Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions - IVUS-XPL
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.
Contribution to the Literature: The IVUS-XPL trial showed that IVUS-guided PCI was superior at reducing major adverse cardiac events.
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%
Other salient features/characteristics:
- Stable angina: 51%
- Unstable angina: 35%
- Acute myocardial infarction (MI): 14%
- Patients with chest pain or evidence of myocardial ischemia undergoing PCI for long coronary lesions (≥28 mm)
The primary outcome (for IVUS-PCI vs. angio-PCI study) of cardiac death, MI, or target lesion revascularization 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
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. Randomized trial data supporting the routine use of IVUS during PCI are limited. 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.
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.
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