Author + information
- Giulia Masiero1,
- Marco Mojoli1,
- Alberto Barioli2,
- Valeria Paradies3,
- Bernardo Cortese4,
- Gaetano di Palma4,
- Attilio Varricchio5,
- Alfonso Ielasi6,
- Bruno Loi7,
- Mostafa Rabea Abdelhaleem Badawy8,
- Paola Tellaroli9,
- Giuseppe Steffenino10,
- Pieter Smits11 and
- Giuseppe Tarantini1
- 1University of Padua - Department of Cardiac, Thoracic and Vascular Sciences, Padova, Padua, Italy
- 2University of Padua - Department of Cardiac, Thoracic and Vascular Sciences, Treviso, Venice, Italy
- 3National Heart Research Institute and National Heart Centre Singapore, Singapore, Singapore
- 4Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli, Milan, Milan, Italy
- 5Cardiology Division, Santa Maria della Pietà Hospital, Nola, NA, Italy, Naples, Naples, Italy
- 6Ospedale Bolognini, Seriate, Bergamo, Italy
- 7Interventional Cardiology Unit, Azienda Ospedaliera Brotzu, Cagliari, Cagliari, Italy
- 8Cardiology Department, Minia, Egypt
- 9Biostatistics, Epidemiology and Public Health Unit of Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy, Padua, Padua, Italy
- 10US Emodinamica, A.S.O. S. Croce e Carle, Cuneo, Cuneo, Italy
- 11Maasstad Ziekenhuis, Rotterdam, Netherland
Small vessel disease (SVD) is a predictor of adverse outcome in patients treated by percutaneous coronary intervention (PCI), both in term of patient- and device-related events. Concerns have been raised with bioresorbable vascular scaffolds (BVS) in this subset. We aimed to compare outcomes of BVS versus a 2nd generation metallic stent in the SVD setting by pooling patients from three large, prospective studies.
Patients with SVD and treated with Absorb BVS were identified in the multicenter RAI Registry and the single-centre MAASSTAD-Absorb registry, while control patients treated with XIENCE V / PRIME or PROMUS metallic stents were identified in the COMPARE II trial. SVD was defined as target lesion(s) with a reference vessel diameter (RVD) ≤2.75 mm by QCA. Patients with a bypass graft stenosis or with multiple target lesions including non-SV lesions (RVD above 2.75 mm) were excluded. We compared clinical outcomes of patients treated by BVS or everolimus-eluting stents (EES) by performing a propensity score matching analysis using several pre-procedural clinical and angiographic variables. Implantation technique was not object of matching, being device-specific.
Out of total 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, 337 pairs of patients were obtained. Pre-procedural characteristics of matched groups were highly comparable, with a high degree of clinical and angiographic complexity in both groups. As expected, pre- and post-dilation rates were significantly higher in the BVS group. No differences were found between BVS versus EES in terms of device-oriented composite end-point (DOCE) at 1-year (HR=1.08, 95%CI 0.5-2.3, p=0.8) and 2-years follow-up (HR=1.28, 95% CI: 0.68-2.43, p=0.5). Notwithstanding, higher incidence of definite/probable stent/scaffold thrombosis (ST) was observed in the BVS versus EES group at 1 year (0.3% vs. 1.3%, HR 4.7, 95%CI 0.8-31.4, p=0.08) and 2 years (0.3% vs. 1.8, HR=8.34 95%CI 1.1-60.2, p=0.04).
In this propensity-matched analysis pooling SVD patients of three large prospective studies, the incidence of device-related events was comparable between BVS and EES, apart from a higher ST rate in BVS.
CORONARY: Bioresorbable Vascular Scaffolds