, Zheng Li 2
, Yong-xiang Zhu 2
, Vincenzo Tufaro 3
, Si-li Feng 2
, Qian Li 2
, Li Liang 2
, Shang Chang 2
, Ling-tong Bu 4
, Bing Liu 5
, Qi-hua Zhou 6
, Nathan A. L. Yap 7
, Christos V. Bourantas 8
, Yao-jun Zhang 2
2Department of Cardiology, Xuzhou Third People’s Hospital, Xuzhou Hospital Affiliated to Jiangsu University; Xuzhou-China
3Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust; London-UK; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London; London-UK
4Department of Cardiology, Xuzhou Third People’s Hospital, Xuzhou Hospital Affiliated to Jiangsu University; Xuzhou-China
5Department of Cardiology, Xuzhou Third People’s Hospital, Xuzhou Hospital Affiliated to Jiangsu University; Xuzhou-China
6Department of Cardiology, Peixian County Guotai Hospital; Xuzhou-China
7Department of Cardiology, Xuzhou Renci Hospital; Xuzhou-China
8Barts and the London School of Medicine and Dentistry; London-UK
9Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust; London-UK; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London; London-UK;Institute of Cardiovascular Sciences, University College London; London-UK
Abstract
Objective: To investigate the safety and efficacy of a percutaneous revascularization strategy that is based on the use of drug-coated balloon for the treatment of patients with acute coronary syndrome and de novo Medina type 0,1,0 or 0,0,1 left main stem bifurcation lesions.
Materials and Methods: In this multicenter, prospective, proof-of-concept study, patients fulfilling the
above criteria were enrolled and received treatment with drug-coated balloon combined with provisional drug-eluting stent implantation in the proximal major branches of the left main stem. Patients who declined this revascularization approach were treated with drug-eluting stent implantation 1-2 mm distally to the left anterior descending or left circumflex artery ostium followed by drug-coated balloon therapy for the ostial disease. The primary endpoint of the study was the calculation of percent diameter stenosis on quantitative coronary angiography post-procedure as well as event rate at 8 months follow-up.
Results: A total of 30 patients were enrolled in the study; their mean age was 60.3 ± 7.8 years, while 22 (73.3%) were male. Twenty-two patients were treated only with drugcoated balloon and provisional drug-eluting stent implantation and 8 had drug-eluting stent implantation followed by drug-coated balloon therapy of the ostium of the left main stem major branch. All the procedures were successful with no immediate complications. The percent diameter stenosis of lesion decreased significantly post-procedure from 87.5% (80.0-90.0) to 20% (17.5-30.0), P <.001. During the follow-up period, no major adverse cardiac events were reported.
Conclusions: This proof-of-concept study indicates that ostial drug-coated balloon therapy of the left main stem major branches is safe and effective. Larger clinical data and longer follow-up are needed before advocating its regular use in clinical practice.