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STICH: Surgical ventricular reconstruction, CABG no better than CABG alone
Surgical ventricular reconstruction takes more time, costs more.
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Patients who received CABG and surgical ventricular reconstruction had similar decreased death and cardiac hospitalization rates at four years of follow-up compared with patients in the STICH clinical trial who received CABG alone.
Robert H. Jones, MD, Mary and Deryl Hart Distinguished Professor of Surgery at Duke University Medical Center, Durham, N.C., presented the STICH hypothesis 2 primary outcome report today at the American College of Cardiology’s 58th Annual Scientific Sessions. Hypothesis 1 is ongoing, he said, and will be presented at a later date.
For the hypothesis 2 arm of the trial, Jones and colleagues enrolled 1,000 patients with ejection fraction <35%; CAD that the study surgeons felt could be well-managed by CABG and an area of scarred, dysfunctional tissue in the anterior-apical region of the heart. About half the patients had moderate-to-severe angina. HF was deemed moderate-to-severe in a similar proportion. More than 60% had triple-vessel disease. The patients were predominately white males, with a median age of 62 years.
Patients were randomly assigned to undergo CABG alone (n=499) or CABG plus surgical ventricular reconstruction (n=501). All patients received intensive medical therapy. Both surgeries improved symptoms and exercise capacity, and surgical ventricular reconstruction was successful in reducing end-systolic volume index by 20% compared with 3% with CABG. However, after a median follow-up of four years, there were no differences between the two groups in combined rates of death or hospitalization for cardiac causes (56% in CABG group vs. 57% in CABG and surgical ventricular reconstruction group).
Jones said surgical ventricular reconstruction added about 30 minutes to the patient’s procedure time.
More data from the hypothesis 1 arm of the trial (n=1,212) is expected to come in two years. That arm of the trial is comparing patients assigned intensive medical therapy with patients assigned intensive medical therapy and CABG, Jones said.
“Those [patients] will continue to be followed every six months until we have 400 deaths in that population. That is an event-driven trial,” Jones said of the first hypothesis arm during a press conference. “That’s going to make a big impact on practice because a lot of the use of PCI is predicated on the benefit that’s been shown in surgery ... if we find out that intensive medical therapy is so good there’s not much room for surgery to improve it anymore, that’s going to change all of cardiology. All the way back to how much noninvasive testing we do, how many caths we do.”
Quality of life outcomes
“Unlike our expectations before the trial started, [surgical ventricular reconstruction with CABG] doesn’t actually provide any benefit and it is substantially more expensive,” Daniel Mark, MD, MPH, director of outcomes research at the Duke Clinical Research Institute said during a press conference.
Mark, who will present results from an economic and quality of life outcome report of the trial on Tuesday during the ACC meeting, said that patients in the United States who underwent surgical ventricular reconstruction (n=200) spent longer in the ICU and the procedure increased the cost of operation and post-operative care by more $14,500 extra.
From a quality of life standpoint, both treatment groups significantly improved their Kansas City Cardiomyopathy Questionnaire. Four percent of pre-operative patients had NYHA I symptoms and 15% had NYHA IV symptoms, while postoperatively, 40% of the survivors were NYHA I and 2% were NYHA IV, demonstrating an overall marked improvement in heart function across both groups. – by Judith Rusk
In an era of calling for comparative effectiveness research, I think this is an outstanding example. It really failed to support the hypothesis that surgical achievement of reduction of wall stress can translate into improved outcomes. If that’s the case then we have to think about what the implications are for other types of interventions that might achieve the same sort of thing. We have a very long series of evidence that reducing end-systolic volume pharmacologically translates into improved outcomes and here we very effectively reduced end-systolic volume and it didn’t improve outcomes. If end-systolic volume means we’ve actually reduced the degree of pathologic myocite hypertrophy then that’s a very good thing, but if it’s achieved simply structurally it might not have the same benefit.
– Marvin A. Konstam, MD
Professor of Medicine, Tufts University School of Medicine, Boston
For more information:
- Jones R. Special Topic #402.
- Mark D. Special Topic #416
- Both presented at: Presented at: 58th American College of Cardiology Annual Scientific Session; March 29-31, 2009; Orlando, Fla.