IVUS guidance superior to angiography guidance for EES implantation in long lesions
ORLANDO, Fla. — Use of IVUS to guide implantation of everolimus-eluting stents in long coronary lesions was associated with better outcomes than angiography-guided implantation, according to data presented at the American Heart Association Scientific Sessions.
Myeong-Ki Hong, MD, PhD, and colleagues conducted the IVUS-XPL study to determine the clinical usefulness of IVUS with second-generation drug-eluting stents. The researchers hypothesized that IVUS would be superior to angiography in guiding placement of those stents in patients with long coronary lesions requiring a stent of at least 28 mm.
Hong and colleagues randomly assigned 1,400 patients (mean age, 64 years; 69% men) to EES implantation with IVUS or angiography guidance. The primary outcome was MACE, defined as cardiac death, target lesion-related MI or ischemia-driven target lesion revascularization, at 12 months.
Twenty-two patients from the IVUS group had to cross over to angiography guidance, and 30 patients from the angiography group had to cross over to IVUS guidance, Hong said during a press conference.
The IVUS group was more likely to have adjunct post-dilatation (76% vs. 51%; P < .001) and had a larger average balloon size (3.14 mm vs. 3.04 mm; P < .001), Hong said.
After the procedure, the IVUS group had a larger mean reference vessel diameter (3.03 mm vs. 2.97 mm; P = .01), a larger minimum lumen diameter (2.64 mm vs. 2.56 mm; P < .001) and less diameter stenosis (12.79% vs. 13.74%; P = .04), according to results presented here.
At 12 months, compared with the angiography group, the IVUS group had less risk for MACE (2.9% vs. 5.8%; HR = 0.48; 95% CI, 0.28-0.83), which was driven by a lower rate of ischemia-driven TLR (2.5% vs. 5%; HR = 0.51; 95% CI, 0.28-0.91), Hong said.
The results showed no significant differences between the groups at 12 months in cardiac death, target lesion-related MI or stent thrombosis.
Within the IVUS group, patients who did not meet IVUS criteria for stent optimization had a higher rate of the primary outcome at 12 months than those who did meet the IVUS criteria (4.6% vs. 1.5%; HR = 0.31; 95% CI, 0.11-0.86).
“Our findings suggest better clinical outcomes of MACE with IVUS guidance compared to angiography guidance for DES implantation, particularly for diffuse long lesions,” Hong, professor of medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea, said here. – by Erik Swain
Hong M-K, et al. Late-Breaking Clinical Trials 3. Presented at: American Heart Association Scientific Sessions; Nov. 7-11, 2015; Orlando, Fla.
Disclosures: The study was funded by Abbott Vascular. Hong reports no relevant financial disclosures.