Abstract Background Effect of statin therapy on coronary plaque stabilisation and reducing adverse cardiovascular events is well known both in primary and secondary prevention. Nevertheless, there is a paucity of data presenting the impact of statins on plaque morphology as assessed by optical coherence tomography (OCT). Purpose The goal of this analysis was to evaluate the plaque morphology using OCT within non-culprit, non-ischaemic coronary lesions in diabetes mellitus (DM) patients with or without statin pre-treatment. Methods All patients of the COMBINE (FFR-OCT) trial underwent fractional flow reserve (FFR) measurement followed by OCT in FFR negative lesions. OCT recorded the presence of thin-cap fibroatheroma (TCFA), plaque rupture (PR), plaque erosion (PE) and calcified nodule (CN). Results From the 391 patients, 82 (21%) had no statin at baseline. OCT was performed in 463 lesions of which 96 lesions assessed in statin naive and 367 lesions in statin treated group. The median angiographic diameter stenosis was 50% and the median FFR value was 0.88 in both groups (p=0.953 and p=0.448, respectively). Myocardial infarction (MI) at presentation was 16.6% and did not differ between groups (p=0.380). Patients without statin pre-treatment were characterized by lower rate of known hypercholesterolemia (47.6% vs. 63.0%; p=0.011), male gender (52.4% vs. 65.7%; p=0.027), active smokers (8.5% vs. 22.3%; p=0.004) and previous MI (22.0% vs. 35.3%; p=0.022) as compared to patients with statin pre-treatment, respectively. The results of the qualitative OCT findings see in Table 1. Conclusions Non-ischemic lesions of DM patients without statin pre-treatment showed more vulnerable and instable plaque features like wider lipid arc, thinner fibrotic cap and a higher prevalence of lipid-rich plaque, TCFA and PR suggesting a stabilizing effect of statins on non-ischemic atherosclerotic lesions. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): The trial is founded from the Department of Cardiology Zwolle Heart-centrum with support from a non-restricted grant from St Jude Medical (now Abbott)

Background Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus. Aim To evaluate the safety and efficacy outcomes of all-comer patients with diabetes up to 2 years after treatment with EE-BRS or EES. Methods We performed a post-hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST). Results A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in EE-BRS and 464.9 PY in EES. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p=0.39; adjusted hazard ratio (HR)=1.48 (95% confidence interval (CI): 0.77-2.87), p=0.24), MACE (9.1 vs. 8.3 per 100 PY, p=0.83; adjusted HR=1.23 (95% CI: 0.70-2.17), p=0.47), and ST (0.9 vs. 0.6 per 100 PY, p>0.99). Conclusion In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.

Diabetes mellitus (DM) patients show higher rates of repeat revascularisation even in the era of modern drug-eluting stents (DES). The concept of bioresorbable scaffolds is becoming captivating, as it might allow for repeat interventions, prolonging the time span during which patients can be treated by percutaneous coronary intervention (PCI). We intend to evaluate the short- and long-term safety and efficacy of Absorb bioresorbable vascular scaffolds (Absorb BVS) in the treatment of coronary artery disease (CAD) in DM patients for any indication. The ABSORB DM Benelux is an international prospective study in DM patients who have undergone PCI with ≥1 Absorb BVS. Major adverse cardiac events (MACE) at 1 year was the primary endpoint, defined as a composite of all-cause death, any myocardial infarction (MI) and ischaemia-driven target vessel revascularisation (TVR). Secondary endpoints were target lesion failure (TLF) and definite or probable scaffold thrombosis (ScT). Between April 2015 and March 2017, 150 DM patients and 188 non-complex lesions were treated. Device implantation was successful in 100%. MACE occurred in 14 (9.5%) patients, with all-cause death occurring in 4 (2.7%), any MI in 6 (4.1%) and ischaemia-driven TVR in 7 (4.8%) respectively. TLF was reported in 11 (7.5%). Definite and probable ScT was observed in 2 (1.4%). Absorb BVS for treatment of anatomically low-risk patients with DM show acceptable safety and efficacy outcomes at 1 year. If these promising results are confirmed after a longer follow-up period, new-generation bioresorbable scaffolds combined with refinement of implantation techniques might open new horizons for CAD treatment in DM patients.

Background Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options. Methods The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT). Results Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT. Conclusion EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registered

Abstract Background Little is known about age-related differences in baseline atherosclerotic plaque morphology and composition in patients with diabetes mellites (DM). Purpose For this purpose, we studied DM patients from the Combine trial. Methods COMBINE (OCT-FFR, NCT02989740) is a multi-center, prospective study focusing on the natural history of non-ischemic, non-culprit coronary lesions and evaluate whether certain OCT-assessed variables could predict future adverse events originating from these lesions in a DM population. OCT analysis identifies plaque composition, estimates calcium arc (o), lipid arc (o), and measures thickness of the fibrous cap covering the lipid core. Moreover, OCT records the presence of typical plaque vulnerability traits like thin fibrous cap atheroma (TCFA), plaque erosion (PE), plaque rupture (PR), calcification nodule (CN), heterogeneous tissues (a probably healed plaque rupture), and macrophages accumulation (bright spots). A dedicated software estimated the interpolated percentage area stenosis (AS, %) measuring the minimal lumen area (MLA) and reference vessel area. The present analysis reports the baseline morphology of these lesions respectively in young (<70 years) vs. old (≥70 years) DM patients. Results OCT imaging was performed in 300 patients (361 lesions) from the COMBINE study, of which 203 lesions assessed in young and 158 lesions in old DM patients. There were no significant differences in MLA (mm2) 2.40 (1.85–315 vs. 2.30 (1.80–3.00), p=0.92), lesions length (mm 24.11 (15.10–33.10) vs. 24.20 (15.10–35.10), p=0.78), AS% (%) 63 (1.85–3.15) vs. 64 (56–73), p=0.41; lipid arc (o), 182 (140–250) vs. 175 (128–240), p=0.35), fibrous cap thickness covering the lipid arc (μm), 117 (65–193) vs. 110 (64–168), p=0.45, in the prevalence of TCFA 37 (18%) vs. 33 (21%), p=0.53, PR 17 (18%) vs. 15 (10%), p=0.71, heterogenous tissue 39 (19%) vs. 31 (20%), p=0.92, and bright spots 98 (48%) vs. 69 (44%), p=0.38. The patients ≥70 years had a higher prevalence of calcified plaques 171 (84%) vs. 143 (90%), p=0.08 and wider calcium arc. These lesions included more PE 7 (3%) vs. 13 (8%), p=0.05, CN 73 (36%) vs. 75 (47%), p=0.03, and CN associated with overlying thrombus 11 (5%) vs. 20 (13%), p=0.02. Conclusion Non-ischemic, non-culprit lesions in elderly DM patients present the same prevalence of soft, vulnerable plaques as it is a younger cohort, however, they have a higher prevalence of calcified plaque including complex calcified plaques as eroded plaques and calcification nodules with overlying thrombus. Whether these complex calcified plaques are associated with a higher risk of adverse events remains questionable and could be further elucidated from longer follow-up data of the COMBINE trial.

Cardiomyopathy in Fabry disease / There is no sweet spot in diabetes 461Amp V2, LVH Score, Q Dur V1, QT Dispersion and Spatial QRS-T angle for the discrimination between the groups.A discriminant score (normalized between 0 and 100) by patient was then set up using the variable coefficients of the models determined from a training set of 80% of both groups.The Logistic model was ultimately selected and led to a 2x2 classification (Table 1) in a test sample of the remaining 20% of the groups giving a 99.1% sensitivity for classifying normal patients and 69.1% sensitivity for correctly classifying Fabry patients.Bootstrap simulations displayed an acceptable stability of the decision rule.Conclusions: Novel ECG parameters identified via a two discriminant stepwise statistical approach may be useful for detection of FD patients with cardiac involvement.These data need to be confirmed in a prospective setting and through a comparison of FD patients with cardiac involvement versus non-FD-associated cardiomyopathy.

Purpose Our aim was to evaluate the acute success and complication rates of the transradial and transulnar access for iliac artery stenting using sheathless guiding systems. Methods Clinical and angiographic data from 156 consecutive patients with symptomatic iliac artery stenosis who were treated with transradial or transulnar access were evaluated. All patients underwent Duplex ultrasound before and after the intervention. The primary endpoints were the procedural success rate, major adverse events, and access site complication rates. The secondary endpoints were the angiographic result of the iliac artery intervention, fluoroscopy time, X‐ray dose, procedure length, crossover rate to another puncture site and hospitalization duration. The impact of the learning curve was also investigated, along with right or left radial access. Results The indication for the intervention was intermittent claudication in 109 patients (69.9%), critical limb ischemia in 44 (28.2%) subjects and acute limb ischemia in three individuals (1.9%). Technical success was achieved in 155 patients (99.4%), with a crossover rate of 3.8%. Radial and ulnar artery access was used in 151 (96.8%) and 7 (4.5%) patients, respectively. The Ankle‐brachial index increased from 0.69 [0.65–0.72] to 0.91 [0.88–0.95] as a result of the procedures ( P < 0.001). The cumulative incidence of major adverse events was 3.8% at the 2‐month follow‐up (0% in patients with intermittent claudication and 13.8% in patients with critical limb ischemia). Radial artery access site complications were encountered in eight patients (5.1%). We documented decreased X‐ray doses (1742.0 [783.9–2701] vs. 1435 [991.1–1879] vs. 692.8 [275.3–1110] Gy cm −2 P < 0.05) over time; however, the fluoroscopy time, procedure time, and contrast consumption were not significantly different. Left hand access was not associated with significantly better results than right radial artery access. Conclusions Iliac artery stenting can be safely and effectively performed using radial or ulnar artery access and sheathless guiding catheters, with acceptable complication rates and high levels of technical success. The physician learning curve plays an important role in decreasing the X‐ray dose. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Background: Although circular ventricle resection techniques are the gold standard of left ventricle restoration, these techniques can lead to suboptimal results. Postoperative systolic resection line can be inadequate, as it must be planned on a heart stopped in diastole. The impaired geometry and contractility may lead to increased short-and long-term mortality. Moreover, postoperative low cardiac output due to insufficient left ventricular volume results in a potentially unstable condition, and cannot be corrected. Our aim was to find a preoperative method to minimize risk and maximize outcome with left ventricle restoration. Methods: We have created a novel method combining surgery with modern imaging techniques to construct a preoperative 3D systolic heart model. The model was utilized to determine resection could be intraoperatively used to create the new left ventricle. Results: The computer assisted ventricle engineering technique is described step by step through a successful aneurysmectomy of a 61-year-old female patient with a complicated giant left ventricle aneurysm. Conclusions: Using this model we are able to find the optimal resection line providing excellent postoperative result, thus minimizing the risk of low cardiac output syndrome. This is the first report of our new combined approach to left ventricle restoration.