IVUS Bests Angiography to Guide Stenting in CKD: ULTIMATE

Batya Swift Yasgur MA, LSW

June 21, 2019

Intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation is superior to traditional angiography-guided DES implantation in reducing target vessel failure (TVF), a new analysis shows.

Investigators conducted a subgroup analysis of data from the prospective multicenter randomized Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions (ULTIMATE) trial, which was designed to explore the impact of IVUS-guided second-generation DES implantations in patients with chronic kidney disease (CKD).

The present study, which was a prespecified subgroup analysis of the ULTIMATE trial, assessed 1443 patients, 723 of whom received IVUS-guided DES implantations and 720 who received angiography-guided DES implantations.

Although DES implantation was associated with a higher risk for TVF at 12 months, the risk for TVF was significantly decreased through IVUS guidance.

"The results from our study show that, compared to angiography guidance procedures, IVUS-guided DES implantation is a new and effective treatment approach," lead investigator Junjie Zhang, MD, PhD, Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, China, said in a statement.

"This procedure has the potential to significantly decrease TVF in CKD patients and, ultimately, improve their quality of life," he added.

The study was presented at the 2019 Society for Cardiovascular Angiography and Interventions (SCAI) meeting, and simultaneously published online May 22 in Catheter Cardiovascular Intervention.

DES Implantation "Controversial"

"Kidney disease is a growing worldwide health issue, affecting one in 10 individuals," Zhang told theheart.org | Medscape Cardiology.

"While several randomized trials and observational studies have established the clinical benefits of IVUS-guided DES implantations for patients with complex lesions, the treatment option remains controversial for patients with CKD, due to longer procedural time and perceived potential risks of acute renal failure and atheroembolism."

The original ULTIMATE trial focused on a broader group of patients, not only those with CKD, encompassing those who had silent ischemia, stable or unstable angina, or myocardial infarction (MI).

The primary end point of the ULTIMATE trial was TVF at 12 months after the index procedure, defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target vessel revascularization (TVR).

Secondary end points included all-cause death, MI, clinically driven target lesion revascularization (TLR), stroke, and each component of the primary end point.

The current study looked at a subgroup of the ULTIMATE trial, focusing on the impact of IVUS-guided DES implantations on patients with CKD.

"The Right Time"

Data on the estimated glomerular filtration rate (eGFR) were available for 1443 patients (mean eGFR, 81.41 ± 28.92 mL/min per 1.73 m2).

Of these, 723 received IVUS guidance during DES implantation and 720 received angiography guidance. CKD, defined as an eGFR of less than 60 mL/min per 1.73 m2, was present in approximately one-quarter (24.2%, n = 349) of patients.

At 12 months, TVF in the CKD group was significantly higher than in the no-CKD group (7.2% vs 3.2%; hazard ratio [HR], 2.30; 95% CI, 1.38 - 3.84; P = .001), with the difference driven primarily by the increased risk for cardiac death (2.9% vs 0.5%; < .001) in patients with CKD.

Of the 25 TVFs in CKD patients, seven (3.9%) were in the IVUS group and 18 (10.7%) were in the angiography group (HR, 0.35; 95% CI, 0.15 - 0.84; = .01).

By contrast, 35 TVFs occurred in patients without CKD — 14 in the IVUS group and 21 in the angiography group (2.6% vs 3.8%; HR, 0.67; 95% CI, 0.34 - 1.32; = 0.25; P for interaction = .24).

Among the CKD patients, the reduced risk for TVF in the IVUS group was driven primarily by the lower risk for TVMI (0.6% vs 3.6%; borderline P = .05) and TVR (1.1% vs 4.7; P = .04).

Zhang called the findings "immediately applicable," saying that it is "the right time to routinely use IVUS in DES implantation for patients with CKD."

Landing Zone

Commenting on the study for theheart.org | Medscape Cardiology, John Blair, MD, assistant professor of medicine, Section of Cardiology, Department of Medicine, the University of Chicago Medicine, called it an "important substudy of the ULTIMATE trial, which itself is part of a growing body of literature supporting the use of intravascular imaging for percutaneous coronary intervention (PCI)."

The study "demonstrates that patients with CKD undergoing PCI are at high risk for TVF and that IVUS guidance, with specific attention to optimizing minimal luminal diameter, stent placement within nondiseased segments, and treatment of any stent-related dissection, resulted in a clinically and statistically meaningful reduction in TVF, driven by reduction in target vessel myocardial infarction," said Blair, who was not involved with the study.

"In this common subset of patients, who unfortunately have a low rate of repeat procedures out of concern for worsening renal function, IVUS should be strongly considered to optimize stent placement in order to avoid repeat procedures down the road and fully optimize outcomes," he said.

Also commenting on the study for theheart.org | Medscape Cardiology, Vitor Osório Gomes, MD, PhD, interventional cardiologist, Hospital Sao Lucas–PUCRS University, Porto Alegre, Brazil, said that patients with impaired renal function are "not usually included in many interventional cardiology trials; however, a significant number of patients who are submitted to invasive procedures have some loss of their kidney function."

For this reason, "studies which include a population with impaired renal function are significantly helpful," said Gomes, who was not involved with the study.

Because the study was a subgroup analysis, "extra attention needs to be given when interpreting and extrapolating its findings," he cautioned. But although the study has its limitations, "it has many interesting features, confirming that patients with impaired renal function have worse cardiovascular outcomes after being submitted to a coronary angioplasty, regardless of using DES," he noted.

Moreover, the "IVUS-guided technique was responsible for a reduction in all outcomes, except cardiac death, making them [CKD patients] similar to the patients with normal renal function."

Gomes suggested that the superiority of IVUS-guided DES may be attributable to "the fact that patients with chronic renal failure have a diffused atherosclerosis pattern that makes it difficult to establish an adequate 'landing zone' using angiography only."

Moreover, "measurement of the diameter of the coronary may not be accurate in CKD patients for the same reason — diffuse atherosclerosis; however, when using IVUS, this limitation is minimized too," he said.

Zhang added that his group plans to report the long-term results of the ULTIMATE trial up to 5 years.

Catheter Cardiovasc Interv. Published online May 22, 2019. Full text

Society for Cardiovascular Angiography and Interventions (SCAI) 2019. Presented May 22, 2019.

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