Calcified coronary lesions are associated with lower procedural success and higher complications with percutaneous coronary intervention.¹ Previous study data have shown improved procedural success with routine use of atherectomy in these patients without meaningful differences in clinical outcomes.²

The ECLIPSE (Orbital Atherectomy vs. Conventional Balloon Angioplasty in Severely Calcified Coronary Arteries Prior to DES Implantation) trial was a multicenter trial of 2,005 patients (mean age 69.9 years; 26% female) that compared orbital atherectomy with conventional balloon angioplasty prior to drug-eluting stent (DES) implantation for severely calcified lesions confirmed by core laboratory analysis.³ Cutting and scoring balloons were allowed, although intravascular lithotripsy was not used. There was no significant difference at 1 year in the primary outcome of in-stent minimal cross-sectional area (MSA) and target-vessel failure (TVF) between orbital atherectomy and balloon angioplasty (MSA: 7.67 vs. 7.42 mm² [p = 0.08]; TVF: 11.5% vs. 10% [p = 0.28]). Intraprocedural complications were similar, although 30-day all-cause and cardiac death were greater with orbital atherectomy (MSA: 1% vs. 0.3% [p = 0.05]; TVF: 0.8% vs. 0% [p = 0.005]), with two deaths related to the device and another two possibly related. Perforations and dissections were similar between groups, although transient slow flow occurred more often with orbital atherectomy (1.4% vs. 0.4% [p = 0.03]). Intravascular imaging was used in approximately 62% of the procedures (much higher than the national trend).⁴

Intravascular imaging offers a better assessment of lesion characterization for procedural guidance, optimal vessel preparation, and stent expansion than does angiography.⁵ Increased use of intravascular imaging likely contributed to the success seen in both arms. The ECLIPSE trial results highlight that severely calcified coronary lesions can be treated with conventional balloon angioplasty prior to DES implantation, albeit with meticulous planning and use of intravascular imaging to guide optimal lesion preparation and DES expansion. Orbital atherectomy should be used only in select patients after careful consideration.

References

1. Cialdella P, Sergi SC, Zimbardo G, et al. Calcified coronary lesions. Eur Heart J Suppl 2023;25:C68-C73.
2. Allali A, Richardt G, Toelg R, et al. High-speed rotational atherectomy versus modified balloons for plaque preparation of severely calcified coronary lesions: two-year outcomes of the randomised PREPARE-CALC trial. EuroIntervention 2023;18:e1365-e1367.
3. Généreux P, Kirtane AJ, Kandzari DE, et al. Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: design and rationale of the ECLIPSE trial. Am Heart J 2022;249:1-11.
4. Malik AO, Saxon JT, Spertus JA, et al. Hospital-level variability in use of intracoronary imaging for percutaneous coronary intervention in the United States. J Soc Cardiovasc Angiogr Interv 2023;2:[ePub ahead of print].
5. Sreenivasan J, Reddy RK, Jamil Y, et al. Intravascular imaging-guided versus angiography-guided percutaneous coronary intervention: a systematic review and meta-analysis of randomized trials. J Am Heart Assoc 2024;13:[ePub ahead of print].