Yazd Cardiovascular Research Center, Non-communicable Diseases Research Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Epidemiologist, Associated Professor, Afshar Research Development Center, Yazd, Iran.
Open Heart. 2024 Aug 25;11(2):e002772. doi: 10.1136/openhrt-2024-002772.
On the one hand, the primary coronary slow flow phenomenon (CSFP) can cause recurrence of chest pain, prompting medical examinations and further healthcare costs, while on the other hand, it can lead to myocardial infarction, ventricular arrhythmia and sudden cardiac death. Nevertheless, there is not any agreement on the optimal treatment for primary CSFP, so we decided to examine the effectiveness of sildenafil in this context.
This pilot study is a 12-week, triple-blind, randomised, placebo-controlled trial for receiving either 50 mg daily oral sildenafil or placebo. Twenty eligible patients aged 30-70 years from a tertiary hospital in Yazd were randomly allocated in a 1:1 ratio to two groups. The primary outcomes were the alterations in functional capacity (metabolic equivalents, METs), Duke treadmill score (DTS) and angina severity (Canadian Cardiovascular Society (CCS) class). The study protocol registration code is IRCT20220223054103N1.
The angina severity in the Sildenafil group improved, with all receivers achieving a state of being asymptomatic during regular physical activity (CCS I). Whereas just 40% of the recipients in the placebo group achieved the same level of improvement (p=0.011). Mean METs at baseline were 9.9 (SD: 3.1) and at week 12 were 13.1 (SD: 3.3) for sildenafil and 9.56 (SD: 2.1) and 9.63 (SD: 2.4) for placebo (difference favouring sildenafil with a median increase of 3.1 (IQR: 1.1 to 4.1, p=0.008)). Median DTS scores at baseline were 3 (IQR: 0 to 9) and at week 12 were 9.5 (IQR: 7.75 to 15) for sildenafil and 7 (IQR: -1.5 to 9.25) and 8 (IQR: 1.5 to 11.25) for placebo (difference favouring sildenafil with a median increase of 5.5 (IQR: 1 to 9.2, p=0.01)).
We suggest that a daily low dose of sildenafil could be a valuable therapeutic option for primary CSFP.
IRCT20220223054103N1.
一方面，原发性冠状动脉慢血流现象（CSFP）可导致胸痛复发，促使进行医学检查并增加医疗保健费用，另一方面，它可导致心肌梗死、室性心律失常和心源性猝死。然而，对于原发性 CSFP 的最佳治疗方法尚无共识，因此我们决定在这方面研究西地那非的疗效。
这是一项为期 12 周的、三盲、随机、安慰剂对照试验，纳入了来自亚兹德一家三级医院的 20 名年龄在 30-70 岁之间的合格患者，按 1:1 的比例随机分为两组，分别接受每日口服 50mg 西地那非或安慰剂治疗。主要结局为功能能力（代谢当量，METs）、杜克跑步机评分（DTS）和心绞痛严重程度（加拿大心血管学会（CCS）分级）的变化。研究方案注册号为 IRCT20220223054103N1。
西地那非组的心绞痛严重程度改善，所有患者在常规体力活动时均达到无症状状态（CCS I）。而安慰剂组仅有 40%的患者达到同样程度的改善（p=0.011）。西地那非组的平均 METs 在基线时为 9.9（SD：3.1），在第 12 周时为 13.1（SD：3.3），而安慰剂组为 9.56（SD：2.1）和 9.63（SD：2.4）（西地那非组优势为平均增加 3.1（IQR：1.1 至 4.1，p=0.008））。西地那非组的中位 DTS 评分在基线时为 3（IQR：0 至 9），在第 12 周时为 9.5（IQR：7.75 至 15），而安慰剂组为 7（IQR：-1.5 至 9.25）和 8（IQR：1.5 至 11.25）（西地那非组优势为中位增加 5.5（IQR：1 至 9.2，p=0.01））。
我们建议每日低剂量西地那非可能是原发性 CSFP 的一种有价值的治疗选择。
IRCT20220223054103N1。
