MUMBAI: The bypass versus angioplasty debate continues.
At the American College of Cardiology’s ongoing annual scientific session in Chicago, cardiologists from Stanford University School of Medicine, California, presented data stating that patients with triple-vessel heart diseases fared equally well whether they underwent open-heart bypass surgery (CABG) or the less invasive angioplasty (also known as percutaneous coronary intervention) at five years of follow-up.
Triple-vessel heart disease is one of the severe forms of heart disease in which three of the major arteries supplying blood to the heart become blocked by cholesterol deposits; such patients could suffer from shortness of breath and heart attack.
“This is the only study to compare CABG and PCI as they are currently used in cardiology––incorporating recent advances in surgical and minimally invasive techniques as well as in medical therapy––in patients with triple-vessel disease,” said William F Fearon, chief of interventional cardiology at Stanford University School of Medicine and the principal investigator of the study called FAME-3. “At five years after random assignment to either PCI or CABG, we found no significant differences between the two groups in the primary endpoint—a composite of death, stroke or heart attack.”
Previous studies had held that patients with triple-vessel disease were less likely to die or have a heart attack or stroke after undergoing CABG (a procedure in which blood vessels from elsewhere in the body are used to bypass the blocked coronary arteries), compared with PCI (a less-invasive procedure that involves placing tiny metal tubes called stents into the partially blocked arteries to prop them open).
CABG is open-heart surgery in which, in most cases, the heart is stopped, and a heart-lung machine takes over pumping blood to the body. It can involve a hospital stay of several days followed by weeks or months of recovery. PCI, by contrast, is not a major surgery and can in some cases be performed as an outpatient procedure. Patients often can resume normal activities a week after PCI. Additionally, new techniques to improve lesion selection, such as fractional flow reserve (FFR) guidance, which measures pressure gradients in partially blocked vessels, as well as medical therapy, have improved PCI outcomes, he said.
The FAME-3 trial enrolled 1,500 patients – average age of 65 years — in North America, Europe, Asia and Australia. The study only considered patients with over 50% blockages in three of the major arteries.
Patients were randomly assigned to one of the two treatment groups. After undergoing CABG or PCI, these patients also took two medications for at least six months to reduce the risk of a heart attack, stroke or blood clot. Blockages with FFR scores above 0.8 did not undergo PCI but were treated with medicine.
“At the one-year analysis, PCI did not meet the preset criterion for non-inferiority compared with CABG. At three years, no significant differences were observed between the two groups for the composite endpoint of death from any cause, stroke or heart attack,’’ said a release sent out during the ACC session.
Almost 95% of patients completed five years of follow-up. At the five-year analysis, more than 90% of patients in both treatment groups were taking an antiplatelet medication to prevent blood clots. A similar percentage were taking a statin to reduce blood levels of “bad” cholesterol. No significant difference was seen between patients assigned to PCI or CABG, the release added.
The study was funded by research grants to Stanford University from Medtronic, Inc., which makes the drug-eluting stent used in the study, and Abbott Vascular, Inc., which makes the FFR measurement device used. This study was simultaneously published online in The Lancet at the time of presentation.
