Medium-Term Bioresorbable Scaffold Outcomes Utilising Data From an Australian Clinical Quality Registry
| Autor: | Jennifer Cooke, Stephen J. Duffy, Victorian Cardiac Outcomes Registry, Robert Gooley, Robert Whitbourn, Harriet Carruthers, Diem Dinh, Jeffrey Lefkovits, Angela Brennan, Chin Hiew, Janine Doyle, Christopher M. Reid, Luke P Dawson, Nicholas Cox, Dion Stub, Ronald Dick, Stephanie Montalto, Jack Gutman |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Pulmonary and Respiratory Medicine medicine.medical_specialty Time Factors medicine.medical_treatment Context (language use) 030204 cardiovascular system & hematology Prosthesis Design 03 medical and health sciences Percutaneous Coronary Intervention 0302 clinical medicine Internal medicine Absorbable Implants medicine Humans Prospective Studies Registries 030212 general & internal medicine Myocardial infarction Prospective cohort study Aged Tissue Scaffolds business.industry Incidence Australia Percutaneous coronary intervention Odds ratio Middle Aged medicine.disease Quality Improvement Comorbidity Confidence interval Treatment Outcome Conventional PCI ST Elevation Myocardial Infarction Female Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | Heart, Lung and Circulation. 29:1440-1448 |
| ISSN: | 1443-9506 |
| DOI: | 10.1016/j.hlc.2019.11.014 |
| Popis: | Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However, recent trials demonstrate higher rates of device failure compared to contemporary drug-eluting stents. This study sought to utilise a clinical quality registry to assess the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), in an Australian context.A prospective, observational study of 192 BRS percutaneous coronary interventions (PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint (POCE) events comprising all-cause mortality, any myocardial infarction (MI), and any revascularisation.Bioresorbable scaffolds patients (mean age 61.6±10.5 years, 79% male) were younger, had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI) presentations, lower rates of multi-lesion disease and more adjuvant devices compared to non-BRS PCI (all p0.01). All-cause mortality was 2.1%, myocardial infarction (MI) 2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4±8.9 months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable to pooled-trial data. Multivariate predictors of POCE were1 scaffold used (odds ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p0.01) and scaffold diameter ≤2.5 mm (OR 3.3, 95% CI 1.4-7.6, p=0.02). Over 95% guideline adherence was achieved in six of eight patient selection criteria and four of six device deployment criteria.In an Australian setting, BRS were used in non-complex patients. Most guidelines for use were adhered to and outcomes were comparable to pooled trial data. Clinical quality registries are effective in assessing novel treatments and technologies when potential safety concerns develop. |
| Databáze: | OpenAIRE |
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