Testing Responsiveness To Platelet Inhibition On Chronic Antiplatelet Treatment For Acute Coronary Syndromes - TROPICAL-ACS
Contribution To Literature:
The TROPICAL-ACS trial showed that de-escalation of maintenance antiplatelet therapy was noninferior to 1 year of prasugrel.
The goal of the trial was to evaluate de-escalation of maintenance antiplatelet therapy compared with control among patients who received a coronary stent for an acute coronary syndrome.
Patients with acute coronary syndrome who underwent percutaneous coronary intervention (PCI) were randomized to de-escalation of antiplatelet therapy (n = 1,304) vs. prasugrel for 12 months (n = 1,306). In the de-escalation group, participants were treated with prasugrel for 1 week, then clopidogrel for 1 week at which time they underwent platelet function testing. If high platelet reactivity was documented, they were switched back to prasugrel. Otherwise, they remained on clopidogrel for 1 year.
- ST-segment elevation MI (STEMI) or NSTEMI
- Underwent PCI
- Planned use of prasugrel for 12 months
- Total number of enrollees: 2,610
- Duration of follow-up: 12 months
- Mean patient age: 59 years
- Percentage female: 78%
- Percentage with diabetes: 22%
Other salient features/characteristics:
- Presentation: STEMI in 55%, NSTEMI in 45%
The primary outcome, incidence of cardiovascular death, MI, stroke, or bleeding (Bleeding Academic Research Consortium [BARC] ≥2), occurred in 7% of the de-escalation group vs. 9% of the control group (p for noninferiority = 0.0004).
Cardiovascular death, MI, stroke, or BARC ≥2 bleeding for those ≤70 years: 5.9% of the de-escalation group vs. 8.3% of the control group (p = 0.03), and for those >70 years: 15.5% of the de-escalation group vs. 13.6% of the control group (p = 0.56) (p for interaction = 0.11).
However, there was significant treatment interaction when age was analyzed ≤57 years and >57 years (p for interaction = 0.03). Net clinical benefit was due to a reduction in major bleeding among younger patients who underwent de-escalation therapy.
- All-cause mortality: 1% vs. 1% (p = 0.85), respectively, for de-escalation vs. control
- MI: 2% vs. 2% (p = 0.59), respectively, for de-escalation vs. control
- BARC type 3 or 5 bleeding: 2% vs. 1% (p = 0.63), respectively, for de-escalation vs. control
Among patients with acute coronary syndrome (STEMI or NSTEMI), de-escalation of maintenance antiplatelet therapy was noninferior to 12 months of prasugrel. De-escalation of antiplatelet therapy was guided by platelet function testing. This strategy was associated with noninferiority regarding the primary outcome of cardiovascular death, MI, stroke, or bleeding BARC ≥2. Younger patients possibly experienced a greater net clinical benefit (due to less bleeding) compared with older patients with de-escalation of antiplatelet therapy. Especially if affordability of medications is an issue, this approach could be an alternative.
Sibbing D, Gross L, Trenk D, et al. Age and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients undergoing percutaneous coronary intervention: results from the randomized TROPICAL-ACS trial. Eur Heart J 2018;39:2749-58.
Sibbing D, Aradi D, Jacobshagen C, et al., on behalf of the TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndromes undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicenter trial. Lancet 2017;390:1747-57.
Editorial Comment: Angiolillo DJ. Dual antiplatelet therapy guided by platelet function testing. Lancet 2017;390:1718-20.
Presented by Dr. Dirk Sibbing at the European Society of Cardiology Congress, Barcelona, Spain, August 27, 2017.
Keywords: Acute Coronary Syndrome, Anticoagulants, Blood Platelets, ESC Congress, ESC2017, Hemorrhage, Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Stents, Stroke
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