ORLANDO -- Patients who underwent long stent placement involving intravascular ultrasound (IVUS) rather than angiographic guidance had fewer coronary events at 1 year resulting from those percutaneous coronary interventions, Korean researchers reported here.
In the trial that included 1,400 patients undergoing stenting with second-generation drug-eluting devices, there was an absolute 2.97% reduction in major adverse coronary events, which translated to a 52% relative risk reduction (P=0.007), said Sung-Jin Hong, MD, of Sanggye Paik Hospital and in Seoul.
Action Points
- Note that this randomized trial found that IV ultrasound-guided long stent placement improved adverse outcomes compared to traditional angiographically guidely stent placement.
- Be aware that the interventionalists were all experts in IVUS, which may have biased the results against angiography.
In the late-breaker study reported at the annual meeting of the American Heart Association, Hong said that the adverse events were mainly ischemia-driven target vessel revascularization. He reported that 17 patients experienced target lesion revascularization compared with 33 patients who underwent angiography-guided stent implantation (P=0.02).
Cardiac death and target lesion–related myocardial infarction were not significantly different between the two groups. Three patients in the IVUS-guided group died compared with 5 patients in the angiography-guided group (P=0.48). Target lesion-related myocardial infarction occurred in one patient in the angiography-guided stent implantation group (P=0.32). The mean stented length of the target lesions was 39.3 mm.
"Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year," Hong said at an AHA press briefing. The study was simultaneously with its presentation at the meeting.
an interventional cardiologist at Henry Ford Hospital in Detroit, and a former president of the American College of Cardiology, told ľֱ, "This study may well change practice. It should make the use of IVUS more routine. IVUS technology is available in more academic and larger hospitals and in many community hospitals as well.
"Using IVUS will cost more money and will take more time, but it appears to make a difference in one in 20 of these patients with long-lesions. Those of us who use IVUS should take comfort in knowing that it is a reasonable approach to placing these longer lesions."
Weaver said there did not appear to be any bias in regard to the patients who were lost to follow-up: 36 in the IVUS-guided stent placement group and four others who withdrew consent; in the angiography-guided group, 34 patients were lost to follow-up and three others withdrew consent.
However, , vice president and chief innovation officer for University Hospitals Health System and professor of medicine at Case Western Reserve University, Cleveland, the designated discussant for the study, told ľֱ, "I think doctors in the United States will want to see this study replicated here before there is a major uptake of IVUS-guided stent placement."
He also suggested that while IVUS-guided treatment did seem to have an advantage over angiography-guided treatment, there may be newer technology that trumps IVUS and may warrant study before changing practice.
The research team recruited the patients from October 2010 to July 2014. Mean patient age was 64 years, Hong and colleagues reported. About 69% of the patients were men and their body mass index was 24.6; about 65% of the patients had hypertension; about 36% had diabetes; about a quarter of the patients were current smokers; 10% had previously undergone a percutaneous coronary intervention.
About half the patients were diagnosed with stable angina; about 355 had unstable angina and about 15% of the patients were experiencing an acute myocardial infarction. At baseline more than 95% of the patients were on statins -- two-thirds of the patients had been diagnosed with dyslipidemia; about 70% of the patients were prescribed beta-blockers; more than 25% of the patients were on angiotensin-converting enzyme inhibitors; about a third of patient were on angiotensin receptor blockers; a third of patients were taking calcium channel blockers.
During the procedure, 11 patients in the IVUS-guided group and nine patients in the angiography-guided group experienced peri-procedural myocardial infarcts (P=0.65). More than 60% of patients had stent placements in the left anterior descending coronary artery, about 20% of patients were treated for lesions in the right coronary artery, and 15% of patients were treated for blockages in the circumflex artery.
The researchers acknowledged that their study had some limitations. "The physicians used in this study were proficient in both approaches, and their expert knowledge of IVUS may have unintentionally biased their approach when using angiography guidance," the authors wrote in the JAMA paper. In addition, they said, "our study does not address cardiac events beyond the 1 year of follow-up." They also noted that the observed overall event rate for the primary end point was lower than anticipated.
Disclosures
Hong and Weaver disclosed no relevant relationships with industry.
Costa disclosed relevant relationships with Abbott Laboratories, Boston Scientific, Cardiokinetix, Cordis Corporation, Daiichi-Sankyo, Eli Lilly Pharmaceuticals Company, Medtronic, Sanofi-Aventis, Scitech Medical, St. Jude Medical, Abbott Vascular, Genae Americas, and Stem Med.
Primary Source
Journal of the American Medical Association
Hong SJ, et al "Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial" JAMA 2015; DOI: 10.1001/jama.2015.15454.