The PRECISE-DAPT and PARIS risk scores (RSs) were recently developed to help clinicians at individualizing the optimal dual antiplatelet therapy duration (DAPT) after percutaneous coronary ...intervention (PCI). Nevertheless, external validation of these RSs it has not yet been performed in ACS (acute coronary syndrome) patients treated with prasugrel or ticagrelor in a real- world scenario.
4424 ACS patients who underwent PCI and survived to hospital discharge, from January 2012 to December 2016 at 12 European centers, were included. PRECISE-DAPT and PARIS bleeding RS, as well as PARIS ischemic RS, were computed, and their performance at predicting major bleeding (MB; BARC type 3 or 5) and ischemic events (MI and stent thrombosis) during follow up was compared.
After a median follow-up of 14 (interquartile range 12–20.9) months, 83 (1.88%) patients developed MB and 133 (3.0%) suffered an ischemic episode. PRECISE-DAPT performed better than PARIS bleeding RS (c-statistic = 0.653 vs. 0.593; p = .01 for comparison) in predicting MB. The RSs performance for MB prediction remained consistent in STEMI patients (c-statistic = 0.632 vs 0.575) or in those treated with prasugrel (c-statistic = 0.623 vs 0.586).
PARIS ischemic RS exhibited superior discrimination in predicting ischemic complications compared to PRECISE-DAPT (c-statistic = 0.604 vs 0.568 p = .05 for comparison).
Our data provide support to the use of PRECISE-DAPT in MB risk stratification for patients receiving DAPT in form of aspirin and prasugrel or ticagrelor whereas the PARIS ischemic RS has potential to complement the risk prediction with respect to ischemic events.
•PRECISE-DAPT performed better than PARIS bleeding RS (c-statistic = 0.650 vs. 0.593; p = .01 for comparison) in predicting MB.•The decision curves analysis demonstrated that the use of PRECISE-DAPT is superior to PARIS bleeding RS at a MB risk threshold of ≥2%.•PARIS ischemic RS exhibited superior discrimination in predicting ischemic complications compared to PRECISE-DAPT (c-statistic = 0.604 vs 0.568 p = .05 for comparison).
Abstract
Background
The presence of a patent foramen ovale (PFO) is associated with several medical conditions, including cryptogenic left circulation thromboembolism. PFO closure was demonstrated to ...reduce recurrent ischaemic stroke in patients with prior cryptogenic stroke. The presence of an inferior vena cava filter (IVCF), however, may impede a transfemoral PFO closure procedure.
Case summary
We describe the case of a 50-year-old man with a PFO suffering from ischaemic stroke from paradoxical thromboembolism originating from deep vein thrombosis and requiring an IVCF. After deep vein thrombosis resolution, due to the high risk of stroke recurrences, the patient was recommended PFO closure. IVCF retrieval by the interventional radiologist was first attempted but failed. A transfemoral PFO closure procedure was thus endeavoured with the IVCF in place and was successful. The patient was then discharged in good clinical status and no stroke recurrences were reported at 5 months follow-up.
Discussion
Albeit an IVCF provides benefit in patients with recurrent thromboembolic events despite adequate anticoagulation therapy, its presence may hinder interventional procedures necessitating delivery systems to advance through the inferior vena cava. We reported on a successful PFO closure procedure via a femoral venous access in a patient with an IVCF in place, thus demonstrating the feasibility of advancing delivery systems through an IVCF. As interventional procedures requiring the advancement of delivery systems through the inferior vena cava are becoming increasingly common, the feasibility of IVCF crossing with catheters and delivery systems alike paves the way for novel interventional possibilities.
Aims:
Randomized clinical trials (RCTs) are the most reliable evidence, even if they require important resource and logistic efforts. Large, cost‐free and real‐world datasets may be easily accessed ...yielding to observational studies, but such analyses often lead to problematic results in the absence of careful methods, especially from a statistic point of view. We aimed to appraise the performance of current multivariable approaches in the estimation of causal treatment and effects in studies focusing on drug‐eluting stents (DES).
Methods and Results:
Pertinent studies published in the literature were searched, selected, ed, and appraised for quality and validity features. Six studies with a logistic regression were included, all of them reporting more than 10 events for covariates and different length of follow‐up, with an overall low risk of bias. Most of the 15 studies with a Cox proportional hazard analysis had a different follow‐up, with less than 10 events for covariates, yielding an overall low or moderate risk of bias. Sixteen studies with propensity score were included: the most frequent method for variable selection was logistic regression, with underlying differences in follow‐up and less than 10 events for covariate in most of them. Most frequently, calibration appraisal was not reported in the studies, on the contrary of discrimination appraisal, which was more frequently performed. In seventeen studies with propensity and matching, the latter was most commonly performed with a nearest neighbor‐matching algorithm yet without appraisal in most of the studies of calibration or discrimination. Balance was evaluated in 46% of the studies, being obtained for all variables in 48% of them.
Conclusions:
Better exploitation and methodological appraisal of multivariable analysis is needed to improve the clinical and research impact and reliability of nonrandomized studies. (J Interven Cardiol 2012;25:611–621)
Prognosis in pulmonary hypertension is strictly linked to right ventricle failure, which results from uncoupling between right ventricle function and its afterload. This study sought to describe how ...to estimate with echocardiography right ventricular wall tension, its correlation with right ventricle haemodynamics and its prognostic role. A total of 190 patients without overt right ventricle failure but with suspected pulmonary hypertension on a previous echocardiogram underwent right heart catheterization and nearly-simultaneous echocardiography. Right ventricular wall tension was estimated according to Laplace’s law as right ventricle length × tricuspid regurgitation peak gradient and it was correlated with right ventricle haemodynamic profile; its potential prognostic impact was tested along with canonical right ventricle function parameters. Right ventricular wall tension correlated significantly with invasive estimation of right ventricle end-diastolic pressure (R: 0.343, p < 0.001) and with several other haemodynamic variables, such as mean pulmonary artery pressure, pulmonary artery compliance, transpulmonary gradient, pulmonary vascular resistance, right atrial pressure and right ventricle stroke work index (all p < 0.001). At a mean follow-up of five years and three months, only right ventricular wall tension was associated to all-cause mortality (p = 0.036), while tricuspid annular plane systolic excursion (p = 0.536), right ventricle fractional area change (p = 0.383), right ventricle fractional area change (p = 0.076), tricuspid regurgitation peak gradient (p = 0.107) and tricuspid annular plane systolic excursion/tricuspid regurgitation peak gradient (p = 0.181) could not. We identified a novel bedside echocardiographic predictor of altered right ventricle haemodynamics, which is precociously altered in patients without overt right ventricle failure and is associated to all-cause mortality at a long-term follow-up. Further studies are needed to confirm its role in pulmonary hypertension patients.
Aims
Instantaneous free‐wave ratio (iFR) has been recently demonstrated non‐inferior to fractional flow reserve (FFR) to drive coronary revascularization; however, no study has compared iFR versus ...coronary angiography (CA). We performed a network meta‐analysis to evaluate efficacy and safety of iFR‐ versus CA‐guided strategy.
Methods and Results
We searched for randomized trials and studies with propensity score matching in The Cochrane Collaboration Central Register of Controlled Trials, EMBASE, and MEDLINE/Pubmed. CA, FFR, and iFR were the three competitive arms, MACE (a composite endpoint of death, myocardial infarction MI, and target vessel revascularization TVR) was the primary endpoint, while its single components the secondary ones. Subgroup analysis was performed for patients presenting with stable coronary artery disease. Eight studies were selected: 4126 patients were evaluated with FFR, 2160 with iFR, and 2214 with CA, acute coronary syndrome (ACS) was the most frequent admission diagnosis. After 12 months, rates of MACE and all‐cause death did not differ between groups (respectively OR 1.04 and OR 0.86 for iFR vs FFR). Both FFR and iFR reduced TVR compared to CA (respectively OR 0.68 and OR 0.70). In patients with stable CAD both FFR and iFR reduced risk of subsequent MI compared to CA (respectively OR 0.66 and OR 0.79).
Conclusion
Compared to CA alone, both FFR and iFR are safe and effective in guiding coronary revascularization at 12 months. In patients with stable CAD, both FFR and iFR‐guided revascularization reduce the risk of subsequent MI at 12 months.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.
Long term survival and its determinants after Percutaneous Coronary Intervention (PCI) on Unprotected Left Main Coronary Artery (ULMCA) remain to be appraised. In 9 European Centers 470 consecutive ...patients performing PCI on ULMCA between 2002 and 2005 were retrospectively enrolled. Survival from all cause and cardiovascular (CV) death were the primary end points, while their predictors at multivariate analysis the secondary ones. Among the overall cohort 81.5% of patients were male and mean age was 66 ± 12 years. After 15 years (IQR 13 to 16), 223 patients (47%) died, 81 (17.2%) due to CV etiology. At multivariable analysis, older age (HR 1.06, 95%CI 1.02 to 1.11), LVEF < 35% (HR 2.97, 95%CI 1.24 to 7.15) and number of vessels treated during the index PCI (HR 1.75, 95%CI 1.12 to 2.72) were related to all-cause mortality, while only LVEF <35% (HR 4.71, 95%CI 1.90 to 11.66) to CV death. Repeated PCI on ULMCA occurred in 91 (28%) patients during the course of follow up and did not significantly impact on freedom from all-cause or CV mortality. In conclusion, in a large, unselected population treated with PCI on ULMCA, 47% died after 15 years, 17% due to CV causes. Age, number of vessels treated during index PCI and depressed LVEF increased risk of all cause death, while re-PCI on ULMCA did not impact survival.
Objectives
The purpose of this study is to compare the long‐term outcomes of patent foramen ovale (PFO) closure using angiography or transesophageal echocardiography as procedural guidance.
...Background
The interventional treatment is emerging as a safe and efficient option for patients with high likelihood of PFO‐related cryptogenic stroke and high risk of recurrence. The “gold‐standard” guidance technique remains an issue.
Methods
Two cohorts of patients undergoing PFO closure for cryptogenic stroke in two catheterization laboratories of the same institution, using similar inclusion criteria but different guidance, were compared with propensity score matching.
Results
A total of 374 patients were enrolled, 161 in Angio‐group and 213 in Echo‐group. No difference was detected in the procedural complication rate. In Angio‐group, radiological exposure (P = .001) and 6‐month residual shunt (16.8% vs 8.0%, P = .015) were higher. After a mean follow‐up of 41 ± 30 months, 28 patients (7.5%) presented any adverse event (death, recurrent cerebral ischemia, device‐related complications, reintervention), with a higher rate in Angio‐group (13.0% vs 3.3%, P = .001), mainly due to repeated percutaneous intervention (10.6% vs 1.4%, P = .001). The results were confirmed after propensity score matching (118 patients/group). The rate of recurrent cerebral ischemia was 1.9% and was not significantly different in the two groups. Intra‐procedural guidance and atrial septum aneurysm were independent predictors of the composite primary endpoint (OR 1.2, P = .016).
Conclusions
The use of intra‐procedural transesophageal echocardiography (TEE) guidance for PFO closure allows lower residual shunt rate, radiological exposure, and adverse events, mainly driven by a significant reduction in percutaneous reintervention.
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