Xu Jie, Wang Yu-Wei, Ma Li-Kun, Hu Hao, Chen Hong-Wu, Hua Jing-Sheng, Kong Xiang-Yong, Li Dan, Li Long-Wei, Wu Jia-Wei
Department of Cardiology, Division of Life Science and Medicine, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, 230001, China.
Trials. 2025 Apr 8;26(1):126. doi: 10.1186/s13063-025-08834-6.
The increasing incidence of coronary heart disease, driven by socio-economic development and population aging, poses significant challenges. Coronary calcification, a major factor complicating percutaneous coronary interventions (PCI), often necessitates rotational atherectomy (RA) for lesion preparation. However, the impact of different RA rotational speeds on procedural and clinical outcomes remains unclear. While low-speed RA (LSRA) has been suggested to reduce intraoperative slow flow, evidence is inconsistent, and the benefits of combining LSRA with high-speed RA (HSRA) are not well established. This study aims to evaluate the effectiveness of different rotational speed protocols to guide clinical practice.
This single-center, randomized controlled trial will target patients with severe coronary artery calcification scheduled for RA. An estimated 210 patients will be enrolled based on sample size calculation, randomly assigned in a 1:1:1 ratio to different rotational speed protocols using a random number table. These will include a continuous low-speed rotation (LSRA) group (140,000 rpm), a continuous high-speed rotation (HSRA) group (180,000 rpm), and a high-speed to low-speed rotation (HSRA + LSRA) group (initially 180,000 rpm, followed by 100,000 rpm). The primary endpoint is the incidence of complications during RA, including coronary artery spasm, slow/no reflow, dissection, burr entrapment, guidewire fracture, and perforation. Secondary outcomes encompass intravascular imaging (IVUS or OCT) assessments (detecting calcific ring disruption and measuring the target lesion's minimum lumen area (MLA) and minimum lumen diameter (MLD)); in-hospital cardiac death, acute stent thrombosis, and heart failure occurrences; and the 1-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE).
The RACE study evaluates the impact of different rotational speeds in coronary rotational atherectomy, aiming to provide guidance for clinical practice. The findings may help standardize RA procedures and inform future clinical guidelines, improving procedural consistency and patient outcomes.
ChiCTR2300076194. Registered on September 27, 2023.
在社会经济发展和人口老龄化的推动下，冠心病发病率不断上升，带来了重大挑战。冠状动脉钙化是经皮冠状动脉介入治疗（PCI）复杂化的一个主要因素，常常需要进行旋磨术（RA）来预处理病变。然而，不同的RA转速对手术过程和临床结果的影响仍不明确。虽然有人提出低速RA（LSRA）可减少术中慢血流，但证据并不一致，而且LSRA与高速RA（HSRA）联合使用的益处也未得到充分证实。本研究旨在评估不同转速方案指导临床实践的有效性。
这项单中心随机对照试验的研究对象为计划接受RA治疗的严重冠状动脉钙化患者。根据样本量计算，预计将招募210名患者，使用随机数字表以1:1:1的比例随机分配到不同的转速方案组。这些方案组将包括持续低速旋转（LSRA）组（140,000转/分钟）、持续高速旋转（HSRA）组（180,000转/分钟）和先高速后低速旋转（HSRA + LSRA）组（初始转速为180,000转/分钟，随后为100,000转/分钟）。主要终点是RA过程中并发症的发生率，包括冠状动脉痉挛、慢血流/无复流、夹层、磨头嵌顿、导丝断裂和穿孔。次要结局包括血管内成像（IVUS或OCT）评估（检测钙化环破裂并测量靶病变的最小管腔面积（MLA）和最小管腔直径（MLD））；院内心源性死亡、急性支架血栓形成和心力衰竭的发生情况；以及主要不良心血管和脑血管事件（MACCE）的1年发生率。
RACE研究评估了不同转速在冠状动脉旋磨术中的影响，旨在为临床实践提供指导。研究结果可能有助于规范RA手术流程，并为未来的临床指南提供参考，从而提高手术的一致性和患者的治疗效果。
ChiCTR2300076194。于2023年9月27日注册。
