6533b872fe1ef96bd12d3737

RESEARCH PRODUCT

P2695ABSORB bioresorbable scaffold versus Xience metallic stent in acute coronary syndromes with treated with percutaneous coronary intervention. A subanalysis of the COMPARE-ABSORB trial

subject

description

Abstract Background The safety and efficacy of the ABSORB scaffold in ACS patients remain unclear. The COMPARE-ABSORB trial compares the ABSORB to the Xience stent in lesions and patients at high risk for restenosis Patients with STEMI and urgent PCI for non-STEMI were not excluded. Methods Patients included in the COMPARE-ABSORB trial undergoing PCI for ACS were eligible. Predefined implantation techniques for ABSORB was mandatory. Primary endpoint is target lesion failure (TLF) at 1 year, defined as a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. Results Of 1670 patients, 842 were treated for ACS. At 1-year, TLF occurred in 22 patients (5.0%) of the ABSORB group and in 14 patients (3.5%) of the Xience group (HR 1.44%; 95% CI 0.74%-2.82%, P=0.284). Definite device thrombosis occurred in 9 patients (2.0%) of the ABSORB group and in 2 patients (0.5%) of the Xience group (HR 4.10%; 95% CI 0.89%-18.9%, P=0.071). Baseline characteristics ABSORB (n=442) XIENCE (n=400) Age, years (SD) 60.7 (9.6) 61.3 (9.1) Male 350/442 (79.2%) 313/400 (78.3%) Current smoker 159/439 (36.2%) 126/397 (31.7%) Diabetes mellitus 152/440 (34.5%) 138/399 (34.6%) Hypertension 298/442 (67.4%) 266/400 (66.5%) Hypercholesterolemia 255/442 (57.7%) 232/400 (58.0%) Family history of coronary artery disease 147/442 (33.3%) 103/400 (25.8%) Previous MI 61/442 (13.8%) 67/400 (16.8%) Established Peripheral Vascular Disease 27/442 (6.1%) 15/400 (3.8%) Previous PCI 83/442 (18.8%) 86/400 (21.5%) Previous CABG 1/442 (0.2%) 4/400 (1.0%) Previous stroke 15/442 (3.4%) 21/400 (5.3%) Renal Insufficiency 9/442 (2.0%) 13/400 (3.3%) Clinical presentation   Unstable angina 149/442 (33.7%) 141/400 (35.3%)   Non-ST elevation myocardial infarction 183/442 (41.4%) 156/400 (39.0%)   ST elevation myocardial infarction 110/442 (24.9%) 103/400 (25.7%) KM plot for target lesion failure Conclusion The COMPARE-ABSORB trial showed no difference in the primary endpoint at one year for the ACS subgroup. The signal for increased thrombosis remained, even with the optimized implantation protocol Acknowledgement/Funding Maasstad Hospital, Rotterdam, the Netherlands