Extended Anticoagulation After Pulmonary Embolism:A Multicenter Observational Cohort Analysis

BACKGROUND: Pulmonary embolism (PE) has a long‐term risk of adverse events, which can be prevented by extended anticoagulation. We compared clinical characteristics and outcomes between patients treated with 2‐year extended anticoagulation and those who were not, in a population who had completed an initial phase of 3 to 6 months of anticoagulant therapy after acute PE. METHODS AND RESULTS: Observational cohort analysis of patients with PE who survived an initial phase of 3 to 6 months anticoagulation. Primary efficacy outcome was all‐cause death or recurrent venous thromboembolism. Primary safety outcome was major bleeding. In total, 858 (71.5%) patients were treated with and 341 (28.5%) were treated without extended anticoagulant therapy during the active study period. Age <65 years, intermediate‐high or high‐risk index PE, normal platelet count, and the absence of concomitant antiplatelet treatment were independently associated with the prescription of extended anticoagulation. The mean duration of the active phase was 2.1±0.3 years. The adjusted rate of the primary efficacy outcome was 2.1% in the extended group and 7.7% in the nonextended group (P<0.001) for patients treated with extended anticoagulant therapy. Rate of bleeding were similar between the extended anticoagulant group and the nonextended group. CONCLUSIONS: Extended oral anticoagulation over 2 and a half years after index PE seems to provide a net clinical benefit compared with no anticoagulation in patients with PE selected to receive extended anticoagulation. Randomized clinical trials are warranted to explore the potential benefit of extended anticoagulation in patients with PE, especially those with transient provoking factors but residual risk

Impact of intravascular ultrasound guidance in stent deployment on 6-month restenosis rate: a multicenter, randomized study comparing two strategies—with and without intravascular ultrasound guidance

AbstractObjectives. We aimed to investigate the impact of intravascular ultrasound (IVUS)-guided stent implantation on the 6-month restenosis rate, which has not yet been fully established in randomized trials.Background. The 6-month angiographic restenosis rate was compared in patients with symptomatic ischemic heart disease who were randomly allocated to angioplasty and stent deployment, with versus without IVUS guidance.Methods. After successful stent implantation, patients were randomized into two groups: Group A had no further dilation, and Group B had additional balloon dilation until achievement of IVUS criterion for stent expansion. The study group consisted of 164 patients, assuming a 50% reduction of the restenosis rate in Group B (15% vs. 30%) (alpha = 10%, beta = 20%).Results. We enrolled 155 patients. Overdilation was carried out in 31 (39%) of 79 Group B patients, with the IVUS criterion being achieved in 63 (80%) of 79. No significant difference was observed in the minimal luminal diameter (MLD), but the stent lumen cross-sectional area (CSA) was significantly larger in Group B (mean ± SD) (7.16 ± 2.48 vs. 7.95 ± 2.21 mm2, p = 0.04). At 6 months, there was no significant difference in the restenosis rate, (28.8% [21 of 73] in Group A vs. 22.5% [16 of 71] in Group B, p = 0.25), but according to the observed difference in the restenosis rate, the power of the study was only 40%. The difference in MLD was also nonsignificant (1.60 ± 0.65 mm in Group A vs. 1.70 ± 0.64 mm in Group B, p = 0.20), whereas the lumen CSA was 20% larger in the IVUS-guided group (4.47 ± 2.59 vs. 5.36 ± 2.81 mm2, p = 0.03). Lumen CSA was the only predictor of restenosis by multivariate logistic regression analysis.Conclusions. A nonsignificant 6.3% absolute reduction in the restenosis rate and a nonsignificant difference in MLD were observed in this study. Nonetheless, we still cannot rule out a beneficial effect of IVUS guidance, although this may have gone undetected owing to a lack of statistical power. A significant increase was observed in immediate and 6-month lumen size, as detected by IVUS, indicating that ultrasound guidance in stent deployment may be beneficial

214: Interpreting troponin elevation in relation to symptom onset in intermediate-risk pulmonary embolism

BackgroundTroponin elevation in the setting of acute pulmonary embolism (PE) is of small magnitude and short duration and can go unnoticed in pts referred late after symptom onset.MethodsProspective, single-center registry of pts with confirmed intermediate-risk PE, defined as at least 1 echocardiographic finding of right ventricular (RV) dysfunction (endo-diastolic (EDRV)/left ventricular (EDLV) end-diastolic diameter ratio >=1 in the 4-chamber view, paradoxical septal systolic motion or pulmonary hypertension defined as RV/atrial gradient >30mmHg), or positive troponin test. Combined in-hospital endpoint was defined as death, non-fatal recurrent PE, or residual pulmonary vascular obstruction (RPVO) ≥35%.Results282 pts were included, age 66±14 years, 59% women, 174 (62%) referred ≤5 days after symptom onset, 108 (38%) after >5 days. Troponin elevation was observed in 126 (72%) treated within ≤5 days, in 60 (56%) treated after >5 days (p=0.004). A significant interaction was observed between time since symptom onset and both troponin elevation and persistence of EDRV/EDLV diameter ratio>1 at 48h. The negative predictive value of troponin elevation was 85% in patients treated within 5 days of symptoms, but fell to 70% in those admitted >5 days after symptom onset (p=0.002). Positive troponin was an independent predictor of adverse outcome (OR=1.43 [1.08-5.56]). ROC curves show that prognostic value of positive troponin test was higher in pts referred ≤5 days than in pts referred >5 days after symptom onset (p=0.01).ConclusionThere is a significant relation between troponin elevation and time since symptom onset in patients with intermediate-risk PE. Negative predictive value of troponin elevation is adequate in pts treated early (≤5 days) but is suboptimal in pts treated >5 days after symptom onset.TableResults<=5 days since symptom onset>5 days since symptom onsetpSensitivity72% (61.3-82.7)51% (42.4-59.6)0.005Specificity42% (44.5-49.5)47% (39.1-54.9)0.33PPV26% (18.4-33.6)30% (22.2-37.8)0.81NPV85% (78.4-91.6)70% (63-77)0.00

025 Benefit of Drug Eluting Stents over Bare Metal Stents after Rotational Atherectomy. A propensity score adjusted comparison in revascularization, mortality and MACE

RationaleRotational atherectomy makes possible to attempt small and calcified arteries while Drug Eluting Stents (DES) properties may reduce the restenosis process, rendering this combination attractive in selected cases. We compared 1year clinical outcome after rotational atherectomy following by either DES or Bare Metal Stents (BMS) implantation.MethodsSingle centre registry including all consecutive cases of rotational atherectomy use. Clinical follow-up was obtained in all patients. Propensity score for being treated with a DES was calculated using 18 clinical, angiographic and procedural variables. Comparison was adjusted on 4 strata of the propensity score.ResultsBetween 2002 and 2008, 223 patients were treated: 114 with BMS and 110 with DES. Most of the patients with BMS between 2002 and 2004 and later with DES. No significant difference was observed in clinical characteristics between groups: age 70 years, reference diameter 2.40±0.60mm, lesion length 10±9mm. Two cases of coronary perforation occurred, 7 lesion failure, and 12 transcient no-reflow. The use of GP2b3a inhibitors was similar in both groups, but, compared with BMS, patients in the DES group had longer duration of combination of aspirin and Clopidogrel. At one year, significantly lower rates of vessel revascularisation (2% vs 12%, p=0.005), of all cause mortality (5% vs 14%, p=0.05) and of MACE (10% vs 22%, p=0.02) were observed in the DES than in the BMS group. Adjustment on the strata of the propensity score did not change significantly these results (figure).ConclusionsDespite propensity score adjusted, this comparison has limitations. After rotational atherectomy we observed clear benefit for DES implantation over BMS on vessel revascularisation, mortality and MACE rates

Prospective Multicenter International Registry of Ultrasound-Facilitated Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism (KNOCOUT PE)

BACKGROUND Prior clinical trials have demonstrated the efficacy of ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk pulmonary embolism (PE) using reduced thrombolytic doses and shorter infusion durations. However, utilization and safety of such strategies in broader PE populations remain unclear. The KNOCOUT PE (The EKoSoNic Registry of the Treatment and Clinical Outcomes of Patients With Pulmonary Embolism) registry is a multicenter international registry designed to study the treatment of acute PE with USCDT, with focus on safety outcomes. METHODS The KNOCOUT PE prospective cohort included 489 patients (64 sites internationally) with acute intermediate-high or high-risk PE treated with USCDT between March 2018 and June 2020. Principal safety outcomes were independently adjudicated International Society on Thrombosis and Haemostasis major bleeding at 72 hours post-treatment and mortality within 12 months of treatment. Additional outcomes included change in right ventricular/left ventricular ratio and quality of life measures over 12 months. RESULTS Mean alteplase (r-tPA [recombinant tissue-type plasminogen activator]) infusion duration was 10.5 hours. Mean total r-tPA dose was 18.1 mg, with 31.0% of patients receiving ≤12 mg. Major bleeding events within 72 hours occurred in 1.6% (8/489) of patients. One patient experienced worsening of a preexisting subdural hematoma after USCDT and therapeutic anticoagulation, which ultimately required surgery. All-cause mortality at 30 days was 1.0% (5/489). Improvement in PE quality of life score was observed with a 41.1% (243/489, 49.7%) and 44.2% (153/489, 31.3%) mean relative reduction by 3 and 12 months, respectively. CONCLUSIONS In a prospective observational cohort study of patients with intermediate-high and high-risk PE undergoing USCDT, mean r-tPA dose was 18 mg, and the rates of major bleeding and mortality were low. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT03426124

Impact of post-procedural glycemic variability on cardiovascular morbidity and mortality after transcatheter aortic valve implantation : a post hoc cohort analysis

International audienceBackground : Glycemic variability is associated with worse outcomes after cardiac surgery, but the prognosis value of early glycemic variability after transcatheter aortic valve implantation is not known. This study was therefore designed to analyze the prognosis significance of post-procedural glycemic variability within 30 days after transcatheter aortic valve implantation.Methods : A post hoc analysis of patients from our center included in the FRANCE and FRANCE-2 registries was conducted. Post-procedural glycemic variability was assessed by calculating the mean daily δ blood glucose during the first 2 days after transcatheter aortic valve implantation. Major complications within 30 days were death, stroke, myocardial infarction, acute heart failure, and life-threatening cardiac arrhythmias.Results : We analyzed 160 patients (age (median [interquartile] = 84 [80–88] years; diabetes mellitus (n) = 41 (26%) patients; logistic Euroscore = 20 [12–32]). The median value of mean daily δ blood glucose was 4.3 mmol l−1. The rate of major complications within 30 days after procedure among patients with the lowest quartile of glycemic variability was 12%, increasing from 12 to 26%, and 39% in the second, third, and fourth quartiles, respectively. In multivariate analysis, glycemic variability was independently associated with an increased risk of major complications within 30 days after the procedure (odds ratio [95% CI] = 1.83 [1.19–2.83]; p = 0.006).Conclusions : This study showed that post-procedural glycemic variability was associated with an increased risk of major complications within 30 days after transcatheter aortic valve implantation

2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS)

Peer reviewe

Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke

BACKGROUND Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy. METHODS In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3. RESULTS A total of 663 patients underwent randomization and were followed for a mean (+/- SD) of 5.3 +/- 2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P&lt;0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P = 0.02). The number of serious adverse events did not differ significantly between the treatment groups (P = 0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone. CONCLUSIONS Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation