Economic analysis of SYNTAX parallels favorable PCI clinical data

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ORLANDO, Fla.—An economic analysis of the SYNTAX data at one year showed that PCI with drug-eluting stents (DES) in patients with three-vessel or left main disease is cost-effective in the low- and intermediate-risk patients, but not in high-risk patients, according to research presented during the i2 Summit at the American College of Cardiology (ACC) 58th annual scientific sessions.

Similar clinical data were released last year showing that patients with SYNTAX scores in the low to intermediate range were excellent to good candidates, respectively, for PCI, while those in the high range fared better with CABG.

The main SYNTAX trial randomly assigned 897 patients to CABG and 903 to PCI. At the one-year mark, rates of death, heart attack or stroke were similar for the PCI and CABG groups, while the number of repeat heart procedures was significantly higher in the PCI group.

The new study set out to determine whether there were differences in the quality of life with the two procedures. Researchers measured not only overall quality of life but also the impact of a patient's heart disease on symptoms, physical limitations, pain, vitality and other factors. In addition, they collected economic data throughout the study on cardiovascular procedures, hospitalizations, outpatient testing, physician visits and medications.

They found that both stenting and CABG improved the overall quality of life over one year of follow-up, although chest pain relief was slightly better with CABG. Under the U.S. healthcare system, surgery was initially about $6,000 (or about 25 percent) more costly than PCI, reflecting higher hospital costs and much higher physician fees. However, PCI added approximately $2,500 in follow-up costs over the next year, mostly because of additional heart procedures and the need for long-term anti-clotting medication, reported David J. Cohen, MD, director of cardiovascular research at Saint-Luke's Mid America Heart Institute and a professor of medicine at the University of Missouri.

A formal cost-effectiveness analysis found that for the population as a whole, the clinical benefits of CABG did not justify its higher cost at one year. However, the complexity of coronary disease-the SYNTAX score-had a substantial influence on cost-effectiveness.

In straightforward three-vessel or left main coronary disease, PCI led to better quality-adjusted life expectancy than CABG and lower healthcare costs. Findings were similar for patients with disease of intermediate complexity. However, for patients with complex three-vessel disease, quality-adjusted life expectancy was better with CABG, while overall costs at one year were nearly identical for the two procedures.

"Clinicians, patients, guideline issuers and payors will find this information helpful in making clinical decisions, as well as in setting treatment priorities," said Cohen. "From a patient's perspective, quality of life differences are very important to consider. Similarly, given current constraints within the healthcare system, evidence that one approach is less costly could also be incorporated into treatment guidelines."

Cohen said the message is that there is no single answer, at least not at one-year follow-up. "The relative cost-effectiveness of PCI and CABG for left main and three-vessel disease depends strongly on the complexity of underlying coronary disease," he said.

Five-year follow-up is planned for all patients in the SYNTAX trial.

In his commentary on the study, Mark A. Hlatky, MD, a professor of health research and policy and a professor of medicine at Stanford University School of Medicine, said it's important for to evaluate both clinical and cost-effectiveness to judge the value of a particular approach.

He cautioned, however, that these data are only for a year, and that surgery costs are generally front-loaded. "Will the cost differences narrow further with more follow-up or will they stabilize? We don't know that yet," Hlatky said.

He also pointed out that most of the negative quality of life scores for CABG are driven by early differences in recovery.