CardioExchange Archive

New Study Raises Fresh Concerns About Clopidogrel and PPIs: In a retrospective analysis of a large insurance plan appearing in Archives of Internal Medicine, patients taking a PPI and clopidogrel had a 93% higher risk of rehospitalization for MI than patients taking clopidogrel alone. To better account for underlying differences associated with PPI use, the investigators matched patients by their baseline risk using propensity scoring. The study also included more women and elderly patients than previous studies, write Karen Stockl and colleagues in their article. Previous studies have centered on the PPI omeprazole; in this study, pantoprazole accounted for nearly two-thirds of PPI usage, suggesting “that the potential interaction between PPIs and clopidogrel is not specific to omeprazole.”

Universal Versus Targeted Screening: The United Kingdom plans to screen for cardiovascular risk all adults between the ages of 40 and 74 who have not already been diagnosed with diabetes or cardiovascular disease. However, a new study in BMJ from the MRC Epidemiology Unit finds that this may not be the most cost effective method to reduce the burden of CVD. Simon Griffin and colleagues analyzed data from a prospective cohort of 17,000 patients and found that by using routine data from electronic patient records to identify high-risk individuals, they could prevent an equal number of events and would only need to screen 60% of the population. In an accompanying editorial, Tom Marshall writes that “universal screening is cost effective compared with no screening but not compared with targeted screening” and recommends that “before we investigate the complicated ideas we should implement the simple ones. There are untreated patients at high risk of cardiovascular disease, most of whom can be identified from their electronic primary care records. We should act on this information.”

Liraglutide Beats Sitagliptin in Glucose Control: A once-daily injection of the GLP-1 analog liraglutide was superior to the DPP-4 inhibitor sitagliptin in reducing glucose levels in type-2 diabetics already taking metformin. The report by Richard Pratley and colleagues on more than 600 patients enrolled in the parallel-group, open-label trial appears in the Lancet. Liraglutide also resulted in greater weight loss. In an accompanying comment, André Scheen and Régis Radermecker observe that some patients may prefer sitagliptin because it has fewer gastrointestinal side effects and does not require an injection.

Endomyocardial Biopsy versus Gene-Expression Profiling: It may be possible to replace routine endomyocardial biopsy with gene-expression profiling in some cardiac-transplant patients, according to a new study presented at the annual meeting of the International Society for Heart and Lung Transplantation and published online in the New England Journal of Medicine. The IMAGE Study Group randomized 602 transplant patients at low risk for rejection and found no significant differences at one year in the primary composite outcome (rejection with hemodynamic compromise, graft dysfunction due to other causes, death, or retransplantation) or at two years in the rate of death.
   In an accompany editorial, John Jarcho writes that the trial’s clinical significance is somewhat limited, due to the low-risk patient population and the wide confidence intervals used in the trial. Jarcho notes that the benefits of routine biopsies have never been demonstrated, and asks whether “it is time to perform a randomized trial that compares a strategy of continuing endomyocardial biopsies indefinitely with that of discontinuing routine endomyocardial biopsies at some specified interval.”
    In an article in the New York Times by Andrew Pollack, study leader Michael Pham is quoted as saying the trial “will cause a paradigm shift in the way we look at monitoring for rejection.” The Times story points out that a biopsy costs $4,000 to $5,000 and the new test costs $3,000. Both tests may be frequently repeated.
  

The IOM Passes the Salt to the FDA: The Institute of Medicine released a report, “Strategies to Reduce Sodium Intake in the United States,” that urges the FDA to set “new government standards for the accept­able level of sodium.” The goal, according to the report, “is to slowly, over time, reduce the sodium content of the food supply in a way that goes unnoticed by most consumers as individuals’ taste sensors adjust to the lower levels of sodium.”
   The FDA said that it has “begun the process of regulating the amount of sodium in foods” but “is not currently working on regulations nor has it made a decision to regulate sodium content in foods at this time.” The FDA said it plans to review the IOM report and “build plans for how the FDA can continue to work with other federal agencies, public health and consumer groups, and the food industry to support the reduction of sodium levels in the food supply.”

Promising Results for Novel Dual DES: A novel sirolimus- and probucol-eluting stent (DUAL DES) continues to perform well at 2 years when compared to the sirolimus-eluting stent (SES) and the zotarolimus-eluting stent (ZES). Robert Byrne and colleagues report the 2-year results of the ISAR-TEST-2 trial in an expedited publication in the Journal of the American College of Cardiology. The investigators had previously reported a lower binary restenosis rate in the DUAL DES group compared to the ZES group but a similar rate when compared to the SES group at 6-8 months. Now, at 2 years, the rate of target lesion revascularization was 7.7% in the DUAL DES group, 10.7% in the SES group, and 14.3% in the ZES group, but only the difference between DUAL DES and ZES achieved statistical significance.

CardioExchange welcomes this guest post reprinted with permission from CardioBrief, a blog written by the news editor of CardioExchange, Larry Husten, PhD.

Small Steps Lead to Big Reduction in Risk for Overweight Mayo Clinic Cardiologist: Moderate changes in lifestyle can lead to big reductions in risk, as reported in a feature story in the Wall Street Journal by Ron Winslow. The story opens with an anecdote from Mayo Clinic cardiologist Stephen Kopecky, who describes the case of a 240-pound, 49-year-old man with a scary lipid profile. “He may not have been a heart attack waiting to happen, but that was the direction he was headed,” writes Winslow.

The man then started to exercise regularly and to eat a healthy diet, resulting in an 18-pound weight loss and a dramatic improvement in his lipids. Winslow quotes Kopecky, who points out that the case shows “that we can all help ourselves tremendously taking small steps and doing something that’s achievable.”

But it’s not until the very end of the story that Winslow pulls the rabbit out of the hat:

“Which brings us back to Dr. Kopecky. The 49-year-old patient whom he describes is now 55, and he is Dr. Kopecky himself. He had been an interventional cardiologist at the Mayo Clinic and says he had performed about 2,000 angioplasty procedures to open up clogged arteries of people who were unable to fend off the disease. He decided to become a preventive cardiologist.

But to do that, he felt he needed to follow his own advice. “It’s not an all-or-none phenomenon,” he says. “But any little benefit is a continuous curve. You add benefit by doing multiple things.”

Winslow ties Kopecky’s story to a much larger theme, much in evidence at last month’s ACC meeting in the ACCORD (first arm; second arm) and RACE II trials, showing that more aggressive therapy doesn’t always translate into better outcomes. Winslow quotes Chris Cannon: “Going the moderation route is what we recommend to get real change for the heart patient.”

“The overall message of the reports,” writes Winslow, “was that patients appear to do just as well aiming for treatment goals that are easier to achieve, at potentially lower cost and with fewer side effects.”

Add Sugar, Add Risk: People with diets that contain large amounts of added sugars (e.g., high-fructose corn syrup) have lower HDL levels and higher triglyceride levels, according to a new report from the National Health and Nutrition Examination Survey (NHANES) appearing in JAMA. “Monitoring trends in consumption and understanding the effect added sugars have on risk of cardiovascular and other diseases is critically important, because added sugars are a potentially modifiable source of calories,” write Jean Welsh and colleagues in their paper.
   “Added sugars are food additives that can be recognized by consumers and have been proposed for specific labeling on food and beverage packaging,” they add. “The results of our study demonstrate that increased added sugars are associated with important cardiovascular disease risk factors, including lower HDL-C levels, higher triglyceride levels, and higher ratios of triglycerides to HDL-C.”

Fill the Plavix Prescription, or Else… One in six patients who received a drug-eluting stent didn’t fill their clopidogrel prescription immediately, and these patients had a greater risk for subsequent events, according to a large retrospective study by P. Michael Ho et al. in Circulation: Cardiovascular Quality and Outcomes. The incidence of death or MI was 7.9% in those who filled their prescriptions on the day of discharge compared to 14.2% in those who delayed filling their prescriptions.

The Wall Street Journal reports that the FDA might terminate TIDE, the ongoing study testing the cardiovascular safety of rosiglitazone and pioglitazone. Alicia Mundy and Jennifer Corbett Dooren write that the agency could also choose to pull rosiglitazone from the U.S. market entirely. But the FDA won’t reach any decision until after an advisory panel meets in July.

CardioExchange welcomes this guest post reprinted with permission from Dr. John M, a blog by private-practice electrophysiologist and CardioExchange member, Dr. John Mandrola.

It was a brightly lit wide open room with many cubicles arranged on the periphery.  The test takers were grown-ups, but all carried that worried student look.  The secretary at the desk who checked you in made TSA people seem jovial.  No personal effects were allowed, including a full-fledged divorce of the cell phone. Mysteriously, the test was devoid of ovals or pencils.

A former senior partner was already checked in and hard at work in his cubicle. At break, I asked him, “Hey, what are you doing here?  You are grandfathered.” 

“I want to be official.”

I thought, “That’s what I’m talking about!”  

Ten years had passed since fellowship.  Wow.  

Many evenings were spent on the internet study modules. Weekend mornings meant a trip to the coffee shop with the review book and legal pad.  Lists of things to remember were made — like the growing number of Long QT syndromes, each with their specific chromosome aberrations.  As if I would possibly remember them a week after the test.  A board review course in a far away city was deemed necessary. Having no corporate disclosures is good for independent opinions, but makes for more expensive travel.  

Yes, preparing to re-certify in both cardiology and electrophysiology was like a long steady climb through a forest of trees that block the sight of the summit.

Unlike my more senior colleagues, my board certification had an expiration date of ten years. No grandfathering.  This is good for our patients as there is oodles to learn in ten years.   The density of knowledge acquired in the months preceding a board exam is staggering.  Learning all this, even if you were sure to forget the seldom used facts, rejuvenates the doctoring spirit. It made me better.

It is perplexing that retesting of doctors is news.  Or maybe, it is newsworthy that prior to the mid-1990s, older doctors were grandfathered forever.  Sometimes mandates are beneficial.

Finding metrics to measure our “quality” is in vogue. Surely, being able to pass a board exam once a decade is an important foundation.

Opening the congratulatory letter from the ABIM injects just a sliver of pride, like the kid at the sports banquet who is pleased with the shiny trophy.

This trophy — a piece of paper — is yet another addition to the dusty old cardboard box in the basement storage room.  The box behind the bicycles.

FDA Permits Boston Scientific to Resume Sales of Most ICDs: Following a 30-day suspension of sales of Boston Scientific ICDs and CRT-Ds, the FDA has given the company a green light to resume sales of most, but not all, of these devices. The suspension occurred after the company made significant manufacturing changes without following FDA approval procedures. Boston Scientific said sales of its current generation of devices, Cognis CRT-Ds and Teligen ICDs, would resume immediately. (Boston Scientific press release; New York Times story.)