TECTONIC CAD and NODULE-SHOCK: IVL in Patients With Severely Calcified Lesions
Two separate studies presented at TCT 2026 and simultaneously published in JACC: Cardiovascular Interventions address the safety and effectiveness of intravascular lithotripsy (IVL) in patients with severely calcified lesions.
In the TECTONIC CAD trial, researchers evaluated IVL with the SonicForce Coronary IVL System and found it to be safe and effective in patients with severely calcified de novo coronary lesions.
A total of 335 patients at 40 centers in the U.S. were part of the study and assessed over a median follow-up period of 30 days. The primary safety endpoint was 30-day target lesion failure, and the primary effectiveness endpoint was procedural success. Additionally, a prespecified optical coherence tomography (OCT) substudy evaluated calcium modification and stent expansion.
At 30 days, target lesion failure was 0.3% and procedural success was 97%. Additionally, Eric Alexander Secemsky, MD, FACC, et al., noted that “OCT and IVUS demonstrated calcium modification and facilitated lumen and stent expansion, providing mechanistic support for the procedural findings.”
In the NODULE-SHOCK trial, Annapoorna Subhash Kini, MBBS, FACC, et al., evaluated phenotype-specific calcium modification in patients with and without severely calcified nodules (CNs) using a new-generation coronary IVL catheter.
Researchers divided 120 patients with severe calcification into two cohorts – those with CNs and those without. Patients in the CN cohort were assigned to either OCT-guided rotational atherectomy (RA) plus IVL or IVL alone, while those without CNs were assigned to maximum or operator-determined IVL.
Overall results found RA plus IVL increased final stent area at the CN site vs. IVL alone in patients with CN lesions. In patients with severe calcification but no CNs, maximum IVL pulses did not significantly increase final stent area at the maximum calcium arc compared with operator-determined pulses.
“These findings warrant validation in larger multicenter trials with clinical endpoints,” the authors said.
Explore more simultaneously published research through JACC Journals’ TCT 2026 Coverage, and visit ACC’s TCT Meeting Coverage for additional studies, clinical insights and news from the meeting.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Aortic Surgery, Interventions and Imaging
Keywords: Transcatheter Cardiovascular Therapeutics, TCT26, Atherectomy, Coronary, Calcium, Tomography, Optical Coherence, Lithotripsy, Phenotype, Catheters, Stents