Is IVL safe for patients with diabetes?
![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_)
Intravascular lithotripsy (IVL) is a viable treatment option for patients with diabetes undergoing percutaneous coronary intervention (PCI), according to new findings published in The American Journal of Cardiology.[1]
“While IVL has demonstrated favorable procedural and clinical outcomes in general populations with calcified lesions, its performance in patients with diabetes mellitus remains insufficiently characterized,” wrote senior author Jose M. Montero-Cabezas, MD, PhD, a cardiologist with Leiden University Medical Center in The Netherlands, and colleagues. “Given the unique anatomical and pathophysiological features of coronary artery disease in diabetic patients, such as medial calcification, longer lesion length, and more frequent multivessel disease, there is a clear need to specifically evaluate the efficacy and safety of IVL in this higher-risk population.”
Montero-Cabezas et al. tracked data from nearly 600 patients who underwent PCI with IVL from May 2019 to September 2024. All data came from the BENELUX-IVL registry, an international database open to all IVL patients. Patients with missing data were excluded.
In total, 33.6% of patients had a confirmed diagnosis of diabetes. Type 2 diabetes was much more common among these patients than type 1 diabetes. Mean patient ages were 73 years old for diabetic patients and 72.8 years old for non-diabetic patients.
The group noted that procedural success was seen in 87% of diabetic patients and 89.5% of non-diabetic patients. Device success, meanwhile, was seen in 95.3% of diabetic patients and 97.9% of non-diabetic patients.
After 30 days, the major adverse cardiovascular event (MACE) rates were 3.1% for diabetic patients and 0.3% for non-diabetic patients. Adverse events among diabetic patients included four myocardial infarctions and one case each of target vessel revascularization and stent thrombosis. A single myocardial infarction was the only adverse event for non-diabetic patients.
After one year and then two years, however, there was no statistically significant difference between the MACE rates of diabetic and non-diabetic patients.
“The comparable MACE rates at one and two years follow-up suggest that IVL-assisted PCI provides durable clinical outcomes in patients with diabetes,” the authors wrote. “However, the significantly higher rate of 30-day MACE among diabetic patients highlights a vulnerable early post-procedural period. This finding aligns with previous data indicating that diabetes is associated with impaired endothelial recovery, pro-inflammatory states and microvascular dysfunction, all of which may contribute to early adverse events following PCI.”
Montero-Cabezas and colleagues also found that adverse events were more common among patients with type 1 diabetes than those with type 2 diabetes.
“Although limited by sample size, these findings suggest that type 1 diabetes may represent a particularly high-risk subgroup warranting intensified follow-up and individualized procedural strategies,” they wrote.
This research was funded by Shockwave Medical, a Johnson & Johnson MedTech company. Shockwave Medical is a pioneer in the IVL space, developing the technology and helping it gain acceptance as a go-to treatment strategy for patients undergoing PCI.
Click here to read the full study.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.