This article is more than 5 years old. Information may no longer be current.
NEXT: Safety, efficacy similar for biodegradable, durable polymer DES at 2 years
WASHINGTON — A biodegradable polymer biolimus-eluting stent led to comparable safety and efficacy outcomes compared with a durable polymer everolimus-eluting stent at 2 years, without any apparent signal suggesting long-term safety concerns.
In the multicenter, randomized, noninferiority NEXT trial, 3,200 patients were randomly assigned to treatment with either a biodegradable polymer biolimus-eluting stent (BP-BES; Nobori, Terumo; n=1600) or a durable polymer everolimus-eluting stent (EES; Xience V, Abbott Vascular/Promus, Boston Scientific; n=1,600).
At 2 years, the primary efficacy endpoint of target lesion revascularization did not differ between the groups (BP-BES, 6.2% vs. EES 6%; P=.79; P for noninferiority=.0001). The primary safety endpoint of death or MI was also equivalent between the two strategies (BP-BES, 7.8% vs. EES, 7.7%; P=.9; P for noninferiority=.003), as were death (BP-BES, 4.7% vs. EES, 4.5%; P=.8) and MI (BP-BES, 3.7% vs. EES, 3.5%; P=.78) separately.
Definite stent thrombosis was 0.31% in the BP-BES arm and 0.19% in the EES arm.
Landmark analysis at 1 year revealed similar findings between the groups.
“Network meta-analyses may be hypothesis generating but require confirmation in appropriately designed head-to-head randomized controlled trials,” said Masahiro Natsuaki, MD, study investigator with Kyoto University Graduate School of Medicine, Saiseikai Fukuoka General Hospital, Japan, at a press conference. “Longer-term follow-up is mandatory to fully understand whether BP-BES could provide any long-term benefit over EES.”
According to Natsuaki, the BP-BES features a PLA biodegradable polymer with an abluminal coating, controlled biodegradability, precise drug release kinetics, and simultaneous release of drug and polymer degradation.
Follow-up in the all-comers NEXT trial will continue to 3 years. – by Brian Ellis
For more information:
Natsuaki M. Late-Breaking Clinical Trials V: TCT@i2. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, DC.
Disclosure: The study was sponsored by Terumo Japan. Natsuaki reports no relevant financial disclosures.
Perspective
Back to Top
Perspective
Back to TopThe NEXT trial compared the outcomes of patients with coronary artery disease (CAD) treated with biodegradable polymers in biolimus-eluting stent designs (BP-BES) versus those treated with durable polymers in everolimus-eluting stent designs (DP-EES). At two years, BP-BES was non-inferior to DP-EES with respect to death or MI, all cause death, MI, definite stent thrombosis, or target lesion revascularization.
In previous randomized controlled trials, such as LEADERS, BP-BES had significantly lower 5-year rates of very late stent thrombosis than durable polymer sirolimus-eluting stents (DP-SES), perhaps indicating that biodegradable polymer confers less long-term inflammation, vascular injury, or predisposition to thrombosis. In network meta-analyses, however, “real world” patients treated with DP-BES had higher rates of MI and stent thrombosis than those receiving DP-EES. What caused this discrepancy in findings? Do second generation DP drug-eluting stents (e.g. DP-EES) have such marked reduction in stent thrombosis compared with first generation DP stents (e.g. DP-SES) that they overcome the potential advantage of the biodegradable polymer? Or, is there a real world patient selection bias, not identified in network meta-analyses, that predisposes to worse outcomes those patients selected by their physicians for BP-BES?
This controversy set the stage for the presentation of the NEXT trial 2-year outcomes at ACC.14. When subjected to the rigorous scrutiny of randomized-controlled study design, BP-BES and DP-EES had equivalent outcomes: the curves representing 2-year outcomes of the two treatment groups with respect to death or MI were virtually supraimposable. The primary endpoint of the study, however, will be determined at three years. By way of comparison, in the LEADERS trial, the stent thrombosis curve for DP-SES began to separate from that of BP-BES at 2 years, and continued to separate further out to 5 years (2.5% for DP-SES vs. 0.7% for BP-BES). If BP-BES does confer a benefit, we may need to wait for further long-term data in the NEXT trial.
I would be cautious to forecast whether the NEXT trial 2-year results will change practice. It is reassuring to see that, when subjected to RCT study design, BP-BES appears to be non-inferior to DP-EES. At present, though, there is no compelling finding to advocate whether one stent platform should be selected over another. With further evaluation of the data, subgroup analysis may help us identify particular patients or lesion types where one platform appears to confer a treatment advantage. In addition, it will be important to identify the optimal duration of dual antiplatelet therapy (DAPT) with each of the respective stent platforms, as this may have important impact on patient selection and future treatment protocols, particularly when the need to interrupt DAPT is anticipated. Additionally, traditional technical parameters may influence stent choice: deliverability, radial force, radio-opacity, performance in complex lesion subsets. As always, an assessment of cost-effectiveness may also play an important role on utilization of this new stent technology.
We will eagerly anticipate the presentation of the NEXT trial three year outcomes, and of important subgroup analyses that may promote our understanding of the role of new stent technologies in our evolving treatment of CAD.