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The Ordering Forum in the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway, Bestillerforum RHF, has commissioned the Norwegian Institute of Public Health to conduct a health technology assessment (HTA) on intracoronary lithotripsy for the treatment of patients with coronary artery disease.
We conducted a HTA according to the protocol. Our systematic search identified 699 references. We did not identify relevant studies matching our inclusion criteria covering our research question about effect and safety of intracoronary lithotripsy for the treatment of patients with coronary artery disease.
We are missing good documentation about the safety and effect of coronary lithotripsy for patients with coronary artery disease.
Coronary artery disease remains one of the most common cardiovascular diseases. The underlying process is arteriosclerosis, leading to thickening, hardening, and loss of elasticity of the artery walls. In the coronary arteries, the process leads to a gradual restriction of blood flow to the heart. Causes are multifactorial, including smoking, poor diet, hypertension, diabetes, hypercholesterolemia and genetic factors. Preventive measures, lifestyle changes and medical therapy reduce morbidity and mortality. In severe cases, invasive intervention may become necessary to deal with pronounced symptoms. Minimally invasive procedures such as percutaneous coronary intervention have become standard approaches for diagnosis and treatment. Advancements of minimal invasive tools provide potential improvements to procedural outcomes. Intracoronary lithotripsy has clinically won over practitioners, and is already utilised by some interventional cardiologist in Norway. A systematic review by Khan et al. 2019 identified, and reviewed the few existing publications looking at usage of lithotripsy in coronary and peripheral arteries up until juli 2018. Khan et al. included all types of study designs, including studies without control groups and did not limit themselves to only coronary arteries.
The objective of this systematic review is to compare the effect and safety of intracoronary lithotripsy for the treatment of coronary artery disease with other conventional treatment options, such as balloon angioplasty, stent implantation, rotational- or laser atherectomy.
We conducted a systematic literature search 20.03.2020 in the following databases: Medline, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and for planned and ongoing trials in clinicaltrials.gov and WHO ICTRP. We did not limit our search by language. Two persons independently read titles and abstracts to identify possibly relevant articles. We evaluated the relevance of selected publications based on our inclusion criteria.
Of the 699 identified references, we (two persons independently) assessed all titles and abstracts against the inclusion criteria and considered two as possibly relevant. We read these studies in full text. None of them met the inclusion criteria. Reasons for exclusion were not matching study design (n =2).
We did not identify any studies that compared intracoronary lithotripsy for the treatment of coronary artery disease with other conventional treatment options.
The systematic review by Khan et al. 2019, was the foundation for this updated systematic review, they reviewed publications up until July 2018 for all types of calcifications treated with lithotripsy including all anatomical localisations. Khan et al. concluded that, further research studies, with more rigorous study designs are needed to determine the effectiveness of lithoplasty in vascular calcification. Our updated systematic review did not identify other or newer studies, confirming a persistent absence of evidence.
There is an absence of published research evidence for intracoronary lithotripsy for patients with coronary artery disease. Therefore, we do not know if intracoronary lithotripsy is more effective than other conventional treatment options. Usage of intracoronary lithotripsy within the framework of a randomised controlled trial would be able to provide needed valuable insight into safety and effect.