September 5, 2008 - The results of the SYNTAX study, a head-to-head comparison between drug-eluting stents (DES) using percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in patients with complex coronary disease, showed bypass is a better option.
The results were announced Sept. 1 at the annual European Society of Cardiology meeting in Munich, Germany.
The overall 12-month adverse cardiovascular or cerebrovascular event rate, including all-cause death, stroke, MI and repeat revascularization, was significantly higher for PCI (17.8 percent compared to 12.1 percent for CABG). The 5.7 percent difference put CABG ahead of PCI as the winner in the study.
In other comparisons showed the safety rate for both techniques are comparable, with a combined rate of all-cause death, stroke and MI of 7.6 percent for PCI and 7.7 percent for CABG. The rate of stroke itself was 0.6 percent for PCI as compared to 2.2 percent for CABG, showing DES better at preventing strokes.
The SYNTAX trial was designed to compare CABG and PCI (using drug coated stents) in patients with coronary blockages affecting either the left main coronary artery (an artery which supplies the vast majority of heart muscle) and/or blockages in multiple other coronary arteries. The study enrolled 1,800 patients, who were split equally into two groups receiving the different treatments.
Patients undergoing PCI received an average number of 4.6 stents, and patients in the CABG group received an average number of 2.8 grafts.
While the results of the trial showed bypass is a little better than DES, Boston Scientific (the sponsor of the trial) said the SYNTAX trial showed comparable safety outcomes for complex patients treated with the TAXUS Express2 DES stents used in the study and bypass surgery. The company said the overall results demonstrated no statistically significant differences between PCI and CABG in rates of death or myocardial infarction (MI).
The SYNTAX trial is the first randomized, controlled clinical trial to compare PCI using DES to CABG in patients with left main disease and three-vessel disease. These patient groups are typically treated with CABG and represent a population with far more complex anatomy and advanced disease than those studied in prior DES clinical trials. The goal of the trial was to expand the body of knowledge of PCI use and help inform physicians on appropriate treatment options for the sickest patients.
The patients recruited in SYNTAX are a unique study group in the PCI field, given their exceptionally complex anatomy and advanced disease. The average SYNTAX patient received 4.6 stents, with one patient having 14. By contrast, the average number of stents implanted in a PCI patient in everyday practice is 1.5. In addition, the patient profile includes 33 percent of patients with >100 mm stented length, 84 percent with bi/trifurcations, 22 percent with chronic total occlusions, and 39 percent with left main disease. Some of the sickest patients in the trial were not eligible for surgery and were treated with drug-eluting stents.
For more information: www.bostonscientific.com