Clopidogrel monotherapy 1 month after PCI lowers bleeding regardless of diabetes status
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In a new analysis of the pooled cohort of the two STOPDAPT-2 trials of patients who had PCI, clopidogrel monotherapy after 1 month of dual antiplatelet therapy was associated with reduced bleeding risk regardless of diabetes status.
As Healio previously reported, in the pooled cohort of patients from the STOPDAPT-2 and STOPDAPT-2 ACS trials, switching from DAPT to clopidogrel monotherapy after 1 month reduced bleeding risk compared with 12-month DAPT, whereas clopidogrel monotherapy after 1 month was noninferior to 12-month DAPT for ischemic events and a composite of ischemic and bleeding events.
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For the present analysis, researchers analyzed the pooled cohort to determine whether the results varied by diabetes status. Of the 5,997 patients in the analysis, 33.8% had diabetes.
The primary outcome was a composite of CV and bleeding endpoints (CV death, MI, definite stent thrombosis, stroke, TIMI major bleeding and TIMI minor bleeding) at 1 year.
The primary outcome was similar in the 1-month DAPT group and the 12-month DAPT group in patients with diabetes (HR = 0.87; 95% CI, 0.56-1.37; P = .55) and in patients without diabetes (HR = 0.99; 95% CI, 0.67-1.48; P = .97; P for interaction = .67), Ko Yamamoto, MD, from the department of cardiovascular medicine, Kyoto University Graduate School of Medicine, Japan, and colleagues wrote.
CV, bleeding outcomes
The CV outcome of CV death, MI, definite stent thrombosis and stroke was also similar between the 1-month DAPT and 12-month DAPT groups in patients with diabetes (HR = 1.1; 95% CI, 0.67-1.81; P = .7) and in patients without diabetes (HR = 1.38; 95% CI, 0.85-2.25; P = .2; P for interaction = .52), according to the researchers.
The bleeding endpoint of TIMI major or minor bleeding significantly favored the 1-month DAPT group in patients with diabetes (HR = 0.2; 95% CI, 0.06-0.68; P = .01) and trended toward favoring the 1-month DAPT group in patients without diabetes (HR = 0.51; 95% CI, 0.25-1.01; P = .054; P for interaction = .19), the researchers wrote.
“Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis-generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial,” Yamamoto and colleagues wrote.
‘Uncertain implications for practice’
In a related editorial, Davide Cao, MD, interventional cardiologist at the Center for Interventional Cardiovascular Research and Clinical Trials at the Icahn School of Medicine at Mount Sinai, and Felice Gragnano, MD, PhD, assistant professor of cardiology at the University of Campania Luigi Vanvitelli in Caserta, Italy, wrote that the analysis “provides important data regarding the use of post-PCI clopidogrel monotherapy after 1 month of DAPT in the high-risk subgroup of [patients with diabetes] but leaves some questions open. In view of the possible tradeoff for ischemic events (especially in ACS) and the neutral effect on net clinical outcomes, the observed bleeding benefit with clopidogrel monotherapy carries uncertain implications for practice. Clopidogrel remains the most commonly used P2Y12 inhibitor worldwide but has well-known limitations that are relevant in [individuals with diabetes].”
Reference:
Perspective
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Short-term DAPT for 1 month followed by clopidogrel monotherapy appears to be safe for diabetic patients who undergo PCI. This strategy did not increase major adverse CV events and there was suggestion of reduction in major bleeding.
This study provides reassurance that a shorter duration of DAPT among diabetic patients who undergo PCI may be appropriate.
Prolonged DAPT (for example, 12 months) came about because of very late stent thrombosis. However, since that time, PCI technique and stent technology have both improved. In this trial, intravascular imaging was used more than 97% of the time, which has been shown to optimize stent implantation.
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