Nobori BES Equals Promus Element in Long Lesions

 
 

A novel biodegradable polymer-based biolimus A9-eluting stent (BES) is equivalent to a durable polymer-based platinum chromium everolimus-eluting stent (EES) for both angiographic and clinical outcomes in long coronary lesions. Results of the LONG-DES V trial were published online May 13, 2014, ahead of print inCirculation: Cardiovascular Interventions.  

For the trial, researchers led by Seung-Jung Park, MD, PhD, of Asan Medical Center (Seoul, South Korea) enrolled 500 patients with stable angina, unstable angina, non–ST-segment–elevation myocardial infarction (NSTEMI) or inducible ischemia. All patients had at least 1 native long coronary lesion suitable for stent implantation, defined as:

  • Stenosis diameter of at least 50%,
  • Visual vessel diameter at least 2.5 mm
  • Visual lesion length at least 25 mm
  • Planned total stent length of at least 28 mm 

Patients were randomized to the Nobori BES (Terumo, Tokyo, Japan; n = 245) or the Promus Element EES (Boston Scientific, Newton, MA, n = 255) between July 2010 and May 2012. 

Previously, 2-year results from the NEXT trial, presented March 31, 2014, during the American College of Cardiology/i2 Scientific Session and simultaneously published as a research letter in JAMA, demonstrated the Nobori stent’s noninferiority  compared with Xience/Promus with regard to death/MI and TLR.

In LONG DES V, the overall rate of device success was 99.8%, with only 1 device failure occurring (in the Nobori group). 

Equivalent Angiographic, Clinical Outcomes

At 9 months, angiography demonstrated the Nobori stent’s noninferiority compared with Promus Element with regard to the primary endpoint of in-segment late luminal loss. Other angiographic, endpoints (table 1) as well as clinical outcomes (table 2), were also low and equivalent between devices.

Table 1. Long DES V: 9-Month Outcomes

 

Nobori

(n = 245)

Promus Element

(n = 255)

P Value

In-segment Late Loss

0.14 ± 0.38 mm

0.11± 0.37 mm

.03a

Restenosis (in-segment)

6.1%

4.9%

.63

Restenosis (in-stent)

3.7%

4.9%

.59

aP for noninferiority.

 

Table 2. 12-Month Clinical Outcomes

 

Nobori

(n = 245)

Promus Element

(n = 255)

P Value

Death

0.8%

0.4%

.62

Cardiac Death

0.8%

0.4%

.62

MI

13.9%

15.7%

.53

Definite/Probable ST

1.2%

0

.12

TLR

3.3%

2.0%

.44

Death, MI, or TVR

16.7%

16.5%

.94

 

“Long coronary artery lesions comprise >20% of current PCI practice and are a major determinant of poor prognostic outcomes after stent implantation,” Dr. Park and colleagues note. 

“The current study showed that both angiographic and clinical outcomes using the biodegradable polymer-based BES and the biocompatible inert platinum-chromium EES were similar for complex coronary lesions. In addition, even in such complex lesions, the majority of events occurred shortly after stenting; thus, the standard use of a 6-month dual antiplatelet regimen could be effective in stable clinical situations with the advanced generation of DESs.”

 

 


Source

 

LeeJY, Park DW, Kim YH, et al. Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element)stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-eluting Stent V trial. Circulation: Cardiovascular Interventions. 2014;Epub ahead of print.

 

Disclosures:

  • The study was supported by funds from the Korea Healthcare Technology Research and Development Project, Ministry of Health and Welfare, and CardioVascular Research Foundation, Seoul, South Korea; and a grant from Terumo, Seoul, Korea, and Terumo, Tokyo, Japan.
  • Dr. Park reports receiving research grant support from Boston Scientific.

 

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