Shockwave Medical’s IVL technology still safe, effective in patients with calcified nodules
![The use of intravascular lithotripsy (IVL) during percutaneous coronary intervention (PCI) is still safe and effective when patients present with calcified nodules (CNs), according to new long-term data published in EuroIntervention.[1] Researchers compared outcomes from patients with and without CNs, highlighting key similarities in stent expansion and luminal gain.](/sites/default/files/styles/top_stories/public/2024-12/screenshot_2024-12-02_at_11.07.21_am.png.webp?itok=YDi6SyF_)
The use of intravascular lithotripsy (IVL) during percutaneous coronary intervention (PCI) is still safe and effective when patients present with calcified nodules (CNs), according to new long-term data published in EuroIntervention.[1] Researchers compared outcomes from patients with and without CNs, highlighting key similarities in stent expansion and luminal gain.
Shockwave Medical’s IVL technology was the focus of this new analysis. Shockwave Medical, now a part of Johnson & Johnson MedTech, first started developing IVL back in 2009. The technology breaks up severely calcified plaques in the coronary and peripheral arteries using powerful ultrasonic pulses, clearing the way for cardiologists before PCI. After gaining U.S. Food and Drug Administration approval in 2021, IVL has consistently been linked to positive real-world outcomes.
For this specific study, researchers aimed to understand how CNs impact the safety and effectiveness of IVL. They explored data from 155 patients treated with Shockwave Medical’s IVL technology from January 2019 to April 2020. All patients were previously included in a Disrupt CAD clinical trial.
Overall, 18.7% of patients presented with a CN. The mean patient age was slightly younger for patients with a CN (71.9 years old) than those without a CN (73.4 years old). A majority of both groups were men. The CN rate was notably higher among patients with renal insufficiency, and they were most commonly found in the right coronary artery. The authors also noted that there was more predilatation when patients presented with a CN, but the use of IVL after dilatation and the number of stents used during treatment were similar for both groups.
IVL was confirmed to be safe when treating patients with and without CNs. After two years, the median minimal stent area was identical—5.7 mm2—for lesions with and without CNs. Median minimal stent expansion was 79.3% for lesions with CNs and 80.2% for lesions without CNs.
“The present study confirms that IVL is mechanistically effective as a frontline preparation tool for the treatment of severe coronary artery calcification with CNs,” wrote first author Ziad A. Ali, MD, DPhil, an interventional cardiologist with St. Francis Hospital in Roslyn, New York, and the Cardiovascular Research Foundation, and colleagues. “The IVL catheter crossed the lesion, delivered therapy and facilitated stent delivery in all cases, resulting in acceptable stent areas and expansion. Despite the greater burden of calcium in CNs, we found no differences in residual area stenosis, stent area, stent expansion, or acute gain comparing CN and non-CN lesions at the sites of pre-IVL minimal lumen area, maximum calcium arc site or final minimal stent area. Furthermore, the post-PCI stent area and expansion at the site of the CNs were in an acceptable range.”
Meanwhile, target lesion failure—a composite outcome including cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization—was seen in 13.9% of patients with a CN and 8% of patients without a CN.
“To the best of our knowledge, the present study is the first to demonstrate durable long-term clinical outcomes after any advanced lesion preparation strategy in lesions with CNs,” the authors wrote. “Moreover, consistent with the pooled data from the Disrupt CAD trials, IVL was safe for the treatment of CNs. Considering the inherent risk of PCI for patients with CNs and more frequent comorbidities, it was not surprising that the event rate was numerically higher in the CN group than the non-CN group, but this difference did not reach statistical significance. Furthermore, the event rate in the CN group was lower than what has been reported in the past.”
Ali et al. did call for more research, including clinical trials specifically powered to focus on clinical outcomes after different plaque modification techniques are used.
Click here to read the team’s full analysis in EuroIntervention. This research was fully funded by Shockwave Medical, now a part of Johnson & Johnson MedTech.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.