Key result
Rotational atherectomy plus IVL increases minimum stent area ~1.2 mm² vs IVL alone in calcified nodules.
Why the study?
Optimal lesion preparation for coronary calcified nodules and intravascular lithotripsy pulse delivery for severe calcification remain uncertain.
Does rotational atherectomy plus intravascular lithotripsy (IVL) compared to IVL alone in coronary calcified nodules, and maximum IVL pulses compared to operator-determined IVL pulses in severe calcification without calcified nodules, increase minimum stent area?
RCT (n=120)
1:1 within Cohort A (CNs) and 1:1 within Cohort B (severe calcification without CNs)
No
Does rotational atherectomy plus intravascular lithotripsy (IVL) compared to IVL alone in coronary calcified nodules, and maximum IVL pulses compared to operator-determined IVL pulses in severe calcification without calcified nodules, increase minimum stent area?
Combining rotational atherectomy with intravascular lithotripsy achieves superior stent expansion compared with intravascular lithotripsy alone in coronary calcified nodules, whereas Routine maximum IVL pulse delivery offers no stent expansion benefit over operator-guided pulsing in non-nodular severe calcification.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Combining these complementary technologies resulted in larger and more uniformly expanded stents. This supports taking a more personalized approach for these complex cases, based on the type of calcium, rather than treating all calcified lesions the same way.”
Supports RA plus IVL for larger stent areas in calcified nodules; extends lesion-preparation strategies in complex PCI.
Background Optimal lesion preparation for coronary calcified nodules (CNs) and intravascular lithotripsy (IVL) pulse delivery for severe calcification remain uncertain. Objectives This study sought to evaluate phenotype-specific calcium modification in severe calcification with and without CNs. Methods In this single-center randomized trial using a new-generation coronary IVL catheter, patients with optical coherence tomography-defined CNs (Cohort A) were assigned 1:1 to rotational atherectomy (RA) plus IVL or IVL alone; patients with severe calcification without CNs (Cohort B) were assigned 1:1 to maximum or operator-determined IVL pulses. Primary endpoints were minimum stent area (MSA) at the CN site in Cohort A and at the maximum calcium arc site in Cohort B. Results Among 120 patients, 66 (55%) were in Cohort A (33 per group) and 54 (45%) in Cohort B (27 per group). MSA at the CN site was 7.41 ± 2.12 mm² with RA plus IVL vs 6.23 ± 1.55 mm² with IVL alone (mean difference: 1.18 mm²; 95% CI: 0.27-2.09; *P* = 0.012). In Cohort B, MSA at the maximum calcium arc site was 5.50 ± 1.19 mm² with maximum IVL pulses vs 5.56 ± 1.45 mm² with operator-determined IVL pulses (mean difference: −0.06 mm²; 95% CI: −0.78 to 0.67; *P* = 0.873). Conclusions RA plus IVL increased final stent area vs IVL alone in CN lesions, whereas maximum IVL pulses did not significantly increase final stent area compared with operator-determined pulses in severe calcification without CNs. These findings warrant validation in larger multicenter trials with clinical endpoints. (Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs Intravascular Lithotripsy Alone: A Prospective, Randomized Trial [NODULE-SHOCK]; ClinicalTrials.gov: NCT07000045)
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Kini et al. (2026) conducted an RCT in Severe coronary calcification with (Cohort A) and without (Cohort B) calcified nodules (CNs) (n=120). Rotational atherectomy (RA) plus intravascular lithotripsy (IVL) in Cohort A; Maximum IVL pulses in Cohort B vs. IVL alone in Cohort A; Operator-determined IVL pulses in Cohort B was evaluated on Minimum stent area (MSA) at the calcified nodule (CN) site in Cohort A (and MSA at the maximum calcium arc site in Cohort B) (MD 1.18, 95% CI 0.27-2.09, p=0.012). Rotational atherectomy plus IVL significantly increased minimum stent area vs IVL alone in coronary calcified nodules (7.41 vs 6.23 mm²; MD 1.18 mm²; 95% CI 0.27-2.09; P=0.012).
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