ULTIMATE

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https://www.ncbi.nlm.nih.gov/pubmed/30261237

ULTIMATE

Clinical Question

In an “all-comers” population undergoing PCI, did intravascular ultrasound (IVUS) guided drug-eluting stent (DES) implantation, as compared to angiography guided DES implantation, improve clinical outcomes?

Bottom Line

In a large heterogeneous population, the routine use of IVUS guided DES implantation as compared to angiography guided DES implantation decreased the composite primary endpoint of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization.

Major Points

Studies have demonstrated lower incidence of in-stent restenosis and stent thrombosis with the use of IVUS guidance for DES implantation, but this benefit has not been studied in a general population of patients undergoing DES implantation.

Guidelines

No guidelines reflect the results of this trial as of January 2020.

Design

  • Randomized, open-label, multicenter trial
  • N=1448
    • Complete revascularization (n=724)
    • Culprit-lesion-only revascularization (n=724)
  • Setting: 8 centers in China
  • Enrollment: August 2014 to May 2017
  • Follow-up: Median 12 months (interquartile range, 12 to 12)
  • Analysis: Intention-to-treat
  • Primary end points:
    • Composite outcome of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization at 12 months

Population

Inclusion Criteria

  • Patients with silent ischemia, stable or unstable angina, myocardial infarction greater than 24 hours from the onset of chest pain to admission
  • Coronary lesion amenable to DES implantation

Exclusion Criteria

  • Comorbidity with life expectancy less than 1 year
  • Intolerant of antithrombotic therapy
  • Significant anemia, thrombocytopenia, or leukopenia
  • History of major hemorrhage
  • Chronic total occlusion of the left anterior descending artery, or left circumflex artery or right coronary artery not recanalized
  • Severe calcification requiring rotational atherectomy
  • Operator volume less than 200 cases per year

Baseline Characteristics

From the IVUS guidance group:

  • Mean age: 65.210.9 years
  • Male sex: 73.9%
  • BMI: 25.318.0
  • Hypertension: 70.7%
  • Diabetes mellitus: 30.0%
  • Hyperlipidemia: 53.7%
  • Current smoker: 7.3%
  • Clinical presentation
    • Silent ischemia: 8.3%
    • Stable angina: 13.1%
    • Unstable angina: 67.4%
    • Acute myocardial infarction: 11.2%
  • Prior PCI: 17.4%
  • Prior stroke: 11.7%
  • Prior CABG: 1.4%
  • Left ventricular ejection fraction: 60.97.9
  • Laboratory values
    • Hemoglobin (g/L): 134.015.8
    • Creatinine (g/L): 82.052.1
    • eGFR <60 ml/min/1.71m2: 24.9%
    • eGFR <45 ml/min/1.71m2: 8.4%
    • LDL-C (mmol/l): 2.30.9
  • Medications at discharge
    • DAPT: 99.4%
    • OAC plus antiplatelet therapy: 0.3%
    • Statin: 99.3%
  • Medications at 1-year follow up
    • DAPT: 96.3%
    • OAC plus antiplatelet therapy: 0.3%
    • Statin: 95.6%
  • Mean lesion length (mm): 35.0621.68
  • Lesion specificities
    • Left main trunk: 9.9%
    • Left anterior descending artery: 47.5%
    • Left circumflex artery: 17.3%
    • Right coronary artery: 25.4%
  • Multivessel disease: 52.6%
  • AHA/ACC lesion type B2/C: 52.6%
  • Bifurcation lesion: 23.5%
    • 2-stent technique: 8.7%
  • Chronic total occlusion: 8.8%
  • Moderate to severe calcific lesions: 25.3%
  • Radial access: 94.8%
  • Post-dilation performed: 96.6%
  • Stent number:
    • Per patient: 2.401.55
    • Per lesion: 1.810.80
  • Complete revascularization: 73.3%
  • Angiographic success: 98.0%
  • CIN: 7.9%

Differences in the IVUS guidance group vs. angiography guidance group:

  • Mean stent diameter (mm):
    • Per patient: 3.150.42 vs. 2.990.38 (p<0.001)
    • Per lesion: 3.140.51 vs. 2.970.48 (p<0.001)
  • Mean stent length (mm):
    • Per patient: 66.4246.17 vs. 66.4944.36 (p=0.98)
    • Per lesion: 49.9925.10 vs. 47.3822.42 (p=0.02)
  • Maximum balloon diameter (mm):
    • Per patient: 3.840.52 vs. 3.620.51 (p<0.001)
    • Per lesion: 3.730.56 vs. 3.510.53 (p<0.001)
  • Maximum post-dilation pressure (atm):
    • Per patient: 19.83.7 vs. 19.23.6 (p=0.003)
    • Per lesion: 19.73.7 vs. 19.03.6 (p<0.001)
  • Procedural time (min): 60.8828.41 vs. 45.4926.43 (p<0.001)
  • Contrast volume (ml): 178.2964.08 vs. 161.9655.44 (p<0.001)

Interventions

  • Randomized to IVUS guidance vs. angiography guidance

Outcomes

Comparisons are IVUS guidance vs. angiography guidance.

Primary Outcome

Cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization at 12 months
2.9% vs. 5.4% (HR 0.530; 95% CI 0.312 to 0.901; p=0.019)

Secondary Outcomes

Cardiac death
Target vessel myocardial infarction
All-cause mortality
Myocardial infarction
Target lesion revascularization
In-stent restenosis
Stroke

Subgroup Analysis

Adverse Events

Criticisms

Funding

Further Reading