IVUS-Guided PCI With Xience Stent Reduces Target Lesion Revascularization at 1 Year

November 11, 2015

ORLANDO, FL – A strategy of using intravascular ultrasound (IVUS) to guide the implantation of an everolimus-eluting stent (Xience Prime, Abbott Vascular) for long lesions resulted in a significant reduction in major adverse cardiovascular events (MACE), a benefit that was driven by a reduction in ischemia-driven target lesion revascularization (TLR)[1].

Presenting the results of the IVUS Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) study here at the American Heart Association (AHA) 2015 Scientific Sessions, Dr Sung-Jin Hong (Yonsei University College of Medicine, Seoul, Korea) reported that the primary composite end point, which included cardiac death, MI, and TLR, occurred in 2.9% of patients undergoing IVUS-guided PCI and 5.8% of patients undergoing angiography-guided stent implantation.

At 1 year, the rate of ischemia-driven TLR was 2.5% in the 700 patients undergoing IVUS-guided PCI vs 5.0% in the 700 patients treated with conventional PCI. The other components of the primary end point were not statistically different between the two treatment strategies.

Writing in the Journal of the American Medical Association, in which the study was published to coincide with the AHA presentation, Sung and colleagues say IVUS provides information on coronary lesions, such as severity, length, and morphology, but also information on stent optimization following the intervention, including stent expansion, extension, and apposition, as well as possible complications after implantation.

Speaking with the media, Dr Marco Costa (Case Western Reserve University, Cleveland, OH), who was not involved in the study, said previous studies have investigated the use of IVUS to guide the implantation of a coronary stent, particularly the implantation of bare-metal stents. In the era of drug-eluting stents, there are a number of reports, including multiple meta-analyses, but limited randomized, controlled data testing IVUS to help guide drug-eluting-stent placement.

Clinical Outcomes at 1 Year

End point IVUS-guided PCI, n=700 (%) Angiography-guided PCI, n=700 (%) P
MACE
2.9 5.8 0.007
Cardiac death 0.4 0.7 0.48
Target-lesion–related MI
0 0.1 0.32
Ischemia-driven TLR
2.5 5.0 0.02
Definite/probable stent thrombosis
0.3 0.3 1.00

Dr Marco Costa

Regarding the IVUS-XPL trial, Costa said investigators selected a very challenging patient population, those with lesions 28 mm and longer. He pointed out that the group also used very "liberal" IVUS criteria for stent optimization after PCI, in this case a minimal lumen cross-sectional area greater than the lumen cross-sectional area at the distal reference segments. For angiography-guided PCI, stent optimization was defined as at least 30% residual stenosis.

"Those criteria are not standard in clinical practice, at least not in the United States," said Costa.

More important, Costa noted that just 55% of patients in the IVUS-guided PCI arm met the IVUS criteria for stent optimization. The researchers acknowledged the low rate of stent optimization using the IVUS criteria and performed an analysis examining only patients in the IVUS-guided stent group. In the post hoc analysis, those who met the IVUS criteria for stent optimization had a significantly lower MACE rate compared with those who did not meet the criteria (1.5% vs 4.6%, P=0.02).

As Costa noted during the discussion, those who met and those who did not meet the IVUS criteria for stent optimization had similar rates of adjunct postdilatation, similar final balloon sizes, and similar maximal inflation pressures—three aspects of care that could affect the results—meaning "something else led to this unique positive outcome of 1.5% at 1 year and should be studied further."

The study was funded by Abbott Vascular. The authors report no relevant financial relationships.

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