OPTION: Feasible to replace aspirin with indobufen in DAPT after PCI
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CHICAGO — In patients who had PCI with a drug-eluting stent, dual antiplatelet therapy with indobufen plus clopidogrel was noninferior to DAPT with aspirin plus clopidogrel, according to the results of the OPTION trial.
Junbo Ge, MD, FACC, FAHA, from the department of cardiology at Zhongshan Hospital, Fudan University, Shanghai, and colleagues randomly assigned 4,551 patients with CAD and a negative cardiac troponin test who underwent PCI with a DES to DAPT with aspirin plus clopidogrel or DAPT with indobufen plus clopidogrel. The results were presented at the American Heart Association Scientific Sessions and published in Circulation.
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“Several unfavorable noncardiac events, such as allergy and intolerance, limit the use of or adherence to aspirin in clinical practice,” Ge said during a presentation. “Indobufen is associated with a better platelet selectivity, tolerability and benefit-risk profile. Exploration of pharmacological alternatives to aspirin on top of a P2Y12 inhibitor is of great interest and clinical relevance.”
All patients received a loading dose of clopidogrel 300 mg to 600 mg before their procedure. Within 24 hours after their procedure, patients were randomly assigned to a regimen of indobufen 100 mg twice daily plus clopidogrel 75 mg once daily or aspirin 100 mg once daily plus clopidogrel 75 mg once daily.
The primary outcome, a composite of CV death, nonfatal MI, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) criteria type 2, 3 or 5 at 1 year, occurred in 6.11% of the aspirin group and 4.47% of the indobufen group (HR = 0.73; 95% CI, 0.56-0.94; P for noninferiority < .001; P for superiority = .015), Ge said during the presentation.
The secondary efficacy endpoint of CV death, nonfatal MI, stroke and definite or probable stent thrombosis at 1 year was virtually identical in both groups (aspirin, 1.4%; indobufen, 1.51%; HR = 1.08; 95% CI, 0.67-1.75; P = .757), whereas the secondary safety endpoint of BARC criteria type 2, 3 or 5 at 1 year favored the indobufen group (4.71% vs. 2.97%; HR = 0.63; 95% CI, 0.46-0.85; P = .002), Ge said.
The results were consistent across all prespecified subgroups, he said.
The mean age of patients was 61 years. The indobufen group consisted of 67% men and the aspirin group consisted of 63% men. About two-thirds of patients had hypertension, about one-third had diabetes, about one-third had hyperlipidemia and about one-quarter were current smokers.
“Indobufen plus clopidogrel DAPT for 12 months is noninferior to the 1-year composite of safety and efficacy outcomes compared to aspirin plus clopidogrel DAPT,” Ge said during the presentation. “There is no statistical difference regarding the 1-year efficacy composite ... between indobufen plus clopidogrel DAPT and conventional DAPT. The decreased BARC bleeding in the indobufen group is mostly driven by a reduction of minor bleeding events.”
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This is one of several Chinese presentations with thousands of patients. This was a well-done study describing the use of indobufen as a substitute for aspirin in DAPT in patients who received stenting, followed over the next year. It showed noninferiority or equivalency of indobufen to aspirin therapy in terms of major adverse CV events during that time, but also with potential for less bleeding.
This gives us another strong option for DAPT following PCI with stenting, because there are many people who have aspirin allergies or intolerance. As there are further studies done, if these results are confirmed at multiple sites in multiple countries, we might be able to determine not only equivalency, but which patient groups might be able to benefit from using indobufen for their antiplatelet therapy following PCI with stenting.
Sanger Heart & Vascular Institute/Atrium Health
Clinical Professor
Wake Forest University School of Medicine
Vice President, American College of Cardiology
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Ge J, et al. LBS.06: Drugs and strategies in ACS and revascularization. Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).
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