First-in-human evaluation of a novel poly-L-lactide based sirolimus-eluting bioresorbable vascular scaffold for the treatment of de novo native coronary artery lesions: MeRes-1 trial

AIMS: The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold (MeRes100 BRS) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities. METHODS AND RESULTS: The MeRes-1 first-in-human trial was a single-arm, prospective, multicentre study, which enrolled 108 patients with de novo coronary artery lesions (116 scaffolds were deployed to treat 116 lesions in 108 patients). At six months, quantitative coronary angiography revealed in-scaffold late lumen loss of 0.15±0.23 mm with 0% binary restenosis. Optical coherence tomography demonstrated minimum scaffold area (6.86±1.73 mm2) and percentage neointimal strut coverage (99.30%). Quantitative intravascular ultrasound analysis confirmed a 0.14±0.16 mm2 neointimal hyperplasia area. At one year, major adverse cardiac events, a composite of cardiac death, any myocardial infarction and ischaemia-driven target lesion revascularisation, occurred in only one patient (0.93%) and there was no scaffold thrombosis reported. At one year, computed tomography angiography demonstrated that all scaffolds were patent and in-scaffold mean percentage area stenosis was 11.33±26.57%...

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).

Impact of post-dilation on the acute and one-year clinicaloutcomes of a large cohort of patients treated solely with theAbsorb Bioresorbable Vascular Scaffold

Aims: We sought to determine the impact of post-dilation (PD) on clinical outcomes in a large cohort of patients treated only with the Absorb Bioresorbable Vascular Scaffold (BVS).Methods and results: We evaluated all consecutive patients enrolled in the multicentre, single-arm ABSORB EXTEND study up to June 2013. The study allowed treatment of up to two coronaries (diameter 2.0 to 3.8 mm) and the use of overlapping (lesion length ²28 mm). Patients with severe lesion calcification/tortuosity were excluded. Aggressive lesion predilation (balloon to artery ratio of 0.9-1.0) was mandatory, and PD was left to the operator’s discretion. Patients were grouped according to whether PD was performed or not, and the one-year incidences of MACE and scaffold thrombosis were compared. A total of 768 patients were enrolled in the study; PD was performed in 526 (68.4%). There were no significant differences between the PD group and non-PD group in the majority of baseline characteristics, including the presence of mod-erate calcification and of B2/C lesions. Lesion length was similar (12.3±5.1 mm vs. 12.1±5.3 mm, p=0.6), as was RVD (2.6 mm for both groups, p=0.2). Residual in-scaffold stenosis (15.5±6.4% with PD, 15.0±6% without PD, p=0.3) and the need for bail-out scaffold/stent (4.2% with PD, 4.6% without PD, p=0.8) were comparable. Acute gain was higher in the non-PD group (1.14±0.3 mm vs. 1.21±0.4 mm, p=0.02). Clinical device success was 98.9% in both groups. At one year, there was no difference in MACE (5.4% in the PD group vs. 2.5% in the non-PD group, p=0.1). All individual components of TLR, death, and MI were similar as well as definite/probable scaffold thrombosis between the two groups...

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).

Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice

Background—The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and Results—Between April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of 1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7 11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade 3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. Conclusions—This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

Safety of coronary sirolimus-eluting stents in daily clinical practice one-year follow-up of the e-cypher registry

Background—The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and Results—Between April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of 1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7 11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade 3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. Conclusions—This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials