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Intravascular Ultrasound Versus
Angiography-Guided Drug-Eluting
Stent Implantation
ULTIMATE Trial
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.
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.
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.
● 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.
● 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.
● 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Thank You
ULTIMATE Trial

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Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation (1).pptx

  • 1. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation ULTIMATE Trial
  • 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.