Safety and Efficacy of the Biodegradable-Polymer Everolimus-Eluting Stent vs.Durable-Polymer Drug-Eluting Stents in High-Risk Patients Undergoing PCI: Insights From the TWILIGHT Trial
Presenter
Usman Baber, M.D., The University Of Oklahoma Health Sciences Center, Oklahoma City, OK
Usman Baber, M.D.1, George D. Dangas, M.D., Ph.D., MSCAI2, Samin K. Sharma, M.D., MSCAI3, Rishi Chandiramani, M.D.3, Shamir Mehta, M.D., M.Sc.4, Carlo Briguori, M.D., Ph.D., FSCAI5, Javier Escaned, M.D., Ph.D.6, Kurt Huber, M.D.7, Vijay Kunadian, M.B.B.S., M.D.8, Keith G. Oldroyd, M.B.Ch.B., M.D. (Hons)9 and Roxana Mehran, M.D., MSCAI3, (1)The University Of Oklahoma Health Sciences Center, Oklahoma City, OK, (2)Mount Sinai Hospital, New York, NY, (3)Icahn School of Medicine at Mount Sinai, New York, NY, (4)McMaster University, Hamilton, ON, CANADA, (5)Clinica Mediterranea, Naples, Campania, Italy, (6)Hospital Clínico San Carlos, Madrid, Spain, (7)Wilhelminenspital, Vienna, Austria, (8)Newcastle upon Tyne Hospitals, Middlesbrough, United Kingdom, (9)Golden Jubilee National Hospital, Glasgow, United Kingdom
Keywords: Coronary, Drug-eluting Stent (DES) and Pharmacotherapy
Background
Drug-eluting stents (DES) coated with biodegradable polymer (BP) may confer a safety advantage without compromising efficacy compared to durable polymer (DP) formulations. Data evaluating the effect of BP-DES versus contemporary DP-DES in high-risk patients treated with ticagrelor are limited.
Methods
We conducted a pre-specified analysis among patients randomized in the TWILIGHT trial treated with the BP everolimus-eluting stent (BP-EES) or a DP-DES. Following 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 primary endpoint was target lesion failure (TLF) [composite of cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization (TLR) or definite/probable stent thrombosis (ST)].
Results
Patients receiving BP-EES (n = 577; 10.0%) were more frequently randomized in North America, underwent left main PCI and had a lower frequency of prior MI compared to those receiving DP-DES (n = 5079; 90.0%). One-year rates of TLF were 6.0% and 4.8% in the BP-EES and DP-DES groups, respectively (p = 0.74). Analogous rates of def/prob ST and TLR were 0.7% vs 0.5% (p = 0.51) and 5.1% vs 3.7% (p = 0.39). The effect of ticagrelor monotherapy on ischemic events was uniform across DES groups (all pint >0.10).
Conclusions
The safety and efficacy profile of the BP-EES is comparable to that of contemporary DP-DES in high-risk patients undergoing PCI. Compared to ticagrelor plus aspirin, the effect of ticagrelor monotherapy is consistent among patients receiving BP-EES or DP-DES. 