November 14th, 2011
MI FREEE: How Much Do Free Medications Really Cost?
Larry Husten, PHD
Could getting rid of copayments improve adherence to post-discharge medications, leading to better outcomes and reduced costs? That’s the theory tested by the MI FREEE (Post-Myocardial Infarction Free Rx Event and Economic Evaluation) trial, which was presented at the AHA and published simultaneously in the New England Journal of Medicine.
Niteesh Choudhry and colleagues randomized 5855 post-MI patients with Aetna insurance to either full prescription coverage or usual prescription coverage for statins, beta-blockers, ACE inhibitors, or ARBs. The rate of adherence increased for all drug categories with full prescription coverage (P<0.001 for all categories):
- ACE inhibitor or ARB increased from 35.9% to 41.1%
- Beta-blocker increased from 45.0% to 49.3%
- Statins increased from 49.0% to 55.1%
- All three medications increased from 38.9% to 43.9%
However, the study did not find a significant difference in the primary outcome of the trial, which was the rate of first major vascular event or revascularization: 17.6 per 100 person-years in the full coverage group versus 18.8% in the usual coverage group (HR, 0.93; 95% CI, 0.82-1.04; P=0.21). On the other hand, benefits were observed in secondary outcomes and in individual components of the composite outcomes:
- total major vascular events or revascularization: HR, 0.89; 95% CI, 0.80-0.99; P=0.03
- first major vascular event: HR 0.86; 95% CI, 0.74-0.99; P=0.03
- stroke: HR, 0.69; 95% CI, 0.50-0.96; P=0.03
Total spending was not significantly different between the 2 groups: $66,008 in the full-coverage group and 71,778 in the usual coverage group. The authors noted that “an intervention that reduces patients’ financial burdens without changing overall spending and with possible clinical benefits is a rarity in health care and suggests that eliminating cost sharing for secondary prevention after myocardial infarction may be cost-effective.”
In an accompanying editorial, Lee Goldman and Arnold Epstein write that “perhaps the most sobering findings were both the low baseline adherence and the small improvement in adherence in what should have been a highly motivated group of patients after myocardial infarction.” Nevertheless, they continue, “reducing or eliminating the costs of highly beneficial medicines is almost certainly one key component of increasing adherence, even if its absolute benefit is distressingly modest.”
November 13th, 2011
What Will Keep Me Coming Back to AHA?
John Ryan, MD
Several Cardiology Fellows who are attending AHA.11 this week are blogging together on CardioExchange. The Fellows include Revathi Balakrishnan, Eiman Jahangir, John Ryan (moderator), and Amit Shah. Read the previous post here. Check back often to learn about the biggest buzz in Orlando.
This morning I spent my time at a special seminar dedicated to emerging concepts of the right ventricle. My research this year is centered around improving RV function in animals models of pulmonary hypertension. As part of this work, I have spent a lot of time reading the literature, getting familiar with different models and trying to come up with new concepts for treatment. Hearing these senior scientists present their best work, published and unpublished, is a gift.
AHA attendance is in decline, and some have attributed this to the fact that the major trials get posted online in major journals and then synthesized into digestible morsels through sites such CardioExchange and theheart.org, or even on twitter. For me, however, this seminar was an incredible resource that yielded both inspiration and practical guidance as to how to develop research questions in this field and novel concepts that can be employed when looking at endpoints. It is special seminars like this one that I suspect will keep bringing me back to AHA year after year, because they cannot be distilled into 140 characters or any other simple summary.
For those at AHA this year, what is it the most that brings you back to the meeting annually? The science? The late-breaking clinical trials? The networking? Or the Epcot center?
November 13th, 2011
Not Just Pomp and Circumstance
David Martin, M.D.
The AHA Opening Session is something I usually avoid, maybe because I feel a bit uncomfortable in large, dark rooms with flashing lights and very loud music (a setup that seems to favor the visually gifted but audiologically impaired). Admittedly, when the recipients of the Distinguished Scientist awards were paraded across the stage to a majestic melody, I did for a fleeting instant wonder if that’s what it’s like to be at the Academy Awards.
All this notwithstanding, a few important themes came through. In addition to a brief overview of the history of CPR, Gordon Tomaselli gave an impassioned talk about the importance of continued funding for research even in these financially difficult times.
And then there were the informal nods to the non-economic costs of doing research. During his acceptance speech for the Basic Research Prize, Peter Libby thanked his wife and children for their “forbearance” when his work distracted him from his family. Then, upon accepting the Population Research Prize, Elizabeth Barrett-Connor joked that women pursuing an academic career and trying to achieve work-life balance should consider doing as she did and “marry a pediatrician.” Of course, the message wasn’t lost on anybody, and it is likely just as relevant to people who have intensely devoted their careers to education, clinical practice, and industry. I thought it was a nice touch of humanity amid a grand celebration of scientific achievement.
If you attended the opening session, what did you think?
November 13th, 2011
AHA’s Best-Kept Secrets
David Martin, M.D.
Late breakers and plenaries aside, a few perennial AHA conference sessions are, I think, often overlooked:
Early Career Sessions. Not just for early career folk, these sessions allow any attendee to hear scientific luminaries talk about why and how they do what they do. Where else might you catch Joe Loscalzo describing how the early research career often includes a period of “darkness,” among other periods that sound suspiciously like Kubler-Ross stages of grieving? Of course, he’s not trying to depress the audience but simply explaining how hard it is to do scientific research — and that people are not alone in feeling this way. Point taken.
Young Investigator Sessions. Where early career investigators present their cutting edge research in a competition format. This is where you might catch future research luminaries in their youth. The presentations are always impressive, thanks to intense preparation and coaching from mentors. At the end of each talk, the presenters field on-the-spot questions from faculty judges. The questions are often tougher than those asked of late-breaking trial presenters. Fewer fireworks but a lot more guts — like college versus pro basketball.
Laennec Session. Although technically a part of the young investigators sessions, this one deserves special mention. I go to the Laennec session at every AHA that I attend. This is where you get to hear amazing clinical cases, the kind that make you reminisce about fellows’ report. I can’t think of another national forum where you get to see great cases presented, beginning to end, and then discussed by preeminent clinical faculty. I don’t think I’ll ever get too old for this one. Where else would you hear a panelist ask the presenter, “Can you explain Kussmaul’s sign?”
Circulation Editors’ Choices. Here’s where you’ll hear about what the Circulation editors regarded as some of the most important research published in the past year — across all journals, including some that not every cardiologist has time to read (e.g., Nature Medicine). After each senior author presents his or her paper, the editor discussant often doesn’t shy away from pointing out both weaknesses and obvious strengths of the research (warning: occasional fireworks). Another bonus is the chance to hear about background and additional analyses that never made it into the published article. But what I like best about this session is the emphasis on how the research should or should not be incorporated into patient care. And reasons listed for “should not” are often more than enough to dampen any “occulo-stenotic” like reflex to put every positive finding into practice.
These four types of sessions come early in the conference and are often missed, probably in part because they’re usually buried in the thin sections at the front of print program — before the “real” sessions are listed. Unlike for many main sessions, though, this content isn’t easily reproduced in abstracts, press releases, or on YouTube. So, if you’re attending the AHA in person, consider checking them out.
And, of course, if there are additional sessions that you think I’ve missed, I would love to hear about them.
November 13th, 2011
Epcot for Foodie Cardiologists
Reva Balakrishnan, MD, MPH
Several Cardiology Fellows who are attending AHA.11 this week are blogging together on CardioExchange. The Fellows include Revathi Balakrishnan, Eiman Jahangir, John Ryan (moderator), and Amit Shah. Read the previous post here and the next one here. Check back often to learn about the biggest buzz in Orlando.
After arriving in Orlando, registering at the center, and settling into my hotel, the hunger pangs started to set in. Being from New York City, I didn’t know what food to expect from Orlando, let alone Disney World (my fondest memories of Disney food consist of astronaut ice cream and goofy ice cream pops with bubble-gum noses). John’s post about restaurants in the area should allay any of my hunger pains.
Yesterday, several of my co-fellows convinced me to join them at Epcot Center’s international food and wine festival, and I’m glad I did. We “travelled ‘round the globe” eating our way through stalls set up in “countries” around the beautifully picturesque Epcot Lake. Some tasty examples: New England lobster rolls, escargot en brioche, and spicy pork with kimchi slaw. Today is the last day; AHA attendees who hurry can get discount tickets at the convention center!
November 13th, 2011
ISAR-REACT 4: Bivalirudin Works Great, Less Bleeding
Richard A. Lange, MD, MBA
In the previously published REPLACE-2 and ACUITY trials, a trend was noted towards an increased incidence of ischemic complications with bivalirudin compared with glycoprotein IIb/IIIa treatment in high-risk patients undergoing PCI. The Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4 (ISAR-REACT 4) trial was designed to show whether abciximab plus unfractionated heparin was superior to bivalirudin with respect to mortality, recurrent MI, urgent target-vessel revascularization, or major bleeding within 30 days.
The study enrolled 1721 NSTEMI patients undergoing PCI within 24 hrs of hospital admission. There was no significant difference between the two treatment arms with respect to the primary composite endpoint. Moreover, there was a higher rate of bleeding in abciximab and unfractionated heparin recipients.
|
30 Day Endpoints |
Abciximab + heparin |
Bivalirudin (n=860) |
P value |
| Primary Endpoint | |||
| Death, large recurrent MI, urgent TVR* or major bleeding |
10.9% |
11.0% |
0.94 |
| Secondary Endpoints | |||
| Death, any MI or urgent TVR* |
12.8% |
13.4% |
0.76 |
| Major bleeding |
4.6% |
2.6% |
0.002 |
*TVR=target vessel revascularization
In no prespecified groups, was there a suggestion of a benefit with abciximab. In this study, major bleeding was defined as the presence of intracranial, intraocular, or retroperitoneal hemorrhage; a decrease in the hemoglobin level of more than 40 g/L plus either overt bleeding or the need for transfusion of 2 or more units of packed red cells or whole blood.
Since all patients in ISAR REACT 4 received a 600 mg loading dose of clopidogrel and most (99%) underwent PCI via the femoral approach with infrequent use of vascular closure devices (used in only 21% of patients), it isn’t known whether these results are applicable to patients who receive newer adenosine receptor antagaonists or have PCI performed through the radial artery.
Although the study was funded by Nycomed Pharma — the former distributor of bivalirudin in Europe – the company reportedly had no role in the design of the study; the collection, analysis, or interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication.
This study and previous ones are consistent in showing that bivalirudin alone provides anti-ischemic protection similar to that offered by abciximab and heparin with fewer bleeding complications in patients undergoing PCI for acute NSTEMI .
So, is there any reason to use a glycoprotein IIb/IIIa rather than bivalirudin in the patient undergoing PCI?
November 13th, 2011
An Unexpected Preconference Overload
Eiman Jahangir, MD
Several Cardiology Fellows who are attending AHA.11 this week are blogging together on CardioExchange. The Fellows include Revathi Balakrishnan, Eiman Jahangir, John Ryan (moderator), and Amit Shah. Read the previous post here. Check back often to learn about the biggest buzz in Orlando.
One thing that I have noticed in the build-up to the AHA is the amount of junk mail I have received. In an era where we assign and discuss conflict of interest like it is part of our names, I am surprised and exhausted by the mailings, emails, and more mailings. I have probably received 50 pages of advertisements at home, and I knew that at the conference there would be even more advertisements. When I arrived at my hotel, even the room key card was an advertisement — this time for Xarelto tablets.
Now I have no issues with sponsorship for conferences. In fact, many of these meetings would not be feasible without the significant resources of private drug and device companies. I also have no issues regarding learning about the latest drugs and devices directly from the companies involved. I think that some level of advertisement has to occur for advancement and use of these products. However, when I am inundated by a tremendous amount of advertisement even before the conference, I stop reading both emails and mailings. This can lead to missing important information such as registrations or schedules of events. I am not sure what a good solution would be. Perhaps the AHA can hold off on advertising until we arrive at the conference center. That way, important information about the conference will not get lost in a large amount of preconference junk mail.
Were you similarly overwhelmed by the amount of advertising you received, even before the conference? What solutions might you have?
November 13th, 2011
Part of the System
John Ryan, MD
Several Cardiology Fellows who are attending AHA.11 this week are blogging together on CardioExchange. The Fellows include Revathi Balakrishnan, Eiman Jahangir, John Ryan (moderator), and Amit Shah. Read the previous post here. Check back often to learn about the biggest buzz in Orlando.
The first AHA meeting that I went to was three years ago. It was also held here in Orlando. I was still a naïve Irishman, and no one had prepped me regarding the appropriate attire for the meeting. I did not pack any ties, I packed one pair of khakis, and all I brought were a few short-sleeve shirts (after all, I was going to Orlando). So, I arrived on my first day in a pair of jeans and a hoodie. The minute I walked into the registration hall, I realized my mistake. One of my co-fellows happened to be walking by — he was of course dressed in a suit. He just started laughing at me. He then politely suggested that I head back to my hotel, get my khakis, put on a shirt, and borrow his tie. The problem was that the hotel I was staying at was actually many, many miles outside Orlando, and not on the bus route. I had booked it at the last minute; I had not realized that the whole of Orlando would sell out. To get there, I had to take either a taxi, not without significant expense, or a public bus that took over an hour to get in every day. Ultimately for the next four days I wore short-sleeved shirts with a tie — I looked like Dwight Schrute from The Office.
Last night, I was packing to go to Orlando for the first time since my inaugural trip three years ago. I ended up packing two suits, four shirts, and five ties (the fifth tie I planned to use for some evening dinners). This time, I am staying in a hotel that I booked in September; it’s about a half mile from the Convention Center on International Drive, on the bus route. I arrived at the convention center, and almost too eerily, I met a first-year fellow from Boston dressed in khakis and a polo shirt. I educated him about the dressing etiquette and rather than use that fifth tie for evening dinners, I donated it to him. I also started thinking about how I had evolved over the past three years, how I had become part of the system, and how I was no longer an innocent Irishman, unfamiliar with the complex ways of the AHA — but was now a seasoned veteran able to get others out of Dodge.
November 13th, 2011
ADOPT Fails to Support Extended Oral Apixaban in High-Risk Post-Discharge Patients
Larry Husten, PHD
Although medically ill patients remain at risk for VTE after hospital discharge, a strategy of extended oral anticoagulation with apixaban did not prove to be successful in the ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial, which was presented by Samuel Z. Goldhaber at the American Heart Association and published simultaneously in the New England Journal of Medicine.
ADOPT randomized 6528 acutely ill patients with at least one additional risk factor for venous thromboembolism (VTE) to standard care with subcutaneous enoxaparin 40 mg once daily for 6 to 14 days or oral apixaban 2.5 mg twice daily for 30 days. In all, 4495 were evaluated for the primary endpoint, a 30-day composite of death related to VTE, PE, symptomatic DVT, or asymptomatic proximal-leg DVT.
Incidence of the composite endpoint did not differ significantly between the two groups:
- 2.71% of the apixaban group versus 3.06% of the enoxaparin group (RR, 0.87; 95% CI, 0.62-1.23; P=0.44)
At 30 days, the incidence of major bleeding events was significantly higher in the apixaban group than in the enoxaparin group:
- 0.47% in the apixaban group versus 0.19% in the enoxaparin group (RR, 2.58; 95% CI, 1.02-7.24; P=0.04)
The authors concluded that ADOPT “does not provide evidence to justify a policy of extended prophylaxis in a broad population of medically ill patients after hospital discharge.” But, they noted, the high rate of VTE after discharge suggests the need for better risk-stratification methods “to identify a narrower spectrum of medically ill patients who may benefit from extended prophylaxis.”
November 13th, 2011
ATLAS ACS 2-TIMI 51: Rivaroxaban Benefits Low-Risk ACS Patients
Larry Husten, PHD
Results of the highly anticipated ATLAS-ACS 2–TIMI 51 trial demonstrate that ACS patients receiving standard therapy, including dual antiplatelet therapy, may benefit from the addition of the factor Xa inhibitor rivaroxaban, although at the cost of some additional bleeding complications. The Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome trial was presented by C. Michael Gibson at the American Heart Association and published simultaneously in the New England Journal of Medicine.
In all, 15,526 patients with ACS were randomized to placebo or either 2.5 mg or 5 mg of rivaroxaban. At a mean follow-up of 13 months, the rate of cardiovascular death, MI, or stroke was reduced in the patients taking rivaroxaban:
- 10.7% in the placebo group vs 8.9% in the rivaroxaban groups (HR for rivaroxaban, 0.84; 95% CI, 0.74-0.96; P=0.008)
Both doses of rivaroxaban were superior to placebo:
- 2.5 mg dose: 9.1% vs. 10.7%; P=0.02
- 5 mg dose: 8.8% vs. 10.7%; P=0.03
The lower dose of rivaroxaban resulted in a significant reduction in death from cardiovascular causes (2.7% vs. 4.1%; P=0.002) and in all-cause mortality (2.9% vs. 4.5%; P=0.002). Those benefits were not observed in higher-dose rivaroxaban, and the difference between the two doses of rivaroxaban was significant.
Rivaroxaban-treated patients experienced more major bleeding and intracranial hemorrhage than controls, but without a significant increase in fatal bleeding:
TIMI major bleeding not related to CABG:
- 2.1% for rivaroxaban vs. 0.6% for placebo; P<0.001
Intracranial hemorrhage:
- 0.6% for rivaroxaban vs. 0.2% for placebo; P=0.009
Fatal bleeding:
- 0.3% vs. 0.2%; P=0.66
The benefits of rivaroxaban were observed across a wide range of subgroups, although the point estimate for patients who had previous stroke or TIA went in the opposite direction.
The authors concluded that “the addition of very-low-dose anticoagulation with rivaroxaban may represent a new treatment strategy in patients with a recent acute coronary syndrome.”
In an accompanying editorial, Matthew Roe and E. Magnus Ohman review the long and complicated history of efforts to incorporate anticoagulants into ACS therapy. They note that ATLAS-ACS 2 had relatively small percentages of elderly patients, women, and patients with impaired renal function, suggesting the results may not be entirely replicated with higher-risk patients in the real world. “We need a better understanding of the role of rivaroxaban in higher-risk patients,” they write. Nevertheless, they conclude, “a new era of secondary prevention after an acute coronary syndrome has begun and will be characterized by the need to balance ischemic versus bleeding risks when selecting the type, number, and duration of antithrombotic therapies for individual patients.”
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