Predictors of bioresorbable scaffold failure in STEMI patients at 3 years follow-up
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Self-reporting Scaffolds for 3-Dimensional Cell Culture
Published on: November 7, 2013
Alberto Polimeni1, Remzi Anadol2, Thomas Münzel2
1Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany; Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro 88100, Italy.
Insights
Long-term outcomes for bioresorbable scaffolds (BRS) in ST-segment elevation myocardial infarction (STEMI) are similar to stable coronary artery disease (SCAD) patients. Optimized implantation techniques reduce scaffold thrombosis in both STEMI and SCAD patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials in Medicine
Background:
- Limited data exist on long-term bioresorbable scaffold (BRS) outcomes in ST-segment elevation myocardial infarction (STEMI).
- Understanding BRS performance in STEMI is crucial for clinical decision-making.
Purpose of the Study:
- To evaluate three-year clinical outcomes of BRS in STEMI patients.
- To identify predictors of BRS failure, specifically scaffold thrombosis (ScT), in STEMI.
- To compare outcomes between STEMI and stable coronary artery disease (SCAD) patients treated with BRS.
Main Methods:
- Pooled analysis of two prospective, single-arm registries.
- Included 183 STEMI patients and 248 SCAD patients treated with BRS.
- Kaplan-Meier and Cox regression analyses were used to assess outcomes and predictors over a three-year follow-up.
Main Results:
- Device-oriented composite endpoint and scaffold thrombosis (ScT) rates were similar between STEMI (11.5% and 3.6%) and SCAD (12.9% and 3.3%) groups at three years.
- Late/very late ScT was observed in STEMI patients, whereas early ScT was more frequent in SCAD patients.
- Vessel size and scaffold sizing were critical predictors of events, with undersizing predicting events in STEMI and oversizing in SCAD.
- Optimized implantation techniques significantly reduced ScT incidence in both patient groups.
Conclusions:
- Three-year event incidence is comparable between STEMI and SCAD patients treated with BRS.
- Scaffold thrombosis characteristics (timing and predictors) differ between STEMI and SCAD.
- Optimized implantation and appropriate sizing are key to improving BRS safety and efficacy in diverse patient populations.
Background:
Little data are available on the long-term outcomes of bioresorbable scaffold (BRS) in the setting of ST-segment elevation myocardial infarction (STEMI). The aim of this study is to investigate three-years outcomes and predictors of BRS failure in patients presenting with STEMI.
Methods And Results:
Two prospective, single-arm registries were pooled. Incidence and predictors of clinical outcome were assessed with Kaplan-Meier and Cox regression analyses. From May-2012 to January-2015, 183 STEMI patients (58 ± 13 years, 77% males, 29% diabetics) who received a total of 256 BRS (1.4 ± 0.8 per patient) were included. 248 patients (65 ± 11 years, 74% males, 27% diabetics) treated for stable coronary artery disease (SCAD) served as control. 3-years follow-up was available in 386 (90%) patients. Device-oriented composite endpoint and scaffold thrombosis (ScT) rates were similar in the two groups (STEMI: 11.5% vs SCAD: 12.9%, P = 0.84; STEMI: 3.6% vs SCAD: 3.3%, P = 0.90). While early ScT was more frequent in SCAD patients, late/very late ScT was a feature of STEMI. While in STEMI patients the incidence of ScT was higher in vessels with RVD > 3.5 mm, a RVD < 2.5 mm was a predictor of events in stable patients. Similarly, BRS undersizing predicted events in STEMI patients, while oversizing was a predictor in stable ones. Finally, the incidence of ScT was reduced in both STEMI and stable patients (from 6.3% to 0% and from 5.80% to 0.9%) when an optimized implantation technique was used.
Conclusions:
The incidence of events for three years follow-up was similar in STEMI and SCAD patients, although different timing and features underlie ScT in the two groups.
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