BACKGROUND: BeGraft Aortic stent (Bentley InnoMed, Hechingen, Germany) allows large postdilation diameter up to 30 mm. With availability of lengths of 19-59 mm and lower stent profile, they can be used in native and recurrent CoA in adults and in pediatric patients.

MATERIALS AND METHODS: This is a multicentre retrospective analysis of 12 implanted BeGraft Aortic stents in CoA between May 2017 and April 2019.

RESULTS: Twelve patients aged 7.7-38 years (median 18.3 years) with body weight of 19.9-56 kg (median 45.5 kg). Eight patients (66%) had native juxtaductal CoA while four had recurrent CoA after previous surgical or transcatheter treatments. The stents were implanted successfully in all the patients with no serious adverse events. The length of the stents ranged from 27 to 59 mm and the implanted stent diameter varied from 12 to 18 mm. The median intraprocedural CoA pressure gradient decreased from 25 mmHg (range 16-66 mmHg) to 2 mmHg (range 0-13 mmHg). The mean follow-up duration was 10.2 months. Two patient (16.6%) had residual stent narrowing requiring staged redilation. One patient (8%) had pseudoaneurysm formation at 1 year cardiac CT follow-up.

METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR).

RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups.

MATERIALS AND METHODS: Twenty surviving patients with expandable endoprosthesis from 2006 till 2015 were scored using Musculoskeletal Tumour Society (MSTS) outcomes instrument and reviewed retrospectively for range of motion of respected joints, limb length discrepancy, number of surgeries performed, complications and oncological outcomes. Patients with less than 2 years of follow-up were excluded from this study.

RESULTS: Forty-five percentage patients reached skeletal maturity with initial growing endoprosthesis and 25% of patients were revised to adult modular prosthesis. One hundred fifty-seven surgeries were performed over the 9-year period. The average MSTS score was 90.83%. The mortality rate was 10% within 5 years due to advanced disease. Infection and implant failure rate was 15% each. The event-free survival was 50% and overall survival rate was 90%.

METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.

RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).

METHODS: The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization.

RESULTS: A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12).

CONCLUSION: The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS.