Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease.

OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Correction to: Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain.

An amendment to this paper has been published and can be accessed via the original article.

MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design.

AIM: Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI. STUDY DESIGN: This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years. CONCLUSION: This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.

Safe and Efficacious Use of 1-Month Triple Therapy in Patients with Atrial Fibrillation and High Bleeding Risk Undergoing PCI.

BACKGROUND: The impact of short or prolonged use of triple therapy (TT) on outcomes in patients with atrial fibrillation (AF) and high risk of bleeding undergoing percutaneous coronary intervention (PCI) is unclear. We compared clinical outcomes according to the duration of TT in patients with AF and HAS-BLED ≥ 3 at 1 year of follow-up. METHODS: A prospective observational cohort enrolled 735 patients with AF between 2010 and 2015. Of these, 521 (70.9%) had HAS-BLED ≥ 3 and 380 (72.9%) were discharged on TT. TT was prescribed for 1 month in 233 patients (61.3%). The primary endpoint was the incidence of Bleeding Academic Research Consortium (BARC ≥ 3). The secondary endpoint was the occurrence of ischemic events (cardiac death, MI, stroke, or stent thrombosis). RESULTS: Patients on 1-month TT had a higher median HAS-BLED. Intracraneal hemorrhage was twofold more frequently in patients on > 1-month TT but without statistical significance (0.9% vs 2.1%, p = 0.20). Rates of the primary endpoint (bleeding BARC ≥ 3) were 8.2% vs 10.9% and did not differ between groups, while secondary endpoint did not occur more frequently in the 1-month TT group compared with the > 1-month TT group (26.6% vs 23.1%). In adjusted multivariate analyses, patients receiving 1-month TT had a similar risk of the primary endpoint compared to those with > 1-month TT (HR 1.47; 95% CI 0.48-4.47, p = 0.50). No difference was found in the secondary ischemic endpoint (HR 1.24; 95% CI 0.77-2.00, p = 0.38). CONCLUSIONS: In patients with AF undergoing PCI at lower ischemic risk and higher bleeding risk, 1 month of TT seems safe and efficacious. Further studies are warranted in patients at high ischemic risk.

Arrhythmia burden in elderly patients with severe aortic stenosis as determined by continuous electrocardiographic recording: toward a better understanding of arrhythmic events after transcatheter aortic valve replacement.

BACKGROUND: This study sought to evaluate the prevalence of previously undiagnosed arrhythmias in candidates for transcatheter aortic valve replacement (TAVR) and to determine the impact on therapy changes and arrhythmic events after the procedure. METHODS AND RESULTS: A total of 435 candidates for TAVR underwent 24-hour continuous ECG monitoring the day before the procedure. Newly diagnosed arrhythmias were observed in 70 patients (16.1%) before TAVR: paroxysmal atrial fibrillation (AF)/atrial tachycardia (AT) in 28, advanced atrioventricular block or severe bradycardia in 24, nonsustained ventricular tachycardia in 26, and intermittent left bundle-branch block in 3 patients. All arrhythmic events but one were asymptomatic and led to a therapy change in 43% of patients. In patients without known AF/AT, the occurrence of AF/AT during 24-hour ECG recording was associated with a higher rate of 30-day cerebrovascular events (7.1% versus 0.4%; P=0.030). Among the 53 patients with new-onset AF/AT after TAVR, 30.2% had newly diagnosed paroxysmal AF/AT before the procedure. In patients who needed permanent pacemaker implantation after the procedure (n=35), 31.4% had newly diagnosed advanced atrioventricular block or severe bradycardia before TAVR. New-onset persistent left bundle-branch block after TAVR occurred in 37 patients, 8.1% of whom had intermittent left bundle-branch block before the procedure. CONCLUSIONS: Newly diagnosed arrhythmias were observed in approximately a fifth of TAVR candidates, led to a higher rate of cerebrovascular events, and accounted for a third of arrhythmic events after the procedure. This high arrhythmia burden highlights the importance of an early diagnosis of arrhythmic events in such patients to implement the appropriate therapeutic measures earlier.

Genetic association study of coronary collateral circulation in patients with coronary artery disease using 22 single nucleotide polymorphisms corresponding to 10 genes involved in postischemic neovascularization.

BACKGROUND: Collateral growth in patients with coronary artery disease (CAD) is highly heterogeneous. Although multiple factors are thought to play a role in collateral development, the contribution of genetic factors to coronary collateral circulation (CCC) is largely unknown. The goal of this study was to assess whether functional single nucleotide polymorphisms (SNPs) in genes involved in vascular growth are associated with CCC. METHODS: 677 consecutive CAD patients were enrolled in the study and their CCC was assessed by the Rentrop method. 22 SNPs corresponding to 10 genes involved in postischemic neovascularization were genotyped and multivariate logistic regression models were adjusted using clinically relevant variables to estimate odds ratios and used to examine associations of allelic variants, genotypes and haplotypes with CCC. RESULTS: Statistical analysis showed that the HIF1A rs11549465 and rs2057482; VEGFA rs2010963, rs1570360, rs699947, rs3025039 and rs833061; KDR rs1870377, rs2305948 and rs2071559; CCL2 rs1024611, rs1024610, rs2857657 and rs2857654; NOS3 rs1799983; ICAM1 rs5498 and rs3093030; TGFB1 rs1800469; CD53 rs6679497; POSTN rs3829365 and rs1028728; and LGALS2 rs7291467 polymorphisms, as well as their haplotype combinations, were not associated with CCC (p < 0.05). CONCLUSIONS: We could not validate in our cohort the association of the NOS3 rs1799983, HIF1A rs11549465, VEGFA rs2010963 and rs699947, and LGALS2 rs7291467 variants with CCC reported by other authors. A validated SNP-based genome-wide association study is required to identify polymorphisms influencing CCC.

Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial.

BACKGROUND: Oral anticoagulation (OAC) is the recommended therapy for patients with atrial fibrillation (AF) because it reduces the risk of stroke and other thromboembolic events. Dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention and stenting (PCI-S). In patients with AF requiring PCI-S, the association of DAPT and OAC carries an increased risk of bleeding, whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events. OBJECTIVE: The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy (TT) in patients with nonvalvular AF at low-to-moderate risk of stroke (CHADS2 score ≤2) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications. DESIGN: The MUSICA-2 is a multicenter, open-label randomized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S. The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events: death, myocardial infarction, stent thrombosis, or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients. CONCLUSIONS: The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications.

Sex-based Differences in Percutaneous Coronary Intervention Outcomes in Patients with Ischaemic Heart Disease.

In high-income countries, ischaemic heart disease is the leading cause of death in women and men, accounting for more than 20% of deaths in both sexes. However, women are less likely to receive guideline-recommended percutaneous coronary intervention (PCI) than men. Women undergoing PCI have poorer unadjusted outcomes because they are older and have greater comorbidity than men, but uncertainty remains whether sex affects outcome after these differences in clinical characteristics are considered. In this paper, we review recent published evidence comparing outcomes between men and women undergoing PCI. We focus on the sex differences in PCI outcomes in different scenarios: acute coronary syndromes, stable angina and complex lesions, including the approach of left main coronary artery. We also review how gender is considered in recent guidelines and offer a common clinical scenario to illustrate the contemporary management strategies an interventional cardiologist should consider when performing PCI on a female patient.

Bioactive or Drug-Eluting Stents in 75 Years or Older Patients: The BIODES-75 Registry.

BACKGROUND: TiNO-coated BAS have demonstrated competitive outcomes compared to drug-eluting stents (DES). These devices allow short antiplatelet regimens and may be a good option for the growing elderly population undergoing percutaneous coronary intervention (PCI). METHODS: Multicenter observational trial in routine clinical practice. A propensity-score matched analysis compared a prospective cohort of patients ≥ 75 years undergoing PCI with BAS, with a contemporary and retrospective cohort treated with last-generation DES. The co-primary endpoints of the study were the Target-Lesion-Failure (Cardiac death, non-fatal myocardial infarction, or target lesion revascularization) and Major Adverse Cardiovascular Events (total death, non-fatal myocardial infarction, stroke, or new revascularization) at 1 year. RESULTS: Whole population included 1000 patients, and 326 patients in each group were matched for analysis. No differences in primary endpoints were found: TLF 10.4% vs. 11% (HR 0.96 (Confidence Interval 95%, 0.36-1.7; p = 0.87)) and MACE 16.3% vs. 17.2% (HR 0.98 (Confidence Interval 95%; 0.3-1.5, p = 0.93)). Patients treated with BAS received shorter antiplatelets regimens (dual antiplatelet therapy at 1 year, 25.7% vs. 70.6%, p = 0.0001), and they presented lower incidence of bleeding (3.7% vs. 11.7%, HR 0.3 (IC 95% 0.16-0.6, p = 0.001)). CONCLUSION: In this real-life registry of patients ≥ 75 years, BAS were similar to the latest-generation DES in terms of efficacy and reduced the duration of the antithrombotic therapy, lowering bleeding events.

Expert Consensus on Sizing and Positioning of SAPIEN 3/Ultra in Bicuspid Aortic Valves.

Severe aortic stenosis patients with bicuspid anatomy have been excluded from the major transcatheter aortic valve replacement (TAVI) randomized clinical trials. As a result, there is no official recommendation on bicuspid TAVI. A panel of bicuspid experts was created to fill this gap. In this consensus statement, an algorithm is proposed to guide the choice of surgery or TAVI within this complex patient population, depending on aortic dilatation, age, surgical risk score, and anatomy. A step-by-step guide for sizing and positioning of the SAPIEN 3/Ultra TAVI bioprostheses is presented. Annular sizing remains the primary strategy in most bicuspid patients. However, some anatomies may require sizing at the supra-annular level, for which patients the panel recommends the circle method, a dedicated sizing and positioning approach for SAPIEN 3/Ultra. The consensus provides valuable pre-operative insights on the interactions between SAPIEN 3/Ultra and the bicuspid anatomy; understanding the valve-anatomy relationship is critical to avoid complications and to optimize outcomes for patients.

Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice.

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.

Worse 12-month prognosis in women with non-valvular atrial fibrillation undergoing percutaneous coronary intervention.

BACKGROUND: Limited data exists on the impact of sex on outcomes in non-valvular atrial fibrillation (NVAF) patients undergoing percutaneous coronary intervention (PCI). We explored the impact of sex on ischemic and bleeding events in these patients within 1-year. METHODS: A prospective register included 1021 patients with NVAF undergoing PCI and 253 (24.8%) were women. The primary end point was a composite of cardiovascular death, stroke or systemic embolism (SSE). The secondary end-point was major bleeding events defined as a Bleeding Academic Research Consortium (BARC ≥ 3a). RESULTS: Women were older (76.8 ±â€¯7.7 vs 71.8 ±â€¯9.1 years, p < 0.0001), and presented more often CHA2DS2-VASc ≥ 2 (adjusted HR 1.15; 95%CI 1.13-1.18, p < 0.0001) and HAS-BLED ≥ 3 (adjusted HR 1.12; 95%CI 1.10-1.14, p < 0.0001) than men. The use of oral anticoagulant at discharge was similar in both sexes (55.9% vs 56.5%, p = 0.45). The time in therapeutic range (TTR ≥ 65%) was lower in women than in men (35.6 ±â€¯24.6% vs 48.9 ±â€¯27.2%, p = 0.002). The incidence of adverse events was higher in women (39.9% vs 28.9%, p = 0.01). After adjusting for confounder variables, cardiovascular death or SSE rate (16.6% vs 10.4%; adjusted HR 1.58; 95%CI 1.07-2.31; p = 0.01) and major bleeding (11.5% vs 5.0%; adjusted HR 2.17; 95%CI 1.31-3.59; p = 0.003) were higher in women, as was cardiovascular death (adjusted HR 1.71; 95%CI, 1.18-2.46, p = 0.004). TTR was negatively correlated with any bleeding event in women (r = -0.41; p = 0.03). CONCLUSIONS: Female with NVAF undergoing PCI showed a lower TTR than men and TTR was associated with bleeding events. Female sex was an independent risk factor for cardiovascular death and major bleeding.

Use and Outcomes of Triple Antithrombotic Therapy with Non-Vitamin K Antagonists in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Triple antithrombotic therapy (TT) is recommended for patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, there is a lack of comparative data in a real-world clinical setting between non-vitamin K antagonist oral anticoagulants (NOAC) and vitamin K antagonists (VKA). The aim of this study was to compare the safety and efficacy of TT with NOAC or VKA after PCI in patients with AF at 1-year of follow-up. MATERIALS AND METHODS: This was an observational retrospective study in 2 tertiary care hospitals during 2013-2016. Patients with indication for anticoagulation due to AF from an initial registry of 5,269 patients undergoing PCI were identified. Safety primary endpoint was the occurrence of major bleeding events as defined by Bleeding Academic Consortium (BARC ≥ 3). The primary efficacy endpoint was defined as major adverse cardiovascular events (MACE). RESULTS: A total of 187 consecutive patients on TT were identified: 45.4% of were discharged on NOAC and 54.6% on VKA. Patients who received VKA presented more comorbidities and had a higher bleeding risk than those who received NOACs. Major bleeding events occurred in 17 patients (9%), with a higher rate in the VKA group (3.5% vs. 13% confidence interval, 0.19-0.86, P = 0.02). There were no differences in the rates of major adverse cardiovascular events, stroke or net clinical benefit. CONCLUSIONS: In this real-world study, patients with AF undergoing PCI treated on NOAC-based TT showed lower bleeding rates than those on VKA, with a lower rate of major bleeding events, while efficacy was similar between groups.

Safety of drug-eluting stents compared to bare metal stents in patients with an indication for long-term oral anticoagulation: A propensity score matched analysis.

BACKGROUND: Drug-eluting stents (DES) reduce stent restenosis compared with bare-metal stents (BMS). However, their use in patients requiring long-term oral anticoagulation (OAC) is controversial owing to increased risk of bleeding associated with OAC plus antiplatelet treatment over time. OBJECTIVE: To assess the safety of DES vs BMS in patients requiring long-term OAC for any reason. METHODS: Prospective observational multicenter study conducted at 6 teaching centers of patients undergoing percutaneous coronary intervention who required OAC for any reason. Adverse outcomes were analyzed at 1 year of follow-up. RESULTS: We identified 1002 patients requiring OAC (mean age: 72 years, male 72%). Six- hundred and thirteen patients (61.2%) received BMS and 389 (38.8%) DES. Diabetes, previous PCI, myocardial infarction and acute coronary syndrome at admission (P < 0.0001) were more common in patients with DES. Antithrombotic prescribing was similar at discharge between groups (TT: 51.5% vs 50.9%, clopidogrel plus OAC: 7.0% vs 5.0% and DAPT: 41.4% vs 42.7%, p = 0.52). DES and BMS patients showed similar rates of total bleeding (15.2% vs 13.4%, adjusted HR 0.82 [0.58-1.17, p = 0.82 and major bleeding (6.2% vs 6.0%; adjusted HR 1.22 [0.71-2.09], p = 0.46) and MACE (15.2% vs 18.6%, adjusted HR: 0.82 [0.57-1.17], p = 0.28, while restenosis was lower in patients with DES (5.3% vs 8.5%, adjusted HR. (0.52 [0.29-0.92], p = 0.02. Cox analysis after propensity score selection of 368 matched pairs demonstrated that DES use was not associated with a higher incidence of total bleeding or major bleeding. CONCLUSION: DES use is safe in patients with an indication for long-term OAC.

Area at risk and collateral circulation in a first acute myocardial infarction with occluded culprit artery. STEMI vs non-STEMI patients.

BACKGROUND: It is unclear why among patients with first acute myocardial infarction and an occluded culprit artery only some present ST segment elevation. In fact, there is no study that compares the angiographic area at risk and the collateral circulation in first NSTEMI vs STEMI patients. METHODS AND RESULTS: 205 patients admitted for myocardial infarction with occluded culprit artery were included, 132 STEMI and 73 NSTEMI. Demographic data, the area at risk determined by the BARI score and collateral supply by the Rentrop score from the 2 groups were compared. NSTEMI patients showed lower peak Tn I than STEMI in the overall group but also in the 3 subsets with different culprit arteries (p < .001). They also presented a higher rate of left circumflex coronary artery (CFX) as culprit artery (52% vs 14%, p < .001), smaller BARI score area of the culprit artery (5.4 vs 7.6, p < .001), and higher frequency of well-developed collaterals (Rentrop score ≥ 2, 1.82 vs 0.41, p < .001). The latter was also higher in each of the 3 different culprit arteries (p = .002-<0.001) Among 38 NSTEMI patients with CFX occlusion, 20 with ≥1 mm ST depression in V2 to V4 (possible posterior infarction) showed a similar Rentrop score than the 18 with other ECG changes but lower Tn I peak (p = .012). CONCLUSIONS: In first acute myocardial infarction with an occluded culprit artery NSTEMI patients - including those with possible posterior infarction - present smaller infarct size and higher collateral blood supply than STEMI patients in each of the 3 main culprit arteries.

Glycative and oxidative stress are associated with altered thrombus composition in diabetic patients with ST-elevation myocardial infarction.

BACKGROUND: The role of type 2 diabetes (T2DM) on composition of thrombus has not been fully characterized in patients with ST-elevation myocardial infarction (STEMI). AIMS: To elucidate the differences between diabetic and non-diabetic patients with STEMI in relation to the composition of coronary thrombus, and the potential association of these differences with glycated haemoglobin levels and markers of oxidative stress. METHODS: Intracoronary thrombi from consecutive thrombus aspiration procedures in STEMI patients, 25 diabetic and 28 non-diabetic, were analyzed by immunofluorescence with confocal microscopy. Plasma biomarkers (P-selectin, vWF, PAI-1, t-PA, D-dimer, TF pathway markers, plasmin and CD34+) were measured in peripheral blood, and the oxidative capacity of plasma as indirect measure of oxidative stress was measured in parallel. RESULTS: Patients with T2DM had higher levels of fibrin (P=0.03), P-selectin (P=0.0001), PAI-1 (P=0.03) and vWF (P=0.006) in the thrombus and higher plasma TF activity (P=0.01) compared to non-diabetics. TF activity and plasmin correlated with HbA1C levels (R2=0.71, P=0.0001; R2=0.46, P=0.04, respectively) and TF was inversely correlated with TFPI (R2=-0.44, P=0.008) and tPA (R2=-0.48, P=0.003). Diabetic patients showed a higher oxidative response of plasma (26.47±6.88% vs 22.06±6.96% of oxidized lipids, P=0.04) (measured by H-NMR spectroscopy) that was associated to increased fibrin content into thrombus (R2=0.76, P=0.01). CONCLUSION: Diabetic patients with STEMI display an increased thrombogenicity that results in a different thrombus composition respect to non-diabetic patients with STEMI. The increased thrombogenicity present in T2DM is related to higher glycoxidative stress, as quantified by HbA1C levels and oxidative response in plasma.

Institutional experience and outcomes of transcatheter aortic valve replacement: Results from an international multicentre registry.

BACKGROUND: Despite rapidly increasing use of TAVR across institutions, limited data is available for the effect of procedural experience on TAVR outcomes. We investigate the relationship between institutional experience and TAVR outcomes. METHODS: 1953 patients undergoing TAVR at 8 international sites were grouped into chronological quantiles (Q) to assess temporal changes on procedural and clinical outcomes and multivariate logistic regression performed to determine predictors of device success, early safety and all-cause mortality. RESULTS: The mean age of patients was 81±7years and 991 (51%) were female. The quantiles comprised of first 62 cases for Q1, 63-133 for Q2, 134 to 242 for Q3 and 243 to 476 for Q4. Device success increased from Q1 to Q4 (78% vs 89%, p<0.001) with significant improvement in the early safety endpoint (19% vs 10%, p<0.001). All cause mortality reduced by half in Q4 compared to Q1 (8% vs 4%, p=0.01) and rates of major vascular complications, major bleeding and valve embolization decreased with increasing experience. The multivariate analysis identified TAVR in Q3 and Q4 to be independently associated with higher device success and lower risk of complications. TAVR in Q4 was independently associated with lower mortality (OR 0.36 95% CI 0.19-0.70, p=0.002). CONCLUSIONS: Greater institutional experience with TAVR procedures improves device success and clinical outcomes. An experience of >242 cases is independently associated with lower mortality. These findings have important implications for defining minimum volume criteria for institutions and training standards for TAVR procedure.

Randomized comparison between the invasive and conservative strategies in comorbid elderly patients with non-ST elevation myocardial infarction.

BACKGROUND: Comorbid elderly patients with non-ST-elevation myocardial infarction (non-STEMI) are underrepresented in randomized trials and undergo fewer cardiac catheterizations according to registries. Our aim was to compare the conservative and invasive strategies in these patients. METHODS: Randomized multicenter study, including 106 patients (January 2012-March 2014) with non-STEMI, over 70years and with comorbidities defined by at least two of the following: peripheral artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal failure or anemia. Patients were randomized to invasive (routine coronary angiogram, n=52) or conservative (coronary angiogram only if recurrent ischemia or heart failure, n=54) strategy. Medical treatment was identical. The main endpoint was the composite of all-cause mortality, reinfarction and readmission for cardiac cause (postdischarge revascularization or heart failure), at long-term (2.5-year follow-up). Analysis of cumulative event rate (incidence rate ratio=IRR) and time to first event (hazard ratio=HR), were performed. RESULTS: Cardiac catheterization/revascularization rates were 100%/58% in the invasive versus 20%/9% in the conservative arm. There were no differences between groups in the main endpoint (invasive vs conservative: IRR=0.946, 95% CI 0.466-1.918, p=0.877) at long-term. The invasive strategy, however, tended to improve 3-month outcomes in terms of mortality (HR=0.348, 95% CI 0.122-0.991, p=0.048), and of mortality or ischemic events (reinfarction or postdischarge revascularization) (HR=0.432, 95% CI 0.190-0.984, p=0.046). This benefit declined during follow-up. CONCLUSIONS: Invasive management did not modify long-term outcome in comorbid elderly patients with non-STEMI. The finding of a tendency towards an improvement in the short-term needs confirmation in larger studies (clinicaltrials.govNCT1645943).