Efecto de la técnica de implantación en los resultados en pacientes tratados con armazón bioabsorbible en diferentes escenarios clínicos
- Luis Ortega Paz 1
- Salvatore Brugaletta 1
- Davide Capodanno 2
- Joan A. Gómez-Hospital 3
- A. Íñiguez Romo 4
- Tommaso Gori 5
- Cristóbal Urbano Carrillo 6
- Holger M. Nef 7
- R. Trillo Nouche 8
- Azeem Latib 9
- Amparo Benedicto Buendía 10
- Giuseppe Caramanno 11
- Armando Pérez de Prado 12
- Carlo Di Mario 13
- Christoph K. Naber 14
- Pablo Salinas Sanguino 15
- J.M. Sanchís García 16
- Julinda Mehilli 17
- Pablo Piñón Esteban 18
- Dinis Martins 19
- Pablo Avanzas Fernández 20
- José Ramón López Mínguez 21
- Cristina Martins 22
- Ricardo Santos 23
- Alfonso Torres 24
- Iñigo Lozano 25
- Raúl Moreno Gómez 26
- Manel Sabaté Tenas 1
- Felipe Hernández Hernández 26
- Show all authors +
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1
Institut d'Investigacions Biomèdiques August Pi i Sunyer
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Institut d'Investigacions Biomèdiques August Pi i Sunyer
Barcelona, España
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2
Azienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele
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Azienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele
Catania, Italia
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3
Hospital Universitari de Bellvitge
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4
Hospital Álvaro Cunqueiro
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Hospital Álvaro Cunqueiro
Vigo, España
- 5 Kardiologische Abteilung, Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz, Mainz, Alemania
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6
Hospital Regional Universitario de Málaga
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- 7 Kardiologische Abteilung, Justus-Liebig-Universität Gießen, Giessen, Alemania
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8
Complexo Hospitalario Universitario de Santiago
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Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, España
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9
Vita-Salute San Raffaele University
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10
Hospital Universitario de la Princesa
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- 11 Divisione Clinicizzata di Cardiologia, Ospedale San Giovanni Di Dio Agrigento, Agrigento, Italia
- 12 Servicio de Cardiología, Fundación Investigación Sanitaria en León, León, España
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13
Azienda Ospedaliero-Universitaria Careggi
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Azienda Ospedaliero-Universitaria Careggi
Florencia, Italia
- 14 Kardiologische Abteilung, Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen, Alemania
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15
Hospital Clínico San Carlos de Madrid
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16
Universitat de València
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17
Ludwig Maximilian University of Munich
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18
Complexo Hospitalario Universitario da Coruña
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19
Hospital do Divino Espírito Santo
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20
Hospital Universitario Central de Asturias
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21
Hospital Infanta Cristina
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22
Hospital Garcia de Orta
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23
Hospital de São Bernardo
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24
Hospital Txagorritxu
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25
Hospital de Cabueñes
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- 26 Servicio de Cardiología, Hospital 12 de Octubre, Madrid, España
ISSN: 2604-7276, 2604-7306
Year of publication: 2019
Volume: 1
Issue: 2
Pages: 83-91
Type: Article
More publications in: REC: Interventional Cardiology
Abstract
Introduction and objectives: The PSP (pre-dilation, sizing and post-dilation) score, derived from the GHOST-EU registry, has evaluated the relationship between the implantation technique of bioresorbable scaffolds and the clinical outcomes. The objective was to perform an external validation of the PSP technique and to determine its effect on adverse cardiac events in various clinical and anatomical scenarios. Methods: Data from the REPARA registry (2230 patients) were used for external validation, whereas a common database combining REPARA and GHOST-EU (3250 patients) data was used to evaluate the effect of PSP technique in various clinical and anatomical scenarios. PSP-1 and PSP-3 were used to score the appropriateness of pre-dilation, scaffold sizing, and post-dilation. The primary endpoint was 1-year device-oriented composite endpoint of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization. The definite/probable scaffold thrombosis according to the Academic Research Consortium criteria was also evaluated. Results: A total of 303 (18.2%) patients were treated with an optimal PSP-1, and 182 (8.2%) with an optimal PSP-3. The external validation showed that PSP has a very high negative predictive value for device-oriented composite endpoint and scaffold thrombosis (91.8% and 89.1% for PSP-1; 98.4% and 97.3% for PSP-3, respectively). Patients with an optimal PSP-3 had a numerically lower rate of device-oriented composite endpoint and scaffold thrombosis compared to those without it (0.5% vs 2.9%; P = .085 and 0.5% vs 1.8%; P = .248, respectively). In the merged database, PSP benefits were seen on many scenarios, except in the ST-segment elevation myocardial infarction where a trend towards no benefit of an optimal PSP technique was present (Pinteraction = .100). Conclusions: In the REPARA registry, at 1-year follow-up, an optimal PSP technique was not associated with a lower rate of device-oriented composite endpoint. Further research is necessary to assess the impact of the PSP technique in longer follow-ups.
Bibliographic References
- 1. Ali ZA, Serruys PW, Kimura T, et al. 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease:a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet. 2017;390:760-772.
- 2. Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II):a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016;388:2479-2491.
- 3. Wykrzykowska JJ, Kraak RP, Hofma SH, et al. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017;376:2319-2328.
- 4. Capodanno D, Angiolillo DJ. Antiplatelet Therapy After Implantation of Bioresorbable Vascular Scaffolds:A Review of the Published Data, Practical Recommendations, and Future Directions. JACC Cardiovasc Interv. 2017;10:425-437.
- 5. Puricel S, Cuculi F, Weissner M, et al. Bioresorbable Coronary Scaffold Thrombosis:Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol. 2016;67:921-931.
- 6. Tamburino C, Latib A, van Geuns RJ, et al. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds:a European perspective. EuroIntervention. 2015;11:45-52.
- 7. Ortega-Paz L, Capodanno D, Gori T, et al. 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. EuroIntervention. 2017;12:2110-2117.
- 8. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials:a case for standardized definitions. Circulation. 2007;115:2344-2351.
- 9. Collins GS, Reitsma JB, Altman DG, and Moons KG. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD):the TRIPOD statement. Ann Inter Med. 2015;162:55-63.
- 10. Steyerberg EW, Vickers AJ, Cook NR, et al. Assessing the performance of prediction models:a framework for traditional and novel measures. Epidemiology. 2010;21:128-138.
- 11. Stone GW, Abizaid A, Onuma Y, et al. Effect of Technique on Outcomes Following Bioresorbable Vascular Scaffold Implantation:Analysis From the ABSORB Trials. J Am Coll Cardiol. 2017;70:2863-2874.
- 12. Tijssen RYG, Kraak RP, Elias J, et al. Implantation techniques (predilatation, sizing, and post-dilatation) and the incidence of scaffold thrombosis and revascularisation in lesions treated with an everolimus-eluting bioresorbable vascular scaffold:insights from the AIDA trial. EuroIntervention. 2018;14:e434-e442.
- 13. McGee S. Simplifying likelihood ratios. J Gen Intern Med. 2002;17:646-649.
- 14. Steinvil A, Rogers T, Torguson R, and Waksman R. Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System. JACC Cardiovasc Interv. 2016;9:1757-1764.
- 15. Zhang ZJ, Marroquin OC, Stone RA, et al. Differential effects of post-dilation after stent deployment in patients presenting with and without acute myocardial infarction. Am Heart J. 2010;160:979-986 e1.
- 16. Fernandez-Rodriguez D, Regueiro A, Brugaletta S, et al. Optimization in stent implantation by manual thrombus aspiration in ST-segment-elevation myocardial infarction:findings from the EXAMINATION trial. Circ Cardiovasc Interv. 2014;7:294-300.
- 17. Kocka V, Maly M, Tousek P, et al. Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction:a prospective multicentre study 'Prague 19'. Eur Heart J. 2014;35:787-794.
- 18. Ielasi A, Campo G, Rapetto C, et al. A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction:The BVS STEMI STRATEGY-IT Study. JACC Cardiovasc. Interv. 2017;10:1855-1864.
- 19. Hioki H, Brugaletta S, Ishida K, et al. Impact of Absorb bioresorbable scaffold implantation technique on post-procedural quantitative coronary angiographic endpoints in ST-elevation myocardial infarction:a sub-analysis of the BVS STEMI STRATEGY-IT study. EuroIntervention. 2018. http://dx.doi.org/10.4244/EIJ-D-18-00504.