By Joseph L. Fredi, M.D., FACC, and Carol R. Scott, B.S.N., M.S.N., Medical Directors, STEMI Network Vanderbilt Heart and Vascular Institute

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1 STEMI Network STEMI News By Joseph L. Fredi, M.D., FACC, and Carol R. Scott, B.S.N., M.S.N., Medical Directors, STEMI Network Vanderbilt Heart and Vascular Institute Joseph L. Fredi, M.D., FACC Unless we are able to change current statistics, one in two Americans will die of cardiovascular disease. For Tennesseans the news is worse than that. According to the Centers for Disease Control and Prevention, Tennessee ranks 47th of 50 states for cardiovascular mortality. Furthermore, for patients suffering from acute myocardial infarction (AMI), hospital performance for AMI patients is one of the five worst in the United States. There are locations in Tennessee where the 30-day mortality for an AMI patient is a staggering 25 percent! Acute myocardial infarction is one of the apex predators in the world of cardiovascular disease. Currently there are about 1 million AMIs/year in the United States, of which ST segment elevation myocardial infarction (STEMI) constitutes at least half. Patients suffering from STEMI generally have a worse prognosis and constitute a specific subset that requires a defined approach to treatment. In January 2007 the Vanderbilt STEMI Network was formed to create such an approach for STEMI patients. Vanderbilt Heart and Vascular Institute had already joined the cardiac stem cell consortium and is still one of only five centers in the United States that offers autologous stem cell treatment following MI as myocardial regenerative therapy. With the formation of the Vanderbilt STEMI Network an important step was taken to try to minimize cardiac damage for STEMI patients. Vanderbilt was the first institution in Tennessee to pioneer both approaches for STEMI patients. STEMI patients present a particular challenge because of the many complications that can ensue. We now know, however, that minimizing cardiac damage at the time of the initial infarct provides the single most powerful treatment we can offer STEMI patients. Timely percutaneous coronary intervention (PCI) at the time of the initial AMI is the best method to achieve that goal. Specialized, coordinated emergency networks can dramatically reduce time to treatment with PCI and improve outcomes. In order to achieve these goals it requires the organization of STEMI networks that coordinate the efforts of EMS personnel, Emergency Departments, and cardiology teams; in the past these teams of providers have coexisted, but now it is important to recognize that for best STEMI care these teams need to coordinate STEMI care into a seamless flow of events from field to hospital to cardiac center. It is that coordination and cooperation that forms the essence of excellent care for STEMI patients. For us in Tennessee and in this region it is critical to do this; we have one of the very highest mortality rates in the country for AMI patients. As part of our efforts to inform and educate, the Vanderbilt STEMI Network will publish the Vanderbilt STEMI newsletter. It will be published three times a year and this is the first issue. It is our hope that we will provide useful information about the care of AMI patients at various points in their illness. It is targeted for all who provide care to AMI patients, from pre-hospital onward. We hope that you will not only find it interesting and educational, but that you also will tell us issues you would like to hear about. Let us know the challenges and obstacles you encounter in caring for the AMI patient. It is imperative that we all play a role to improve the care of AMI patients in this region. Communication and cooperation can achieve this goal. Our patients deserve nothing less. Vanderbilt Heart and Vascular Institute Publication Winter 2010 Volume 1 Issue 1 VanderbiltSTEMI.com

2 A Cardiac Cath Lab Perspective By Michael R. Clark, Special Procedures Technologist Cardiac Lab In the normal working of the day, the cool of the evening, or the dark of the night, all gets interrupted by the beeping sound of our pagers. We respond to the hospital operator, and off we go to work, dropping whatever is going on. The typical cath lab staff member thinks nothing much out of the ordinary; it is part of the job. Rushing to work to help stop a heart attack from continuing to kill tissue and muscle is all in a day s work. I have been a part of this scene for a number of years. I have been on call for different cath labs, and the emergency call backs have been quite similar. From the time a patient comes to the ER, we need to get the affected vessel open within 90 minutes (national goal). This happens in many cities and towns across this country daily. There is a recent improvement in the overall system that has helped everyone concerned. A STEMI network benefits the local hospital, the big heart center, the working staff, and most importantly, the patients and their families. The network is set up to recognize and initiate the protocol to help an individual having an ST elevation myocardial infarction, commonly known as a heart attack. The communities that are involved are educated and made aware of this network. Patients with symptoms such as severe chest pain, shortness of breath, heaviness in chest, pain radiating to jaws or arms or other characteristics are urged to go directly to the local ER. The local hospitals have been taught to react, recognize the situation, and activate the network with one phone call. The patient gets an electrocardiogram (ECG) and it is read in a matter of minutes. The physician reads the ECG, and if a heart attack is in progress, calls our heart center, in my case, Vanderbilt University Medical Center, and activates the STEMI team. A cardiologist calls and confers with the ER physician, while transportation is being arranged (ambulance or helicopter) to bring the patient to the heart center or hospital. The cath lab staff is activated and arrives and is set up with all emergency equipment and training to find the source of the heart attack and to stop it shortly after the patient arrives. Some of the numerous advantages of a network like this are: Local communities get more education and are more aware of warning signs of a heart attack. The affected areas of the heart will stop working in about six hours from the start of a heart attack. Patients and families can help by getting to the local hospital quickly. The first thing most people do is ignore these warning signs. Local hospitals receive these patients and get an ECG soon after arrival. They can confer with a trained cardiologist and even fax the ECG for verification. These local hospitals are taught and equipped to take immediate action on these patients. The team is given advance notice of a patient coming to the cath lab, and the hospital is fully ready to receive and treat this patient immediately upon arrival. The cardiologist will call and give the referring hospital and physician an update as soon as we are done with the procedure. The families can have confidence in every leg of this scenario that their loved one is receiving the best care possible in the most timely manner allowed. Most importantly, the patient gets a heart attack stopped before permanent damage is done to the heart or worse. We have said for a long time, Time is muscle. The staff of nurses, doctors, and technologists that are privileged to work in cardiac cath labs take pride in stopping these types of heart attacks at our hospitals. I am proud to work in a facility like Vanderbilt that not only gives patients in Nashville this option, but patients who reside within 120 miles of Nashville that we call our STEMI network. This network is still expanding and changing to enhance patient safety, comfort and quality of life.

3 Case Study A 52-year-old male presented to Vanderbilt s Emergency Department on Dec. 17, 2009, with c/o chest pain radiating to bilateral arms and SOB. Reported pain is similar to previous heart attack pain. Recently discharged s/p Inferior MI on 12/11/09 receiving bare metal stent to proximal right coronary artery. Admits to being non-compliant with medications including Clopidogrel. Physical Exam: BP 129/103 P 119 R 24 T 96.9 SaO2 100% room air General: awake, alert, anxious Respiratory: clear to auscultation, no wheezing Cardiac: rate regular rhythm, tachycardic, no murmur Diagnostic Tests: ECG What is your diagnosis? Review this ECG and then visit our Web site and click on STEMI newsletter to see the answer and to view the catheterization video of this case. We hope you enjoy this first edition of the STEMI newsletter. If you have questions or suggestions, please contact Carol Scott, FNP, Coordinator of Vanderbilt STEMI Network, at (615) or carol.scott@vanderbilt.edu.

4 Reducing D2B Times By Jared McKinney M.D., Assistant Professor of Emergency Medicine Jared McKinney M.D. There is no question that limiting the time it takes to get a patient suffering from an acute ST elevation myocardial infarction (STEMI) to the cardiac catheterization lab has a direct impact on morbidity and mortality. However, achieving a goal door-toballoon (D2B) time of 90 minutes is often difficult. The question also remains: do we need to push for D2B times less than 90 minutes? A recent large review of more than 40,000 patients from multiple PCI centers around the United States demonstrated that a reduction of even a few minutes in D2B, even for those patients who receive PCI in less than 90 minutes, can lead to a significant decrease in mortality. How can hospitals reliably achieve D2B times of 90 minutes or less? An article in 2006 published in the New England Journal of Medicine titled Strategies for Reducing the Door-to-Balloon Time in Acute Myocardial Infarction addressed that issue. While multiple strategies were associated with a reduction in doorto-balloon time, activation of the catheterization lab prior to patient arrival in the Emergency Department was one of the most beneficial. In order for that to be possible EMS must take an active role in the chain of survival as it relates to acute myocardial infarction. This has led to the concept of E2B time, or EMS arrival-to-balloon time. Many EMS agencies have embraced this role and have started to focus on interventions that can reduce E2B time. Scene times must be kept to a minimum, and a scoop and run mentality similar to that seen in major trauma should be the focus. Crews should acquire a 12-lead ECG as soon as possible and transport to the most appropriate hospital limiting transport times. Pre-hospital 12- leads have been shown in multiple studies to significantly reduce D2B time and are the key for pre-hospital activation of the PCI lab. In order for pre-arrival activation to work, paramedics must be able to reliably identify ST elevation consistent with myocardial infarction. This is incredibly important as false activation of the cardiac catheterization lab is expensive and leads to decreased trust in EMS. While studies have shown that paramedics can interpret STelevation on a 12-lead ECG as well as cardiologists and ED physicians, the addition of another set of eyes can significantly decrease the rate of false activations of the cardiac catheterization lab. Paramedics with the Nashville Fire Department have been transmitting ECGs since 2004, and local hospitals have encouraged their ED physicians to activate the cath lab when they receive 12 leads that are consistent with a STEMI. This policy has gone exceedingly well and has been well received. Most hospitals now have D2B times below 90 minutes and some even have E2B times below 90 minutes. E2B times are reviewed closely and are shared with our crews. This is important for continuous quality improvement and allows our paramedics to see the importance of what they are doing in the field with patients suffering from acute myocardial infarction. Hospitals as well as EMS should continue to focus on system improvements that can limit time to definitive intervention in patients with acute ST elevation myocardial infarction. The importance of pre-hospital 12 lead ECGs and pre-arrival activation of the cath lab cannot be understated and both have a direct impact on patient outcomes.

5 Use of Prasugrel in Acute Coronary Syndromes by Robert Huang, M.D., M.P.H., Cardiovascular Medicine Fellow Robert Huang, M.D. Current guidelines recommend the use of antiplatelet drugs in patients presenting with acute coronary syndromes (ACS) defined as unstable angina (UA), non ST-segment elevation myocardial infarction (Non-STEMI), and ST-segment elevation myocardial infarction (STEMI). 1,2 Prasugrel (60mg loading dose followed by 10mg daily maintenance dose) was approved by the Food and Drug Administration (FDA) in February 2009 for high-risk ACS patients undergoing percutaneous coronary intervention (PCI). Prasugrel (Efficent - Eli Lilly and Company) is also a thienopyridine adenosine diphosphate antagonist that irreversibly inactivates platelets; however, it is 10 times more potent than clopidogrel (Plavix) for inhibiting platelet aggregation, inhibiting thrombus formation, and prolonging bleeding times. 3 The PRINCIPLE-TIMI 41 randomized, controlled trial compared clopidogrel 600 mg loading dose mg daily to Prasugrel 60 mg loading dose + 10 mg daily for patients undergoing PCI. The study showed inhibition of platelet activity (IPA) at 6 hours was significantly greater with the prasugrel regimen than the clopidogrel regimen (74.8 ± 13.0% vs ± 21.1%, p < 0.001). 4 Clinical outcomes in ACS patients with planned PCI were improved with prasugrel compared to clopidogrel in the TRITON-TIMI 38 trial that showed a decrease in the primary endpoint of nonfatal MI, cardiovascular death, and nonfatal stroke (9.9% vs. 12.1%, HR = 0.81, 95% CI = , p<0.001) driven mainly by nonfatal MI (7.3% vs. 9.5%, HR 0.75, 95% CI , p<0.001). However, the prasugrel showed a significant increase in bleeding events compared to clopidogrel; major bleeding (2.4% vs. 1.3%, p= 0.03), life-threatening bleeding (1.4% vs. 0.9%, p=0.01), and fatal major hemorrhage (0.4% vs. 0.1%, p=0.01). Of note, the fatal bleeding sites in the prasugrel arm included intracranial hemorrhage, retroperitoneal, GI, and puncture and surgical sites; whereas the clopidogrel arm was due to only intracranial hemorrhage. Coronary artery bypass graft (CABG)-related major bleeding occurred in 24 patients in the prasugrel group compared to 6 patients in the clopidogrel group (13.4% vs. 3.2%, p<0.001). 5 The STEMI subgroup analysis of the TRITON-TIMI 38 group was recently published and showed a benefit of prasugrel compared to clopidogrel for the primary endpoint at 15 months (10.0% vs 12.4%, p=0.022). However, secondary PCI patients (those receiving PCI 12 hours-14 days after symptom onset) were the only group to show a significant benefit for prasugrel (p=0.015). Another interesting aspect of this study was that life-threatening, major, and minor bleeding was similar between prasugrel and clopidogrel. However, CABG-related bleeding was significantly increased with prasugrel (p=0.0033). 6 Based on those studies, the FDA summarized the risk-benefit profile as the following: for each 1,000 patients treated with prasugrel instead of clopidogrel there were 24 cardiovascular end-points prevented (21 nonfatal MI and 3 CV deaths); however, 10 excess major or minor bleeding events would occur (2 fatal bleeds, 3 nonfatal major bleeding events, and 5 minor bleeds). 3 Prasugrel has been shown to be superior to clopidogrel for decreasing cardiovascular endpoints in ACS patients undergoing PCI; however, there is an increased bleeding risk and physicians will have to weigh the risks and benefits as well as the higher cost of the drug when applying this to realworld patients. Groups that could also potentially benefit from prasugrel are those who have failed prior clopidogrel therapy presenting (Continued)

6 VANDERBILT UNIVERSITY Vanderbilt Heart Communications MCE, 5th floor, Ste st Ave. S. Nashville, TN Non-Profit Org. U.S. Postage PAID Nashville, TN Permit No Visit VanderbiltSTEMI.com for more information on Vanderbilt Heart programs Use of Prasugrel in Acute Coronary Syndromes (Continued) with in-stent thrombosis, clopidogrel non-responders, and those that require proton-pump inhibitor therapy. Prasugrel is contraindicated in patients with prior history of stroke or TIA and active pathological bleeding. Other risk factors for bleeding include age 75, awaiting CABG or other surgical procedure, body weight < 60kg, propensity for bleeding, and those on warfarin. 1. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-st-elevation myocardial infarction:. a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines..J Am Coll Cardiol. 2007;50 (7):e1-e Kushner FG, Hand M, Smith SC, et al Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction. J Am. Coll. Cardiol. 2009;54; U.S. Food and Drug Administration. Cardiovascular and Renal Drug Advisory Committee briefing document on prasugrel for ACS. February 3, Available at: riefing/ b1-01-fda.pdf. 4. Wiviott SD, Trenk D, Frelinger AL, et al. Prasugrel compared with high loadingand maintenance-dose clopidogrel in patients with planned percutaneous coronary intervention: the Prasugrel in Comparison to Clopdiogrel for Inhibition of Platelet Activation and Aggregation Thrombolysis in Myocardial Infarction 44 trial. Circulation. 2007; 116(25): Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007; 357(20): Montalescot G, Wiviott SD, Braunwald E, et al. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for STelevation myocardial infarction (TRITON- TIMI 38): double-blind, randomized controlled trial. Lancet. 2009;373(9665): Thank you for our partners: