Long-term follow-up of BVS from a prospective multicenter registry: Impact of a dedicated implantation technique on clinical outcomes

Damiano Regazzoli, Azeem Latib, Babu Ezhumalai, Akihito Tanaka, Pier Pasquale Leone, Sara Khan, Vijay Kumar, Vishal Rastogi, Marco Bruno Ancona, Antonio Mangieri, Francesco Giannini, Satoru Mitomo, Ashok Seth, Antonio Colombo

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Objectives: The aim of this study was to evaluate the impact of a consistent and dedicated implantation strategy on long-term outcomes after implantation of bioresorbable vascular scaffold (BVS) in a real-world cohort of patients with a high prevalence of complex lesions. Background: Bioresorbable vascular scaffolds may result in a reduced incidence of late and very-late scaffold thrombosis (ScT) after the complete reabsorption of the scaffold, but this hypothesis is hampered by data from RCTs that showed a higher than expected incidence of late events. However, these studies did not adopt a dedicated implantation technique, that proved to be fundamental in reducing the incidence of adverse events. Methods: 573 consecutive patients (912 lesions) treated with bioresorbable scaffolds between May 2012 and December 2014 were enrolled in 3 high-volume centers that used a dedicated implantation strategy from the beginning. Primary endpoints were target-lesion failure (TLF) and definite and probable ScT. Secondary endpoints included myocardial infarction, target-lesion and target-vessel revascularization. Results: The registry enrolled a high complexity subset of lesions (69.4% of type B2 or C lesions; 10.3% of severe calcific lesions; 26.1% of bifurcations). Predilatation was performed in almost all cases (99.2%); intracoronary imaging was liberally adopted (37.3%). Mean scaffold length was 42.9 ± 27.4 mm per patient, and post-dilation with a 1:1 high-pressure (22 ± 3.5 atm) balloon was performed in 99.9% of lesions. Median follow-up (available for 98.6% of patients) was 981 days (IQR 802–1133). Overall incidence of ScT was reassuringly low: three thrombotic events occurred during the first year (0.5%), while only one event ensued in the second year of follow-up, and ScT rate remained stable thereafter up to the fourth year (0.7%). Cumulative TLF rates at 1, 2, 3 and 4 years were 3.0%, 6.0%, 7.8% and 12.2%. Conclusions: These long-term results from a complex “real-world” population appear to be reassuring as regards to the incidence of ScT and TLF when BVS are implanted by experienced operators with a dedicated implantation technique.

Original languageEnglish (US)
Pages (from-to)113-117
Number of pages5
JournalInternational Journal of Cardiology
Volume270
DOIs
StatePublished - Nov 1 2018
Externally publishedYes

Keywords

  • Bioresorbable scaffolds
  • Implant technique
  • Scaffold thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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