Stenting Stands Up to Surgery in Unprotected Left Main Disease

Treatment of unsupported left main coronary artery disease with stent-supported percutaneous intervention results in favorable early outcomes when compared with surgical revascularization, according to results from the ongoing LE MANS prospective, randomized study.

At 1 year, there was a lower risk of 30-day major adverse cardiac and cerebrovascular events (MACCE) and other major adverse events, after PCI, compared with coronary artery bypass grafting (CABG), said Dr. Pawel E. Buszman and coinvestigators at the University Center in Katowice, Poland, and the American Heart of Poland satellite centers in Poland's Silesia region.

At 2 years' follow-up, freedom from MACCE was similar in the two groups, the researchers reported.

The trial enrolled 105 patients with greater than 50% left main stenosis, with or without multivessel disease. Those with total occlusions were excluded. Patients were evenly randomized to PCI or to CABG, and there were no crossovers. The mean age of both arms was 61 years. Men comprised 60% of the PCI arm and 73% of the CABG arm (J. Am. Coll. Cardiol. 2008;51:538–45).

The average number of diseased vessels was two in both arms. In the CABG group, an average of three arteries were grafted, compared with an average of two arteries dilated in the PCI group, a significant difference. In addition to being left main bypass naive, all patients were deemed by both the principal interventional and surgical investigators to be technically eligible for either procedure, the researchers said.

At 30 days, there were no deaths in the PCI group and two deaths in the CABG group. Over the same period, both major adverse events and MACCEs were significantly more common in the CABG arm (28% versus 8%, and 13% versus 2% respectively). Hospital length-of-stays were 7 days and 12 days, respectively.

However, the number of repeat revascularizations at 1 year was significantly higher in the PCI arm, at 15, compared with 5 in the CABG group.

At 1 year, left ventricular ejection fraction improved only in the PCI group, the investigators said. “Both groups demonstrate similar improvement in angina and good long-term functional capacity on exercise stress testing,” they explained.

The actuarial 1-year survival was lower in surgical patients, but the difference did not reach statistical significance: 92.5% for CABG and 98% for PCI.

“The importance of our study is that it provides the first randomized, prospective data comparing percutaneous stenting with surgery in unprotected left main artery disease,” said Dr. Jack L. Martin, the U.S.-based coauthor of the article. “Importantly, major adverse events—including respiratory infection, the need for respiratory support, renal failure, and the need for blood transfusion—were much lower in the percutaneously treated patients,” said Dr. Martin, chief of interventional cardiology in the Main Line Heart System, Philadelphia.

The study's size was smaller than the investigators would have liked because at the time of approval, stenting for left main disease was not an accepted treatment, Dr. Martin explained in an interview, noting that American Heart Association and American College of Cardiology guidelines state that left main stenting should only be done when the patient is not a good candidate for bypass surgery.

LE MANS was sponsored by the Polish Ministry of Science and Informatics. Dr. Martin reported no conflicts of interest.

Treatment of unsupported left main coronary artery disease with stent-supported percutaneous intervention results in favorable early outcomes when compared with surgical revascularization, according to results from the ongoing LE MANS prospective, randomized study.

At 1 year, there was a lower risk of 30-day major adverse cardiac and cerebrovascular events (MACCE) and other major adverse events, after PCI, compared with coronary artery bypass grafting (CABG), said Dr. Pawel E. Buszman and coinvestigators at the University Center in Katowice, Poland, and the American Heart of Poland satellite centers in Poland's Silesia region.

At 2 years' follow-up, freedom from MACCE was similar in the two groups, the researchers reported.

The trial enrolled 105 patients with greater than 50% left main stenosis, with or without multivessel disease. Those with total occlusions were excluded. Patients were evenly randomized to PCI or to CABG, and there were no crossovers. The mean age of both arms was 61 years. Men comprised 60% of the PCI arm and 73% of the CABG arm (J. Am. Coll. Cardiol. 2008;51:538–45).

The average number of diseased vessels was two in both arms. In the CABG group, an average of three arteries were grafted, compared with an average of two arteries dilated in the PCI group, a significant difference. In addition to being left main bypass naive, all patients were deemed by both the principal interventional and surgical investigators to be technically eligible for either procedure, the researchers said.

At 30 days, there were no deaths in the PCI group and two deaths in the CABG group. Over the same period, both major adverse events and MACCEs were significantly more common in the CABG arm (28% versus 8%, and 13% versus 2% respectively). Hospital length-of-stays were 7 days and 12 days, respectively.

However, the number of repeat revascularizations at 1 year was significantly higher in the PCI arm, at 15, compared with 5 in the CABG group.

At 1 year, left ventricular ejection fraction improved only in the PCI group, the investigators said. “Both groups demonstrate similar improvement in angina and good long-term functional capacity on exercise stress testing,” they explained.

The actuarial 1-year survival was lower in surgical patients, but the difference did not reach statistical significance: 92.5% for CABG and 98% for PCI.

“The importance of our study is that it provides the first randomized, prospective data comparing percutaneous stenting with surgery in unprotected left main artery disease,” said Dr. Jack L. Martin, the U.S.-based coauthor of the article. “Importantly, major adverse events—including respiratory infection, the need for respiratory support, renal failure, and the need for blood transfusion—were much lower in the percutaneously treated patients,” said Dr. Martin, chief of interventional cardiology in the Main Line Heart System, Philadelphia.

The study's size was smaller than the investigators would have liked because at the time of approval, stenting for left main disease was not an accepted treatment, Dr. Martin explained in an interview, noting that American Heart Association and American College of Cardiology guidelines state that left main stenting should only be done when the patient is not a good candidate for bypass surgery.

LE MANS was sponsored by the Polish Ministry of Science and Informatics. Dr. Martin reported no conflicts of interest.

Treatment of unsupported left main coronary artery disease with stent-supported percutaneous intervention results in favorable early outcomes when compared with surgical revascularization, according to results from the ongoing LE MANS prospective, randomized study.

At 1 year, there was a lower risk of 30-day major adverse cardiac and cerebrovascular events (MACCE) and other major adverse events, after PCI, compared with coronary artery bypass grafting (CABG), said Dr. Pawel E. Buszman and coinvestigators at the University Center in Katowice, Poland, and the American Heart of Poland satellite centers in Poland's Silesia region.

At 2 years' follow-up, freedom from MACCE was similar in the two groups, the researchers reported.

The trial enrolled 105 patients with greater than 50% left main stenosis, with or without multivessel disease. Those with total occlusions were excluded. Patients were evenly randomized to PCI or to CABG, and there were no crossovers. The mean age of both arms was 61 years. Men comprised 60% of the PCI arm and 73% of the CABG arm (J. Am. Coll. Cardiol. 2008;51:538–45).

The average number of diseased vessels was two in both arms. In the CABG group, an average of three arteries were grafted, compared with an average of two arteries dilated in the PCI group, a significant difference. In addition to being left main bypass naive, all patients were deemed by both the principal interventional and surgical investigators to be technically eligible for either procedure, the researchers said.

At 30 days, there were no deaths in the PCI group and two deaths in the CABG group. Over the same period, both major adverse events and MACCEs were significantly more common in the CABG arm (28% versus 8%, and 13% versus 2% respectively). Hospital length-of-stays were 7 days and 12 days, respectively.

However, the number of repeat revascularizations at 1 year was significantly higher in the PCI arm, at 15, compared with 5 in the CABG group.

At 1 year, left ventricular ejection fraction improved only in the PCI group, the investigators said. “Both groups demonstrate similar improvement in angina and good long-term functional capacity on exercise stress testing,” they explained.

The actuarial 1-year survival was lower in surgical patients, but the difference did not reach statistical significance: 92.5% for CABG and 98% for PCI.

“The importance of our study is that it provides the first randomized, prospective data comparing percutaneous stenting with surgery in unprotected left main artery disease,” said Dr. Jack L. Martin, the U.S.-based coauthor of the article. “Importantly, major adverse events—including respiratory infection, the need for respiratory support, renal failure, and the need for blood transfusion—were much lower in the percutaneously treated patients,” said Dr. Martin, chief of interventional cardiology in the Main Line Heart System, Philadelphia.

The study's size was smaller than the investigators would have liked because at the time of approval, stenting for left main disease was not an accepted treatment, Dr. Martin explained in an interview, noting that American Heart Association and American College of Cardiology guidelines state that left main stenting should only be done when the patient is not a good candidate for bypass surgery.

LE MANS was sponsored by the Polish Ministry of Science and Informatics. Dr. Martin reported no conflicts of interest.