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Letters to the Editor |
Would a randomized controlled trial testing the effects of statins on patients undergoing cardiothoracic surgery be ethical?
a Department of Clinical Biochemistry (Vascular Disease Prevention Clinics), Royal Free Hospital, London, UK
b Department of Vascular Surgery, Red Cross Hospital, Athens, Greece
Received 22 January 2008; accepted 25 January 2008.
* Corresponding author. Address: Department of Clinical Biochemistry (Vascular Disease Prevention Clinics), Royal Free Hospital, Pond Street, London NW3 2QG, UK. Tel.: +44 20 7830 2258; fax: +44 20 7830 2235. (Email: paraskevask{at}hotmail.com).
Key Words: Statins • Cardiothoracic surgery • Perioperative mortality
Unfortunately, the comments by Dr Hudorovic [1] are inaccurate and incorrect. Dr Hudorovic states that ‘there are a number of recent studies, unfortunately the author cited only one, that suggest statin therapy may reduce the risk of perioperative complications [2–4]’. This statement is not true; of the ‘recent studies’ he mentions [2–4], two [2,3] are actually cited in my article [5]; one is reference number 183 [2] and the other is reference number 17 [3]. The third ‘recent’ reference he mentions [4], is not so ‘recent’ (5 years old); instead of this, two more recent, comprehensive reviews by the same group are cited (references 20 and 21).
Regarding the part when Dr Hudorovic mentions that ‘unfortunately, the author cited only one (study)’, it may be of interest that the ‘study’ cited, is actually an extensive review we published on the effects of statin therapy on perioperative (and long-term) morbidity and mortality rates in patients undergoing non-cardiac vascular surgery (reference number 184). Two of the ‘recent’ studies mentioned by Dr Hudorovic [2,3] are also cited in this review; the third [4] could not be cited, as it was published 6 months after our article.
The next comment by Dr Hudorovic is also incorrect (‘statin therapy is a preventive measure of subclinical atherosclerosis, but in the same time it is not a predictive factor of postoperative cardiovascular events.’). For example, in reference number 181 of my article [5], statin use was associated with a 2.5-fold reduction in the risk of all-cause mortality and a more than three-fold reduction in the risk of long-term cardiovascular mortality in 510 patients undergoing abdominal aortic aneurysm repair after a median follow-up of 4.7 (range: 2.7–7.3) years.
Dr Hudorovic claims ‘no definitive evidence has been proved and this conclusion needs to be confirmed by a multicenter, prospective randomized trial’; this statement is correct. However, due to the uniform positive results of observational studies, there may now be ethical restrictions when designing double-blind placebo-controlled trials to assess the effects of statins on patients undergoing cardiothoracic surgery. It may also be difficult for an ethical committee to approve of such a randomized controlled trial due to the reported benefits of statin therapy [2–5]. In light of the current evidence [2–5], would Dr Hudorovic prefer his patients to quit taking their statin preoperatively? I doubt any surgeon would!
References
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