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Neoplasm Detection and Dual Antiplatelet Therapy
Study Questions:
What are the frequency of and factors associated with new nonbenign neoplasm events among acute coronary syndrome (ACS) patients treated with dual antiplatelet therapy (DAPT), what is the effect of these events on the occurrence and timing of cardiovascular and bleeding endpoints, and what are treatment-related differences in the detection of subsequent progression of new nonbenign neoplasms?
Methods:
This was a secondary analysis of the TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) trial, in which 9,326 participants with ACS received aspirin plus clopidogrel or prasugrel. The primary outcome was detection of new nonbenign neoplasm. Factors associated with neoplasm events, the relationship of these events to cardiovascular and bleeding endpoints, and treatment-related differences in neoplasm detection were studied. History of neoplasm occurrence(s) and cancer screening tests/procedures performed before and after randomization were collected for all participants.
Results:
A total of 187 distinct new nonbenign neoplasm events were determined to have occurred post-randomization in 170 participants who received one or more doses of the study drug (1.8% of 9,240 treated participants). A total of 2,153/9,240 (23.3%) treated participants permanently discontinued study drug treatment during follow-up, with a significantly higher frequency among those with a new nonbenign neoplasm event (53.5 vs. 22.7%; p < 0.001). The frequencies of the primary composite endpoint of cardiovascular death, myocardial infarction, or stroke (18.2 vs. 13.5%) and all-cause death (28.2 vs. 8.1%) were numerically higher among those treated participants with vs. without a new nonbenign neoplasm. Among the prespecified population without a history of neoplasm or previous curative treatment for neoplasm (n = 9,105), the incidence of neoplasm events was similar with prasugrel vs. clopidogrel (1.8% vs. 1.7%; hazard ratio, 1.04; 95% confidence interval, 0.77-1.42; p = 0.79).
Conclusions:
The detection of new nonbenign neoplasm events occurred infrequently during prolonged treatment with DAPT; such events were associated with high rates of study drug discontinuation and ischemic and bleeding events; and there was no statistical difference observed by treatment with prasugrel vs. clopidogrel.
Perspective:
This is an important study that leverages a novel process for collecting and adjudicating neoplasm data in the TRILOGY ACS trial. Although limited by the infrequent detection of neoplasm events observed and the lack of ascertainment afforded by short-term trials (when cancer development is subject to long-term and complex influences), the current analysis provides some reassurance that neoplasm events are infrequent during long-term DAPT and unrelated to prasugrel vs. clopidogrel.
Keywords: Acute Coronary Syndrome, Aspirin, Blood Platelets, Early Detection of Cancer, Hemorrhage, Myocardial Infarction, Neoplasms, Platelet Aggregation Inhibitors, Stroke, Ticlopidine
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