The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled

Aims: The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system(Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A andcohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a globalcontinued access study (outside of the USA) to expand experience with the Absorb BVS system to differentgeographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels.We report in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population.Methods and results: ABSORB EXTEND is a prospective, single-arm, open-label clinical study whichwill enrol up to 800 patients at up to 100 sites. Included are patients with lesions ≤28 mm in length and referencevessel diameter of 2.0-3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum oftwo de novo native coronary artery lesions is permitted when each lesion is located in a different epicardialvessel. An independent clinical events committee adjudicates all endpoint-related events. At one year, for thefirst 512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemiadriventarget vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definiteand probable scaffold thrombosis for this population was 0.8% at one year.Conclusions: This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffoldthrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

The ABSORB EXTEND study: preliminary report of the twelvemonth clinical outcomes in the first 512 patients enrolled

Aims: The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system(Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A andcohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a globalcontinued access study (outside of the USA) to expand experience with the Absorb BVS system to differentgeographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels. Wereport in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population.Methods and results: ABSORB EXTEND is a prospective, single-arm, open-label clinical study whichwill enrol up to 800 patients at up to 100 sites. Included are patients with lesions ≤28 mm in length and referencevessel diameter of 2.0-3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum of twode novo native coronary artery lesions is permitted when each lesion is located in a different epicardial vessel.An independent clinical events committee adjudicates all endpoint-related events. At one year, for the first512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemia-driventarget vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definite andprobable scaffold thrombosis for this population was 0.8% at one year.Conclusions: This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffoldthrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Avaliação do stent coronário eluidor de everolimus XIENCE TM V na cpopulação feminina latino-americana do estudo de braço único SPIRIT Women: acompanhamento clínico de um ano / Evaluation of the XIENCE TM V everolimus-eluting coronary stent system in the female latin american population of the SPIRIT Women single-arm study: one-year clinical follow-up data

INTRODUÇÃO: Os estudos com stents farmacológicos têm avaliado predominantemente populações masculinas de descendência europeia. O estudo de braço único SPIRIT Women avalia o stent eluidor de everolimus XIENCE TM V em lesões de novo complexas em uma população feminina do mundo real, incluindo pacientes latino-americanas. Esta análise permite compreender como essa população responde ao implante de stent, comparativamente a pacientes não-latino-americanas. MÉTODOS: Das 1.572 pacientes matriculadas em 73 locais fora dos Estados Unidos, 138 (9%) foram recrutadas na Argentina, no Brasil e na Venezuela. RESULTADOS: As lesões-alvo tinham diâmetro de referência do vaso entre 2,25 mm e 4 mm e extensão da lesão ≤ 28 mm. As características basais foram semelhantes entre os grupos, com exceção de maior prevalência de hipertensão arterial, infarto do miocárdio (IM) de parede anterior e história familiar de doença arterial coronária na coorte latino-americana. As lesões tendiam a ser mais complexas em mulheres latino-americanas, com menor diâmetro de referência do vaso-alvo, maior extensão da lesão, maior excentricidade e angulação e mais lesões tipo B2/C. Os eventos foram adjudicados de acordo com as definições do Academic Research Consortium. Em um ano, o desfecho combinado de morte por todas as causas, IM e revascularização do vaso-alvo (RVA) foi de 12,1% na população não-latino-americana e de 10,1% na população latino-americana (P = 0,58). CONCLUSÕES: Em um ano, os baixos índices de eventos cardíacos adversos, incluindo trombose do stent, falha da lesão-alvo, morte cardíaca, IM e RVA nas mulheres latino-americanas foram comparáveis aos das mulheres não-latino-americanas, apesar da maior complexidade das lesões. Esses resultados demonstram a segurança e a eficácia do stent XIENCE TM V nessa pequena coorte de pacientes latino-americanas, à semelhança do que é observado com populações maiores e mais variadas.

BACKGROUND: Drug-eluting stent trials have predominantly examined male populations of European descent. SPIRIT Women single-arm study evaluates the XIENCE TM V everolimus-eluting stent in complex de novo lesions in a real world female population, including Latin American patients. This analysis provides an insight into how this population responds to stenting when compared to non-Latin American patients. METHODS: Of the 1,572 patients enrolled from 73 non-US sites, 138 (9%) were recruited from Argentina, Brazil and Venezuela. RESULTS: Target lesions had reference vessel diameter ranging between 2.25 mm and 4 mm and lesion length ≤ 28 mm. Baseline characteristics were similar between the groups, with exception to a higher prevalence of hypertension, anterior myocardial infarction (MI) and family history of coronary artery disease in the Latin American cohort. Lesions tended to be more complex in Latin American women with a smaller reference vessel diameter, longer lesion length, increased eccentricity and angulation, and more type B2/C lesions. Events were adjudicated according to the guidelines of the Academic Research Consortium. At 1 year, the composite endpoint of death, MI and target vessel revascularization (TVR) was 12.1% in the non-Latin American population and 10.1% in the Latin American population (P = 0.58). CONCLUSIONS: At 1 year, the low rates of adverse cardiac events, including stent thrombosis, target lesion failure, cardiac death, MI and TVR in Latin American women were comparable to those of the non-Latin American women, despite the higher complexity of lesions. These results demonstrate the safety and efficacy of the XIENCE TM V stent in this small cohort of Latin American patients, in line with what is observed in larger and more varied populations.