Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression

Prior treatment

• Any acute cardiovascular event (i.e. ACS, MI, Stroke, TIA, Limb ischemia), unstable angina or revascularization within 30 days prior to screening
• Previous CABG
• Subjects have previously participated in this study, or in an interventional study (drug or medical device) within 30 days of screening (participation in observational studies/registries allowed)

Other illness

• Severe uncontrolled hypertension (at the discretion of investigator)
• Diabetes
• Subjects have known serious infection or chronic inflammatory systemic disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)
• Subjects have a known non-cardiovascular disease that is associated with poor prognosis (e.g. metastatic cancer)
• Patient with currently active cancer or history of cancer within the last 5 years
• Subjects have hypersensitivity or any other warnings listed in the local labeling for THS
• Subjects have hypersensitivity to imaging iodine contrast agents
• Subjects have any other clinical condition that would jeopardize the subject's safety while participating in this study, per Investigator's judgment

Lab values

• Preexisting heart failure with reduced ejection fraction (EF \<50%)
• GFR\<45 ml/min/1,73 m2

Other

• Planned coronary intervention (PCI, CABG) at screening
• Subjects with documented genetic familial hypercholesterolemia
• Subjects who could not participate for any reason other than medical (e.g., psychological and/or social reason) per Investigator's judgment
• Female subject is pregnant or breast-feeding, or planning to become pregnant during the study
• Subjects have a close affiliation with the investigational site: a close relative of the investigator, a person dependent on the investigational site (e.g. employee or student of the investigational site)
• Subjects are current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)

• Adults aged \>18 years and \<75 years
• Subjects with stable chronic coronary syndrome defined as the presence of at least one coronary artery stenosis \>=20% due to coronary plaque visible on coronary computed tomography angiography (CCTA), in an artery with a reference diameter \> 2.0mm
• History of smoking pack-years ≥10 (Pack-years will be calculated by taking the average number of cigarettes smoked per day divided by 20 and multiplied by the number of years smoked), based on self-reporting
• Current smokers with a minimum of self-reported current smoking pattern of \>10 cigarettes/day during the last 6 months prior to screening, smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL)
• Patients that have been advised to quit smoking and informed of a smoking risk and cessation programs (per local SOC) and who are still not willing to set a quit date within the next 30 days at screening
• Stable treatment for coronary atherosclerosis according to the guidelines
• Have understood the study and have signed informed consent