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Intravascular Lithotripsy or Mechanical Debulking in Complex Calcified Coronary Arteries: Multicenter, Prospective
Enrico Cerrato1, Marco Pavani1, Simone Zecchino1
1Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano and ASLTO3 Infermi Hospital, Rivoli, (Turin), Italy.
Insights
Intravascular lithotripsy (IVL) showed similar procedural success to atherectomy (AT) for severely calcified coronary arteries. IVL demonstrated a significantly lower rate of major adverse cardiac events at 30 days and 12 months in a real-world patient population.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Limited prospective data exist on contemporary coronary calcium debulking techniques.
- Real-world evidence is crucial for comparing intravascular lithotripsy (IVL) and atherectomy (AT) devices.
Purpose of the Study:
- To compare the safety and efficacy of IVL versus AT devices in an all-comer population with severely calcified coronary lesions.
- To evaluate procedural success and major adverse cardiac events (MACE) at 30 days and 12 months.
Main Methods:
- The ROLLING STONE Registry prospectively enrolled 1,005 patients across 23 Italian centers.
- Patients were treated with IVL and/or AT (rotational and orbital).
- Propensity score matching and inverse probability weighting were used to compare outcomes.
Main Results:
- Procedural success rates were similar between IVL and AT groups (85.4% vs 86.3%).
- The 30-day MACE rate was significantly lower with IVL (5.7% vs 8.6%, P=0.045), driven by reduced cardiovascular death.
- After propensity matching, the 12-month MACE rate was significantly lower in the IVL group (6.8% vs 14.3%, P=0.022).
Conclusions:
- IVL and AT are feasible, safe, and effective for treating severely calcified coronary lesions in an unselected population.
- IVL demonstrated comparable procedural success to AT.
- IVL showed a superior 12-month safety profile compared to AT in this cohort.
Background:
Prospective data on the contemporary use of different coronary calcium debulking techniques are lacking.
Objectives:
The authors compared intravascular lithotripsy (IVL) vs atherectomy (AT) devices (rotational and orbital atherectomy) in a real-world all-comer population.
Methods:
The ROLLING STONE Registry prospectively enrolled patients treated with IVL and/or AT across 23 Italian centers. Primary efficacy endpoint was procedural success (residual stenosis <30% and absence of in-hospital major adverse cardiac events (MACE) (cardiac death, myocardial infarction, target vessel revascularization). Primary safety endpoint was freedom from MACE at 30 days, whereas the secondary endpoint was MACE at 12 months. Propensity score matching and inverse probability weighting were applied to compare 30-day and 12-month safety endpoints.
Results:
A total of 1,005 patients were enrolled, including 544 (59%) in the IVL group vs 380 (41%) in the AT group, excluding 81 patients treated with both. Primary efficacy endpoint was similar between groups (85.4% in IVL vs 86.3% in AT; relative risk: 1.01; 95% CI: 0.88-1.17). MACE rate at 30 days was significantly lower in the IVL group (5.7% vs 8.6%; HR: 0.60; 95% CI: 0.36-0.99; P = 0.045), driven primarily by lower rate of cardiovascular death (1.7% vs 3.9%; HR: 0.40; 95% CI: 0.18-0.92; P = 0.030). After propensity score matching (n = 320) and inverse probability weighting (n = 532), the MACE rate at 12 months was significantly lower in the IVL group (6.8% vs 14.3%; HR: 0.43; 95% CI: 0.21-0.89; P = 0.022).
Conclusions:
The study confirms the feasibility, safety, and efficacy of IVL and AT in an unselected population, with similar procedural success rates. After propensity matching, IVL seems to demonstrate in our cohort a better 12-month safety outcome. (Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions [ROLLING-STONE]; NCT05016726).
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