CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

April 4th, 2011

STICH Illuminates CABG in Heart Failure, Finally

After a very long wait, the Surgical Treatment for Ischemic Heart Failure (STICH) trial has finally shed light on the common but poorly understood use of CABG in heart failure patients with ischemic heart disease. The results were presented by Eric Velazquez at the ACC and published simultaneously in the New England Journal of Medicine.

Some 1212 patients with an ejection fraction of 35% or less and coronary artery disease were randomized to medical therapy plus CABG  or medical therapy alone. At 56 months’ median follow-up. the death rate (the primary endpoint of the study) was 41% in the medical therapy group versus 36% in the CABG group (HR with CABG: 0.86, CI 0.72-1.04, p=0.12).

  • Cardiovascular death occurred in 33% of the medical therapy group versus 28% of the CABG group (HR 0.81, CI 0.66-1.00, p=0.05).
  • The rate of death plus hospitalization for cardiovascular causes was 68% in the medical therapy group versus 58% in the CABG group (HR 0.74, CI 0.64-0.85, p<0.001).

Some 100 patients in the medical therapy group ended up having CABG during follow-up; 555 patients in the CABG group actually underwent surgery.

With the exception of 30-day mortality, secondary clinical outcomes favored CABG. As expected, CABG resulted in an early risk, so that for the first 2 years after randomization the risk for death was higher in the surgical group.

The investigators had initially planned to enroll 2000 patients, but slower than desired enrollment led them to adjust the trial, so that fewer patients were followed for a longer period in order to accumulate enough endpoints.

The authors cautioned that “when the analysis in any trial fails to detect a significant difference between treatment groups with respect to the primary outcome, analyses of secondary outcomes showing a benefit must inevitably be considered to be somewhat provisional.”

STICH Myocardial Viability Substudy

A myocardial viability substudy of STICH was presented immediately following the main study and was also published simultaneously in the New England Journal of Medicine. First author Robert Bonow said that physicians often use myocardial viability tests to determine whether patients with coronary artery disease and LV dysfunction should undergo CABG, but that this strategy has never been tested.

In the substudy, 601 patients who had already undergone myocardial viability testing were randomized to either medical therapy plus CABG or medical therapy alone. The death rate was 37% among the 487 patients with viable myocardium and 51% among the 114 patients without viable myocardium (HR for patients with viable myocardium, 0.64, CI 0.48-0.86, p=0.003). However, this association lost all statistical significance after adjustment for other baseline characteristics.

The authors write that their results indicate “that assessment of myocardial viability alone should not be the deciding factor in selecting the best therapy for these patients.”

Editorial

James Fang, in an accompanying editorial entitled “Underestimating Medical Therapy for Coronary Disease … Again,” writes that patients like those enrolled in the STICH trial should receive aggressive medical therapy and that revascularization “should be carefully weighed but can be safely deferred,” though it should be offered to those with “persistent or progressive symptoms.”

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

Categories: Cardiac Surgery, Heart Failure
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5 Responses to “STICH Illuminates CABG in Heart Failure, Finally”

  1. Kishaloy Sur, MBBS says:
    April 4, 2011 at 9:54 am

    Disagree with editorial by James Fang.Voluminous evidence still favoring CABG over medical therapy as well as PCI,if “Cardiovascular mortality” considered as primary as well as hard end point.

  2. Larry Husten, PHD says:
    April 4, 2011 at 11:21 am

    I just want to offer a brief update to the news story above, which was based on the NEJM publications. Velazquez’s presentation at the late-breaker session was much more emphatically pro-CABG, and emphasized a number of secondary analyses and trends which favored CABG. One of the discussants, Bernard Gersh, said STICH was a strongly positive trial, but he was criticized by session co-chair Gregg Stone, who urged caution about this interpretation of the trial and reminded the audience that the trial was technically a negative trial.

  3. Luis L Correia, MD, PhD says:
    April 6, 2011 at 7:44 pm

    The same old story. When people don’t like the final result of a trial, they look for secondary end-points. This is a negative trial and it should not be controversial. We just have to accept the result of a well-designed trial, with enough statistical power to reject the null hypothesis. If the null hypothesis was not rejected, we must accept it.
    In fact, it should not be disapointing, because now we know where is the true regarding revascularization in HF patients. This is a trial that provided us a paradigm shift. We must give science the value it deserve.

    Competing interests pertaining specifically to this post, comment, or both:
    No Conflict of interest

  4. Jose Augusto Barreto Filho, MD; PhD says:
    April 6, 2011 at 11:18 pm

    Unfortunately, regarding the decision making process and based on the results of the STITCH trial, in general, it seems not reasonable to indicate CABG for patients with Left Ventricular Dysfunction:
    1. Patients will be exposed to a higher risk in the next 1-2 years with no objective gain in the end.
    2. I guess that the 30-day mortality (4%) would not be reproduced in the real world. Only highly qualified centers were selected to participate in the STITCH trial. So,the minimal differences in the secondary outcomes may even disappear in the real world.

    But I see the STITCH trial bringing out some good news.
    1. Patients and MDs have an updated knowledge regarding the tradeoffs of CABG in this selected population.
    2. Opportunity to cut costs. We could learn from entrepreneurs who research to cut costs. Why not celebrate the fact that, using an evidenced-based method, we can avoid wasting money with studies to investigate myocardial viability that does not impact clinical outcomes?

  5. William L Blanchet, MD says:
    April 6, 2011 at 11:54 pm

    If revascularization in ischemic patients with heart failure provides no survival benefit, when should revascularization be used outside of treating refractory angina?