Rotational Atherectomy, Lithotripsy, or Laser for Calcified Coronary Stenosis: One-Year Outcomes From the ROLLER COASTER-EPIC22 Trial
ABSTRACT
Background
The ROLLER COASTR-EPIC22 was the first randomized trial to directly compare rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL) for the treatment of patients with calcified coronary stenosis.
Aims
The aim of this study is to report and compare its 1-year clinical outcomes.
Methods
The ROLLER COASTR-EPIC22 trial randomized 171 patients with angiographic moderate to severe calcified coronary lesions to PCI with RA (n = 57), IVL (n = 57), or ELCA (n = 57). A pre-specified analysis of clinical events at one year from the index PCI was conducted. The clinical endpoints analyzed at one year were the rate of major adverse cardiovascular events (MACE), defined as the occurrence of cardiac death, target vessel myocardial infarction (TV-MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis. Furthermore, the rate of all-cause mortality, non-fatal TV-MI, TVR, TLR, and stent thrombosis were analyzed separately. Kaplan-Meier analysis was performed to assess time-to-event outcomes. The adjudication of clinical events was conducted in accordance with the intention-to-treat principle.
Results
The mean age was 70.9 ± 8.2 years and 77.2% of the patients were men. Clinical presentation was acute coronary syndrome in 35.7% of patients and severe angiographic calcification was observed in 82.5% of lesions by the independent core laboratory unaware to the treatment arm. All patients showed criteria of severe calcification, either angiographic or at optical coherence tomography (OCT). At OCT evaluation, mean calcium arc was 300.8° ± 78.9°, maximum calcium thickness 1.17 ± 0.24 mm, calcification length 30.9 ± 12.9 mm and 30.5% of patients presented calcium nodules. Baseline characteristics were well balanced between groups. At one year, there were no significant differences in MACE incidence among the three arms (RA 5.3%, IVL 5.3%, ELCA 3.5%; p = 0.88). Furthermore, there were no significant differences in all-cause death between groups (p = 0.22), with no events in the IVL group (RA 5.3%, IVL 0%, ELCA 5.3%). No significant differences were observed among the 3 arms in the terms of TV-MI (RA 1.7, IVL 1.7, ELCA 0%; p = 0.61), TVR (RA 3.5%, IVL 5.3%, ELCA 1.7%; p = 0.59), TLR (RA 1.7%, IVL 1.7%, ELCA 1.7%; p = 1.00), or stent thrombosis (RA 1.7%, IVL 0%, ELCA 1.7; p = 0.61).
Conclusions
This is the first randomized trial comparing RA, IVL, and ELCA for the treatment of patients with calcified coronary lesions and reporting long-term clinical outcomes. At one year, no significant differences were observed among the three arms in the composite endpoint of one-year all-cause mortality, AMI, TVR, TLR and stent thrombosis. Similarly, no significant differences were found when analyzing the individual components of the endpoint separately.
Conflicts of Interest
Dr. Jurado-Román is a proctor for Abbott, Boston Scientific, World Medica, and Philips; has received consulting fees from Boston Scientific and Philips; and has received speaker fees from Abbott, Boston Scientific, Shockwave Medical, Philips, and World Medica. Dr. Ojeda has received consulting fees from Medtronic and Edwards Lifesciences; and has received speaker fees from Abbott, Boston Scientific, Philips, and World Medical. The other authors declare no conflicts of interest
Open Research
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
