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It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.

Aims The effect of low-density lipoprotein cholesterol-lowering therapy with alirocumab or evolocumab on individual clinical efficacy and safety endpoints remains unclear. We aimed to evaluate the efficacy and safety of alirocumab and evolocumab in patients with dyslipidaemia or atherosclerotic cardiovascular disease. Methods and results We performed a review of randomized controlled trials (RCTs) comparing treatment with alirocumab or evolocumab vs. placebo or other lipid-lowering therapies up to March 2018. Primary efficacy endpoints were all-cause death, cardiovascular death, myocardial infarction (MI), and stroke. We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. We included 39 RCTs comprising 66 478 patients of whom 35 896 were treated with proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitors (14 639 with alirocumab and 21 257 with evolocumab) and 30 582 with controls. Mean weighted follow-up time across trials was 2.3 years with an exposure time of 150 617 patient-years. Overall, the effects of PCSK9 inhibition on all-cause death and cardiovascular death were not statistically significant (P = 0.15 and P = 0.34, respectively). Proprotein convertase subtilisin–kexin type 9 inhibitors were associated with lower risk of MI (1.49 vs. 1.93 per 100 patient-year; RR 0.80, 95% CI 0.74–0.86; I 2 = 0%; P Conclusion Proprotein convertase subtilisin–kexin type 9 inhibition with alirocumab or evolocumab was associated with lower risk of MI, stroke, and coronary revascularization, with favourable safety profile.

Background: Data on the impact of residual inflammatory risk (RIR) in patients undergoing percutaneous coronary intervention (PCI) with baseline low-density lipoprotein cholesterol (LDL-C) ≤70 mg/dl are scarce. Objectives: The purpose of this study was to characterize the prevalence and impact of persistent high RIR after PCI in patients with baseline LDL-C ≤70 mg/dl. Methods: All patients undergoing PCI between January 2009 and December 2016 in a single tertiary center, with baseline LDL-C ≤70 mg/dl and serial high-sensitivity C-reactive protein (hsCRP) assessments (at least 2 measurements ≥4 weeks apart) were retrospectively analyzed. High RIR was defined as hsCRP >2 mg/l. Patients were categorized as persistent low RIR (first low then low hsCRP), attenuated RIR (first high then low hsCRP), increased RIR (first low then high hsCRP), or persistent high RIR (first high then high hsCRP). Primary endpoint of interest was major adverse cardiac and cerebrovascular accident (MACCE) (death, myocardial infarction, or stroke), within 1 year of the second hsCRP measurement. Results: A total of 3,013 patients were included, with persistent low, attenuated, increased, and persistent high RIR in 1,225 (41.7%), 414 (13.7%), 346 (11.5%), and 1,028 (34.1%) patients, respectively. Overall, there was a stepwise increase in the incidence rates of MACCE, transitioning from the persistent low to the attenuated, increased, and persistent high RIR (respectively, 64.4 vs. 96.6 vs. 138.0 vs. 152.4 per 1,000 patient-years; p < 0.001). After adjustment, the presence of persistent high RIR remained strongly associated with MACCE (adjusted hazard ratio: 2.10; 95% confidence interval: 1.45 to 3.02; p < 0.001). Conclusions: Among patients undergoing PCI with baseline LDL-C ≤70 mg/dl, persistent high RIR is frequent and is associated with increased risk of MACCE. Targeting residual inflammation in patients with optimal LDL-C control may further improve outcomes after PCI.

BACKGROUND The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. METHODS AND RESULTS We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). CONCLUSIONS Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

Clinical Case Download : Download full-size image A 69-year-old female patient with known hypertension underwent coronary angiography due to anginal symptoms 3 years ago. The coronary angiogram back then showed a right dominant system with intermediate lesions in a small-sized posterior descending artery and ramus intermedius. Treatment was conservative, with optimization of medical therapy. However, the patient’s blood pressure had not been well controlled over the last 2 years. The patient now experiences recurrent severe angina and presents with a troponin rise. An electrocardiogram (ECG) did not show any ST elevation. The coronary angiogram now shows a 60% stenosis of the left anterior descending artery (LAD) and complete occlusion of the small- sized second obtuse marginal branch (OM2). The latter was considered the culprit lesion. How would you manage this patient? Abstract The field of percutaneous coronary interventions (PCI) in ischemic heart disease is in continuous evolution. New insights on coronary stenting, dual antiplatelet therapy (DAPT), and mechanical support are generated daily. However, most data report on best therapies in the overall PCI population, which may not be directly applicable to women. Women are a minority in the PCI population, accounting for approximately one-third of the patient population treated with PCI. Women undergoing PCI have more comorbidities than their male counterparts. They have smaller coronary vessels and are more likely to experience radial artery spasm. As a result, trans radial access is less commonly used in women than in men. Women also have a higher chance of bleeding after PCI, which affects decision making regarding stent type and DAPT regimen. Many operators prefer stents that allow for shorter DAPT duration. Clinical outcomes after PCI in women remain less favorable compared to men, with higher rates of target lesion failure and higher all-cause death. These sex-related differences are driven by variation in comorbidities, clinical presentation, and lesion characteristics. While the field of mechanical assist devices is evolving rapidly, only very limited sex-specific data are available on this topic. Further research is needed to improve outcomes in women undergoing interventions for ischemic heart disease.

International audience; Background: Chronic kidney disease (CKD) patients undergoing percutaneous coronary intervention (PCI) experience greater ischemic events including clinically driven target lesion revascularization (CD-TLR). Whether the COMBO biodegradable-polymer sirolimus-eluting stent promotes better outcomes in these patients by virtue of endothelial progenitor cell capture technology is unknown.Objective: We examined one-year outcomes by CKD status from the COMBO collaboration.Methods: The COMBO collaboration was a patient-level pooled dataset from the REMEDEE and MASCOT registries (3,614 patients) of all-comers undergoing attempted COMBO stent PCI. The primary endpoint was one-year target lesion failure (TLF), composite of cardiac death, target-vessel myocardial infarction (TV-MI) or CD-TLR. Secondary endpoints included stent thrombosis (ST).Results: The study included 6.4% (n = 231) CKD and 93.6% (n = 3,361) non-CKD patients. CKD patients were older and included more women with greater prevalence of several comorbidities but similar rate of acute coronary syndrome (50.6% vs. 54.5%, p = .26). CKD patients underwent radial PCI less often (56.1% vs. 70.3%, p < .001) and received clopidogrel (78.6% vs. 68.3%) more often (p = .004). One-year TLF occurred in 7.9% CKD vs. 3.7% non-CKD patients, p = .001. CKD patients also demonstrated greater incidence of cardiac death (6.2% vs. 1.2%, p < .0001), TV-MI (2.7% vs. 1.1%, p = .04) but similar CD-TLR (2.7% vs 2.2%, p = .61) and definite/probable ST (1.4% vs. 0.8%, p = .42), compared to non-CKD patients.Conclusions: CKD patients treated with COMBO stents had significantly greater incidence of one-year TLF compared to non-CKD patients driven by cardiac death and to a lesser extent TV-MI but not CD-TLR. They had similar rates of definite/probable ST.

Background: With optical coherence tomography (OCT), details of arterial injuries during percutaneous coronary intervention can be assessed accurately. There might be an increased risk of stent edge dissections with the novel delivery system for the STENTYS stent. We evaluated the prevalence of stent edge dissections using the novel Xposition delivery device as compared with the conventional delivery device.Methods: A total of 38 patients who were treated with the self-apposing STENTYS stent and with OCT assessment at our center were retrospectively analysed. Twenty patients were treated using the Xposition- and 18 using the conventional delivery device. OCT was performed according to study protocol. Frames with poor quality were excluded.Results: A total of 12(18%) dissections were detected, 7(20%) in the Xposition delivery device group, and 5(15%) in the conventional group (p=1). Using the Xposition delivery device 4(33%) dissections were found proximally, using the conventional delivery device 3(25%) (p=ns). Mean longitudinal dissection length was 2.071.80mm, 8(67%) appeared as flaps, 4(33%) as cavities. Morphometric parameters were comparable in both groups.Conclusions: Detailed OCT assessment of stent edge dissections was possible, which revealed no large differences using the Xposition delivery device as compared with conventional delivery device, however large studies are warranted

Background: Low systolic blood pressure (SBP) values are associated with an increased risk of cardiovascular events, giving rise to the so-called J-curve phenomenon. We assessed the association between on-treatment SBP levels, cardiovascular events, and all-cause mortality in patients randomized to different SBP targets. Methods: Data from 2 large randomized trials that randomly allocated hypertensive patients at high risk for cardiovascular disease to intensive (SBP Results: The pooled data consisted of 194 875 on-treatment SBP measurements in 13 946 patients (98.9%). During a median follow-up of 3.3 years, cardiovascular events occurred in 1014 patients (7.3%), and 502 patients died (3.7%). For both blood pressure targets, an identical shape of the J curve was present, with a nadir for cardiovascular events and all-cause mortality just below the SBP target. Patients in the lowest SBP stratum were older, had a higher body mass index, smoked more often, and had a higher frequency of diabetes mellitus and cardiovascular events. Conclusions: Low on-treatment SBP levels are associated with increased cardiovascular events and all-cause mortality. This association is independent of the attained blood pressure level because the J curve aligns with the SBP target. Our results suggest that the benefit or risk associated with intensive blood pressure–lowering treatment can be established only via randomized clinical trials. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifiers: NCT01206062 and NCT00000620.

Objectives: To evaluate the impact of coronary artery disease (CAD) with or without recent (≤ 30 days) percutaneous coronary intervention (PCI) in women undergoing transcatheter aortic valve replacement (TAVR). Background: Although women display a specific risk-profile for both PCI and TAVR, the impact of CAD and PCI in the setting of TAVR in women is unclear. Methods: The multinational Women's International Transcatheter Aortic Valve implantation registry enrolled consecutive female patients undergoing contemporary TAVR in 19 centers between 2013 and 2015. Patients with available coronary angiography or CT scan in the pre-operative assessment of TAVR were categorized as without CAD, with CAD but no recent PCI and CAD and recent PCI (≤30 days). All events were adjudicated according to the VARC-2 criteria. Results: A total of 787 patients were included in this analysis, among whom 459 (58.3%) had no CAD, 247 (31.4%) had CAD without recent PCI and 81 (10.3%) underwent recent PCI (≤ 30 days before TAVR). After multivariable adjustment, both groups of CAD patients, without and with recent PCI, presented with higher risk of death, myocardial infarction or stroke, compared with patients without CAD (adjHR 1.56, 95%CI 1.03–2.39, P = 0.038 and adjHR 1.96, 95% CI 1.1–3.5, P =.021, respectively). Patients with recent PCI had increased risk of all-cause death (adjHR 1.89, 95% CI 1.0–3.5, P = 0.04) and stroke (adjHR 3.7, 95% CI 1.0–13.5, P = 0.046) compared with patients without CAD. Conclusion: The presence of CAD in women undergoing TAVR, with or without recent PCI, was associated with long-term poorer outcomes.

Background: High-intensity statins (HIS) are recommended for secondary prevention following percutaneous coronary intervention (PCI). We aimed to describe temporal trends and determinants of HIS prescriptions after PCI in a usual-care setting. Methods: All patients with age ≤75 years undergoing PCI between January 2011 and May 2016 at an urban, tertiary care center and discharged with available statin dosage data were included. HIS were defined as atorvastatin 40 or 80 mg, rosuvastatin 20 or 40 mg, and simvastatin 80 mg. Results: A total of 10,495 consecutive patients were included. Prevalence of HIS prescriptions nearly doubled from 36.6% in 2011 to 60.9% in 2016 (P

Aims: It remains unknown what percentage of patients treated with percutaneous coronary artery intervention (PCI) have high residual inflammatory risk (RIR). Moreover, the impact of RIR on clinical outcomes has not been established. The objective of this study is to determine the prevalence of patients with persistent high levels of inflammation after PCI and to evaluate clinical outcomes according to inflammatory response. Methods and results: This is a retrospective cohort study assessing patients undergoing PCI between 2009 and 2016 with serial inflammatory status assessment from a large, prospective, and single-centre PCI registry. Assessment of inflammation status with at least two high sensitive C-reactive protein (hsCRP) measurements at baseline and follow-up with >4 weeks apart. High RIR was defined as an hsCRP≥ 2 mg/L. Patients were divided into four groups: persistent high RIR, increased RIR (first low-, then high hsCRP), attenuated RIR (first high-, then low hsCRP), or persistent low RIR. The primary endpoint was all-cause mortality at 1 year follow-up. Occurrence of myocardial infarction (MI) was assessed as secondary outcome. Seven thousand and twenty-six patients were identified with serial hsCRP measurements (30.8% of all PCI patients). Of these patients 2654 (38%) had persistent high RIR, 719 patients (10%) had increased RIR, 1088 patients (15%) had attenuated RIR, and persistent low RIR was seen in 2565 patients (37%). All-cause mortality at 1 year was 2.6% in patients with persistent high RIR, compared with 1.0% in increased RIR, 0.3% in attenuated RIR, and 0.7% in persistent low RIR patients, P

Pre-existing atrial fibrillation (AF) is common among patients who underwent transcatheter aortic valve implantation (TAVI) and has been associated with adverse outcomes. The specific impact of AF at baseline in women who underwent TAVI, however, remains unknown. The Women's International Transcatheter Aortic Valve Implantation is a prospective, multinational registry evaluating the safety and performance of contemporary TAVI in women in 19 centers between January 2013 and December 2015. Patients with available electrocardiogram at baseline were compared according to the presence of AF. All events were adjudicated according to the Valve Academic Research Consortium 2 criteria. Associations between AF and outcomes were tested using multivariate Cox regression model. Of the 993 women with available baseline electrocardiogram included in the study, 200 (20.1%) presented with AF. Patients with AF at baseline had higher Euroscore I score values and more frequently had chronic kidney disease or prior stroke. Patients without AF more frequently had coronary artery disease. There was no difference regarding in-hospital events between the two groups aside from longer length of stay for patients with AF (13.3 ± 11 vs 11.5 ± 7.1 days, p = 0.01). In multivariate analysis, AF at baseline was associated with an increase of all-cause and cardiovascular death at 12 months (adjHR 1.67 95%CI 1.11 to 2.50, p = 0.013 and adjHR 1.85 95%CI 1.19 to 2.86, p = 0.006 respectively). In conclusion, in this prospective registry of women who underwent contemporary TAVI, the presence of AF at baseline was associated with significantly increased 12-month mortality.

The novel COMBO dual-therapy stainless-steel coronary stent (DTS) (OrbusNeich Medical BV, Hoevelaken, the Netherlands) is a device that combines a sirolimus-eluting layer with a prohealing layer with anti-CD34+ antibodies, which attracts circulating endothelial progenitor cells. These endothelial

Background The arterial switch operation is the current treatment for transposition of the great arteries. Long-term outcome mainly depends on the patency of the transferred coronary arteries. This study assessed the presence of abnormal coronary findings and neoaortic root dilation late after arterial switch operation. Methods In 30 adult patients after arterial switch operation (22 men, 22 ± 3 years), computed tomography angiography was performed to assess the coronary anatomy and abnormal coronary findings, defined as significant stenosis, interarterial coronary course, and acute angled coronary origins. Neoaortic root dimensions and coronary takeoff height were also assessed. Results The most common coronary anatomy pattern was found in 24 of 30 patients. Variant anatomy patterns were seen in 6 patients (5 with aberrant circumflex artery, 1 with a single ostium). The prevalence of abnormal coronary findings was higher in patients with variant coronary pattern as compared with patients with common coronary pattern (100% and 29%, respectively; p = 0.003). In particular, an acute angle of the coronary origin was frequently observed. In patients with an acute angle, larger dimensions of the aortic annulus ( p = 0.016) and the sinus of Valsalva ( p = 0.002) were observed. Moreover, a higher takeoff of the right ( p = 0.030) and left ( p = 0.002) coronary ostium was noted in patients with acute angles. Conclusions Abnormal coronary findings were frequently observed in adult patients after arterial switch operation, especially in patients with a variant coronary anatomy pattern. Neoaortic root dilation and a higher coronary takeoff may explain part of the pathophysiology. Long-term follow-up is needed to determine the clinical significance of these findings.