Pharmaco-Invasive Approach for STEMI

Transcription

1 Pharmaco-Invasive Approach for STEMI Michael C. Kontos, MD Medical Director, Coronary Intensive Care Unit Director, Chest Pain Evaluation Center Associate Professor Departments of Internal Medicine (Cardiology), Radiology and Emergency Medicine Virginia Commonwealth University Medical Center Richmond, Virginia

2 Disclosures Consultant: Roche

3 Primary PCI vs Thrombolysis in STEMI: Quantitative Analysis (23 RCTs, N=7739) Keeley EC, et al. Lancet. 2003;361:13-20

4 Treatment Strategies for Patients with Who Require Transfer for Primary PCI Primary PCI (no matter how long it takes) Full dose fibrinolytics with elective transfer or for rescue PCI Full dose fibrinolytics with routine transfer and rescue PCI as needed Half dose fibrinolytics with transfer and rescue PCI as needed

5 30 Day Mortality for Transfer for Primary PCI vs Immediate Thrombolysis 23% decrease (p=0.02) 58% decrease in re-mi Giuseppe De Luca et al Ann of Emer Med 2008;52;

6 Odds of Death With Fibrinolysis Fibrinolysis Better PCI Better Advantage of PCI Compared With Fibrinolysis Decreases as PCI-Related Delay Increases PCI-Related Delay (door-to-balloon door-to-needle time), min Pinto DS, et al. Circulation. 2006;114:

7 STEMI Door-to-Balloon Times For Transfer Patients Remain Prolonged Time (min) 25 th %tile median Transfer in DTB Times Non-Transfer in DTB Times ACTION Registry-GWTG DATA: January 01, December 31, 2014

8 Facilitated PCI A strategy to enhance primary PCI by improved early infarct vessel patency Options: full dose thrombolytics half dose thrombolytics with GP IIb/IIIa inhibitors GP IIb/IIIa inhibitors alone No benefit and/or worse outcomes ASSENT-IV trial--tnk FINESSE trial TNK +/- abciximab Limitations: minimal delay to PCI, no routine ADP antagonist used

9 Pharmaco-Invasive PCI A strategy to improve fibrinolysis outcomes for patients where transfer for primary PCI cannot be achieved in recommended times Fibrinolytics administered per current guidelines Immediate transfer to PCI centers PCI of the infarct related artery subsequently performed

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11 45% decrease re-mi 35% decrease D/MI

12 April 11, 2013

13 PCI Hospital Ambulance/ER Study Protocol 1892 patients randomized STEMI <3 hrs from onset symptoms, PPCI <60 min not possible, 2 mm ST-elevation in 2 leads RANDOMIZATION 1:1 by IVRS, OPEN LABEL Strategy A: pharmaco-invasive Strategy B: primary PCI <75y:full dose Aspirin Clopidogrel: LD 300 mg + 75 mg QD Enoxaparin: 30 mg IV + 1 mg/kg SC Q12h ECG at 90 min: ST resolution 50% YE S angio >6 to 24 hrs PCI/CABG if indicated After 75y: 20% ½ of dose the TNK planned recruitment, the TNK Aspirin dose was Clopidogrel: reduced by 50% among 75 mg patients QD 75 Enoxaparin: 0.75 years mg/kg of SC age. Q12h N immediate O angio + rescue PCI if indicated no lytic Antiplatelet and antithrombin treatment according to local standards Standard primary PCI Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30

14 Median Times to Treatment (min) Sx onset 1st Medical contact Randomize IVRS Rx TNK min Sx onset 61 1st Medical contact Randomize IVRS 78 min difference Rx PPCI n= Hour 2 Hours 117 min D2B Time 178 min

15 Median Times to Treatment (min) Sx onset 62 1st Medical contact Randomize IVRS 29 9 Rx TNK 100 min 36% Rescue PCI at 2.2h 64% non-urgent cath at 17h Sx onset 61 1st Medical contact Randomize IVRS Rx PPCI n= Hour 2 Hours 178 min 117 min D2B Time

16 a Dth/Shock/CHF/ReMI (%) PRIMARY ENDPOINT TNK vs PPCI Relative Risk 0.86, 95%CI ( ) PPCI 14.3% TNK 12.4% p=0.24

17 30 Day End-Points Pharmaco-invasive PPCI P-value (N=944) (N=948) All cause death (43/939) 4.6% (42/946) 4.4% 0.88 Cardiac death (31/939) 3.3% (32/946) 3.4% 0.92 Congestive heart failure (57/939) 6.1% (72/943) 7.6% 0.18 Cardiogenic shock (41/939) 4.4% (56/944) 5.9% 0.13 Reinfarction (23/938) 2.5% (21/944) 2.2% 0.74

18 Association of PCI-Related Delay and Treatment STREAM Sub-Study 30-day death/chf/mi/shock Gershlick AH et al. Heart 2015;101:692

19 Mortality with Pharmaco-Invasive vs Primary PCI Observational Studies , ,3 4,4 4,4 4,1 3 2, Ottawa Minneapolis Korea Mayo Pharmaco-Invasive Primary PCI Primary PCI

20 Unanswered Questions What does of fibrinolytics should be used? Full dose? 1/2 dose? Is there a benefit of using newer P2Y12 antagonists? ticagrelor, prasugrel When is the ideal time to perform angiography? Immediately? Delayed?

21 No Harm For Early PCI After Fibrinolytics Patient Level Data From 7 Pharmaco-Invasive Trials Maden M, et al JACC Interv 2015;8;166

22 No Harm For Early PCI After Fibrinolytics Patient level Data 7 Trials Maden M, et al JACC Interv 2015;8;166

23 Conclusions Primary PCI remains the optimal reperfusion therapy when performed within guideline recommended times A pharmaco-invasive strategy in patients in whom primary PCI is delayed is effective with similar (if not better) outcomes compared to primary PCI Angiography with intent to carry out revascularization after fibrinolytic treatment should be routinely performed Reduced dose fibrinolytics may be considered in older patients

24 Gracias! Virginia Commonwealth University Medical Center (Medical College of Virginia) Founded 1838 Richmond, Virginia Original Hospital

25 From: Early routine percutaneous coronary intervention after fibrinolysis vs. standard therapy in ST-segment elevation myocardial infarction: a meta-analysis Eur Heart J. 2010;31(17): doi: /eurheartj/ehq204 Eur Heart J Published on behalf of the European Society of Cardiology. All rights reserved. The Author For permissions please journals.permissions@oxfordjournals.org

26 Guideline for STEMI Non-PCI Hospitals

27 ESC Recommendations

28 Median door-in to door-out (DIDO) times, 2009 CMS Data, 1034 hospitals, 13,776 patients Median time 68 (52-91) minutes 9.7% < 30 minutes 31% > 90 minutes Longer DIDO time assoc with increased Mortality! Arch Intern Med. 2011;171(21):

29 Reperfusion Therapy for Patients with STEMI