Update on Care of ST-Elevation MI Patient: The EMMC Experience. Peter VerLee MD Northeast Cardiology Cath Lab Director EMMC

Transcription

1 Update on Care of ST-Elevation MI Patient: The EMMC Experience Peter VerLee MD Northeast Cardiology Cath Lab Director EMMC

2 Conflict of Interest No conflict to declare

3 7 Alternatives to Evidence Based Medicine Basis for Clinical Decisions Marker Measuring device Unit of measurement Evidence Randomized Meta-analysis Odds Ratio Controlled trial Eminence Radiance of Luminometer Optical Density white hair Vehemence Stridency Audiometer Decibels Eloquence Smoothness Teflometer Adhesin score of tongue Providence Level of religious Sextant to measure IU of piety fervor angle of genuflection Diffidence Level of gloom Nihilometer Sighs Nervousness Litigation phobia Every conceivable Bank Balance level test imaginable Arrogance* Bravado Sweat test No Sweat *Applies only to surgeons BMJ 1999;319:1618

4 Update on STEMI Care Brief History of STEMI studies Current studies Current protocols EMMC outcomes

5 STEMI case RR - 69 yo male with sudden onset of right sided arm weakness, heartburn, indigestion, throat tightness Friend gave him 325 aspirin, drove him to SJH ED PMH HTN, lipids, DM II, smoker, On no meds Exam BP 173/78, HR 46 normal heart sounds (bradycardic) clear lungs, abd soft, nl pulses, nl neuro Cr 1.32, HB 15, plt 282, trop I < 0.04

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7 STEMI case Patient was treated with asa/ticagrelor 180 heparin bolus and drip and taken by Bangor Fire from SJH to CCL

8 RCA LAO projection 100% RCA Occlusion

9 RCA RAO

10 Post balloon

11 Stent Deployment

12 Final Stent

13 Final RAO

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15 Apical 4

16 Apical long

17 STEMI Case Patient returned for LAD and Cx stents 10/30, DC on 10/31 Peak CK 943, MB 67.9 Echo EF = 62 % DC on ASA/plavix/Amlodipine/Atorva/NTG prn

18 STEMI care 70s & 80s small studies using guide wire to dislodge thrombus 80s multiple studies using IC and IV streptokinase for STEMI 90s emergence of tpa/tnk IV lytic strategies. Emphasis on Door-to-Needle time End of 90s Primary PCI emerges

19 Summary of Lytic trials Regimen of Aspirin, Heparin, TNK achieves a mortality floor of ~6% Plavix now added as well (CLARITY study) TNK or rpa are favored agents now due to ease of use. More aggressive agents or combinations led to increased intracranial hemorrhage 20% of patients don t reperfuse; 40% don t achieve normal microvascular flow

20 Primary PCI studies DANAMI-2 and PRAGUE-2 studies showed superior outcomes with Primary PCI compared to lytic Rx (4-5% mortality) Initially PTCA used CADILLAC study showed superior outcomes with stents Mortality as low as 3% in some studies

21 Primary PCI vs Lytics Primary PCI Lower mortality 95% vessel patency 80% normal microvascular flow Very low rates of reinfarction-reocclusion Virtually 0% risk of intracranial hemorrhage Requires a cath lab-only 1/3 of patients eligible in Northern Maine Lytic Rx Ease of use 75% vessel patency 50-60% normal microvascular flow Higher rates of reinfarction-reocclusion ~1% risk of intracranial hemorrhage More widely available 2/3 of patients in Northern Maine

22 Northeastern Maine is Different National estimates suggest that 70-80% of patients live within an hour of a hospital capable of primary PCI In Northern Maine, 30% of patients in our referral area live within an hour of EMMC

23 What about a combination strategy? Facilitated PCI failed in early studies, increased risk of bleeding, no benefit in mortality Things are a little different now, more use of thienopyridines, better understanding of vascular complications Facilitated PCI has not caught on

24 Some definitions Primary PCI-Patient presents to Hospital with a Cath Lab and is taken immediately to CCL. Asa/plavix/heparin. Facilitated PCI-Patient is given a regimen of ASA/Plavix plus Lytic+2b3a and taken to CL in less than 90 min Rescue PCI-Patient is treated with lytics (at non-ccl hospital) and undergoes PCI when/if they fail to reperfuse Pharmaco-Invasive PCI. TRANSFER-AMI study. PCI 2-6 hours after standard asa/plavix/heparin/lytic.

25 How is Pharmaco-invasive different from Facilitated PCI? Cath 2-6 hours after regimen, instead of immediately For many patients, they are the same From a practical standpoint, this works well in Northern Maine, where Transfer times typically take 2-6 hours TRANSFER-AMI study, landmark trial showing superiority of a lyse, ship & cath everyone, regardless of how they are doing after lytic regimen.

26 TRANSFER AMI study 1000 Patients presented with STEMI to non-pci hospitals in Ontario CA. All patients received ASA/heparin/TNK strongly encouraged to receive plavix Randomized to immediate transfer for PCI or wait-and-see approach Patients in immediate transfer arm cathed/stented around 2-4 hours. In delayed arm, cath/stented around 27 hours

27 High Risk ST Elevation MI within 12 hours of symptom onset Community Hospital Emergency Department TNK + ASA + Heparin / Enoxaparin + Clopidogrel Pharmacoinvasive Strategy Urgent Transfer to PCI Centre Standard Treatment Assess chest pain, ST resolution at minutes after randomization Failed Reperfusion* Successful Reperfusion PCI Centre Cath Lab Cath / PCI within 6 hrs regardless of reperfusion status Cath and Rescue PCI GP IIb/IIIa Inhibitor Elective Cath PCI > 24 hrs later Repatriation of stable patients within 24 hrs of PCI * ST segment resolution < 50% & persistent chest pain, or hemodynamic instability Randomization stratified by age ( 75 vs. > 75) and by enrolling site

28 n=496 n=508 Primary Endpoint: 30-Day Death, re-mi, CHF, Severe Recurrent Ischemia, Shock % of Patients OR=0.537 (0.368, 0.783); p= Standard PCI > 24 hrs (n=496) Invasive < 6 hrs (n=508) Days from Randomization

29 Components of Primary Endpoint Standard Treatment (n=498) Death 3.6 Reinfarction 6.0 Recurrent Ischemia 2.2 Death/MI/Ischemia 11.7 New / worsening CHF 5.2 Cardiogenic Shock 2.6 Pharmacoinvasive Strategy P-Value (n=512)

30 Safety Endpoints - Bleeding Standard Treatment (n=498) Intracranial hemorrhage 1.2 TIMI scale Major 4.6 Major (non-cabg-related) 3.2 GUSTO scale Moderate 2.2 Severe 1.4 Severe (non-cabg-related) 1.2 Transfusions 5.5 Pharmacoinvasive Strategy P-Value (n=512)

31 Conclusions For high-risk STEMI patients receiving thrombolysis at non-pci centres, urgent transfer and PCI within 6 hours is associated with significantly less ischemic complications and no excess in bleeding Transfers to PCI centres should be initiated immediately after thrombolysis without waiting to see whether reperfusion is successful Regional systems should be developed to ensure timely transfers of STEMI patients to PCI centres

32 Summary Compared with Standard Treatment, a Pharmacoinvasive Strategy of routine early PCI within 6 hrs after thrombolysis is associated with a 6% absolute (46% relative) reduction in the composite of death, reinfarction, recurrent ischemia, heart failure and shock The pharmacoinvasive strategy is not associated with any increase in transfusions, severe bleeding or intracranial hemorrhage despite high use of GP IIb/IIIa inhibitors during PCI In contrast to older trials, routine early PCI after thrombolysis using stents and contemporary pharmacotherapy is safe and effective Benefit seen despite high cath/pci rates in Standard Treatment group (including ~40% rescue PCI)

33 Current EMMC protocols Greater Bangor area-primary PCI Outside GBA- Pharmaco-invasive PCI How do we do?

34 Bangor Area Since 2001, all patients with STEMI get primary PCI 24 hours a day Asa/Plavix/heparin/+Integrilin ED Activates Code STEMI. Since ECG in field paramedic calls ED Activates Code STEMI (thank you Dr. Busko)

35 Outside Bangor area Since 2009 lyse, ship & cath strategy Pharmaco-invasive strategy Asa/Plavix/TNK/Heparin Transfer patient as quickly as possible Patients usually taken to cath lab within 6 hours

36 Outcomes in STEMI PCI Past 3 years 511 STEMI patients Cases Deaths Mortality Rate 2.65% 2.44% 2.04% Combined Primary and Facilitated/Rescue/ PCI Data from NNE database

37 Breakdown of STEMI PCI Cases Deaths Mortality Rate ST elevation or new LBBB % Primary % Rescue % Facilitated % Unknown % Combined Rescue/Facilitated/Unknown PCI = 3 deaths in 303 cases or 1% Probable Selection bias. Doesn t count patients who didn t survive to reach the cath lab

38 Outcomes by subgroups Cases Deaths Mortality Rate ST elevation or new LBBB % Diabetes No Diabetes Male Female Under 75 years years or Older

39 Average Door-to-Balloon Time Target = 90 min FY 00 n = 16 FY 01 n = 19 FY 02 FY 03 n = 31 FY 04 n = 39 FY 05 n = 38 FY 06 n = 46 FY 07 n = 42 FY 08 n = 35 FY 09 n = 27 Min

40 Percent of Patients with D2B times 90 min 100% 80% 60% 40% 20% 0% FY 00 n = 16 FY 01 n = 19 FY 02 FY 03 n = 31 FY 04 n = 39 FY 05 n = 38 FY 06 n = 46 FY 07 n = 42 FY 08 n = 35 FY 09 n = 27 Met Target 27% 29% 25% 39% 46% 68% 65% 86% 83% 96%

41 minutes Average Door-to-Balloon Time: By Time of Day (Cath Lab Regular vs Off Hrs) Key Factors: Code STEMI activated pre-arrival ED-Bypass---EMS direct to cath lab 0 FY 00 FY 01 FY 02 FY 03 FY 04 FY 05 FY 06 FY 07 FY 08 FY 09 Reg Hrs Off Hrs

42 PCI at EMMC Pretreatment with ASA/Plavix/Heparin Aspiration with Export Catheter if large thrombus Direct stenting when possible (without predilation) Bare Metal Stents for large vessels and patients where compliance with DAPT is uncertain Drug Eluting Stents for small vessels, diabetics, if DAPT compliance is felt to be high

43 Coronary stent

44 Thrombectomy Many procedures marked by No Reflow phenomenon No Reflow due to embolism of thrombus/plaque, microvascular dysfunction, spasm Can often be prevented by thrombus aspiration TAPAS trial showed lower cardiac death and recurrent MI at one year with thrombus aspiration Thrombus aspiration now routine in cases where large thrombus visible or artery is occluded

45 Hypothermia Patients with VF with STEMI After return of spontaneous circulation with no neurologic recovery, hypothermia protocol initiated Cooling blanket, paralysis, sedation, ventilation, temp kept at 32-34º C for 24 hrs Possible to do cath/stenting in hypothermic patient Studies have shown improved survival to discharge with hypothermia, 40-50% vs 15-20%.

46 New Directions Extension of primary PCI to outside GBA How large to make the circle? 40 miles? Patients picked by EMS with a 12 lead ECG within 40 mile circle would bypass local hospital and drive directly to EMMC Obviously, we need to get the buy-in hospitals affected by this

47 40 mile circle From EMMC

48 Distances from EMMC Based on Google Maps Mayo Dover-Foxcroft -38 miles CAD-Greenville-72 miles MRH-Millinocket-70 miles PVH Lincoln -45 miles MCMH Ellsworth-29 miles MDI Bar Harbor-49 miles BHMH-Blue Hill-38 miles WCGH-Belfast-39 miles PVH-Pittsfield-37 miles IH-Waterville-48 miles (same for MGH) RFGH-Skowhegan-54 miles

49 Distances from EMMC Only Pittsfield, Dover-Foxcroft, Ellsworth, Blue Hill and Belfast are within the 40 mile limit

50 Conclusions EMMC cardiology has excellent outcomes. 4% mortality in primary PCI for STEMI Outcomes in rescue/pharmaco-invasive probably artificially low do to selection bias PCI/stenting has become the standard for treatment of STEMI either as primary PCI or pharmaco-invasive strategy Current regimen of Aspirin/Plavix/Heparin thrombectomy and stenting results in nearly 100% vessel patency with low risk of bleeding, vascular complications New directions include expanding EMS and community awareness of PCI for STEMI, enlarging the circle of eligible patients