JACC: SES beats cutting balloons, ties newer stents for treating DES restenosis
Sirolimus-eluting stents (SES) proved to be more effective than cutting balloon angioplasty for treatment of drug-eluting stent (DES) in-stent restenosis for focal lesions and are comparable to everolimus-eluting stents for treatment of diffuse DES in-stent restenosis, according to a study published March 20 in the Journal of the American College of Cardiology.
In-stent restenosis (ISR) rates have declined with the use of DES but they remain a clinically significant problem, Hae-Geun Song, MD, of the Asan Medical Center at the University of Ulsan College of Medicine in Seoul, South Korea, and colleagues wrote. The low incidence of DES restenosis and diverse etiology have made it difficult to study treatments to identify the optimal strategy, they noted.
To address that gap, the researchers designed a prospective, randomized open-label, seven-center study to compare cutting balloon angioplasty with repeat DES for treating focal ISR. Cutting balloon angioplasty often was used for treating focal ISR in the era of bare-metal stents (BMS), the authors explained. Additionally, because no studies had compared the first-generation with newer DES used to treat diffuse ISR, they also examined the effectiveness of the new versus the old stent strategies.
Patients with stable or acute coronary syndrome or inducible ischemia and restenosis with a 50 percent or greater diameter stenosis in the stented segment with or without edge involvement by quantitative coronary angiography were included. The enrollment period was July 2008 to March 2011.
After diagnostic angiography and before angioplasty, they were stratified by lesion length. Those with lesions 10 mm or less qualified for the focal IRS group and were randomized to receive either SES (Cypher Select, Cordis, a subsidiary of Johnson & Johnson) implantation or cutting balloon angioplasty (Boston Scientific). Those with lesions beyond 10 mm were put in the diffuse ISR group and randomized to SES or EES (Xience V, Abbott Vascular).
The primary end point was late lumen loss at nine months after the index procedure. Secondary endpoints included composite of major adverse cardiac events (MACE) and target vessel revascularization (TVR) at 12 months.
They enrolled 96 patients in the focal group, equally split between SES and cutting balloon angioplasty. The cutting balloon angioplasty group had a 95.8 percent success rate; the SES group had 100 percent. They performed follow-up angiography in 60 percent of the cutting balloon group (median of 282 days) and 67 percent of the SES group (median of 276 days).
In the diffuse group, 32 patients received SES and 34 EES. The device success rate was 97.9 percent of the SES group and 95.7 percent for the EES group. They performed follow-up angiography in 62.5 percent of the SES group (median of 302 days) and 62 percent of the EES group (median of 272 days).
In the focal group, in-segment late loss was lower using SES compared with cutting balloon angioplasty and the in-segment restenosis rate tended to be lower, at 3.1 percent with SES vs. 20.7 with cutting balloon angioplasty. The two groups had comparable incidences of MACE and TVR at 12-month clinical follow-up. In the two diffuse groups, the in-segment late loss, in-segment restenosis rate and MACE and TLR did not differ.
“In the cases of focal type DES restenosis, repeat implantation of SES showed [a] more effective trend for preventing late luminal loss compared with cutting balloon angioplasty,” Song and colleagues wrote. “However, in the cases of diffuse type DES restenosis, SES and EES implantation showed similar angiographic and clinical outcomes.”
They continued that their results suggest that repeat implantation of DES is more effective than cutting balloon angioplasty in the prevention of recurrent restenosis, even for focal DES restenosis. But in diffuse DES restenosis, the new generation stents were not more effective than the first-generation SES for improving outcomes.
They pointed out that lower angiographic follow-up rates may have introduced follow-up biases in the results and that their sample size was not powered to detect minor differences in outcomes, limitations that might be overcome with a large, multicenter study.
In-stent restenosis (ISR) rates have declined with the use of DES but they remain a clinically significant problem, Hae-Geun Song, MD, of the Asan Medical Center at the University of Ulsan College of Medicine in Seoul, South Korea, and colleagues wrote. The low incidence of DES restenosis and diverse etiology have made it difficult to study treatments to identify the optimal strategy, they noted.
To address that gap, the researchers designed a prospective, randomized open-label, seven-center study to compare cutting balloon angioplasty with repeat DES for treating focal ISR. Cutting balloon angioplasty often was used for treating focal ISR in the era of bare-metal stents (BMS), the authors explained. Additionally, because no studies had compared the first-generation with newer DES used to treat diffuse ISR, they also examined the effectiveness of the new versus the old stent strategies.
Patients with stable or acute coronary syndrome or inducible ischemia and restenosis with a 50 percent or greater diameter stenosis in the stented segment with or without edge involvement by quantitative coronary angiography were included. The enrollment period was July 2008 to March 2011.
After diagnostic angiography and before angioplasty, they were stratified by lesion length. Those with lesions 10 mm or less qualified for the focal IRS group and were randomized to receive either SES (Cypher Select, Cordis, a subsidiary of Johnson & Johnson) implantation or cutting balloon angioplasty (Boston Scientific). Those with lesions beyond 10 mm were put in the diffuse ISR group and randomized to SES or EES (Xience V, Abbott Vascular).
The primary end point was late lumen loss at nine months after the index procedure. Secondary endpoints included composite of major adverse cardiac events (MACE) and target vessel revascularization (TVR) at 12 months.
They enrolled 96 patients in the focal group, equally split between SES and cutting balloon angioplasty. The cutting balloon angioplasty group had a 95.8 percent success rate; the SES group had 100 percent. They performed follow-up angiography in 60 percent of the cutting balloon group (median of 282 days) and 67 percent of the SES group (median of 276 days).
In the diffuse group, 32 patients received SES and 34 EES. The device success rate was 97.9 percent of the SES group and 95.7 percent for the EES group. They performed follow-up angiography in 62.5 percent of the SES group (median of 302 days) and 62 percent of the EES group (median of 272 days).
In the focal group, in-segment late loss was lower using SES compared with cutting balloon angioplasty and the in-segment restenosis rate tended to be lower, at 3.1 percent with SES vs. 20.7 with cutting balloon angioplasty. The two groups had comparable incidences of MACE and TVR at 12-month clinical follow-up. In the two diffuse groups, the in-segment late loss, in-segment restenosis rate and MACE and TLR did not differ.
“In the cases of focal type DES restenosis, repeat implantation of SES showed [a] more effective trend for preventing late luminal loss compared with cutting balloon angioplasty,” Song and colleagues wrote. “However, in the cases of diffuse type DES restenosis, SES and EES implantation showed similar angiographic and clinical outcomes.”
They continued that their results suggest that repeat implantation of DES is more effective than cutting balloon angioplasty in the prevention of recurrent restenosis, even for focal DES restenosis. But in diffuse DES restenosis, the new generation stents were not more effective than the first-generation SES for improving outcomes.
They pointed out that lower angiographic follow-up rates may have introduced follow-up biases in the results and that their sample size was not powered to detect minor differences in outcomes, limitations that might be overcome with a large, multicenter study.