IVL may be safer than atherectomy in patients with severely calcified lesions
![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) and atherectomy are both effective debulking techniques when patients with severely calcified coronary artery lesions present for percutaneous coronary intervention (PCI), according to new real-world data published in JACC: Cardiovascular Interventions.[1]
However, researchers noted, IVL was linked to improved safety outcomes following treatment.
New real-world data comparing IVL and atherectomy
“Among the available options, coronary atherectomy and IVL are currently widely adopted debulking strategies,” wrote first author Enrico Cerrato, MD, PhD, an interventional cardiologist with San Luigi Gonzaga University Hospital in Italy, and colleagues. “Observational studies and registries have consistently demonstrated favorable outcomes with drug-eluting stent implantation following rotational atherectomy or orbital atherectomy, even in patients with highly complex coronary anatomy and significant comorbidities. Conversely, IVL has primarily been assessed in single-arm, nonrandomized studies that have shown high device success rates and promising early angiographic and clinical outcomes. Although more recent all-comers registries have provided additional support, data on specific subsets as well as long-term efficacy of IVL remain limited.”
Cerrato et al. hoped to learn more with ROLLING STONE, a new analysis of more than 1,000 patients who underwent PCI for calcified coronary artery disease that required plaque modification. Patients were treated at one of 23 facilities in Italy from 2022 to 2023.
Overall, 544 patients with a mean age of 75 years old underwent IVL and 380 patients with a mean age of 76 years old underwent atherectomy. An additional 81 patients underwent a combination of IVL and atherectomy, but they were excluded from this analysis.
Devices used for these procedures included Shockwave Medical’s coronary IVL catheters, Boston Scientific’s Rotapro Rotational Atherectomy System and Abbott’s Diamondback 360 Coronary Orbital Atherectomy System.
The study’s primary efficacy endpoint—procedural success with no in-hospital major adverse cardiac event (MACE)—occurred in 85.4% of IVL patients and 86.3% of atherectomy patients. The MACE rate after 30 days, meanwhile, was 5.7% for IVL patients and 8.6% for atherectomy patients. This difference was driven primarily by the fact that IVL was associated with a lower cardiovascular mortality rate (1.7%) than atherectomy (3.9%).
After propensity score matching, the authors added, the MACE rate was still significantly lower for IVL (6.8%) than atherectomy (14.3%).
“When comparing IVL and atherectomy, our results demonstrate no significant differences in procedural success, confirming both as highly effective and, to some extent, interchangeable strategies for plaque modification,” the authors wrote. “However, a lower incidence of MACE at one month in the IVL group suggests a potential early advantage, which persisted over time and reached statistical significance at 12 months in favor of IVL.”
Cerrato and colleagues put a spotlight on their study’s “large and unique” cohort of real-world patients. They also pointed to certain limitations, including the fact that this was a nonrandomized study where clinicians selected the treatment option for each case.
Calling for more research comparing IVL and atherectomy
The group concluded by saying additional studies on this topic were still needed.
“Further real-world data are needed to determine the optimal treatment strategy for severe coronary artery calcifications across different patient subsets,” they wrote. “The generation of such evidence, along with the potential execution of randomized trials, may help refine the selection of the most appropriate device for each clinical scenario.”
Shockwave Medical, now a part of Johnson & Johnson MedTech, did fund this analysis, but was not involved in developing, conducting or analyzing it in any way.
Click here to read the full study in JACC: Cardiovascular Interventions.
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.