In high-risk ACS, long-term DAPT confers reduced ischemic events without rise in bleeding
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Among patients at high ischemic and bleeding risk, longer duration of dual antiplatelet therapy after PCI for ACS was associated with lower risk for adverse events at 30 months vs. shorter duration DAPT, a speaker reported.
According to data presented at the virtual Society for Cardiovascular Angiography and Interventions Scientific Sessions, more than 12 months of DAPT after PCI for ACS did not increase bleeding risk among the patients who were at higher initial risk for bleeding events.
“Our findings suggested that prolonged DAPT in ACS patients who present with a particularly higher risk for thrombotic complications without excessive risk,” Hao-Yu Wang, MD, cardiologist at the Coronary Heart Disease Center at Fuwai Hospital, Beijing, said in a press release. “Not only did we see long-term DAPT was associated with a lower risk of a major cardiovascular event without an increase in bleeding events, but it could be considered an effective strategy to balance the risk for bleeding and ischemia in high-risk patients with ACS. Our results reinforce prolonged DAPT in patients with acute coronary syndrome without excessive risk of bleeding should remain the standard of care.”
As Healio previously reported, in the TWILIGHT study, among patients who underwent PCI with a drug-eluting stent and were prescribed DAPT for 3 months, switching to ticagrelor monotherapy (Brilinta, AstraZeneca) lowered risk for bleeding without increasing ischemic risk compared with continued DAPT.
For this analysis, researchers included 4,875 high-risk TWILIGHT-like patients with ACS who underwent PCI with DES and had no events at 12 months after PCI, of whom 3,335 were on DAPT for more than 12 months and 1,540 were on DAPT for 12 months or less.
The primary endpoint was a composite of all-cause mortality, MI or stroke at 30 months. The secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding.
Patients included in this study met the TWILIGHT study inclusion criteria that required the presence of at least one additional clinical and angiographic feature associated with high risk for ischemic or bleeding events.
DAPT for more than 12 months reduced the primary endpoint by 63% compared with DAPT for less than 12 months in a multivariable analysis (1.5 vs. 3.8%; adjusted HR = 0.374; 95% CI, 0.256-0.548; P < .001). A propensity-matched analysis produced similar results (aHR = 0.361; 95% CI, 0.221-0.59).
Moreover, in the propensity-matched analysis, DAPT for more than 12 months was associated with lower risk for CV death (aHR = 0.049; 95% CI, 0.007-0.362; P = .003) compared with shorter duration DAPT. The results in the multivariable analysis were similar.
Researchers observed no significant difference between the two groups for BARC type 2, 3 or 5 bleeding in the multivariable analysis (aHR = 0.668; 95% CI, 0.379-1.178; P = .164) or in the propensity-matched analysis (aHR = 0.721; 95% CI, 0.369-1.41; P = .339).
“It’s reminiscent of the randomized prospective DAPT trial because you’re taking a population of patients who are free of bleeding and ischemia events at 12 months and then looking at their outcomes; but instead of being randomized, this is obviously a clinically determined duration,” J. Dawn Abbott, MD, director of the interventional cardiology fellowship training program at the Warren Alpert Medical School of Brown University and interventional cardiologist at Rhode Island Hospital, said during a discussion after the presentation. “It would be important to look at the interaction with the DAPT score because, certainly, we can identify patients that benefit from that prolonged gap. It would also be helpful if all of these duration trials, we .... consistently present a standard bleeding risk score, whether that’s something like PRECISE-DAPT or ARC-HBR, because we have to be able to speak the same language and using TWILIGHT criteria is complicated because the clinical and angiographic criteria are specific to that individual trial. I would just advocate looking at some more standard definitions.
“This is an important message and would emphasize that clinical judgment in risk stratifying these patients, both in terms of their ischemic risk upfront as well as their bleeding risk upfront, allows us to tailor therapy to the individual patient,” Abbott said. “These data confirm that patients who are at low bleeding risk actually do well on longer-term antiplatelet therapy. We, for the most part, can identify those folks upfront. The drive to shorten dual antiplatelet therapy in and of itself may not be the right answer in all patients.”
Reference:
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Wang HY, et al. Featured Clinical Research: Acute coronary and cardiogenic shock. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; April 28-May 1, 2021 (virtual meeting).
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