Giuseppe Biondi Zoccai1,2, Roberto Carnevale3,4, Matteo Vitali5, Luigi Tritapepe6, Ombretta Martinelli7, Francesco Macrina8, Chris Bullen9, Mariangela Peruzzi3,4, Elena Cavarretta3,4, Antonino G Marullo3, Antonio Abbate10, Enrico Romagnoli11, Sebastiano Sciarretta3,12, Rebecca Casati13, Giuseppe Visconti14, Francesco Versaci13, Giacomo Frati3,12. 1. Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University, Latina, Italy - giuseppe.biondizoccai@uniroma1.it. 2. Mediterranea Cardiocentro, Naples, Italy - giuseppe.biondizoccai@uniroma1.it. 3. Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University, Latina, Italy. 4. Mediterranea Cardiocentro, Naples, Italy. 5. Department of Public Health and Infectious Diseases, Sapienza University, Rome, Italy. 6. Unit of Anesthesiology and Intensive Care, San Camillo-Forlanini Hospital, Rome, Italy. 7. Department of Vascular Surgery, Sapienza University, Rome, Italy. 8. Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, Sapienza University, Rome, Italy. 9. School of Population Health, National Institute for Health Innovation, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand. 10. Pauley Heart Center, Wright Center for Clinical and Translation Research, Virginia Commonwealth University, Richmond, VA, USA. 11. IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy. 12. IRCCS Neuromed, Pozzilli, Naples, Italy. 13. UOC UTIC Emodinamica e Cardiologia, Santa Maria Goretti Hospital, Latina, Italy. 14. ASL Latina, Latina, Italy.
Abstract
BACKGROUND:Traditional combustible cigarette (TCC) smoking remains a major cause of preventable cardiovascular morbidity and mortality. Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) may be safer than TCC but may still have detrimental oxidative, platelet and vascular effects of particular importance to people with symptomatic coronary artery disease (CAD). METHODS: We aimed to compare the acute coronary, systemic and environmental effects of two leading MRP in 20 TCC smokers admitted for invasive coronary assessment of CAD and willing to quit or after prior failed quitting attempts. After confirmation at angiography of an intermediate coronary stenosis, coronary flow reserve (CFR) will be appraised. Patients will then be randomized 1:1 to use a single EVC or a single HNBC in the catheterization laboratory, followed by repeat CFR measurement. The primary endpoint will be the change in CFR before and after product use. Quantitative coronary angiography, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR) will also be measured. RESULTS: We expected to accrue results able to: 1) test whether MRP have in general 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. In addition, by directly informing participants of their individual results, they will be further empowered to quit TCC. CONCLUSIONS: The Sapienza University of Rome-Vascular Assessment of Proatherosclerotic Effects of Smoking (SUR-VAPES) 3 trial will provide important insights into the pathophysiologic cardiovascular impact of EVC and HNBC, also suitable to inform patients and individualize their smoking cessation strategy.
RCT Entities:
BACKGROUND: Traditional combustible cigarette (TCC) smoking remains a major cause of preventable cardiovascular morbidity and mortality. Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) may be safer than TCC but may still have detrimental oxidative, platelet and vascular effects of particular importance to people with symptomatic coronary artery disease (CAD). METHODS: We aimed to compare the acute coronary, systemic and environmental effects of two leading MRP in 20 TCC smokers admitted for invasive coronary assessment of CAD and willing to quit or after prior failed quitting attempts. After confirmation at angiography of an intermediate coronary stenosis, coronary flow reserve (CFR) will be appraised. Patients will then be randomized 1:1 to use a single EVC or a single HNBC in the catheterization laboratory, followed by repeat CFR measurement. The primary endpoint will be the change in CFR before and after product use. Quantitative coronary angiography, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR) will also be measured. RESULTS: We expected to accrue results able to: 1) test whether MRP have in general 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. In addition, by directly informing participants of their individual results, they will be further empowered to quit TCC. CONCLUSIONS: The Sapienza University of Rome-Vascular Assessment of Proatherosclerotic Effects of Smoking (SUR-VAPES) 3 trial will provide important insights into the pathophysiologic cardiovascular impact of EVC and HNBC, also suitable to inform patients and individualize their smoking cessation strategy.
Authors: Mariangela Peruzzi; Elena Cavarretta; Giacomo Frati; Roberto Carnevale; Fabio Miraldi; Giuseppe Biondi-Zoccai; Sebastiano Sciarretta; Francesco Versaci; Vittoria Cammalleri; Pasquale Avino; Carmela Protano; Matteo Vitali Journal: Int J Environ Res Public Health Date: 2020-08-19 Impact factor: 3.390