Clinical Outcomes of Patients Treated With the Bioresorbable Scaffold

Abstract

Bioresorbable scaffold (BRS) is a novel device to treat coronary lesions. It may induce a revolution in percutaneous coronary intervention (PCI) and a novel treatment termed vascular restoration therapy. These devices provide short-term scaffolding of the vessel and then dissolve, which would treat the plaque and coronary lumen without inflicting a permanent foreign body in the coronary artery. This study sought to describe scaffolding in a cohort of Tunisian coronary diseased patients and assess its immediate and mid-term outcomes.
Twenty nine patients with 42 lesions were enrolled. Mean age was 51.4 years. Mean number of scaffolds per patient was 1.57. Our population was at high cardiovascular risk cumulating at least 3 risk factors. Most of them presented with an acute coronary syndrome (66.6%). In 76.1% there were type A/B1 lesions. Moderate calcification was present in 42.2%. Bifurcation lesions were present in 21.3% and just one chronic total occlusion was treated. Clinical device success and clinical procedural success were respectively 93.1% and 90.3%.Using Kaplan-Meier methods. At 18 months :
- The major adverse cardiac events (MACE) rate was 44.8%.
- The probability of survival without target lesion revascularization (TLR) was 59.5%.
- Definite or Possible scaffold thrombosis rate was 6.9%.
In our study, BRS implantation was associated with a high rate of adverse events in the longer term except in case of IVUS guidance with respect of Predilatation + Sizing + Postdilatation (PSP) protocol. The theoretical concept of Scaffolding is attractive. One must put into perspective that it is still significantly evolving and improving.