recruiting hospitals. CHS was classified as mild (headache only) and moderate-severe (seizure, impaired level of consciousness, or development of focal neurological signs)., [Results] A total of 757 CAS procedures were performed. CHS occurred in 22 (2.9%) patients, in which 16 (2.1%) had moderate-severe CHS and 6 (0.8%) had mild CHS (only headache). The rate of hemorrhages was 0.7% and was associated with high mortality (20%). Pre-operative predictors of moderate-severe CHS in multivariate analysis were female sex (odds ratio [OR]: 3.24; 95% confidence interval [CI]: 1.11 to 9.47; p = 0.03), older patients (OR: 1.09; 95% CI: 1.01 to 1.17; p = 0.02), left carotid artery treated (OR: 4.13; 95% CI: 1.11 to 15.40; p = 0.03), and chronic renal failure (OR: 6.29; 95% CI: 1.75 to 22.57; p = 0.005). The area under the curve of this clinical and radiological model was 0.86 (95% CI: 0.81 to 0.92; p = 0.001)., [Conclusions] The rate of CHS in the HISPANIAS study was 2.9%, with moderate-severe CHS of 2.1%. CHS was independently associated with female sex, older age, history of chronic kidney disease, and a treated left carotid artery. Although further investigations are needed, the authors propose a model to identify high-risk patients and develop strategies to decrease CHS morbidity and mortality in the future.

Published
2019

16. Dose adjustment of clopidogrel in hyper-responder patients with unruptured intracranial aneurysms treated with stents

Author

González, Alejandro, Ortega-Quintanilla, Joaquín, Zapata‐Arriaza, Elena, Albóniga-Chindurza, Asier de, García-Lozano, José Raúl, Luque Vega, María Isabel, Cayuela, Aurelio, González, Alejandro, Ortega-Quintanilla, Joaquín, Zapata‐Arriaza, Elena, Albóniga-Chindurza, Asier de, García-Lozano, José Raúl, Luque Vega, María Isabel, and Cayuela, Aurelio

Abstract

[Background] The management of clopidogrel in hyper-responders has not been well described. We report the treatment and dose adjustment individualization with clopidogrel oral solution (COS) in hyper-responder patients with an unruptured intracranial aneurysm treated with a stent., [Methods] A prospective study (2015–2018) in patients receiving clopidogrel prior to endovascular treatment was performed. Platelet reactivity after clopidogrel therapy was evaluated with the VerifyNow PRU test. Initial values ≤80 PRU (P2Y12 reactivity units) were classified as a hyper-response according to prior evidence. Patients were treated with clopidogrel for 7–10 days before stent treatment. Seven days post-procedure the dose of COS was gradually reduced (30 mg–20 mg–10 mg–5 mg) every 5 days to 5 mg (1 mL)/day., [Results] Twenty patients with 24 aneurysms were classified as having a hyper-response to clopidogrel. Mean age was 55.2 years (range 42–64) and 80% were women. Mean baseline PRU value and the percentage of platelet inhibition were 16.4±11.5 PRU and 92.05±7.5%, respectively. The mean time used to decrease the dose of clopidogrel to 5 mg/day was 27±4.3 days. Modified dosing strategies were shown to increase the final PRU values and to decrease the percentage of platelet inhibition (137.42±27.4 and 41.5±14.8%, respectively). Two of the 20 patients with dose adjustment of oral solution of clopidogrel (5 mg/day) in our cohort exhibited a delayed conversion to hypo-response. No patients suffered thromboembolic events related to the dose adjustment of clopidogrel with 5 mg/day during the follow-up., [Conclusion] Reduction of the daily maintenance dose of clopidogrel in hyper-responder patients could provide a similar antiplatelet effect to the standard dose of clopidogrel, allowing a PRU value in the optimal range.

Published
2019

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