TY - JOUR
T1 - Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events
T2 - Development and internal validation of the PSP score
AU - Ortega-Paz, Luis
AU - Capodanno, Davide
AU - Gori, Tommaso
AU - Nef, Holger
AU - Latib, Azeem
AU - Caramanno, Giuseppe
AU - Di Mario, Carlo
AU - Naber, Christoph
AU - Lesiak, Maciej
AU - Capranzano, Piera
AU - Wiebe, Jens
AU - Mehilli, Julinda
AU - Araszkiewicz, Aleksander
AU - Pyxaras, Stelios
AU - Mattesini, Alessio
AU - Geraci, Salvatore
AU - Naganuma, Toru
AU - Colombo, Antonio
AU - Münzel, Thomas
AU - Sabaté, Manel
AU - Tamburino, Corrado
AU - Brugaletta, Salvatore
N1 - Publisher Copyright:
© Europa Digital & Publishing 2017. All rights reserved.
PY - 2017/4
Y1 - 2017/4
N2 - Aims: The aim of the study was to develop a scoring model to evaluate the quality of bioresorbable vascular scaffold (BVS) implantation and determine the model's usefulness in predicting adverse cardiac events. Methods and results: The implantation technique and clinical outcomes of 1,736 lesions treated with BVS were analysed using the GHOST-EU registry. Predilation, scaffold sizing, and post-dilation (PSP) were scored according to the hazard model derived from the weight of these variables. The primary end-point was a one-year device-oriented composite endpoint (DoCE) composed of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation. Definite/probable scaffold thrombosis was also evaluated as defined by the Academic Research Consortium. The PSP model performance was evaluated by internal validation. Predilation, correct scaffold sizing, and post-dilation with a non-compliant balloon were performed in 95.7%, 50.2%, and 26.2% of the cases and scored 0.63, 1.96 and 1.93 points, respectively, in the PSP-1 model. PSP-1 was an independent predictor of one-year DoCE (HR 0.75, 95% CI: 0.61-0.93; p=0.007), but with poor calibration and discrimination (AUC 0.611, 95% CI: 0.545-0.677). No patient with a maximum PSP-1 score had scaffold thrombosis, compared to those with a non-maximum PSP-1 score (0% vs. 2.3%; p=0.095). Conclusions: At one-year follow-up, the PSP-1 score was an independent predictor of DoCE. External validation and prospective studies are needed to determine the clinical usefulness of this score.
AB - Aims: The aim of the study was to develop a scoring model to evaluate the quality of bioresorbable vascular scaffold (BVS) implantation and determine the model's usefulness in predicting adverse cardiac events. Methods and results: The implantation technique and clinical outcomes of 1,736 lesions treated with BVS were analysed using the GHOST-EU registry. Predilation, scaffold sizing, and post-dilation (PSP) were scored according to the hazard model derived from the weight of these variables. The primary end-point was a one-year device-oriented composite endpoint (DoCE) composed of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation. Definite/probable scaffold thrombosis was also evaluated as defined by the Academic Research Consortium. The PSP model performance was evaluated by internal validation. Predilation, correct scaffold sizing, and post-dilation with a non-compliant balloon were performed in 95.7%, 50.2%, and 26.2% of the cases and scored 0.63, 1.96 and 1.93 points, respectively, in the PSP-1 model. PSP-1 was an independent predictor of one-year DoCE (HR 0.75, 95% CI: 0.61-0.93; p=0.007), but with poor calibration and discrimination (AUC 0.611, 95% CI: 0.545-0.677). No patient with a maximum PSP-1 score had scaffold thrombosis, compared to those with a non-maximum PSP-1 score (0% vs. 2.3%; p=0.095). Conclusions: At one-year follow-up, the PSP-1 score was an independent predictor of DoCE. External validation and prospective studies are needed to determine the clinical usefulness of this score.
KW - Bioresorbable scaffolds
KW - Clinical research
KW - Risk stratification
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U2 - 10.4244/EIJ-D-16-00974
DO - 10.4244/EIJ-D-16-00974
M3 - Article
C2 - 28246060
AN - SCOPUS:85020431069
SN - 1774-024X
VL - 12
SP - 2110
EP - 2117
JO - EuroIntervention
JF - EuroIntervention
IS - 17
ER -