Effect of implantation technique on outcomes in patients receiving bioresorbable scaffolds in various clinical scenarios

Luis Ortega-Paz, Salvatore Brugaletta, Davide Capodanno, Joan A. Gomez-Hospital, Andres Iniguez, Tommaso Gori, Cristobal Urbano, Holger Nef, Ramiro Trillo, Azeem Latib, Amparo Benedicto, Giuseppe Caramanno, Armando Perez de Prado, Carlo Di Mario, Christoph Naber, Pablo Salinas, Juan Sanchis, Julinda Mehilli, Pablo Pinon, Dinis MartinsPablo Avanzas, Jose R. Lopez-Minguez, Cristina Martins, Ricardo Santos, Alfonso Torres, Inigo Lozano, Raul Moreno, Manel Sabate, Felipe Hernandez

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)83-91
Number of pages9
JournalREC: Interventional Cardiology
Volume1
Issue number2
DOIs
StatePublished - Jul 2019
Externally publishedYes

Keywords

  • Bioresorbable scaffolds
  • Bioresorbable vascular scaffolds
  • Coronary artery disease
  • Percutaneous coronary intervention

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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