Publications

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Background The efficacy and safety of ticagrelor monotherapy in elderly patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) or stable coronary artery disease (CAD) has not been evaluated. Purpose To evaluate the efficacy and safety of ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI in relation to age and clinical presentation in the GLOBAL LEADERS study cohort. Methods This is a subanalysis of the randomized multicentre GLOBAL LEADERS study, comparing the experimental strategy of 23-month ticagrelor monotherapy after 1 month of ticagrelor and aspirin with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy in 15991 patients undergoing PCI. Patients were categorized into elderly and very elderly according to a pre-specified cut-off of 75 years and a post-hoc defined cut-off of 80 years. Impact of age and clinical presentation (ACS versus stable CAD) on clinical outcome at 2 years was evaluated. The primary endpoint was a composite of all-cause mortality or nonfatal, centrally adjudicated, new Q-wave myocardial infarction. Results In the overall elderly (>75 years) population (n=2565), primary endpoint occurred in 7.2% of patients in the experimental group and in 9.4% of patients in the reference group (p=0.041) at 2 years (p int =0.23). Elderly patients in the experimental group had a lower rate of definite stent thrombosis (ST) (0.2% vs. 0.9%, p=0.043, p int=0.03), definite or probable ST (0.4 vs. 1.3%, p=0.015, p int=0.01) and a numerically higher rates of BARC 3 or 5 type bleeding (5.0% vs. 3.9%, p=0.192, p int=0.06), when compared to the reference arm. Among elderly patients presenting with ACS both treatment groups did not differ in the rates of primary endpoint (9.1% vs. 10.8%, p=0.367) and BARC 3 or 5 type bleeding (4.7% vs. 5.7%, p=0.458), whereas among elderly patients with stable CAD the experimental strategy was associated with numerically lower rates of the primary endpoint (5.7% vs. 8.4%, p=0.046) (p int =0.42) and a higher rate of BARC 3 or 5 type bleedings (5.3% vs. 2.6%, p=0.012) (p int =0.02) at 2 years. Exploratory analyses among very elderly (≥80 years) patients (n=1169) indicated no significant differences between treatment groups in the rates of the primary endpoint (10.2% vs. 11.7% p=0.411, p int=0.940) and BARC 3 or 5 type bleeding (6.0% vs. 5.3%, p=0.630, p int=0.514) at 2 years. Conclusions The efficacy and safety of the experimental treatment strategy of 23-month ticagrelor monotherapy after 1-month DAPT following PCI was not identified as age-dependent. Among elderly patients the anti-ischemic benefit was derived at the expense of increased rate of BARC 3 or 5 type bleeding in stable CAD subgroup, but not in ACS subgroup. Acknowledgement/Funding European Clinical Research Institute, which received unrestricted grants from Biosensors International, AstraZeneca, and the Medicines Company.

Objectives The aim of this study was to investigate the feasibility of using quantitative differential echogenicity to monitor the in vivo absorption process of a drug-eluting poly-l-lactic-acid (PLLA) bioabsorbable stent (BVS, Abbott Vascular, Santa Clara, California). Background A new bioabsorbable, balloon-expanded coronary stent was recently evaluated in a first-in-man study. Little is known about the absorption process in vivo in diseased human coronary arteries. Methods In the ABSORB (Clinical Evaluation of the BVS everolimus eluting stent system) study, 30 patients underwent treatment with the BVS coronary stent system and were examined with intracoronary ultrasound (ICUS) after implantation, at 6 months and at 2-year follow-up. Quantitative ICUS was used to measure dimensional changes, and automated ICUS-based tissue composition software (differential echogenicity) was used to quantify plaque compositional changes over time in the treated regions. Results The BVS struts appeared as bright hyperechogenic structures and showed a continuous decrease of their echogenicity over time, most likely due to the polymer degradation process. In 12 patients in whom pre-implantation ICUS was available, at 2 years the percentage-hyperechogenic tissue was close to pre-implantation values, indicating that the absorption process was either completed or the remaining material was no longer differentially echogenic from surrounding tissues. Conclusions Quantitative differential echogenicity is a useful plaque compositional measurement tool. Furthermore, it seems to be valuable for monitoring the absorption process of bioabsorbable coronary stents made of semi-crystalline polymers.

Despite tremendous advances in cardiovascular medicine, significant opportunities remain to improve coronary artery disease (CAD) prevention and treatment strategies. The key limitation lies in the understanding of disease formation and progression mechanisms. The coronary anatomy plays an important role in local haemodynamics, governing endothelial health and, thus, pathophysiological responses. The significant variation of the coronary anatomy among patients, with significant trends across different populations, increases the complexity of understanding the details of disease progression. This review covers different aspects of the current status and understanding of the blood flow investigation in coronary arteries. We summarised the current knowledge of the haemodynamic effect of coronary anatomy and its evaluation and analysis methods. We discussed recent progress across medical imaging techniques and computational haemodynamic analysis. Based on the reviewed papers, we identified the persisting knowledge gaps and challenges in the field. We then elaborated on future directions and opportunities to increase understanding of the fundamental mechanism of CAD in individuals representative of large populations and how this may translate to the patient's bedside.

Introduction: The first-generation bioresorbable scaffolds (BRSs) had a large strut profile to compensate for the insufficient radial strength of bioresorbable polymer materials, resulting in higher scaffold thrombosis rates than conventional drug-eluting stents. To improve the clinical safety and efficacy, the new generation BRSs have been improved by optimal structure design, post-processing of bioresorbable polymer materials, or altering bioresorbable metallic alloys.Areas covered: This review summarizes the lessons learned from the first-generation BRS, updates the clinical outcomes of trials evaluating ABSORB bioresorbable vascular scaffold at long-term and bioresorbable metallic alloy-based devices, and examines recent outcomes of BRS treated in STEMI patients. This review also provides an overview of the current clinical data of seven BRSs manufactured in Asia, and of the BRSs extended application in other clinical arenas.Expert opinion: Drawbacks of the first-generation BRSs need to be addressed by the next generation of these stents with novel materials and technologies. Clinical research, including randomized controlled trials, are required to further evaluate BRSs application in coronary artery disease. The encouraging results of BRSs innovation applied in the peripheral arteries and gastrointestinal tracts support other potential clinical applications of BRS technology.

Prior aspirin treatment is considered a risk factor for adverse outcomes in acute coronary syndrome (ACS) patients. The relationships between aspirin pretreatment and findings on quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS), as well as clinical outcomes, are not well understood.In the PROSPECT trial, QCA and triple-vessel IVUS imaging were performed after successful percutaneous coronary intervention (PCI) of the culprit lesion(s) in ACS patients. We compared patients receiving aspirin within 7 days of enrollment to those naive to aspirin. Propensity score matching was performed to adjust for differences in baseline characteristics.Aspirin-pretreated patients (n = 236; 35%) were older and more likely to have known coronary disease than those without pretreatment (P≤.01 for all). Pretreated patients had more untreated non-culprit lesions with angiographic and IVUS characteristics predictive of future events (53.1% vs 38.6%; P<.001). There were no significant differences in overall major adverse cardiac event (MACE) rates at 3 years between the aspirin and no-aspirin groups (23.6% vs 18.8%, respectively; P=.17) in unadjusted or propensity-adjusted analyses. Prior aspirin use was not an independent predictor of MACE at 3 years (hazard ratio, 1.21; 95% confidence interval, 0.73-2.01; P=.45).In the PROSPECT trial, aspirin pretreatment identifies an older population with more advanced coronary disease. Aspirin pretreatment was not an independent predictor of MACE in ACS patients treated with an early invasive strategy. The extent to which aspirin pretreatment is a risk factor for adverse events after PCI in ACS should be revisited.

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Assessment of stent strut coverage by optical coherence tomography (OCT) is not standardized. The methodology most commonly used is based on a visual binary qualitative assessment (strut covered or not). However, the influence of magnification (zoom setting) to the inter- and intra-observer agreements has not yet been evaluated. Aim of our study was therefore to evaluate the agreements of this approach, taking into account various zoom settings. 126 struts from 10 selected frames were independently evaluated by four observers using a stepwise approach increasing the zoom setting as following: (1) full view of the lumen (FV), (2) half view of the lumen (HV) and (3) a quarter view of the lumen (QV). Intra- and inter-observer agreements (κ) were assessed. The rate of uncoverage was determined for each strut as the number of times it was defined as uncovered divided by the total number of observations (maximum 12 = 3 zoom settings × 4 analysts) and expressed as percentage. The inter-observer κ values (mean [range]) were 0.32 [0.07-0.63], 0.40 [0.18-0.69] and 0.33 [0.09-0.6], within FV, HV and QV respectively. The intra-observer κ values were 0.60 [0.50-0.70], 0.75 [0.75-0.76] and 0.60 [0.50-0.70], within FV, HV and QV respectively. By increasing zoom setting the κ value of intra-observer agreement was 0.74 [0.58-0.83] (from FV to HV), 0.70 [0.56-0.83] (from HV to QV) and 0.70 [0.37-0.86] (from FV to QV). Overall, the rate of uncoverage was 15.5% [8.3-100%]. The OCT qualitative evaluation of strut coverage has wide inter and intra-observer agreements and is dependent of the zoom setting used during the analysis. A more reproducible approach would be needed to eventually increase the probability to link uncovered struts with clinical events.