Intravascular Lithotripsy or Mechanical Debulking in Complex Calcified Coronary Arteries: Multicenter, Prospective...

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.