Two-year clinical outcomes of the “Italian diffuse/multivessel disease absorb prospective registry” (IT-DISAPPEARS)

Marco De Carlo, Luca Testa, Massimo Leoncini, Elisa Nicolini, Ferdinando Varbella, Bernardo Cortese, Flavio Ribichini, Antonio L. Bartorelli, Paolo Calabria, Ciro Indolfi, Fabrizio Tomai, Bruno Loi, Dionigi Fischietti, Giuseppe Tarantini, Francesco Bedogni, A. Sonia Petronio

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Large prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. Methods: We enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. Results: Clinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47 ± 22 mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5 mm scaffolds were independent predictors of DOCE. Conclusions: The 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.

Original languageEnglish
Pages (from-to)21-26
Number of pages6
JournalInternational Journal of Cardiology
Volume290
DOIs
Publication statusPublished - Sep 1 2019

Keywords

  • Bioresorbable scaffolds
  • Diffuse coronary artery disease
  • Multiple vessel disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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