This is Steve Stiles, editor of heartwire on Medscape, inviting you to follow us in this mini-not-quite-micro blogging space as the meeting unfolds over the next few days. We've already published a few stories during the past week following their early embargo times, and coverage of the first late-breaking trials and other presentations "hits the stands" in earnest Saturday morning.
We also welcome Deborah Brauser, a long-time Medscape contributor who will be covering this year's ACC as a new member of the heartwire reporting team!
ACC 2015 Kicking Off in Sunny San Diego! Here's theheart.org team, including Dr. Melissa Walton-Shirley, reporter Marlene Busko, reporter Deborah Brauser (new to the team!), editorial director Tricia Ward, Dr. John Mandrola, and Dr. Seth Bilazarian. Managing editor Steve Stiles is shaking Steve's hand.
The first late breacking clinical trial presentations from ACC 2015 will be PROMISE:, A Randomized Comparison of Anatomic versus Functional Diagnostic Testing Strategies in Symptomatic Patients with Suspected Coronary Artery Disease and PEGASUS: Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin. Stay tuned for topline findings...
ACC President Patrick O'Gara kicked off the opening session after an intro video that looked and sounded like a trailer for the latest Hollywood blockbuster.
ACC President Patrick O'Gara on EHR in opening session, "Pearls of wisdom cannot be measured in a single drop- down menu". Are we compromising patient care to improve billing and archiving?
Dr. Pamela Douglas presenting the results of the PROMISE trial during the late-breaking clinical trials session at ACC 2015. In the US, more than 4 million stress tests ordered each year for patients with chest pain but there is little data to show which test is preferable.
In today's opening session of the ACC 2015: Dr. Abraham Verghese-Infectious disease specialist, gave a lecture entitled, "I Carry Your Heart". "The electronic medical record are a waste of words. They are about billing. They have nothing to do with the patient's heart. My problem isn’t that it isn’t just fiction. I like fiction, I read fiction and I write fiction for God’s sake. Does the word 'electronic' medical record just grate on you? My problem is what it does with the actual words we would get to spend with the patient.. In the coming days, you will be discussing the metaphorical heart, but the real heart awaits you the next time you see a patient. It will come with the other heart for which you have tracings and other kinds of data. When you listen and touch with skill your own heart, then your head and your heart will be fulfilled, ....it will be a kind of poetry. You will have said without words, "I carry your heart. I carry you in my heart”. Real advice for real practitioners with real patients. He is an oracle for the ages.
Over 2 years, coronary CT angiography did not reduce hard clinical events compared with functional testing, PROMISE showed. Low event rate in both treatment arms, around 3.1%, which is likely the result of patients being well treated with cardiovascular medications.
In the functional testing arm of PROMISE, 67% received a stress nuclear test, 23% received stress echo, and 10% underwent exercise ECG testing.
So, what to make of PROMISE? Dr. Douglas says that CTA is a viable alternative to functional testing in patients with chest pain. She said the study shows patients, overall, have a very, very good prognosis over 2 years. It also shows they would be less likely to end up in the cath lab for nonobstructive CAD if they selected CTA. Dr. Harrington said he is intrigued by the secondary finding, especially for interventionalists who don't want to take patients to the cath lab if they don't need to be there.
When Dr. Pam Douglas was asked regarding the PROMISE TRIAL, "What is your view on impact of guidelines? Reply: “You need two trials to get level of evidence A but there were thousands of patients, so I’d anticipate a big change for appropriate use criteria.”.
Dr. Jennifer Mieres on PROMISE: 50% were women in this cohort ! Congratulations!
Bob Harrington on PEGASYS (Tigagrelor 90 mg vs. 60 mg vs. placebo with history of remote MI): "It’s nice to to see the North American results going along with the rest of the trials!! (audience laughter) . "Now that we’ve seen the DAPT trial results on stented patients, it seems pretty clear there is not a time you should EVER come off the dual platelet therapy. If you were treated with 90-mg bid up front, when you get to a year should we down titrate? Presenter Dr. Mark Sabatine's Answer: Our treatment spanned from a minimum of 16 mo. to 4-years, ¼ were a half decade out from their qualifying MI and it looks like the curves continue to diverge. The 90-mg dose performed exceedingly well in the acute setting. In terms of platelet inhibition patients may require something different 2 -hours vs. 2- years out. I think the question about titrating should be a topic of future study . I think I’d start at 90-mg (acutely) and at one-year downward titrate to 60 mg bid.
Melissa holds the PROMISE investigators' feet to the fire at the press conference!
It's been a several hours since the keynote by Abraham Vergehse on the impact that the business of medicine especially the electronic health record has had on the sacred and extraordinary relationship doctors have with their patient.
I can't help but acknowledge all that has been lost and regret that much of the "healing arts" has been lost and SOME of it is physicians fault. But we are increasingly becoming employed physicians (As i walk around seeing friends from residency and fellowship almost all are now employed by the dominant medical gorilla in their market)
It will be increasingly difficult to change back to these subjective healing experiences in a RVU and meaningful use dominated world.
In the "Debating the Optimal Pharmacology for PCI in ACS" session-BallRoom ACC 2015: 3-hour Post PCI infusion of Bivaliruden in AMI eliminates the SAT issue, (effectively reducing bleeding and therefore reducing mortality). Excellent review oF Bivalirudin by Dr. Greg Stone.
More from "Debating Optimal Pharmacology in ACS". Per Dr. Greg Stone, " Finally, in the last few minutes we have the real world NCDR-Cath PCI registry. If you do the procedure with Bivalirudin and use a femoral closure device, bleeding is reduced. (Even in patients with radial access? YES!!! ) "Bivalirudin still substantially reduced major bleeding" because "major NON-access bleeding is GI bleeding which drives mortality. Bivalirudin reduces both." In the words of the late Mr. Spock, "FASCINATING". No exclamation point ..... of course.
Beta Blockers under attack at session here today question their use in uncomplicated post MI with changes in guideline recommendations being highlighted.
To kick it off the new smart phone audience response system was used and 75% of the audience only use oral beta blockers prior to discharge in uncomplicated MI - therefore do not use beta blockers early or IV
Arguing for Beta Blockers in MI Robert DiDomenico
The physiologic effects and anti-ischemic effects and potential antiatherosclerotic effects are rationale for their protective effects of beta blockers - There are 1685 trial of beta blockers over the last 5 years
First trial published 50 years ago this year => Lancet 1965;2:551-3 Propranolol reduced mortality by 50%. (patient's were hospitalized for 28 days post MI)
In BHAT trial JAMA 1982;247:1707-14 reduced mortality 9.8 to 7.2% at 3 years ARR=2.6%
ISIS-1 used early IV and then 7 days of beta blocker with atenolol - only 7 days had benefit that extended to 20 months
There are 7 large trials of > 1000 patients which show benefit - meta analysis are challenging to interpret since they include some beta blocker trials which included non FDA approved beta blockers
He says that even if mortality benefit is challenged the reinfarction data for beta blockers is wrong and rivals the reinfarction benefits seen in DAPT trials
In addition cardiac biomarker changes have changed the definition of MI - early trials 1965-80 used transaminases for MI Dx, from 1980 - 2000 we used CPK and now are using trepan which "picks up" smaller MI
2. 50 yrs of evidence
3. data arguing for reduced role have limitations
Douglas Jennings argues against
arguing that beta blocker use should stop =. "COMMIT to other drug therapies"
COMMIT trial (2005) of MI patients NOT treated with PCI had IV metoprolol early and then orally at 200 mg for 28 days had no benefit of death, reinfarction or cardiac arrest. There was significantly more hazard from CHF, hypotension and cardiogenic shock in beta blocker treated patients. Characteristics of shock patients were age > 70, HR > 110, SBP < 120 and patient with Fillip 3 were all had high risk for shock with beta blockers. In the lowest risk patients the likelihood of shock was neutral but he medium and high shock index patients were at significantly higher risk. The takeaway was that the overall effect was neutral but there is a significant risk of shock in these patients that DID NOT receive PCI
COMMIT led to ACC/AHA guideline change for STEMI care in 2008 and maintained in 2014 STEMI guidelines making IV Beta Blockers a Class III recommendation (may be harmed)
Most contemporary dat in MI is for anti platelet trials, DES, strategies of PPCI like thrombectomy and the beta blocker data is mostly before 2980 (except for COMMIT). Beta blockers were beneficial in reperfussion era but in meta analysis in repercussion era showed increased CHF and shock but decrease angina and recurrent MI.
CHARISMA shows no benefit of beta blockers on mortality. REACH showed no survival benefit of beta blockers
"Stick with aspirin and statin"
1. Avoid IV Beta blocker
2. Reconsider routine use of oral beta blockers post MI - the destruction of myocytes that beta blockers provided in older era is no longer an issue because of mechanical revascularization with primary PCI
3. Avoid routine use in stable CAD
Joe Alpert (moderator) says the therapy should be individualized - beta blocker should be used on a case by case basis e.g. hypertension. Avoid them in patients with bradycardia
My take home on this controversy on Beta Blocker use in MI
1. Avoid IV beta blockers (obviously follow the guidelines)
2. Similar to hypertension guidelines using beta blockers is more sensible if there is an additional reason for their use - tachycardia, cardiomyopathy
3. Reassess beta blocker use in patients with prior MI and consider weaning them off after 1 year because of the potential hazard (obesity, diabetes, erectile dysfunction, afternoon fatigue) and lack of late cardiovascular benefit
4. In this era of polypharamcy with many of our patients the value of beta blockers fall well below statin and aspirin and may fall below DAPT so r emoving them may be of significant benefit for patients
5. Like ALL therapies we need better tools to individualize therapies rather than use a "one size fits all" strategy post MI
It was a thrill to sit down and talk with Dr. Abraham Verghese minutes after his Simon Dack lecture. His speech set the tone for #acc15. Dr. Verghese used the voices of poetry and literature and philosophy to convince heart doctors to see past the companion heart, with its ECGs, pressure tracings, and ultrasound images. We must see the spiritual heart. Not one. Two hearts, is what I heard.
I have always felt this about the human heart. Yes, surely, as an organ, it’s a beautiful marvel—but it’s more than just physics and physiology. It’s the connections. To carry the hearts of our patients means making that human connection. And one way to connect is listen, skillfully exam, and be mindful of the power of the patient doctor encounter. Our patients crave to be recognized. They want us to see them as human beings.
“A patient’s feeling towards his cardiac physician is a bit like love. You are typically thrust onto your physician by an event. Here comes this capable person who cares for you.” Are we up for this? I hope so.
Because…As technology advances, this notion has never been more important. Stay tuned for my interview with this inspirational leader.
What to look forward to on Sunday at ACC15
Late-Breaking Clinical Trial Session II features:
OSLER: Effect of the PCSK9 Inhibitor Evolocumab on Cardiovascular Outcomes
EMBRACE STEMI: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous Bendavia™ on Reperfusion Injury in Patients Treated with Standard Therapy Including Primary PCI and Stenting for ST-segment Elevation Myocardial Infarction
REG1: A Randomized, Open-Label, Multi-Center, Active-Controlled, Parallel Group Study To Determine the Efficacy and Safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention
SCOT-HEART: Computed Tomography Coronary Angiography In Patients With Suspected Angina Due To Coronary Heart Disease
Late-Breaking Clinical Trial Session III features:
PARTNER 1: Five-Year Outcomes after Randomization to Transcatheter or Surgical Aortic Valve Replacement: Final Results of the PARTNER 1 Trial
A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis Deemed at Increased Risk for Surgery 2-Year Outcomes
SAPIEN 3: Early Clinical and Echocardiographic Outcomes with the SAPIEN 3 Transcatheter Aortic Valve Replacement System in Inoperable, High-Risk and Intermediate-Risk Aortic Stenosis Patients
DEFLECT III: A Prospective Randomized Evaluation of The TriGuardTM HDH Embolic DEFLECTion Device During Transcatheter Aortic Valve Replacement
Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States
BEST TREATMENTS FOR PPCI
Roxanne Mehran Bivalrudin vs Heparin in STEMI. She takes the Bivalrudin is best position
Heparin has several limitations - it's unpredictable and causes platelet activation and ha a longer half life
Bivalrudin inhibits platelet activation and is a specific inhibitor of Factor X
In REPLACE, ACUITY, HORIZON there was mortality benefit and less transfusion
In HORIZON 3 yr MI 5.1% vs 2.9% (Bivalrudin compared to heparin + GPI)
In Euromax Bivalrudin had lower mortality than Heparin plus routine or bailout GPI
BRIGHT had 1/3 heparin monotherapy 1/3 bivalrudin 1/3 heparin + GPI with no mortality benefit but less bleeding with bivarudin
HEAT showed 30 day MACE Bivalrudin 8.7% vs Heparin 5.7% but criticized because bilvalrudin had stent thrombosis of 2.7% - this was also found in met analysis
Expect to get results from Angio-MATRIX of 7500 patients expected on Monday here at ACC
1. Consistent benefit of NACE
2. Will rely on ANGIO-MATRIX to validate or refute HEAT findings especially stent thrombosis
Upstream therapy for STEMI
Excess stent thrombosis with bivalrudin seen in meta analysis with a benefit on bleeding Lancet 2014;384:599-606
In ATOLL trial there was a trend toward benefit in per protocol MACE was at 1 month using enoxapirin 0.5 mg IV and lower bleeding compared to heparin. Also similar benefit of LMWH in FINESSE and ACOS and FAST-MI
1. Shorter acting agents (bivalrudin and LMWH) are safer for bivalrudin and more effective fro LMWH compared to UFH
2. Moderate anticoagulation is needed after primary PCI
Robert Harrington - Optimal Upstream platelet inhibition
STEMI guidelines DAPT is a Class 1 indication for primary PCI; US guidelines do not distinguish between clopidogrel and new agents but European guidelines recommend new agents over clopidogrel because in bothPLATO & TRITON there was a significant benefit in STEMI or PPCI populations compared to clopidogrel
In ATLANTIC for NSEMI showed no benefit using ticagrelor early Stent thrombosis at 50 days 1.2 vs 0,2% favoring early treatment
In STEMI, Clopidogrel absorption is worse than in health volunteers making its use more problematic. Morphine may also effect bioavailability
Cangrelor (an IV ADP inhibitor) is rapid on and rapid off and might be attractive in STEMI been shown to have lower stent thrombosis tan clopidogrel
My take home from best practices in STEMI patients receiving PCI (PPCI)
1. The trials don't address exactly what many programs do: patients are given heparin in the field by EMS or in the ER and come to the lab with that on board. Once access is gained (for us almost always radially) the option is to check an ACT and give additional dose as needed or begin bivalrudin)
2. Patients have all received aspirin either in the field usually (or by themselves at home)
3. Adding the second agent for DAPT is the standard protocol with different institutions choosing diffrenet agents (ticagrelor or prasugrel) before the patient comes to the lab
4. The unanswered question for me is - can we wait to give the P2Y12 inhibitor until the angiogram is complete in case the patient needs emergency coronary bypass surgery? Is it worth the hazard of not giving it to the 95% who will get PCI and possibly benefit by it vs the hazard/ inconvenience of having to wait four days for surgical revasculalrization for the < 5%.
We are now cranking up the live Blog from the floor of the ACC 2015 Sunday Morning Late Breaking Joint Session of the American College of Cardiology/Jama. It is chaired by Eric Peterson and Jeffrey Kuvin. Panelists: Chris Cannon, George Dangas, Judith Hochman, James McClurken, and Sortirios Tsimikas. ,Presenters: Marc Sabatine, Michael Gibson, Roxana Mehran, David Newby and Daniel Mark. Topics: PCSK9 inhibitors, EMBRACE (Bendavia), REG1 anticoagulation, and two topics on CTA. Stay tuned!
The data from OSLER looks particularly impressive with massive LDL-cholesterol lowering. The median decline in the trial was from 120 mg/dL to 48 mg/dL. The study even hinted at a decline in cardiovascular events, although this analysis was just exploratory. The one-year trial was not powered for hard endpoints. Still, as Dr. Seth Bilazarian told the heartwire reporters, this is probably the last real look at the PCSK9 inhibitor data before a possible FDA approval.