Is Nobori NEXT? Biodegradable-Polymer DES Noninferior to EES

SAN FRANCISCO, CA—A next-generation biodegradable-polymer, biolimus A9-eluting stent (BES) showed noninferiority compared with a current-generation everolimus-eluting stent (EES) with regard to clinical and angiographic endpoints. Results of the NEXT trial were presented March 10, 2013, at the American College of Cardiology/i2 Scientific Session.

Researchers led by Masahiro Natsuaki, MD, of Kyoto University Graduate School of Medicine (Kyoto, Japan), randomized 3,235 patients undergoing PCI with DES at 98 Japanese centers to receive either the Nobori BES (Terumo, Tokyo, Japan) or the Xience V/Promus EES (Boston Scientific, Abbott Vascular) in an all-comer study design.

Acute device success was high in both arms (99.6% with each stent type), as was patient success (97% with each).

With a 1-year TLR rate of 4.2% in each arm and angiographic in-segment late loss of 0.03 mm with BES vs. 0.06 mm with EES, Nobori proved noninferior to Xience/Promus for both primary endpoints (P for noninferiority < 0.0001 for each comparison).

Other clinical endpoints were low and similar at 1 year, with a trend for less definite stent thrombosis with Xience/Promus (table 1).

Table 1. One-Year Clinical Outcomes

TLR results were maintained across multiple subgroups, with a trend for better performance in patients receiving Nobori who were on hemodialysis (HR 0.6; 95% CI 0.28-1.28; P = 0.19), showing a P value for interaction of 0.16.

On an angiographic substudy performed at 8-12 months, binary in-segment restenosis also was similar between the Nobori and Xience/Promus groups (7.1% vs. 7.5%; P = 0.86), as was in-stent late loss (0.17 ± 0.35 mm vs. 0.14 ± 0.36 mm; P = 0.35). Nobori devices did show a higher rate of stent fracture (3.1% vs. 0; P = 0.004). Location and patterns of restenosis were both similar between groups, as was peri-stent contrast staining.

Dr. Natsuaki noted that despite the all-comer study design, the actual population included in the trial consisted mostly of patients with stable CAD, and that the 1-year rate of TLR was lower than expected due to less complex coronary anatomy.

Shockingly Low Event Rates

He added that overall, the 1-year clinical outcomes for both stents were excellent, as were the  low rates of TLR and stent thrombosis.

Several panelists remarked on the dearth of adverse events. Cindy L. Grines, MD, of Detroit Medical Center (Detroit, MI), said she was “shocked at how low the TLR rates and stent thrombosis rates are.”

But Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), noted a different potential implication from the event rates. “You tried to enroll an all-comer trial, but most of the patients were single-lesion, single-vessel disease,” he commented to Dr. Natsuaki. “Syntax scores were low, and these event rates were so different than what we see in SYNTAX and FREEDOM, where we’ve got 8 to 10 times the event rates. Do you think there was any selection bias going on where very complex patients were not enrolled?”

While denying the presence of any selection bias, Dr. Natsuaki acknowledged that for the trial to reflect real-world practice, “we should enroll high risk patients with higher Syntax scores.”

Note: Dr. Stone is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD.

Source:
Natsuaki M. One-year outcome of a trial comparing second generation drug-eluting stents using either biodegradable polymer or durable polymer. The Nobori biolimus-eluting versus Xience/Promus everolimus-eluting stent trial (NEXT). Presented at: American College of Cardiology Scientific Session; March 10, 2013; San Francisco, CA.

Disclosures:

• NEXT was sponsored by Terumo.
• Dr. Natsuaki reports no relevant conflicts of interest.

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