More than six percent of patient who underwent successful PCI with drug-eluting stents had post-discharge bleeding within two years, according to a prospective study. A multivariable analysis found post-discharge bleeding was the strongest predictor of two-year mortality.

Post-discharge bleeding was associated with higher rates of all-cause mortality, while the effect size of post-discharge bleeding on two-year mortality was higher than that of post-discharge MI.

The two-year all-cause mortality rates were 13.0 percent in patients with post-discharge bleeding and 3.2 percent in patients who did not bleed. The cardiac mortality rates were 5.1 percent and 1.9 percent, respectively.

Lead researcher Philippe Généreux, MD, of Columbia University Medical Center in New York, and colleagues published their results in the Journal of the American College of Cardiology on Aug. 24.

They analyzed data on 8,582 patients who were prospectively enrolled at 11 hospitals in the U.S. and Europe. All patients were successfully treated with at least one drug-eluting stent and received dual antiplatelet therapy consisting of aspirin and clopidogrel. Patients were excluded if they had major complications during the procedure or before platelet function testing or if they planned on having bypass surgery following their PCI.

Previous research found dual antiplatelet therapy was effective at preventing stent-related and non-stent-related adverse ischemic events, although it was also associated with periprocedural bleeding. Gregg W. Stone, MD, a study author from Columbia, said some studies showed an increase in mortality with the long-term use of dual antiplatelet therapy.

Current guidelines in the U.S. recommend the use of dual antiplatelet therapy for at least a year following PCI. However, Stone said the guidelines could soon change based on recent studies that found an increased risk of bleeding with dual antiplatelet therapy.

“Right now there’s a tremendous debate going on as to the appropriate duration of dual antiplatelet therapy after drug-eluting stents,” Stone told Cardiovascular Business.

Whereas most trials examined the role of dual antiplatelet therapy in periprocedural bleeding, the researchers evaluated their role in post-discharge events, including bleeding and MI.

After a median follow-up of 729 days, 6.2 percent had post-discharge bleeding, which was more common than post-discharge MI. The magnitude of the effect of post-discharge bleeding on mortality was 2.6 times greater than the effect of post-discharge MI on mortality.

“Preventing post-discharge bleeding is essential,” Stone said. “This may also explain why using prolonged dual antiplatelet therapy in an unrestricted patient population after [PCI with a drug-eluting stent] may increase mortality.”

Gastrointestinal bleeding occurred in 61.7 percent of patients who had a bleeding event, while peripheral bleeding (12.2 percent), genitourinary bleeding (8.6 percent), central nervous system (7.4 percent), access site (7.0 percent) and retroperitoneal (3.2 percent) bleeding also occurred in multiple patients.

Of the bleeding events, 10.5 percent occurred within 30 days, 48.2 percent occurred from 30 days to one year and 41.3 percent occurred after at least one year. The median time to the first bleeding event was 300 days.

Patients who had post-discharge bleeding within two years were more likely to be female and have hypertension, hyperlipidemia, peripheral arterial disease, congestive heart failure, previous MI, previous coronary revascularization and lower levels of baseline hemoglobin and creatinine clearance.