Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial

Inclusion criteria

• Age ≥ 18 years;
• Target lesion with diameter stenosis ≥ 50% (visual estimation) associated with evidence of myocardial ischemia;
• Target lesion must be a de novo, in-situ severely calcified coronary lesion, where severe calcification is defined as: radiopacity visible prior to contrast injection and in the absence of cardiac pulsation, typically involving both sides of the vessel wall; and ≥270° circumferential calcification as evidenced by intravascular ultrasound (IVUS);
• Target vessel reference diameter between 2.5 and 4.0 mm, with successful guidewire traversal;
• A maximum of two non-target lesions requiring interventional treatment, which must be successfully treated prior to the target lesion;
• Patients presenting with evidence of symptomatic or asymptomatic myocardial ischemia, stable or unstable angina pectoris, or prior myocardial infarction;
• Signed written informed consent obtained.

Exclusion criteria

• Cardiogenic shock or hemodynamic instability;
• Chronic total occlusion (CTO);
• Requirement for intraprocedural mechanical circulatory support, such as intra-aortic balloon pump (IABP) or Impella device;
• Acute ST-segment elevation myocardial infarction (STEMI) occurring within 1 month prior to enrollment;
• Angiographically visible thrombus at the target lesion site;
• Left main ostial lesion with stenosis ≥ 50%;
• Left ventricular ejection fraction (LVEF) < 40%;
• New-onset stroke or transient ischemic attack (TIA) within 90 days;
• Bypass graft lesion;
• Coronary artery dissection of type B or greater (NHLBI classification);
• Pregnant or lactating patients;
• Life expectancy < 1 year;
• Active bleeding;
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²;
• Presence of cognitive or psychiatric disorders, as confirmed by clinical diagnosis or investigator assessment;
• Illiteracy, semi-literacy, or any visual impairment, reading/writing disability that prevents the patient from independently reading the patient information sheet and personally providing written informed consent without assistance.