Diseño del estudio ROLLERCOASTR: aterectomía rotacional, litotricia o láser para el tratamiento de estenosis coronarias calcificadas
Alfonso Jurado-Román, Antonio Gómez-Menchero, Ignacio J. Amat-Santos, Juan Caballero-Borrego, Soledad Ojeda, Raymundo Ocaranza-Sánchez, Santiago Jiménez-Valero, Guillermo Galeote and Raúl Moreno.
Introduction and objectives: Coronary calcification is one of the leading factors that affect negatively the safety and effectiveness of percutaneous coronary intervention. Several calcium modification techniques exist. However, there is a lack of randomized evidence on the therapy of choice in this scenario.
Methods: The ROLLERCOASTR is a prospective, multicenter, randomized clinical trial designed to compare the safety and efficacy profile of 3 plaque modification techniques in the moderate-to-severe coronary calcification setting: rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL). The study primary endpoint is stent expansion evaluated by optical coherence tomography. An intention-to-treat analysis will be conducted with an alpha coefficient of 0.05 between the reference group (RA) and the remaining 2 groups (ELCA and IVL). An analysis of the study primary endpoint per protocol will be conducted for consistency purposes. If the non-inferiority hypothesis is confirmed, a superiority 2-sided analysis will be conducted. Both the clinical events committee and the independent core laboratory will be blinded to the treatment arm. Assuming an α error of 0.05, an β error of 0.2 (80% power), a margin of irrelevance (ε) of 7, and losses of 10% due to measurement difficulty or impossibility to complete the intervention, we estimate a sample size of 56 cases per group. The study secondary endpoints are device success, procedural success, crossover rate among the different techniques used, and the occurrence of major adverse cardiovascular events at 1-year follow-up.
Conclusions: The ROLLERCOASTR trial will evaluate and compare the safety and effectiveness of 3 plaque modification techniques: RA, ELCA, and IVL in patients with calcified coronary stenosis. This trial was registered at clinicaltrials.gov with identifier NCT04181268.