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Optimal dual antiplatelet therapy (DAPT) duration for patients undergoing percutaneous coronary intervention (PCI) for coronary bifurcations is an unmet issue. The BIFURCAT registry was obtained by merging two registries on coronary bifurcations. Three groups were compared in a two-by-two fashion: short-term DAPT (≤ 6 months), intermediate-term DAPT (6-12 months) and extended DAPT (>12 months). Major adverse cardiac events (MACE) (a composite of all-cause death, myocardial infarction (MI), target-lesion revascularization and stent thrombosis) were the primary endpoint. Single components of MACE were the secondary endpoints. Events were appraised according to the clinical presentation: chronic coronary syndrome (CCS) versus acute coronary syndrome (ACS). 5537 patients (3231 ACS, 2306 CCS) were included. After a median follow-up of 2.1 years (IQR 0.9-2.2), extended DAPT was associated with a lower incidence of MACE compared with intermediate-term DAPT (2.8% versus 3.4%, adjusted HR 0.23 [0.1-0.54], p

Systematic prescription of beta-blockers after myocardial infarction remains an open question in the era of revascularization, especially for patients with uncomplicated myocardial infarction.To evaluate in a real-life registry the proportion of patients with uncomplicated myocardial infarction (preserved left ventricular ejection fraction and no cardiovascular event within the first 6 months), and to report their characteristics, outcomes and beta-blocker use.We included 1887 consecutive patients with ST-segment elevation myocardial infarction from the prospective ePARIS registry. Patients were divided into three groups: the "uncomplicated myocardial infarction" group (n=1060), defined by a left ventricular ejection fraction ≥ 40% and a 6-month period free from cardiovascular events; the "complicated myocardial infarction" group (n=366), defined by a left ventricular ejection fraction ≥ 40% and a recurrent cardiovascular event in the first 6 months; and the "left ventricular dysfunction" group (n=461), defined by a left ventricular ejection fraction40%.During a median follow-up of 2.7 years (interquartile range 1.0-4.9 years), the "uncomplicated myocardial infarction" group was at low mortality risk compared with the "complicated myocardial infarction" group (hazard ratio 0.38, 95% confidence interval 0.25-0.58; P0.01) and the "left ventricular dysfunction" group (hazard ratio 0.22, 95% confidence interval 0.15-0.32; P0.01). Beta-blockers were prescribed at discharge predominantly in the "uncomplicated myocardial infarction" group (93%) compared with 87% in the "complicated myocardial infarction" group and 81% in the "left ventricular dysfunction" group.Beta-blockers are less prescribed in patients who may need them the most. The benefit of beta-blockers-largely prescribed in lower-risk patients-remains to be shown beyond the first 6 months for these patients with no left ventricular dysfunction and no recurrent events.

International audience; Background: Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.Methods: The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.Findings: Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).Interpretation: Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.Funding: ACTION Study Group and AstraZeneca.

International audience; Stratifying prognosis following coronary bifurcation percutaneous coronary intervention (PCI) is an unmet clinical need that may be fulfilled through the adoption of machine learning (ML) algorithms to refine outcome predictions. We sought to develop an ML-based risk stratification model built on clinical, anatomical, and procedural features to predict all-cause mortality following contemporary bifurcation PCI. Multiple ML models to predict all-cause mortality were tested on a cohort of 2393 patients (training, n = 1795; internal validation, n = 598) undergoing bifurcation PCI with contemporary stents from the real-world RAIN registry. Twenty-five commonly available patient-/lesion-related features were selected to train ML models. The best model was validated in an external cohort of 1701 patients undergoing bifurcation PCI from the DUTCH PEERS and BIO-RESORT trial cohorts. At ROC curves, the AUC for the prediction of 2-year mortality was 0.79 (0.74–0.83) in the overall population, 0.74 (0.62–0.85) at internal validation and 0.71 (0.62–0.79) at external validation. Performance at risk ranking analysis, k-center cross-validation, and continual learning confirmed the generalizability of the models, also available as an online interface. The RAIN-ML prediction model represents the first tool combining clinical, anatomical, and procedural features to predict all-cause mortality among patients undergoing contemporary bifurcation PCI with reliable performance.

International audience; Background: The PARIS risk score (PARIS-rs) and percutaneous coronary intervention complexity (PCI-c) predict clinical and procedural residual ischemic risk following PCI. Their accuracy in patients undergoing unprotected left main (ULM) or bifurcation PCI has not been assessed.Methods: The predictive performances of the PARIS-rs (categorized as low, intermediate, and high) and PCI-c (according to guideline-endorsed criteria) were evaluated in 3,002 patients undergoing ULM/bifurcation PCI with very thin strut stents.Results: After 16 (12-22) months, increasing PARIS-rs (8.8% vs. 14.1% vs. 27.4%, p < .001) and PCI-c (15.2% vs. 11%, p = .025) were associated with higher rates of major adverse cardiac events ([MACE], a composite of death, myocardial infarction [MI], and target vessel revascularization), driven by MI/death for PARIS-rs and target lesion revascularization/stent thrombosis for PCI-c (area under the curves for MACE: PARIS-rs 0.60 vs. PCI-c 0.52, p-for-difference < .001). PCI-c accuracy for MACE was higher in low-clinical-risk patients; while PARIS-rs was more accurate in low-procedural-risk patients. ≥12-month dual antiplatelet therapy (DAPT) was associated with a lower MACE rate in high PARIS-rs patients, (adjusted-hazard ratio 0.42 [95% CI: 0.22-0.83], p = .012), with no benefit in low to intermediate PARIS-rs patients. No incremental benefit with longer DAPT was observed in complex PCI.Conclusions: In the setting of ULM/bifurcation PCI, the residual ischemic risk is better predicted by a clinical risk estimator than by PCI complexity, which rather appears to reflect stent/procedure-related events. Careful procedural risk estimation is warranted in patients at low clinical risk, where PCI complexity may substantially contribute to the overall residual ischemic risk.

Background The clinical impact of stent strut thickness in coronary bifurcation lesions in small vessels has not been assessed in a real-world population. Methods and results All 506 patients enrolled in the RAIN study, undergoing PCI in a vessel with a diameter 2.5 mm or less were retrospectively evaluated and divided into two groups according to stent strut thickness: 74 μm (n = 206) versus 81 μm (n = 300); 87.1% of the lesions involved bifurcations. TLF [defined as a composite of myocardial infarction (MI) and target lesion revascularization (TLR)] was the primary endpoint, with MACE (a composite of death, MI and TLR), its components and stent thrombosis the secondary endpoint. After 16 (14-18) months, a lower incidence of TLF (4.3 vs. 9.8%, P = 0.026) and ST (1.0 vs. 3.0%, P = 0.042) was seen in the 74 μm group, whereas MACE occurred in 60 of 506 patients, with no statistical difference between the two groups (9.7 vs. 13.3%, P = 0.070). At multivariate analysis, chronic renal failure increased the risk of TLF while thinner strut was an independent protective factor (hazard ratio 0.51, CI 0.17-0.85, P = 0.005). Conclusion In this real-world population, patients being treated for small vessels lesions with thinner strut stents had lower rates of TLF, MI and ST.

International audience; Background: The European study MetaCardis aims to investigate the role of the gut microbiota in health and cardiometabolic diseases in France, Germany, and Denmark. To evaluate long-term diet-disease relationships, a food frequency questionnaire (FFQ) was found to be the most relevant dietary assessment method for the MetaCardis study.Objective: The objectives of this study were to describe the development of three semiquantitative online FFQs used in the MetaCardis study-one FFQ per country-and to assess the relative validity of the French MetaCardis FFQ.Design: The layout and format of the MetaCardis FFQ was based on the European Prospective Investigation of Cancer (EPIC)-Norfolk FFQ and the content was based on relevant European FFQs. Portion size and nutrient composition were derived from national food consumption surveys and food composition databases. To assess the validity of the French MetaCardis FFQ, a cross-sectional study design was utilized.Participants/setting: The validation study included 324 adults recruited between September 2013 and June 2015 from different hospitals in Paris, France.Main outcome measures: Food intakes were measured with both the French MetaCardis FFQ and 3 consecutive self-administered web-based 24-hour dietary recalls (DRs).Statistical analyses performed: Several measures of validity of the French MetaCardis FFQ were evaluated: estimations of food groups, energy, and nutrient intakes from the DRs and the FFQ, Spearman and Pearson correlations, cross-classification, and Bland-Altman analyses.Results: The French MetaCardis FFQ tended to report higher food, energy, and nutrient intakes compared with the DRs. Mean correlation coefficient was 0.429 for food, 0.460 for energy, 0.544 for macronutrients, 0.640 for alcohol, and 0.503 for micronutrient intakes. Almost half of participants (44.4%) were correctly classified within tertiles of consumption, whereas 12.9% were misclassified in the opposite tertile. Performance of the FFQ was relatively similar after stratification by sex.Conclusions: The French MetaCardis FFQ was found to have an acceptable level of validity and may be a useful instrument to rank individuals based on their food and nutrient intakes.

Background: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group. Objectives: The objective of this article was to perform an economic evaluation of the SENIOR trial. Methods: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping. Results: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from (sic)13 752 to (sic)20 511/MACCE avoided and from (sic)42 835 to (sic)68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of (sic)50000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries. Conclusion: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.

OBJECTIVES: Report the results at 2 years of the patients included in the SENIOR trial. BACKGROUND: Patients above 75 years of age represent a fast-growing population in the cathlab. In the SENIOR trial, patients treated by percutaneous coronary intervention (PCI) with drug eluting stent (DES) and a short duration of P2Y12 inhibitor (1 and 6 months for stable and unstable coronary syndromes, respectively) compared with bare metal stents (BMS) was associated with a 29% reduction in the rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR) at 1 year. The results at 2 years are reported here. METHODS AND RESULTS: We randomly assigned 1,200 patients (596[50%] to the DES group and 604[50%] to the BMS group). At 2 years, the composite endpoint of all-cause mortality, MI, stroke and ID-TLR had occurred in 116 (20%) patients in the DES group and 131 (22%) patients in the BMS group (RR 0.90 [95%CI 0.72-1.13], p = .37). IDTLR occurred in 14 (2%) patients in the DES group and 41 (7%) patients in the BMS group (RR 0.35 [95%CI 0.16-0.60], p = .0002). Major bleedings (BARC 3-5) occurred in 27(5%) patients in both groups (RR 1.00, [95%CI 0.58-1.75], p = .99). Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52 [95%CI 0.01-1.95], p = .27). CONCLUSION: Among elderly PCI patients, a strategy combining a DES together with a short duration of DAPT is associated with a reduction in revascularization up to 2 years compared with BMS with very few late events and without any increased in bleeding complications or stent thrombosis. https://doi.org/10.1002/ccd.29159 ispartof: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS vol:97 issue:5 pages:E607-E613 ispartof: location:United States status: published

Background: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. Methods: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [ Results: Two thousand seven hundred forty-two patients were included. At 16 months (8–20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P =0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P =0.030) and target lesion revascularization (7.3% versus 15.2%; P =0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P =0.034), while long overlap was not (6.8% versus 5.4%; P =0.567). Conclusions: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03544294.

International audience; Introduction: In new generation drug eluting stents (DESs) era, the impact of stent geometry on freedom from recurrent events has been poorly explored. Impact of struts thickness and the number of crowns and connectors on clinical outcomes were evaluated in the present study.Methods: Randomized controlled trials comparing last generation DESs were selected. The primary endpoint was the rate of target lesion revascularization (TLR), while secondary was definite stent thrombosis (ST).Results: Fifty-three studies with 52,006 patients were included. A struts thickness ≤81 nm was associated with a lower incidence of TLR (2.9%: 2.4-3.4 vs. 3.6%: 3.0-4.3) and ST (0.8%: 0.6-1.1 vs. 1.3%: 0.9-1.8). A mean number of connectors >2.5 was also associated with a lower incidence of TLR (3.2%: 2.8-3.6 vs. 3.5%: 2.9-4.2) and ST (1.0%:0.8-1.3 vs. 1.3%: 0.9-1.7 vs. for ST). On the other hand, stents with average number of crowns

Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with thin stents (

Background There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. Methods In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 μm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed. Results From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12–22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES. Conclusion In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events. Trial registration ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.

International audience; Objectives: To evaluate the independent clinical impact of stent structural features in a large cohort of patients undergoing unprotected left main (ULM) or coronary bifurcation percutaneous coronary intervention (PCI) with a range of very thin strut stents.Background: Clinical impact of structural features of contemporary stents remains to be defined.Methods: All consecutive patients enrolled in the veRy thin stents for patients with left mAIn or bifurcatioN in real life (RAIN) registry were included. The following stent structural features were studied: antiproliferative drugs (everolimus vs. sirolimus vs. zotarolimus), strut material (platinum-chromium vs. cobalt-chromium), polymer (bioresorbable vs. durable), number of crowns (

Objectives The authors sought to assess the association between admission time with patient’s care, procedure characteristics, and clinical outcomes within a contemporary ST-segment elevation myocardial infarction (STEMI) network of patients referred for primary percutaneous coronary intervention (PCI). Background The effect of admission time on STEMI patient9s outcomes remains controversial when primary PCI is the preferred reperfusion strategy. Methods Characteristics and clinical outcomes of 2,167 consecutive STEMI patients admitted in a tertiary PCI-capable center were collected. On-hours were defined as admission from Monday through Friday between 8 am and 6 pm and off-hours as admission during night shift, weekend, and nonworking holidays. In-hospital and 1-year all-cause mortality were assessed as well as key time delays. Results A total of 1,048 patients (48.3%) were admitted during on-hours, and 1,119 patients (51.7%) during off-hours. Characteristics were well-balanced between the 2 groups, including rates of cardiac arrest (7.9% vs. 8.8%; p = 0.55) and cardiogenic shock (12.3% vs. 14.7%; p = 0.16). Median symptom-to-first medical contact time and median first medical contact-to-sheath insertion time did not differ according to on- versus off-hours admission (120 min vs. 126 min; p = 0.25 and 90 min vs. 93 min; p = 0.58, respectively), as well as the rate of radial access for catheterization (85.6% vs. 87.5%; p = 0.27). There was no association between on- versus off-hours groups and in-hospital (8.1% vs. 7.0%; p = 0.49) or 1-year mortality (11.0% vs. 11.1%; p = 0.89), respectively. Conclusions In a contemporary organized STEMI network, patients admitted in a high-volume tertiary primary PCI center during on-hours or off-hours had similar management and 1-year outcomes.

ObjectivesContrast-induced acute kidney injury (CI-AKI) is a common and potentially severe complication in patients with ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI). There is no consensus on the best definition of CI-AKI to identify patients at risk of haemodialysis or death. The objective of this study was to assess the association of CI-AKI, using four definitions, on inhospital mortality, mortality or haemodialysis requirement over 1-year follow-up, in patients with STEMI treated with pPCI.MethodsIn this prospective, observational study, all patients with STEMI referred for pPCI were included. We identified independent variables associated with CI-AKI and mortality.ResultsWe included 1114 consecutive patients with STEMI treated by pPCI. CI-AKI occurred in 18.3%, 12.2%, 15.6% and 10.5% of patients according to the CIN, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) Modification of Diet in Renal Disease (MDRD) and RIFLE Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) definitions, respectively. The RIFLE (CKD-EPI) definition was the most discriminant definition to identify patients at higher risk of inhospital mortality (27.1% vs 4.0%; adjusted OR 2.7 (95% CI 1.4 to 5.1), p=0.003), 1-year mortality (27.4% vs 6.6%; adjusted OR 2.8 (95% CI 1.5 to 5.3), p=0.002) and haemodialysis requirement at 1-year follow-up (15.6% vs 2.7%; adjusted OR 6.7 (95% CI 3.3 to 13.6), p=0.001). Haemodynamic instability, cardiac arrest, preexisting renal failure, elderly age and a high contrast media volume were independently associated with 1-year mortality. Of interest, contrast-media volume was not correlated to increase of creatininaemia (r=0.06) or decrease in estimated glomerular filtration rate (r=0.05) after percutaneous coronary intervention in our population.ConclusionsCI-AKI is a frequent and serious complication of STEMI treated by pPCI. The RIFLE definition is the most accurate definition to identify patients with CI-AKI at high risk of mortality or haemodialysis.

Aims The differential impact on ischaemic and bleeding events of the type of drug-eluting stent [durable polymer stents [DES] vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS)] and length of dual antiplatelet therapy (DAPT) remains to be defined. Methods and results Randomized controlled trials comparing different types of DES and/or DAPT durations were selected. The primary endpoint was Major Adverse Cardiovascular Events (MACE) [a composite of death, myocardial infarction (MI), and target vessel revascularization]. Definite stent thrombosis (ST) and single components of MACE were secondary endpoints. The arms of interest were: BRS with 12 months of DAPT (12mDAPT), biodegradable polymer stent with 12mDAPT, durable polymer stent [everolimus-eluting (EES), zotarolimus-eluting (ZES)] with 12mDAPT, EES/ZES with 12 months of DAPT (DAPT > 12 m). Sixty-four studies with 150 arms and 102 735 patients were included. After a median follow-up of 20 months, MACE rates were similar in the different arms of interest. EES/ZES with DAPT > 12 m reported a lower incidence of MI than the other groups, while BRS showed a higher rate of ST when compared to EES/ZES, irrespective of DAPT length. A higher risk of major bleedings was observed for DAPT > 12 m as compared to shorter DAPT. Conclusion Durable and biodegradable polymer stents along with BRS report a similar rate of MACE irrespective of DAPT length. Fewer MI are observed with EES/ZES with DAPT > 12 m, while a higher rate of ST is reported for BRS when compared to EES/ZES, independently from DAPT length. Stent type may partially affect the outcome together with DAPT length.

Background Differences between long-term outcomes among women and men treated by percutaneous intervention (PCI) are unknown. Purpose To compare characteristics mortality and impact of gender on poor outcomes after PCI. Methods Consecutive men and women admitted for PCI between 2008 and 2011 were prospectively included and followed-up until January 2019. Major adverse cardiovascular and cerebrovascular events (MACCE) and causes of death were collected through consultations, calls and death certificates. The primary endpoint was all-cause mortality according to gender. Secondary endpoints were cardiovascular death, non-cardiovascular death and MACCEs. Results A total of 3524 patients including 2720 men (77.1%) and 804 women (22.8%) were followed-up for a median time of 7.0 years (IQ1: 5.4; IQ 3: 7.2) with a follow rate of 97.6%. At baseline, women were older (70 ± 13.1 vs. 64.6 ± 12 years old) and smoked less (18.9% vs. 30.4%), had more frequently hypertension (67.9% vs. 58.1%) and chronic kidney disease (42.6% vs. 22.7%), whereas diabetes rate was similar around 29%. PCI for myocardial infarction at admission represented 23% with no difference according to gender. Prognosis was severe as all-cause death occurred for 30.3% and MACCE for 40.9% of all patients. In unadjusted analyses, women had a higher risk of all-cause mortality (35% vs. 29%, HR = 1.25, 95%CI [1.09–1.43], P = 0.0015) and cardiovascular mortality (61% vs. 57%, HR = 1.31, 95%CI [1.10–1.56]) but there was no difference on occurrence of MACCE (HR = 1.079, 95%CI [0.9271–1.221]). After adjustment for baseline cardiovascular risk factors, presentation and severity of coronary disease, there was no difference between men and women for mortality ( Fig. 1 ). Conclusions In this long-term follow-up, women had a higher risk of all-cause and cardiovascular mortality after PCI in unadjusted analyses. However, gender was not independently associated with mortality after adjustment for cardiovascular risk factors.

Background Thinner stent struts of new DES (drug eluting stent) are associated with shorter time of reendothelialization, a reduction of shear stress and inflammation of coronary walls. Despite this great innovations their clinical safety and efficacy in challenging scenarios as non left main bifurcation coronary lesions has not been tested. Methods RAIN is a multicenter registry enrolling patients treated on bifurcated coronary lesions and left main with thin-strut DES. Baseline characteristics and procedural data were recorded. Target lesion revascularization (TLR) was the primary endpoint, whereas major adverse clinical events (MACE; composite of all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), TLR and stent thrombosis (ST)) along with its single components were the secondary endpoints. A multivariate analysis to identify predictors of TLR and sub-analysis according to stenting strategy (provisional vs 2-stent technique), use of final kissing balloon (FKB) and IVUS/OCT optimization were performed. Results Data from 1803 patients (59% ACS, 61% stable CAD) treated on bifurcations were retrospectively evaluated. Follow up was available for 1685 (94%) patients for a median of 12 months (IQR 7–18). TLR occurred globally in 2.5% of cases (2.2% in provisional stenting, 3.5% in 2-stent technique). The rate of MACE was 9.4%, whereas all-cause death and MI, occurred in 4.1% and 3.2% of cases respectively. TVR and definite ST incidence were 3.7% and 1.1%. At multivariate analysis, chronic kidney disease (CKD) negatively influenced the main endpoint (HR 1.95, 95% CI 1.06–3.6, p=0.03), whereas post-dilatation (HR 0.56, 95% CI 0.3–0.93, p=0.04) and provisional stenting resulted being protective factors. FKB reduced TLR occurrence at FU only in 2-stent technique (p=0.03), whereas intracoronary imaging (performed in 29% of patients) were uninfluential. Conclusion Very thin-strut DES represents a highly effective solution in bifurcation lesions. The risk of TLR is reduced by post-dilatation and provisional stenting. FKB is recommended in 2-stent technique, whereas further studies are required to address the impact of intracoronary imaging in this setting.

Background Comparative long-term outcomes among women and men treated with percutaneous intervention (PCI) are unknown. Objective To describe and compare mortality and predictors of poor outcomes among men and women who underwent PCI. Methods Consecutive men and women admitted for PCI between 2008 and 2011 were prospectively included and followed-up in this cohort study. Major adverse cardiovascular and cerebrovascular events (MACCE) and causes of death were collected through consultations, calls and death certificate. The primary endpoint was all-cause mortality according to gender. Secondary endpoints were cardiovascular death, non-cardiovascular death and MACCEs. Last detailed cardiovascular and vital status were collected in January 2019. Results A total of 3524 patients including 2720 men (77.1%) and 804 women (22.8%) were followed-up for a median time of 7.0 years (IQ1: 5.4; IQ 3: 7.2). The follow-up rate was 97.6%. Women were older at baseline (70±13.1 vs. 64.6±12), smoked less often (18.9% vs. 30.4%) but suffered more frequently of hypertension (67.9% vs. 58.1%) and chronic kidney disease (42.6% vs. 22.7%). All-cause death occurred for 30.3% (n=1070) and MACCE for 40.9% (n=1443) of patients in the cohort. In unadjusted analyses, women had a higher risk of all-cause mortality (35% vs 29%, HR = 1.25, 95% CI [1.09–1.43], p=0.0015) and cardiovascular mortality (61% vs. 57%, HR = 1.31, 95% CI [1.10–1.56]) but there was no difference on occurrence of MACCE (HR = 1.079, 95% CI = [0.9271–1.221]). After adjustments for baseline cardiovascular risk factors, presentation and severity of coronary disease, women and men shared a similar risk of mortality along time (adHR = 0.90, 95% CI [0.77–1.05]). Survival curves in women vs. men Conclusions In this long-term follow-up, women had a higher risk of all-cause and cardiovascular mortality after PCI in unadjusted analyses. However, gender was not independently associated with mortality after adjustment for cardiovascular risk factors.

Background Causes of death after percutaneous coronary intervention (PCI) along multiple time-periods are poorly described. Objective To describe causes and predictors of short-term, intermediate-term, and long-term mortality after PCI. Methods Consecutive men and women admitted for PCI from 2008 to 2011 were prospectively included and followed-up in this cohort study. A dedicated follow-up by independent reviewers was performed to collect the outcomes and adjudicate the causes of death. A log-rank analysis was used to compare the occurrence of cardiovascular and non-cardiovascular death at 30 days, one year and up to 8 years. Last detailed cardiovascular and vital status were collected in January 2019. Results A total of 3524 patients including 2720 men (77.2%) and 804 women (22.8%) were followed-up for a median time of 7.0 years (IQ1: 5.4; IQ 3: 7.2). The rate of complete follow-up was 97.6%. All-cause death occurred for 30.3% (n=1070) of patients in the cohort, in a median time of 2.5 years after PCI, with a rate of 5.3 deaths per 100 patient-years. Overall, mortality was mostly related to cardiovascular causes than non-cardiovascular causes (17.7% versus 12.6%, log-rank Survival after PCI Conclusions In this long-term cohort study, cardiovascular death was more frequent than non-cardiovascular death in patients treated with PCI in the short and intermediate-term but not beyond one year. Cancer accounted for one fifth of the overall mortality.

Introduction Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with ultrathin stents in unprotected left main (ULM) or coronary bifurcation remain undefined. Methods All consecutive patients presenting with a critical lesion of an ULM or a lesion involving a main coronary bifurcation and treated with very thin strut stents were included. MACE (a composite end point of cardiovascular death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) was the primary endpoint, while target vessel revascularization (TVR) was the secondary endpoint. Moreover, type and occurrence of ST and occurrence of ST, CV death and MI during DAPT or after DAPT discontinuation were also evaluated. All analyses were performed according to length of DAPT dividing the patients in 3 groups: short DAPT (3-months), intermediate DAPT (3–12 months) and long DAPT (12-months). Results 117 patients were discharged with an indication for DAPT≤3 months (median 1:1–2.5), 200 for DAPT between 3 and 12 months (median 8:7–10) and 1958 with 12 months DAPT. After 12.8 months (8–20), MACE was significantly higher in the 3-month group compared to 3–12 and 12-month groups (9.4% vs. 4.0% vs. 7.2%, p≤0.001), mainly driven by MI (4.4% vs. 1.5% vs. 3%, p≤0.001) and overall ST (4.3% vs. 1.5% vs. 1.8%, p≤0.001). ST post DAPT cessation were comparable (1.7% vs. 0% vs. 0.7%, p=0.42) with a median time to ST post DAPT discontinuation of 1.67 months (0.48–4.7). At multivariate analysis, DAPT of 12-months compared to 3-months reduces the risk of overall ST (OR 0.103: 0.019–0.0563, 95% CI) while only a trend was noted for DAPT between 3 and 12 months (OR 0.61: 0.186–2.005, 95% CI). When analysed by stent strategy a 2-stent strategy predicted ST post DAPT cessation (OR 3.241: 1.048–10.026, 95% CI), which was reduced by use of FKB (OR 0.101:0.01–0.872, 95% CI). Conclusion Even stents with very thin strut when implanted in real-life ULM or coronary bifurcation patients discharged with short DAPT have a relevant risk of ST, which remains high although not significant after DAPT cessation. The correct identification before PCI of the more fragile patients who may receive a shorter DAPT regimen could help identify the safest PCI technique: provisional stenting and use of final kissing balloon (FKB) are the safest options.

Introduction In new generation drug eluting stents (DESs) era, the impact of stent geometry on freedom from recurrent events has been poorly explored. Impact of struts thickness, number of crowns and connectors on clinical outcomes was evaluated in the present study. Methods Randomized controlled trials comparing last generation DESs were selected. The primary endpoint was the rate of target lesion revascularization (TLR), while secondary was Definite Stent Thrombosis (ST). Results 53 studies with 52006 patients were included. A struts thickness ≤81 nm was associated with a lower incidence of TLR (2.9%: 2.4–3.4 vs. 3.6%: 3.0–4.3) and ST (0.8%: 0.6–1.1 vs. 1.3%: 0.9–1.8). A mean number of connectors >2.5 was also associated with a lower incidence of TLR (3.2%: 2.8–3.6 vs. 3.5%: 2.9–4.2) and ST (1.0%:0.8–1.3 vs. 1.3%: 0.9–1.7 vs for ST). On the other hand, stents with average number of crowns Conclusions The findings of the study support that lower struts thickness and higher numbers of connectors have a positive clinical outcome reducing stent thrombosis and target lesion revascularizations, while the average number of stent crowns plays a secondary role.

International audience; OBJECTIVES:Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation.BACKGROUND:PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation.METHODS:We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints.RESULTS:Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45).CONCLUSIONS:PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.

Introduction Percutaneous coronary intervention (PCI) for complex lesions, including unprotected left main (ULM) and bifurcations, is gaining a relevant role in treating coronary artery disease with good outcomes, also thanks to new generation stents. The daily risk of adverse cardiovascular events and their temporal distribution after these procedures is not known. Methods All consecutive patients presenting with a critical lesion of ULM or bifurcation treated with very thin struts stents, enrolled in the RAIN-Cardiogroup VII study, were analyzed. The daily risk of major acute cardiovascular events (MACE), target lesion revascularization (TLR) and stent thrombosis (ST) and their temporal distribution in the first year of follow-up was the primary endpoint. Differences among subgroups (ULM, patient presentation, kind of stent polymer) were the secondary endpoint. Results 2745 patients were included, mean age 68 ± 11 years, 33.3% diabetics, 54.5% had an acute coronary syndrome (ACS); 88.5% of treated lesions were bifurcations, 27.2% ULM. Average daily risk was 0.022% for MACE, 0.005% for TLR and 0.004% for ST, in the first year. Bimodal distribution of adverse events, especially TLR, with an early peak in the first 50 days and a late one after 150 days, was observed. Patients with ULM presented a significantly higher daily risk of events, and ACS patients presented higher MACE risk. No difference emerged according to the type of stent polymer. Conclusions The daily risk of adverse events in the first year after complex PCI in our study is acceptably low. PCI on ULM carries a higher risk of complications.

Few data are available about the impact on outcomes of procedural strategies for percutaneous coronary intervention with thin-struts stents on unprotected left main (ULM): 792 patients with an ULM stenosis treated with percutaneous coronary intervention with thin-strut stents were enrolled in the present multicenter registry. Target lesion revascularization (TLR) was the primary end point. MACE (a composite of all-cause death, myocardial infarction, TLR, and stent thrombosis) and its single components, along with target vessel revascularization were the secondary end points. Subgroup analyses were performed according to complex versus noncomplex bifurcation lesions. After 16 months, 5.5% of patients experienced a TLR. At multivariate analysis, provisional stenting (odds ratio [OR] 0.46: 0.85 to 0.23, p = 0.006), use of imaging (OR 0.45: 0.23 to 0.98, p = 0.003) and final kissing balloon (FKB) (OR 0.41: 0.83 to 0.21, p = 0.001) reduced risk of TLR. FKB reduced risk of overall TLR only for 2 stents-strategy (6.2% vs 32.4%, p

Background Data concerning long-term mortality after percutaneous coronary intervention (PCI) and factors of poor outcomes are scarce. Objective To describe short-term, intermediate-term, and long-term mortality and their correlates after PCI. Methods In this prospective cohort study, we included and followed-up consecutive patients admitted for PCI from 2008 to 2011. Independent adjudicators reviewed the ischemic outcomes and causes of death until January 2019. A survival analysis was performed to compare the occurrence of cardiovascular and non-cardiovascular death at 30 days, one year and up to 8 years. Results Of the 3524, patients treated with PCI from 2008 to 2011, 2720 (77.2%) were men and 804 (22.8%) were women with a mean age of 65.8 years old. The median follow-up was 7.0 years (IQ1: 5.4; IQ3: 7.2) and complete for 97.6% of the patients. One third of the patients died (30.3%; n = 1070) in a median time of 2.5 years after PCI, with a rate of 5.3 deaths per 100 patient-years. Overall, mortality was mostly related to cardiovascular causes than non-cardiovascular causes (17.7% versus 12.6%, log-rank Fig. 1 ). Cardiovascular death was more frequent within 30 days (4.7% vs. 0.3%, P Conclusions Cardiovascular death was more frequent than non-cardiovascular death in patients treated with PCI in the short and intermediate-term but not beyond one year. Cancer accounted for one fifth of the overall mortality.

Background and objectives Whether prolonged dual antiplatelet therapy (DAPT) is more protective in patients with CKD and drug-eluting stents compared with shorter DAPT is uncertain. The purpose of this meta-analysis was to examine whether shorter DAPT in patients with drug-eluting stents and CKD is associated with lower mortality or major adverse cardiovascular event rates compared with longer DAPT. Design, setting, participants, & measurements A Medline literature research was conducted to identify randomized trials in patients with drug-eluting stents comparing different DAPT duration strategies. Inclusion of patients with CKD was also required. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or stent thrombosis (definite or probable). Major bleeding was the secondary outcome. The risk ratio (RR) was estimated using a random-effects model. Results Five randomized trials were included (1902 patients with CKD). Short DAPT (≤6 months) was associated with a similar incidence of the primary outcome, compared with 12-month DAPT among patients with CKD (48 versus 50 events; RR, 0.93; 95% confidence interval [95% CI], 0.64 to 1.36; P=0.72). Twelve-month DAPT was also associated with a similar incidence of the primary outcome compared with extended DAPT (≥30 months) in the CKD subgroup (35 versus 35 events; RR, 1.04; 95% CI, 0.67 to 1.62; P=0.87). Numerically lower major bleeding event rates were detected with shorter versus 12-month DAPT (9 versus 13 events; RR, 0.69; 95% CI, 0.30 to 1.60; P=0.39) and 12-month versus extended DAPT (9 versus 12 events; RR, 0.83; 95% CI, 0.35 to 1.93; P=0.66) in patients with CKD. Conclusions Short DAPT does not appear to be inferior to longer DAPT in patients with CKD and drug-eluting stents. Because of imprecision in estimates (few events and wide confidence intervals), no definite conclusions can be drawn with respect to stent thrombosis.

The disruption of systemic immune homeostasis is a key mediator in the progression of cardiometabolic diseases (CMDs). We aimed to extend knowledge regarding the clinical relevance of CMD-associated variation of circulating mucosal-associated invariant T (MAIT) cell abundance and to explore underlying cellular mechanisms. We analyzed cross-sectional data from 439 participants of the Metagenomics in Cardiometabolic Diseases (MetaCardis) study, stratified into 6 groups: healthy control subjects and patients with metabolic syndrome (MS), obesity, type 2 diabetes mellitus (T2DM), and coronary artery disease (CAD) without, or with congestive heart failure (CAD-CHF). Blood MAIT cell frequency was significantly decreased in all CMD groups, including early (MS) and later (CAD and CAD-CHF) stages of disease progression. Reduced MAIT cell abundance was associated with increased glycosylated hemoglobin, inflammation markers, and deterioration of cardiac function. Glucose dose dependently promoted MAIT cell apoptosis in vitro, independently of anti-CD3 and cytokine-mediated activation. This outcome suggests the prominence of metabolic over an antigenic or cytokine-rich environment to promote MAIT cell reduction in patients with CMD. In summary, all stages of CMDs are characterized by reduced circulating MAIT cells. Chronically elevated blood glucose levels could contribute to this decline. These data extend the pathologic relevance of MAIT cell loss and suggest that MAIT cell abundance may serve as an indicator of cardiometabolic health.-Touch, S., Assmann, K. E., Aron-Wisnewsky, J., Marquet, F., Rouault, C., Fradet, M., Mosbah, H., MetaCardis Consortium, Isnard, R., Helft, G., Lehuen, A., Poitou, C., Clement, K., Andre, S. Mucosal-associated invariant T (MAIT) cells are depleted and prone to apoptosis in cardiometabolic disorders.

Background Latent heart failure could be unmasked during exercise. Left atrial (LA) remodeling reflects the cumulative effects of left ventricular (LV) filling pressure over time and is usually determined by measurement of the LA volume indexed to body surface area (LAVi). We hypothesized that an indexation of the LA volume to the LV volume (LA/LV) would be more sensitive to detect abnormal exercise LV filling pressure as an index of early-stage heart failure with preserved ejection fraction (HFpEF) Purpose To assess the value of the LA/LV ratio to detect abnormal exercise LVEDP in patients with preserved LV ejection fraction (LVEF) and to investigate its association with maximal exercise capacity in two different cohorts. Methods We invasively measured LVEDP at rest and during low-level exercise in 45 patients with LVEF > 50% and normal resting LVEDP (LVEDP ≤ 16 mmHg). Correlations and receiver operator characteristic (ROC) curves were used to evaluate the association of LA/LV and LAVi with resting LVEDP, exercise LVEDP and ΔLVEDP (exercise LVEDP–resting LVEDP). The association of LA size indices with maximal exercise capacity during exercise echocardiography was also evaluated in 207 other patients. Results In the invasive study, 27 out of 45 patients had abnormal LV filling pressures during exercise. LA/LV and LAVi were not correlated to resting LVEDP. Among the two, only LA/LV was significantly correlated to exercise LVEDP (r = 0.42, P = 0.004), ΔLVEDP (r = 0.39, P = 0.007), and had a significant diagnostic value to detect early-stage HFpEF (area under the ROC curve 0.74, P = 0.007). In the non-invasive study, LA/LV was significantly associated with exercise capacity in multivariate analysis (β = −0.153, P = 0.012) while LAVi was not in a similar model. Conclusion The relative expansion of the LA over the LV as an early sign of heart remodeling appears more valuable than the conventional LAVi to detect early-stage HFpEF.

Background Diabetic patients account for an increasing number of patients undergoing percutaneous coronary intervention (PCI). However, diabetes mellitus (DM) is associated with increased residual platelet activity during dual antiplatelet treatment (DAPT) and DM patients have worse clinical outcomes after PCI as compared to non-DM. Objective To evaluate efficacy and safety of short duration DAPT (S-DAPT) and long duration DAPT (L-DAPT) after drug eluting stent (DES) implantation in DM and non-DM patients. Methods We searched Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) to identify randomized controlled trials (RCTs) assessing the effect of S-DAPT versus L-DAPT after DES implantation in DM and non-DM patients. Efficacy endpoints were all-cause mortality, cardiac mortality, myocardial infarction (MI), stent thrombosis (ST), target vessel revascularization (TVR), and composite end point of net adverse clinical events (NACE) (all-cause mortality, cardiac mortality, MI, ST, TVR, stroke, major bleeding). Safety endpoints were major bleeding and stroke. Event rates were compared using a forest plot of relative risk using a random effects model. Results We included eight RCTs that randomized 28,318 patients to S-DAPT versus L-DAPT (8234 DM and 20,084 non-DM). S-DAPT was associated with an increased rate of ST in non-DM patients [3.67 (2.04, 6.59)]. There was no significant difference in the rate of all-cause mortality, cardiac mortality, ST, MI, TVR, major bleeding, stroke and NACE with S-DAPT and L-DAPT in DM patients [1.19 (0.72–1.95); 1.25 (0.69, 2.25); 1.52 (0.70, 3.29); 1.33 (0.88, 2.01); 1.39 (0.89, 2.17); 0.92 (0.19, 4.42); 0.98 (0.29, 3.28); and 0.94 (0.57, 1.54) respectively]. Further, there was no significant difference in the rate of all-cause mortality, cardiac mortality, MI, TVR, major bleeding, stroke and NACE with S-DAPT and L-DAPT in non-DM patients [0.93 (0.58, 1.48); 0.75 (0.42, 1.35); 1.52 (0.81, 2.83); 0.99 (0.71, 1.39); 0.72 (0.28, 1.84); 1.01 (0.40, 2.56); and 1.01 (0.77, 1.32) respectively]. Conclusion Compared to L-DAPT, S-DAPT was associated with significant increase in rate of ST in non-DM patients. Duration of DAPT had no significant impact on rates of all-cause mortality, cardiac mortality, MI, ST and TVR among DM patients.

Aims To assess the incidence, risk factors and prognosis of periprocedural myocardial infarction (MI) and myocardial injury in patients undergoing elective percutaneous coronary intervention (PCI). Methods and results We included all consecutive patients who underwent elective PCI with a negative troponin level at admission from 1 January 2014 to 31 December 2015. The primary endpoint was defined as the composite of periprocedural MI (Type 4a MI), stent thrombosis (Type 4b MI), and myocardial injury according to the Third universal definition of MI. Multivariable analysis was performed to identify independent predictors of periprocedural MI and myocardial injury and its relation to 30-day and 1-year clinical outcome. Of the 1390 elective PCI patients, the primary endpoint occurred in 28.7% of patients, including 7.0% of Type 4a MI, 0.14% of Type 4b MI, and 21.6% of myocardial injury. Independent risk factors for the occurrence of the primary endpoint were left main PCI, total stent length >30 mm, multiple stenting, chronic kidney disease (estimated glomerular filtration rate 75 years. At 30 days, patients with periprocedural MI and myocardial injury had a higher rate of cardiovascular events [5.5% vs. 1.2%, adjusted hazard ratio (adjHR) = 3.8, 95% confidence interval (CI) 1.9-6.9; P

Background Although some randomized controlled trials (RCTs) and meta-analyses have suggested that prolonged dual-antiplatelet therapy (DAPT) may be associated with increased mortality, the mechanistic underpinnings of this association remain unclear. Objectives The aim of this study was to analyze the associations among bleeding, mortality, and DAPT duration after drug-eluting stent implantation in a meta-analysis of RCTs. Methods RCTs comparing different DAPT durations after drug-eluting stent placement were sought through the MEDLINE, Embase, and Cochrane databases and the proceedings of international meetings. Deaths were considered possibly bleeding related if occurring within 1 year of the episodes of bleeding. Primary analysis was by intention-to-treat. Secondary analysis was performed in a modified intention-to-treat population in which events occurring when all patients were on DAPT were excluded. Results Individual patient data were obtained for 6 RCTs, and aggregate data were available for 12 RCTs. Patients with bleeding had significantly higher rates of mortality compared with those without, and in a time-adjusted multivariate analysis, bleeding was an independent predictor of mortality occurring within 1 year of the bleeding episode (hazard ratio: 6.93; 95% confidence interval: 4.53 to 10.60; p< 0.0001). Shorter DAPT was associated with lower rates of all-cause death compared with longer DAPT (hazard ratio: 0.85; 95% confidence interval: 0.73 to 1.00; p= 0.05), which was driven by lower rates of bleeding-related deaths with shorter DAPT compared with prolonged DAPT (hazard ratio: 0.65; 95% confidence interval: 0.43 to 0.99; p= 0.04). Mortality unrelated to bleeding was comparable between the 2groups. Similar results were apparent in the modified intention-to-treat population. Conclusions Bleeding was strongly associated with the occurrence of mortality within 1 year after the bleeding event. Shorter compared with longer DAPT was associated with lower risk for bleeding-related death, a finding that mayunderlie the lower all-cause mortality with shorter DAPT in the RCTs of different DAPT durations after DES.

The ratio of early diastolic trans-mitral flow velocity to tissue-Doppler mitral annular early diastolic velocity (E/e′), and left ventricular end-diastolic pressure(LVEDP) have been shown to be correlated at rest, provided that patients are not on positive inotropic drugs. Data concerning the latter correlation during exercise stress are conflicting. Therefore, we investigated if use of negative inotropic drugs (NID), impacts the accuracy of E/e′ as a surrogate for LVEDP during low-level exercise. An exercise(50 watts) during cardiac invasive hemodynamic monitoring and an exercise echocardiography were performed prospectively within 24 hours in 54 patients (81%male, 62 ± 9years) with preserved LV Ejection-Fraction. Before exercise, the patients had scattered LVEDP (13.8 ± 5.8 mmHg) and septal E/e′ (8.7 ± 2.7). Half of them were on NID, mainly betablockers(n = 26). The correlation between septal-E/e′ and LVEDP was low for examinations performed at rest (r = 0.35,p = 0.01) with no significant impact of NID. For measurements performed at 50 Watts, NID had a significant impact on the association between septal-E/e′50 watts and LVEDP50 watts (β = −0.28,p = 0.03). Correlation between septal-E/e′50 watts and LVEDP50 watts persisted in patients on NID (r = 0.61,p = 0.001) while it disappeared in the group of patients with no NID (r = 0.15,p = 0.47). NID use is an important confounding factor to take into consideration when assessing exercise LVFP using stress E/e′ in patients with preserved LVEF.

Objective To study the cumulative evidence for vorapaxar use in patients with atherosclerotic cardiovascular disease. Methods A systematic review of randomized control trials in MEDLINE, EMBASE, EBSCO, CINAHL, Web of Science and Cochrane databases comparing vorapaxar with placebo was performed. Pre-specified efficacy endpoints were all-cause mortality, CV mortality, myocardial infarction (MI), ischemic stroke and repeat revascularization. The pre-specified safety endpoint was intracranial hemorrhage (ICH) and a composite of TIMI major and minor bleeding. Risk ratios were used as the metric of choice by applying random effects models. Results Five randomized controlled trials with 40,630 patients were included in final analysis. Compared with placebo, vorapaxar led to a statistically non-significant reduction in risk of MI [RR 0.86; 95% CI 0.80–0.93, p=0.427] and ischemic stroke [RR 0.84; 95% CI 0.72–0.97, p=0.920]. No differences were observed between vorapaxar and placebo with respect to all-cause mortality [RR 0.99; 95% CI 0.90–1.08, p=0.620], cardiovascular mortality [RR 0.94; 95% CI 0.83–1.06, p=0.351], repeat revascularization [RR 0.97; 95% CI 0.82–1.15, p=0.236], and TIMI bleeding [RR 1.29; 95% CI 0.98–1.69, p=0.126]. Vorapaxar was associated with a statistically non-significant higher risk of ICH [RR 2.36; 95% CI 1.40–3.96, p=0.137] compared with placebo. Conclusion Addition of Vorapaxar to standard medical therapy in in patients with atherosclerotic disease led to a statistically non-significant reduction in the risk of MI and ischemic stroke at the cost of statistically non-significant increase in risk of ICH.

Background Multiple risk factors of cardiac allograft vasculopathy (CAV) have been described, particularly through the analysis of large northern American cohorts. However, discrepancies in donor selection between the US and European countries are important, particularly concerning donor age. Purpose To evaluate the risk factors for the early development and progression of CAV in a European heart transplantation high volume center. Methods We performed an observational, retrospective single center study. All patients with heart transplantation between 10/01/2008 and 12/31/2013 who had at least one coronary angiography were included. We searched for risk factors of #1 the occurrence of moderate to severe CAV (CAV grades 2 to 3) and #2 the evolution of CAV during follow-up (CAV grade+1 or more compared to baseline) by analyzing the effect of #1 donor risk factors (age, sex, cardiovascular risk factors…), #2 recipient cardiovascular risk factors and #3 recipient transplant-related risk factors (CMV infection, ischemic time, pre-formed donor specific antibodies, biopsy proven rejections…). Results During the study period, 398 patients were transplanted at our center. Among them, 287 had at least one coronary angiogram (analysis of risk factors for CAV 2–3 occurrences) including 206 patients with at least two coronary angiograms (analysis of the evolution of CAV during follow-up). The median follow-up was 5.2 years. After multivariate analyses, only donor risk factors were significantly associated with 1) the risk of occurrence of CAV 2 to 3 (donor age > 40 years: sHR = 6.3, CI = 2–20; smoking: sHR = 2.1, CI = 1.1–4.1; donor sex: female sex: sHR = 0.31, CI = 0.13–0.73) and the risk of CAV progression during follow-up (donor age > 40 years: sHR = 2.9, CI = 1.2–7.2; donor sex: female sex: sHR = 0.2, CI = 0.1–0.6). Conclusion Early moderate to severe CAV occurrence and early CAV progression after heart transplantation were mostly driven by donor characteristics.

BACKGROUND: This study assessed if invasive coronary angiogram (CA) could be replaced by multislice (64- or 256-row) computed tomography (MSCT) to systematically rule out coronary allograft vasculopathy in heart transplant patients. METHODS: Electrocardiogram-gated contrast-enhanced MSCT (64-row for the first 25 patients and 256row for the others) was compared with CA. MSCT parameters, adapted to the patient’s weight, included 120 kV, 800 mAs, 0.625-mm slice thickness, and 0.42/0.27-second rotation time. The primary end point was the negative predictive value (NPV) of MSCT for the detection of significant (4 50%) coronary stenosis. Secondary end points were the comparison of X-ray (mSv) and iodine contrast agent (ml) exposures. RESULTS: The study prospectively included 102 patients (mean age, 53 14 years). Transplantation occurred 6 5 years before inclusion. At CA, 41.8% had stenosis r 50% and 8% had stenosis 4 50%. Among the 1,308 angiographic coronary segments Z 1.5 mm, 1,250 (95.6%) were evaluable by MSCT. The NPV of MSCT was 96.6% by patient analysis and 99.7% by segment analysis. The positive predictive value (PPV) was 45.5%. The total volume of contrast agent was 139 43 vs 91 12 vs 56 19 ml (p o 0.05) with 64-row MSCT, 256-row MSCT, and CA, respectively. The effective radiation dose was higher using retrospective gating (17.8 5.5 mSv, p o 0.05), but similar with prospective gating (6.2 1.9 mSv, p ¼ 0.571) compared with CA (6.0 3.5 mSv). CONCLUSION: Newer generations of MSCT (64- or 256-row) have a good NPV and may represent an alternative to invasive CA to rule out significant (4 50%) coronary vasculopathy in heart transplant patients, despite a low PPV. J Heart Lung Transplant 2012; 31: 1262‐68 r 2012 International Society for Heart and Lung Transplantation. All rights reserved.

The “2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease” is a thorough consensus on duration of dual antiplatelet therapy (DAPT) in patients with coronary artery disease dealing with a large scope of different specific situations (1). One may ask if a new, long manuscript of 96 pages including the Supplements was necessary given the large amount of randomized clinical trials, meta-analyses, commentaries, editorials already recently published in this field. Undoubtedly, the answer is yes for several reasons. First, because some very recent trials have been published after the formulation of the latest recommendations for duration of DAPT in prior guidelines (2). Secondly, because after the extensive reading of these new guidelines, the reader will probably have a better understanding of the current knowledge according to the different situations he will have to deal with. The goal of these new guidelines was to update, harmonize and simplify recommendations on duration of DAPT in patients with coronary artery disease. Among the different clinical circumstances, the most debated one is the optimal duration of DAPT after drug-eluting stents (DES) (3). It is also a very frequent question in every day clinical practice because the implantation of (DES) has become a standard treatment for the management of patients with coronary artery disease. Millions of patients worldwide undergo coronary stenting each year.

The optimal duration of dual antiplatelet therapy (DAPT) after implantation of newer-generation drug-eluting stents (DES) remains uncertain. Similarly, questions remain about the role of DAPT in long-term therapy of stable post-myocardial infarction (MI) patients.Our objective was to compare the incidence of death, major hemorrhage, MI, stent thrombosis, and major adverse cardiac events in patients randomized to prolonged or short-course DAPT after implantation of newer-generation DES and in secondary prevention after MI.We used traditional frequentist statistical and Bayesian approaches to address the following questions: Q1) What is the minimum duration of DAPT required after DES implantation? Q2) What is the clinical benefit of prolonging DAPT up to 18 to 48 months? Q3) What is the clinical effect of DAPT in stable patients who are1 year past an MI?We reviewed evidence from 11 randomized controlled trials (RCTs) that enrolled 33 051 patients who received predominantly newer-generation DES to answer: A1) Use of DAPT for 12 months, as compared with use for 3 to 6 months, resulted in no significant differences in incidence of death (odds ratio [OR]: 1.17; 95% confidence interval [CI]: 0.85 to 1.63), major hemorrhage (OR: 1.65; 95% CI: 0.97 to 2.82), MI (OR: 0.87; 95% CI: 0.65 to 1.18), or stent thrombosis (OR: 0.87; 95% CI: 0.49 to 1.55). Bayesian models confirmed the primary analysis. A2) Use of DAPT for 18 to 48 months, compared with use for 6 to 12 months, was associated with no difference in incidence of all-cause death (OR: 1.14; 95% CI: 0.92 to 1.42) but was associated with increased major hemorrhage (OR: 1.58; 95% CI: 1.20 to 2.09), decreased MI (OR: 0.67; 95% CI: 0.47 to 0.95), and decreased stent thrombosis (OR: 0.45; 95% CI: 0.24 to 0.74). A risk-benefit analysis found 3 fewer stent thromboses (95% CI: 2 to 5) and 6 fewer MIs (95% CI: 2 to 11) but 5 more major bleeds (95% CI: 3 to 9) per 1000 patients treated with prolonged DAPT per year. Post hoc analyses provided weak evidence of increased mortality with prolonged DAPT. We reviewed evidence from 1 RCT of 21 162 patients and a post hoc analysis of 1 RCT of 15 603 patients to answer: A3): Use of DAPT1 year after MI reduced the composite risk of cardiovascular death, MI, or stroke (hazard ratio: 0.84; 95% CI: 0.74 to 0.95) but increased major bleeding (hazard ratio: 2.32; 95% CI: 1.68 to 3.21). A meta-analysis and a post hoc analysis of an RCT in patients with stable cardiovascular disease produced similar findings.The primary analysis provides moderately strong evidence that prolonged DAPT after implantation of newer-generation DES entails a tradeoff between reductions in stent thrombosis and MI and increases in major hemorrhage. Secondary analyses provide weak evidence of increased mortality with prolonged DAPT after DES implantation. In patients whose coronary thrombotic risk was defined by a prior MI rather than by DES implantation, the primary analysis provides moderately strong evidence of reduced cardiovascular events at the expense of increased bleeding.

To evaluate the potential benefit and risk of addition of vorapaxar to standard medical therapy in patients who underwent coronary revascularization with either percutaneous coronary revascularization (PCI) or coronary artery bypass graft surgery (CABG). We searched PubMed, EMBASE, the Cochrane

Aim This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation. Methods and results Patients ( N = 1799) who had undergone placement of ≥1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009–January 2013). Patients ( N = 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1:1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50–1.28; P = 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34–1.22; P = 0.18). Rates of major bleeding were identical (2.0%, P = 0.95). Conclusions Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment. ClinicalTrials.gov number NCT00822536.

International audience; Objective: To assess outcomes following primary percutaneous coronary intervention (PCI) for ST-segment elevation acute myocardial infarction (STEMI) in nonagenarian patients.Methods: We conducted a multicentre retrospective study between 2006 and 2013 in five international high-volume centres and included consecutive all-comer nonagenarians treated with primary PCI for STEMI. There were no exclusion criteria. We enrolled 145 patients and collected demographic, clinical and procedural data. Severe clinical events and mortality at 6 months and 1 year were assessed.Results: Cardiogenic shock was present at admission in 21%. Median (IQR) delay between symptom onset and balloon was 3.7 (2.4–5.6) hours and 60% of procedures were performed through the transradial approach. Successful revascularisation of the culprit vessel was obtained in 86% of the cases (thrombolysis in myocardial infarction flow of 2 or 3). Major or clinically relevant bleeding was observed in 4% of patients. Median left ventricular ejection fraction post PCI was 41.5% (32.0–50.0). The in-hospital mortality was 24%, with 6 months and 1-year survival rates of 61% and 53%, respectively.Conclusions: In our study, primary PCI in nonagenarians with STEMI was achieved and feasible through a transradial approach. It is associated with a high rate of reperfusion of the infarct-related artery and 53% survival at 1 year. These results suggest that primary PCI may be offered in selected nonagenarians with acute myocardial infarction