Compared with patients with chronic coronary syndromes, patients with acute coronary syndromes (ACS) are more likely to suffer from long term major adverse cardiac events (MACE). To prevent this, both the American and the European guidelines recommend prolonging dual antiplatelet therapy (DAPT) in this population for at least 12 months.
However, in patients with certain clinical characteristics (elderly, chronic kidney disease, peripheral vascular disease, etc.), DAPT is associated with a higher risk of bleeding (minor or major), which poses a constant search for an alternative for this population.
In recent years, several randomized trials have attempted to answer this question, with a benefit observed in patients with abbreviated DAPT in endpoints balancing ischemic risk vs. bleeding risk (net clinical events). Such an effect is mostly at the expense of the use of a specific P2Y12 inhibitor: ticagrelor.
The aim of this study, recently published in JAMA Cardiology, was to analyze the safety of abbreviated DAPT and subsequent clopidogrel monotherapy in patients with ACS treated with an everolimus-eluting cobalt-chromium stent (Abbott).
A multicenter, non-inferiority study was conducted with 4169 patients with ACS (one cohort was the ACS subgroup of the original STOPDAPT-2 study, while another prospective cohort was the STOPDAPT-2 ACS cohort), of which 56% presented ST-segment elevation acute coronary syndrome, 20% non-ST-segment elevation acute coronary syndrome, and 20% unstable angina.
All patients received aspirin plus a second P2Y12 inhibitor (clopidogrel 75 mg/day or prasugrel 3.75 mg/day). Subsequently at 30-59 days from percutaneous transluminal coronary angioplasty (PTCA), patients were randomized 1:1 to clopidogrel monotherapy vs. continuation of DAPT (prasugrel patients changed to clopidogrel).
The primary outcome was a composite of MACE (cardiovascular death, acute myocardial infarction, stent thrombosis, stroke) or presence of bleeding (major or minor thrombosis in myocardial infarction). At a 1-year follow-up, abbreviated therapy with DAPT for 1 or 2 months and subsequent clopidogrel monotherapy did not reach the non-inferiority threshold (hazard ratio [HR]: 1.14; confidence interval [CI]: 0-8-1.6; p = 0.06). Patients who received the abbreviated treatment experienced more MACE (mainly at the expense of AMI) (HR: 1.50; CI: 0.99-2.26) and fewer bleeding episodes (HR: 0.46, non-significant), with no difference in terms of mortality.
Conclusions
In patients with ACS, who underwent angioplasty with an everolimus-eluting cobalt-chromium stent (Abbott), abbreviated DAPT for 1-2 months and subsequent clopidogrel monotherapy did not reach the non-inferiority threshold, with fewer episodes of major bleeding, at the expense of significantly increased rates of MACE.
Personal commentary
Recently, papers and meta-analyses have been published on abbreviated therapies involving ticagrelor, specifically. In the TICO (ticagrelor monotherapy after 3 months of DAPT in ACS) and TWILIGHT (ticagrelor monotherapy after 3 months of DAPT in ACS patients at high risk of bleeding) studies, the non-inferiority threshold was reached, and the strategy could be considered as safe (evidence 2A in the American guidelines). The case of clopidogrel is different, as greater rates of MACE were observed with the abbreviated therapy and, as such, its safety as monotherapy in ACS is debatable, although its usefulness as an alternative in de-escalation should not be ruled out.
Dr. Omar Tupayachi.
Member of the Editorial Board, SOLACI.org
Reference: JAMA Cardiol. 2022 Mar 2; e215244. doi: 10.1001/jamacardio.2021.5244. Online ahead of print.
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