First-in-human experience with the Medtronic Bifurcation Stent System.

Aims: The BRANCH study was a prospective, multicentre, non-randomised, single arm trial to investigate the feasibility, safety, efficacy, and performance of the bare metal Medtronic Bifurcation Stent System for the treatment of de novo bifurcation lesions.

Methods And Results: Sixty patients were enrolled in the study. After a learning curve of one case at seven centres, 53 patients from six centres were prospectively treated. The primary endpoint was target vessel failure (TVF) at 30 days. Secondary endpoints included acute device, lesion, and procedure success and TVF at 12 months. Medina complex bifurcation lesions (1,1,1; 1,1,0; 1,0,1; 0,1,1) were treated in 71.7%. The stent was successfully implanted in 86.8% of cases. Acute device, lesion, and procedure success rates were 83.0%, 92.5%, and 88.7%, respectively. TVF occurred in 2/52 patients (3.8%) at 30 days. No other major adverse cardiac adverse events (MACE) occurred through 30 days follow-up. At 12 months, TVF occurred in 6/47 (12.8%) patients, and MACE occurred in 5/47 (10.6%) patients.

Conclusions: Results from the BRANCH study demonstrate that the Medtronic Bifurcation Stent System is safe and can be successfully and effectively deployed in a variety of bifurcation lesions with good clinical outcomes.