ORLANDO, Fla. — Among patients requiring drug-eluting stent (DES) implantation for long coronary lesions, intravascular ultrasound (IVUS) guidance reduced the rate of major adverse cardiac events (MACE) at 1 year compared with angiography guidance, due mainly to lowering the risk for target lesion revascularization.
According to IVUS-XPL study investigator Myeong-Ki Hong, MD, PhD, of the Yonsei University College of Medicine in Seoul, Korea, there are no adequately powered randomized clinical trials to prove the clinical usefulness of IVUS in second-generation DES.
“The hypothesis of [the IVUS-XPL] study is that the clinical outcome of IVUS-guided second-generation DES implantation would be superior to those of angiography-guided DES implantation in a subset of patients with long coronary lesions,” Dr Hong said during a press conference at the American Heart Association Scientific Sessions.
For the prospective, randomized trial, Dr Hong and colleagues enrolled 1400 patients with long coronary lesions, defined as ≥28 mm in length, from October 2010 to July 2014 at 20 centers in Korea. Patients were randomly assigned to receive either IVUS-guided (n=700) or angiography-guided (n=700) everolimus-eluting stent (Xience Prime, Abbott Vascular) implantation.
One-year MACE—a composite of cardiac death, target lesion-related myocardial infarction (MI) and ischemia-driven target lesion revascularization—served as the primary outcome measure, and was analyzed by intention-to-treat.
Baseline clinical characteristics were similar between the 2 groups, as was the mean stent length (39 mm in each group).
At 1 year, follow-up was complete in 94.5% of patients.
Rates of 1-year MACE were 2.9% in the IVUS-guided arm compared with 5.8% in the angiography-guided arm (hazard ratio [HR]=0.48; 95% confidence interval [CI], 0.28 to0.83; P=.007). This difference was primarily driven by a reduction in the rate of ischemia-driven target lesion revascularization in the IVUS-guided cohort (2.5% vs 5%; HR=0.51; 95% CI, 0.28 to0.91; P=.02).
The rates of cardiac death (IVUS guidance, 0.4% vs angiography guidance, 0.7%; P=.48) and target lesion-related MI (IVUS guidance, 0% vs angiography guidance, 0.1%; P=.32) did not significantly differ between groups.
Furthermore, in the IVUS-guided cohort, researchers found that patients who met the IVUS criteria for stent optimization were at decreased risk for the primary endpoint compared with those who did not meet the criteria (1.5% vs 4.6%; HR=0.31; 95% CI, 0.11 to0.86; P=.017).
“Our findings suggest better clinical outcomes of MACE with IVUS-guidance compared to angiography-guidance for DES implantation, particularly for diffuse long lesions,” Dr Hong concluded.
Disclosures: Hong reports no relevant financial disclosures.
1. Hong JH, Kim BK, Shin DH, et al; for the IVUS-XPL Investigators. Effect of Intravascular Ultrasound-Guided vs. Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial. JAMA. 2015;doi:10.1001/jama.2015.15454.
2. Hong MK. LBCT III: ACS and PCI: The Continuum of Care. Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial. Presented at: American Heart Association Scientific Sessions; November 7-11, 2015; Orlando, FL.