Overall, stroke recurred in four (2%) of 250 patients in the intention-to-treat population: three in the antiplatelet group versus one in the anticoagulant group, all ipsilateral (appendix p 2). All recurrent strokes occurred in patients in whom the presenting symptom was stroke (four [2%] of 194 patients; three carotid, one vertebrobasilar).No deaths occurred, therefore the primary endpoint of ipsilateral stroke or death occurred in three (2%) of 126 patients in the antiplatelet group
versus one (1%) of 124 in the anticoagulant group (odds ratio 0·335, 95% CI 0·006–4·233; p=0·63; table 2). In the per-protocol population, stroke recurred in four (2%) of 196 patients overall, and in four (3%) of 151 who presented with stroke (appendix). For the intention-to-treat population, ipsilateral transient ischaemic attack occurred in one (1%) of 126 patients in the antiplatelet group versus four (3%) of 124 patients in the anticoagulant group (one [1%] of 101 vs three [3%] of 96 in the per-protocol population). Other transient ischaemic attack occurred in only one patient in the antiplatelet group, in both the intention-to-treat and per-protocol populations (appendix). None of the secondary endpoints diff ered signifi cantly between treatment groups. Results in the intention-to- treat and per-protocol populations were much the same (table 2). Table 3 shows adverse events. One major bleed occurred in the anticoagulant group (none in the anti- platelet group), in a patient with vertebral dissection with extension intracranially who developed a subarachnoid haemorrhage. This patient presented with headache with no focal neurological symptoms and CT brain imaging showed intraventricular blood. Two minor bleeds occurred in the anticoagulant group (one haematuria and one haemoptysis), and none in the antiplatelet group. To establish whether recurrent events might have occurred before recruitment and randomisation, we did a post-hoc analysis of patients presenting with stroke in whom previous transient ischaemic attack or minor stroke had occurred. In the intention-to-treat population, nine such patients were present in the anticoagulant group versus ten in the antiplatelet group (seven vs seven in the per-protocol population). The mean time between previous symptoms and subsequent stroke was 3·4 days (SD 5·5, range 0·04–21; median 1 day, IQR 0·25–4·0) in the intention-to-treat population, and 3·9 days (SD 6·3, range 0·13–21; median 1 day, IQR 0·3–5·0) in the per- protocol population.
โดยรวม โรคหลอดเลือดสมอง recurred ในสี่ (2%) ของผู้ป่วย 250 ในประชากรตั้งใจรักษา: สามใน antiplatelet กลุ่มเมื่อเทียบกับในกลุ่ม anticoagulant, ipsilateral ทั้งหมด (p ภาคผนวก 2) จังหวะการเกิดซ้ำทั้งหมดที่เกิดขึ้นในผู้ป่วยที่อาการนำเป็นจังหวะ (สี่ [2%] ผู้ป่วย 194 สาม carotid, vertebrobasilar หนึ่ง) ตายไม่เกิดขึ้น ดังนั้น ปลายทางหลักของ ipsilateral จังหวะหรือการตายเกิดขึ้นในสาม (2%) ของผู้ป่วยที่ 126 ในกลุ่ม antiplatelet versus one (1%) of 124 in the anticoagulant group (odds ratio 0·335, 95% CI 0·006–4·233; p=0·63; table 2). In the per-protocol population, stroke recurred in four (2%) of 196 patients overall, and in four (3%) of 151 who presented with stroke (appendix). For the intention-to-treat population, ipsilateral transient ischaemic attack occurred in one (1%) of 126 patients in the antiplatelet group versus four (3%) of 124 patients in the anticoagulant group (one [1%] of 101 vs three [3%] of 96 in the per-protocol population). Other transient ischaemic attack occurred in only one patient in the antiplatelet group, in both the intention-to-treat and per-protocol populations (appendix). None of the secondary endpoints diff ered signifi cantly between treatment groups. Results in the intention-to- treat and per-protocol populations were much the same (table 2). Table 3 shows adverse events. One major bleed occurred in the anticoagulant group (none in the anti- platelet group), in a patient with vertebral dissection with extension intracranially who developed a subarachnoid haemorrhage. This patient presented with headache with no focal neurological symptoms and CT brain imaging showed intraventricular blood. Two minor bleeds occurred in the anticoagulant group (one haematuria and one haemoptysis), and none in the antiplatelet group. To establish whether recurrent events might have occurred before recruitment and randomisation, we did a post-hoc analysis of patients presenting with stroke in whom previous transient ischaemic attack or minor stroke had occurred. In the intention-to-treat population, nine such patients were present in the anticoagulant group versus ten in the antiplatelet group (seven vs seven in the per-protocol population). The mean time between previous symptoms and subsequent stroke was 3·4 days (SD 5·5, range 0·04–21; median 1 day, IQR 0·25–4·0) in the intention-to-treat population, and 3·9 days (SD 6·3, range 0·13–21; median 1 day, IQR 0·3–5·0) in the per- protocol population.
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