Treatment strategies for “stable” CAD patients: COURAGE, OAT, SWISSI II, VIAMI in perspective

1. Treatment strategies for “stable” CAD patients:COURAGE, OAT, SWISSI II, VIAMI in perspective Pierfrancesco Agostoni, MD Antwerp Cardiovascular Institute Middelheim Department of Interventional Cardiology

2. Clinical Outcomes Utilizing Revascularization And Aggressive DruGEvaluation

3. To determine whether PCI plus optimal medical therapy (OMT) reduces the risk of death or nonfatal MI in symptomatic patients with stable CAD, as compared with OMT alone. Patients with stable angina (CCS I-III or initial CCS IV medically stabilized) ALL underwent coronary angiography and where then randomized to PCI + OMT vs. OMT alone Primary Outcome Death or Nonfatal MI

4. Inclusion Criteria • 1, 2, or 3 vessel disease (> 80% visual stenosis of proximal coronary segment) • Anatomy suitable for PCI (not better specified…) • CCS Class I-III angina • Objective evidence of ischemia at baseline • ACC/AHA Class I or II indication for PCI Exclusion Criteria • Uncontrolled unstable angina / CCS IV on therapy • Complicated post-MI course • Revascularization within 6 months • Ejection fraction <30% • Cardiogenic shock/severe heart failure • Markedly positive stress test (ST changes at 1° stage) • Significant unprotected LM disease

5. 50 hospitals (USA and Canada) 2,287 patients enrolled between 6/99-1/04 6% of screened

7. Despite 60% were 2- or 3VD, 60% received only 1 stent, while only 40% received >1 stent Total: 2276 vessels diseased… thus lesions… Only 1688 (74%) were attempted in the trial…

8. At a median f.u. time of 4.6 years…

9. But… if we look at quality of life…

10. Is this a “transient” reduction??

11. and effectively performed

12. Occluded Artery Trial

13. To evaluate outcomes of percutaneous coronary intervention (PCI) versus medical therapy among stable, high-risk, asymptomatic patients with persistent total occlusion of the infarct-related artery post-myocardial infarction (MI). Patients presenting late post-MI ALL underwent angiography from >24 hours to 28 days post-MI and were randomized to PCI of the IRA + optimal medical therapy or conservative medical therapy Primary Outcome Death / Nonfatal MI / NYHA IV HF

14. Inclusion Criteria • total occlusion of the infarct-related artery with poor or absent antegrade flow (TIMI flow 0 or 1) • increased risk, defined as ejection fraction <50%, proximal occlusion of a major epicardial vessel with a large risk region, or both Exclusion Criteria • NYHA class III-IV heart failure or caridogenic shock • serum creatinine concentration >2.5 mg/dl • significant LM or 3-V coronary artery disease • angina at rest • severe ischemia on stress testing

15. ST depression >2 mm No completion of stage 1 Reversible perfusion defectsin multiple territories Decreased wall motion in >2 segments on echo

16. Enrolled to screened ratio?

18. Additional PCI in non-IRA vessels: 6-7% • Crossover to PCI in medical therapy group: 6%

19. At a mean f.u. time of 3 years…

20. Published only on online supplement!! Medication at discharge

22. The SWiss Interventional Study on Silent Ischemia Type II

23. To determine long-term outcome of asymptomatic subjects with silent ST-segment depression during exercise ECG andsilent myocardial ischemia documented by an imaging technique To compare the effects of PCI alone with anti-ischemic medical therapy on outcome, each combined with secondary preventive advice, aspirin and statin therapy Primary Outcome Cardiac death / Nonfatal MI / symptom-driven PCI or CABG

24. Inclusion Criteria • documented, first MI (STEMI or NSTEMI) within the preceding 3 months • maximal symptom-limited exercise test without chest pain, but with significant ST depression • silent ischemia confirmed by stress imaging • 1- to 2-vessel coronary artery disease (CAD) at coronaryangiography (performed in ALL patients) suitable for PCI Exclusion Criteria • malignancy • symptomatic ischemia • 3V disease • no written informed consent

25. May 1991 – February 1997 3 centers Enrolled to Screened ratio ~ 19%

27. At a mean f.u. time of 10 years… Primary composite end point 1.00 0.75 PCI group 27 (28%) Event-free survival 0.50 0.25 MED group 67 (64%) Log-rank: p < 0.001 0.00 0 5 10 15 Time from randomization (years) Absolute event reduction: 6.3% per year (95% CI, 3.7%-8.9%; P < 0.001) Adjusted hazard ratio: 0.33 (95% CI, 0.20-0.55; P < 0.001)

28. At a mean f.u. time of 10 years… Single end points PCI group MED group Cardiac death Non-fatal MI PCI CABG

29. Change in LVEF over time: PCI group: + 1.7% MED group: - 10.9%

31. VIAMI VIAMI study VIability-guided Angioplasty after Acute Myocardial Infarction

32. To demonstrate that, in MI patients after thrombolysis or with late presentation, stenting of the infarct-related coronary artery will significantly reduce the risk of ischemia in patients with viability in the infarct-area (determined by dobutamine echo) To confirm that patients without viability have a low risk of recurrent ischemic events Primary Outcome Death / Recurrent MI / Unstable angina

33. Inclusion Criteria • Age 18 - 80 yr • Acute MI treated with thrombolysis • (Sub) acute MI without reperfusion therapy • Uneventful before dobutamine echocardiography Exclusion Criteria • Poor echo window • Primary or rescue PCI for AMI • Contraindications to coronary angiography

34. Acute myocardial infarction (post-thromboysis or late presentation) Low-dose dobutamine echo (48-72 h) viability no viability randomisation registry Infarct-related artery conservative stenting (+abciximab) ischemia-guided (angio only in strategy these patients) No angiographic exclusion criteria

35. Invasive Conservative Non-viable (n=106) (n=110) (n=75) Age (y) 60.8 59.7 63.7 Male (%) 75 80 66 Prior MI (%) 6 4 10 Anterior MI (%) 31 33 47 Thrombolysis (%) 53 47 48 T. random – Angio (days) 2 - - Protocol PCI (%) 73 - - CABG (%)11 - - No revascularisation (%)16 - -

36. At 6 months follow up… Invasive Conservative (n=106) (n=110) p-value Prim. Endpoint (%) 6.6 15.5 0.04 Death (%) 1.9 0.9 ns Recurrent MI (%) 1.9 2.7 ns Unstable Angina (%) 2.8 11.8 0.012 Elective revasc. (%) 0 17.3 < 0.01 All revascularisations (%) 4.7 27.3 < 0.01 Non- Viable- viable Conservative (n=75) (n=110) Ischemic events (%) 5.3 14.5 RR 65% (UA or Recurrent MI) P < 0.05

37. Patients with viability in the infarct-area significantly benefit from a strategy of early (in-hospital) stenting • of the infarct-related coronary artery (+abciximab). • This strategy results in a clear reduction of ischemic events and a long-term uneventful clinical course • Patients without viability have a low incidence of • recurrent ischemic events • Viability testing should become a standard tool • in the clinical evaluation of patients in the early • phase after thrombolysis and in STEMI-patients without reperfusion therapy • In patients with viability revascularisation should be considered before hospital discharge

38. (Personal) Conclusions • NEVER forget optimal medical therapy! • If the patient is (remains?) symptomatic… let’s treat! • If the patient is asymptomatic… let’s search for ischemia/viability… but only if high risk (example: post-MI… other subgroups: diabetics? post-CABG?)… • Avoid stress tests as “screening” in asymptomatic low-risk patients… • A lesion-based approach (“FFR” and “pullback FFR”), although invasive, has the potential to be more accurate than a patient-based approach (non-invasive stress tests)…

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