DES Beats BMS for Saphenous Vein Graft Stenosis

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post–coronary artery bypass graft, in ISAR-CABG, the largest study ever performed to compare these two types of stents in this setting.

Specifically, DES significantly reduced the rate for the combined primary end point of death, MI, and repeat revascularization procedures.

“This study shows us that we don't have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents],” Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR (Intracoronary Stenting and Antithrombotic Regimen) at the German Heart Center in Munich, said at the meeting.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of stents (sirolimus, paclitaxel, and biodegradable sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up after percutaneous coronary intervention for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Their mean age was about 71.5 years, and the age of their stents averaged 13.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, and about 55% had a previous MI. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts.

At 1 year, the primary end point was reduced by a significant 35% with DES, compared with BMS, with rates of 15.4% and 22.1%, respectively. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or MI were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

“Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients,” Dr. Mehilli said.

She noted that, in Germany, the overwhelming majority of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli has received lecture fees from Abbott.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post–coronary artery bypass graft, in ISAR-CABG, the largest study ever performed to compare these two types of stents in this setting.

Specifically, DES significantly reduced the rate for the combined primary end point of death, MI, and repeat revascularization procedures.

“This study shows us that we don't have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents],” Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR (Intracoronary Stenting and Antithrombotic Regimen) at the German Heart Center in Munich, said at the meeting.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of stents (sirolimus, paclitaxel, and biodegradable sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up after percutaneous coronary intervention for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Their mean age was about 71.5 years, and the age of their stents averaged 13.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, and about 55% had a previous MI. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts.

At 1 year, the primary end point was reduced by a significant 35% with DES, compared with BMS, with rates of 15.4% and 22.1%, respectively. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or MI were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

“Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients,” Dr. Mehilli said.

She noted that, in Germany, the overwhelming majority of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli has received lecture fees from Abbott.

NEW ORLEANS – Drug-eluting stents outperformed bare-metal stents when placed in saphenous vein graft lesions that developed post–coronary artery bypass graft, in ISAR-CABG, the largest study ever performed to compare these two types of stents in this setting.

Specifically, DES significantly reduced the rate for the combined primary end point of death, MI, and repeat revascularization procedures.

“This study shows us that we don't have to be afraid of DES in patients with these high-risk lesions, because use of DES cuts down the need for target vessel revascularization by 50% and does not increase myocardial infarction mortality and stent thrombosis formation when compared with BMS [bare-metal stents],” Dr. Julinda Mehilli, director of clinical research and data coordinating ISAR (Intracoronary Stenting and Antithrombotic Regimen) at the German Heart Center in Munich, said at the meeting.

ISAR-CABG enrolled 610 patients who underwent a first CABG with a saphenous vein graft and developed at least one stenotic lesion of at least 50% in the graft. Patients were randomized to receive either a DES or a BMS in a 1:1 ratio. In the DES group, patients were assigned 1:1:1 to three commonly used types of stents (sirolimus, paclitaxel, and biodegradable sirolimus) to mirror real-world use, Dr. Mehilli explained.

The primary end point was a composite of death, myocardial infarction, and target-vessel revascularization at 1 year of follow-up after percutaneous coronary intervention for stent placement. Secondary end points were each of those events separately, as well as ARC (Academic Research Consortium)-definite stent thrombosis.

Both groups had comparable characteristics at baseline. Their mean age was about 71.5 years, and the age of their stents averaged 13.5 years; about 15% were female, about 72% had hypertension, about 36% had diabetes, about 7% were current smokers, about 87% had hyperlipidemia, and about 55% had a previous MI. Also, disease characteristics were similar between the two groups. About 50% of patients had diffuse disease. More than 60% had unstable angina, and 99% had multivessel disease. Lesions were evenly distributed in the saphenous vein graft. The degeneration score for saphenous vein grafts and the distribution of lesions within the graft were similar between groups, with about 40% of patients having moderate or severely degenerative grafts.

At 1 year, the primary end point was reduced by a significant 35% with DES, compared with BMS, with rates of 15.4% and 22.1%, respectively. The reduction in the DES group was driven primarily by a significant 52% reduction in target vessel revascularizations, which occurred in 7.2% of the DES patients, compared with 13.1% of the BMS recipients.

Both types of stent were comparable in safety, with a similar rate of stent thrombosis, death, or myocardial infarction, said Dr. Mehilli. The rates of all-cause death or MI were similar between the two groups, at 8.5% and 10.9% of patients in the DES and BMS groups, respectively. One patient and zero patients, respectively, experienced ARC-definite stent thrombosis.

“Although saphenous vein graft lesions remain a challenging disease subset for angioplasty, this study demonstrates that DES can be safely used to reduce adverse events in this high-risk subset of patients,” Dr. Mehilli said.

She noted that, in Germany, the overwhelming majority of stents used in saphenous vein graft lesions are DES, and that the current study supports this practice.

The study was funded by the German Heart Center in Munich and by Cordis. Dr. Mehilli has received lecture fees from Abbott.