NEXT at 2 Years: Nobori DES Still Noninferior to Xience/Promus

Maintaining the results achieved at 1 year, findings from the NEXT trial continue to demonstrate at 2 years the noninferiority of a novel biolimus A9-eluting, biodegradable-polymer stent (BES) compared with a current-generation everolimus-eluting stent (EES). Results of the late-breaking trial were presented March 31, 2014, during the American College of Cardiology/i2 Scientific Session and simultaneously published as a research letter in the Journal of the American Medical Association.

One-year results of the NEXT (Nobori biolimus-eluting versus Xience/Promus everolimus-eluting Stent) trial were initially presented at the ACC/i2 Scientific Session in San Francisco, CA, in March 2013.

Researchers led by Masahiro Natsuaki, MD, of Kyoto University Graduate School of Medicine (Kyoto, Japan), randomized 3,235 patients with mostly stable CAD 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-comers study design. At 2 years, the Nobori stent showed noninferiority compared with Xience/Promus with regard to death/MI and TLR (table 1).

Table 1. NEXT Clinical Outcomes at 2 Years

 

Nobori

Xience/Promus

P Value for Noninferiority

Death/MI

7.83%

7.69%

0.003

TLR

6.23%

5.95%

0.0001


Individual and secondary  outcomes were likewise low and similar between groups at 2 years (table 2).

 

Table 2. NEXT Additional Outcomes at 2 Years

 

Nobori

Xience/Promus

P Value

All-cause Death

4.7%

4.5%

0.8

MI

3.7%

3.5%

0.78

Definite Stent Thrombosis

0.31%

0.19%

0.48

Clinically Driven TLR

4.4%

4.3%

0.95

 

In a landmark analysis capturing events occurring between 1 and 2 years, outcomes such as death/MI (2.5% vs 2.4%; P = 0.999) and TLR (2.0% vs 1.5%; P = 0.27) were still low and equivalent between the Nobori and EES groups.

Dr. Natsuaki cautioned that 2-year follow-up may not be sufficient to compare the long-term outcomes between the biodegradable-polymer Nobori stent and the durable-polymer EES. “The advantage of polymer degradation and no permanent polymer in the vessel wall might emerge with longer follow-up,” he said. In animal models, the Nobori stent’s PLA polymer degraded within 12 months.

Panel co-chair Gregg W. Stone, MD, of Columbia University School of Medicine (New York, NY), noted that despite the NEXT trial’s all-comers study design, the majority of patients had stable angina, whereas in most practices, ACS patients are commonly treated via PCI. Dr. Natsuaki replied that the small number of ACS patients in the study was more a result of enrollment issues than any broader practice patterns.

DES on a Plateau?

Panel co-chair David E. Kandzari, MD, of the Piedmont Heart Institute (Atlanta, GA) noted that the evolution of stent design is part of “the DNA” of interventional cardiology, and that the ever-present assumption of “what’s next is always going to be better” is challenged by the NEXT results. "But that the stent restores itself to the phenotype of a bare-metal stent certainly would fulfill the expectation of a true next-generation drug eluting stent,” he said.

The challenge, Dr. Kandzari continued is that “the opportunity to demonstrate superiority of these newer stent designs is challenged to a large extent by the fact that we’re realizing the best outcomes with currently available DES than we ever have before. Have we reached a plateau  or a class effect of drug eluting stents today?”

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


Source:
Natsuaki M, Kozuma K, Morimoto T, et al. Two-year outcome of a randomized trial comparing second-generation drug-eluting stents using biodegradable or durable polymer [research letter]. JAMA. 2014;Epub ahead of print.

Disclosures:

  • NEXT was sponsored by Terumo (Tokyo, Japan).
  • Dr. Natsuaki reports no relevant conflicts of interest.

 

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