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An Evidence-Based Approach to STEMI: The Emergency Department Perspective

Learn about ST-Elevation Myocardial Infarction (STEMI) management approaches in the emergency department, including early reperfusion therapy, time-dependent outcomes, care protocols, and contraindications. Stay updated on the latest studies and guidelines.

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An Evidence-Based Approach to STEMI: The Emergency Department Perspective

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  1. An Evidence-Based Approach to STEMI: The Emergency Department Perspective Charles V Pollack, Jr, MA, MD, FACEP, FAAEM Professor and Chairman, Emergency MedicinePennsylvania HospitalUniversity of Pennsylvania Health System Philadelphia, Pennsylvania

  2. Spectrum of Acute Coronary Syndromes Presentation Ischemic Discomfort at Rest No ST-segment Elevation ST-segment Elevation Emergency Department + + + + In-hospital 6-24 h NSTEMI Q-waveMI Non-Q-waveMI Unstable Angina (+ : positive cardiac biomarker)

  3. Evidence-Based Therapy 2006: STEMI • Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction. Full text at www.acc.org; also in Circulation. 2004;110:e82-e293. • Pollack CV, Diercks DB, Roe MT, Peterson ED. 2004 ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: Implications for emergency department practice. Ann Emerg Med. 2005;45:363-376. • New studies of interest since the Guidelines Antman EM, et al. Circulation. 2004;110:e82-e293. Pollack CV, et al. Ann Emerg Med. 2005;45:363-376.

  4. Importance of Early Reperfusion Therapy in STEMI Outcomes Dependent Upon: • Time to treatment: TIME IS STILL MUSCLE • Early and full restoration of coronary blood flow • Sustained restoration of flow

  5. Time Delays and 30-Day Outcome Loss of benefitper hour of delay:1.6 ± 0.6 lives per 1000 patients 40 3000 14,000 30 12,000 45,000 patients in placebo-controlled lytic trials Lives Saved/1000 Patients 9000 20 10 7000 0 0 6 12 18 24 Hours From Onset of Symptomsto Randomization Collins R, et al. N Engl J Med. 1997;336:847-860.

  6. Time Delays and 30-Day Outcome 2.2 P < .001 P < .001 P = .01 1.8 1.62 1.61 1.41 1.4 Multivariate Adjusted Odds of Death 1.15 1.14 1 0.6 0.2 0-60 61-90 91-120 121-150 151-180 > 180 n = 2230 5734 6616 4461 2627 5412 Door-to-Balloon Time, min NRMI, National Registry of Myocardial Infarction; PCI, percutaneous coronary intervention. Cannon CP, et al. JAMA. 2000;283:2941-2947.

  7. Patients Transported by EMS After Calling 911 Hospital Fibrinolysis: Door-to-needle within 30 min Onset of STEMI Symptoms EMSTriagePlan Not a PCI- Capable Hospital • EMS on scene • Encourage 12-lead ECGs • Consider prehospital fibrinolyticifcapableand EMS-to-needle within 30 min Call 911—Call Fast InterhospitalTransfer 911 EMS Dispatch PCI- Capable Hospital PPCI: Door-to-balloon within 90 min GOALS: Patient Dispatch EMS transport EMS on scene EMS transport: EMS to balloon within 90 min 5 min after Sx onset Within 8 min Patient self-transport: Hospital door-to-balloonwithin 90 min 1 min Total ischemic time: Within 120 min* * Golden hour = first 60 minutes. Antman EM, et al. Circulation. 2004;110:e82-e293.

  8. Hospital Care: STEMI C C C C B B I IIa IIb III Basic Therapy Oxygen if pulmonary congestion Oxygen to all STEMI patients during first 6 h NTG for ongoing ischemic discomfort or for management of pulmonary congestion No NTG if SBP < 90 or if evidence of RV infarction No NTG if patient has received sildenafil < 24 h MS is analgesic of choice for STEMI pain NTG, nitroglycerin; MS, morphine sulfate; SBP, systolic blood pressure; RV, right ventricular. Antman EM, et al. Circulation. 2004;110:e82-e293.

  9. Hospital Care: STEMI C C A A B I IIa IIb III Immediate aspirin (ASA) ASA dose is 162-325 mg Substitute clopidogrel or ticlopidine if true ASA allergy is present IV→oral -blocker therapy given promptly unless contraindicated, regardless of management strategy Basic Therapy Antman EM, et al. Circulation. 2004;110:e82-e293.

  10. Reperfusion Therapy for STEMI C C A A A I IIa IIb III If expert primary PCI is not available within90 min of first medical contact, lysis unless contraindicated In absence of absolute contraindications, lysis for symptoms of STEMI and: • ST  > 0.1 mV in ≥ 2 contiguous leads • New or presumably new LBBB • ECG findings of true posterior AMI No lytic therapy for: • Asx patients with symptoms > 24 h ago • Only ST  unless true posterior MI is suspected Antman EM, et al. Circulation. 2004;110:e82-e293.

  11. Contraindications to Lytic Therapy • Class I • Any history of ICH • Significant CHI past 3 months • Ischemic CVA past 3 months • Uncontrolled hypertension • Class IIA • TIA or ischemic CVA past 3 to 6 months • History of dementia • “It is preferable to treat STEMI patients at substantial (≥ 4%) ICH risk with PCI rather than with fibrinolytic therapy” ICH, intracranial hemorrhage; CHI, closed head injury; CVA, cerebrovascular accident; TIA, transient ischemic attack. Antman EM, et al. Circulation. 2004;110:e82-e293.

  12. Angioplasty Facilities in the US 10% Hospitals with angioplastyfacilities with on-site cardiacsurgical support: 10% 10% Hospitals with angioplastyfacilities that lack on-sitecardiac surgical support: 10% 80% Hospitals without angioplastyfacilities: 80% Antman EM, et al. Circulation. 2004;110:e82-e293.

  13. Implications for the ED • “Time is Muscle” • In most US hospitals, expert intervention for STEMI is not available within 90 minutes; even in fully interventional centers, a lytic protocol should be in place

  14. STEMI Reperfusion Options Lytics PCI Reperfusion should be “early, complete, and sustained” in both the coronaries and the microcirculation

  15. Symptoms < 3 h Goal = myocardial salvage Lytics and PCI have similar benefit Symptoms > 3 h Goal = Open the infarct-related artery PCI more beneficial Problem 95 min (mean) Sx onset to hospital arrival “Golden Window” of Salvage 0 4 8 12 16 20 24 Shifts in Potential Outcomes With Different Treatment Strategies A to B No Benefit A to C Benefit B to C Benefit D to B Harm D to C Harm 100 D 80 60 C Mortality Reduction, % 40 20 B A Extent of Myocardial Salvage 0 Time From Symptom Onset to Reperfusion Therapy, h Critical Time-Dependent Period Goal: Myocardial Salvage Time-Independent PeriodGoal: Open Infarct-Related Artery Gersch BJ, et al. JAMA. 2005;293:979-986.

  16. CAPTIM: 1-Year Results: Sx to Treatment Analysis STEMI Within 6 h; N = 840 (419 PHL, 421 PPCI) Sx  2 h Sx  2 h 7.5 10.0 Death Death P = .058 P = .47 5.7 7.5 5.0 5.9 Percent Percent 5.0 3.7 2.2 2.5 2.5 0.0 0.0 Prehospital Lysis Primary PCI Prehospital Lysis Primary PCI Steg PG, et al. Circulation. 2003;108:2851-2856.

  17. DANAMI-2: Results STEMI < 12 h; N = 1572 Only 2% of patients randomized to lysis required rescue PCI . . . and 96% of transfer patients had DTB < 2h! Death Recurrent MI Stroke P = .35 P < .001 P = .15 7.8 8 8 8 6.6 6.3 6 6 6 Death/MI/Stroke, % 4 4 4 2.0 2 2 2 1.6 1.1 0 0 0 Lytic Primary PCI Lytic Primary PCI Lytic Primary PCI Anderson HR, et al. N Engl J Med. 2003;349:733-742.

  18. PRAGUE-2: 30-Day Mortality STEMI < 12 h; N = 850 Sx  3 h (n = 551) Sx  3 h (n = 299) 20.0 20.0 Death Death P = NS P ≤ .02 15.3 15.0 15.0 Mortality, % Mortality, % 10.0 10.0 7.4 7.3 6.0 5.0 5.0 0.0 0.0 Lysis Primary PCI Lysis Primary PCI Widimsky P, et al. Eur Heart J. 2003;24:94-104.

  19. Skilled PCI laboratory available with surgical backup Medical contact-to-balloon time is < 90 min Door-to-balloon minus door-to-needle time is < 60 min High risk from STEMI Cardiogenic shock Killip class ≥ 3 Contraindications to fibrinolysis, including increased risk of bleeding and ICH Late presentation Symptom onset was > 3 h ago Diagnosis of STEMI is in doubt Fibrinolysis is generally preferred if: Very early presentation (3 h or less from symptom onset and delay to invasive strategy) Invasive strategy is not an option Cath lab occupied/not available Vascular access difficulties Lack of access to a skilled PCI lab: Operator experience > 75 PPCI cases per year AND team experience > 36 PPCI cases per year Delay to invasive strategy Prolonged transport Door-to-balloon minus door-to-needle time is > 60 min Medical contact-to-balloon time is > 90 min Fibrinolytic Versus Interventional Management An invasive strategy is generally preferred if:

  20. Mortality Rates With Primary PCI as a Function of PCI-Related Time Delay Circle sizes = sample size of the study Solid line = weighted meta-regression 15 10 P = .006 Absolute Risk Difference in Death, % 5 BenefitFavors PCI 62 min 0 HarmFavors Lysis –5 20 60 80 0 40 100 PCI-Related Time Delay (door-to-balloon—door-to-needle) For every 10-min delay to PCI: 1% reduction in mortality difference towards lytics Nallamothu BK, Bates ER. Am J Cardiol. 2003;92:824-826.

  21. Mortality Rates With Primary PCI as a Function of PCI-Related Time Delay If door-to-balloon time is 62 min longer than door-to-needle time, the lytic approach should be strongly considered.

  22. Post-2004 Guidelines Data

  23. CLARITY-TIMI 28 Trial: Study Design Double-blind, randomized, placebo-controlled trial in3491 patients, aged 18-75 y, with STEMI < 12 h Fibrinolytic, ASA, Heparin R A N D O M I Z E D Clopidogrel 300 mg + 75 mg QD Placebo Study Drug Primary Endpoint: Occluded artery (TIMI flow grade 0/1) or death/MI by time of angio Coronary Angiogram (2-8 days) Open-label clopidogrel per MD inboth groups 30-day clinical follow-up Sabatine MS, et al. N Engl J Med. 2005;352:1179-1189.

  24. CLARITY-TIMI 28 Trial: Primary Endpoint Occluded Artery or Death/MI (Before Angio/HD) 25 20 15 10 5 0 Odds Ratio: 0.64(95% CI, 0.53-0.76) 36% Odds Reduction 21.7 P < .001 15.0 Occluded Artery or Death/MI, % 0.4 0.6 0.8 1.0 1.2 1.6 Clopidogrel Better Placebo Better n = 1752 n = 1739 Clopidogrel Placebo HD, hospital discharge. Sabatine MS, et al. N Engl J Med. 2005;352:1179-1189.

  25. CLARITY-TIMI 28: LMWH Versus UFH—30-Day Outcomes Sabatine MS, et al. Circulation. 2005;112:3846-3854.

  26. ExTRACT-TIMI 25: Protocol Design STEMI < 6 hLytic eligible Lytic choice by MD(TNK, tPA, rPA, SK) ASA Double-blind, double-dummy ENOXAPARIN (N=10,256) < 75 y: 30 mg IV bolus SC 1.0 mg / kg q 12 h (Hosp DC) ≥ 75 y: No bolus SC 0.75 mg / kg q 12 h (Hosp DC) CrCl < 30: 1.0 mg / kg q 24 h UFH (N = 10,223)60 U / kg bolus (4000 U) Inf 12 U / kg / h (1000 U / h)Duration: at least 48 hCont’d at MD discretion Day 301° Efficacy End Point: Death or Nonfatal MI1° Safety End Point: TIMI Major Hemorrhage ExTRACT = Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Antman EM et al. N Engl J Med. 2006;354:1477-1488. Adapted with permission from http://www.clinicaltrialresults.com.

  27. ExTRACT-TIMI 25: Primary End Point (ITT) Death or Nonfatal MI UFH 12.0% 17% RRR 9.9% Enoxaparin Primary End Point (%) Relative Risk0.83 (95% CI, 0.77 to 0.90)P<.001 Lost to follow-up = 3 Days after Randomization Adapted with permission from Antman EM, et al. N Engl J Med. 2006;354:1477-1488.

  28. ExTRACT-TIMI 25: Death or Nonfatal MI Day 30 Major Subgroups Reduction In Risk (%) 18 Male Sex All Interaction TestsP = NS 16 Female 20 < 75 y Age (y) 6 > 75 y 11 Infarct Anterior Location 23 Other 17 No DM Diabetes 21 DM 17 No Prior MI Prior MI 20 Prior MI 13 Streptokinase Fibrinolytic 18 Fibrin-specific 23 < Median Time to Rx 12 > Median 17 P < .001 20,479 OVERALL 0.5 1 2 ENOX Better UFH Better Relative Risk Adapted with permission from Antman EM, et al. N Engl J Med. 2006;354.

  29. ExTRACT-TIMI 25: Bleeding End Points (TIMI) at 30 Days UFH Enoxaparin ARD = 0.7%RR = 1.53P <.001 ARD = 0.4%RR = 1.39P = .014 ARD = 0.1%RR = 1.27P = .14 % Events Major Bleed(fatal + nonfatal) NonfatalMajor Bleed ICH Antman EM, et al. N Engl J Med. 2006;354:1477-1488.

  30. ExTRACT-TIMI 25: For Every 1000Patients Treated With Enoxaparin (No increase in nonfatal ICH) Events / 1000 Pts Nonfatal reMI Urgent Revasc. Nonfatal TIMI Major Bleed Death Antman EM, et al. N Engl J Med. 2006;354:1477-1488.

  31. ExTRACT PCI Cohort: Efficacy Results Primary Endpoint: Death or Nonfatal MI by 30 Days UFH 15 13.8% 23% RRR 10.7% 10 Enoxaparin Death or MI (%) Relative Risk 0.77 P=0.001 5 0 0 5 10 15 20 25 30 Days After Randomization Nonfatal Recurrent MI by 30 Days 15 UFH 10.9% 28% RRR 10 7.8% Nonfatal MI (%) Enoxaparin 5 Relative Risk 0.72 P<0.001 0 0 5 10 15 20 25 30 Days After Randomization Gibson CM et al. Presented at: ESC/WCC; September 4, 2006; Barcelona, Spain. Presentation 708001. Available at http://www.escardio.org/knowledge/congresses/CongressReports/hotlinesandctus/708001_Gibson.htm. Accessed September 14, 2006.

  32. OASIS-6 Trial: Study Design 12,092 patients presenting with STEMI within 24 hours of symptom onset (shortened to 12 hours of symptom onset midway through trial) Randomized, Blinded, Factorial. 28% female, mean age, 62 years, mean follow-up, 3-6 months Stratum 2 (UFH) N=6,434 Stratum 1 (No UFH) N=5,658 UFH N=3,221 Fondaparinux N=3,213 2.5 mg/day for up to 8 days or hospital discharge Fondaparinux N=2,823 2.5 mg/day for up to 8 days or hospital discharge Placebo N=2,835 • Primary end point: Composite of death or reinfarction at 30 days • Secondary end point: Composite of death or reinfarction at 9 days and at final follow-up Yusuf S, et al. JAMA. 2006;295:1519-1530. Adapted with permission from www.clinicaltrialresults.org.

  33. OASIS-6 Trial: Results Reduction in Death/MI at 30 days: Stratum 1 (No UFH indicated) P<.05 14% 14% Primary End Point: Death/Reinfarction (%) 11.2% 12% 10% 14.8% 15% 8% 13.4% 6% 11.2% 12% 4% 9.7% 8.9% 2% 9% 7.4% Frequency 0% Fondaparinux Placebo 6% Reduction in Death/MI: Stratum 2 (UFH Indicated) P=NS 14% 3% P=.008 P=.003 P=.008 12% 0% 10% 8.7% 8.3% 30 days 9 days 3-6 months 8% p=0.97 6% Control (n=6056) Fondaparinux (n=6036) 4% 2% 0% Yusuf S, et al. JAMA. 2006;295:1519-1530. Adapted with permission from www.clinicaltrialresults.org Fondaparinux UFH

  34. OASIS-6: Severe Bleeding at 9 Days Yusuf S, et al. JAMA. 2006;295:1519-1530.

  35. OASIS-6 Trial: PCI Substudy at 30 Days Primary Endpoint of Death or MI in PCI Cohort (%) P =.19 • There was no difference in the primary endpoint for patients who were managed with primary PCI (6.1% vs 5.1%, P=.19) • Guiding catheter thrombosis in the primary PCI cohort occurred more often with fondaparinux compared with control (n=22 vs n=0, P <.001) Yusuf S, et al. JAMA. 2006;295:1519-1530. Adapted with permission from www.clinicaltrialresults.org

  36. OASIS-6 Trial: PCI Substudy (cont.) Coronary Complications P=.04 • Coronary complications occurred in more patients treated with fondaparinux compared to control (n=270 vs n=225, P=.04) • Coronary complications include abrupt closure, no reflow, dissection, new angiographic thrombus, perforation, or catheter thrombus Yusuf S, et al. JAMA. 2006;295:1519-1530. Adapted with permission from www.clinicaltrialresults.org

  37. OASIS-6 Trial: Clinical Implications • In patients with STEMI, particularly those not undergoing primary PCI, fondaparinux significantly reduces mortality and reinfarction without increasing bleeding and strokes compared with placebo/UFH • Benefits of fondaparinux were observed in Stratum 1 where placebo or no antithrombin was administered • Fondaparinux trended to produce less severe bleeding • Fondaparinux was associated with a hazard inthose patients who underwent primary PCI, including the development of guiding catheter thrombosis

  38. New data from the Vienna STEMI registry reinforces benefit—mostly seen in Europe—of prehospital lysis • Reducing time to treatment requires close collaboration among prehospital, ED, and cardiology resources Kalla K et al, Circulation 2006;113:2398-2405

  39. Conclusions: STEMI • Optimal medical care of STEMI begins in the prehospital setting, continues in the ED, and culminates in a prompt and informed decision about reperfusion strategy. • Optimal outcomes in STEMI can be achieved only with a multidisciplinary approach. The ACC/AHA Guidelines invest initial decision making authority in the emergency physician.

  40. Conclusions: STEMI • Even though direct PCI is preferable when available, lysis remains a viable option in selected patients, even in “cathing centers” when delays to PCI intervene. • New research indicates that lytic outcomes can be improved with new adjunctive agents. • Prehospital lysis, not often used in the US, may further improve outcomes.

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