Author + information
- Giuseppe Tarantini1,
- Marco Mojoli1,
- Giulia Masiero1,
- Bernardo Cortese2,
- Gaetano di Palma2,
- Giuseppe Steffenino3,
- Attilio Varricchio4,
- Alfonso Ielasi5,
- Bruno Loi6,
- Daisuke Ueshima7,
- Paola Tellaroli8,
- Valeria Paradies9,
- Georgios Vlachojannis10 and
- Pieter Smits11
- 1University of Padua - Department of Cardiac, Thoracic and Vascular Sciences, Padova, Padua, Italy
- 2Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli, Milan, Milan, Italy
- 3US Emodinamica, A.S.O.S. Croce e Carle, Cuneo, Cuneo, Italy
- 4Cardiology Division, Santa Maria della Pietà Hospital, Nola, NA, Italy, Naples, Naples, Italy
- 5Ospedale Bolognini, Seriate, Bergamo, Italy
- 6Interventional Cardiology Unit, Azienda Ospedaliera Brotzu, Cagliari, Cagliari, Italy
- 7Tokyo Medical and Dental University, Tokyo, Japan
- 8Biostatistics, Epidemiology and Public Health Unit of Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy, Padua, Padua, Italy
- 9National Heart Research Institute and National Heart Centre Singapore, Singapore, Singapore
- 10Maasstad Hospital, Rotterdam, Netherlands
- 11Maasstad Ziekenhuis, Rotterdam, Netherlands
Diabetes mellitus (DM) is associated with increased risk of subsequent events after PCI. To evaluate the impact of Absorb bioresorbable vascular scaffold (BVS) in this setting, we aimed to compare the 1-year outcomes of Absorb BVS versus 2nd generation drug eluting stents (DES) by pooling diabetic patients treated with BVS or DES from three large, prospective studies.
Patients with medically-treated DM and treated by Absorb BVS in the Italian multicenter RAI Registry and in the single-centre MAASSTAD-Absorb registry, or treated by XIENCE V/PRIME or PROMUS metallic stents in the COMPARE II trial, were pooled for analysis. A propensity score matching analysis of several pre-procedural clinical and angiographic variables was used. The implantation technique was not object of matching, being device-specific. The primary endpoints were a device-oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction and target lesion revascularization, and stent thrombosis.
Out of total 4635 enrolled subjects, 935 were diabetics. After matching, there were 189 matched pairs of patients. Clinical and angiographic characteristics of matched groups were highly comparable. As expected, pre-dilatation (98% vs. 67%, d-value 0.9) and post-dilatation (94% vs. 36%, d-value 1.3) rates remained significantly higher in the BVS group. At 30-day follow-up, we observed a numerically but not statistically significant increase of DOCE (1.6% vs. 05%, HR 3.0 [95%CI 0.3-28.9], p 0.3) and definite/probable stent thrombosis (ST) (1.6% vs. 05%, HR=3.0 [0.3-28.9], p=0.3) in the BVS vs. EES group. Conversely, 1-year DOCE was significantly higher in the BVS group (5.8% vs. 1.6%, HR 4.2 [1.1-15.4], p 0.03) mainly due to a higher TLR rate. Similarly, higher rates of ST were observed in the BVS group (3.2% vs. 0.5%, p=0.06, HR= 6.1 [0.7-51.7], p=0.1) at 1-year follow-up.
This propensity-matched analysis pooling diabetic patients of three large prospective studies, and comparing BVS versus 2nd generation DES, showed a higher rate of DOCE and ST in BVS-treated patients at 1 year.
CORONARY: Bioresorbable Vascular Scaffolds