Feature | September 26, 2014

IVUS-guided Interventions Show Improved Outcomes in Patients With CTOs

Results of IVUS-CTO Trial Reported at TCT 2014

IVUS, CTOs
September 14, 2014 – A new study found that intravascular ultrasound (IVUS)-guided intervention in patients with chronic total occlusion (CTO) could improve outcomes compared to a conventional angiography-guided approach during percutaneous coronary intervention (PCI). The IVUS-CTO study is the first randomized trial to examine the clinical impact of IVUS guidance for CTO intervention. Findings were reported at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 
 
A chronic total occlusion is a complete or nearly complete blockage of a coronary artery that has been present for more than 30 days. PCI of CTO lesions is one of the most challenging forms of PCI, with some of the highest rates of recurrent restenosis due to the complexity of the procedures and lesions. IVUS evaluates coronary arteries using sound waves, and can be used to optimize post-PCI stent results, but whether there is demonstrable efficacy of this technique has not been adequately studied in CTO PCI.  
 
The prospective, multi-center trial randomized 402 patients with CTOs to either the IVUS-guided or angiography-guided groups after successful guidewire crossing. Patients were then additionally randomized to zotarolimus-eluting stents or biolimus-eluting stents. The primary endpoint was the composite of cardiac death, myocardial infarction, and target-vessel revascularization (TVR) at 12 months. Secondary endpoints included a composite rate of cardiac death or myocardial infarction and individual components of the primary endpoint.
 
After a 12-month follow up, occurrence of the primary endpoint was significantly lower in the IVUS-guided group compared to the angiography-guided group (2.6 vs. 7.1 percent; hazard ratio=0.35, 95% CI=0.13-0.97; p=0.035). Occurrence of the composite of cardiac death and myocardial infarction was also significantly lower in the IVUS-guided group vs. the angiography-guided group (p=0.045). IVUS guidance led to more aggressive balloon inflations during PCI. At follow-up, TVR was non-significantly lower in the IVUS-guided group compared with the angiography-guided group (2.6 vs. 5.2 percent; hazard ratio=0.48, 95% CI=0.17-1.42; p=0.186). 
 
Cross-over rates were 2.5 percent from IVUS-guided to the angiography-guided group, and 17.4 percent from angiography-guided to the IVUS-guided group (p<0.001). Based on the per-protocol analysis, occurrence of the primary endpoint was lower in the IVUS-guided group than in the angiography-guided group (2.2 vs. 8.4 percent; hazard ratio=0.26, 95% CI=0.09–0.71; p=0.005). 
 
“This first-of-its kind trial demonstrates that compared with conventional angiography-guided CTO intervention, IVUS-guided intervention significantly improved 12-month clinical outcomes after new-generation drug-eluting stent implantation,” said lead investigator Yang-Soo Jang, M.D., Ph.D. director of the Research Institute at the Severance Cardiovascular Hospital and Research Institute and Yonsei University Health System in Seoul, Korea. “Findings show that IVUS-guidance for CTO intervention is superior to the conventional approach.”
 
The IVUS-CTO trial was funded by a grant from the Cardiovascular Research Center in Seoul, Korea. Jang reported no disclosures.
 
For more information: www.crf.org, www.tctconference.com
 

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Overlay Init