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October 7, 2019

Five-Year IVUS-XPL Outcomes Support Intravascular Ultrasound-Guided EES Implantation

September 29, 2019—The 5-year follow-up results of the IVUS-XPL randomized trial were published online by Sung-Jin Hong, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions simultaneously with their presentation in a late-breaking trial session at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 25–29 in San Francisco, California.

Previously, intravascular ultrasound (IVUS) to guide implantations of everolimus-eluting stents (EESs) showed favorable clinical outcomes at 1 year. Those data from IVUS-XPL were published in November 2015 in JAMA: Journal of the American Medical Association.

The goal of the current investigation was to evaluate whether the beneficial effect of IVUS is sustained for long-term follow-up.

As summarized in JACC: Cardiovascular Interventions, the retrospective and prospective follow-up IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥ 28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) EES implantation. The 5-year clinical outcomes were investigated in patients who completed the original trial.

The primary outcome was the composite of major adverse cardiac events (MACE; including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization) at 5 years, analyzed by intention-to-treat.

With follow-up completed in 1,183 patients (85%) at 5 years, the investigators reported:

  • MACE occurred in 36 (5.6%) patients receiving IVUS-guidance and in 70 (10.7%) patients receiving angiography-guidance (hazard ratio [HR], 0.5; 95% confidence interval [CI], 0.34−0.75; P = .001).
  • The difference in MACE was mainly driven by a lower risk of target lesion revascularization, with 31 patients in the IVUS group and 55 patients in the angiography group (4.8% vs 8.4%; HR, 0.54; 95% CI, 0.33−0.89; P = .007).
  • By landmark analysis, MACE between 1 and 5 years occurred in 17 patients receiving IVUS-guidance and in 31 (5.2%) patients receiving angiography-guidance (2.8% vs 5.2%; HR, 0.53; 95% CI, 0.29–0.95; P = .031).

Compared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of MACE up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years postimplantation, concluded the investigators in JACC: Cardiovascular Interventions.

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October 8, 2019

REVIVE-HF European RCT Commences for BioVentrix' Revivent TC System

October 2, 2019

Gore's Cardioform ASD Occluder Approved and Launched in Europe