Author + information
- Marco Mojoli1,
- Giuseppe Tarantini1,
- Giulia Masiero1,
- Bruno Loi2,
- Bernardo Cortese3,
- Alfonso Ielasi4,
- Attilio Varricchio5,
- Luciano Moretti6,
- Leonardo Misuraca7,
- Giampaolo Pasquetto8,
- Paolo Calabro'9,
- Donatella Corrado10 and
- Giuseppe Steffenino11
- 1University of Padua - Department of Cardiac, Thoracic and Vascular Sciences, Padova, Padua, Italy
- 2Interventional Cardiology Unit, Azienda Ospedaliera Brotzu, Cagliari, Cagliari, Italy
- 3Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli, Milan, Milan, Italy
- 4Ospedale Bolognini, Seriate, Bergamo, Italy
- 5Cardiology Division, Santa Maria della Pietà Hospital, Nola, NA, Italy, Naples, Naples, Italy
- 6Division of Cardiology, Mazzoni Hospital; Ascoli Piceno, Ascoli Piceno, Macerata, Italy
- 7Cardiology Unit, Ospedale della Misericordia, Grosseto, Grosseto, Grosseto, Italy
- 8Ospedali Riuniti Padova Sud, Este, Padua, Italy
- 9Division of Cardiology, Department of Cardio-Thoracic Sciences, Università degli Studi della Campania “Luigi Vanvitelli, Napoli, Naples, Italy
- 10“Mario Negri” Research Institute, Milan, Chieti, Italy
- 11US Emodinamica, A.S.O. S. Croce e Carle, Cuneo, Cuneo, Italy
Diabetes mellitus (DM) is a major predictor of poor prognosis following percutaneous coronary intervention. We aimed to assess the interplay between the use of bioresorbable scaffold (BRS) and DM in a large multicentre registry.
The RAI (Registro Absorb Italiano) Registry is a large, prospective registry, investigating the outcomes of the Absorb BVS (ABBOTT Vascular, Santa Clara, CA) implantation in an “all-comers” setting. We identified patients with at least 12-months follow-up and assessed the clinical outcomes of diabetic patients compared to non-DM controls. Patients treated with Absorb BVS because of in-stent restenosis or bypass graft disease were excluded from current analysis.
Out of 1505 consecutively enrolled patients, 1183 were eligible for this analysis (DM, 231 patients; non-DM, 952 patients). Acute coronary syndromes were >55% in both cohorts. Compared to controls, DM patients were significantly older (62 vs. 58 years, p<0.001), with higher SYNTAX score (13±7 vs. 11±7, p=0.005), prevalence of multivessel disease (69% vs. 54%, p<0.001) and calcified lesions (29% vs. 19%, p<0.001). A similar number of BRS per patient were used in both groups (1.5± 0.7), but with higher average scaffold length in the DM group (38±23 mm vs. 34±22, p=0.04). Pre- and post-dilatation rates were similar (>96%) between groups. At 1-year follow-up, no differences were found between groups in terms of a device-oriented composite end-point (DOCE) (4.3% vs. 6.6%; p=0.6) or its individual components (cardiac death, target-vessel myocardial infarction and ischemia-driven TLR). Conversely, the incidence of the patient-oriented composite end-point (POCE) was significantly higher in DM vs. non-DM cohorts (16% vs. 11%; p=0.02), mainly driven by a greater rate of non-TLRs. Definite and probable scaffolds thrombosis (ST) rate was similar (2.2% vs. 1.2%, p=0.2).
In this subanalysis of the large RAI Registry, diabetic and non-diabetic patients had similar incidence of device-related events at 1-year follow-up. Conversely, patient-related adverse events were significantly higher in the DM group compared to non-DM controls.
CORONARY: Bioresorbable Vascular Scaffolds