Publications

We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys bifurcation stent.The Stentys stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side-branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years. In addition to angiographic QCA evaluation, documentary IVUS and/or OCT were used in all cases to assess the stent's deployment. The patient population consisted of 85% males with an average age of 62 years. Almost half had previous PCI, 31% previous MI and 5% previous CABG. The majority of lesions (80%) involved the LAD-D, 42% of the patients had disease affecting the side-branch, with all three arms diseased in 24% of the cases. The average lesion length in the main branch was 12.95 +/- 3.63 mm with a bifurcation angle of 55 degrees (range 30 degrees - 80 degrees). Procedural success was achieved in 39/40 cases (95.5%) due to inability to track the stent in one patient with an extremely tortuous vessel. In total 6 (15%) paclitaxel eluting and 33 (85%) BMS Stentys stents were successfully implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved in 37/39 cases (94.9%); in two cases, disconnection was not attempted. The MACE at 30 days was 5.1% as a result of one non Q-wave MI following the procedure and one ischemia-driven revascularisation six days after the procedure.This first-in-man (FIM) study demonstrates that the Stentys stent is safe and feasible resulting in an excellent procedural success rate and a low MACE rate. The struts can be easily and safely disconnected to perform provisional stenting.

Reliable assessment of the aortic valvar apparatus (AVAp) is essential as it may facilitate consistent outcomes with percutaneous aortic valvar therapies. The commonly referenced aortic annulus is problematic since this measurement does not correspond to any actual anatomic structure. We aim to describe a reliable method of measuring relevant structures of the AVAp based on widely available computed tomography analyses. Retrospective analysis of computed tomograms of 75 patients with severe aortic stenosis (45 females, age 81.2 ± 7.8 years). Curved multiplaner reconstruction technique was used to measure average diameters of the 'Aortic Leaflets Basal Attachment Plane' (ALBAP), sinuses of Valsalva (SV), sinutubular junction (STJ), ascending aorta (AA), and distance from coronary arteries to the base of the cusps. Angulation between the AA and the left ventricle (LV) was measured in one plane that included the LV inflow long axis and the maximum visualization of the aortic root. Inter-rater reliability and absolute agreement among three raters were evaluated. Intra-class correlation coefficients for ALBAP, SV, STJ, and AA diameters were 0.90, 0.99, 0.95, and 0.94, respectively (P < 0.001) with 95% limits of agreement of the observed differences falling in the less than 1 mm range. Intra-class correlation coefficients were 0.82 for the angle and 0.61 and 0.78 for distances to the right and left coronary arteries (P < 0.001). This method showed a high degree of inter-rater reliability and absolute agreement for AVAp diameters. Agreement was lower for AA–LV angle and distance to coronary artery measurements, emphasizing the need for software improvements and standardized image acquisition protocols.

No abstract is provided for this article.

The aim of this analysis was to assess the effect of body mass index (BMI) on 1-year outcomes in patients enrolled in a contemporary percutaneous coronary intervention trial comparing a sirolimus-eluting stent with a durable polymer to a biolimus-eluting stent with a biodegradable polymer. A total of 1,707 patients who underwent percutaneous coronary intervention were randomized to treatment with either biolimus-eluting stents (n = 857) or sirolimus-eluting stents (n = 850). Patients were assigned to 1 of 3 groups according to BMI: normal (<25 kg/m2), overweight (25 to 30 kg/m2), or obese (>30 kg/m2). At 1 year, the incidence of the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was assessed. In addition, rates of clinically justified target lesion revascularization and stent thrombosis were assessed. Cox proportional-hazards analysis, adjusted for clinical differences, was used to develop models for 1-year mortality. Forty-five percent of the patients (n = 770) were overweight, 26% (n = 434) were obese, and 29% (n = 497) had normal BMIs. At 1-year follow-up, the cumulative rate of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was significantly higher in the obese group (8.7% in normal-weight, 11.3% in overweight, and 14.5% in obese patients, p = 0.01). BMI (hazard ratio 1.47, 95% confidence interval 1.02 to 2.14, p = 0.04) was an independent predictor of stent thrombosis. Stent type had no impact on the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization at 1 year in the 3 BMI groups (hazard ratio 1.08, 95% confidence interval 0.63 to 1.83, p = 0.73). In conclusion, BMI was an independent predictor of major adverse cardiac events at 1-year clinical follow-up. The higher incidence of stent thrombosis in the obese group may suggest the need for a weight-adjusted dose of clopidogrel.

Side-branch occlusion (SBO) has been implicated as a contributing factor to the development of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention. Mechanisms to explain the incidence of SBO after the metallic platform stent implantation have included mechanical vessel straightening and enlargement of the stented vessel, bifurcation carina shift, and/or coronary plaque shift into the orifice of the side branch. In a nonrandomized comparison using historical data, Absorb scaffold was associated with a higher incidence of postprocedural SBO compared with the everolimus-eluting stent (EES). There were no statistically significant differences in the incidence of cardiac biomarker (CB) rise and periprocedural myocardial infarction (PMI) between Absorb and EES. Overlapping of scaffolds or stents might be a precipitating factor of myocardial injury. Implantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with higher 1-year major adverse cardiac events (MACE) rates driven by more frequent early MI.

Summary Vaccinations against SARS-CoV-2 are effective in COVID-19. However, with limited vaccine access, vaccine hesitancy and variant breakthroughs, there is still a need for effective and safe early treatments. Two community-based clinical trials of the inhaled corticosteroid, budesonide, have recently been published showing and improvement in patients with COVID-19 treated early with budesonide 1,2 . To understand mechanistically how budesonide was beneficial, inflammatory mediators were assessed in the nasal mucosa of patients recruited to the Steroids in COVID (STOIC 1 ) trial and a cohort of SARS-CoV-2 negative individuals. Here we show that in early COVID-19, elevation in viral response proteins and Th1 and Th2 inflammation occurs. Longitudinal sampling in the natural course of COVID-19 showed persistently high interferon levels and elevated concentrations of the eosinophil chemokine, CCL11. In patients who deteriorate, the initial nasal mucosal signal is characterised by a marked suppression of the early inflammatory response, with reduced concentrations of interferon and inflammatory cytokines, but elevated eosinophil chemokines. Systemic inflammation remained altered in COVID-19 patients, implying that even after symptom resolution, changes in immunological mediators do not resolve. Budesonide treatment decreased IL-33 and IFN-γ, implying a reduction in epithelial damage and dampening of the interferon response. Budesonide treatment also increased CCL17 concentrations, suggesting an improved T-cell response; and significantly alters inflammatory pathways giving further insight into how this treatment can accelerate patient recovery. Abstract Figure

The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial.The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory-assessed SS using multivariable Cox proportional hazards regression.A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5-74); 24.1% of patients had angiographic core laboratory-assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (Pinteraction=0.33). Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG. As a result, the major secondary composite end point of major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization) occurred more frequently with PCI than CABG (28.0% versus 22.0%, P=0.01), a difference which rose progressively with increasing SS (Pinteraction=0.03).In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD.URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.