RESUMO
Background: Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. Methods: The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. Results: The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16). Conclusions: The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.
RESUMO
BACKGROUND: Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. METHODS: The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. RESULTS: The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs.
Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Doenças Cardiovasculares , EverolimoRESUMO
AIMS: The aim of this study was to evaluate the safety and efficacy of the BioMime sirolimus-eluting coronary stent (SES) compared to the XIENCE family of everolimus-eluting coronary stents (EES) in the treatment of patients with de novo native coronary artery lesions. METHODS AND RESULTS: The meriT-V is a prospective, multicentre, randomised, open-label, active-controlled, non-inferiority trial. A total of 256 patients with up to two de novo native coronary artery lesions were enrolled and randomly assigned (2:1) to BioMime SES or XIENCE EES. BioMime SES was non-inferior to XIENCE EES for the primary endpoint of in-stent late lumen loss (0.15±0.27 mm vs. 0.15±0.29 mm; difference: -0.006 mm; 95% confidence interval: -0.085 to 0.072; p=0.87; p for non-inferiority <0.0001) at nine-month follow-up. The major adverse cardiac events rate was numerically lower in the BioMime SES group (2.98% vs. 7.14%; p=0.13), driven by a statistically significant lower risk of any myocardial infarction (0.60% vs. 4.76%; p=0.03), when compared with the XIENCE EES group. There was no difference in target vessel myocardial infarction (p=0.62) between the groups. There was no definite or probable stent thrombosis in either group. CONCLUSIONS: In the treatment of de novo native coronary artery lesions, the biodegradable polymer ultra-thin SES (BioMime) was non-inferior to a durable polymer EES (XIENCE) at nine-month follow-up. Further studies powered for clinical endpoints are needed.
Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Everolimo , Humanos , Polímeros , Estudos Prospectivos , Sirolimo , Resultado do TratamentoRESUMO
AIMS: Earlier generation self-expanding stents (SExS) showed high restenosis rates and long-term stent over-expansion. A novel SExS with reduced outward expansive force has been developed to overcome these limitations. This first-in-human study aimed to evaluate the safety and feasibility of the low pressure self-expanding nitinol-based vProtect™ luminal shield (LS) in the treatment of intermediate coronary lesions. METHODS AND RESULTS: A total of 29 patients with clinical evidence of myocardial ischaemia and intermediate de novo coronary lesions were included. The LS was deployed after low-pressure balloon pre-dilatation. Acute procedural and device success was achieved in all patients. Angiographic follow-up at nine months showed an in-stent lumen loss of 0.50±0.30 mm and a binary restenosis rate of 10.3%. There were no cases of late LS over-expansion or acute/late malapposition as evaluated by intravascular ultrasound (IVUS). The cumulative major adverse cardiac events (MACE) rate at nine months was 10.3%, consisting of three target lesion revascularisations, with no cases of death, myocardial infarction or stent thrombosis. CONCLUSIONS: Implantation of the LS in non-complex coronary lesions of intermediate severity was feasible, safe, and resulted in low rates of late loss and restenosis. IVUS analysis at nine months showed favourable mechanical properties of the LS without evidence of late device over-expansion.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Stents , Idoso , Ligas , Angioplastia Coronária com Balão/efeitos adversos , Colômbia , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
In large clinical trials enrolling patients with acute coronary syndromes, a high loading dose of clopidogrel (600 mg) has been found to be more effective compared to a low loading dose (300 mg). However, the applicability of these data to stable patients who undergo elective percutaneous coronary intervention is still unclear. A total of 400 patients who underwent elective PCI were prospectively randomized to receive either 600 mg (n = 200) or 300 mg (n = 200) of clopidogrel, followed by a daily maintenance dose of 75 mg. The primary end point was the presence of major adverse cardiovascular events (combined death, myocardial infarction, acute neurologic event, stent thrombosis, and need for percutaneous or surgical revascularization of the target vessel) during hospitalization and at 30 days. The secondary end point was periprocedural vascular complications, major bleeding, and cardiac enzyme elevation. There were no differences in the primary end point among the groups immediately after the procedure (3.5% of patients in the 300-mg group vs 4.5% of those in the 600-mg group, p = 0.799) or at 30 days (6% vs 5%, respectively, p = 0.826). The rates of periprocedural vascular complications (2.5% vs 3%, respectively, p = 1.00), bleeding complications (9% vs 8.5%, respectively, p = 1.00), and cardiac enzyme elevation (11% vs 15.5%, respectively, p = 0.317) were similar between the 2 groups. In conclusion, adverse cardiovascular events and bleeding complications during the initial hospitalization and at 30-day follow-up were similar when a 600-mg loading dose of clopidogrel was used compared to the conventional dose of 300 mg.