The Safety and Efficacy of Intravascular Lithotripsy in the Treatment of Severe Coronary Artery Calcification in 261 Cases: A Retrospective Study

Background

Coronary artery calcification is strongly linked to factors such as advanced age, dyslipidemia, and chronic kidney disease. Severe coronary artery calcification significantly elevates the complexity and risk of percutaneous coronary intervention (PCI), potentially giving rise to complications such as incomplete stent expansion, restenosis, and thrombosis. Intravascular lithotripsy (IVL), a novel approach, can break up calcified plaques and facilitate stent delivery and expansion. Nevertheless, its comprehensive safety and efficacy in pretreating severe coronary artery calcification lesions remain uncertain, and research data is relatively scarce compared to traditional techniques, especially in the large hospital setting of Henan with a considerable population base.

Aims

To retrospectively analyze the safety and efficacy of IVL in the treatment of severe coronary artery calcification in 261 cases.

Methods

From January 2022 to March 2024, 261 patients with at least one coronary artery lesion diagnosed as severe calcification and undergoing PCI based on IVL in Fuwai Central China Cardiovascular Hospital and Henan Provincial People's Hospital were selected for the study. A retrospective analysis was conducted on 272 diseased vessels treated with IVL for PCI. The primary endpoint was procedural success, while the main safety endpoints were no cardiac death, myocardial infarction, and target vessel revascularization within 30 days.

Results

Among the 261 patients, 234 (89.7%) had acute coronary syndrome (ACS), including 195 (74.7%) with non-ST-segment elevation myocardial infarction (NSTEMI). Various techniques like noncompliant balloon, cutting balloon, and orbital grinding were employed for IVL preparation, and the proportion of direct IVL treatment was 8.8% (24 cases). The minimum lumen area significantly increased from (1.5 ± 0.6) mm² before treatment to (7.2 ± 1.8) mm² after treatment, with an acute gain rate of (243 ± 105)%, (p < 0.001), indicating a statistically significant difference. The primary efficacy endpoint was achieved 100%, and the primary safety endpoint was 2.6%. Perioperative complications were infrequent and were managed successfully.

Conclusions

As a new technology for modifying calcified plaques, the IVL system proves to be safe, effective, and straightforward to operate, offering a new and preferred option for patients with severe coronary calcified lesions, particularly those with ACS.