‘Nuisance’ Bleeding After AMI Common, Affects QoL
Nuisance bleeding occurs in more than one-third of patients in the year after acute myocardial infarction (AMI), according to a study scheduled to be published online March 26, 2013, ahead of print in the Journal of the American College of Cardiology. The complication, which is associated with ongoing use of dual antiplatelet therapy, adversely affects quality of life (QoL).
Richard G. Bach, MD, of Washington University School of Medicine (St. Louis, MO), and colleagues looked at data from 3,560 AMI patients enrolled in the multisite TRIUMPH registry between April 2005 and December 2008. Follow-up was performed at 1, 6, and 12 months after AMI to investigate the incidence and predictors of nuisance bleeding, defined as type 1 by the Bleeding Academic Research Consortium (BARC), and to document its impact on quality of life.
More Than a Nuisance
Within 1 year after AMI, roughly one-third of patients (37.5%) reported nuisance bleeding. Most nuisance bleeds occurred early, within 1 month (64.7%), but these events continued through 6 (25.3%) and 12 months (35.7%) of follow-up. The most common type reported was ‘bruising and bleeding’ (53.5% at 1 month; 20.4% at 6 months; and 30.9% at 12 months).
Multivariate analysis found that ongoing dual antiplatelet therapy was the strongest predictor of nuisance bleeding (RR 1.44 at 1 month, 1.89 at 6 months, and 1.39 at 12 months; P < 0.01 for all). The association remained even after adjustment for CRUSADE bleeding risk score, the GRACE mortality risk score, history of A-fib, warfarin use, and other covariates. Other variables independently associated with nuisance bleeding were female gender (RR 1.29; P < 0.0001) and history of A-fib (RR 1.35; P = 0.0002).
Patients who developed nuisance bleeding had more pain/discomfort (P = 0.103) and anxiety/depression (P = 0.005), and had overall lower QoL as assessed by EuroQOL-5D (EQ-5D) scores at 1, 6, or 12 months (P = 0.046, 0.068, 0.043, respectively). Multivariate analysis showed that nuisance bleeding within 1 month was associated with a reduction of 2.81 EQ-5D points at 1 month, regardless of baseline quality of life and other covariates.
Kaplan-Meier analyses estimated that patients with nuisance bleeding at 1 month were more likely to experience rehospitalization by 12 months (P = 0.024). However, after multivariable adjustment, this association was no longer significant (P = 0.13).
Nuisance bleeding within 30 days of discharge was not associated with severe TIMI major or minor bleeding during subsequent follow-up. However, patients with nuisance bleeding at 1 month were more likely to develop subsequent nuisance bleeding at 6 or 12 months (62.5%) than those without such bleeding at 1 month (38.25%; adjusted RR 1.61; 95% CI 1.39-1.86; P < 0.0001).
Implications for Patient Education
“Our findings suggest that these adverse patient experiences, which are largely ignored in clinical trials, may be important issues in clinical practice and warrant consideration at the time of AMI treatment,” Dr. Bach and colleagues write.
Since early nuisance bleeding makes future bleeding more likely, its recognition could alert clinicians to the need for closer monitoring of these patients, they note.
The study also provides information that can “have important implications for the design of future studies and comparative effectiveness trials of newer, more potent antiplatelet agents,” the authors suggest, adding that it “underscores the importance of educating patients to anticipate nuisance bleeding and to not use that as a reason to discontinue [dual antiplatelet therapy] without talking first with their physician.
In an editorial accompanying the story, Harold L. Dauerman, MD, of the University of Vermont (Burlington, VT), remarks that the frequency of nuisance bleeding found in TRIUMPH is “striking.”
The study “remind[s] us that the bleeding story is not yet fully elucidated,” he writes, noting that it “adds a new chapter to the bleeding story by connecting soft bleeding endpoints with a clinical impact that will not show up as mortality or transfusions.”
If future studies confirm that nuisance bleeding is clinically relevant, he adds, “then we could potentially individualize therapy decisions based not only on clinical trial data but via potent predictors of enhanced risk for this complication.”
1. Amin AP, Bachuwar A, Reid KJ, et al. Nuisance bleeding with prolonged dual antiplatelet therapy after acute myocardial infarction and its impact on health status. J Am Coll Cardiol. 2013;Epub ahead of print.
2. Dauerman HL. The softer side of bleeding. J Am Coll Cardiol. 2013;Epub ahead of print.
- Dr. Bach reports no relevant conflicts of interest.
- Dr. Dauerman reports serving as a consultant to Medtronic and The Medicines Company and receiving research grants from Abbott Vascular and Medtronic.