Our Review Summary
This news release describes extended outcomes of a large, randomized controlled trial comparing the effects of coronary artery bypass grafting (CABG) surgery plus medical treatment with those of medical treatment alone on patients with dysfunction or failure of their heart’s pumping function. The study showed significantly lower rates of death from any cause (59% vs 66%) and death from a heart or blood vessel-related cause (41% vs 49%) as well as greater median survival (7.7 vs 6.3 years) among those who received CABG and medical treatment compared to those who received medical treatment alone. This release covered much of what we like to see in news releases but omitted cost and harms.
Why This Matters
This study offers important information on the positive long-term impact of a widely performed surgery on a population previously thought to be too sick to receive it. As the U.S. population ages, more and more people suffer from cardiovascular disease, and more of those patients suffer from heart failure and left ventricular insufficiency. Improved treatment for these patients is important. The initial study also showed that CABG could be used to treat these sicker patients. Whether the median increase in longevity of 1.4 years and a 7 percent increased chance of living for 10 years is significant in human terms must be weighed against the availability of other treatments and the risks of major surgery.
Criteria
Not Satisfactory
There is no discussion of cost in this release. Perhaps the cost of medical treatment is moot as both groups received that, but it’s useful context for the reader. CABG is major surgery and consequently expensive. Some estimates of cost for uninsured patients range from $70,000 to $200,000. Even with medical insurance coverage, deductibles can be very large. It’s also possible that the high cost of surgery could be offset by less need for downstream care among surgical patients who appeared to fare better in the study — e.g. less need for hospitalizations and other costly care. Discussion of any or all of these points would have earned the release a Satisfactory rating.
Satisfactory
The benefits of this approach are discussed in the release and quantified. “The bypass surgery was associated with an overall 1.4-year increase in median survival time (7.7 vs. 6.3 years),” according to the release. Overall, the release did a nice job of presenting absolute rates of death in each group of study participants, but there was no mention of statistical significance which would have been helpful to include for more savvy readers.
Not Satisfactory
The potential harms of a major surgery like CABG should have been mentioned as they must be considered and weighed against the benefits of 1.4 years of additional survival. The National Heart Lung and Blood Institute says the risks of CABG include “wound infection and bleeding, reactions to anesthesia, fever, pain, stroke, heart attack, or even death.”
Satisfactory
The release does a good job of characterizing the quality of the evidence, but we’re always open to even more details, such as how the study was blinded to prevent bias. The researchers managed to track nearly all of the subjects in the initial study. It is unclear how they accounted for those patients who later received CABG, left ventricular assist devices or heart transplants, but the 10 follow-up data appear well done.
Satisfactory
There is no disease mongering here. Coronary artery disease is widespread among the older American population.
Satisfactory
The funding sources are clearly stated in the paper. As this is part of a clinical trial, there appears to be no conflict of interest.
Satisfactory
The study itself compared alternatives, with half the patients randomized for medical treatment only and the other half for medical treatment and CABG. No comparison was made to the alternatives of heart transplant or left ventricular assist devices, but these do seem to be unusual treatments in this population.
Not Applicable
The release doesn’t talk about how often or widely CABG is used but it is well known that CABG is available and has been in use for many years. It would have been helpful to mention that CABG is performed on sicker patients in some specialty hospitals.
Satisfactory
The release claims novelty through this statement by a lead investigator: “The current 10-year follow-up provides new important insights about patient subgroups that are more likely to benefit from CABG as compared to medical therapy alone.” The procedure itself is not novel but this appears to be new information concerning patient outcomes in a specific subgroup.
Satisfactory
There is no unjustifiable language here.
Total Score: 7 of 9 Satisfactory
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