TY - JOUR
T1 - One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents
T2 - a propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials
AU - de Ribamar Costa, José
AU - Abizaid, Alexandre
AU - Bartorelli, Antonio L
AU - Whitbourn, Robert
AU - Jepson, Nigel
AU - Perin, Marco
AU - Steinwender, Clemens
AU - Stuteville, Marrianne
AU - Ediebah, Divine
AU - Sudhir, Krishnankutty
AU - Serruys, Patrick W
PY - 2016/11/20
Y1 - 2016/11/20
N2 - AIMS: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial.METHODS AND RESULTS: ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation.CONCLUSIONS: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.
AB - AIMS: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial.METHODS AND RESULTS: ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation.CONCLUSIONS: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.
KW - Absorbable Implants
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Angioplasty, Balloon, Coronary/methods
KW - Cardiovascular Agents/administration & dosage
KW - Drug-Eluting Stents
KW - Everolimus/therapeutic use
KW - Female
KW - Humans
KW - Immunosuppressive Agents/therapeutic use
KW - Male
KW - Metals
KW - Middle Aged
KW - Myocardial Infarction/therapy
KW - Propensity Score
KW - Prospective Studies
KW - Risk Factors
KW - Time Factors
KW - Treatment Outcome
UR - https://www.scopus.com/pages/publications/85002444319
U2 - 10.4244/EIJV12I10A206
DO - 10.4244/EIJV12I10A206
M3 - Article
C2 - 27866134
SN - 1969-6213
VL - 12
SP - 1255
EP - 1262
JO - EuroIntervention
JF - EuroIntervention
IS - 10
ER -