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One-year clinical results of the Italian diffuse/multivessel disease ABSORB prospective registry (IT-DISAPPEARS)

1. Department of Cardiology, IRCCS Policlinico S. Donato, Milan, Italy; 2. Department of Clinical and Experimental Medicine, University of Pisa, Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy; 3. Department of Cardiovascular Sciences, European Hospital, Rome, Italy; 4. Catheterization Laboratory, Sanremo Hospital, Sanremo, Italy; 5. Division of Cardiology, “Infermi” Hospital, Rivoli, Italy; 6. Catheterization Laboratory, Interventional Cardiology, “Fatebenefratelli” Hospital, Milan, Italy; 7. Azienda Ospedaliero-Universitaria Ancona, Ancona, Italy; 8. Department of Cardiology, Ospedale S. Giovanni di Dio, Agrigento, Italy; 9. Azienda Ospedaliera Brotzu, Cagliari, Sardinia; 10. Ospedale S. Giovanni Bosco, Turin, Italy; 11. Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari, Policlinico Universitario, Padua, Italy; 12. Cardiologia Interventistica ed Emodinamica, Ospedale Vito Fazzi, Lecce, Italy; 13. Catheterization Laboratory, “Misericordia” Hospital, Grosseto, Italy; 14. Department of Medicine, University of Verona, Verona, Italy; 15. Cardiovascular Department, University of Catania, Catania, Italy; 16. Department of Medical and Surgical Sciences, University “Magna Graecia”, Catanzaro, Italy; 17. Monzino Cardiology Hospital, University of Milan, Milan, Italy

Aims: The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study.

Methods and results: Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac death occurred in five patients (0.5%), while target vessel MI and TLR each occurred in 45 (4.7%) patients. The one-year rates of all-cause death, non-fatal MI, and any revascularisation were 1.2%, 5.4%, and 10.9%, respectively. The rate of definite/probable scaffold thrombosis was 0.9%.

Conclusions: This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease. The mandatory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies, in particular with respect to the rate of DOCE and scaffold thrombosis. (ClinicalTrials.gov: NCT02004730)

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