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Interact CardioVasc Thorac Surg 2007;6:519-522. doi:10.1510/icvts.2007.155788 © 2007 European Association of Cardio-Thoracic Surgery
Does enteric-coated aspirin result in a lower incidence of gastrointestinal complications compared to normal aspirin?
a Department of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, UK Received 9 March 2007; received in revised form 19 March 2007; accepted 20 March 2007
*Corresponding author. Tel.: +44 (0)7710272021.
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether enteric-coated aspirin results in a lower incidence of gastrointestinal complications compared to normal aspirin in CABG surgery. Using the reported search, 340 papers were identified. Nine papers represented the best evidence on the subject. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, weaknesses, results and study comments were tabulated. Five randomised controlled trials of healthy volunteers undergoing endoscopy after a period of either enteric-coated aspirin or plain aspirin administration all demonstrated a clear reduction of gastric mucosal injury. However, these trials on healthy volunteers taking short-term aspirin have not been supported by clinical studies in older age-group adults taking lower doses of aspirin for long periods. No clinical benefits in terms of reduction of gastrointestinal bleeding or ulceration with enteric coating have, therefore, been successfully demonstrated, although the endoscopic studies show that potentially these benefits could exist.
Key Words: Aspirin; Enteric coated tablets; Gastrointestinal complications; Coronary artery bypass grafts
A best evidence topic was constructed according to a structured protocol. This protocol is fully described in the ICVTS [1].
You have performed a coronary artery bypass graft on a 72-year-old recent ex-smoker with triple vessel disease and hypercholestrolaemia, who has done very well postoperatively. You usually prescribe dispersible aspirin on discharge, but this gentleman has taken enteric-coated aspirin for three years and he tells you that he got terrible indigestion with dispersible aspirin but that the enteric-coated aspirin tablets were no problem at all. You wonder if you should prescribe enteric-coated aspirin to all your patients if it is so ‘good to your stomach’ instead of your usual dispersible aspirin.
Medline 1950 to week 2 February 2007 using the OVID interface. [exp Aspirin/OR aspirin.mp] AND [exp tablets, enteric-coated/OR enteric coat$.mp]
Three hundred and forty papers were found in MEDLINE. Nine were deemed to be relevant. Two systematic reviews and a guideline that considered these papers were included. These are summarised in Table 1.
The evidence surrounding enteric-coated aspirin (ECA) falls into two clear categories. Some studies selected random volunteers, confirmed good gastric-health via endoscopy and administered ECA or ASA (acetylsalicylic acid) for a period of time before repeat endoscopy. A third category of studies looked retrospectively at patients with gastric complications. Cole et al. [2] performed endoscopy on 12 healthy volunteers after randomising to various preparations of aspirin. Eighteen gastric erosions were found in patients taking 300 mg of plain aspirin, two erosions in patients taking 75 mg of plain aspirin and no erosions in the enteric coating groups. Dammann and colleagues [3] performed endoscopy on 59 healthy volunteers in two study arms. In one arm the patients were randomised to plain aspirin (100 mg) and had a three-fold increase in mucosal lesions compared to patients having enteric-coated aspirin (100 mg) for seven days. Blondon et al. [4] performed endoscopy on 24 healthy volunteers eight days after 300 mg of enteric-coated aspirin, plain aspirin or placebo. There was a non-statistically significant improvement in gastrointestinal tolerance with enteric coating vs. plain aspirin. Hawthorne and coworkers [5] performed endoscopy on volunteers who were randomised to plain aspirin (300 mg), plain aspirin (300 mg) 4-times daily (qds), enteric-coated aspirin (300 mg), and enteric-coated aspirin (300 mg qds) for five days. The enteric coating resulted in substantially reduced gastric erosion scores and mucosal bleeding scores compared to plain aspirin. Petroski [6] performed endoscopy in 80 volunteers who received placebo, or 325 mg of plain aspirin, or buffered aspirin, or enteric-coated aspirin for three months. Enteric-coated aspirin produced significantly reduced gastric mucosal damage compared to aspirin and the score was identical to placebo. Strengths of these studies include the random design and the sensitivity and good reproducibility of endoscopy as an outcome measure. However, healthy volunteers taking aspirin for five days to three months, often in doses much higher than our own patients, are clearly very different to patients post-cardiac surgery. Also, no correlation with adverse clinical outcomes are shown by these studies. Of the studies considering adverse clinical outcomes, Kelly et al. [7] performed a case-control study, taking 550 patients admitted with GI bleed confirmed on endoscopy and comparing them to 1202 normal controls. They found a three-fold increase in the risk of GI bleed with all preparations of aspirin but no differences between the different types of preparation. This study was large but did not account for other possible causes of a GI bleed, long-term exposure to aspirin or concomitant use of non-steroid anti-inflammatory drugs (NSAIDS). De Abajo et al. [8] looked at a general practice database and identified cases of upper GI bleeds (n=2105) and compared this group to a control group (n=11,500). Two hundred and eighty-seven of these cases had been exposed to aspirin. No relative risk reduction was seen with enteric coating compared to plain aspirin, but the number of patients in both plain and the coated groups was small. Takada et al. [9] looked at prescription in patients with prescriptions for ASA or ECA. They found more H2-antagonist and proton pump inhibitor use in enteric-coated aspirin patients. However, it is impossible to interpret these results as there is no information on any patient demographics and the reasons for prescribing differences are unknown. Banoob et al. [10] carried out a systematic review in 2002. Possible faults were highlighted in previous studies, such as not accounting for influential factors in GI complications (i.e. tobacco use, chronic alcohol use and drug abuse). They concluded that ECA could offer a safer alternative to ASA but called for further research in this area. Of interest in the UK, the British National Formulary (www.bnf.org) lists the price of a 28-tablet pack of non-proprietary aspirin to be 87p and Caprin, a brand of enteric-coated aspirin to be £1.55.
Five randomised controlled trials of healthy volunteers undergoing endoscopy after a period of either enteric-coated aspirin or plain aspirin administration all demonstrated a clear reduction of gastric mucosal injury. However, these trials on healthy volunteers taking short-term aspirin have not been supported by clinical studies in older age-group adults taking lower doses of aspirin for long periods. No clinical benefits in terms of reduction of gastrointestinal bleeding or ulceration with enteric coating have, therefore, been successfully demonstrated, although the endoscopic studies show that potentially these benefits could exist.
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Abstract
1. Introduction