Ticagrelor after 3-month DAPT post-PCI may benefit patients with high bleeding risk
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Ticagrelor monotherapy after 3 months of dual antiplatelet therapy lowered the incidence of major bleeding events vs. continued DAPT among patients with high bleeding risk who underwent PCI, according to new insights from TWILIGHT.
Published in the European Heart Journal, the prespecified analysis of the TWILIGHT trial also indicated a trend for greater absolute risk reduction in Bleeding Academic Research Consortium (BARC) 2, 3 and 5 bleeding with ticagrelor (Brilinta, AstraZeneca) monotherapy for patients at higher bleeding risk compared with those not at high risk.
Rethinking DAPT regimens
“Contemporary advances in device technologies and pharmacological strategies have allowed extending PCI to older and more vulnerable cohorts,” Javier Escaned, MD, PhD, head of interventional cardiology at Hospital Clinico San Carlos in Madrid, and colleagues wrote. “As such, an increasing number of patients undergoing PCI have high bleeding risk conditions, which make a standard DAPT regimen clinically undesirable.”
As Healio previously reported, in the main results of TWILIGHT, 3-month DAPT followed by ticagrelor monotherapy lowered bleeding risk without raising ischemic risk in patients who underwent PCI compared with continued longer DAPT.
“As bleeding complications after PCI are intrinsically related to the duration and intensity of DAPT, identification of new management strategies, like early aspirin withdrawal followed by P2Y12 inhibitor monotherapy, are crucial to improve the safety of PCI among high-risk patients,” Davide Cao, MD, interventional cardiologist at the Center for Interventional Cardiovascular Research and Clinical Trials at the Icahn School of Medicine at Mount Sinai, told Healio.
Within the TWILIGHT cohort, 17.2% participants met the ARC definition of being high bleeding risk.
Researchers observed that 3-month DAPT followed by ticagrelor monotherapy reduced the incidence of BARC 2, 3 or 5 bleeding compared with continued DAPT in both patients who had high bleeding risk (6.3% vs. 11.4%; HR = 0.53, 95% CI, 0.35-0.82; P = .004) and those who did not (3.5% vs. 5.9%; HR = 0.59; 95% CI, 0.46-0.77; P < .001) with no evidence of heterogeneity (P for interaction = .67). However, Escaned and colleagues observed a trend toward greater absolute risk reduction for BARC 2, 3 or 5 bleeding among patients who had high bleeding risk compared with those who did not (difference in absolute risk differences, –2.8%; 95% CI, –6.4 to 0.8; P = .13).
Moreover, researchers observed a similar pattern for the more severe outcome of BARC 3 or 5 bleeding, with a greater absolute risk reduction observed among patients classified as high bleeding risk (difference in absolute risk differences, –3%; 95% CI, –5.2 to –0.8; P = .008).
“The TWILIGHT-HBR study demonstrated that 3 months of DAPT followed by ticagrelor monotherapy is a safe and effective bleeding-avoidance strategy for patients at high bleeding risk undergoing PCI,” Cao told Healio. “This approach may be particularly beneficial in subjects with concomitantly elevated ischemic risk, such as those presenting with an ACS or undergoing complex PCI, whom the treating physician intend to discharge on a potent P2Y12 inhibitor.”
No difference in ischemic outcomes
There was no significant difference in the high bleeding risk group by treatment arm for CV death, MI or ischemic stroke (3-month DAPT followed by ticagrelor monotherapy, 5.9%; standard DAPT duration, 5.5%), according to the study.
“The present study was not powered to detect clinically relevant differences in ischemic events, and therefore findings must be seen as hypothesis-generating and warrant prospective confirmation in dedicated high bleeding risk trials investigating a strategy of P2Y12 inhibitor monotherapy post-PCI,” Cao told Healio. “Avoiding a tradeoff in antithrombotic efficacy is the most challenging aspect of any bleeding-reduction strategy involving short DAPT. Risk prediction models, such as the ARC-HBR tradeoff model, may help clinicians in tailoring antithrombotic therapies based on the estimated ischemic and bleeding risk of each individual.”
For more information:
Davide Cao, MD, can be reached at davide.cao@mountsinai.org.
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