Transcript Final Three-Year Outcome of a Randomized Trial Comparing Second Generation Drug-eluting Stents Using Either Biodegradable Polymer or Durable Polymer The NOBORI Biolimus-Eluting versus XIENCE/PROMUS.

Final Three-Year Outcome of
a Randomized 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)
Masahiro Natsuaki, MD
Kyoto University Graduate School of Medicine, Saiseikai Fukuoka General Hospital
Ken Kozuma, MD; Takeshi Morimoto, MD, MPH; Kazushige Kadota, MD;
Toshiya Muramatsu, MD, Yoshihisa Nakagawa, MD, Takashi Akasaka, MD;
Keiichi Igarashi, MD; Kengo Tanabe, MD; Yoshihiro Morino, MD; Tetsuya Ishikawa, MD;
Hideo Nishikawa, MD; Masaki Awata, MD; Masaharu Akao, MD; Hisayuki Okada, MD;
Yoshiki Takatsu, MD; Nobuhiko Ogata, MD; Kazuo Kimura, MD; Kazushi Urasawa, MD;
Yasuhiro Tarutani, MD; Nobuo Shiode, MD; and Takeshi Kimura, MD
On behalf of the NEXT Investigators
Potential conflicts of interest
Speaker's name: Masahiro Natsuaki
 I do not have any potential conflict of interest
Study sponsor: Terumo Japan
Background
The advantage of coronary stent using biodegradable polymer could emerge beyond
1-year after stent implantation, when polymer has been fully degraded.
However, there are only a few randomized controlled trials other than the NEXT
reporting the clinical outcomes beyond 1-year after biodegradable polymer
biolimus-eluting stent (BP-BES) implantation as compared with durable polymer
everolimus-eluting stent (DP-EES) implantation.
Therefore, we report the clinical outcomes of BP-BES compared with DP-EES through
3-year and beyond 1-year after stent implantation in the largest ever reported
prospective multicenter randomized open label trial.
Smits P. EuroPCR 2014.
COMPARE II Cardiac death, myocardial infarction and TVR at 3-year
NEXT Trial
Multicenter, randomized, non-inferiority trial comparing BP-BES with DP-EES
3235 patients scheduled for PCI using drug-eluting stent
No Exclusion Criteria (All-comer Design)
Randomization 1:1
Nobori BP-BES
(N=1617)
BP-BES
(N=1576)
<1035 days follow-up: N=41
Enrollment from 98 Japanese centers
between May and October, 2011
3-Year Clinical Follow-up
(N=3158; 97.6%)
Xience/Promus DP-EES
(N=1618)
DP-EES
(N=1582)
<1035 days follow-up: N=36
<Primary Endpoint>
Efficacy: Target lesion revascularization at 1-year
Safety: Death or Myocardial Infarction at 3-year
<Power Calculation>
3000 patients would yield 91% power to detect non-inferiority
with the non-inferiority margin of 4.3% (True rate 12.2%)
Baseline Characteristics
BP-BES (1617)
DP-EES (1618)
P
69.1 ± 9.8
69.3 ± 9.8
0.49
Male gender
77 %
77 %
0.76
Diabetes
46 %
46 %
0.85
Hypertension
81 %
82 %
0.81
Prior PCI
50 %
51 %
0.9
Age (years)
Clinical diagnosis
0.62
Acute myocardial infarction
5.1 %
4.5 %
Unstable angina
12 %
11 %
Stable coronary artery disease
83 %
84 %
Hemodialysis
6.5 %
5.2 %
0.11
Prior myocardial infarction
28 %
28 %
0.81
Prior stroke
10 %
11 %
0.43
Multivessel disease
51 %
51 %
0.9
10 (6-17)
10 (6-16)
0.17
No. of lesions treated per patient
1.27 ± 0.56
1.24 ± 0.51
0.1
No. of stents per patient
1.59 ± 0.84
1.6 ± 0.83
0.74
Total stent length per patient (mm)
33.0± 20.3
32.9 ± 20.7
0.87
Stent diameter (mm)
2.88 ± 0.67
2.87 ± 0.64
0.7
Multivessel treatment
13%
11%
0.21
SYNTAX score
Non-inferiority Assessment for the Primary Safety Endpoint
Death or Myocardial Infarction at 3-year
BP-BES 9.9% vs. DP-EES 10.3%
Pnon-inferiority < 0.0001
Difference:
-0.44%
Upper one-sided 97.5% CI: 2.2%
4.3%
2.2%
-1.0%
0%
1.0%
2.0% 3.0%
4.0%
5.0%
Non-inferiority margin
Cumulative Incidence (%)
Cumulative 3-year Incidence
Primary Safety Endpoint
Primary Efficacy Endpoint
Death or Myocardial Infarction
Target Lesion Revascularization
BP-BES
BP-BES
DP-EES
DP-EES
10.3%
Log-rank P=0.7
Log-rank P=0.8
7.4%
9.9%
7.1%
Days after PCI
Interval
0 day
BP-BES group
N of patients with
at least 1 event
N of patients at risk
1617
Cumulative Incidence
DP-EES group
N of patients with
at least 1 event
N of patients at risk
365 days
Days after PCI
730 days
1095 days
89
126
159
1524
1478
1416
5.5%
7.8%
9.9%
87
124
166
1618
1529
1482
1413
-1.0%
5.4%
7.7%
10.3%
Cumulative Incidence
1.0%
Interval
BP-BES group
N of patients with
at least 1 event
N of patients at risk
0 day
1617
Cumulative Incidence
DP-EES group
N of patients with
at least 1 event
N of patients at risk
Cumulative Incidence
2.0% 3.0%
1618
365 days
730 days
1095 days
68
99
116
1506
1432
1353
4.3%
6.3%
7.4%
72
97
112
1506
1440
1359
4.5%
6.1%
7.1%
4.0%
5.0%
Clinical Outcomes at 3-Year
Death
Cardiac
death
MI
Stent
thrombosis
Stroke
P = 0.85
P = 0.57
P = 0.72
P = 0.74
P = 0.93
15%
Cumulative Incidence
9.9%
DP-EES
6.8% 7.0%
4.0% 3.7%
5%
2.7%
3.1% 3.2%
2.4%
0.31% 0.26%
0%
P = 0.21
11.3%
BP-BES
10%
TVR
Landmark Analysis at 1-year
Cumulative Incidence (%)
20%
Primary Safety Endpoint
Primary Efficacy Endpoint
Death or Myocardial Infarction
Target Lesion Revascularization
20%
10%
BP-BES
BP-BES
DP-EES
DP-EES
Log-rank P=0.88
5.5%
5.2%
5.4%
4.6%
0%
0
10%
Log-rank P=0.46
365
730
Log-rank P=0.39
Log-rank P=0.72
4.5%
3.3%
0%
1095
0
4.3%
2.7%
365
730
Definite Stent Thrombosis
5%
2.5%
BP-BES
BP-BES: 0.04%/year
DP-EES
DP-EES: 0.1%/year
Log-rank P=0.18
Log-rank P=0.32
0.2%
0.07%
0.25%
0.06%
0%
0
1.0%
365
2.0% 7303.0%
4.0%
1095
1095
Conclusions
The safety and efficacy outcomes of BP-BES remained comparable to
those of DP-EES through 3-year and beyond 1-year after stent implantation.
There was no apparent signal suggesting either improvement or
impairment of clinical outcomes with BP-BES compared with DP-EES.
Longer-term follow-up is mandatory to fully understand whether BP-BES
could provide any long-term benefit over DP-EES.