European Registry On Plaque ModifiCAtion in the STEMI Population (ROCA-STEMI)

The ROCA-STEMI study is an European prospective cohort study from February 2023 until February 2024. The investigators want to analyze the clinical success, efficacy and safety of consecutive patients who presented with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) for de novo heavily calcified culprit lesion using plaque modification devices before stent implantation.

Clinical and angiographic endpoints will be defined according to the recommendations of the Academic Research Consortium. Academic Research Consortium represents a step toward standardization, facilitating the evaluation of the safety and effectiveness of devices.

Bleeding as a safety endpoint will be defined according to the Bleeding Academic Research Consortium. Major bleeding will be defined as Bleeding Academic Research Consortium types 3 and 5.

Severe coronary calcified lesion: Imaging evidence of severe calcium at the culprit lesion site was based on the angiographic presence of radio-opacities noted without cardiac motion before contrast injection involving both sides of the arterial wall in at least 1 location, or presence of ≥270° of calcium at 1 cross-section through IVUS.

Major adverse cardiovascular events (MACE): will be defined as the composite of cardiac death; MI; stroke, and revascularization, including percutaneous coronary intervention, and coronary artery bypass graft. Deaths will be regarded to be attributable to a cardiac cause unless a non-cardiac death could be confirmed.