Combination of Thrombolysis and Statins in Acute Stroke Is Safe Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin)
Por:
Montaner, J, Bustamante, A, Garcia-Matas, S, Martinez-Zabaleta, M, Jimenez, C, de la Torre, J, Rubio, FR, Segura, T, Masjuan, J, Canovas, D, Freijo, M, Delgado-Mederos, R, Tejada, J, Lago, A, Bravo, Y, Corbeto, N, Giralt, D, Vives-Pastor, B, de Arce, A, Moniche, F, Delgado, P, Ribo, M
Publicada:
1 nov 2016
Resumen:
Background and Purpose-The STARS trial (Stroke Treatment With Acute Reperfusion and Simvastatin) was conducted to demonstrate the efficacy and safety of simvastatin treatment in acute stroke.
Methods-STARS07 was a multicentre, phase IV, prospective, randomized, double-blind, placebo-controlled trial. Patients with Acute ischemic stroke recruited within 12 hours from symptom onset were randomized to oral simvastatin 40 mg or placebo, once daily for 90 days. Primary outcome was proportion of independent patients (modified Rankin Scale score of 2) at 90 days. Safety end points were hemorrhagic transformation, hemorrhagic events, death, infections, and serious adverse events.
Results-From April 2009 to March 2014, 104 patients were included. Fifty-five patients received intravenous tissue-type plasminogen activator. No differences were found between treatment arms regarding the primary outcome (adjusted odds ratio, 0.99 [0.35-2.78]; P=0.98). Concerning safety, no significant differences were found in the rate of hemorrhagic transformation of any type, nor symptomatic hemorrhagic transformation. There were no differences in other predefined safety outcomes. In post hoc analyses, for patients receiving tissue-type plasminogen activator, a favorable effect for simvastatin treatment was noted with higher proportion of patients experiencing major neurological recovery (adjusted odds ratio, 4.14 [1.18-14.4]; P=0.02).
Conclusions-Simvastatin plus tissue-type plasminogen activator combination seems safe in acute stroke, with low rates of bleeding complications. Because of the low recruitment, the STARS trial was underpowered to detect differences in simvastatin efficacy.
Filiaciones:
Montaner, J:
Univ Autonoma Barcelona, Inst Recerca, Dept Neurol, Stroke Unit, Barcelona, Spain
Univ Autonoma Barcelona, Inst Recerca, Neurovasc Res Lab, Barcelona, Spain
Bustamante, A:
Univ Autonoma Barcelona, Inst Recerca, Neurovasc Res Lab, Barcelona, Spain
Garcia-Matas, S:
Hosp Univ Vall Hebron, Vall Hebron Inst Oncol, Barcelona, Spain
Martinez-Zabaleta, M:
Hosp Univ Donostia, Dept Neurol, Neurovasc Unit, Donostia San Sebastian, Spain
Jimenez, C:
Hosp Univ Son Espases, Dept Neurol, Palma De Mallorca, Spain
de la Torre, J:
Hosp Univ Virgen Rocio, Inst Biomed Seville, Stroke Program, Seville, Spain
Rubio, FR:
Hosp Univ Bellvitge, IDIBELL, Dept Neurol, Barcelona, Spain
Segura, T:
Hosp Univ Virgen Victoria, Dept Neurol, Albacete, Spain
Masjuan, J:
Univ Hosp Ramon & Cajal, Dept Neurol, Stroke Unit, IRYCIS, Madrid, Spain
Canovas, D:
Hosp Univ Parc Tauli, Dept Neurol, Sabadell, Spain
Freijo, M:
Hosp Basurto, Dept Neurol, Bilbao, Spain
Delgado-Mederos, R:
Hosp Santa Creu & Sant Pau, IIB St Pau, Dept Neurol, Barcelona, Spain
Tejada, J:
Hosp Univ Leon, Dept Neurol, Leon, Spain
Lago, A:
Hosp Univ La Fe, Dept Neurol, Stroke Unit, Valencia, Spain
Bravo, Y:
Hosp Univ Gen Yague, Dept Neurol, Burgos, Spain
Corbeto, N:
Univ Autonoma Barcelona, Inst Recerca, Neurovasc Res Lab, Barcelona, Spain
Giralt, D:
Univ Autonoma Barcelona, Inst Recerca, Neurovasc Res Lab, Barcelona, Spain
Vives-Pastor, B:
Hosp Univ Son Espases, Dept Neurol, Palma De Mallorca, Spain
de Arce, A:
Hosp Univ Donostia, Dept Neurol, Neurovasc Unit, Donostia San Sebastian, Spain
Moniche, F:
Hosp Univ Virgen Rocio, Inst Biomed Seville, Stroke Program, Seville, Spain
Delgado, P:
Univ Autonoma Barcelona, Inst Recerca, Neurovasc Res Lab, Barcelona, Spain
Ribo, M:
Univ Autonoma Barcelona, Inst Recerca, Dept Neurol, Stroke Unit, Barcelona, Spain
Open Access
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