Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia.

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).

Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial.

BACKGROUND: Safety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR vs BAV pre-TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519). METHODS: Clinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n = 228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation). RESULTS: Median follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ± 6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, P = 0.6). Prevalence of predicted prothesis-patient mismatch was low (n = 13 [11.4%] in the direct TAVR group vs n = 15 [13.2%] in BAV group) and similar between both groups (P = .7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (P = .4, P = .7, P = .3, and P = .3 respectively). CONCLUSION: Direct implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible. CLINICAL TRIALS REGISTRATION NUMBER: NCT05140317.

Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

BACKGROUND: The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. PURPOSE: We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. METHODS: Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. RESULTS: The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). CONCLUSION: Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.

Transcatheter aortic valve implantation in patients with uninterrupted vitamin K antagonists.

BACKGROUND: Bridging of vitamin K antagonist (VKA) with heparin is usually not promoted during interventional or surgical procedures related to increased risk of bleeding and thrombotic events but this strategy has not been evaluated during transcatheter aortic valve implantation (TAVI). PURPOSE: The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA. METHODS: From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (International Normalized Ratio [INR] between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI was performed according to current guidelines and a 50 U/kg bolus of heparin was injected at the beginning of the procedure for all patients. Vascular and bleeding complications were assessed using the Valve Academic Research Consortium 3 (VARC3) and the Bleeding Academic Research Consortium (BARC) definitions at a 30-day follow-up. RESULTS: A total of 88 patients were included with a median age of 84 years (81.8-87.0), 42% being female. The median society of thoracic surgeons score was 5.1 (4.1-7.5), the median CHADS2-VASc was 5.5 (5-6) and 60.2% had a chronic kidney failure. Median INR at the time of implantation was 2.1 (1.8-2.6). The main VKA indication was atrial fibrillation. Transfemoral access was used in 88.6% of the patients. Major bleeding (BARC ≥ 3b) occurred in five patients (5.7%) and major vascular complications occurred in seven patients (8.0%). At 1 month follow-up, major bleeding (BARC ≥ 3) or vascular complications occurred in 10 patients (11.4%). In patients with major bleeding peripheral arterial disease (RR = 10.95; 95% confidence interval (CI) 1.63-73.75; p = 0.014) and carotid access (RR = 8.56; 95% CI 1.19-1.51; p = 0.033) were more common. INR > 2.5 was significantly associated with vascular complications (RR = 7.14; 95% CI 1.29-39.63; p = 0.025). At 30 days, mortality and stroke rates were 2.3% and 4.5%, respectively. CONCLUSION: TAVI with uninterrupted VKA treatment seems feasible and safe with a low risk of major bleeding and vascular complications in this first single-center experience. Particular caution is advocated in high body mass index patients and to keep INR < 2.5.

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial.

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.

Transcarotid versus transfemoral access in patients undergoing transcatheter aortic valve replacement with complex aortofemoral anatomy.

AIMS: While major vascular complications (MVC) remains an issue after Transfemoral (TF) transcatheter aortic valve replacement (TAVR), we compared outcomes in TF versus transcarotid (TC) approaches in patients with complex vascular anatomy. METHODS AND RESULTS: Among patients undergoing TAVR in our center between 2015 and 2018, we evaluated patients with complex vascular anatomy defined on CT scan as: (a) iliofemoral diameter between 5.5 and 6 mm or <6.5 mm with severe calcifications or tortuosity AND/OR (b) abdominal aorta pathology. The primary endpoint included access failure, mortality, MVC, major bleeding and stroke at 1-month. Among 483 patients, 131 (31.2%) with complex vascular anatomy underwent TF (n = 51;39.2%) or TC (n = 80;60.8%) TAVR. The mean age was 81.7 ± 6.9. TC group had higher STS score (p = .01), higher incidence of coronary artery disease (p = .04) and lower left ventricular ejection fraction (p < .001). In TC group, primary endpoint occurred twice less without reaching significance compared to TF group (n = 8; 10.0% vs. n = 10; 19.6% respectively; p = .1). Incidence of MVC was higher in TF group (11.8 vs. 1.3% in the TC group; p = .01) with similar incidence of stroke between groups (p = .8). CONCLUSIONS: Despite higher patient risk profile, TC approach in complex aortofemoral anatomy provides similar favorable outcomes with less MVC compared to TF approach.

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry.

OBJECTIVES: To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS). BACKGROUND: CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP. METHODS: This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST). RESULTS: Data from 130 patients were analyzed (mean age 72.5 ± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2 ± 12.8 month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion. CONCLUSIONS: The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.

Radial versus femoral artery access for percutaneous coronary artery intervention in patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock: Subanalysis from the CULPRIT-SHOCK trial.

BACKGROUND: The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear. METHODS: This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes. RESULTS: Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively). CONCLUSIONS: In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.

Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.

BACKGROUND: Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y12 receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting. METHODS: Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier). CONCLUSION: ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.

Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial.

BACKGROUND: Appropriate information about the benefits and risks of invasive procedures is crucial, but limited data is available in this field. The aim of this study was to evaluate the incremental value of a short video about coronary angiography compared with standard information, in terms of patient understanding, satisfaction and anxiety. METHODS: This prospective multicenter study included patients admitted for scheduled coronary angiography, who were randomized to receive either standard information or video information by watching a three-dimensional educational video. After information was delivered, patients were asked to complete a dedicated 16-point information questionnaire, as well as satisfaction and anxiety scales. RESULTS: From 21 September to 4 October 2015, 821 consecutive patients were randomized to receive either standard information (n=415) or standard information with an added educational video (n=406). The information score was higher in the video information group than in the standard group (11.8±2.8 vs 9.5±3.1; P<.001). This result was consistent across age and education level subgroups. Self-reported satisfaction was also higher in the video information group (8.4±1.9 vs. 7.7±2.3; P<.001), while anxiety level did not differ between groups. The variables associated with a higher information score were the use of the educational video, younger age, higher level of education, previous follow-up by a cardiologist, prior information about coronary angiography and previous coronary angiography. CONCLUSIONS: In comparison with standard information, viewing a dedicated educational video improved patients' understanding and satisfaction before scheduled coronary angiography. These results are in favor of widespread use of this incremental information tool.

Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC): an open-label, blinded-endpoint, randomised controlled superiority trial.

BACKGROUND: Elderly patients are at high risk of ischaemic and bleeding events. Platelet function monitoring offers the possibility to individualise antiplatelet therapy to improve the therapeutic risk-benefit ratio. We aimed to assess the effect of platelet function monitoring with treatment adjustment in elderly patients stented for an acute coronary syndrome. METHODS: We did this multicentre, open-label, blinded-endpoint, randomised controlled superiority study at 35 centres in France. Patients aged 75 years or older who had undergone coronary stenting for acute coronary syndrome were randomly assigned (1:1), via a central interactive voice-response system based on a computer-generated permuted-block randomisation schedule with randomly selected block sizes, to receive oral prasugrel 5 mg daily with dose or drug adjustment in case of inadequate response (monitoring group) or oral prasugrel 5 mg daily with no monitoring or treatment adjustment (conventional group). Randomisation was stratified by centre. Platelet function testing was done 14 days after randomisation and repeated 14 days after treatment adjustment in patients in the monitoring group. Study investigators and patients were not masked to treatment allocation, but allocation was concealed from an independent clinical events committee responsible for endpoint adjudication. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, and Bleeding Academic Research Consortium-defined bleeding complications (types 2, 3, or 5) at 12 months' follow-up. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01538446. FINDINGS: Between March 27, 2012, and May 19, 2015, we randomly assigned 877 patients to the monitoring group (n=442) or the conventional group (n=435). The primary endpoint occurred in 120 (28%) patients in the monitoring group compared with 123 (28%) patients in the conventional group (hazard ratio [HR], 1·003, 95% CI 0·78-1·29; p=0·98). Rates of bleeding events did not differ significantly between groups. INTERPRETATION: Platelet function monitoring with treatment adjustment did not improve the clinical outcome of elderly patients treated with coronary stenting for an acute coronary syndrome. Platelet function testing is still being used in many centres and international guidelines still recommend platelet function testing in high-risk situations. Our study does not support this practice or these recommendations. FUNDING: Eli Lilly and Company, Daiichi Sankyo, Stentys, Accriva Diagnostics, Medtronic, and Fondation Coeur et Recherche.

Optimization of a simultaneous dual-isotope 201Tl/123I-MIBG myocardial SPECT imaging protocol with a CZT camera for trigger zone assessment after myocardial infarction for routine clinical settings: Are delayed acquisition and scatter correction necessary?

BACKGROUND: Dual-isotope 201Tl/123I-MIBG SPECT can assess trigger zones (dysfunctions in the autonomic nervous system located in areas of viable myocardium) that are substrate for ventricular arrhythmias after STEMI. This study evaluated the necessity of delayed acquisition and scatter correction for dual-isotope 201Tl/123I-MIBG SPECT studies with a CZT camera to identify trigger zones after revascularization in patients with STEMI in routine clinical settings. METHODS: Sixty-nine patients were prospectively enrolled after revascularization to undergo 201Tl/123I-MIBG SPECT using a CZT camera (Discovery NM 530c, GE). The first acquisition was a single thallium study (before MIBG administration); the second and the third were early and late dual-isotope studies. We compared the scatter-uncorrected and scatter-corrected (TEW method) thallium studies with the results of magnetic resonance imaging or transthoracic echography (reference standard) to diagnose myocardial necrosis. RESULTS: Summed rest scores (SRS) were significantly higher in the delayed MIBG studies than the early MIBG studies. SRS and necrosis surface were significantly higher in the delayed thallium studies with scatter correction than without scatter correction, leading to less trigger zone diagnosis for the scatter-corrected studies. Compared with the scatter-uncorrected studies, the late thallium scatter-corrected studies provided the best diagnostic values for myocardial necrosis assessment. CONCLUSIONS: Delayed acquisitions and scatter-corrected dual-isotope 201Tl/123I-MIBG SPECT acquisitions provide an improved evaluation of trigger zones in routine clinical settings after revascularization for STEMI.

Copeptin and high-sensitivity cardiac troponin to exclude severe coronary stenosis in patients with chest pain and coronary artery disease.

PURPOSE: The purpose was to evaluate the incremental value of copeptin associated with high-sensitivity cardiac T troponin (hs-cTnT) to exclude severe coronary stenosis in patients with coronary artery disease (CAD) and acute chest pain. METHODS: This monocentric prospective study included 96 consecutive patients with documented CAD and admitted to the intensive care unit for chest pain lasting for less than 10 hours. Acute coronary syndrome was excluded with electrocardiography and baseline hs-cTnT values <14 ng/L with dynamic changes ≤50% 3 hours later (Roche Diagnostics, COBAS 8000). Copeptin (Thermofisher, Kryptor Compact) was considered as positive when >10 pmol/L. Primary end point was severe coronary stenosis at coronary angiography or myocardial ischemia on perfusion single-photon emission computed tomography imaging. RESULTS: Mean age of patients was 60 ± 13.8 years, and the mean time between chest pain onset and blood samples of copeptin was 4.2 ± 2.7 hours. According to clinical decision, coronary angiography was performed in 71 patients (73.9%) and severe stenosis diagnosed in 14 of them (14.6%). No ischemia was detected on single-photon emission computed tomography imaging (n = 25). Among the 69 patients with a negative kinetic of hs-cTnT and a negative baseline copeptin, 5 (7.4%) had a severe stenosis (negative predictive value, 0.93; 95% confidence interval, 0.87-0.99), 4 of them related to in-stent restenosis (negative predictive value for exclusion of native coronary stenosis, 0.98; 95% confidence interval, 0.93-1). CONCLUSIONS: For patients with preexisting CAD and acute chest pain, and once acute coronary syndrome is excluded, copeptin provides a useful additional triage strategy to exclude severe coronary stenosis, particularly those not related to in-stent restenosis.

Kinetics of high-sensitivity cardiac troponin T or troponin I compared to creatine kinase in patients with revascularized acute myocardial infarction.

BACKGROUND: Cardiac biomarkers are the cornerstone of the biological definition of acute myocardial infarction (AMI). The key role of troponins in diagnosis of AMI is well established. Moreover, kinetics of troponin I (cTnI) and creatine kinase (CK) after AMI are correlated to the prognosis. New technical assessment like high-sensitivity cardiac troponin T (hs-cTnT) raises concerns because of its unclear kinetic following the peak. This study aims to compare kinetics of cTnI and hs-cTnT to CK in patients with large AMI successfully treated by percutaneous coronary intervention (PCI). METHODS: We prospectively studied 62 patients with anterior AMI successfully reperfused with primary angioplasty. We evaluated two consecutive groups: the first one regularly assessed by both CK and cTnI methods and the second group by CK and hs-cTnT. Modeling of kinetics was realized using mixed effects with cubic splines. RESULTS: Kinetics of markers showed a peak at 7.9 h for CK, at 10.9 h (6.9-12.75) for cTnI and at 12 h for hs-cTnT. This peak was followed by a nearly log linear decrease for cTnI and CK by contrast to hs-cTnT which appeared with a biphasic shape curve marked by a second peak at 82 h. There was no significant difference between the decrease of cTnI and CK (p=0.63). CK fell by 79.5% (76.1-99.9) vs. cTnI by 86.8% (76.6-92.7). In the hs-cTnT group there was a significant difference in the decrease by 26.5% (9-42.9) when compared with CK that fell by 79.5% (64.3-90.7). CONCLUSIONS: Kinetic of hs-cTnT and not cTnI differs from CK. The role of hs-cTnT in prognosis has to be investigated.

One year results of coronary bifurcation revascularization with the re-POT provisional sequential technique. The CABRIOLET registry.

BACKGROUND: Re-POT (proximal optimization technique (POT)) is a simple provisional sequential technique for percutaneous coronary bifurcation revascularization with better arterial geometry respect compared to classical techniques. Re-POT has demonstrated excellent mechanical and short-term clinical results. The multicenter CABRIOLET registry (NCT03550196) evaluate the long-term clinical benefit of the re-POT sequence in non-selected patients. METHODS: All consecutive patients presenting a coronary bifurcation lesion for which provisional stenting was indicated were included in 5 european centers. Re-POT strategy was systematically attempted. The primary endpoint was target lesion failure (TLF), comprising cardiac death, myocardial infarction, stent thrombosis and target lesion revascularization (TLR) at 12 months' follow-up. The secondary endpoints were the individual components of the primary endpoint, all-cause death, target vessel failure (TVF) and target vessel revascularization (TVR). Complex bifurcation was defined as Medina 0.1.1 or 1.1.1. RESULTS: A total of 500 patients aged 67.7 ± 11.7 years, 78.4% male, were included from 2015 to 2019, 174 of whom (34.8%) were considered having complex bifurcation lesions. Bifurcations involved the left main in 35.2% of cases. The full re-POT sequence was systematically performed in all cases. At 1 year, TLF was 2.0% (1.7% in complex vs. 2.1% in non-complex bifurcation; p = NS), and TLR was 1.6%, (1.1% vs. 1.8% respectively; p = NS). TVF and TVR rates were 3.2% and 2.8%. On multivariate analysis, only multivessel disease was predictive of TLF at 1 year (OR = 1.66 (1.09-2.53), p = 0.02). CONCLUSIONS: In this large prospective all-comer registry, provisional stenting with re-POT technique appeared safe and effective at 1 year, without anatomical bifurcation restriction.

Carbon monoxide and prognosis in smokers hospitalised with acute cardiac events: a multicentre, prospective cohort study.

Background: Smoking cigarettes produces carbon monoxide (CO), which can reduce the oxygen-carrying capacity of the blood. We aimed to determine whether elevated expiratory CO levels would be associated with a worse prognosis in smokers presenting with acute cardiac events. Methods: From 7 to 22 April 2021, expiratory CO levels were measured in a prospective registry including all consecutive patients admitted for acute cardiac event in 39 centres throughout France. The primary outcome was 1-year all-cause death. Initial in-hospital major adverse cardiac events (MAE; death, resuscitated cardiac arrest and cardiogenic shock) were also analysed. The study was registered at ClinicalTrials.gov (NCT05063097). Findings: Among 1379 patients (63 ± 15 years, 70% men), 368 (27%) were active smokers. Expiratory CO levels were significantly raised in active smokers compared to non-smokers. A CO level >11 parts per million (ppm) found in 94 (25.5%) smokers was associated with a significant increase in death (14.9% for CO > 11 ppm vs. 2.9% for CO ≤ 11 ppm; p < 0.001). Similar results were found after adjustment for comorbidities (hazard ratio [HR] [95% confidence interval (CI)]): 5.92 [2.43-14.38]) or parameters of in-hospital severity (HR 6.09, 95% CI [2.51-14.80]) and propensity score matching (HR 7.46, 95% CI [1.70-32.8]). CO > 11 ppm was associated with a significant increase in MAE in smokers during initial hospitalisation after adjustment for comorbidities (odds ratio [OR] 15.75, 95% CI [5.56-44.60]) or parameters of in-hospital severity (OR 10.67, 95% CI [4.06-28.04]). In the overall population, CO > 11 ppm but not smoking was associated with an increased rate of all-cause death (HR 4.03, 95% CI [2.33-6.98] and 1.66 [0.96-2.85] respectively). Interpretation: Elevated CO level is independently associated with a 6-fold increase in 1-year death and 10-fold in-hospital MAE in smokers hospitalized for acute cardiac events. Funding: Grant from Fondation Coeur & Recherche.

Restrictive vs Liberal Blood Transfusions for Patients With Acute Myocardial Infarction and Anemia by Heart Failure Status: An RCT Subgroup Analysis.

BACKGROUND: Red blood cell transfusion can cause fluid overload. We evaluated the interaction between heart failure (HF) at baseline and transfusion strategy on outcomes in acute myocardial infarction (AMI). METHODS: We used data from the randomized REALITY trial. HF was defined as history of HF or Killip class > 1 at randomization. Primary outcome was major adverse cardiovascular events (MACE): composite of all-cause death, nonrecurrent AMI, stroke, or emergency revascularization prompted by ischemia at 30 days. RESULTS: Among 658 randomized patients, 311 (47.3%) had HF. Patients with HF had higher rates of MACE at 30 days and 1 year and higher rates of nonfatal new-onset HF. There was no interaction between HF and effect of randomized assignment on the primary outcome or nonfatal new-onset HF. A liberal transfusion strategy was associated with increased all-cause death at 30 days and at 1 year in patients with HF (Pinteraction = 0.009 and P = 0.049, respectively). The main numerical difference in cause of death between restrictive and liberal strategies was death by HF at 30 days (4 vs 11). CONCLUSIONS: HF is frequent in patients with AMI and anemia and is associated with higher risk of MACE (including all-cause death) and nonfatal new-onset HF. Although there was no interaction of HF with effect of transfusion strategy on MACE, a liberal transfusion strategy was associated with higher all-cause death that appears driven by a higher risk of early death caused by HF. CLINICAL TRIAL REGISTRATION: NCT02648113.

Rationale and design of the French cohort of acute myocarditis diagnosed by cardiac magnetic resonance imaging (MyocarditIRM).

BACKGROUND: Acute myocarditis usually presents as chest pain with rising troponin and normal coronary arteries. Despite frequent favourable evolution at the acute phase, it is associated with heart failure and ventricular rhythm disorders, and is considered the leading cause of sudden cardiac death in young, apparently healthy, adults. There are no specific recommendations for acute myocarditis diagnosis and management, only expert consensus, given the lack of large databases. AIM: The main objective is to describe the contemporary presentation of acute myocarditis, its management and in-hospital outcomes. Secondary objectives are to investigate survival and event-free survival for up to 10years of follow-up, the determinants of prognosis, the modalities of treatment and follow-up and the gaps between expert consensus and real-life management. METHODS: MyocarditIRM is a prospective multicentre cohort that enrolled 803 consecutive patients with acute myocarditis in 49 participating centres in France between 01 May 2016 and 28 February 2019. The diagnosis of acute myocarditis was acknowledged by cardiac magnetic resonance, using the Lake Louise Criteria. Exclusion criteria were age<18years, lack of health coverage, contraindication to cardiac magnetic resonance and refusal to participate. Detailed information was collected prospectively, starting at admission. Cardiac magnetic resonance imaging (diagnosis and follow-up) is analysed centrally by the certified core laboratory IHU ICAN. Ten years of follow-up for each patient is ensured by linking with the French National Health Database, and includes information on death, hospital admissions, major clinical events and drug consumption. CONCLUSION: This prospective cohort with long-term follow-up represents the largest database on acute myocarditis worldwide, and will improve knowledge about its presentation, management and outcomes.