Incidence and outcome of gastrointestinal bleeding in patients receiving aspirin with or without clopidogrel over 10 years- An observational study

AIMS: To determine the long-term incidence and outcome of gastrointestinal (GI) bleeding in users of aspirin with (dual antiplatelet therapy, DAPT) or without clopidogrel. SETTINGS AND DESIGN: Prospective hospital based 12-year study. METHODS AND MATERIAL: There were 1047 patients on either aspirin 150 md/day alone (n = 574, 54.8%) or aspirin 75 md/day + clopidogrel 75 md/day (n = 473, 45.2%) were followed up for any incident GI bleed, rebleed and mortality. Those simultaneously using other drugs known to cause GI bleeding were excluded. Comorbidities, concomitant use of proton pump inhibitors and statins were noted. RESULTS: GI bleed occurred in 11.8% after 8,683 person years of follow up. 56 (45%) patients had lower GI source of bleed [colon 9 (7%), small gut 47 (38%)] and 68 (55%) had upper GI source [duodenum 39 (32.3%), stomach 28 (22.6%) and oesophagus 1 (0.1%)]. Whereas stomach and duodenum were the chief sites in the first year, small gut predominated in later years. The cumulative bleeding rate after 1, 5 and 10 years was 5%, 8% and 11%, respectively, higher in the DAPT group. Bleeding stopped spontaneously in 98% on drug withdrawal, and 7.3% patients rebled in the next 6.2 years. The overall mortality was 33.1% but only 1.6% was due to the bleed being significantly lower in the DAPT group. On multivariate analysis coronary interventions, diabetes mellitus, renal and multiorgan dysfunction were the significant predictors of GI bleed and mortality. CONCLUSIONS: Though the incidence and mortality are low, GI bleed increases with longer use of antiplatelet agents predominantly from the lower GI tract.