IVUS or Angiography Guidance for Percutaneous Coronary Intervention in Complex Coronary Bifurcation Lesions: The DKCRUSH VIII Randomized Clinical Trial.

Abstract

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) is associated with fewer clinical events than angiography-guided PCI. Whether the use of IVUS guidance improves the outcomes as compared with angiography guidance in patients with complex coronary bifurcation lesion undergoing double kissing (DK) crush is uncertain. This study aimed to investigate the treatment effect of IVUS-guided PCI, as compared with angiography-guided PCI, in patients with complex bifurcation lesions. We conducted a multicenter, randomized, open-label trial at 24 centers in China. Patients with clinical indications for PCI and a complex bifurcation lesion based on DEFINITION (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) criteria (particularly side branch lesion length ≥10 mm) from coronary angiography were randomly assigned in a 1:1 ratio to IVUS-guided PCI or angiography-guided PCI. The primary endpoint was a composite of target vessel failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization at 1 year after randomization. We assigned 555 patients to IVUS-guided PCI (n = 277) or angiography-guided PCI (n = 278). A total of 124 patients (44.8%) in the IVUS-guided PCI group and 122 (43.9%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. DK crush was used in 96.8% of patients. At 1 year, a primary endpoint event occurred in 17 patients (6.1%) in the IVUS-guided PCI group and in 41 patients (14.7%) in the angiography-guided PCI group (HR: 0.40; 95% CI: 0.23-0.71; P = 0.002), driven mainly by reductions in target vessel myocardial infarction or target vessel revascularization. In the present randomized trial comparing IVUS-guided vs angiography-guided PCI for complex coronary bifurcation lesions treated with the 2-stent DK crush technique, the benefits of IVUS-guided PCI at 1 year was achieved largely through achievement of IVUS-defined optimization targets rather than IVUS use alone. (IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions [DKCRUSH VIII]; NCT03770650).