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Safety and efficacy of different rotational speed during rotational atherectomy in coronary heart disease patients
Jie Xu1, Yu-Wei Wang1, Li-Kun Ma1
1Department of Cardiology, Division of Life Science and Medicine, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, 230001, China.
Insights
This study investigates rotational atherectomy speeds for coronary artery disease. Findings will guide optimal rotational atherectomy (RA) protocols to improve patient outcomes and procedural consistency.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Increasing coronary heart disease and population aging present challenges.
- Coronary calcification complicates percutaneous coronary interventions (PCI), often requiring rotational atherectomy (RA).
- Optimal RA rotational speeds for procedural and clinical outcomes are not well-established.
Purpose of the Study:
- To evaluate the effectiveness of different rotational speed protocols in rotational atherectomy (RA).
- To provide evidence-based guidance for clinical practice in RA procedures.
- To improve procedural consistency and patient outcomes in managing severe coronary artery calcification.
Main Methods:
- A single-center, randomized controlled trial enrolling 210 patients with severe coronary artery calcification.
- Patients randomly assigned to continuous low-speed RA (LSRA), continuous high-speed RA (HSRA), or sequential HSRA followed by LSRA.
- Primary endpoint: incidence of intra-procedural complications; secondary outcomes include intravascular imaging, in-hospital events, and 1-year MACCE.
Main Results:
- Data on complication rates, intravascular imaging findings (calcific ring disruption, MLA, MLD), and in-hospital events are being collected.
- Long-term outcomes including 1-year MACCE will be assessed.
- Analysis will compare the safety and efficacy of different rotational speed strategies.
Conclusions:
- The RACE study aims to clarify the impact of varying rotational speeds during RA.
- Findings are expected to inform clinical guidelines and standardize RA procedures.
- This research seeks to optimize RA protocols for better patient care in interventional cardiology.
Introduction:
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.
Methods And Analysis:
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).
Discussion:
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.
Registration Number:
ChiCTR2300076194. Registered on September 27, 2023.
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