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TCT: IVUS Tops Angiography Guidance for Stent Implantation

— Intravascular ultrasound-guidance cut TVF in all-comers trial

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SAN DIEGO -- Implanting drug-eluting stents under intravascular ultrasound-guided (IVUS) guidance improves outcomes compared with angiography guidance, a randomized trial from China found.

The primary endpoint at 12-month follow-up showed less target vessel failure (TVF, 21 vs 39 cases, 2.9% vs 5.4%, P=0.019), reported Junjie Zhang, MD, of Nanjing Medical University in Nanjing, China, here at the Transcatheter Cardiovascular Therapeutics meeting and online in the .

This study extends prior findings suggesting overall favorable effect of IVUS guidance in certain types of lesions to now support benefit for all-comers, Zhang noted in a press release.

Even with a good angiographic approach, IVUS still wins, said panel discussant John McB. Hodgson, DO, of MetroHealth in Cleveland, calling the study confirmatory.

And the particularly impressive part was analysis comparing optimal use, commented panel discussant Gary Mintz, MD, of the Cardiovascular Research Foundation in New York City.

"If you don't use IVUS correctly, you don't get a benefit, because the ones who did not get optimal stenting were very similar to the angiographic group," he emphasized.

Optimally-stented patients in the IVUS group had a TVF rate of 1.6%, compared with 4.4% in patients (HR 0.349, P=0.029) in those who didn't simultaneously meet all three IVUS-defined criteria (>5.0 mm2 minimal lumen area in the stented segment or 90% at the distal reference segments, <50% plaque burden 5 mm proximal or distal to the stent edge, and no edge dissection involving media with length >3 mm).

The patients were randomly assigned to the angiography guidance study arm (n=724) and intravascular ultrasound guidance study arm (n=724). All 30-day endpoints were similar between groups.

Individual components of the 1-year primary endpoint came out similar between groups: Clinically-driven target vessel revascularization (TVR; 11 vs 21; P=0.07), cardiac death (5 vs 10; P=0.19), and target-vessel myocardial infarction (TV-MI; 7 vs 11; P=0.34).

Other 1-year follow-up findings, comparing IVUS versus angiography groups, showed the following:

  • Target lesion failure: (20 vs 37 cases; P=0.023)
  • Clinically-driven target lesion revascularization TLR or definite stent thrombosis (ST): (9 vs 19 cases; P=0.053)
  • All cause death: (10 vs 17 cases; P=0.17)
  • Definite and probable ST: (1 vs 5 cases; P=0.10)
  • Definite ST: (0 vs 2 cases; P=0.16)
  • Probable ST: (1 vs 3 cases; P=0.32)
  • Stroke: (5 vs 4 cases; P=0.75)

The findings were dependent on a study design that implements IVUS more than once, noted Hodgson.

"They did IVUS pre and post, which I think is important and to be able to plan the procedure accurately. Some of the studies have just done IVUS post, but I think doing it pre is important," he said.

Another factor was that these weren't simple lesions, he argued. "The average stent length of the patient was 66 mm, almost 50 mm per lesion. I mean these were not simple cases."

Disclosures

The trial was funded by National Natural Science Foundation of China, Six Talent Peaks Project in Jiangsu Province, Nanjing Health and Family Planning Commission, Nanjing Health Youth Talent Training project, and Nanjing Municipal Commission of Science & Technology.

Zhang did not report any conflicts of interest.

Primary Source

Transcatheter Cardiovascular Therapeutics meeting

Zhang J, et al "Ultimate: A Multicenter, Prospective, Randomized Trial Comparing Intravascular Ultrasound-guided versus Angiography-guided Implantation of Drug-Eluting Stent in All-comers," TCT 2018.

Secondary Source

Journal of the American College of Cardiology

Zhang J, et al "Intravascular ultrasound-guided versus angiography-guided implantation of drug eluting stent in all-comers: the (ULTIMATE) trial" JACC 2018; DOI: 10.1016/j.jacc.2018.09.013.