Giuseppe Tarantini1, Giulia Masiero1, Alberto Barioli1, Valeria Paradies2, Georgios Vlachojannis2, Paola Tellaroli3, Bernardo Cortese4, Gaetano di Palma4, Attilio Varricchio5, Alfonso Ielasi6, Bruno Loi7, Giuseppe Steffenino8, Daisuke Ueshima1, Marco Mojoli1, Pieter Smits2. 1. Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. 2. Maastad Ziekenhuis, Rotterdam, Netherlands. 3. Biostatistics, Epidemiology and Public Health Unit of Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. 4. Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli, Italy. 5. Cardiology Division, Santa Maria della Pietà Hospital, Nola, Naples, Italy. 6. Cardiology Division, A.O. Bolognini, Seriate, Bergamo, Italy. 7. Cardiology Division, A.O. Brotzu, Cagliari, Italy. 8. USD Emodinamica, A.S.O. S.Croce e Carle, Cuneo, Italy.
Abstract
BACKGROUND: Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE: We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS: Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS: Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION: In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.
BACKGROUND:Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVDpatients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE: We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS:Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS: Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION: In this propensity-matched analysis pooling SVDpatients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.
Authors: Yaokun Liu; Bo Zheng; Bin Zhang; Robert Ndondo-Lay; Fangfang Nie; Naijie Tang; Yongsheng Miao; Jianping Li; Yong Huo Journal: Front Cardiovasc Med Date: 2022-07-22