Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions - IVUS-XPL

Sep 29, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Cardiovascular Research Center, and Abbott Vascular
Date Presented:
09/29/2019
Date Published:
09/29/2019
Date Updated:
09/29/2019
Original Posted Date:
11/10/2015
References

Contribution To Literature:

The IVUS-XPL trial showed that IVUS-guided PCI was superior at reducing major adverse cardiac events.

Description:

The goal of the trial was to evaluate intravascular ultrasound (IVUS)-guided versus angiography-guided percutaneous coronary intervention (PCI) among patients undergoing drug-eluting stent implantation for long coronary lesions.

Study Design

  • Randomized
  • Parallel

Patients undergoing drug-eluting stent implantation for long coronary lesions were randomized to IVUS-guided PCI (n = 700) versus angiography-guided PCI (n = 700). By factorial design, patients were also randomized to 6 months of dual antiplatelet therapy (DAPT) (n = 699) versus 12 months of DAPT (n = 701).

  • Total number of enrollees: 1,400
  • Duration of follow-up: 1 year
  • Mean patient age: 64 years
  • Percentage female: 31%
  • Percentage diabetics: 36%

Inclusion criteria:

  • Patients with chest pain or evidence of myocardial ischemia undergoing PCI for long coronary lesions (≥28 mm)

Other salient features/characteristics:

  • Stable angina: 51%
  • Unstable angina: 35%
  • Acute myocardial infarction (MI): 14%

Principal Findings:

The primary outcome (for IVUS-PCI vs. angio-PCI study) of cardiac death, MI, or target lesion revascularization at 1 year occurred in 2.9% of the IVUS-guided PCI group vs. 5.8% of the angiography-guided PCI group (p = 0.007).

The primary outcome (for 6-month DAPT vs. 12-month DAPT study) of cardiac death, MI, stroke, or major bleeding occurred in 2.2% of the 6-month DAPT group vs. 2.1% of the 12-month DAPT group (p = 0.85).

Secondary outcomes for IVUS-PCI vs. angio-PCI study:

  • Cardiac death: 0.4% with IVUS-guided PCI vs. 0.7% with angiography-guided PCI
  • MI: 0% with IVUS-guided PCI vs. 0.1% with angiography-guided PCI
  • Target lesion revascularization: 2.5% with IVUS-guided PCI vs. 5.0% with angiography-guided PCI (p = 0.02)
  • Definite/probable stent thrombosis: 0.3% with IVUS-guided PCI vs. 0.3% with angiography-guided PCI

Secondary outcomes for 6-month DAPT vs. 12-month DAPT study:

  • Stent thrombosis: 0.3% with 6-month DAPT vs. 0.3% with 12-month DAPT
  • Major bleeding: 0.7% with 6-month DAPT vs. 1.0% with 12-month DAPT

Five-year outcomes: Cardiac death, MI, or target lesion revascularization at 5 years occurred in 5.6% of the IVUS-guided PCI group vs. 10.7% of the angiography-guided PCI group (p = 0.001). Ischemia-driven revascularization at 5 years occurred in 4.8% of the IVUS-guided PCI group vs. 8.4% of the angiography-guided PCI group (p = 0.007).

Interpretation:

Among individuals undergoing PCI for long coronary lesions (the majority with stable angina), IVUS-guided PCI was superior at reducing adverse cardiac events compared with angiography-guided PCI. This benefit was due to a reduction in target lesion revascularization with the use of IVUS, which was sustained to 5 years of follow-up. Randomized trial data supports the routine use of IVUS during PCI. Observational studies have suggested a reduction in stent thrombosis with the use of IVUS. While this study did not support a reduction in stent thrombosis, IVUS did reduce future revascularization procedures. Outcomes were similar with 6 months of DAPT compared with 12 months of DAPT.

References:

Hong SJ, Mintz GS, Ahn CM, et al., on behalf of the IVUS-XPL Investigators. Effect of Intravascular Ultrasound-Guided Drug-Eluting Stent Implantation: Five-Year Follow-Up of the IVUS-XPL Randomized Trial. JACC Cardiovasc Interv 2019;Sep 29:[Epub ahead of print].

Presented by Dr. Myeong-Ki Hong at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019), San Francisco, CA, September 29, 2019.

Hong SJ, Shin DH, Kim JS, et al. 6-month versus 12-month dual-antiplatelet therapy following long everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial. JACC Cardiovasc Interv 2016;May 17:[Epub ahead of print].

Hong SJ, Kim BK, Shin DH, et al., on behalf of the IVUS-XPL Investigators. Effect of Intravascular Ultrasound–Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial. JAMA 2015;314:2155-63.

Presented by Dr. Myeong-Ki Hong at the American Heart Association Scientific Sessions, Orlando, FL, November 10, 2015.

Keywords: Angina Pectoris, Angina, Stable, Angina, Unstable, Angiography, Coronary Restenosis, Drug-Eluting Stents, Myocardial Infarction, Percutaneous Coronary Intervention, Sirolimus, Stents, Thrombosis, Ultrasonography, Interventional, AHA Annual Scientific Sessions, Transcatheter Cardiovascular Therapeutics, TCT19


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