Ticagrelor monotherapy after PCI poses no extra revascularization risk vs. continued DAPT
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Key takeaways:
- Ticagrelor monotherapy after 3-month DAPT was not associated with greater risk for repeat revascularization or MACCE at 1 year after PCI vs. continued DAPT.
- Monotherapy conferred lower risk for bleeding.
Ticagrelor monotherapy after 3-month dual antiplatelet therapy was not associated with greater risk for repeat revascularization or MACCE at 1 year after PCI vs. continued DAPT, a speaker reported.
The TWILIGHT trial, for which the main results were presented at TCT 2019, evaluated the efficacy and safety of ticagrelor plus aspirin compared with ticagrelor alone for bleeding and ischemic adverse events among 7,119 patients 3 months after PCI.
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As Healio previously reported, 3-month DAPT followed by ticagrelor monotherapy lowered bleeding risk without raising ischemic risk after PCI compared with continued DAPT. Usman Baber, MD, MS, associate professor of medicine and director of interventional cardiology and of the cardiac catheterization laboratory at the University of Oklahoma Health Sciences Center, presented a new analysis of the TWILIGHT trial at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
For the present analysis, Baber and colleagues evaluated the rate of repeat revascularization among patients assigned to 3-month DAPT followed by ticagrelor monotherapy compared with continued DAPT in the TWILIGHT cohort.
“We know that repeat revascularization is frequent after PCI. It is a common component of composite outcomes in trials. Some studies have shown that repeat revascularization does impact mortality, particularly if it occurs in the setting of acute coronary syndrome. There is some data to suggest that if you treat patients with more potent or intense antithrombotic therapies, you can reduce the risk of repeat revascularization,” Baber said during a press conference. “What’s not so clear is whether or not a monotherapy strategy with a potent P2Y12 inhibitor like ticagrelor can affect this outcome as well.”
The primary outcome was clinically driven revascularization, defined as repeat PCI or CABG for recurrent or persistent symptomatic ischemia. Secondary outcomes included target lesion or target vessel revascularization; MACCE, defined as all-cause death, nonfatal MI, stroke or clinically driven revascularization; and net adverse cardiac events, defined as all-cause death, nonfatal MI, stroke, clinically driven revascularization or Bleeding Academic Research Consortium 2, 3 or 5 bleeding.
Baber reported that clinically driven revascularization at 1 year was not significantly different between patients who switched to ticagrelor monotherapy after 3-month DAPT compared with continued DAPT (ticagrelor monotherapy, 7.1%; DAPT, 6.6%; HR = 1.09; 95% CI, 0.9-1.3; log-rank P = .3623).
The researchers observed no significant differences between the two groups for TLR, non-target lesion revascularization, non-target vessel revascularization or MACCE.
Ticagrelor monotherapy was associated with lower risk for net adverse cardiac events compared with DAPT (HR = 0.83; 95% CI, 0.73-0.94; P = .004) which was primarily driven by less BARC 2, 3 or 5 bleeding (HR = 0.56; 95% CI, 0.45-0.69; P < .001).
Moreover, there was no significant difference in clinically driven revascularization between ticagrelor monotherapy or DAPT among subgroups stratified by PCI complexity (P for interaction = .498), ACS status (P for interaction = .183) or diabetes status (P for interaction = .766).
“Patients who underwent complex PCI did have higher rates of repeat revascularization. But again, ticagrelor monotherapy did not confer any additional incremental risk as compared to ticagrelor plus aspirin. Same story ... for ACS,” Baber said during the press conference. “Patients with diabetes had almost twofold higher rates for repeat revascularization, but again, ticagrelor monotherapy appeared to be just as effective as ticagrelor plus aspirin with preventing repeat revascularization.”
Perspective
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Karim M. Al-Azizi, MD, FACC, FSCAI, FESC
TWILIGHT was a trial that randomly assigned patients to ticagrelor and aspirin or ticagrelor plus placebo, essentially monotherapy, for a period of 12 months. These are high-risk PCI patients, and a total of 7,000 patients continued with an observation period of 3 months beyond the 12-month period. The primary outcome of the study was clinically driven repeat revascularization, defined as repeat PCI or CABG for recurrent or persistent symptomatic ischemia.
The point here is that clinically driven revascularization at 1 year was similar, with a P value of .3623. Looking through the breakdown of adverse events at 1 year, one may think that reducing DAPT to monotherapy may be risking those patients for events, exchanging one risk for the other. Reducing risk for bleeding, but perhaps raising risk for events. Thankfully, based the study outcomes, what we see here is that ticagrelor monotherapy was not really associated with increased risk for clinically driven repeat revascularization or MACCE, but with a reduction of net adverse clinical events compared with standard DAPT therapy. It is a reassuring signal that as we continue to evolve with novel stents, perhaps, using imaging, doing good PCI, we can get away with potent antiplatelet monotherapy as compared with traditional DAPT.
Perspective
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This is really a landmark trial for interventional cardiologists. We have better stents and now some of the stent companies have a 1-month DAPT indication. Looking at clopidogrel and ticagrelor, either one of those two, it is going to be important that you can use shorter DAPT to reduce risk for bleeding without penalty of an ischemic event or revascularization event.
Some of the unanswered questions might remain. If somebody cannot tolerate ticagrelor, are they still going to be a player to use clopidogrel? About 20% to 25% of people in the PLATO trial could not tolerate ticagrelor because of dyspnea. So, if they're a clopidogrel nonresponder, then we need to know that. This is not just a set it and forget it.
The other unanswered question is what do we do after 1 year? Do you just keep patients on ticagrelor for the rest of their life? Maybe at the same dose, 90 mg twice a day? Do you go down to 60 mg twice a day? Do you switch them over to clopidogrel if they are a responder or not? The longer term is really what we are going to have to struggle with. We are going to need a lot more data and it's going to take a lot more time.
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Baber U, et al. Late-Breaking Presentation IX. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 18-20, 2023; Phoenix.
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