Use of IVL in Calcified Coronary Lesions in a Real World Population

The presence of calcification in coronary arteries (CAC) remains a challenge for the percutaneous treatment of these lesions. Several studies have established the link between CAC and poor long term results. Intravascular lithotripsy (IVL) has surged as a tool to induce calcified plaque fracture. Even though studies on this strategy are not randomized, they have shown high success rates for this device with good clinical and angiographic results.

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The aim of this prospective, multicenter study was to assess the safety and efficacy of IVL in calcified lesions in a real world cohort of consecutive patients.

The efficacy primary outcome was defined as procedural success, that is, successful PCI with residual stenosis <20%, with no in-hospital complications (cardiac death, acute myocardial infarction or need for target vessel revascularization (TVR)). The safety secondary end point was major adverse cardiac events (MACE), defined as death, acute MI, or TVR.

It included 426 patients (456 lesions), mean age 73, with a higher prevalence of men. The most common clinical presentation was acute coronary syndrome (ASC) in 63% of cases. Most patients presented good ventricular function (EF >50%), and the transradial approach was the most used (76%). The most affected coronary artery was the anterior descending (44%), followed by the right coronary (31%), the circumflex (12%) and the left main (11%).

As regards the safety end point, it was reached in 66% of patients, with similar rates between ACS patients (65%) and those with chronic coronary syndrome (CCS) (68%). In addition, there were no significant differences in angiographic success after IVL between these two groups of patients. As regards the safety end point, the 30-day MACE rate resulted 3%: 1% in CCS patients and 5% ACS patients (p=0.073).

Conclusion

The use of IVL was shown feasible and safe in a real world population, facilitating the effective stenting of severe calcified lesions. Even though ACS patients showed angiographically similar rates, they showed a trend towards higher 30-day MACE vs. CCS patients. More long term studies are required to assess the clinical benefits associate to this therapeutic tool.