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Improving Cardiovascular Outcomes through Systems Approach to Evidence Based Care

Improving Cardiovascular Outcomes through Systems Approach to Evidence Based Care. Les Barnette, MD Medical Director, Healthcare Improvement. Evidence Review . 30,000 foot overview over the cardiovascular literature jungle Looking for major landmarks . Goals.

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Improving Cardiovascular Outcomes through Systems Approach to Evidence Based Care

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  1. Improving Cardiovascular Outcomes through Systems Approach to Evidence Based Care Les Barnette, MD Medical Director, Healthcare Improvement

  2. Evidence Review • 30,000 foot overview over the cardiovascular literature jungle • Looking for major landmarks

  3. Goals • To briefly review major cardiovascular strategies for treatment of AMI, and summarize the evidence of benefit • To keep you awake

  4. Acute Myocardial Infarction • Use of Aspirin • Use of Beta Blockers • Use of ACE Inhibitors • Use of Acute Reperfusion Strategies • Role of Cholesterol Management

  5. Concepts • Relative Risk Reduction--RRR • Absolute Risk Reduction--ARR • Number Needed to Treat--NNT (1/ARR)

  6. Example • If study shows reduction in mortality from 8% to 4% then • Relative Risk Reduction is 50% • Absolute Risk Reduction is 4% • Number needed to treat to save one life is 25 (1/0.04)

  7. AMI--Aspirin Use • Early use • ISIS-2 trial • Randomized to ASA 162.5 mg, IV SK, both or neither • SK or ASA vs placebo 23-25% RRR (2.4-2.8% ARR) • Antiplatelet Trialist's Collaboration • in AMI-reduction in one month mortality from 14 to 10%

  8. Aspirin Use • National median 84% • National range 65-97% • Washington State 86%

  9. Beta Blockers in Acute MI • Early use (<12 hours) • Late use (at discharge)

  10. Beta Blockers--Early Use • Initiation IV within first 12 hours of MI • Benefits independent of concomitant thrombolytic therapy • Appears to reduce: • infarct size in patients not receiving thrombolytics • rate of reinfarction in patients receiving thrombolytics

  11. Beta Blocker Use Early in MI • TIMI 2B • All patients treated with tPA in < 4 hours • Immediate IV Metoprolol followed by oral v. oral Metoprolol on day 6 • ISIS-1 • acute MI treated with IV atenolol within 12 hours • MIAMI • IV metoprolol • No thrombolytics

  12. TIMI-2B Results • No overall mortality difference • BUT • lower incidence of reinfarction 2.7% v 5.1% • lower incidence of recurrent ischemia 18.8% v 24.1%

  13. ISIS-1 Results • 7 day mortality reduced from 4.6% - 3.9% (p<0.04) • Mortality difference was evident by end of Day 1 and sustained

  14. MIAMI Results • 15 day mortality 4.9% v. 4.3% (p=0.29) • BUT only 15% received beta blockers within 6 hours (v. ISIS 38% in 4 hours) • Emphasizes need for earlier administration of beta-blockers

  15. Meta-analysis of Early Beta Blockers • 7 day mortality 4.3% v 3.7% • NNT= 167

  16. Beta Blockers--Late Use • Initiation within first few days of MI • BHAT • Used propanolol in patients with documented acute MI • Excluded patients likely to have CABG • 2-4 year follow-up

  17. BHAT Results • Total Mortality 9.8% v 7.2% • Sudden death 4.6% v 3.3% • NNT to prevent one death over 2-4 years=38

  18. Caveats • Most benefit from beta blockers in patients with: • recurrent ischemia • clinical evidence of LV dysfunction • arrhythmia

  19. Early Use of Beta Blockers WA State 67% Nat’l median 64% Nat’l range 33-80% Beta Blockers at Discharge WA State 66% Nat’l median 72% Nat’l range 47-93% Beta Blocker Use in MI

  20. ACE Inhibitors in AMI • ACC/AHA Recommendation • Within 24 hours of presentation in acute MI with two or more anterior leads involved or with heart failure • in MI with EF <40% • CHF secondary to systolic pump dysfunction during and after convalescence • absence of significant hypotension (SBP<100) or contraindication to ACEI

  21. Evidence for ACE Inhibitors in AMI • All studies using oral ACE Inhibitors have shown benefit • ISIS 4--58000 patients, Captopril, <24h after onset • 7% RRR in 5 week mortality, maintained at 1 year(7.19 v7.69%) • Greatest benefit in anterior MI or prior MI • 5 deaths prevented per 1000 patients treated (NNT=200)

  22. Evidence for ACE Inhibitors in AMI (continued) • SAVE (Survival and Ventricular Enlargement Trial) • Captopril given 3-16 days post MI to patients with LV dysfunction (mean EF 31%) mean f/u 42 months • Mortality reduced 19%/decreased onset of severe CHF/ hospitalization • Reduced risk of recurrent MI by 25%

  23. HOPE Trial • RCT studying effect of ACE I and Vit E on cardiac events • N=9541 Age >55 with hx of CVD event or DM and additional CVD risk factor • Ramipril 10 mg/day • Mean f/u 4.5 years

  24. Outcomes • MI/CVA or death ARR 3.6% NNT 27 • Total Mortality ARR 2.0% NNT 50 • Revascularization ARR 2.3% NNT 43 • Suggests that all patients (>55 ?) with CVD or DM + CVD risk factors should be on ACEI

  25. ACE I post MI • Washington State 76% • National median 71% • USA range 59-84%

  26. Reperfusion in AMI • 1980 DeWood et al published evidence that AMI caused by acute coronary occlusion due to thrombus • 1986 GISSI published showing benefit of IV Streptokinase in acute MI • 21 day mortality 10.7% v 13% • larger relative reduction if given within 3 hours

  27. Reperfusion in AMI (cont) • 15 years of accumulated studies showing thrombolysis reduces mortality in acute MI • Various thrombolytics (Streptokinase, tPA, rPA…) • Various protocols (bolus, front loaded…)

  28. ACC/AHA Recommendations • Thrombolytics indicated in AMI with ST elevation in two contiguous leads • <12 hours since onset of symptoms • Age <75 (increased risk >75, but still may be beneficial) • Bundle branch block obscuring ST changes and hx c/w MI

  29. Benefits greatest in • Early administration (<3 hours) • Anterior MI • HR > 100 • Low blood pressure

  30. Mechanical Re-perfusion • Primary PTCA is an alternative to thrombolytic therapy … “only if performed in a timely fashion by individuals skilled in the procedure and supported by experienced personnel in high volume centers.”

  31. Meta-analysis of Thrombolytics vs PTCA • 30 day mortality 6.5% v 4.4% • Death plus nonfatal reinfarction 11.9% v 7.2% • Stroke 2% v 0.7%

  32. “Primary PTCA appears to be superior to thrombolytic therapy... with the proviso that success rates for PTCA are as good as those achieved in the trials”

  33. Intracoronary Stent for Acute MI • PAMI-STENT trial (PTCA v Stent) • high rate of primary success. (98% of patients randomized to stent got one) • 15% crossover for bailout stent • better initial success with stent (25% v 11% residual stenosis) • angiographic restenosis (>50%) at 6 months 20% v 32%

  34. PAMI-STENT (cont’d) • Target vessel revascularization 21% v 13% • No significant difference in death, recurrent MI, or disabling stroke

  35. Key to Success is Rapid Delivery of Effective Therapy • MITI II looking at prehospital delivery of thrombolytic therapy • Patients treated in <70 minutes from onset of symptoms had 2 year survival of 98% versus those treated >70 minutes who had 88% survival

  36. Washington State Performance • Time to thrombolytic therapy delivery 46 minutes (Median 40) • Time to PTCA 121 minutes (ACC/AHA Goal 60-90 minutes)

  37. Scandinavian Simvastatin Survival Study (4S) • Randomized 4444 patients with angina or MI • Mean follow-up 5.4 years • Baseline cholesterol 210-310 mg/dl • Dose titrated to cholesterol 115-200 mg/dl

  38. 4S Outcomes • Cholesterol decreased 25%, LDL 35% • Mortality reduced from 11.5% to 8.2% (NNT=30) • Risk of major coronary event reduced from 22.6% to 15.9% (NNT=15) • Revascularization reduced from 17.2% to 11.3% (NNT=17)

  39. Selected References--Myocardial Infarction DeWood MA, et al.Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction. NEJM. 1980; 303: 897-902. ACC/AHA Practice Guidelines. Guidelines for the Management of Patients with Acute Myocardial Infarction. JACC 1996; 28:1328-1428 JACC 1999; 34; 891-911. Antiplatelet Trialist’s Collaboration. Collaborative overview of randomized trials of antiplatelet therapy. M\BMJ 1994,308: 81-106.

  40. The MIAMI Trial Research Group. Metoprolol in Acute Mycardial Infarction: patient population. Am J Card. 1985; 56: 1G-57G. ISIS-2 (Second International Infarct Survival) Collaborative Group. Randomized trial of intravenous streptokinase, oral aspirin, both or neither among 17,187 cases of suspected myocardial infarction. ISIS-2. Lancet 1988,2: 349-360. The TIMI Study Group. Comparison of invasive and conservation strategies after treatment with tissue plasminogen activator in acute myocardial infarction: result of the thrombolysis in myocardial (TIMI) phase II trial. NEJM. 1989.320: 618-627 Selected References--Myocardial Infarction II

  41. Selected References--Myocardial Infarction III Ferguson J. Meeting Highlights. Highlights of the 71st Scientific Session of the American Heart Association(news) Circulation 1999, 99: 2486-2491. (STENT-PAMI) Pfeffer, MA et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators. NEJM 1992;327:669-77

  42. Thank You Questions?

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