A new report from the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial shows that the advantages of bypass surgery are less obvious once quality of life and economic data are included in the analysis. Instead, the complexity of coronary artery disease becomes a major factor in determining whether stenting or surgery is the preferred treatment according to research presented during the i2 Summit at the American College of Cardiology's 58th annual scientific session.

A new report from the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial shows that the advantages of bypass surgery are less obvious once quality of life and economic data are included in the analysis. Instead, the complexity of coronary artery disease becomes a major factor in determining whether stenting or surgery is the preferred treatment.

"Clinicians, patients, guideline issuers and payers will find this information helpful in making clinical decisions, as well as in setting treatment priorities," said David J. Cohen, M.D., MSc, director of cardiovascular research at Saint-Luke's Mid America Heart Institute and a professor of medicine at the University of Missouri. "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."

The main SYNTAX trial enrolled 1,800 patients with a build-up of cholesterol plaque in either three coronary arteries or the critically important left main coronary artery, randomly assigning 897 to coronary artery bypass grafting (CABG) and 903 to PCI with drug-coated stents. At the one-year mark, rates of death, myocardial infarction 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 angina 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 procedures and the need for long-term anticoagulants.

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 - determined by such factors as where the plaque was located, the number of lesions to treat, the length of lesions and whether they were calcified or layered with fragile blood clots - 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.

"The most important message is that there is no single answer. The relative cost-effectiveness of PCI and CABG for left main and three-vessel disease depends strongly on the complexity of underlying coronary disease," Cohen said. "It is also important to note that our analysis applies only to the U.S. healthcare system. Given differences in treatment patterns and resource costs, the specific balance of costs and effectiveness may be very different in other countries."
Five-year follow-up is planned for all patients in the SYNTAX trial.