TY - JOUR
T1 - One-year clinical results of the Italian diffuse/multivessel disease ABSORB prospective registry (IT-DISAPPEARS)
AU - Testa, Luca
AU - De Carlo, Marco
AU - Petrolini, Alessandro
AU - Rapetto, Claudio
AU - Varbella, Ferdinando
AU - Cortese, Bernardo
AU - Gabrielli, Gabriele
AU - Geraci, Salvatore
AU - Loi, Bruno
AU - Boccuzzi, Giacomo
AU - Tarantini, Giuseppe
AU - Fischetti, Dionigi
AU - Calabria, Paolo
AU - Tomai, Fabrizio
AU - Ribichini, Flavio
AU - Tamburino, Corrado
AU - Indolfi, Ciro
AU - Bartorelli, Antonio L
AU - Petronio, Anna Sonia
AU - Bedogni, Francesco
PY - 2017/7/20
Y1 - 2017/7/20
N2 - AIMS: The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study.METHODS AND RESULTS: Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac death occurred in five patients (0.5%), while target vessel MI and TLR each occurred in 45 (4.7%) patients. The one-year rates of all-cause death, non-fatal MI, and any revascularisation were 1.2%, 5.4%, and 10.9%, respectively. The rate of definite/probable scaffold thrombosis was 0.9%.CONCLUSIONS: This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease. The mandatory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies, in particular with respect to the rate of DOCE and scaffold thrombosis.
AB - AIMS: The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study.METHODS AND RESULTS: Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac death occurred in five patients (0.5%), while target vessel MI and TLR each occurred in 45 (4.7%) patients. The one-year rates of all-cause death, non-fatal MI, and any revascularisation were 1.2%, 5.4%, and 10.9%, respectively. The rate of definite/probable scaffold thrombosis was 0.9%.CONCLUSIONS: This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease. The mandatory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies, in particular with respect to the rate of DOCE and scaffold thrombosis.
KW - Journal Article
U2 - 10.4244/EIJ-D-17-00246
DO - 10.4244/EIJ-D-17-00246
M3 - Article
C2 - 28504219
VL - 13
SP - 424
EP - 431
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 4
ER -