CardioExchange Archive

RACE II: Van Gelder et al. randomized 614 patients with AF to either strict rate control (resting heart rate < 80 bpm and heart rate during moderate exercise <110 bpm) or lenient rate control (resting heart rate < 80 bpm). The results were presented at the ACC in Atlanta and published simultaneously in the New England Journal of Medicine. After 3 years, the combined rate of CV death, hospitalization for HF, stroke, systemic embolism, bleeding, and life-threatening arrhythmic events was 12.9% in the lenient-control group compared to 14.9% in the strict control group. The difference between the two groups  met the prespecified noninferiority margin. As might be expected, more patients reached their target heart rate in the lenient-control group than in the strict-control group, and they required fewer total visits. The investigators concluded that “for both patients and health care providers, lenient rate control is more convenient, since fewer outpatient visits and examinations are needed.”
In an accompanying editorial Paul Dorian said that the RACE II investigators “have made an important contribution to our understanding of the potential benefits and risks of the current guideline-recommended approach to ventricular rate control in patients with persistent atrial fibrillation.”

SORT OUT III– Investigators in Denmark randomized randomized 2332 PCI patients to receive either a zotarolimus-eluting stent (ZES) or sirolimus-eluting stent (SES). The rate of major adverse cardiac events at 9 months was 6% in the ZES arm versus 3% in the SES arm (HR 2·15, 95% CI 1·43–3·23; p=0·0002). This difference remained significant at 18 month followup. At 18 months, but not at 9 months, there was a significant difference in mortality in favor of SES (4% vs 3%; 1·61, 1·03–2·50; p=0·035).

The trial was presented at the ACC and published online in the Lancet. The authors concluded that “the sirolimus-eluting stent is superior to the zotarolimus-eluting stent for patients receiving routine clinical care.”

Dual Antiplatelet Therapy: Korean investigators combined data from two trials, REAL-LATE and ZEST-LATE, that randomized 2701 DES patients to receive either dual antiplatelet therapy or aspirin monotherapy. There was no difference at two years in the rate of MI or cardiac death (1.8% with dual therapy versus 1.2% with aspirin monotherapy, HR 1.65, CI 0.80-3.36, p=0.17). The trial was presented at the ACC in Atlanta and published in the New England Journal of Medicine.
In an accompanying editorial, Peter Berger asks: “Can this study inform physicians’ practice with any degree of confidence? Sadly, no. It is an interim analysis of two ongoing, underpowered studies…”

See previous post (ACC Day 1) and the following one (ACC Day 3)

Several Fellows in Cardiology who are attending this week’s ACC meeting are blogging together right here. The Fellows include Shane LaRue, Justin Bachmann, Nihar Desai, Shanti Bansal, and Hansie Mathelier. Check back often to learn about the biggest buzz at the ACC — whether it’s a poster, a presentation, or the word in the hallways.

Shanti Bansal
3/15   11:54 pm

As the meeting is wrapping up, I wanted to reflect upon my time at the ACC.

5 favorite things:
1. Meeting some really famous cardiologists — whom I didn’t even know were still alive
2. The new robotics system for surgery
3. The live CTO case from Yale
4. Catching up with old friends
5. Showing off my poster

5 annoying things:
1. Authors who claim to have no disclosures – when that is not true
2. Bad pizza for sale
3. Topics that were well above my head
4. 6 AM meeting on a Sunday —  Yuk!
5. No time to see Atlanta

Shane LaRue
3/15  6:42 p.m.

Few thoughts as my 2nd day comes to an end. (I actually had many profound thoughts, but due to iPhone operator error, it was erased before I sent it, so you get the quick rehashing.)

The meeting is exhausting. I have to agree with the earlier post, the variety is incredible. As a first year fellow, it is tough to plan my day. Do I go to the review/educational sessions or to new research presentations, or do I support the faculty from my institution?

I did all of the above today, hopefully with an appropriate balance.

The FIT bootcamp talks have been the most useful. The ‘my own worst complication’ talk (draw your own parallel to my maiden voyage into the blogosphere) was the most entertaining part of my day.

Now, time for drinks and sushi (likely even more entertaining)

Nihar Desai
3/15 12:38 p.m.

Wow, another day of wonderful programming, too many options! I made it to the late breaking trials and was fairly underwhelmed by the claimed benefit of ablation in afib. The interventional trials this morning looking at cilostazol and duration of dual antiplatelet therapy were underpowered but generated some buzz… Looking forward to the FIT programming as well and will likely see you all there, Shane and Justin.

Justin Bachmann
3/15 11:33 a.m.

I spent the morning moving between two Core Curriculum sessions up on the 4th floor, Hemodynamics and Electrophysiology. I’m on my cath rotation right now so the hemodynamics review was helpful. The electrophysiology session was taught by one of my instructors back in Baltimore, Joe Marine.  It’s nice to see familiar faces at the meeting.

I’ll see you at the FIT forum, Shane. Apparently Dr. Fuster and Dr.Harrington will both be speaking.  Looking forward to it.

Hansie Mathelier
3/15 10:08 a.m.

“Feel the Burn or take a pill”- the motto of my first experience on Day 2. I attended the later part of the late breaking session. The first discussion I heard was warfarin vs. long-acting oral direct Xa. Interesting result but the exclusion criteria was quite extensive. For me, rat poison is winning out thus far. My next session  was discussion for the CABANA trial — a multicenter study involving older patients. Should be interesting to see the final outcome…burning (ablation) vs a pill (rate /rhythm). Try to listen to “heart sounds” but the line was too long. Oh well perhaps this afternoon. Now off to “atrial fibrillation and heart failure”…where there is a packed house. Hope I will get a seat.

Shane LaRue
3/15 9:33 a.m.

Monday morning is here.. A happy day because I am officially no longer the consult fellow.  Also had a great breakfast meeting the CardioExchange folks. (during which dr krumholz took my first blog topic and outed my awe in having breakfast with such an esteemed group)

Moved onto FIT bootcamp, interventional fundamentals. Not a single seat in the room, so learned about ivus and thrombotic lesions from the hallway. Looking forward to FIT forum lunchtime talks at the Omni Hotel about career paths.

The ACC started the day with the release of 3 highly-anticipated clinical trials.

ACCORD (Action to Control Cardiovascular Risk in Diabetes Study) tested two separate therapeutic approaches in type 2 diabetics. In one arm, 5,518 patients already taking simvastatin were randomized to fenofibrate or placebo. After 4.7 years of followup, the annual rate of nonfatal MI, nonfatal stroke, or CV death was 2.2% in the fenofibrate group versus 2.4% in the placebo group (HR 0.92, CI 0.79-1.08, p=0.32). The investigators reported a possible benefit in the subgroup of patients who had both elevated triglycerides at baseline and low HDL cholesterol.

The second arm of the study tested a strategy of aggressive blood pressure control versus standard control in 4,733 subjects to intensive-therapy, where the systolic blood pressure target was 120 mm Hg or lower, or standard therapy, where the goal was 140 mm Hg. The annual rate of nonfatal MI, nonfatal stroke, or CV death was 1.87% in the intensive therapy group versus 2.09% in the standard-therapy group, a nonsignificant difference. There were fewer strokes in the intensive therapy group but the more intense drug therapy resulted in more serious adverse events caused by drug therapy.

In an companying editorial, Peter Nilsson writes that “we learn from the completed ACCORD study that flexible goals should probably be applied to the control of hyperglycemia, blood pressure, and dyslipidemia in patients with type 2 diabetes, taking into account individual clinical factors of importance.”

NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research) randomized, in a 2 x 2 factorial design, 9306 patients with impaired glucose tolerance to valsartan or placebo and nateglinide (a short-acting insulin secretagogue) or placebo. In the valsartan arm of the trial, valsartan therapy resulted in a significant reduction in the incidence of diabetes from 33.1% in the valsartan group versus 36.8% in the placebo group (HR 0.86; CI .80=.92, p<0.001). Unfortunately, this difference did not translate into clinical benefit, as there were no significant differences in any of the clinical endpoints.
In the nateglinide arm of the trial, there were no significant differences in clinical outcomes between patients who received nateglinide and patients who received placebo.
In an accompanying editorial, David Nathan writes that “the prevention of diabetes remains a critical public health priority, but for now we should steer away from these two drugs and use effective lifestyle interventions and, in selected persons, metformin to combat the epidemic.”

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study ) is the first large trial of catheter-based mitral valve repair in which 279 patients with significant mitral regurgitation (MR) and suitable anatomy were randomized on a 2:1 basis to the MitraClip (184) or surgery (95). At 30 days the new device was much safer than surgery: 1 MitraClip patient had a GI complication requiring surgery and 12 required significant transfusions. By contrast, in the surgery group there were 2 deaths, 2 major strokes, 1 patient who underwent reoperation, 4 patients who had urgent CV surgery, 4 patients who required ventilation for more than 48 hours, and 42  patients who required significant transfusions.
At one year, clinical efficacy was similar between the two groups. The clinical success rate, defined as freedom from the combined outcome of death, MV surgery or re-operation for MV dysfunctions, or an MR score >2 at 1 year, was 72.4% in the MitraClip group versus 87.8% in the control group.
Presenting the results of the pivotal trial, Ted Feldman concluded that “the MitraClip procedure is an important therapeutic option for selected patients with significant mitral regurgitation given the demonstrated safety, effectiveness and clinical benefit.”
 
 

Frederic J Raal et al. report results in the Lancet of a phase 3 study in patients with homozygous familial hypercholesterolemia. Fifty one subjects on high dose lipid-lowering drugs were randomized (on a 2:1 basis) to either placebo or mipomersen, a novel antisense inhibitor of apolipoprotein B synthesis. Patients on mipomersen had a 24.7% decrease in LDL, compared with a 3.3% decrease with placebo (p=0.0003). However, most patients on mipomersen failed to reach target LDL levels. Increases of alanine aminotransferase of three times or more the upper limit of normal was observed in 4 (12%) of patients on mipomersen but none of the patients on placebo. In an accompanying comment,  Neely and Bassendine said that the drug “is a promising new treatment option for refractory hypercholesterolemia, with the potential to be used in combination with statins in patients with genetically defined familial hypercholesterolemia who have not responded adequately, or as monotherapy in those who are intolerant of lipid-lowering regimens.” Broader use of the drug, however, would require more studies to evaluate the safety of the drug, they wrote.

See Next Post (ACC Day 2)

Several Fellows in Cardiology who are attending this week’s ACC meeting are blogging together right here. The Fellows include Shane LaRue, Justin Bachmann, Nihar Desai, Shanti Bansal, and Hansie Mathelier. Check back often to learn about the biggest buzz at the ACC — whether it’s a poster, a presentation, or the word in the hallways.

And, if you want to learn how to make the most of a national meeting, click here.

Justin Bachmann
3/14 4:03 p.m

Busy day.  I’m glad there was another fellow at the  Healthcare Reform keynote, Shane. The room was absolutely packed.  Must have been 300-400 people.  Personally I thought it was great.  Rep.  Paul Ryan (a Republican) and Chris Jennings, a Democratic health policy  consultant, slugged it out.  They didn’t seem to reach consensus on  much.  I think it’s a good illustration of how difficult the healthcare  debate has become.

Then it was off to the Integrated Imaging talk.  Lots of good stuff. 3-D echo, speckle tracking, strain imaging. Many of these techniques seem to be technology searching for a purpose, but hopefully they will find their way into routine clinical practice.

As a member of the ACC Fellow-in-Training committee I would be remiss if I didn’t point out that there is a FIT Community Room in B216.  Don’t ever pay for coffee folks; it’s free along with other food in the  fellows’ room.  There are also fast desktop computers. The only rub is that it’s quite a hike. It’s way on the far end of the B building. The exhibitors are also giving out plenty of coffee that I used to fuel up throughout the day.  One booth is even making protein shakes.

And the day isn’t over yet. I’m off to the ACC all-chapter reception in the Omni grand ballroom, where I’ll meet up with some of the other Texas cardiologists. Talk to you all soon.

Shane LaRue
3/14 3:41 p.m.

Just watched a live CTO case.  Have to agree with Shanti re the great pictures. Also a good way to mentally refresh after listening to several talks.

Moved onto terumo radial access demonstration in the exhibit hall. Very informative talk, especially as we get little arm exposure as general fellows. The real reason to come by is that you can get access on a dummy radial artery. (in case any of you share my joy in sticking things with needles).

Hansie Mathelier
3/14 3:22

So offline, Harlan Krumholz asked for the fellowship training perspective on new presentation and data—do we read based on the presentations or is the meeting a replacement for that kind of study? For me, it is on a presentation-by-presentation basis as to whether I will do follow-up reading.

For example, I just attended a lunch conference with “management of RV failure.” There were 6 case presentations. I was surprised many times — as were other individual in the audience and panel — regarding the high dose of milrinone (0.75) used in the management of the case patients. For me, it reinforces the fact that people clearly manage pt differently. Based on my experiences in residency and fellowship this made me skeptical on the data the presenter had. Thanks to my blackberry I googled the speaker to ascertain her background. What I also took away from this lunch session was that there is also extensive center and regional variability when it comes to the decision of inotropes, RVAD /LVAD placement, and transplant listing .

By the end I was wanting more. Perhaps a more organized discussion or more controversial cases to generate a more lively discussion. Off to the “Management of ADHF: past present and foreseeable future”

FYI Fellow bloggers there was free coffee in the exhibit hall. Just in case you didn’t want to spend $15 on coffee per day.

Nihar Desai
3/14 2:57 p.m.

Wow, what a Sunday at the ACC…. Started off this morning with the late breakers, was wondering if you think anything we heard this morning will change practice. I was sitting with a couple other first year cardiology fellows and we were most surprised with the ACCORD BP results suggesting no benefit of intensive (SBP<120) blood pressure control in diabetic patients at risk for adverse CV events.

What did you think about the EVEREST II Mitraclip presentation?  I think too often we assume that newer technology is necessarily better and I think the panel discussion afterwards included a healthy skepticism.

I just wanted to echo the comments on health care reform and how central a role it is playing at this meeting. Very telling to have David Blumenthal here and I also had a chance to attend several very good sessions on using registries to drive quality improvement and how to implement a performance improvement program.

It was also nice for me to walk through the poster session, see some interesting science, catch up with friends from medical school and residency, and support colleagues!

Shanti Bansal
3/14 2:25 p.m.

I am at the Yale CTO live case. This is really impressive live feed coming from Yale.  You can see everything going on at Yale very clearly. This is like watching NBC olympics with professional commentary.  I hope they start selling a TV like this at Best Buy.

Shane LaRue
3/14 2:06 p.m.

Ok, first, thanks to the organizers for the coffee stands every 20 ft. 2nd large coffee down and the 6am flight (after the time change) is a distant memory.  Well worth the $4.75.

Healthcare reform is (mercifully) just finishing. This is obviously a provocative topic, but my foremost thought is, my med school self would be very disappointed in my fellowship self. One of the physicians vocalized my persective on the topic. We first have to decide whether everyone should be covered. If that is the case, then find the way to make it work. I am stuck at the ‘we need to find a way to make it work’ stage. I literally go cross-eyed listening to the debate. Speaking of which, the discussion at times felt a little like watching fox news, with the republican (Paul Ryan) speaking loudly, confidantly (and to his credit clearly), while the democrat mumbled, softly.  The only universal applause was when they agreed that the cuts to cards reimbursement this year were poorly researched/inappropriate.  Go figure.  Off to find another talk, hopefully will not get so lost this time.

Shanti Bansal
3/14 1:45 p.m.

I came into atlanta friday night after an annoying interaction with US airways.  I am here with my papa johns pizza watching Geoge Beller explain preoperative risk stress testing. There was a very spirited discussion of how to manage an 80-year-old female with hip fracture with trop of 0.15 and anterior twi. Any thoughts on this? My personal view point is that she should stress them rather than be more aggressive as a first step.

Hansie Mathelier
3/14/ 1:15 p.m.

The second half of the morning was interesting. Walking around the exhibit hall. Time to reflect on the morning and time to plan for lunch. Should I go to “Management  of RV failure” vs. “Clearing the Cardiac patient for noncardiac surgery.”. Being a first year fellow, I am assume I know how to “clear” a pt but what is the new data out there vs the neglected ventricle. I chose the neglected ventricle. Should be interesting to hear cardiologist and cardiac surgeons perspective. Just a side note… Thank goodness I am not a vegetarian. The selection for food options for vegetarians are limited. One of my cofellow isn’t eating lunch because his options were cheese pizza or salad.

Justin, For this afternoon I was debating about 3D echo vs mgmt of acute decompensated HF. I will email after my lunch time talk to assess imaging vs ccu

Justin Bachmann
3/14 12:15 p.m.

Anyone else get stuck on the tarmac yesterday?  My connecting flight from Charlotte came close to being cancelled, but I made it in.  I’m glad I did.  This morning I went to the Health Information Technology keynote featuring David Blumenthal, MD.  He’s at Johns Hopkins, where Hansie and I trained. There was a nice discussion between Dr. Blumenthal, Dr. Lewin and Dr. Bove about the capacity of electronic medical records to improve outcomes and efficiency. Dr. Bove mentioned that he’s effectively used HIT to enhance communication with his patients.  Apparently his heart failure patients are able to routinely send in their weights and other data through an electronic system.  This allows him to track his patients much more closely than monthly follow-up visits.

I also dropped by the Heart Songs demonstration, which was a lot of fun, as well as the exhibition hall. The hybrid OR mockup is pretty sweet. And I got a kick out of the matching lime green ties that all of the Effient folks are wearing.

Right now I’m heading towards the Health System Reform keynote with Jack Lewin and Jim Fasules, the ACC’s director of advocacy.  I’m anticipating a pretty spirited discussion.  If any of you are politically inclined, be sure to check out the ACC Political Action Committee’s hospitality suite. It’s in room #3808 at the Marriott Marquis.

I’ll probably go to the Integrated Imaging Spotlight this afternoon, Hansie.  Want to meet me there?  There will be some interesting talks on 3-D echo.  Talk to you all soon.

Hansie Mathelier
3/14 10 a.m.
Starting on my ACC experience. My first decision was to take the shuttle bus or walk 8 blocks. I chose to walk since I always try to tell my patients to exercise more. Also gave me time for me to think do I want to go for my first session. If you are interested in many topics it is hard to pick a first session. Do you go to the late breaking session or an interesting symposium or spotlight (moderators from my home institution)? I chose to go “special topics” – Joint Session of the ABC and ACC discussing race and ethnicity in different topics, ie (1) hispanics and heart failure (2) atrial fibrillation in African-Americans (3) registries being set up across the us focusing on hispanic. (4) recurring themes in cardiovascular health and race. As I leave this session wondering how do I get access to these registries? Ideas of studies that could be done with these registries. I wonder what session my fellow bloggers attended? As I look at the schedule for this afternoon, which lunch and afternoon session should I go to? What suggestions do you have, Justin, Shane, and Nihar? How about among our readers?

The FDA has added a black box warning to the Plavix (clopidogrel) label. The black box warns about people “who do not effectively metabolize the drug… and therefore may not receive the full benefits of the drug.” The warning also informs healthcare professionals about tests that can identify the underlying genetic differences in clopidogrel metabolism and advises them “to consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.” Click here for the full FDA communication.

Interest in blood pressure variability is likely to rise considerably with the publication of four simultaneous papers on the subject by Oxford’s Peter Rothwell in the Lancet and Lancet Neurology. Rothwell points out that by relying on traditional assessment of mean systolic blood pressure, researchers have been unable to fully understand the contribution of blood pressure to stroke and coronary disease and have been baffled by some key findings in clinical trials. By adding in assessments of blood pressure variability, Rothwell maintains it may be possible to significantly improve prediction of vascular events and may have important implications for choice of therapy. The different effects of antihypertensive agents on blood pressure variability appear to explain why calcium channel blockers are more effective at reducing the risk of stroke than might be expected based on traditional blood pressure measurements and why beta-blockers are less effective. (The four papers include a Lancet cohort study, a Lancet meta-analysis, a Lancet review, and a Lancet Neurology study.)

    In an accompanying comment, Bo Carlberg and Lars Hjalmar Lindholm ask whether treatment decisions should now be modified: “Not quite yet,” they conclude, “because results from clinical trials with standardized recordings and treatment care are difficult to translate into everyday practice in which patients often receive several different drugs that can change over a short time. The notion presented by Rothwell and co-workers today is, however, challenging and will raise many questions. Researchers with data from population-based cohorts or randomized trials are likely to investigate whether Rothwell’s findings can be replicated, taking other risk factors into account.”

According to a recent study, of almost 400,000 patients referred for elective coronary angiography, only 38% had obstructive CAD.  Those with a positive noninvasive test before angiography were only moderately more likely to have obstructive CAD than those who did not undergo any testing (41% vs 35%, respectively).  However, in a comment in Journal Watch, Harlan Krumholz notes that the study’s reporting of noninvasive testing is inadequate for assessing the implications of positive results. Furthermore, the presence of typical symptoms was a much better predictor of CAD than a positive noninvasive test (ORs, 1.91 and 1.28, respectively); still, 30% of those referred for angiography had no anginal symptoms.

More than 9 million myocardial perfusion imaging studies are performed annually in the U.S.  How do we improve the quality of noninvasive testing?  In the absence of planned transplantation or valvular surgery, should asymptomatic patients be referred for coronary angiography?