TWILIGHT-Stent: Results Consistent Regardless of Stent Type

George Dangas, MD, PhD

An analysis of the TWILIGHT study presented at the European Society of Cardiology (ESC) Congress 2021 suggests the benefits of ticagrelor monotherapy compared with DAPT with aspirin were consistent regardless of the stent type used.

Stratifying patients into 3 groups based on drug-eluting stent (DES) type, results of TWILIGHT-Stent indicate use of ticagrelor monotherapy after 3-month DAPT in patients undergoing PCI lowered bleeding complications without increasing risk of ischemic with no significant differences among DES types.

“We found that ticagrelor monotherapy was well tolerated and very successful in reducing bleeding and without a penalty in increasing ischemic endpoints. So high consistency regardless of the broader drug eluting stent type,” said George Dangas, MD, PhD, director of cardiovascular innovation at Icahn School of Medicine at Mount Sinai, in an interview with Practical Cardiology.

The current analysis was performed by TWILIGHT investigators out of an interest in describing the effects of ticagrelor monotherapy against ticagrelor plus aspirin according to type of newer generation stent used in the trial. For the purpose of analysis, patients were classified into 3 groups based on whether they received adurable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Investigators identified cohorts of 3014 with DP-EES, 1350 with DP-ZES, and 1405 with BP-DES.

Stent types included in the DP-EES group were: Promus Premier, Promuse Element, Xience Alpine, Xience Expedition, Xience Prime II, and Xience Pro. Stent types included in the DP-ZES group were: Onyx and Endeavor. Stent types included in the BP-DES group were: Orsiro, Ultimaster, Alex, Abluminus, Tetriflex, Supraflex, Yukon Choice Flex, Yukon Choice Elite, Biomime, Metafor, MiStent, Destiny, Firehawk, EUCATECH/eucaLimus, Bioss LIM C, XLIMUS, BuMA, TIVOLI, HELIOS, NOYA, Prolim, Cordimax, GuReater, Synergy, Tetrilimus, Biomatrix Flex, Biomatrix Alpha, and AXXESS.

The primary outcome of interest for the analysis was incidence of BARC 2, 3, or 5 bleeding from 0-12 months after randomization. The secondary outcome of interest was incidence of target lesion failure and incidence of major adverse cardiovascular or cerebral events (MACCE), including all-cause death, nonfatal myocardial infarction, and nonfatal stroke from 0-12 months after randomization.

Upon analysis, results indicated ticagrelor monotherapy was associated with significantly lower rates of BARC type 2, 3, or 5 bleeding, regardless of stent type (P for interaction=.76). Additionally, results suggested use of ticagrelor monotherapy resulted in similar rates of MACCE in patients with DP-EES (4.2% vs 4.3%; HR: 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs. 3.1%; HR, 1.32 [95% CI, 0.75-2.33]), and BP-DES (3.9% vs 4.2%; 95% CI: 0.54-1.55; P for interaction=0.60) when compared against ticagrelor plus aspirin. Investigators also pointed out no differences were observed in ischemic or bleeding complications according to DES type in both unadjusted and covariate-adjusted analyses.

“Comparing this among the 3 drug-eluting stent types, we found no major differences among them and, very importantly, rates of late stent thrombosis within each one of these buckets of drug-eluting stents were very, very low in the 0.5% range or lower sometimes,” Dangas added. “So, that indicates a tremendous I would say success, a clinical success with these type of stents in a population that regardless of randomization had to have 1 angiographic high-risk criteria, like a bifurcation, a double stent, a long stent, a left main, (or) CT coronary occlusion, and a clinical high-risk characteristic.”

This study “TWILIGHT-Stent: Ticagrelor Monotherapy According to Stent Type,” was presented at ESC Congress 2021.