Risk of two types of polymer stents seen as comparable

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 March 31 at the annual meeting of the American College of Cardiology and published simultaneously in JAMA (doi:10.1001/jama.2014.3584).

NEXT aims to determine the noninferiority of the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES) as measured by target lesion revascularization and whether BP-DES 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).

Dr. Natsuaki and colleagues 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 is the first randomized trial to report outcomes longer than 1 year, Dr. Natsuaki said, which could be why these results differ from those of previous studies. In addition, previous meta-analyses pooled "several different biodegradable drug-eluting stents as a class, different risk profiles of enrolled patients across trials, and the wide variation in the ages of the trials, with changes in clinical practices such as duration of dual antiplatelet therapy." In NEXT, dual antiplatelet therapy continued in 69% of BP-BES patients and 70% of DP-EES patients at 2 years.

The researchers said that patients with MI were underrepresented in their sample and that "event rates were less than expected."

NEXT was sponsored by Terumo Japan, the maker of the biodegradable stents used in the study. Two investigators disclosed that they serve as 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 March 31 at the annual meeting of the American College of Cardiology and published simultaneously in JAMA (doi:10.1001/jama.2014.3584).

NEXT aims to determine the noninferiority of the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES) as measured by target lesion revascularization and whether BP-DES 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).

Dr. Natsuaki and colleagues 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 is the first randomized trial to report outcomes longer than 1 year, Dr. Natsuaki said, which could be why these results differ from those of previous studies. In addition, previous meta-analyses pooled "several different biodegradable drug-eluting stents as a class, different risk profiles of enrolled patients across trials, and the wide variation in the ages of the trials, with changes in clinical practices such as duration of dual antiplatelet therapy." In NEXT, dual antiplatelet therapy continued in 69% of BP-BES patients and 70% of DP-EES patients at 2 years.

The researchers said that patients with MI were underrepresented in their sample and that "event rates were less than expected."

NEXT was sponsored by Terumo Japan, the maker of the biodegradable stents used in the study. Two investigators disclosed that they serve as 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 March 31 at the annual meeting of the American College of Cardiology and published simultaneously in JAMA (doi:10.1001/jama.2014.3584).

NEXT aims to determine the noninferiority of the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES) as measured by target lesion revascularization and whether BP-DES 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).

Dr. Natsuaki and colleagues 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 is the first randomized trial to report outcomes longer than 1 year, Dr. Natsuaki said, which could be why these results differ from those of previous studies. In addition, previous meta-analyses pooled "several different biodegradable drug-eluting stents as a class, different risk profiles of enrolled patients across trials, and the wide variation in the ages of the trials, with changes in clinical practices such as duration of dual antiplatelet therapy." In NEXT, dual antiplatelet therapy continued in 69% of BP-BES patients and 70% of DP-EES patients at 2 years.

The researchers said that patients with MI were underrepresented in their sample and that "event rates were less than expected."

NEXT was sponsored by Terumo Japan, the maker of the biodegradable stents used in the study. Two investigators disclosed that they serve as advisers for Terumo Japan and Abbott Vascular Japan, maker of the durable polymer stents used.