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SPARCL

SPARCL. S troke P revention by A ggressive R eduction in C holesterol L evels trial. SPARCL: Background and rationale. Patients with prior stroke/TIA are at risk for future cardiovascular (CV) events

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SPARCL

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  1. SPARCL Stroke Prevention by Aggressive Reduction in Cholesterol Levels trial

  2. SPARCL: Background and rationale • Patients with prior stroke/TIA are at risk for future cardiovascular (CV) events • Statins stroke incidence in patients at risk for CV disease; however, stroke risk reduction with statin therapy has not been demonstrated in patients with a history of stroke or TIA SPARCL was designed to evaluate whether high-dose statin treatment reduces risk of stroke in patients with a recent stroke or TIA and no history of coronary heart disease SPARCL Investigators. Cerebrovasc Dis. 2003;16:389-95.Heart Protection Study Collaborative Group. Lancet. 2004;363:757-67.

  3. SPARCL: Study design Stroke or TIA in ≤6 months,no known CHD, LDL-C 100–190 mg/dLN = 4731 Atorvastatin 80 mg daily n = 2365 Placebo n = 2366 Randomized Double blind Primary end point: Fatal/nonfatal strokeSecondary end points: Major coronary or CV events Follow-up:~5 years (until >540 primary end points) SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  4. SPARCL: Baseline characteristics SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  5. SPARCL: Entry events N = 4731 *Ischemic stroke or TIA in >97% of patients SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  6. SPARCL: Concomitant medications N = 4731 SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  7. SPARCL: High-dose statin treatment reduces fatal/nonfatal stroke Primary outcome Placebo NNT = 46 patientsfor 5 years 16 16% RRR* HR 0.84 (0.71–0.99) P = 0.03 12 Fatal/ nonfatal stroke(%) Atorvastatin 8 4 0 0 1 2 3 4 5 6 Time since randomization (years) *Adjusted SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  8. SPARCL: Treatment effect on stroke and TIA N = 4731 • Primary outcome • Stroke (total) • Fatal • Nonfatal • Secondary outcomes • Stroke or TIA • TIA Aggressive statin therapy HR* (95% CI) 0.84 (0.71–0.99) 0.57 (0.35–0.95) 0.87 (0.73–1.03) 0.77 (0.67–0.88) 0.74 (0.60–0.91) P 0.03 0.03 0.11 <0.001 0.004 Better Worse 0.3 1.0 1.7 Hazard ratio *Adjusted SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  9. SPARCL: High-dose statin reduces majorcoronary events and stroke 30 20% RRR HR 0.80 (0.69–0.92) P = 0.002 NNT = 29 patientsfor 5 years Placebo 20 Major CV events*(%) Atorvastatin 10 0 0 1 2 3 4 5 6 Time since randomization (years) *Cardiac death, MI, resuscitatedcardiac arrest, and stroke SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  10. SPARCL: Reductions in major coronary events 10 8 Placebo 35% RRR HR 0.65 (0.49–0.87) P = 0.003 6 Major coronary events*(%) 4 Atorvastatin 2 0 0 1 2 3 4 5 6 Time since randomization (years) *Cardiac death, MI, resuscitated cardiac arrest SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  11. SPARCL: Adverse events N = 4731 SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  12. SPARCL: Summary Atorvastatin 80 mg yielded: Primary end point 16% fatal/nonfatal stroke (P = 0.03) • Significant benefit despite small hemorrhagic stroke with atorvastatin (2.3%) vs placebo (1.4%) Secondary end points 35% major coronary events (P = 0.003) 20% major CV events (P = 0.002) 42% any coronary events (P < 0.001) 26% any CV events (P < 0.001) 45% revascularizations (P < 0.001) SPARCL Investigators. N Engl J Med. 2006;355:549-59.

  13. SPARCL: Implications • Aggressive statin therapy should be strongly considered soon after stroke or TIA • Magnitude of benefit may vary depending on baseline stroke subtype • SPARCL results support the concept of stroke or TIA as a CHD risk equivalent SPARCL Investigators. N Engl J Med. 2006;355:549-59.

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