TRATAMIENTO INVASIVO ENFERMEDAD ISQUEMICA ESTABLE. Jonathan Poveda CLINICA BIBLICA 2015

Transcription

1 TRATAMIENTO INVASIVO ENFERMEDAD ISQUEMICA ESTABLE Jonathan Poveda CLINICA BIBLICA 2015

2

3

4

5 COURAGE

6 First coronary angioplasty lesion (circles) two days before (A), immediately after (B), and one month after (C) balloon dilation The First Coronary Angioplasty for Stable CAD; 1977

7 Conventional Wisdom Treatment Assumptions in CAD Management: Patients with symptomatic CAD and chronic angina who have significant coronary stenoses need revascularization Revascularization is required to improve prognosis PCI is less invasive than CABG surgery (i.e., is safer) and, therefore, should be selected

8 Hypothesis PCI + Optimal Medical Therapy will be Superior to Optimal Medical Therapy Alone

9 Primary Outcome Death or Nonfatal MI

10 Secondary Outcomes Death, MI, or Stroke Hospitalization for Biomarker (-) ACS Cost, Resource Utilization Quality of Life, including Angina Cost-Effectiveness

11 Design Randomization to PCI + Optimal Medical Therapy vs Optimal Medical Therapy alone Intensive, guideline-driven medical therapy and lifestyle intervention in both groups 2.5 to 7 year (mean 4.6 year) followup

12 Inclusion Criteria Men and Women 1, 2, or 3 vessel disease (> 70% visual stenosis of proximal coronary segment) Anatomy suitable for PCI CCS Class I-III angina Objective evidence of ischemia at baseline ACC/AHA Class I or II indication for PCI

13 Exclusion Criteria Uncontrolled unstable angina Complicated post-mi course Revascularization within 6 months Ejection fraction <30% Cardiogenic shock/severe heart failure History of sustained or symptomatic VT/VF

14 Objective Evidence of Ischemia Spontaneous ST-T changes on ECG > 1 mm ST deviation on treadmill test Ischemic imaging defect

15 Survival Free of Death from Any Cause and Myocardial Infarction 1.0 Optimal Medical Therapy (OMT) PCI + OMT Hazard ratio: % CI ( ) P = 0.62 Number at Risk Years Medical Therapy PCI

16 Overall Survival 1.0 PCI + OMT OMT Hazard ratio: % CI ( ) P = 0.38 Number at Risk Years Medical Therapy PCI

17 Survival Free of Hospitalization for ACS OMT PCI + OMT Hazard ratio: % CI ( ) P = Number at Risk Years Medical Therapy PCI

18 Survival Free of Myocardial Infarction OMT PCI + OMT Hazard ratio: % CI ( ) P = Number at Risk Years Medical Therapy PCI

19 Conclusions As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, MI, or other major cardiovascular events when added to optimal medical therapy As expected, PCI resulted in better angina relief during most of the follow-up period, but medical therapy was also remarkably effective, with no between group difference in angina-free status at 5 years

20 FREEDOM Trial Main Results AHA 2012 November 4, 2012 Los Angeles, CA Valentin Fuster, MD PhD

21 SYNTAX Trial design: Patients with severe three-vessel or LM disease were randomized to CABG or DES-PCI with paclitaxel-eluting stents. Clinical outcomes were compared at 12 months. Results % (p = 0.002) MACCE CABG (n = 897) % p < 0.001) Repeat revascularization DES-PCI (n = 903) MACCE was significantly lower in CABG arm compared with PCI (12.4% vs. 17.8%, p = 0.002), especially for diabetics (p = ) Significant in the need for repeat revascularization in CABG arm (p < 0.001) Death and MI were similar; CVA with CABG (p = 0.003) Conclusions CABG was associated with fewer repeat revascularizations compared with DES-PCI in patients with LM or three-vessel disease, but a higher rate of stroke No difference in death, MI, or thrombosis Diabetics are especially more likely to benefit with CABG compared with DES-PCI Serruys PW, et al. N Engl J Med 2009;360:961-72

22 (J Am Coll Cardiol 2013;62: )

23 (J Am Coll Cardiol 2013;62: )

24 Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial Friedrich W Mohr, MD, Marie-Claude Morice, MD, A Pieter Kappetein, MD, Ted E Feldman, MD, Elisabeth Ståhle, MD, Antonio Colombo, MD, Michael J Mack, MD, David R Holmes, MD, Marie-angèle Morel, BSc, Nic Van Dyck, RN, Vicki M Houle, PhD, Keith D Dawkins, MD and Patrick W Serruys, MD The Lancet Volume 381, Issue 9867, Pages (February 2013) DOI: /S (13)

25 Source: The Lancet 2013; 381: (DOI: /S (13) ) Terms and Conditions

26 Source: The Lancet 2013; 381: (DOI: /S (13) ) Terms and Conditions

27 (J Am Coll Cardiol 2013;62: )

28

29

30 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Fractional Flow Reserve Guided PCI versus Medical Therapy in Stable Coronary Disease FAME 2 Clinicaltrials.gov NCT Bernard De Bruyne, Nico H.J. Pijls, William F Fearon, Peter Juni, Emanuele Barbato, Pim Tonino, for the FAME 2 study group

31 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Flow Chart Stable CAD patients scheduled for 1, 2 or 3 vessel DES-PCI N = 1220 Randomized Trial FFR in all target lesions Registry At least 1 stenosis with FFR 0.80 (n=888) When all FFR > 0.80 (n=332) Randomization 1:1 PCI + MT 73% MT 27% MT 50% randomly assigned to FU Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years

32 Cumulative incidence (%) FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Primary Outcomes PCI+MT vs. MT: HR 0.32 ( ); p<0.001 PCI+MT vs. Registry: HR 1.29 ( ); p=0.61 MT vs. Registry: HR 4.32 ( ); p< No. at risk MT PCI+MT Registry Months after randomization

33

34

35 Nam, C.W. et al. JACC 2011

36

37 Original Article Randomized Trial of Stents versus Bypass Surgery for Left Main Coronary Artery Disease Seung-Jung Park, M.D., Young-Hak Kim, M.D., Duk-Woo Park, M.D., Sung-Cheol Yun, Ph.D., Jung-Min Ahn, M.D., Hae Geun Song, M.D., Jong-Young Lee, M.D., Won- Jang Kim, M.D., Soo-Jin Kang, M.D., Seung-Whan Lee, M.D., Cheol Whan Lee, M.D., Seong-Wook Park, M.D., Cheol-Hyun Chung, M.D., Jae-Won Lee, M.D., Do-Sun Lim, M.D., Seung-Woon Rha, M.D., Sang-Gon Lee, M.D., Hyeon-Cheol Gwon, M.D., Hyo-Soo Kim, M.D., In-Ho Chae, M.D., Yangsoo Jang, M.D., Myung-Ho Jeong, M.D., Seung-Jea Tahk, M.D., and Ki Bae Seung, M.D. N Engl J Med Volume 364(18):

38 Cumulative Incidence of the Primary End Point of Major Adverse Cardiac or Cerebrovascular Events in the Two Study Groups. Park S-J et al. N Engl J Med 2011;364:

39 Cumulative Incidence of Death from Any Cause, Myocardial Infarction, or Stroke in the Two Study Groups. Park S-J et al. N Engl J Med 2011;364:

40 Clinical End Points. Park S-J et al. N Engl J Med 2011;364:

41 Conclusions In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive.

42 Original Article Randomized Trial of Preventive Angioplasty in Myocardial Infarction David S. Wald, M.D., Joan K. Morris, Ph.D., Nicholas J. Wald, F.R.S., Alexander J. Chase, M.B., B.S., Ph.D., Richard J. Edwards, M.D., Liam O. Hughes, M.D., Colin Berry, M.B., Ch.B., Ph.D., Keith G. Oldroyd, M.D., for the PRAMI Investigators N Engl J Med Volume 369(12): September 19, 2013

43 Enrollment and Follow-up. Wald DS et al. N Engl J Med 2013;369:

44 Kaplan Meier Curves for the Primary Outcome. Wald DS et al. N Engl J Med 2013;369:

45 Details Regarding PCI and Medical Therapy at Discharge. Wald DS et al. N Engl J Med 2013;369:

46 Wald DS et al. N Engl J Med 2013;369: Prespecified Clinical Outcomes.

47 Conclusions In patients with STEMI and multivessel coronary artery disease undergoing infarct-artery PCI, preventive PCI in noninfarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct artery.

48

49

50

51

52

53 ENFERMEDAD MULTIVASO EHJ 2011; 32:

54 FREEDOM Design (1) Eligibility: DM patients with MV-CAD eligible for stent or surgery Exclude: Patients with acute STEMI Randomized 1:1 MV-Stenting With Drug-eluting CABG With or Without CPB All concomitant Meds shown to be beneficial were encouraged, including: clopidogrel, ACE inhib., ARBs, b-blockers, statins

55 MYOCARDIAL INFARCTION Myocardial Infarction, % PCI/DES CABG Logrank P< PCI/DES 13.9 % 6.0% CABG Years post-randomization PCI/DES N CABG N

56 All-Cause Mortality, % ALL-CAUSE MORTALITY 30 PCI/DES CABG 20 Logrank P=0.049 PCI/DES 10 CABG 0 5-Year Event Rates: 16.3% vs. 10.9% Years post-randomization PCI/DES N CABG N

57 Stroke, % STROKE Severely Disabling Scale CABG PCI/DES NIH > 4 55% 27% Rankin >1 70% 60% CABG PCI/DES Logrank P= CABG 5.2% 0 PCI/DES N CABG N PCI/DES 2.4% Years post-randomization

58 Repeat Revascularization, % REPEAT REVASCULARIZATION 30 PCI/DES CABG Log rank P< % 10 PCI/DES 5% 0 CABG Months post-procedure PCI/DES N CABG N

59 Freedom from Event (%) Freedom from Event (%) Freedom from Event (%) PRIMARY ENDPOINT DEATH / STROKE / MI TREATMENT / SYNTAX INTERACTION - SYNTAX Score 22 (N=669) 5-Year Event Rates: 23.2% 17.2% PCI/DES CABG p= SYNTAX Score (N=844) 5-Year Event Rates: 27.2% 17.7% PCI/DES CABG Years post-randomization Years post-randomization SYNTAX Score 33 (N=374) 5-Year Event Rates: 30.6% 22.8% PCI/DES CABG Years post-randomization

60 SUBGROUP ANALYSES CABG Worse PCI/DES Worse Treatment x Subgroup Interaction 5-yr Rate (%) PCI/DES CABG ALL SUBJECTS 1900 SYNTAX SYNTAX SYNTAX Males 1356 Females 544 Caucasian 1452 African-American Vessel Disease Vessel Disease 1573 LVEF < 40% 32 LVEF 40% 1259 No LAD involved 151 LAD involved 1737 Hx stroke 65 No Hx stroke 1835 Renal insuff. 129 No Renal insuff HbA1c < 7% 630 HbA1c 7% 1119 N. American Site 770 Non-N. American 1130 P=0.58 P=0.46 P=0.55 P=0.75 P=0.37 P=0.83 P=0.57 P=0.62 P=0.99 P= Hazard Ratio for Death/Stroke/MI

61

62

63

64

65

66

67

68

69