STEMI Care 2014 at the Crossroads: Taking the right road

Transcription

1 STEMI Care 2014 at the Crossroads: Taking the right road Robert C. Welsh, MD, FRCPC, FESC, FAHA, FACC Professor of Medicine Vice President, The Canadian Association of Interventional Cardiology Director, Adult Cardiac Catheterization and Interventional Cardiology Co-Chair, Vital Heart Response

2 Robert C. Welsh Faculty Disclosure Relationships with commercial interests: Grants/Research Support: Abbott Vascular, Astra Zeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Jansen, Johnson and Johnson, Pfizer, Portola, Regado, Roche, Sanofi Aventis Honoraria: Abbott Vascular, Astra Zeneca, Bayer, Bristol Myers-Squibb, Boehringer Ingelheim, Edwards Lifesciences, Eli Lilly, Medtronic, Roche, Sanofi-Aventis Consulting Fees: Abbott Vascular, Astra Zeneca, Bayer, Edwards Lifesciences, Eli Lilly, Medtronic, Roche, Sanofi-Aventis Other: Employee of Alberta Health Services and University of Alberta and President of The Canadian Centre for Clinicians and Scientists

3 STEMI Care 2014 at the Crossroads 1. Discuss the impact of the primary PCI for all STEMI strategy and its potential global impact. 2. Reaffirm that optimal regional STEMI care requires a dual reperfusion strategy (primary PCI and fibrinolysis). 3. Use clinical trial evidence and real world evidence to elucidate the fibrinolysis pharmacoinvasive strategy.

4 Historical References/Reflections Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Keeley et al; Lancet, 2003 Jan 4;361(9351): A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. Andersen et al; NEngl J Med Aug 21;349(8):

5 Historical References/Reflections Contemporary guidelines recommend primary PCI as the preferred reperfusion strategy Many urban regions and their surrounding referral centres have implemented primary PCI as the sole reperfusion strategy Regions and in fact certain Countries have entirely abandoned fibrinolysis despite the reality that many STEMI patients present to non-pci hospitals The question that remains unclear has the near abandonment of pharmacological reperfusion improved STEMI patients outcomes?

6 Door-to-Balloon Times 30-Day Unadjusted Mortality. Door-to-balloon time and mortality among patients undergoing primary PCI (CathPCI Registry) Menees DS et al. N Engl J Med 2013;369:

7 Evolution of a Regional STEMI Reperfusion Model: The 6-year VCHA Experience C Fordyce, G Wong, J Cairns, K Ramanathan, M Gao, J Park, M Perry, R Vandegriend, CJC Oct 2014, (abst.)

8 % of patients All patients: Initial reperfusion strategy Phase 1 Phase 2 Phase 3 ppci (n=1534) Fibrinolysis (n=340) No reperfusion (n=167) C Fordyce, G Wong, J Cairns, K Ramanathan, M Gao, J Park, M Perry, R Vandegriend, CJC Oct 2014, (abst.)

9 In-hospital mortality (%) All patients: In-hospital mortality 15 n = All pa ents Phase 1 Phase 2 Phase 3 n=2041 n=278 n=979 n=784 C Fordyce, G Wong, J Cairns, K Ramanathan, M Gao, J Park, M Perry, R Vandegriend, CJC Oct 2014, (abst.)

10 Door to Balloon Alliance

11 Vital Heart Response Implementation of STEMI reperfusion resources to Central/Northern Alberta Total area 661,190 km2 Population 3.7 million Rapid diagnosis, triage and treatment

12 Vital Heart Response Contemporary Management of Acute MI Pre-hospital ambulance Pre-hospital fibrinolysis Pre-hospital triage for PCI or in-hospital fibrinolysis Tertiary hospital Edmonton and Patient Northern Alberta Risk higher Inclusive STEMI 3600 patients lower 44% Primary PCI, 40% Pharmacoinvasive 16% - no reperfusion In-hospital mortality 5.9% Rescue PCI Transfer for Primary PCI Pre-hospital fibrinolysis Pre-hospital triage for in-hospital fibrinolysis Community hospital Adapted from Welsh et al AHJ, Jan 2003

13 PRIMARY ENDPOINT Dth/Shock/CHF/ReMI (%) STEMI patients < 3 hours from symptom onset TNK vs PPCI Relative Risk 0.86, 95%CI ( ) PPCI 14.3% TNK 12.4% p=0.24 All cause death or shock or CHF or reinfarction up to day 30 Armstrong PW et al. NEJM, 2013

14 1. Following fibrinolysis the pharmacoinvasive approach improves outcomes compared to a conservative approach 2. A fibrinolytic pharmacoinvasive strategy is associated with similar outcomes to timely primary PCI in patients presenting within 3 hours of symptom onset

15 Pharmacoinvasive Strategy Definition Following evidence based fibrinolysis with appropriate conjunctive anticoagulant and antiplatelet therapy; Failure to Successfully Reperfuse Rescue angiography assessed as <50% ST resolution in the worst lead ST elevation at 90 minutes (60-90 minutes) Hemodynamic instability or refractory ventricular arrhythmia Urgent Angiography following successful reperfusion early (< 6 hours) recurrent ischemia Successful Reperfusion Scheduled angiography within 6-24 hours following successful fibrinolysis (>50% ST resolution in worst lead ST elevation) Armstrong et al, Am Heart J Jul;160(1):30-35

16 Minutes Detailed assessment of the Pharmacoinivasive Strategy 99 min Rescue PCI 130 Rx TNK Sheath insertion min Scheduled PCI Sx onset 1st Medical contact Randomize IVRS Rx PPCI min Median times to treatment (min) according to treatment received Welsh et al; Am J Cardiol Jul 8. 1 Hour 2 Hours 3 Hours 4 Hours 19.9 Hours

17 Dth/Shock/CHF/ReMI (%) Primary Endpoint by treatment received Rescue vs Scheduled Log-Rank: p<0.001 Relative Risk 2.92, 95%CI ( ) PPCI vs Scheduled Log-Rank: p<0.001 Relative Risk 2.32, 95%CI ( ) Rescue 18.7% 40% PPCI 13.9% 5 Scheduled 5.5% 60% Pharmacoinvasive 0 strategy allows a more measured approach to revascularization with: Number at risk: Days since randomization Rescue: PPCI: /5 th managed medically and higher utilization of CABG Scheduled: (5.4% underwent CABG vs. 2.2% with primary PCI (p<0.001)) Poisson regression model with robust error variance. Relative risks (RR) with two-side 95% CI were reported, and these associations were adjusted for the TIMI Risk Score for STEMI. Welsh et al; Am J Cardiol Jul 8.

18 30 day events by treatment received Observed Event Rate, % Adjusted RR(95%CI) P value Death Rescue versus Scheduled Primary PCI versus Scheduled ( ) 1.44( ) Shock Rescue versus Scheduled ( ) Primary PCI versus Scheduled ( ) CHF Rescue versus Scheduled ( ) <0.001 Primary PCI versus Scheduled ( ) <0.001 ReMI Rescue versus Scheduled Primary PCI versus Scheduled ( ) 1.25( ) Rescue or Primary PCI Better Scheduled Angiography Better Poisson regression model with robust error variance. Relative risks (RR) with two-side 95% CI were reported, and these associations were adjusted for the TIMI Risk Score for STEMI. Welsh et al; Am J Cardiol Jul 8.

19 % Myocardial Infarct Size and CHF/Shock: Does the reperfusion strategy matter in early STEMI? 700 Infarct size groups vs. Reperfusion strategy p = 0.02 PI ppci day CHF/ shock stratified by infarct size PI ppci No Small Medium Large Infarct size 0 Small Medium Large Infarct Size Infarct size divided into three groups by peak biomarkers: small: 2x ULN, medium: 2-5x ULN, large: 5x ULN Shavadia et al, CJC Oct 2014 (abstract)

20 Reflections on STEMI care Research translation into practice ASSENT 3+ ( ) WEST ( ) Vital Heart Response ( onwards) - Established paramedic based pre-hospital fibrinolysis in Canada - Expanded pre-hospital reperfusion opportunities - Demonstrated the benefit of a systematic approach with abbreviated time to treatment and excellent clinical outcomes -A region wide systematic approach to STEMI care based on best evidence and regional expertise -Focused on earliest point of care

21 Vital Heart Response 35% 30% 25% 20% 15% 10% 5% 0% Temporal analysis of aborted MI rates according to reperfusion therapy Time of symptom onset to reperfusion P total therapy trend <0.001 PCI Fibrinolysis Total Bainey et al. CJC, Sept 2014 in press

22 Vital Heart Response Clinical impact of aborted STEMI * * * N= * P <= 0.05 comparison between aborted MI vs. STEMI Bainey et al. CJC, Sept 2014 in press

23 Reperfusion Strategy Rural STEMI Patients Metropolitan (Metro) and Non-Metropolitan patients (Non-Metro) N=1990 N=1602 Shavadia et al. Can J Cardiol Jan 14.

24 Vital Heart Response - In-hospital events Metropolitan (Metro) and Non-Metropolitan patients (Non-Metro) N=1990 N=1602 % A Dedicated Fibrinolysis Pharmacoinvasive Strategy applied to non-metropolitan patient negates the risk of living in a rural environment. Shavadia et al. Can J Cardiol Jan 14.

25 Summary 1. In 2014, optimal STEMI care requires regional access to primary PCI and fibrinolysis with an individual patient risk - based reperfusion strategy 2. Following fibrinolysis the pharmacoinvasive strategy improves outcomes and should be employed within a dedicated STEMI system of care

26 Summary Pharmacoinvasive 3. Clinical vigilance for reperfusion success and urgent catheterization in the setting of reperfusion failure (rescue) or with early recurrent ischemia is warranted 4. Following successful fibrinolysis - scheduled early angiography (6-24 hours) should be encouraged Provides an optimal medical and interventional interplay with excellent patient outcomes and rational cost effective approach to revascularization

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