Bleeding Common but Often Unreported in ACS Patients on Antiplatelet Therapy

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Approximately 1 in 7 patients with acute coronary sydromes (ACS) who take antiplatelet therapy following percutaneous coronary intervention (PCI) experience bleeding or severe bruising in the first 6 weeks, according to registry findings published online January 29, 2014, ahead of print in the Journal of the American College of Cardiology. While most of these cases appear to be nuisance bleeding not requiring rehospitalization, they often go unreported to treating clinicians or result in changes to therapy without the cardiologist’s involvement.

Researchers led by Tracy Y. Wang, MD, MSc, of Duke University Medical Center (Durham, NC), analyzed data on 9,177 MI patients treated with PCI and enrolled in the TRANSLATE-ACS (TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment patterns and Events after Acute Coronary Syndrome) registry. Patients were discharged on clopidogrel, prasugrel, or ticagrelor from 219 US hospitals between April 2010 and October 2012.

In all, 1,264 patients (14%) reported early bleeding/severe bruising, of whom 91 (7%) were rehospitalized for that complication. Fatal bleeding occurred in 1 patient. There was no CABG-related bleeding within the first 6 weeks post-discharge. Three percent of reported cases were BARC type 3 and 54% BARC type 2.

Female sex (P < 0.001) and white race (P = 0.03) were associated with higher rates of post-discharge bleeding, as were lower functional status (P < 0.001) or baseline depression (P = 0.002). Major bleeding during the index hospitalization, however, was not predictive (P = 0.19). On multivariable analysis, discharge on prasugrel or ticagrelor vs clopidogrel remained associated with higher bleeding risk (OR 1.63; 95% CI 1.41-1.87; P < 0.001).

Rates of MACE were generally low except in patients with severe bleeding. Compared with patients who did not have bleeding, those who experienced BARC 3 or higher bleeding had a greater risk of MACE (OR 3.28; 95% CI 1.27-8.47).

Nearly Half of Bleeding Not Reported

Overall, 7% of patients had stopped or interrupted antiplatelet therapy at 6 weeks. Those who reported bleeding were more likely than those who did not to permanently discontinue their therapy (4.5% vs 2.7%; P = 0.004). Notably, 28% of patients who discontinued therapy had recently received DES. Early discontinuation was more common among bleeding patients on clopidogrel than on second-generation antiplatelet drugs (5.8% vs 2.4%; P = 0.009). Patients with bleeding were also more likely to temporarily stop therapy than those without (2.6% vs 1.6%; P = 0.007).

Importantly, 43% of post-discharge bleeding events were never brought to clinical attention and 28% of changes to antiplatelet therapy in response to bleeding were made without cardiologist involvement. Patients who did not report bleeding to a clinician were less likely than those who did to have had a follow-up appointment made for them prior to discharge (66.3% vs 70.2%; P = 0.02).

According to Dr. Wang and colleagues, recognition of patients at higher risk for bleeding is important so that clinicians can ensure early clinical follow-up, which “may be a key first step in both raising subsequent bleeding events to clinical attention and avoiding premature [ADP receptor inhibitor] discontinuation.”

More Patient Education Needed

“One thing this may [reflect] is that as clinicians, when we see acute MI patients, we don’t get long periods of time to talk with them,” observed Neal S. Kleiman, MD, of Methodist DeBakey Heart and Vascular Center (Houston, TX), in a telephone interview with TCTMD. “Maybe we’re not picking up on some of these patients who are not going to be compliant or those who are at risk for stopping their clopidogrel for whatever reason.”

Dr. Kleiman said until data show otherwise, he counsels patients to continue antiplatelet therapy for a year.

“That being said, we’re waiting for data from DAPT that may show us we are overtreating,” he added, referencing the randomized trial currently comparing 12 months vs 18 more months (30 months total), of dual antiplatelet therapy after stent implantation. “But quite frankly, I think [this study] and others remind us that we should spend more time educating patients, especially about things like bruises that some might find upsetting. We need to let them know [these side effects] are not serious and are not a reason to stop taking their medication.”

However, Dr. Kleiman cautioned that while registries such as TRANSLATE-ACS are “very good for telling us what and how people do after PCI,” selection bias remains an issue, as does the low level of monitoring compared with a clinical trial.

 

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Source:
Wang TY, McCoy L, Henry TD, et al. Early post-discharge bleeding and antiplatelet therapy discontinuation among acute myocardial infarction patients treated with percutaneous coronary intervention. J Am Coll Cardiol. 2014;Epub ahead of print.

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