Liang Pan1, Wenjie Lu1, Zhanying Han1, Sancong Pan2, Xi Wang1, Yingguang Shan1, Xule Wang1, Xiaolin Zheng1, Ran Li1, Yanjun Zhou1, Peng Qin3, Qiangwei Shi1, Shuai Zhou1, Wencai Zhang1, Sen Guo1, Peisheng Zhang4, Xiaofei Qin1, Guoju Sun1, Zhongsheng Qin2, Zhenwen Huang1, Chunguang Qiu5. 1. Department of Cardiovascular Medicine, The First Affiliated Hospital of Zhengzhou University, No. 1, Jianshe East Road, Zhengzhou, Henan, China. 2. Department of Cardiovascular Medicine, Jincheng People's Hospital, No. 456, Wenchang East Road, Jincheng, Shanxi, China. 3. Department of Geriatric Cardiology, The First Affiliated Hospital of Zhengzhou University, No. 1, Jianshe East Road, Zhengzhou, Henan, China. 4. Department of Cardiology, The Fifth Affiliated Hospital of Zhengzhou University, No. 3, Kangfu Qianjie, Zhengzhou, Henan, China. 5. Department of Cardiovascular Medicine, The First Affiliated Hospital of Zhengzhou University, No. 1, Jianshe East Road, Zhengzhou, Henan, China. qcg123@163.com.
Abstract
BACKGROUNDS: Although drug-eluting stents are the most common interventional devices for patients with coronary disease, drug-coated balloons (DCBs) represent a novel therapeutic alternative in certain scenarios. This prospective, observational all-comers study explored the clinical outcomes of DCB use in patients with coronary lesions. METHODS AND RESULTS: All patients treated with DCBs were enrolled in this study, including patients with in-stent restenosis (ISR) or de novo lesions. The primary outcome was the target lesion revascularization (TLR) rate at one year. We enrolled 2306 patients with 2660 lesions and performed DCB angioplasty in 399 patients (17.3%) with ISR and 1907 patients (82.7%) with de novo lesions. During follow-up (366 ± 46 days), the TLR rate was lower in the de novo lesion group (1.31%) compared to the ISR group (7.02%) [odds ratio (OR) 0.176, 95% confidence interval (CI) 0.101-0.305, p < 0.001]. Patients with de novo lesions had a lower yearly incidence of MACE compared to ISR patients (2.73 vs. 9.27%, respectively, OR 0.274, 95% CI 0.177-0.424, p < 0.001) and a lower incidence of any revascularization (5.09 vs. 13.03%, OR 0.358, 95% CI 0.251-0.510, p < 0.001). No significant differences between groups were observed in the rates of cardiac death (OR 0.783, 95% CI 0.258-2.371, p = 0.655) or MI (OR 0.696, 95% CI 0.191-2.540, p = 0.573). CONCLUSIONS: DCB angioplasty in this all-comers, real-world, prospective study was safe and efficient with low TLR and MACE rates. Thus, DCB appears to be an attractive alternative for the stent-less treatment of de novo coronary lesions. ISR in-stent restenosis; OR odds ratio; CI confidence interval; TLR target lesion revascularization; MACE major adverse cardiovascular events; MI myocardial infraction. MACE defined as the composite outcome of cardiac death, myocardial infarction, and target vessel revascularization. Any revascularization includes any percutaneous coronary intervention, and coronary artery bypass grafting.
BACKGROUNDS: Although drug-eluting stents are the most common interventional devices for patients with coronary disease, drug-coated balloons (DCBs) represent a novel therapeutic alternative in certain scenarios. This prospective, observational all-comers study explored the clinical outcomes of DCB use in patients with coronary lesions. METHODS AND RESULTS: All patients treated with DCBs were enrolled in this study, including patients with in-stent restenosis (ISR) or de novo lesions. The primary outcome was the target lesion revascularization (TLR) rate at one year. We enrolled 2306 patients with 2660 lesions and performed DCB angioplasty in 399 patients (17.3%) with ISR and 1907 patients (82.7%) with de novo lesions. During follow-up (366 ± 46 days), the TLR rate was lower in the de novo lesion group (1.31%) compared to the ISR group (7.02%) [odds ratio (OR) 0.176, 95% confidence interval (CI) 0.101-0.305, p < 0.001]. Patients with de novo lesions had a lower yearly incidence of MACE compared to ISR patients (2.73 vs. 9.27%, respectively, OR 0.274, 95% CI 0.177-0.424, p < 0.001) and a lower incidence of any revascularization (5.09 vs. 13.03%, OR 0.358, 95% CI 0.251-0.510, p < 0.001). No significant differences between groups were observed in the rates of cardiac death (OR 0.783, 95% CI 0.258-2.371, p = 0.655) or MI (OR 0.696, 95% CI 0.191-2.540, p = 0.573). CONCLUSIONS: DCB angioplasty in this all-comers, real-world, prospective study was safe and efficient with low TLR and MACE rates. Thus, DCB appears to be an attractive alternative for the stent-less treatment of de novo coronary lesions. ISR in-stent restenosis; OR odds ratio; CI confidence interval; TLR target lesion revascularization; MACE major adverse cardiovascular events; MI myocardial infraction. MACE defined as the composite outcome of cardiac death, myocardial infarction, and target vessel revascularization. Any revascularization includes any percutaneous coronary intervention, and coronary artery bypass grafting.
Authors: Franz-Josef Neumann; Miguel Sousa-Uva; Anders Ahlsson; Fernando Alfonso; Adrian P Banning; Umberto Benedetto; Robert A Byrne; Jean-Philippe Collet; Volkmar Falk; Stuart J Head; Peter Jüni; Adnan Kastrati; Akos Koller; Steen D Kristensen; Josef Niebauer; Dimitrios J Richter; Petar M Seferovic; Dirk Sibbing; Giulio G Stefanini; Stephan Windecker; Rashmi Yadav; Michael O Zembala Journal: Eur Heart J Date: 2019-01-07 Impact factor: 29.983
Authors: Marco Valgimigli; Héctor Bueno; Robert A Byrne; Jean-Philippe Collet; Francesco Costa; Anders Jeppsson; Peter Jüni; Adnan Kastrati; Philippe Kolh; Laura Mauri; Gilles Montalescot; Franz-Josef Neumann; Mate Petricevic; Marco Roffi; Philippe Gabriel Steg; Stephan Windecker; Jose Luis Zamorano; Glenn N Levine Journal: Eur Heart J Date: 2018-01-14 Impact factor: 29.983
Authors: Rosli Mohd Ali; Ralf Degenhardt; Robaayah Zambahari; Damras Tresukosol; Wan Azman Wan Ahmad; Haizal bin Haron Kamar; Sim Kui-Hian; Tiong Kiam Ong; Omar bin Ismail; Safari bin Elis; Wasan Udychalerm; Hanns Ackermann; Michael Boxberger; Martin Unverdorben Journal: EuroIntervention Date: 2011-05 Impact factor: 6.534