Drug-Eluting Balloon Angioplasty Treats In-Stent Restenosis

SAN FRANCISCO – Treating in-stent restenosis in patients with drug-eluting stents by using drug-eluting balloon angioplasty limited late lumen loss at 6 months to 0.43 mm instead of 1.03 mm with plain angioplasty in a randomized trial of 110 patients.

PEPCAD (Treatment of DES-In-Stent Restenosis With SeQuent Please Paclitaxel Eluting PTCA Catheter) – a multicenter, single-blind study – randomized 72 patients at seven centers to paclitaxel-coated balloon angioplasty (PCBA) using the SeQuent Please system and 38 patients to plain old balloon angioplasty (POBA), followed by 3 months of dual-antiplatelet therapy. The length of the balloon overlapped the stenotic segment by at least 2 mm at the proximal and distal margins in both groups.

With follow-up on 100% of patients in the first 6 months of the 3-year study, the minimum lumen diameters in the PCBA group were 1.75 mm in the target lesion and 1.65 in the total segment, compared with 1.10 mm and 1 mm, respectively, in the POBA group, Dr. Harald Rittger reported at Transcatheter Cardiovascular Therapeutics 2011, which was sponsored by the Cardiovascular Research Foundation.

The percentage of angiographic restenosis at 6 months was 17% in both the target lesion and the total segment in the PCBA group, compared with 58% in-lesion restenosis and 61% total segment restenosis in the POBA group, said Dr. Rittger of the University of Erlangen, Germany.

These differences between the groups were statistically significant.

The PCBA group also had a significantly lower rate of major adverse cardiovascular events, comprising a combination of target lesion revascularization, MI attributable to the target vessel, and cardiac death. Rates of major adverse cardiovascular events were 17% with PCBA and 50% with POBA. This difference seemed to be driven primarily by a lower rate of target lesion revascularization in the PCBA group (15%), compared with the POBA group (37%), he said.

The study included patients with lesions in native coronary arteries; restenosis in stents eluting sirolimus, everolimus or paclitaxel; and indications for percutaneous coronary intervention. They had reference vessel diameters of 2.5-3.5 mm at enrollment and lesion lengths up to 22 mm.

Dr. Ron Waksman, director of experimental angioplasty at the Washington Hospital Center commented, "With the increased dissemination of drug-eluting stents [DES] and less use of bare-metal stents [BMS], the in-stent restenosis we’re going to see in the future is going to be DES in-stent restenosis. I think that’s why this study is important – to see if this is a good therapy for DES restenosis. I would say these are modest results, and there is room for improvement."

Paclitaxel-coated balloon angioplasty previously has been shown to be superior to POBA and noninferior to implanting a paclitaxel-eluting stent to treat in-stent restenosis in BMS.

The results of the current study showed poorer results in treating DES in-stent restenosis, compared with studies treating BMS in-stent restenosis using paclitaxel-coated balloon angioplasty, Dr. Waksman noted. "So, either this is more difficult to treat, or this is not sufficient treatment for this."

Dr. Rittger said that the difference in results might be due to different populations being treated. Patients with DES in-stent restenosis are more complex patients and are more likely to have multiple stent layers. Half of the current cohort had more than one stent layer. The patient with the most had four stent layers.

Treating in-stent restenosis by implanting an additional stent adds another layer of metal within the coronary arteries, reducing the physiologic vasoreactivity of the vessel.

A subgroup analysis is underway to see if the drug-eluting balloon angioplasty worked better to treat in-stent restenosis in patients with one drug-eluting stent, compared with others.

Dr. Roxana Mehran, professor of medicine and director of interventional cardiovascular research at Mount Sinai School of Medicine, New York, commented, "It’s nice to have a choice of using drug-coated balloons for in-stent restenosis, especially when you’re dealing with multiple layers. I’d like to hear about patterns of restenosis. If these are all focal restenoses, I’m not too thrilled about the binary restenosis rates and the clinical outcomes."

Dr. Rittger said the restenoses were focal in about 80% of cases.

The study excluded patients with acute MI, chronic total occlusions, lesions in bypass grafts or bifurcations, multiple lesions in the target vessel, left main lesions, in-stent restenosis in bare-metal stents, or contraindications to aspirin or clopidogrel therapy.

Even though drug-eluting stents decrease the risk of restenosis, the incidence of in-stent restenosis has remained high because more people are getting drug-eluting stents, Dr. Rittger said.

The study was funded by B. Braun Melsungen Vascular Systems, which makes the SeQuent Please paclitaxel-coated balloon system. Dr. Waksman said he has no relevant conflicts of interest. Dr. Rittger has received fees for consulting, speaking or honoraria from B. Braun and from Siemens Medical Solutions. Dr. Mehran has received honoraria or funds for consulting, speaking, or research from Bristol-Myers Squibb, the Medicines Co., AstraZeneca, and Ortho-McNeil.

SAN FRANCISCO – Treating in-stent restenosis in patients with drug-eluting stents by using drug-eluting balloon angioplasty limited late lumen loss at 6 months to 0.43 mm instead of 1.03 mm with plain angioplasty in a randomized trial of 110 patients.

PEPCAD (Treatment of DES-In-Stent Restenosis With SeQuent Please Paclitaxel Eluting PTCA Catheter) – a multicenter, single-blind study – randomized 72 patients at seven centers to paclitaxel-coated balloon angioplasty (PCBA) using the SeQuent Please system and 38 patients to plain old balloon angioplasty (POBA), followed by 3 months of dual-antiplatelet therapy. The length of the balloon overlapped the stenotic segment by at least 2 mm at the proximal and distal margins in both groups.

With follow-up on 100% of patients in the first 6 months of the 3-year study, the minimum lumen diameters in the PCBA group were 1.75 mm in the target lesion and 1.65 in the total segment, compared with 1.10 mm and 1 mm, respectively, in the POBA group, Dr. Harald Rittger reported at Transcatheter Cardiovascular Therapeutics 2011, which was sponsored by the Cardiovascular Research Foundation.

The percentage of angiographic restenosis at 6 months was 17% in both the target lesion and the total segment in the PCBA group, compared with 58% in-lesion restenosis and 61% total segment restenosis in the POBA group, said Dr. Rittger of the University of Erlangen, Germany.

These differences between the groups were statistically significant.

The PCBA group also had a significantly lower rate of major adverse cardiovascular events, comprising a combination of target lesion revascularization, MI attributable to the target vessel, and cardiac death. Rates of major adverse cardiovascular events were 17% with PCBA and 50% with POBA. This difference seemed to be driven primarily by a lower rate of target lesion revascularization in the PCBA group (15%), compared with the POBA group (37%), he said.

The study included patients with lesions in native coronary arteries; restenosis in stents eluting sirolimus, everolimus or paclitaxel; and indications for percutaneous coronary intervention. They had reference vessel diameters of 2.5-3.5 mm at enrollment and lesion lengths up to 22 mm.

Dr. Ron Waksman, director of experimental angioplasty at the Washington Hospital Center commented, "With the increased dissemination of drug-eluting stents [DES] and less use of bare-metal stents [BMS], the in-stent restenosis we’re going to see in the future is going to be DES in-stent restenosis. I think that’s why this study is important – to see if this is a good therapy for DES restenosis. I would say these are modest results, and there is room for improvement."

Paclitaxel-coated balloon angioplasty previously has been shown to be superior to POBA and noninferior to implanting a paclitaxel-eluting stent to treat in-stent restenosis in BMS.

The results of the current study showed poorer results in treating DES in-stent restenosis, compared with studies treating BMS in-stent restenosis using paclitaxel-coated balloon angioplasty, Dr. Waksman noted. "So, either this is more difficult to treat, or this is not sufficient treatment for this."

Dr. Rittger said that the difference in results might be due to different populations being treated. Patients with DES in-stent restenosis are more complex patients and are more likely to have multiple stent layers. Half of the current cohort had more than one stent layer. The patient with the most had four stent layers.

Treating in-stent restenosis by implanting an additional stent adds another layer of metal within the coronary arteries, reducing the physiologic vasoreactivity of the vessel.

A subgroup analysis is underway to see if the drug-eluting balloon angioplasty worked better to treat in-stent restenosis in patients with one drug-eluting stent, compared with others.

Dr. Roxana Mehran, professor of medicine and director of interventional cardiovascular research at Mount Sinai School of Medicine, New York, commented, "It’s nice to have a choice of using drug-coated balloons for in-stent restenosis, especially when you’re dealing with multiple layers. I’d like to hear about patterns of restenosis. If these are all focal restenoses, I’m not too thrilled about the binary restenosis rates and the clinical outcomes."

Dr. Rittger said the restenoses were focal in about 80% of cases.

The study excluded patients with acute MI, chronic total occlusions, lesions in bypass grafts or bifurcations, multiple lesions in the target vessel, left main lesions, in-stent restenosis in bare-metal stents, or contraindications to aspirin or clopidogrel therapy.

Even though drug-eluting stents decrease the risk of restenosis, the incidence of in-stent restenosis has remained high because more people are getting drug-eluting stents, Dr. Rittger said.

The study was funded by B. Braun Melsungen Vascular Systems, which makes the SeQuent Please paclitaxel-coated balloon system. Dr. Waksman said he has no relevant conflicts of interest. Dr. Rittger has received fees for consulting, speaking or honoraria from B. Braun and from Siemens Medical Solutions. Dr. Mehran has received honoraria or funds for consulting, speaking, or research from Bristol-Myers Squibb, the Medicines Co., AstraZeneca, and Ortho-McNeil.

SAN FRANCISCO – Treating in-stent restenosis in patients with drug-eluting stents by using drug-eluting balloon angioplasty limited late lumen loss at 6 months to 0.43 mm instead of 1.03 mm with plain angioplasty in a randomized trial of 110 patients.

PEPCAD (Treatment of DES-In-Stent Restenosis With SeQuent Please Paclitaxel Eluting PTCA Catheter) – a multicenter, single-blind study – randomized 72 patients at seven centers to paclitaxel-coated balloon angioplasty (PCBA) using the SeQuent Please system and 38 patients to plain old balloon angioplasty (POBA), followed by 3 months of dual-antiplatelet therapy. The length of the balloon overlapped the stenotic segment by at least 2 mm at the proximal and distal margins in both groups.

With follow-up on 100% of patients in the first 6 months of the 3-year study, the minimum lumen diameters in the PCBA group were 1.75 mm in the target lesion and 1.65 in the total segment, compared with 1.10 mm and 1 mm, respectively, in the POBA group, Dr. Harald Rittger reported at Transcatheter Cardiovascular Therapeutics 2011, which was sponsored by the Cardiovascular Research Foundation.

The percentage of angiographic restenosis at 6 months was 17% in both the target lesion and the total segment in the PCBA group, compared with 58% in-lesion restenosis and 61% total segment restenosis in the POBA group, said Dr. Rittger of the University of Erlangen, Germany.

These differences between the groups were statistically significant.

The PCBA group also had a significantly lower rate of major adverse cardiovascular events, comprising a combination of target lesion revascularization, MI attributable to the target vessel, and cardiac death. Rates of major adverse cardiovascular events were 17% with PCBA and 50% with POBA. This difference seemed to be driven primarily by a lower rate of target lesion revascularization in the PCBA group (15%), compared with the POBA group (37%), he said.

The study included patients with lesions in native coronary arteries; restenosis in stents eluting sirolimus, everolimus or paclitaxel; and indications for percutaneous coronary intervention. They had reference vessel diameters of 2.5-3.5 mm at enrollment and lesion lengths up to 22 mm.

Dr. Ron Waksman, director of experimental angioplasty at the Washington Hospital Center commented, "With the increased dissemination of drug-eluting stents [DES] and less use of bare-metal stents [BMS], the in-stent restenosis we’re going to see in the future is going to be DES in-stent restenosis. I think that’s why this study is important – to see if this is a good therapy for DES restenosis. I would say these are modest results, and there is room for improvement."

Paclitaxel-coated balloon angioplasty previously has been shown to be superior to POBA and noninferior to implanting a paclitaxel-eluting stent to treat in-stent restenosis in BMS.

The results of the current study showed poorer results in treating DES in-stent restenosis, compared with studies treating BMS in-stent restenosis using paclitaxel-coated balloon angioplasty, Dr. Waksman noted. "So, either this is more difficult to treat, or this is not sufficient treatment for this."

Dr. Rittger said that the difference in results might be due to different populations being treated. Patients with DES in-stent restenosis are more complex patients and are more likely to have multiple stent layers. Half of the current cohort had more than one stent layer. The patient with the most had four stent layers.

Treating in-stent restenosis by implanting an additional stent adds another layer of metal within the coronary arteries, reducing the physiologic vasoreactivity of the vessel.

A subgroup analysis is underway to see if the drug-eluting balloon angioplasty worked better to treat in-stent restenosis in patients with one drug-eluting stent, compared with others.

Dr. Roxana Mehran, professor of medicine and director of interventional cardiovascular research at Mount Sinai School of Medicine, New York, commented, "It’s nice to have a choice of using drug-coated balloons for in-stent restenosis, especially when you’re dealing with multiple layers. I’d like to hear about patterns of restenosis. If these are all focal restenoses, I’m not too thrilled about the binary restenosis rates and the clinical outcomes."

Dr. Rittger said the restenoses were focal in about 80% of cases.

The study excluded patients with acute MI, chronic total occlusions, lesions in bypass grafts or bifurcations, multiple lesions in the target vessel, left main lesions, in-stent restenosis in bare-metal stents, or contraindications to aspirin or clopidogrel therapy.

Even though drug-eluting stents decrease the risk of restenosis, the incidence of in-stent restenosis has remained high because more people are getting drug-eluting stents, Dr. Rittger said.

The study was funded by B. Braun Melsungen Vascular Systems, which makes the SeQuent Please paclitaxel-coated balloon system. Dr. Waksman said he has no relevant conflicts of interest. Dr. Rittger has received fees for consulting, speaking or honoraria from B. Braun and from Siemens Medical Solutions. Dr. Mehran has received honoraria or funds for consulting, speaking, or research from Bristol-Myers Squibb, the Medicines Co., AstraZeneca, and Ortho-McNeil.