Divergence Between Clinical Trial Evidence and Actual Practice in Use of Dual Antiplatelet Therapy After Transient Ischemic Attack and Minor Stroke.

Autor: De Matteis E; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy (E.D.M., F.D.S., R.O., M.F., F.P., S.S.)., De Santis F; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy (E.D.M., F.D.S., R.O., M.F., F.P., S.S.)., Ornello R; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy (E.D.M., F.D.S., R.O., M.F., F.P., S.S.)., Censori B; Department of Neurology, ASST Cremona Hospital, Italy (B.C., V.P., L.V., A.G.)., Puglisi V; Department of Neurology, ASST Cremona Hospital, Italy (B.C., V.P., L.V., A.G.)., Vinciguerra L; Department of Neurology, ASST Cremona Hospital, Italy (B.C., V.P., L.V., A.G.)., Giossi A; Department of Neurology, ASST Cremona Hospital, Italy (B.C., V.P., L.V., A.G.)., Di Viesti P; Department of Neurology, Casa sollievo della sofferenza, San Giovanni Rotondo, Italy (P.D.V., V.I., G.M.F.)., Inchingolo V; Department of Neurology, Casa sollievo della sofferenza, San Giovanni Rotondo, Italy (P.D.V., V.I., G.M.F.)., Fratta GM; Department of Neurology, Casa sollievo della sofferenza, San Giovanni Rotondo, Italy (P.D.V., V.I., G.M.F.)., Diomedi M; Department of Systems Medicine, Tor Vergata University Hospital, Rome, Italy (M.D., M.R.B.)., Bagnato MR; Department of Systems Medicine, Tor Vergata University Hospital, Rome, Italy (M.D., M.R.B.)., Cenciarelli S; Department of Neurology, Città di Castello Hospital, Italy (S.C., C.B., C. Padiglioni, S.R.)., Bedetti C; Department of Neurology, ASST Cremona Hospital, Italy (B.C., V.P., L.V., A.G.).; Department of Neurology, Città di Castello Hospital, Italy (S.C., C.B., C. Padiglioni, S.R.)., Padiglioni C; Department of Neurology, Città di Castello Hospital, Italy (S.C., C.B., C. Padiglioni, S.R.)., Tassinari T; Department of Neurology, Santa Corona Hospital, Pietra Ligure, Italy (T.T., V.S., A.R.)., Saia V; Department of Neurology, Santa Corona Hospital, Pietra Ligure, Italy (T.T., V.S., A.R.)., Russo A; Department of Neurology, Santa Corona Hospital, Pietra Ligure, Italy (T.T., V.S., A.R.)., Petruzzellis M; Department of Neurology and Stroke Unit 'F. Puca,' AOU Consorziale Policlinico, Bari, Italy (M. Petruzzellis, D.M.M., M.C.)., Mezzapesa DM; Department of Neurology and Stroke Unit 'F. Puca,' AOU Consorziale Policlinico, Bari, Italy (M. Petruzzellis, D.M.M., M.C.)., Caccamo M; Department of Neurology and Stroke Unit 'F. Puca,' AOU Consorziale Policlinico, Bari, Italy (M. Petruzzellis, D.M.M., M.C.)., Rinaldi G; Department of Neurology, Di Venere Hospital, Bari, Italy (G. Rinaldi, A.B.)., Bavaro A; Department of Neurology, Di Venere Hospital, Bari, Italy (G. Rinaldi, A.B.)., Paciaroni M; Stroke Unit, University Hospital Santa Maria della Misericordia, Perugia, Italy (M. Paciaroni, M.G.M.)., Mosconi MG; Stroke Unit, University Hospital Santa Maria della Misericordia, Perugia, Italy (M. Paciaroni, M.G.M.)., Foschi M; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy (E.D.M., F.D.S., R.O., M.F., F.P., S.S.).; Department of Neuroscience, S. Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy (M.F., P.Q.)., Querzani P; Department of Neuroscience, S. Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy (M.F., P.Q.)., Muscia F; Department of Neurology, ASST Ovest Milanese, Legnano, Italy (F.M., S.G.C.)., Gallo Cassarino S; Department of Neurology, ASST Ovest Milanese, Legnano, Italy (F.M., S.G.C.)., Candelaresi P; Department of Neurology and Stroke Unit, AORN Antonio Cardarelli, Naples, Italy (P.C., A.D.M.)., De Mase A; Department of Neurology and Stroke Unit, AORN Antonio Cardarelli, Naples, Italy (P.C., A.D.M.)., Guarino M; IRCCS Istituto delle Scienze Neurologiche di Bologna, Department of Neurology, Policlinico S. Orsola-Malpighi, Bologna, Italy (M.G.)., Cupini LM; Department of Neurology and Stroke Unit, S. Eugenio Hospital, Rome, Italy (L.M.C.)., Sanzaro E; Department of Neurology and Stroke Unit, Umberto I Hospital, Siracusa, Italy (E.S.)., Zini A; IRCCS Istituto delle Scienze Neurologiche di Bologna, Department of Neurology and Stroke Center, Maggiore Hospital, Bologna, Italy (A.Z.)., La Spada S; Department of Neurology, Antonio Perrino Hospital, Brindisi, Italy (S.L.S.)., Palmieri C; Department of Neurology, Hospital 'E. Agnelli,' Pinerolo, Italy (C. Palmieri)., Sepe FN; Department of Neurology and Stroke Unit, S.S. Biagio e Arrigo Hospital, Alessandria, Italy (F.N.S.)., Beretta S; Department of Neurology, Fondazione IRCCS San Gerardo dei Tintori Monza, Italy (S.B.)., Paci C; Neurology Unit, Ospedale Provinciale 'Madonna del Soccorso,' San Benedetto del Tronto, Italy (C. Paci)., Caggia EA; Department of Neurology, Giovanni Paolo II Hospital, Ragusa, Italy (E.A.C.)., De Angelis MV; Department of Neurology and Stroke Unit, S.S. Annunziata Hospital, Chieti, Italy (M.V.D.A.)., Bonanni L; Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. d'Annunzio di Chieti-Pescara e Clinica Neurologica e Stroke Unit Ospedale Clinicizzato S.S. Annunziata di Chieti, Italy (L.B.)., Volpi G; Department of Neurology, San Jacopo Hospital, Pistoia, Italy (G. Volpi)., Tassi R; Stroke Unit, Azienda Ospedaliera Universitaria Senese, Siena, Italy (R.T.)., Pistoia F; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy (E.D.M., F.D.S., R.O., M.F., F.P., S.S.)., Scoditti U; Department of Emergency-Neurology-Stroke Care, University Hospital of Parma, Italy (U.S.)., Tonon A; Department of Neurology, Ospedale Civile S.S. Giovanni e Paolo, Venezia, Italy (A.T.)., Viticchi G; Clinical and Experimental Medicine Department, Marche Polytechnic University, Ancona, Italy (G. Viticchi)., Ruzza G; Stroke Unit, Cittadella Hospital, Cittadella, Italy (G. Ruzza)., Nencini P; Stroke Unit, Careggi University Hospital, Florence, Italy (P.N.)., Cavallini A; Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino Foundation, Pavia, Italy (A.C.)., Toni D; Department of Human Neurosciences, University of Rome La Sapienza, Italy (D.T.)., Ricci S; Department of Neurology, Città di Castello Hospital, Italy (S.C., C.B., C. Padiglioni, S.R.)., Sacco S; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy (E.D.M., F.D.S., R.O., M.F., F.P., S.S.).
Jazyk: angličtina
Zdroj: Stroke [Stroke] 2023 May; Vol. 54 (5), pp. 1172-1181. Date of Electronic Publication: 2023 Mar 23.
DOI: 10.1161/STROKEAHA.122.041660
Abstrakt: Background: Randomized controlled trials (RCTs) proved that short-term (21-90 days) dual antiplatelet therapy (DAPT) reduces the risk of early ischemic recurrences after a noncardioembolic minor stroke or high-risk transient ischemic attack (TIA) without substantially increasing the hemorrhagic risk. We aimed at understanding whether and how real-world use of DAPT differs from RCTs.
Methods: READAPT (Real-Life Study on Short-Term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or TIA) is a prospective cohort study including >18-year-old patients treated with DAPT after a noncardioembolic minor ischemic stroke or high-risk TIA from 51 Italian centers. The study comprises a 90-day follow-up from symptom onset. In the present work, we reported descriptive statistics of baseline data of patients recruited up to July 31, 2022, and proportions of patients who would have been excluded from RCTs. We compared categorical data through the χ² test.
Results: We evaluated 1070 patients, who had 72 (interquartile range, 62-79) years median age, were mostly Caucasian (1045; 97.7%), and were men (711; 66.4%). Among the 726 (67.9%) patients with ischemic stroke, 226 (31.1%) did not meet the RCT inclusion criteria because of National Institutes of Health Stroke Scale score >3 and 50 (6.9%) because of National Institutes of Health Stroke Scale score >5. Among the 344 (32.1%) patients with TIA, 69 (19.7%) did not meet the RCT criteria because of age, blood pressure, clinical features, duration of TIA, presence of diabetes score <4 and 252 (74.7%) because of age, blood pressure, clinical features, duration of TIA, presence of diabetes score <6 and no symptomatic arterial stenosis. Additionally, 144 (13.5%) patients would have been excluded because of revascularization procedures. Three hundred forty-five patients (32.2%) did not follow the RCT procedures because of late (>24 hours) DAPT initiation; 776 (72.5%) and 676 (63.2%) patients did not take loading doses of aspirin and clopidogrel, respectively. Overall, 84 (7.8%) patients met the RCT inclusion/exclusion criteria.
Conclusions: The real-world use of DAPT is broader than RCTs. Most patients did not meet the RCT criteria because of the severity of ischemic stroke, lower risk of TIA, late DAPT start, or lack of antiplatelet loading dose.
Registration: URL: https://www.
Clinicaltrials: gov; Unique identifier: NCT05476081.
Databáze: MEDLINE