Chicago, IL—In the American College of Cardiology Foundation-the Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revas cularization Strategies (ASCERT), a large nationwide study of health outcomes in nearly 190,000 patients aged ≥65 years with coronary artery disease, long-term survival appears to be better with coronary artery bypass grafting (CABG) surgery than with percutaneous coronary intervention (PCI). At 4 years, adjusted mortality was 16.41% with bypass surgery and 20.8% with PCI. Lead investigator William S. Weintraub, MD, FACC, Chair of Cardiology, Christiana Care Health System, Newark, DE, presented the results at the 2012 American College of Cardiology (ACC) meeting.
“This study should help inform decision- making concerning the choice of revascularization in patients with stable ischemic heart disease,” said Dr Weintraub, who cautioned that the results do not indicate that bypass surgery is right for every patient. The results, however, reinforce the need to include the patient in the decisionmaking, he said, and this study provides evidence for the physician and the patient to support this process. Furthermore, it should open communication between the interventionalist, the surgeon, and the patient to determine the best approach for the individual patient. The results of this comparative effectiveness research (CER) are largely consistent with previously published clinical trials and observational studies.
The researchers combined patient data from the ACC Foundation Cath-PCI database, the Society of Thoracic Surgeons (STS) CABG database, and the Medicare claims database to compare survival rates among 86,000 bypass surgery patients and 103,000 PCI patients who underwent treatment from 2004 to 2007 at 644 sites.
David R. Holmes, Jr, MD, Professor of Medicine at Mayo Clinic College of Medicine, Consultant in the Department of Internal Medicine, Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, and immediate past president of the ACC, said that this collaboration of ACC and STS initiated during his presidency is a landmark movement for interventionalists and surgeons to work together, and that such collaborations to obtain health outcomes data are needed in today’s medicine.
Adjusted mortality at 1 year was similar with both strategies. All patients had 2- or 3-vessel disease, and none had a previous myocardial infarction. At baseline, more patients in the PCI group had 2-vessel disease; in the bypass surgery group, more had 3-vessel disease and were older and sicker.
A surprise finding was the consistency of the data overall and across all subgroups, regardless of the statistical method used. “Survival was better with coronary surgery for all patient subgroups,” said Dr Weintraub. Even the patients whose propensity scores were consistent with being selected for a PCI had a better survival rate with surgery.
According to Dr Weintraub, another important contribution of the ASCERT study is that it provides critical experience in CER using observational data. Acknowledging that randomized clinical trials are the gold standard, he said, observational studies complement the clinical trials, and that both have critical roles for CER to meet its potential. Furthermore, he said, the generalizability of clinical trials is a common complaint, and the totality of evidence, including from analyses like these, is needed for best decision-making.
Additional analyses on composite end points, angiographic outcomes, and economics are under way