March 25th, 2012
Eric Peterson to Succeed Bob Harrington as Director of the Duke Clinical Research Institute
Larry Husten, PHD
The Duke Clinical Research Institute has announced that its new director will be Eric Peterson. The DCRI was founded by Robert Califf, who, as the director of the Duke Translational Medicine Institute (DTMI), will be Peterson’s boss. The DCRI’s second director, Robert Harrington, announced earlier this year that he was leaving Duke to become the chairman of the department of medicine at Stanford.
“Dr. Peterson’s accomplishments in clinical research and quality improvement over the past 20 years have prepared him well for this new responsibility,” said Califf, in the DCRI announcement. “Eric has demonstrated a special ability to expand the reach of the DCRI into areas of outcomes, comparative effectiveness, and implementation that perfectly complement the clinical trials focus of the past few decades, and he has done so by creating local, national, and international collaborations.”
Among his many current positions, Peterson is the director of the coordinating center for the NHLBI’s Centers for Cardiovascular Outcomes Research and principal investigator for the AHRQ Duke Center for Education and Research on Therapeutics (CERTs). Peterson came to Duke in 1992 as a cardiology fellow and has been on the faculty since 1995.
Peterson was early rumored to be the likely choice to succeed Harrington. Said Califf: “When Bob informed us of his decision to move to this major position at Stanford, Eric immediately rose to the top of the list of possible successors. In his interviews he showed that he will be ideally suited to lead a major effort to closely integrate the DCRI with the other components of the DTMI and the rest of Duke Medicine, while attending to the DCRI’s mission to promote novel clinical research on a global scale.”
Three Generations of DCRI Leadership: Rob Califf, Bob Harrington, and Eric Peterson
March 25th, 2012
Study Supports PCI Without On-Site Surgical Backup
Larry Husten, PHD
Here’s a great example of genuine medical progress: 10% of the first 50 patients who received balloon angioplasty from the procedure’s developer, Andreas Grüntzig, required emergency bypass surgery. By 2002 only 0.15% of PCI patients required emergency surgery, leading many to believe that surgical backup was no longer necessary.
Now a large new study provides strong evidence that PCI can, in fact, be performed safely and effectively at hospitals without surgical backup. In a presentation at the American College of Cardiology and published simultaneously in the New England Journal of Medicine, Thomas Aversano and colleagues in the Cardiovascular Patient Outcomes Research Team (C-PORT) report the results of a trial that randomized 18,867 patients to undergo PCI at hospitals with or without surgical backup.
- The 6-week mortality rate was 0.9% at hospitals without surgical backup versus 1.0% at hospitals with surgical backup, which was well within the predefined margin of noninferiority of a 0.4% difference in risk (P=0.004).
- The 9-month composite rate of death, Q-wave MI, or target-vessel revascularization was 12.1% and 11.2%, respectively, which met the predefined margin of noninferiority of a 1.8% difference in risk (P=0.05).
The authors noted that high-risk patients were excluded from the study, raising the possibility that the study population may differ from the general PCI population. “The study shows that under certain circumstances, non-primary angioplasty can be performed safely and effectively at hospitals without on-site cardiac surgery,” said Aversano, in an ACC press release.
March 24th, 2012
Whither Conferences? Searching for the South by Southwest Passage
John Ryan, MD
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here. Read the next post here.
Attendance to cardiology conferences is in decline. It is an obvious fact observed by the decreasing numbers of attendees in the halls walking between sessions, and perhaps more tellingly by the decreased number of companies willing to send exhibitors to the ACC and AHA to promote their products.
There are a variety of reasons given for this, the most popular one being that the poor economy is effecting both academic institutions and private practitioners. People also argue that there are simply too many meetings these days, especially as the field has become more subspecialized. Finally, the immediate digital availability of these conferences. A snapshot of my Twitter feed from an hour ago demonstrates that you can get a pretty good idea about the results being presented in real time:
However, I think these common conceptions are inaccurate and misleading I have another theory.
These common concerns could equally be applied to other conferences. However, Comic Con in San Diego continues to attract 130,000 attendees every year for four days of TV, science fiction and comic book discussions. Similarly, the South by South West Festival continues to grow every year, with attendance reaching 20,000 this past year a 100% increase from 4 years ago. Think that these pop culture comparisons aren’t fair? Fine, take the HIMSS conference focused on health care informatics held in Las Vegas just over a month ago: it surpassed expected attendance by 5,000, drawing 37,000 in all.
The audiences of these events aren’t immune to downturns in the economy, they have plenty of gatherings large and small to choose from, and they are at least as digitally savvy as cardiologists. These conferences clearly are providing an in-person experience that cardiology conferences are not, as manifest by their growth in numbers and our decline. I think the simplest reason that conference attendance at ACC and AHA is decreasing is because people are not getting enough out of it. The design and content has not evolved since the hay-day of 30,000-plus attendees. What worked before—such as the unveiling of clinical trials and vibrant exhibition halls—simply does not attract people anymore. In my opinion, the common thread contributing to the current growth in the events like South by Southwest is the focus on user-generated content and the fact that the attendees feel themselves to be a part of the conferences, not just seat fillers.
The organizers of the ACC, the AHA probably only have a few years to figure out how how to generate this sense of ownership.
How can this best be achieved?
Is it by increasing the number of abstracts accepted? Or does the manner in which the landmark trials are presented need to be changed? Our field needs your ideas, so please share them.
March 24th, 2012
Opening with a Bang
Megan Coylewright, MD MPH
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here. Read the next one here.
The opening session began with a “montage” fit for a Stars Wars sequel, complete with an exhilirating soundtrack. The use of media in this conference borders on the excessive, but it’s certainly entertaining. I wonder how the instant availability of the sessions changes who attends. Still, I’m here just 24 hours, and there is no question the value of connecting with people face to face.
Exciting news from the earliest of the late-breakers: the latest study on bone marrow mononuclear cells for LV dysfunction was negative, and the study on a new anti-platelet to be added to standard of care, vorapaxar, was positive. Both had many caveats, the former with the technical details (how are cells selected? prepared? injected) and the latter with the practical details (Panelist Eduardo Marban: if I were stranded on a desert island, this wouldn’t be in my doctor’s bag given the high NNT). ACC President David Holmes continues to encourage us to dream big, and this positive, uplifting attitude is one that he carries every day in the cath lab.
He concluded saying, “These results (on vorapaxar) demonstrate the continued need to individualize care.” Just how do we do that? A small plug for the decision making session Monday morning.
Don’t forget the FIT Mix and Mingle later this afternoon at 3:30 (South, Hall A, Bistro).
March 24th, 2012
On the Shoulders of Giants
Tariq Ahmad, MD, MPH
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here. Read the next one here.
As another meeting of cardiologists from around the world gets under way, it is a good time to reflect on the journey that has brought us here.
Tools and procedures we take for granted today—like echocardiography and coronary interventions—are relatively young introductions into the cardiologists’ armamentarium. Current 2D echocardiographic techniques are largely based on papers that were published in the 1970s. Andreas Gruentzig presented his landmark research on coronary angioplasty by way of a research poster at the AHA meeting in 1977!
Even the stethoscope is a relatively recent medical invention. Prior to Rene Laennec’s description of a hollow tube that could be used to listen to the heart in 1819 (De l’Auscultation Médiate), cardiac auscultation remained a rudimentary art. Dr. Willem Einthoven did the first real EKG in 1903 and won a Nobel prize for this invention.
For centuries before that, from the time of ancient Egypt through the middle-ages, the diagnosis and treatment of cardiovascular diseases remained inexact and ineffectual.
As a community, cardiologists place a premium on new ideas and excel at creating forums to share and discuss research results. These qualities have led to several paradigms shifts in our understanding of heart disease and saved numerous lives.
So, dear fellows, let’s enjoy this extraordinary event, and in the words of Steve Jobs: “stay hungry, stay foolish”.
March 24th, 2012
Honoring the Legends
Megan Coylewright, MD MPH
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here. VIew the next one here.
Last night there was a reception for the five “legends” being honored by the ACC with a new lecture series. Hard to know how to explain the impact of hearing Dr. Braunwald chart his life’s course, and his journey from bench to bedside, and back again- when asked to explain his success, he shared, “I was in the right place at the right time.”
A common theme among the 5 honorees was summarized by Dr. Colombo when he stated that persistence may indeed be even more important than intelligence—and then he quipped, “I’m not saying I’m not intelligent.”
Most surprising was the global role that both Dr. Fuster and Dr. Yacoub have grown into, the first in public health focusing preventive efforts in young children, and the second in ensuring that developing nations have the technology and resources needed to provide care, including cardiac surgery.
Many agreed that Dr. Somerville stole the show, as her honest and clever retelling of succeeding as an outsider resonated with the entire audience: she received the longest applause I’ve heard at a national meeting.
Walking away, most noted how remarkably humble these leaders are, and how their primary message—to do what you feel is right for patients, even if unpopular—has never been more relevant.
P.S. Spring has arrived- it is pouring rain.
March 24th, 2012
Novel Antiplatelet Agent Reduces CV Events But Increases Bleeding
Larry Husten, PHD
Vorapaxar, the novel antiplatelet agent from Merck, appears to effectively reduce cardiovascular death and ischemic events in patients with MI, ischemic stroke, or peripheral vascular disease, but its potential utility is clouded by bleeding complications, including intracranial hemorrhage. Results from the TRA 2P-TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) trial were presented in Chicago on Saturday at the American College of Cardiology and published simultaneously in the New England Journal of Medicine.
Results of TRA 2P-TIMI 50 were broadly consistent with those from the TRACER trial (published last November in the New England Journal of Medicine), which tested the same drug in patients with acute coronary syndromes. In that trial also, vorapaxar effectively reduced negative outcomes but at the cost of an increase in serious bleeding complications. Earlier optimism over the drug had been greatly reduced in January 2011, when the combined data and safety monitoring board (DSMB) for the two trials halted TRACER and curtailed TRA 2P-TIMI 50.
TRA 2P-TIMI 50 randomized 26,449 patients with a history of MI, ischemic stroke, or peripheral arterial disease to either vorapaxar or placebo in addition to standard therapy. Because of an increased risk of intracranial hemorrhage in patients with a history of stroke, at 2 years the DSMB stopped treatment with vorapaxar in patients with a history of stroke.
At 3 years, the rate of cardiovascular death, MI, or stroke was significantly reduced by vorapaxar, but there were also more bleeding events associated with the drug:
9.3% in the vorapaxar group versus 10.5% in the placebo group (HR, 0.87; 95% CI, 0.80-0.94; P<0.001)
- CV death: 2.7% vs. 3.0% (HR, 0.89; P=0.15)
- MI: 5.2% vs. 6.1% (HR, 0.83; P=0.001)
- Stroke: 2.8% in both groups
Moderate or severe bleeding: 4.2% with vorapaxar versus 2.5% with placebo (HR, 1.66; P<0.001)
- Intracranial bleeding: 1% vs. 0.5% (HR, 1.94; P<0.001)
The investigators reported that in the subgroup of patients with a qualifying diagnosis of MI, vorapaxar caused a 20% reduction in the primary endpoint. In light of the heightened risk for stroke patients, the investigators also performed a separate analysis of patients without a history of stroke and found “a significant benefit” in this subgroup.
In an ACC press release, lead investigator David Morrow said: “In the lab, we have seen very compelling science showing the importance of thrombin’s action on platelets causing blood clots in arteries. This is the first study to show definitively that blocking this pathway reduces the risk of suffering another cardiovascular event.”
March 23rd, 2012
Early Morning, Early Start to ACC
Megan Coylewright, MD MPH
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the first post here. Read the next one here.
When I arrived at the airport in Rochester this morning at 6 a.m., it was dark (but, amazingly, warm). Already, half a dozen fellows and consultants with suitcases in tow were there, ready for Chicago. The banter was light; everyone seemed excited for reconnecting, learning, sharing, networking, and, for us from quiet, southern Minnesota, some needed time in the city.
Before the meeting even starts, we get the opportunity to sit down with some of the greatest leaders in our field: Drs. Braunwald, Colombo, Fuster, Somerville and Yacoub at the Legends of Cardiovascular Medicine Roundtable. I’ll be heading over in a bit to McCormick Place, South Building, Room S100c for this landmark event of “where we are and what the future holds.”
A few friends of mine are also leading a charge to get fellows on camera during ACC 2012 — these “roving reporters” will be wanting your two cents worth on posters, sessions, social events and the like. I hope you’ll indulge us and provide short snippets on how fellows experience the meeting. Looks like John and Tariq have shared some great resources to get us all started.
See you all soon,
Megan
March 22nd, 2012
Large Meta-Analysis Finds Very Low Thrombosis Rates for Xience Stent
Larry Husten, PHD
A large new meta-analysis published in the Lancet provides the best evidence yet that the cobalt-chromium everolimus eluting (CoCr-EES) stents (Xience and Promus) have a significantly lower rate of stent thrombosis than bare-metal stents (BMS) and other drug-eluting stents (DES).
Tullio Palmerini and colleagues analyzed data from 49 randomized trials comparing different stents in more than 50,000 patients.
Odds ratios for 1-year definite stent thrombosis for CoCr-EES compared with:
- BMS: OR 0·23, CI 0·13–0·41
- paclitaxel-eluting stents: OR 0·28, CI 0·16–0·48
- permanent polymer-based sirolimus-eluting stents: OR 0·41, CI 0·24–0·70
- phosphorylcholine-based zotarolimu-seluting stents: OR 0·21, CI 0·10–0·44
- Resolute zotarolimus-eluting stents: OR 0·14, CI 0·03–0·47
The superiority of the CoCr-EES over BMS emerged within the first month, suggesting that the findings were not simply a reflection of longer duration of dual antiplatelet therapy. At 2 years, the CoCr-EESs still had a lower rate of definite stent thrombosis than both bare-metal stents (OR 0·35, CI 0·17–0·69) and paclitaxel-eluting stents (OR 0·34, CI 0·19–0·62). Since concerns were first raised a number of years ago about the higher rate of stent thrombosis with drug-eluting stents, the new results, write the authors, represent “a paradigm shift.”
In an accompanying comment, John Ormiston and Mark Webster point out that a meta-analysis should only “be regarded as hypothesis-generating,” but write that “despite these limitations” the findings are “very reassuring.” They conclude: “CoCr-EES should be regarded as the standard against which future design improvements are compared.”
March 22nd, 2012
Promising Phase 1 Results for New Monoclonal Antibody to PCSK9
Larry Husten, PHD
Promising results from very early studies with an experimental new cholesterol-lowering drug, a monoclonal antibody to PCSK9, have been published in the New England Journal of Medicine. Evan Stein and colleagues report the results of two single-dose studies in which the drug, REGN727, was administered intravenously or subcutaneously to healthy subjects. In a third, randomized, placebo-controlled, dose-ranging trial, REGN727 was administered subcutaneously on days 1, 29, and 43 in adults with and without familial hypercholesterolemia (FH).
REGN727 was well tolerated, and no subjects stopped taking the drug due to adverse events. Five patients had brief elevations in creatine kinase over three times the upper limit of normal. The drug had a powerful LDL-lowering effect. In the dose-ranging study in subjects already receiving atorvastatin:
- the 50-mg dose caused a 39-percentage-point reduction of LDL cholesterol to 77.5 mg/dL,
- the 100-mg dose caused a 54-percentage-point reduction of LDL cholesterol to 61.3 mg/dL,
- the 150-mg dose caused a 61-percentage-point reduction of LDL cholesterol to 53.8 mg/dL.
In an accompanying editorial, Stephen Young and Loren Fong write that “at this point, the status of PCSK9 therapeutics appears to be full speed ahead.” But they also express caution, noting that much work remains to be done:
In the end, evidence of long-term safety, along with data showing protection from coronary disease, will be needed to define the role of these agents in clinical practice. High-risk patients who have not reached their recommended cholesterol target and patients who cannot tolerate statins could benefit greatly. Patient selection will undoubtedly be influenced by cost–benefit considerations.
Monty Krieger, a well-known lipid researcher at MIT, offered the following comment:
There are individuals who cannot tolerate statins, yet appear to be at increased risk for CHD because of elevated LDL cholesterol levels. Effective, alternative methods to treat these individuals to lower LDL cholesterol are clearly desirable and PCSK9 is one of the most attractive targets for such an approach. The report by Stein et all in NEJM confirms the importance of PCSK9-based approaches for LDL cholesterol lowering. It is encouraging that the highest dose administered three times over a 43-day period lowered LDL cholesterol significantly over a period extending beyond the last injection (days 8-85). One hopes that a safe, small molecule pharmaceutical approach directed at PCSK9 can be developed to achieve robust LDL cholesterol lowering without the issues associated with injecting antibodies.
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