The Secondary Prevention of Small Subcortical Strokes (SPS3) study

International Journal of Stroke

Volumn 6, Issue 2, 2011, Pages 164-175

  Benavente, Oscar R ^a   White, Carole L ^b   Pearce, Lesly ^c   Pergola, Pablo ^b   Roldan, Ana ^a   Benavente, Marie France ^a   Coffey, Christopher ^d   Mcclure, Leslie A ^e   Szychowski, Jeff M ^e   Conwit, Robin ^f   Heberling, Patricia A ^b   Howard, George ^e   Bazan, Carlos ^b   Vidal Pergola, Gabriela ^b   Talbert, Robert ^g   Hart, Robert G ^b  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^c Bel Air Court ^*  (United States)

^d UNIVERSITY OF IOWA   (United States)

^e UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^f NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE   (United States)

^g UNIVERSITY OF TEXAS AT AUSTIN   (United States)

Author keywords

Antiplatelet therapy; Hypertension; Lacunar stroke; Randomised clinical trial; SPS3

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL;

ARTICLE; BRAIN HEMORRHAGE; BRAIN INFARCTION; BRAIN ISCHEMIA; COGNITIVE DEFECT; HUMAN; MULTICENTER STUDY (TOPIC); NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENCE RISK; SECONDARY PREVENTION; STROKE; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; VASCULAR DISEASE;

ANTIHYPERTENSIVE AGENTS; ASPIRIN; COGNITION DISORDERS; HUMANS; HYPERTENSION; MAGNETIC RESONANCE IMAGING; PLATELET AGGREGATION INHIBITORS; RECURRENCE; RESEARCH DESIGN; SECONDARY PREVENTION; STROKE; TICLOPIDINE;

EID: 79952287859     PISSN: 17474930     EISSN: 17474949     Source Type: Journal    
DOI: 10.1111/j.1747-4949.2010.00573.x     Document Type: Article

References (97)

1. Bogousslavsky J, Van Melle G, Regli F. The Lausanne Stroke Registry: analysis of 1, 000 consecutive patients with first stroke. Stroke 1988; 19:1083-92.
2. Kolominsky-Rabas PL, Weber M, Gefeller O, Neundoerfer B, Heuschmann PU. Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence, and long-term survival in ischemic stroke subtypes: a population-based study. Stroke 2001; 32:2735-40.
3. Wolfe CD, Rudd AG, Howard R et al. Incidence and case fatality rates of stroke subtypes in a multiethnic population: the South London Stroke Register. J Neurol Neurosurg Psychiatry 2002; 72:211-6.
4. Del Brutto OH, Mosquera A, Sánchez X, Santos J, Noboa CA. Stroke subtypes among Hispanics living in Guayaquil, Ecuador. Results from the Luis Vernaza Hospital Stroke Registry. Stroke 1993; 24:1833-6.
5. Lavados PM, Sacks C, Prina L et al. Incidence, 30-day case-fatality rate, and prognosis of stroke in Iquique, Chile: a 2-year community-based prospective study (PISCIS project). Lancet 2005; 365:2206-15.
6. Sacco RL, Kargman DE, Gu Q, Zamanillo MC. Race-ethnicity and determinants of intracranial atherosclerotic cerebral infarction. The Northern Manhattan Stroke Study. Stroke 1995; 26:14-20.
7. Sacco RL, Kargman DE, Zamanillo MC. Race-ethnic differences in stroke risk factors among hospitalized patients with cerebral infarction: the Northern Manhattan Stroke Study. Neurology 1995; 45:659-63.
8. Saposnik G, Del Brutto OH, Iberoamerican Society of Cerebrovascular Diseases Stroke in South America: a systematic review of incidence, prevalence, and stroke subtypes. Stroke 2003; 34:2103-7.
9. Saposnik G, Gonzalez L, Lepera S et al. Southern Buenos Aires Stroke Project. Acta Neurol Scand 2001; 104:130-5.
10. Worley KL, Lalonde DR, Kerr DR, Benavente O, Hart RG. Survey of the causes of stroke among Mexican Americans in South Texas. Tex Med 1998; 94:62-7.
11. Zweifler RM, Lyden PD, Taft B, Kelly N, Rothrock JF. Impact of race and ethnicity on ischemic stroke: the University of California at San Diego Stroke Data Bank. Stroke 1995; 26:245-8.
12. Boiten J, Lodder J. Prognosis for survival, handicap and recurrence of stroke in lacunar and superficial infarction. Cerebrovasc Dis 1993; 3:221-6.
13. Ross GW, Petrovitch H, White LR et al. Characterization of risk factors for vascular dementia: the Honolulu-Asia Aging Study. Neurology 1999; 53:337-43.
14. Tatemichi TK, Desmond DW, Paik M et al. Clinical determinants of dementia related to stroke. Ann Neurol 1993; 33:568-75.
15. Benavente O, Eliasziw M, Streifler J, Barnett HJ. Prognosis of lacunar stroke patients in association with leukoaraiosis. Stroke 2000; 32:366.
16. Benavente O, Palacio S, Kesava P, Bazan C, Pearce L, Hart RG. White matter abnormalities in lacunar stroke patients. Stroke 2000; 32:343.
17. Boiten J, Lodder J, Kessels F. Two clinically distinct lacunar infarct entities? A hypothesis. Stroke 1993; 24:652-6.
18. Pantoni L. Cerebral small vessel disease: from pathogenesis and clinical characteristics to therapeutic challenges. Lancet Neurol 2010; 9:689-701.
19. Bamford J, Sandercock P, Jones L, Warlow C. The natural history of lacunar infarction: the Oxfordshire Community Stroke Project. Stroke 1987; 18:545-51.
20. Benavente O, Hart RG, Palacio S et al. Secondary Prevention of Small Subcortical Strokes (SPS3) pilot trial: final results. Stroke 2003; 34:238-322.
21. Benavente O, Pearce L, Amarenco P, Streifler J, Kase C. Is there a different effect of clopidogrel plus aspirin versus clopidogrel alone on stroke patients with small vessel disease and large artery atherosclerosis? Analysis from MATCH. Stroke 2007; 38:522.
22. Mohr JP, Thompson JL, Lazar RM et al. A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke. N Engl J Med 2001; 345:1444-51.
23. Petty GW, Brown RD, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO. Ischemic stroke subtypes: a population-based study of functional outcome, survival, and recurrence. Stroke 2000; 31:1062-8.
24. Jackson C, Sudlow C. Comparing risks of death and recurrent vascular events between lacunar and non-lacunar infarction. Brain 2005; 128:2507-17.
25. Miyao S, Takano A, Teramoto J, Takahashi A. Leukoaraiosis in relation to prognosis for patients with lacunar infarction. Stroke 1992; 23:1434-8.
26. Snowdon DA, Greiner LH, Mortimer JA, Riley KP, Greiner PA, Markesbery WR. Brain infarction and the clinical expression of Alzheimer disease. The Nun Study. JAMA 1997; 277:813-7.
27. Breteler MM, van Swieten JC, Bots ML et al. Cerebral white matter lesions, vascular risk factors, and cognitive function in a population-based study: the Rotterdam Study. Neurology 1994; 44:1246-52.
28. Vermeer SE, Hollander M, Rotterdam Scan Study et al. Silent brain infarcts and white matter lesions increase stroke risk in the general population: the Rotterdam Scan Study. Stroke 2003; 34:1126-9.
29. Wen HM, Mok VC, Fan YH et al. Effect of white matter changes on cognitive impairment in patients with lacunar infarcts. Stroke 2004; 35:1826-30.
30. Samuelsson M, Söderfeldt B, Olsson GB. Functional outcome in patients with lacunar infarction. Stroke 1996; 27:842-6.
31. Bruno A, Carter S, Qualls C, Nolte KB. Incidence of spontaneous intracerebral hemorrhage among Hispanics and non-Hispanic whites in New Mexico. Neurology 1996; 47:405-8.
32. Frey JL, Jahnke HK, Bulfinch EW. Differences in stroke between white, Hispanic, and Native American patients: the Barrow Neurological Institute Stroke Database. Stroke 1998; 29:29-33.
33. Morgenstern LB, Smith MA, Lisabeth LD et al. Excess stroke in Mexican Americans compared with non-Hispanic whites: the Brain Attack Surveillance in Corpus Christi Project. Am J Epidemiol 2004; 160:376-83.
34. Zahuranec DB, Brown DL, Lisabeth LD et al. Differences in intracerebral hemorrhage between Mexican Americans and non-Hispanic whites. Neurology 2006; 66:30-4.
35. Bousser MG, Eschwege E, Haguenau M et al. 'AICLA' controlled trial of aspirin and dipyridamole in the secondary prevention of athero-thrombotic cerebral ischemia. Stroke 1983; 14:5-14.
36. Chinese Acute Stroke Trial Collaborative Group. CAST: randomised placebo-controlled trial of early aspirin use in 20, 000 patients with acute ischaemic stroke. Lancet 1997; 349:1641-9.
37. Gent M, Blakeley JA, Easton D et al. The Canadian American Ticlopidine Study (CATS) in thromboembolic stroke. Lancet 1989; 1:1215-20.
38. Gotoh F, Tohgi H, Hirai S et al. Cilostazol Stroke Prevention Study: a placebo-controlled double-blind trial for secondary prevention of cerebral infarction. J Stroke Cerebrovasc Dis 2000; 9:147-57.
39. Sacco RL, Diener HC, Yusuf S et al. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med 2008; 359:1238-51.
40. Yusuf S, Zhao F, Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators et al. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001; 345:494-502.
41. ACTIVE Investigators, Connolly SJ, Pogue J et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009; 360:2066-78.
42. Bhatt DL, Fox KA, Hacke W et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med 2006; 354:1706-17.
43. Steinhubl SR, Berger PB, Mann JT III et al. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002; 288:2411-20.
44. Gueyffier F, Boissel JP, Boutitie F et al. Effect of antihypertensive treatment in patients having already suffered from stroke. Gathering the evidence The INDANA (INdividual Data Analysis of Antihypertensive intervention trials) project collaborators. Stroke 1997; 28:2557-62.
45. Gueyffier F, Froment A, Gouton M. New meta-analysis of treatment trials of hypertension: improving the estimate of therapeutic benefit. J Hum Hypertension 1996; 10:1-8.
46. Rashid P, Leonardi-Bee J, Bath P. Blood pressure reduction and secondary prevention of stroke and other vascular events: a systematic review. Stroke 2003; 34:2741-8.
47. PROGRESS Collaborative Group Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6, 105 individuals with previous stroke or transient ischaemic attack. Lancet 2001; 358:1033-41.
48. Chapman N, Huxley R, Anderson C et al. Effects of a perindopril-based blood pressure-lowering regimen on the risk of recurrent stroke according to stroke subtype and medical history: the PROGRESS trial. Stroke 2004; 35:116-21.
49. ACCORD Study Group, Cushman WC, Evans GW et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010; 362:1575-85.
50. Tzourio C, Dufouil C, Ducimetière P, Alpérovitch A. Cognitive decline in individuals with high blood pressure: a longitudinal study in the elderly. EVA study group. Epidemiology of Vascular Aging. Neurology 1999; 53:1948-52.
51. Forette F, Seux ML, Staessen JA et al. The prevention of dementia with antihypertensive treatment: new evidence from the systolic hypertension in Europe (Syst-Eur) study. Arch Intern Med 2002; 162:2046-52.
52. Tzourio C, Anderson C, Chapman N et al. Effects of blood pressure lowering with perindopril and indapamide therapy on dementia and cognitive decline in patients with cerebrovascular disease. Arch Intern Med 2003; 163:1069-75.
53. Bosch J, Yusuf S, Pogue J et al. Use of ramipril in preventing stroke: double blind randomised trial. BMJ 2002; 324:699-702.
54. Allhat Officers and Coordinators for the Allhat Collaborative Research Group Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288:2981-97.
55. Sacco RL, Adams R, Albers G et al. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention. Circulation 2006; 113:e409-49.
56. Fisher CM. Lacunar infarcts - a review. Cerebrovasc Dis 1991; 1: 311-20.
57. Easton JD, Saver JL, Albers GW et al. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. Stroke 2009; 40:2276-93.
58. Cordonnier C, Potter GM, Jackson CA et al. Improving interrater agreement about brain microbleeds: development of the Brain Observer Microbleed Scale (BOMBS). Stroke 2009; 40:94-9.
59. Wahlund LO, Barkhof F, Fazekas F et al. A new rating scale for age-related white matter changes applicable to MRI and CT. Stroke 2001; 32:1318-22.
60. Fazekas F, Chawluk JB, Alavi A, Hurting HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. Am J Roentgenol 1987; 149:351-6.
61. Fox AJ. How to measure carotid stenosis. Radiology 1993; 186:316-8.
62. Hazuda HP, Comeaux PJ, Stern MP, Haffner SM, Eifler CW, Rosenthal M. A comparison of three indicators for identifying Mexican Americans in epidemiologic research. Methodological findings from the San Antonio Heart Study. Am J Epidemiol 1986; 123:96-112.
63. Folstein MF, Folstein SE, McHugh PR. 'Mini-mental state'. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12:189-98.
64. Norris J. Comment on 'study design of stroke treatments'. Stroke 1982; 13:527-8.
65. Farrell B, Godwin J, Richards S, Warlow C. The United Kingdom transient ischaemic attack (UK-TIA) aspirin trial: final results. J Neurol Neurosurg Psychiatry 1991; 54:1044-54.
66. Rankin J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J 1957; 2:200-15.
67. Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index. MD State Med J 1965; 14:61-5.
68. Hansson L, Hedner T, Dahlöf B. Prospective Randomized Open Blinded End-point (PROBE) study. A novel design for intervention trials. Prospective randomized open blinded end-point. Blood Press 1992; 1:113-9.
69. Hansson L, Zanchetti A, Carruthers SG et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. Lancet 1998; 351:1755-62.
70. Lindholm LH, Hansson L, Dahlöf B et al. The Swedish Trial in Old Patients with hypertension-2 (STOP-hypertension-2): a progress report. Blood Press 1996; 5:300-4.
71. Ogihara T, Matsuzaki M, Matsuoka H, Shimamoto K, Shimada K, Rakugi H. The combination therapy of hypertension to prevent cardiovascular events (COPE) trial: rationale and design. Hypertens Res 2005; 28:331-8.
72. Ling J, Ohara Y, Orime Y, Noon GP, Takatani S. Clinical evaluation of the oscillometric blood pressure monitor in adults and children based on the 1992 AAMI SP-10 standards. J Clin Monit 1995; 11:123-30.
73. Pérgola PE, White CL, Graves JW et al. Reliability and validity of blood pressure measurement in the Secondary Prevention of Small Subcortical Strokes study. Blood Press Monit 2007; 12:1-8.
74. Chobanian AV, Bakris GL, Black HR et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003; 289:2560-71.
75. Wiklund I, Halling K, Rydén-Bergsten T, Fletcher A. Does lowering the blood pressure improve the mood? Quality-of-life results from the Hypertension Optimal Treatment (HOT) study. Blood Press 1997; 6:357-64.
76. Williams LS, Weinberger M, Harris LE, Biller J. Measuring quality of life in a way that is meaningful to stroke patients. Neurology 1999; 53:1839-43.
77. Pfeiffer E. (ed): Multidimensional Functional Assessment: The Oars Methodolgy: A Manual. Durham: Center for the Study of Aging and Human Development, 1975.
78. Fillenbaum GG, Smyer MA. The development, validity, and reliability of the OARS multidimensional functional assessment questionnaire. J Gerontol 1981; 36:428-34.
79. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders Patient Health Questionnaire. JAMA 1999; 282:1737-44.
80. Williams LS, Brizendine EJ, Plue L et al. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke 2005; 36:635-8.
81. Teng E, Hasegawa K, Homma A et al. The Cognitive Abilities Screening Instrument (CASI): a practical test for cross-cultural epidemiological studies of dementia. Int Psychogeriatrics 1994; 6:45-58.
82. Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics 1983; 39:499-503.
83. McClure LA, Szychowsk IJF, Benavente O, Hart RG, Coffey CS. The effect of an unplanned sample size re-estimation on the type I error rate. Clinical Trials 2010; 7:421.
84. Jennison C, Turnbull BW. Group Sequential Methods with Applications to Clinical Trials. Boca Raton: Chapman & Hall/CRC, 2000.
85. Elkind MS, Luna JM, Coffey CS et al. The Levels of Inflammatory Markers in the Treatment of Stroke Study (LIMITS): inflammatory biomarkers as risk predictors after lacunar stroke. Int J Stroke 2010; 5:117-25.
86. Bhat V, Pergola P, Pearce L, Vidal-Pergola G, Hart RG, Benavente O. Is there a relationship between renal dysfunction and white matter disease? Stroke 2010; 41:142.
87. Arauz A, Murillo L, Cantú C, Barinagarrementeria F, Higuera J. Prospective study of single and multiple lacunar infarcts using magnetic resonance imaging: risk factors, recurrence, and outcome in 175 consecutive cases. Stroke 2003; 34:2453-8.
88. Saposnik G, Caplan LR, Gonzalez LA et al. Differences in stroke subtypes among natives and caucasians in Boston and Buenos Aires. Stroke 2000; 31:2385-9.
89. van Gijn J. The PROGRESS Trial: preventing strokes by lowering blood pressure in patients with cerebral ischemia. Emerging therapies: critique of an important advance. Stroke 2002; 33:319-20.
90. Ramsay LE, Williams B, Johnston GD et al. British hypertension society guidelines for hypertension management 1999: summary. BMJ 1999; 319:630-5.
91. Cooper-DeHoff RM, Gong Y, Handberg EM et al. Tight blood pressure control and cardiovascular outcomes among hypertensive patients with diabetes and coronary artery disease. JAMA 2010; 304:61-8.
92. Steinhubl SR, Bhatt DL, Brennan DM et al. Aspirin to prevent cardiovascular disease: the association of aspirin dose and clopidogrel with thrombosis and bleeding. Ann Intern Med 2009; 150:379-86.
93. Diener HC, Bogousslavsky J, Brass LM et al. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet 2004; 364:331-7.
94. Peters RJ, Mehta SR, Fox KA et al. Effects of aspirin dose when used alone or in combination with clopidogrel in patients with acute coronary syndromes: observations from the Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) study. Circulation 2003; 108:1682-7.
95. Derry S, Loke YK. Risk of gastrointestinal haemorrhage with long term use of aspirin: meta-analysis. BMJ 2000; 321:1183-7.
96. Eikelboom JW, Hankey GJ, Thom J et al. Incomplete inhibition of thromboxane biosynthesis by acetylsalicylic acid: determinants and effect on cardiovascular risk. Circulation 2008; 118:1705-12.
97. Crum RM, Anthony JC, Bassett SS, Folstein MF. Population-based norms for the mini-mental state examination by age and educational level. JAMA 1993; 269:2386-91.