6533b7d6fe1ef96bd1266ff2
RESEARCH PRODUCT
Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: Development and internal validation of the PSP score
Stelios PyxarasThomas MünzelToru NaganumaSalvatore GeraciSalvatore BrugalettaPiera CapranzanoCorrado TamburinoMaciej LesiakJens WiebeCarlo Di MarioManel SabatéHolger NefJulinda MehilliAntonio ColomboGiuseppe CaramannoTommaso GoriAzeem LatibDavide CapodannoAlessio MattesiniChristoph NaberLuis Ortega-pazAleksander Araszkiewiczsubject
Target lesionBioresorbable scaffoldmedicine.medical_specialtyAntineoplastic Agents030204 cardiovascular system & hematologyRisk AssessmentClinical research03 medical and health sciencesBlood Vessel Prosthesis ImplantationOutcome Assessment (Health Care)0302 clinical medicinePostoperative ComplicationsTheoreticalBlood vessel prosthesisModelsInternal medicineOutcome Assessment Health CaremedicineHumans030212 general & internal medicineMyocardial infarctionEverolimusAdverse effectProspective cohort studyBioresorbable scaffolds; Clinical research; Risk stratification; Antineoplastic Agents; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Everolimus; Humans; Outcome Assessment (Health Care); Retrospective Studies; Risk Assessment; Tissue Scaffolds; Models Theoretical; Postoperative Complications; Cardiology and Cardiovascular MedicineRisk stratificationRetrospective StudiesEverolimusTissue Scaffoldsbusiness.industryRetrospective cohort studyModels Theoreticalmedicine.diseaseThrombosisSurgeryBlood Vessel ProsthesisCardiologyBioresorbable scaffoldsbusinessCardiology and Cardiovascular Medicinemedicine.drugdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2017-01-01 |