Important recent trials of bifurcation stenting

1. BIFURCATION TRIALS
-ROHIT WALSE
SENIOR RESIDENT
DM CARDIOLOGY
SCTIMST

2. BIFURCATION TRIALS
Non-LM lesions
• NORDIC
• CACTUS
• British Bifurcation Coronary
(BBC) Study
• EBC Two study
• DK CRUSH II
• NORDIC BALTIC
BIFURCATION STUDY IV
• DEFINITION II
LM lesions
• DK CRUSH V
• EBC Main

3. TRIAL, JRNL YEAR,
COUNTRY
STRATEGY RESULTS CONCLUSION
NORDIC I
(LM-1.5%)
CIRC
2006,
Multicentric
RCT
Simple(207) vs
complex (206)
-6 months
MACE-MV
2.9%, MV+SB
3.4%; P=NS
Restenosis-
MV 5.3%,
MV+SB 5.1%
P=NS
Simple strategy
can be
recommended
as the routine
bifurcation
stenting
technique
CACTUS study
(LM-0%)
CIRC
[2008 EuroPCR]
2009,
Multicentric
RCT
Provisional (173)
vs Crush(177)
-6 months
MACE-
Provisional
15% vs
Crush 15.8%
P=NS
Provisional
strategy is
effective, with
SB stent
required in 1/3
British
Bifurcation
Coronary (BBC)
Study
(LM-excluded)
CIRC
[2008 TCT]
2010,
Multicentric
RCT
Simple(250) vs
complex (250)
-9 months
MACE-MV 8%,
MV±SB 15.2%;
P=0.002
Provisional
technique
should remain
the preferred
strategy

4. (Circ Cardiovasc Intervent. 2009;2:409-415.)

7. Conclusion
• Double Stenting   risk of myocardial infarction and
possible excess risk of stent thrombosis.
• Double stenting of both the main vessel and the side
branch vessel in bifurcation lesions should be avoided.
• Perhaps double stenting could be considered in cases
of a very big bifurcation branch, such as main stem
lesions or lesions involving bifurcation branches with
diameter almost as big as that of the main branch.

8. TRIAL, JRNL YEAR,
COUNTRY
STRATEGY, F/U RESULTS CONCLUSION
NORDIC I
JACC
2013,
Multicentric
RCT
Simple(202) vs
complex (202)
-5 yrs
MACE-MV
15.8%, MV+SB
21.8% P=0.15
@ 5 yrs
Simple
approach
thus remains
the
recommended
bifurcation
treatment
strategy

11. TRIAL, JRNL YEAR, COUNTRY STRATEGY, F/U RESULTS CONCLUSION
SMART
STRATEGY
(LM-44%)
JACC
2016, Single
Center, RCT
(Korea)
Conservative
(128) vs
Aggressive (130)
- 3 yrs
TVF-
Conservative
11.7% vs
Aggresive 20.8%;
P= 0.049
Conservative
strategy -
preferred
approach for
provisional SB
intervention
DK CRUSH II
(LM-16.7%)
CIRC
2016,
Multicentric RCT
Provisional(185)
vs
DK CRUSH(185)
- 5 yrs
MACE-
Provisional
23.8% vs
DK crush
15.7%;P=0.051
TLR-16.2% vs
8.6%; P=0.027
Sustained
benefits of DK
crush stenting
for true coronary
bifurcation
lesions
EBC TWO Study
(European
Bifurcation
Coronary TWO)
(LM-0%)
2016,
Multicentric RCT
Provisional(103)
vs
Culotte(97)
-12 months
MACE-
Provisional 7.7%
vs
Culotte 10.3%;
P=0.53
MI-
4.9% vs 10.3%;
P=0.14
Provisional T-
stent strategy
remains the
technique of
choice for
bifurcation
lesions of all
types

12. TRIAL, JRNL YEAR,
COUNTRY
STRATEGY, F/U RESULTS CONCLUSION
NORDIC BALTIC
BIFURCATION
STUDY IV
(LM~2%)
BMJ
[2015 EuroPCR]
2020,
Multicentric
RCT
Provisional(218)
vs 2 stents(228)
strategy for a
SB≥2.75 mm,
≥50% diameter
stenosis
- 2 yrs
MACE-
Provisional
12.9% vs
Two-stent-8.4%
(HR 0.63, 95%
CI 0.35 to 1.13,
p=0.12)
For bifurcation
lesions
involving a
large SB with
ostial stenosis,
routine two-
stent
techniques did
not improve
outcome
significantly.

13. P value =0.10
P value =0.51

14. • Eight RCTs
• N = 2778 patients
• Mean f/u= 3.0±1.6 years

19. • Meta-regression analyses identified increased
risk of MACE with PS in patients presenting
with acute coronary syndrome (p=0.05)
• Conclusion- PS strategy may be associated
with improved long-term outcomes
compared with TS technique in stable patients
with CAD

20. TRIAL, JRNL YEAR, COUNTRY STRATEGY, F/U RESULTS
DEFINITION II
(LM-28%)
EHJ
2020, Multicentric
RCT
Provisional(325) vs 2
stents(328)
For complex
coronary lesions
- 12 months
TLF-
Provisional 11.4%
vs
Two-stent-6.1%;
P=0.019
TVMI-
7.1% vs 3%;
P=0.025

23. • Two-stent strategy reduced TLF at 1 year compared with a
provisional strategy in patients with DEFINITION criteria-defined
complex bifurcation lesions

24. LM TRIALS

29. Conclusion
• A planned DK crush 2-stent strategy reduced
TLF and ST through 3-year follow-up
compared with a PS strategy in patients with
true distal LM bifurcation lesions.

30. • Multicentric RCT
• Stepwise provisional (230) vs systematic dual
(237)
• Mean f/u- 1 yr

34. Conclusion
• Among patients with true bifurcation left main
stem stenosis requiring intervention, fewer
MACE occurred with a stepwise layered
provisional approach than with planned dual
stenting, although the difference was not
statistically significant.
• The stepwise provisional strategy should
remain the default for distal left main stem
bifurcation intervention