Photo by Sage Ross
ROME—A subanalysis of the PRODIGY study suggests a longer duration of dual antiplatelet therapy (DAPT) improves outcomes after percutaneous coronary intervention (PCI) for patients with peripheral arterial disease (PAD).
Receiving long-term DAPT after PCI reduced the risk of atherothrombotic events and death in patients with PAD, without increasing the risk of actionable bleeding episodes.
However, patients without PAD fared better with short-term DAPT.
These results were presented at ESC Congress 2016 (abstract 5154) and published in JAMA Cardiology.
Marco Valgimigli, MD, PhD, of Bern University Hospital in Bern, Switzerland, and his colleagues performed this analysis of PRODIGY data.
The study included patients from tertiary care hospitals who had stable coronary artery disease or acute coronary syndromes, with or without concomitant PAD, and were undergoing PCI.
There were 246 patients with PAD—118 who were randomized to receive DAPT for 24 months after PCI and 128 who were randomized to DAPT for 6 months or less.
There were 1724 patients without PAD—869 who were randomized to receive DAPT for 24 months after PCI and 855 who were randomized to DAPT for 6 months or less.
The patients with PAD were older and more frequently underwent multivessel intervention. They were also more likely to have hypertension, type 1 or 2 diabetes, previous myocardial infarction, previous coronary artery bypass grafting, non-ST-segment elevation myocardial infarction, and more complex coronary artery disease.
At 30 days, patients with PAD were more often taking diuretics, and patients without PAD were more often taking beta-blockers and statins.
Patients with PAD who were randomized to long-term DAPT were younger, had a higher body mass index, and less frequently underwent PCI of the left main coronary artery than PAD patients randomized to short-term DAPT.
Having PAD was associated with a higher risk of death and ischemic events, with a hazard ratio (HR) of 2.80 (95% CI, 2.05-3.83; P<0.001).
Results
The primary efficacy endpoint of this study was a composite of death, myocardial infarction, and cerebrovascular accidents.
Among patients with PAD, those who received long-term DAPT had a lower risk of this endpoint than those who received short-term DAPT—16.1% and 27.3%, respectively. The HR was 0.54 (95% CI, 0.31-0.95; P=0.03).
Among patients without PAD, there was no significant difference in the incidence of the primary endpoint according to DAPT duration. It occurred in 9.3% of patients who received long-term DAPT and 7.4% of patients who received short-term DAPT. The HR was 1.28 (95% CI, 0.92-1.77; P=0.15).
The key safety endpoint was a composite of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.
There was no significant difference in this endpoint according to DAPT duration for patients with PAD, but long-term DAPT was associated with a significant increase in this endpoint for patients without PAD.
Among patients with PAD, BARC type 2, 3, or 5 bleeding occurred in 5.2% of those receiving long-term DAPT and 6.9% of those receiving short-term DAPT. The HR was 0.77 (95% CI, 0.27-2.21; P=0.62).
Among patients without PAD, BARC type 2, 3, or 5 bleeding occurred in 8% of those receiving long-term DAPT and 3.1% of those receiving short-term DAPT. The HR was 2.61 (95% CI, 0.27-2.21; P<0.001).
The researchers said the apparent neutral effect of long-term DAPT on bleeding risk in PAD patients requires further evaluation in adequately powered studies, but this research suggests patients with PAD will benefit from prolonged DAPT after PCI.
