Safety and efficacy of different rotational speed during rotational atherectomy in coronary heart disease patients (RACE): study protocol for a randomized controlled trial.

Abstract

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.