Rotational Atherectomy Plus Intravascular Lithotripsy Versus Intravascular Lithotripsy Alone for Coronary Calcified Nodules: The NODULE-SHOCK Trial
Authors' conclusion
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).
Study context
- Population
- Patients with optical coherence tomography-defined coronary calcified nodules (CNs) (Cohort A) and patients with severe calcification without CNs (Cohort B)33 per group in Cohort A, 27 per group in Cohort B · Cohort A 66 (55%) · Cohort B 54 (45%)
- Participants
- 120 patients
- Comparison
- Cohort A: Rotational atherectomy (RA) plus intravascular lithotripsy (IVL) vs IVL alone; Cohort B: maximum vs operator-determined IVL pulses
- RA plus IVL (Cohort A)n = 33
- IVL alone (Cohort A)n = 33
- Maximum IVL pulses (Cohort B)n = 27
- Operator-determined IVL pulses (Cohort B)n = 27
- Primary endpoint
- Minimum stent area (MSA) at the CN site in Cohort A and at the maximum calcium arc site in Cohort B
Methodological detailsusing a new-generation coronary IVL catheter, assigned 1:1, Prospective
- Using a new-generation coronary IVL catheter
- Assigned 1:1
- Prospective
Primary result
As reported in the abstract
RA plus IVL (Cohort A) vs IVL alone (Cohort A)
Maximum IVL pulses (Cohort B) vs Operator-determined IVL pulses (Cohort B)
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →