Objectives: This study sought to assess the impact of intravascular ultrasound (IVUS) guidance on clinical outcomes following drug-eluting stent implantation when treating long lesions. Background: The role of IVUS guidance when treating long lesions has been tested during bare-metal stent, but not during drug-eluting stent, implantation. Methods: A total of 543 patients treated with stents ≥28 mm in length were randomly assigned to IVUS guidance (n = 269) versus angiography guidance (n = 274). The primary endpoint was a composite of major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction, target vessel revascularization, or stent thrombosis at 1 year following intervention. Results: In the intention-to-treat analysis, total stent length was 32.4 mm in the IVUS-guided arm versus 32.3 mm in angiography-guided arm (p = 0.84). Adjunct post-dilation was more frequently performed in the IVUS-guided arm (54.6% vs. 44.5%, p = 0.03); post-intervention minimal lumen diameters were similar (2.55 vs. 2.55 mm, respectively, p = 0.50); and MACE occurred in 12 (4.5%) patients in IVUS-guided arm and in 20 (7.3%) patients in the angiography-guided arm (p = 0.16). However, among the 269 patients assigned to IVUS guidance, IVUS was not used in 13 patients (4.8%); conversely, in 274 patients assigned to angiography alone, 41 patients (15.0%) were treated with IVUS guidance. Therefore, in a per-protocol analysis according to actual IVUS usage, minimum lumen diameter was larger (2.58 vs. 2.51 mm, p = 0.04), and MACE rates were lower: 4.0% in the IVUS-guided arm versus 8.1% in the angiography-guided arm (p = 0.048). Conclusions: A strategy of routine IVUS for drug-eluting stent implantation in long lesions did not improve the 1-year MACE rates. The IVUS use per operator decision was associated with improved results.
Bibliographical noteFunding Information:
This study was supported by the Cardiovascular Research Center, Seoul, Korea; Medtronic Inc.; and grants from the Korea Healthcare Technology Research and Development Project, Ministry for Health, Welfare, and Family Affairs , Republic of Korea ( #A085012 and #A102064 ) and the Korea Health 21 Research and Development Project, Ministry of Health and Welfare , Republic of Korea ( #A085136 ). Dr. Mintz has received grant support and/or honoraria from Volcano Therapeutics , Boston Scientific Corp. , and St. Jude Medical . All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The first two authors contributed equally to this paper.
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine