Clinical outcomes of drug-coated balloon in coronary lesions: a real-world, all-comers study,Clinical Research in Cardiology

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Clinical outcomes of drug-coated balloon in coronary lesions: a real-world, all-comers study
Clinical Research in Cardiology ( IF 3.8 ) Pub Date : 2021-07-27 , DOI: 10.1007/s00392-021-01895-y
Liang Pan ₁ , Wenjie Lu ₁ , Zhanying Han ₁ , Sancong Pan ₂ , Xi Wang ₁ , Yingguang Shan ₁ , Xule Wang ₁ , Xiaolin Zheng ₁ , Ran Li ₁ , Yanjun Zhou ₁ , Peng Qin ₃ , Qiangwei Shi ₁ , Shuai Zhou ₁ , Wencai Zhang ₁ , Sen Guo ₁ , Peisheng Zhang ₄ , Xiaofei Qin ₁ , Guoju Sun ₁ , Zhongsheng Qin ₂ , Zhenwen Huang ₁ , Chunguang Qiu ₁

Affiliation

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.

Graphic abstract

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.

中文翻译：

药物涂层球囊在冠状动脉病变中的临床结果：一项真实的、全员参与的研究

背景

尽管药物洗脱支架是冠状动脉疾病患者最常见的介入设备，但药物涂层球囊 (DCB) 在某些情况下代表了一种新的治疗选择。这项前瞻性、观察性的全来者研究探讨了 DCB 用于冠状动脉病变患者的临床结果。

方法和结果

所有接受 DCB 治疗的患者都参加了这项研究，包括支架内再狭窄 (ISR) 或新发病变的患者。主要结果是一年的目标病变血运重建（TLR）率。

我们招募了 2306 名患者，有 2660 个病灶，并对 399 名 ISR 患者（17.3%）和 1907 名新发病灶患者（82.7%）进行了 DCB 血管成形术。在随访期间（366 ± 46 天），新发病变组的 TLR 率（1.31%）低于 ISR 组（7.02%）[优势比 (OR) 0.176, 95% 置信区间 (CI) 0.101–0.305，p < 0.001]。与 ISR 患者相比，新发病变患者的 MACE 年发生率较低（分别为 2.73 和 9.27%，OR 0.274, 95% CI 0.177–0.424，p < 0.001）和任何血运重建的发生率较低（5.09 与 0.001）。 13.03%，或 0.358，95% CI 0.251–0.510，p < 0.001）。组间心源性死亡率无显着差异（OR 0.783, 95% CI 0.258–2.371, p = 0.655) 或 MI (OR 0.696, 95% CI 0.191–2.540, p = 0.573)。