A recent study published in EuroIntervention confirms the sustained safety and efficacy of intravascular lithotripsy (IVL) in treating patients with coronary artery calcification, particularly those with calcified nodules (CNs). The research, a pooled analysis of the Disrupt CAD trials, indicates that IVL effectively facilitates stent delivery and expansion in lesions with CNs, yielding comparable outcomes to lesions without CNs.
Key Findings on Stent Expansion and Safety
After two years, the median minimal stent area was identical—5.7 mm2—for lesions with and without CNs. The median minimal stent expansion was 79.3% for lesions with CNs and 80.2% for lesions without CNs. These results suggest that IVL is mechanistically effective in preparing severely calcified coronary arteries for stenting, irrespective of the presence of CNs.
Clinical Outcomes and Target Lesion Failure
Target lesion failure, a composite outcome including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, was observed in 13.9% of patients with CNs and 8% without CNs. While the event rate was numerically higher in the CN group, this difference did not reach statistical significance. Importantly, the event rate in the CN group was lower than previously reported rates for this high-risk population.
Expert Commentary
"The present study confirms that IVL is mechanistically effective as a frontline preparation tool for the treatment of severe coronary artery calcification with CNs," stated Dr. Ziad A. Ali, an interventional cardiologist with St. Francis Hospital and the Cardiovascular Research Foundation, and the study's first author. "The IVL catheter crossed the lesion, delivered therapy and facilitated stent delivery in all cases, resulting in acceptable stent areas and expansion."
Implications for Clinical Practice
The study's findings suggest that IVL is a safe and effective option for treating patients with heavily calcified coronary lesions, including those with CNs. The researchers noted that IVL was safe for the treatment of CNs, which is consistent with data from the Disrupt CAD trials. Given the inherent risks of percutaneous coronary intervention (PCI) in patients with CNs and more frequent comorbidities, the observed event rate in the CN group was not unexpected and remained lower than historical benchmarks.
Future Research Directions
While the study provides valuable insights into the long-term outcomes of IVL in treating calcified coronary lesions, the authors call for further research, including clinical trials specifically powered to focus on clinical outcomes after different plaque modification techniques are used. This will help refine treatment strategies and optimize outcomes for patients with complex coronary artery disease.
