Both randomized and observational studies have reported the clinical advantages of IVUS-guided PCI in patients who have complex lesions.
●The benefits of IVUS guidance over angiography guidance in all-comers who receive 2nd generation DES implantation still remain understudied. Three IVUS criteria were simultaneously used to define optimal PCI, which could underestimate the advantages of IVUS usage.
●We did not directly compare the rate of TVF stratified by different IVUS-defined criteria.
●lesion-level analysis was underpowered because only TLR and definite ST (secondary endpoints) were able to be calculated from sample size.
●Longer-term follow up (through 5 years) is required
2. Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
3. BACKGROUND
● Both randomized and observational studies have
reported the clinical advantages of IVUS-guided PCI
in patients who have complex lesions.
● The benefits of IVUS guidance over angiography
guidance in all-comers who receive 2nd generation
DES implantation still remain understudied.
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
4. STUDY DESIGN
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
5. ● Silent ischemia, Stable angina or unstable angina
● Acute myocardial infarction >24 h
● De novo lesion
MAJOR INCLUSION CRITERIA
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
6. ● Life expectancy <12 months
● Intolerant of DAPT
● CTO not recanalized
● Severe calcification needing rotational atherectomy
MAJOR EXCLUSION CRITERIA
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
7. ● Stent size by visual estimation
● Routine post-dilation
● Angiographic success
○ TIMI 3 flow
○ Residual stenosis <20%
○ Dissection <Type B
ANGIOGRAPHY GUIDED PCI
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
8. Pre-stenting IVUS Assessment
LD: 3.3 mm LD: 2.1 mm LD: 2.5 mm LD: 2.8 mm
VD: 4.4 mm VD: 3.9 mm VD: 3.9 mm VD: 3.1 mm
PB: 40.9% MLA: 3.85 mm2 PB: 55.9% PB: 19.6%
IVUS GUIDED PCI
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
9. Post-stenting IVUS Assessment
LA: 10.95 mm2 LA: 5.44 mm2 LA: 6.05 mm2
VA: 15.14 mm2 MSA: 5.23 mm2 VA: 12.33 VA: 7.53 mm2
PB: 27.7% PB: 55.9% PB: 19.6%
IVUS GUIDED PCI
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
10. 1. Minimal lumen CSA in stented
segment >5.0 mm2 , or 90% of
distal reference lumen CSA;
2. Plaque burden at the 5-mm
proximal or distal to the stent edge
<50%; 3.
3. no edge dissection involving media
with length >3mm.
IVUS DEFINED CRITERIA FOR THE
OPTIMAL STENT DEPLOYMENT
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
11. Endpoints Timing of follow-up Powered for
Primary composite endpoint
TVF 12 months Superiority
Secondary endpoints
CD, TVMI, TVR, TLR separately 12 months -
Safety endpoints
Definite/probable ST 12 months -
ENDPOINTS
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
12. SAMPLE SIZE CALCULATION
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
13. ENROLLMENT
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
14. BASELINE CLINICAL DATA
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
15. CORE LAB LESIONS DATA
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
16. CORE LAB LESIONS DATA
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
17. PROCEDURAL DATA
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
18. PROCEDURAL DATA
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
19. PROCEDURAL DATA
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
20. CLINICAL OUTCOMES
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
21. PRIMARY ENDPOINT
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
22. SECONDARY ENDPOINT
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
23. ON SITE POST PROCEDURE
IVUS ASSESSMENT
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
24. OPTIMAL VS. SUBOPTIMAL
IVUS GUIDED PCI
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
25. LIMITATIONS
● Three IVUS criteria were simultaneously used to define optimal PCI,
which could underestimate the advantages of IVUS usage.
● We did not directly compare the rate of TVF stratified by different IVUS-
defined criteria.
● lesion-level analysis was underpowered because only TLR and definite ST
(secondary endpoints) were able to be calculated from sample size.
● Longer-term follow up (through 5 years) is required
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.
26. CONCLUSION
The randomized trial demonstrated that IVUS-guided DES
implantation in all-comer patients resulted in lower incidence of
TVF at 12 months, compared with angiography guidance,
particularly for patients who had an IVUS-defined optimal
procedure.
Zhang, Junjie, et al. "Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial." Journal of the American College of Cardiology 72.24 (2018): 3126-3137.