Intravascular lithotripsy ‘safely and effectively’ facilitates stent delivery for CAD patients

Coronary intravascular lithotripsy (IVL) can play a key role in the treatment of patients with severely calcified lesions prior to drug-eluting stent (DES) implantation, according to new findings presented Thursday, Oct. 15, at TCT Connect 2020.

The study, which was simultaneously published in the Journal of the American College of Cardiology, included data from nearly 400 patients with coronary artery disease (CAD) treated in the United States, United Kingdom, France and Germany.

All patients were undergoing percutaneous coronary intervention and had presented with “stable, unstable or silent ischemia” and severely calcified coronary artery lesions. Treatment occurred from Jan. 9, 2019, to March 27, 2020.  

Overall, 92.2% of patients went 30 days without a major adverse cardiovascular event (MACE). The primary effectiveness endpoint—DES delivery with a residual stenosis of less than 50% and no in-hospital MACE—was achieved in 92.4% of patients.

“IVL safely and effectively facilitates stent delivery and optimizes stent expansion in patients with severely calcified coronary lesions,” wrote lead author Jonathan M. Hill, MD, Christ Hospital Heart and Vascular Center in Cincinnati, Ohio, and colleagues. “Longer-term clinical follow-up (ongoing in this study through two years) is required to determine the durability of clinical benefit associated with IVL-optimized stent implantation.”

The team also noted that their research “provides new data that confirm and extend prior observations regarding the unique mechanism of action of IVL.”

“By emitting acoustic pressure waves in a circumferential, transmural fashion, IVL frequently produces circumferential calcium fractures in multiple planes and in this regard rarely results in uniplanar ‘troughs’ that can occur due to guidewire bias with atherectomy technologies,” they wrote. “Calcium fracture is the likely mechanism through which IVL enhances vessel compliance to facilitate optimal stent expansion as evidenced by increased fracture width following stent expansion.”

Shockwave Medical, the company behind the IVL system used in this analysis, provided funding. Some authors reported prior consulting or funding relationships with Shockwave Medical, and Hill owns stock in the company.  

All Journal of the American College of Cardiology studies related to TCT 2020 are available here.

Additional research related to IVL, published in Circulation: Cardiovascular Interventions back in September, can be read here.