Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University, Latina, Italy -
Mediterranea Cardiocentro, Naples, Italy -
Minerva Cardioangiol. 2020 Dec;68(6):548-555. doi: 10.23736/S0026-4725.20.05181-6. Epub 2020 Jun 2.
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).
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.
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.
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.
传统可燃香烟（TCC）吸烟仍然是可预防心血管发病率和死亡率的主要原因。改良风险产品（MRP），如电子蒸气香烟（EVC）和加热不燃烧香烟（HNBC），可能比 TCC 更安全，但仍可能对有症状的冠心病（CAD）患者产生有害的氧化、血小板和血管作用。
我们旨在比较两种领先的 MRP 在 20 名 TCC 吸烟者中的急性冠状动脉、全身和环境影响，这些吸烟者因 CAD 的有创冠状动脉评估而入院并愿意戒烟或在先前戒烟尝试失败后入院。在血管造影确认中等冠状动脉狭窄后，将评估冠状动脉血流储备（CFR）。然后，患者将按 1:1 随机分配到导管实验室使用单一 EVC 或单一 HNBC，然后重复测量 CFR。主要终点将是产品使用前后 CFR 的变化。还将测量定量冠状动脉造影、分数流量储备（FFR）和瞬时无波比（iFR）。
我们预计能够得出以下结果：1）测试 MRP 总体上是否对 TCC 吸烟者的冠状动脉血管功能产生有害影响；2）测试 EVC 是否对冠状动脉功能产生不同于 HNBC 的影响；3）提供关于在有已确诊心血管疾病的 TCC 吸烟者中使用 MRP 的急性风险和安全性概况的辅助病理生理学和转化见解，包括冠状动脉、心脏、全身和环境影响之间的复杂相关性。此外，通过直接向参与者提供他们的个人结果，他们将进一步有能力戒烟。
罗马萨皮恩扎大学 - 动脉粥样硬化吸烟前体效应的血管评估（SUR-VAPES）3 试验将提供有关 EVC 和 HNBC 的病理生理学心血管影响的重要见解，也适合为患者提供信息并为他们的戒烟策略个性化。
