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22. European Stroke Conference 5 Large clinical trials (RCTs) A 12:20 - 12:30 Effects of Blood Pressure Targets in Patients with Recent Lacunar Stroke: Results of the SPS3 Trial O.R. Benavente1, R.G. Hart2, L.A. McClure3, P.E. Pergola4, R. Conwit5 The SPS3 Investigators University of British Columbia, Vancouver, CANADA1,University of McMaster, Hamilton, CANADA2, University of Alabama at Birmingham, Birmingham, USA3, University of Texas, San Antonio, USA4, NIH-NINDS, Washington, USA5 Background: Hypertension is the single most powerful risk factor for stroke, and lowering blood pressure (BP) is proven to prevent stroke. Lacunar strokes account for >25% of brain infarcts. Despite their frequency and importance, no clinical trial has focused on this stroke subtype. Optimal target levels of BP control to prevent stroke recurrence in patients with cerebral small vessel disease are lacking. We hypothesized that targeting systolic BP (SBP) <130 mmHg would re-duce stroke recurrence in patients with recent lacunar stroke. Methods: The SPS3 trial (NCT00059306) is a randomized multicenter clinical trial conducted in 8 countries, aimed at defining strategies for reducing stroke recurrence, cognitive decline, and major vascular events. Patients had MRI-proven symptomatic lacunar infarcts, and were assigned in factorial design to: A)Aspirin 325 mg/d vs Aspirin 325 +Clopidogrel 75 mg/d. (double-blinded) B)Two targets of SBP; “higher” (130-149 mmHg) vs “lower” (<130 mmHg). (open-label with blinded event assessment) Results: We recruited 3020 participants, mean age 63 y. At 1 y, mean SBP was 138 mmHg in the higher and 127 mmHg in the lower group. At last study visit, mean difference in SBP be-tween groups was 11 mmHg. Mean follow-up was 3.7 y and rate of recurrent stroke among those assigned to higher target was 2.77%/y, compared with 2.25% in the lower target group (HR 0.81, 95% CI 0.64-1.03). Intracerebral hemorrhage was reduced by 63% in those assigned to the lower target group (HR 0.37 95% CI, 0.14-0.89, p=0.03). Serious complications of BP lowering were infrequent and equal between groups. Additional efficacy and safety data will be presented. Conclusions: Lowering systolic blood pressure to a target of <130mmHg in patients with recent lacunar stroke significantly reduced intracerebral hemorrhage and is likely to reduce all stroke. The lower target is safe and well tolerated. 4 Large clinical trials (RCTs) A 12:10 - 12:20 The third international stroke trial (IST-3): benefits of iv thrombolysis on functional out-come and health-related quality of life (HRQoL) persist to 18 months after treatment P.A.G. Sandercock1, R.I. Lindley2, J.M. Wardlaw3, M.S. Dennis4, G. Cohen5 IST3 collaborative group University of Edinburgh, Edinburgh, UNITED KINGDOM1,University of Sydney, Syd-ney, AUSTRALIA2, University of Edinburgh, Edinburgh, UNITED KINGDOM3, University of Edinburgh, Edinburgh, UNITED KINGDOM4, University of Edinburgh, Edinburgh, UNITED KINGDOM5, Edinburgh, 6 Background: IST-3 assessed the short- and long-term effects of i.v. rtPA for acute ischaemic stroke. We assessed whether the benefits in functional outcome and HRQoL at six months per-sisted to 18 months. Design: Multi-centre, randomized, open trial of intravenous rtPA 0.9 mg/kg in acute ischaemic stroke <6h. Patients were followed up at 6 & 18 months. Outcome was as-sessed by the Oxford Handicap Scale (OHS); HRQoL by the EQ5D, and questions about other aspects of function. The OHS and the 5 3-level domains of EQ5D were analysed by ordinal lo-gistic regression, adjusting for key baseline prognostic factors. Results. At 18 months 393/1515 (32%) allocated alteplase vs 354/1520 (28%) control were alive and independent (OHS 0-2), odds ratio (OR) 1.27 (95% CI 1.04-1.56, p=0.02). Adjusted ordinal analysis of OHS showed a favourable shift in the distribution of OHS; OR 1.30 (95% CI 1.10-1.54, p=0.002), Across each domain of the EQ5D, alteplase was associated with significantly reduced adjusted proportion-al odds of having problems with: self-care (0.69, 95% CI 0.55-0.85, p=0.001), usual activities (OR 0.75, 95% CI 0.61-0.92, p=0.006), mobility OR 0.76, 95% CI 0.62-0.94, p=0.01), pain or discomfort (OR 0.80, 95% CI 0.65-0.98, p=0.035) but not anxiety or depression (OR 0.96, 95% CI 0.78- 1.18). rt-PA was associated with significant absolute reductions in the number of patients per 1000 patients treated reporting (95% CI): ‘stroke left me with problems’ 87 (41- 133), ‘need help with everyday activities’ 79 (27-132) ‘need help to walk’ 50 (-4-104), ‘major problems speaking’, 50 (2-99). Conclusion. Allocation to rt-PA was associated with statistically significant improvements in functional outcome (OHS) and HRQoL at 18 months; the size of the absolute differences suggest that these health gains are clinically significant. IST-3 is the first trial to show that the benefits of rt-PA are maintained at least to 18 months and the first to confirm rt-PA improves HRQoL. 34 © 2013 S. Karger AG, Basel Scientific Programme


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