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Results of a TWILIGHT subanalysis suggest ticagrelor monotherapy might cause less bleeding without increasing events in patients with requiring complex PCI.
George Dangas, MD, PhD
New data from a TWILIGHT trial sub analysis presented at the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) is shedding light on the benefit of ticagrelor monotherapy compared to dual antiplatelet therapy for patients with complex heart disease undergoing percutaneous coronary intervention (PCI).
Results of the TWILIGHT-COMPLEX study, which included patients with blockages in 3 or more arteries or other complications that received multiple stents, indicated ticagrelor monotherapy was associated with less bleeding and no increase in myocardial infarction, stroke, or other adverse events when compared to ticagrelor plus aspirin.
“Among patients with complex coronary artery disease who completed three months of ticagrelor plus aspirin, ticagrelor monotherapy significantly reduced the incidence of clinically relevant bleeding without increasing the risk of additional heart attacks, strokes or death, compared with those who received ticagrelor plus aspirin,” said lead investigator George Dangas, MD, PhD, professor of medicine, cardiology and surgery at Mount Sinai School of Medicine, in a statement.
Of the original 7116 individuals included in the original TWILIGHT trial, investigators considered 2342 (33%) as requiring complex PCI. Complex PCI was defined as treating 3 vessels, 3 or more lesions treated, total stent length greater than 60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PXI, surgical bypass graft, or chronic total occlusion as target lesions.
Briefly, all participants in the randomized, placebo-controlled, double-blind TWILIGHT trial underwent 1:1 randomization to either ticagrelor plus placebo or ticagrelor plus aspirin and were followed for 1 year—all patients received therapy with aspirin before randomization for the first 3 months following PCI. Similarly to the TWILIGHT trial, the primary endpoint of this sub analysis was BARC 2, 3, or 5 bleeding and investigators also assessed for a composite ischemic endpoint of all-cause death, myocardial infarction (MI), or stroke.
Of the 2342 patients that met the criteria for complex PCI, 1158 were randomized to ticagrelor plus placebo and 1184 were randomized to ticagrelor plus aspirin. Of note, more than half (51.8%) of the patients in the TWILIGHT-COMPLEX study required a stent of 60 mm or more in length.
Results of the analysis indicated ticagrelor plus aspirin was associated with significantly lower rates of BARC 2, 3, or 5 bleeding (4.2% vs. 7.7%; HR, 0.54; 95% CI, 0.38-0.76; P <.0001), and BARC 3 or 5 type bleeding when compared to ticagrelor plus aspirin (1.1% vs. 2.6%; HR, 0.41; 95% CI, 0.21-0.80; P=.009).
Results also indicated no significant differences in ischemic outcomes between the ticagrelor plus placebo group compared to the ticagrelor plus aspirin group in terms of death, MI, or stroke (3.8% vs. 4.9%; HR, 0.77; 95% CI, 0.52-1.15) as well as cardiovascular death, MI or stroke (3.6% vs. 4.8%; HR, 0.75; 95% CI, 0.50-1.12). Investigators noted no significant differences in all-cause deaths between groups (0.9% vs. 1.5%; HR, 0.59; 95% CI, 0.27-1.29).
“In this patient subset with complex heart disease, we found that it was okay to withdraw aspirin and that doing so reduced bleeding without increasing heart attacks or other complications,” Dangas said in the aforementioned statement.
This study, “Safety And Efficacy Of Ticagrelor Monotherapy After Complex PCI: The TWILIGHT-COMPLEX Substudy,” was presented at ACC.20/WCC.