ESC Focus on Interventions & PC - 12

Late-Breaking Science

Written by Toni Rizzo

A meta-analysis reported similar efficacy and safety
outcomes during 26 months of follow-up after implantation of a biodegradable polymer biolimus-eluting stent
(BP-BES) compared with a durable polymer everolimuseluting stent (DP-EES) [El-Hayek G et al. JACC Cardiovasc
Interv. 2017]. A follow-up beyond 1 year may be required
to evaluate the efficacy and safety of a BP-BES because
of the stent-related adverse events occurring before
biodegradable polymer degradation. The aim of this follow-up extension of the NEXT trial [NCT01303640], presented by Masahiro Natsuaki, MD, Saga University, Saga,
Japan, was to evaluate the 5-year clinical outcomes
of the BP-BES compared with the second-generation
DP-EES.
The NEXT trial randomised patients scheduled for percutaneous coronary intervention to implantation with the
Nobori BP-BES (n = 1,617) or the Xience V/Promus DP-EES
(n = 1,618). Follow-up was scheduled at 1, 2, and 3 years,
with extension study follow-up at 5 and 10 years. The primary analysis was for noninferiority of BP-BES compared
with DP-ESS for the safety endpoint of death or myocardial infarction (MI) and the efficacy endpoint of target lesion
revascularisation (TLR). A total of 3,235 patients were
included in the 3-year follow-up analysis, 2,568 patients
entered the extended follow-up study, and complete
5-year follow-up was achieved in 2,408 patients.
Figure 1. Death or Myocardial Infarction

Cumulative Incidence (%)

50
BP-BES

40

DP-EES

BP-BES 15.1%
DP-EES 16.5%

30

20

10

Log-rank P = .37
0
1

0

Interval
BP-BES group
N of patients with at least 1 event
N of patients at risk
Cumulative incidence
DP-EES group
N of patients with at least 1 event
N of patients at risk
Cumulative incidence

2
3
Years After PCI

4

5

0 day 30 days 1 year

2 years

3 years

4 years

5 years

1283

39
1243
3.0%

77
1203
6.0%

104
1170
8.1%

131
1134
10.0%

161
1058
12.7%

190
1009
15.1%

1285

39
146
3.0%

71
1213
5.5%

100
1179
7.8%

137
1135
10.7%

171
1054
13.5%

208
991
16.5%

BP-BES, biopolymer biolimus-eluting stent; DP-EES, durable polymer everolimuseluting stent; PCI, percutaneous coronary intervention.

Baseline and procedural characteristics were similar
between the 2 groups. At the 5-year follow-up, there
were no significant differences between the 2 groups
in either of the primary endpoints. The primary safety
endpoint of death or MI had occurred in 15.1% of patients
in the BP-BES group compared with 16.5% of patients in
the DP-EES group (log-rank P = .37; Figure 1).
At 5 years, 9.8% of patients in the BP-BES group had
undergone TLR compared with 9.3% of patients in the
DP-EES group (log-rank P = .79; Figure 2).
Figure 2. Target-Lesion Revascularisation
50
Cumulative Incidence (%)

No Difference in 5-Year Clinical
Outcomes With Biodegradable vs
Durable Polymer Drug-Eluting
Stents

BP-BES

40

DP-EES

BP-BES 9.8%
DP-EES 9.3%

30

20

10

Log-rank P = .79
0
1

0

Interval
BP-BES group
N of patients with at least 1 event
N of patients at risk
Cumulative incidence
DP-EES group
N of patients with at least 1 event
N of patients at risk
Cumulative incidence

2
3
Years After PCI

4

5

0 day 30 days 1 year

2 years

3 years

4 years

5 years

1283

2
1279
0.2%

55
1192
4.4%

78
1138
6.2%

95
1083
7.7%

106
1004
8.6%

118
947
9.8%

1285

2
1281
0.2%

63
1191
5.0%

84
1141
6.7%

97
1089
7.8%

102
1017
8.2%

114
951
9.3%

BP-BES, biopolymer biolimus-eluting stent; DP-EES, durable polymer everolimuseluting stent; PCI, percutaneous coronary intervention.
Reproduced with permission from M Natsuaki, MD.

Clinical outcomes at 5 years were not significantly
different between the BP-BES and DP-EES groups,
including death (11.7% vs 12.6%; P = .51), cardiac death
(4.4% vs 3.9%; P = .54), MI (5.2% vs 4.8%; P = .72);
stent thrombosis (0.49% vs 0.34%; P = .52); stroke
(4.8% vs 5.7%; P = .38); target vessel revascularisation
(TVR; 14.2% vs 12.4%; P = .22), and TIMI major or minor
bleeding (6.5% vs 6.4%; P = .99).
A landmark analysis conducted from years 1 to 5
found no significant difference in the cumulative incidence of death or MI (BP-BES 9.7% vs DP-EES 11.6%;
log-rank P = .13) or TLR (BP-BES 5.6% vs DP-EES 4.5%;
log-rank P = .25) between groups. The cumulative incidence of TVR was significantly higher in the BP-BES
(8.1%) than the DP-EES group (5.9%; P = .04). There
were no significant differences in the other clinical outcomes between the groups in the landmark analysis.
In summary, the safety and efficacy outcomes of the
BP-BES were similar to those of the DP-EES through 5
years after stent implantation. The authors concluded
that a very long-term follow-up of 10 years may be necessary to show the potential benefits of the BP-BES
over the DP-EES.

Reproduced with permission from M Natsuaki, MD.

12

October 2017

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