May 14, 2020
TWILIGHT Substudy Compares Safety of Bioabsorbable Polymer and Durable Polymer DES in High-Risk Patients Undergoing PCI
May 14, 2020—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that subgroup findings from the TWILIGHT trial sought to reveal whether drug-eluting stents (DESs) coated with a bioabsorbable polymer (BP) provided a safety advantage without compromising efficacy compared with durable polymer (DP) formulations. The study examined the Synergy platform (Boston Scientific Corporation) in a higher-risk patient population than previously studied and evaluated the effect of ticagrelor monotherapy in such patients. The data were presented during the SCAI 2020 Scientific Sessions Virtual Conference held May 14-16.
According to SCAI, investigators conducted a prespecified analysis among patients enrolled in the TWILIGHT trial treated with the Synergy BP everolimus-eluting stent (BP-EES) or a DP-DES. After successful percutaneous coronary intervention (PCI) and 3 months of ticagrelor plus aspirin, patients were randomized to aspirin or placebo for 1 year; DES choice was at physician discretion.
The study's primary endpoint was target lesion failure (TLF; a composite of cardiac death, target vessel myocardial infarction [MI], clinically driven target lesion revascularization [TLR], or definite/probable stent thrombosis [ST]).
In the study, 9.2% (n = 653) of patients received BP-EES versus 90.8% (n = 6,404) treated with DP-DES. Patients receiving BP-EES were more frequently randomized in North America and had a lower frequency of previous MI. The total stent length was approximately 39 mm in both groups. The investigators reported that 1-year rates of TLF were 6.4% for BP-EES versus 6.1% for DP-DES (P = .72) with analogous rates of definite/probable ST (0.8% vs 0.9%; P = .49) and TLR (5.3% vs 4.4%; P = .96) The effect of ticagrelor monotherapy on ischemic and bleeding events was uniform across DES groups (all Pint > .1).
“Our work shows that the Synergy stent performs similarly to other durable polymer DESs in relatively high-risk patients enrolled in the TWILIGHT trial,” commented the study's lead author, Usman Baber, MD, in the SCAI announcement. “This is a clinically relevant finding as it provides randomized evidence supporting the use of this platform in such patients. In addition, the effect of ticagrelor monotherapy on ischemic and bleeding events observed in the overall trial was preserved among patients receiving a Synergy DES, suggesting this strategy may be a safe alternative in high bleeding-risk patients treated with the Synergy stent.”
Dr. Baber continued, “These findings broaden the generalizability of adopting a strategy of P2Y12 inhibitor monotherapy to patients treated with different DES platforms. In addition, our results provide reassurance that the Synergy platform performs similarly to other newer-generation DES in high-risk patients.”