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Biodegradable biolimus-eluting stents are as safe and effective as durable everolimus-eluting stents at 2 years’ follow-up, with no significant differences seen in rates of target lesion revascularization, mortality, or myocardial infarction.
The findings come from NEXT (NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial), a 3-year randomized trial led by Dr. Masahiro Natsuaki of Saiseikai Fukuoka (Japan) General Hospital. They were presented at the annual meeting of the American College of Cardiology and published in JAMA (doi:10.1001/jama.2014.3584).
NEXT compared the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES), measuring target lesion revascularization and whether BP-BES carries a risk for excess mortality or MI, compared with DP-EES, as shorter studies and meta-analyses have suggested.
Dr. Natsuaki and colleagues randomized 3,235 patients from nearly 100 treatment centers to BP-BES (n = 1,617) or DP-EES (n = 1,618), with 98% of all patients completing follow-up. Mortality and MI were comparable for both stents (7.8% for BP-BES vs. 7.7% for DP-EES; noninferiority, P = .003), and the need for target lesion revascularization was also comparable for both stents (6.2% vs. 6%; noninferiority, P less than .001). The researchers noted that "2 years is not long enough to confirm the long-term safety of BP-BES, and the study was underpowered for the interim analysis. Follow-up at 3 years will be important."
NEXT was sponsored by Terumo Japan, maker of the biodegradable stents. Two investigators disclosed they are advisers for Terumo Japan and Abbott Vascular Japan, maker of the durable polymer stents used.
Biodegradable biolimus-eluting stents are as safe and effective as durable everolimus-eluting stents at 2 years’ follow-up, with no significant differences seen in rates of target lesion revascularization, mortality, or myocardial infarction.
The findings come from NEXT (NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial), a 3-year randomized trial led by Dr. Masahiro Natsuaki of Saiseikai Fukuoka (Japan) General Hospital. They were presented at the annual meeting of the American College of Cardiology and published in JAMA (doi:10.1001/jama.2014.3584).
NEXT compared the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES), measuring target lesion revascularization and whether BP-BES carries a risk for excess mortality or MI, compared with DP-EES, as shorter studies and meta-analyses have suggested.
Dr. Natsuaki and colleagues randomized 3,235 patients from nearly 100 treatment centers to BP-BES (n = 1,617) or DP-EES (n = 1,618), with 98% of all patients completing follow-up. Mortality and MI were comparable for both stents (7.8% for BP-BES vs. 7.7% for DP-EES; noninferiority, P = .003), and the need for target lesion revascularization was also comparable for both stents (6.2% vs. 6%; noninferiority, P less than .001). The researchers noted that "2 years is not long enough to confirm the long-term safety of BP-BES, and the study was underpowered for the interim analysis. Follow-up at 3 years will be important."
NEXT was sponsored by Terumo Japan, maker of the biodegradable stents. Two investigators disclosed they are advisers for Terumo Japan and Abbott Vascular Japan, maker of the durable polymer stents used.
Biodegradable biolimus-eluting stents are as safe and effective as durable everolimus-eluting stents at 2 years’ follow-up, with no significant differences seen in rates of target lesion revascularization, mortality, or myocardial infarction.
The findings come from NEXT (NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial), a 3-year randomized trial led by Dr. Masahiro Natsuaki of Saiseikai Fukuoka (Japan) General Hospital. They were presented at the annual meeting of the American College of Cardiology and published in JAMA (doi:10.1001/jama.2014.3584).
NEXT compared the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES), measuring target lesion revascularization and whether BP-BES carries a risk for excess mortality or MI, compared with DP-EES, as shorter studies and meta-analyses have suggested.
Dr. Natsuaki and colleagues randomized 3,235 patients from nearly 100 treatment centers to BP-BES (n = 1,617) or DP-EES (n = 1,618), with 98% of all patients completing follow-up. Mortality and MI were comparable for both stents (7.8% for BP-BES vs. 7.7% for DP-EES; noninferiority, P = .003), and the need for target lesion revascularization was also comparable for both stents (6.2% vs. 6%; noninferiority, P less than .001). The researchers noted that "2 years is not long enough to confirm the long-term safety of BP-BES, and the study was underpowered for the interim analysis. Follow-up at 3 years will be important."
NEXT was sponsored by Terumo Japan, maker of the biodegradable stents. Two investigators disclosed they are advisers for Terumo Japan and Abbott Vascular Japan, maker of the durable polymer stents used.
Major finding: Mortality and myocardial infarction were comparable for BP-BES (7.8%) vs. DP-EES (7.7%); noninferiority, P = .003), as was the need for target lesion revascularization (6.2% vs. 6%; noninferiority, P less than .001).
Data source: The NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial, a randomized trial of 3,235 patients.
Disclosures: NEXT was sponsored by Terumo Japan, the maker of BP-BES. Two investigators disclosed that they serve as advisers for Terumo Japan and Abbott Vascular Japan, maker of DP-EES.