9 research outputs found

    Stent thrombosis: Insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials

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    Aims: Recent studies have suggested that EES may reduce ST compared to PES, but no individual trial has been adequately powered for this endpoint. The incidence of stent thrombosis, as well as the impact of dual antiplatelet therapy (DAPT) discontinuation during the first two years following everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) deployment were therefore analysed from a pooled, patient-level database derived from four randomised clinical trials. Methods and results: Data from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials (n=6,789 patients) were analysed. Two-year ST rates were determined using time-to-event methods and compared with the log-rank test. ST rates were also determi

    A pooled gender based analysis comparing the XIENCE V® everolimus-eluting stent and the TAXUS paclitaxel-eluting stent in male and female patients with coronary artery disease, results of the SPIRIT II and SPIRIT III studies: Two-year analysis

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    Aims: To assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the TAXUS paclitaxel-eluting stent (PES) in women at two years. Methods and results: In this pooled analysis, a cohort of 395 women and 906 men was studied by using patient level and lesion level clinical data from SPIRIT II and SPIRIT III studies. Women enrolled in these two studies had higher demographic and lesion risk characteristics than their male counterparts. In-stent and insegment late loss (LL) was significantly less in the women in the EES group compared to the women in the PES group (in-stent 0.15±44 mm vs. 0.45±51 mm; P<0.01, in-segment 0.09±46 mm vs. 0.29±40 mm; P<0.01). In women, EES compared to PES resulted in significant reductions in major adverse cardiac events (MACE) (8.5% vs 16.4%; p=0.02) and in target vessel failure (TVF) (11.2% vs 19.5%; p=0.02) at two years. In men, a significant difference was seen in in-stent LL and in-stent % diameter stenosis (DS) favouring EES (in-stent LL 0.14±33 mm vs. 0.28±47 mm; P<0.01, in-stent %DS 9.28±3.86 vs. 13.64±8.31; P<0.01). MACE rates at two years were lower in males treated with EES compared to PES (6.7% vs. 10.9%; p=0.03). The interaction between gender and stent type was not found to be significant for MACE at two years. Conclusions: In this pooled analysis of two randomised trials, at two years, EES compared to PES resulted in reduced angiographic LL, fewer MACE and TVF events in women and reduced angiographic LL and %DS and fewer MACE events in men

    In vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus-eluting device: An OCT ad hoc analysis of the revision 1.0 and revision 1.1 stent design in the ABSORB clinical trial

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    Aims: The ABSORB Cohort A clinical study has shown the feasibility and safety of the fully bioabsorbable everolimus-eluting structure (BVS, revision 1.0). However, the study also demonstrated somewhat higher acute and late recoil with the BVS structure compared to metallic drug eluting stents. Based on these clinical observations, modifications to the stent design (BVS, revision 1.1) were introduced for the ABSORB Cohort B study in order to decrease recoil. The aim was to compare in vivo the strut distribution between the BVS revision 1.0 (Cohort A), and BVS revision 1.1 (Cohort B) designs. Methods and results: OCT analysis was performed by two independent analysts in four patients from each cohort of the ABSORB study. Strut distribution was assessed in cross-section, and longitudinally in a frame-by-frame analysis. Variables recorded included inter-strut angle, maximum inter-strut angle and number of frames with ≥3 struts. The inter-observer correlation coefficient was also assessed. For both designs, on a patient level there was no significant difference in the number of analysed struts corrected for the length of the scaffold (p=0.78). Likewise, on a frame by frame analysis mean stent area, number of struts per frame, mean maximum inter-strut angle, and mean inter-strut angle were similar for both groups. However, in both structures there was a cyclical variation in the maximum number of struts per frame. The frequency of this variation was significantly higher in Cohort B. The inter-observer correlation coefficient for strut counts, inter-strut angle and maximum inter-strut angle was 0.91, 0.87 and 0.74 respectively. Conclusions: This ad hoc analysis confirms that the revision 1.1 BVS design has a different longitudinal strut distribution to the revision 1.0 BVS design, indicating that the new design has a reduced maximum circular unsupported cross sectional area

    Comparison between the first and second generation bioresorbable vascular scaffolds: A six month virtual histology study

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    Aims: To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS). Methods and results: IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10±0.46mm 2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57±1.3 mm 2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external e
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