A randomized trial comparing the acute coronary, systemic, and environmental effects of electronic vaping cigarettes versus heat-not-burn cigarettes in traditional combustion cigarette smokers undergoing invasive coronary assessment: The SUR-VAPES 4...
Componente | Categoria |
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Giuseppe Biondi Zoccai | Componenti strutturati del gruppo di ricerca |
Andrea Morelli | Componenti strutturati del gruppo di ricerca |
Daniele Vecchio | Dottorando/Assegnista/Specializzando componente non strutturato del gruppo di ricerca |
Traditional combustion cigarette (TCC) smoking remains a major cause of preventable morbidity and mortality worldwide. Modified risk products (MRP) such as electronic vaping cigarettes (EVC) improve smoking cessation rates in apparently healthy TCC smokers. However, EVC and their novel alternative, heat-not-burn cigarettes (HNBC), have detrimental oxidative, platelet and vascular effects. Yet, there are no data on the effects of EVC or HNBC in smokers with established cardiovascular disease. We aim to compare the acute coronary, systemic and environmental effects of two leading MRP in TCC smokers undergoing invasive coronary assessment. We will enroll 20 TCC smokers admitted for coronary artery disease (CAD), excluding emergency cases. After demonstration at invasive angiography of a coronary stenosis of intermediate severity, coronary flow reserve (CFR) will be appraised. Then, patients will be randomized 1:1 to smoke a 1 EVC versus 1 HNBC in the catheterization laboratory, and CFR will be measured again after smoking. The primary endpoint will be the change in CFR before and after smoking. Quantitative coronary angiography, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR) will also be measured. In addition, peripheral artery, peripheral vein, and coronary sinus blood draws will be collected to measure markers of oxidative stress, anti-oxidant reserve, inflammation, and platelet function. Finally, heart rate, blood pressure,
pulse wave velocity and environmental pollution will be measured. This study will thus be able to: 1) test whether MRP have a detrimental impact on coronary vascular function in TCC smokers; 2) test whether EVC have a different impact than HNBC on coronary function; 3) provide ancillary pathophysiologic and translational insights on the acute risk and safety profile of MRP in TCC smokers with established cardiovascular disease, including complex correlations between coronary, cardiac, systemic and environmental effects.