Search

AIMS The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p

Aims: The study sought to compare the acute gain and two-year follow-up late lumen loss (LLL) between the Absorb bioresorbable vascular scaffold (BVS) and the analogous everolimus-eluting metallic stent (EES). Methods and results: The current analysis included all the patients recruited in the ABSORB Cohort B and SPIRIT II trials implanted with a single 3.0x18 mm device (Absorb BVS or EES) who underwent serial angiographic examinations at baseline and at two-year follow-up. The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD). The in-stent/scaffold LLL was calculated as the difference in stent/scaffold segment between the post-procedural MLD and follow-up MLD. Thirty-three patients (33 lesions) implanted with the Absorb BVS, and 26 patients (28 lesions) implanted with the EES were studied. The acute gain was similar in the Absorb BVS group (1.23 +/- 0.38 mm) compared to the EES group (1.32 +/- 0.26 mm, p=0.29). The in-stent/scaffold LLL at two-year follow-up in the Absorb BVS group (0.26 +/- 0.19 mm) was also similar compared to the EES group (0.22 +/- 0.22 mm, p=0.29). Although the two groups had similar two-year clinical outcomes (major adverse cardiac events: Absorb BVS: 6.1% vs. EES: 0.0%), patients treated with the Absorb BVS exhibited a significantly lower two-year in-stent/scaffold MLD compared to the EES (2.02 +/- 0.26 mm vs. 2.22 +/- 0.34 mm, p=0.01). Conclusions: Although BVS and EES demonstrated similar two-year clinical outcomes, patients treated with the Absorb BVS exhibited a significantly lower two-year in-stent/scaffold MLD compared to patients treated with the EES. Appropriately powered randomised trials are necessary to confirm these exploratory results and evaluate their prognostic and clinical significance.

The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy.This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis.Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.

Cumulative evidence has demonstrated that transcatheter aortic valve implantation (TAVI) constitutes an effective treatment option for patients with severe symptomatic aortic stenosis and a high operative risk. New valve designs and TAVI-enabling devices have simplified the procedure, reduced the risk of complications, and broadened the applications of this treatment. The global adoption of TAVI allows us to appreciate the advantages, potentialities and caveats of the technology, identify patients who would benefit from TAVI and stratify more accurately the risk of complications. The focus of this article is to discuss the advances in this field, present the current evidence, and highlight the developments and strategies proposed to address the limitations of TAVI treatment.