ABSTRACT
Patients with coronary artery disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, cost-efficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease. The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronary intervention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months. The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI. Trial registration: ClinicalTrials.gov: NCT06095765.
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BACKGROUND: Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. AIMS: To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. METHODS: Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). RESULTS: Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. CONCLUSIONS: In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.
Subject(s)
Platelet Aggregation Inhibitors , Thrombosis , Humans , Platelet Aggregation Inhibitors/adverse effects , Anticoagulants/adverse effects , Fibrinolytic Agents/adverse effects , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Treatment Outcome , Hemorrhage/chemically induced , Thrombosis/etiology , Thrombosis/prevention & control , RegistriesABSTRACT
BACKGROUND: Diagnosis-to-ablation time (DAT) strongly predicts recurrence of atrial fibrillation (AF) after ablation. Whether this association holds with any lower and/or upper limits is unknown. OBJECTIVES: The goal of this study was to assess the impact of DAT on AF recurrence in search of lower and upper DAT thresholds. METHODS: A total of 2,000 patients with AF from 2 cohorts of 1,000 patients each (69% male; age 62 ± 10 years) undergoing pulmonary vein isolation (PVI) between 2005-2014 and 2017-2019 were followed up for 3 years. RESULTS: Clinical success was achieved in 61.7% of patients. Median DAT decreased over time from 36 months (Q1-Q3: 12-72 months) in the first cohort to 12 months (Q1-Q3: 5-48 months) in the second cohort (P < 0.001). A multivariable Cox proportional hazards fitted model of AF recurrence rate in relation to DAT (range: 0-288 months) showed a steep rise in AF recurrence, from 27% to 40% in the first 36 months (d%/dt = 0.36), with a first inflection point at 36 months, and a less steep rise to 45% until 90 months (d%/dt = 0.09), with flattening beyond 90 months (d%/dt = 0.026). Rise in AF recurrence rate in the first 36 months was higher in patients with persistent AF (from 40% to 54%; d%/dt = 0.39) than in patients with paroxysmal AF (19% to 29%; d%/dt = 0.28). CONCLUSIONS: The association between DAT and AF recurrence has no lower limit ("the shorter the better"), whereas little gain is to be expected beyond 36 months ("the longer the more irrelevant"). Our data advocate for performing PVI as early as possible, certainly within 3 years of AF diagnosis, and even more so in persistent AF.
Subject(s)
Atrial Fibrillation , Humans , Male , Middle Aged , Aged , Female , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Treatment Outcome , Time FactorsABSTRACT
OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.
Subject(s)
Pacemaker, ArtificialABSTRACT
BACKGROUND: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). AIMS: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. METHODS: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. RESULTS: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). CONCLUSIONS: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.
Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Humans , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Heart Valve Prosthesis/adverse effects , Postoperative Complications/etiology , Prosthesis Design , Retrospective Studies , Transcatheter Aortic Valve Replacement/adverse effects , Treatment OutcomeABSTRACT
AIMS: Standard of care (SoC) device size selection with transoesophageal echocardiography (TOE) and computed tomography (CT) in LAAO can be challenging due to a certain degree of variability at both patient and device levels. The aim of this study was to prospectively evaluate the clinical impact of 3D computational modelling software in the decision-making of left atrial appendage occlusion (LAAO) with Amplatzer Amulet. METHODS AND RESULTS: SoC preprocedural assessments as well as CT-based 3D computational simulations (FEops) were performed in 15 consecutive patients scheduled for LAAO with Amulet. Preprocedural device size selection and degree of confidence were determined after SoC and after FEops-based assessments and compared to the implanted device. FEops-based preprocedural assessment correctly selected the implanted device size in 11 out of 15 patients (73.3%), compared to 7 patients (46.7%) for SoC-based assessment. In 4 patients (26.7%), FEops induced a change in device size initially selected by SoC. In the 7 patients (46.7%) in which FEops confirmed the SoC device size selection, the degree of confidence of the size selection increased from 6.4 ± 1.4 for SoC to 8.1 ± 0.7 for FEops. One patient (6.7%) could not be implanted for anatomical reason, as correctly identified by FEops. CONCLUSIONS: Preprocedural 3D computational simulation by FEops impacts Amulet size selection in LAAO compared to TOE and CT-based SoC assessment. Operators could consider FEops computational simulation in their preprocedural device size selection.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Aged , Aged, 80 and over , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Cardiac Catheterization , Echocardiography, Transesophageal , Female , Humans , Male , Tomography, X-Ray ComputedABSTRACT
BACKGROUND: Familial hypercholesterolaemia (FH) is underdiagnosed in most countries. We report our first experience from a national pilot project of cascade screening in relatives of FH patients. METHODOLOGY: Participating specialists recruited consecutive index patients (IP) with Dutch Lipid Clinic Network (DLCN) score ≥6. After informed consent, the relatives were visited by the nurses to collect relevant clinical data and perform blood sampling for lipid profile measurement. FH diagnosis in the relatives was based on the DLCN and/or MEDPED FH (Make-Early-Diagnosis-to-Prevent-Early-Deaths-in-FH) criteria. RESULTS: In a period of 18 months, a total of 127 IP (90 with definite FH and 37 with probable FH) were enrolled in 15 centres. Out of the 270 relatives visited by the nurses, 105 were suspected of having FH: 31 with DCLN score >8, 33 with DLCN score 5-8 and 41 with MEDPED FH criteria. In a post-hoc analysis, another set of MEDPED FH criteria established in the Netherlands and adapted to Belgium allowed to detect FH in 51 additional relatives. CONCLUSION: In a country with no national FH screening program, our pilot project demonstrated that implementing a simple phenotypical FH cascade screening strategy using the collaboration of motivated specialists and two nurses, allowed to diagnose FH in 127 index patients and an additional 105 of their relatives over the two-year period. Newly developed MEDPED FH cut-offs, easily applicable by a nurse with a single blood sample, might further improve the sensitivity of detecting FH within families.
Subject(s)
Hyperlipoproteinemia Type II , Belgium/epidemiology , Cholesterol, LDL , Feasibility Studies , Humans , Hyperlipoproteinemia Type II/diagnosis , Hyperlipoproteinemia Type II/epidemiology , Hyperlipoproteinemia Type II/genetics , Mutation , Pilot ProjectsABSTRACT
BACKGROUND: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied. METHODS: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial. CONCLUSIONS: Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).
Subject(s)
Aspirin/therapeutic use , Clopidogrel/therapeutic use , Hemorrhage/chemically induced , Platelet Aggregation Inhibitors/therapeutic use , Thrombosis/prevention & control , Transcatheter Aortic Valve Replacement , Administration, Oral , Aged , Aged, 80 and over , Aspirin/adverse effects , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/mortality , Clopidogrel/adverse effects , Drug Therapy, Combination , Female , Hemorrhage/epidemiology , Humans , Incidence , Male , Platelet Aggregation Inhibitors/adverse effects , Postoperative Period , Thrombosis/epidemiologyABSTRACT
BACKGROUND: The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied. METHODS: We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non-procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P = 0.01); most bleeding events were at the TAVI access site. Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, -14.3 percentage points; 95% CI for noninferiority, -25.0 to -3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, -3.9 percentage points; 95% CI for noninferiority, -11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31). CONCLUSIONS: In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).
Subject(s)
Anticoagulants/therapeutic use , Clopidogrel/therapeutic use , Hemorrhage/chemically induced , Platelet Aggregation Inhibitors/therapeutic use , Transcatheter Aortic Valve Replacement , Administration, Oral , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/mortality , Clopidogrel/adverse effects , Drug Therapy, Combination , Hemorrhage/epidemiology , Humans , Incidence , Kaplan-Meier Estimate , Male , Platelet Aggregation Inhibitors/adverse effects , Transcatheter Aortic Valve Replacement/adverse effectsABSTRACT
BACKGROUND: ACEF score has been shown to have predictive ability in the patients undergoing percutaneous coronary intervention (PCI). The ACEF II score has recently been developed to predict short-term mortality after cardiac surgery. We compared the predictive ability of the ACEF and ACEF II scores to predict mortality after PCI in the all-comers population. METHODS: The ACEF and ACEF II scores were calculated in 15,968 patients enrolled in the GLOBAL LEADERS study. Discrimination and calibration were assessed for outcomes after PCI. Recalibration of the regression model by updating the intercept and slope were performed to adjust the original ACEF model to the PCI setting. In a stratified approach, patients were divided into quintiles according to the score. Outcomes were compared between quintiles. RESULTS: The ACEF and ACEF II score were available in 14,941 and 14,355 patients respectively. Discrimination for 30-day all-cause mortality was acceptable for both scores (C-statistic ACEF 0.75 and ACEF II 0.77). For 2-year all-cause mortality, the discrimination of ACEF score was acceptable (C-statistic 0.72) while the discrimination of ACEF II score was moderate (C-statistic 0.69). Both scores identified patients at high risk of mortality but overestimated all-cause mortality at 30â¯days in all quintiles. After recalibration, agreement between predicted and observed 30-day all-cause mortality in both scores are close to the identity line. CONCLUSIONS: The ACEF II model did not improve the predictive ability of the ACEF score. Recalibrated ACEF model can be used to estimated all-cause mortality rate at 30â¯days after PCI.
Subject(s)
Coronary Artery Disease/diagnosis , Heart Ventricles/diagnostic imaging , Percutaneous Coronary Intervention , Registries , Risk Assessment/methods , Stroke Volume/physiology , Age Factors , Cause of Death/trends , Coronary Angiography , Coronary Artery Disease/epidemiology , Coronary Artery Disease/surgery , Europe/epidemiology , Female , Heart Ventricles/physiopathology , Humans , Incidence , Male , Middle Aged , Postoperative Period , Prognosis , Prospective Studies , Risk Factors , Survival Rate/trendsABSTRACT
AIMS: This study aimed to assess the safety and efficacy at midterm follow-up of left atrial appendage occlusion (LAAO) using different devices, in real life in Belgium. METHODS AND RESULTS: Between June 2009 and November 2016, 457 consecutive patients (63% male, 75±12 yrs, CHA2DS2-VASc 4±0.6, HAS-BLED 3.5±0.7) undergoing LAAO were included. Technical success was 97.1%. There were 19 periprocedural major adverse events (4.1%) including three deaths (0.6%), nine tamponades (1.9%), four major bleedings (0.8%) and two device embolisations (0.4%). Among patients successfully implanted having a complete follow-up (672 patient-years, median follow-up 370 days), the actual annual stroke rate was 1.2%, lower than the expected stroke risk of 4% (70% reduction). The observed bleeding rate was 2%, while the calculated risk was 3.7% (46% reduction). Kaplan-Meier analysis showed a similar overall survival (93±2% and 87±3% versus 91±3% and 87±4%; p=0.35) and event-free survival (92±2% and 84±3% versus 88±3% and 80±5%; p=0.17) at one and two years, for the ACP/Amulet versus the WATCHMAN groups of patients, respectively. CONCLUSIONS: The data from the Belgian left atrial appendage occlusion registry suggest that the procedure is effective and relatively safe in a real-world setting, using either the WATCHMAN or the ACP/Amulet device.
Subject(s)
Atrial Appendage , Atrial Fibrillation/therapy , Cardiac Catheterization , Stroke/prevention & control , Aged , Aged, 80 and over , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Atrial Fibrillation/complications , Atrial Fibrillation/mortality , Atrial Fibrillation/physiopathology , Belgium , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Echocardiography, Transesophageal , Female , Humans , Male , Middle Aged , Registries , Risk Factors , Stroke/etiology , Stroke/mortality , Time Factors , Treatment OutcomeABSTRACT
Aims: To define predictors of complications of pulmonary vein isolation (PVI) and compare safety between different ablation techniques. Methods and results: One thousand patients with atrial fibrillation (AF) (age 60 ± 10, 72% males, CHA2DS2-VASc score 1 ± 1) underwent PVI using various techniques: conventional PVI (CPVI) using mapping with irrigated point-per-point RF ablation (n = 576), multi-electrode RF ablation with the pulmonary vein ablation catheter (PVAC) (n = 272) or high density mesh ablator (HDMA) (n = 59) and cryoballoon (CB) ablation (n = 93). A complication was defined as any procedure-related adverse event resulting in permanent injury or death, requiring intervention or treatment, or prolonging/requiring hospitalization for >48 h. A total of 105 (10.5%) complications occurred in 101 (10.1%) patients. No periprocedural death occurred. Most frequent complications were vascular complications (4%) and pericarditis (3.1%). Seven patients experienced permanent deficit due to PV stenosis (n = 3, 1 CPVI, 2 PVAC) (n = 3) and phrenic nerve palsy (PNP) (n = 4, 3 CPVI, 1 PVAC). Independent predictors of complications were female sex [odds ratio (OR) = 1.73; 95% confidence interval (CI) 1.08-2.79; P = 0.023], CHA2DS2-VASc score (OR = 1.24; 95% CI 1.01-1.52; P = 0.039), and ablation technique (P = 0.006) in multivariable-adjusted analysis. Among the different techniques, CB (P = 0.047) and PVAC ablation (P = 0.003) had lowest overall complication rates. Complication profile (type/severity) differed between techniques (association between CB and PNP, CPVI and pericardial injury, PVAC and transient ischaemic attack/PV stenosis). Conclusion: Overall complication rate of PVI with various techniques is 10.5%. Permanent deficit occurred only after PVAC and CPVI in 0.7% of patients. Female sex and a higher CHA2DS2-VASc score increase, while PVAC and CB-PVI decrease, overall risk. Differences in overall safety and individual complication profile make selection of the ablation technique in relation to clinical risk profile possible.
Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Cryosurgery/adverse effects , Postoperative Complications/epidemiology , Pulmonary Veins/surgery , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/physiopathology , Belgium/epidemiology , Cardiac Catheters , Catheter Ablation/instrumentation , Clinical Decision-Making , Comorbidity , Cryosurgery/instrumentation , Electrodes , Equipment Design , Female , Humans , Male , Middle Aged , Patient Selection , Postoperative Complications/diagnosis , Postoperative Complications/therapy , Prevalence , Pulmonary Veins/physiopathology , Registries , Risk Assessment , Risk Factors , Sex Factors , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Stent thrombosis (ST) is a serious complication following coronary stenting. Intravascular optical coherence tomography (OCT) may provide insights into mechanistic processes leading to ST. We performed a prospective, multicenter study to evaluate OCT findings in patients with ST. METHODS: Consecutive patients presenting with ST were prospectively enrolled in a registry by using a centralized telephone registration system. After angiographic confirmation of ST, OCT imaging of the culprit vessel was performed with frequency domain OCT. Clinical data were collected according to a standardized protocol. OCT acquisitions were analyzed at a core laboratory. Dominant and contributing findings were adjudicated by an imaging adjudication committee. RESULTS: Two hundred thirty-one patients presenting with ST underwent OCT imaging; 14 (6.1%) had image quality precluding further analysis. Of the remaining patients, 62 (28.6%) and 155 (71.4%) presented with early and late/very late ST, respectively. The underlying stent type was a new-generation drug-eluting stent in 50.3%. Mean reference vessel diameter was 2.9±0.6 mm and mean reference vessel area was 6.8±2.6 mm2. Stent underexpansion (stent expansion index <0.8) was observed in 44.4% of patients. The predicted average probability (95% confidence interval) that any frame had uncovered (or thrombus-covered) struts was 99.3% (96.1-99.9), 96.6% (92.4-98.5), 34.3% (15.0-60.7), and 9.6% (6.2-14.5) and malapposed struts was 21.8% (8.4-45.6), 8.5% (4.6-15.3), 6.7% (2.5-16.3), and 2.0% (1.2-3.3) for acute, subacute, late, and very late ST, respectively. The most common dominant finding adjudicated for acute ST was uncovered struts (66.7% of cases); for subacute ST, the most common dominant finding was uncovered struts (61.7%) and underexpansion (25.5%); for late ST, the most common dominant finding was uncovered struts (33.3%) and severe restenosis (19.1%); and for very late ST, the most common dominant finding was neoatherosclerosis (31.3%) and uncovered struts (20.2%). In patients presenting very late ST, uncovered stent struts were a common dominant finding in drug-eluting stents, and neoatherosclerosis was a common dominant finding in bare metal stents. CONCLUSIONS: In patients with ST, uncovered and malapposed struts were frequently observed with the incidence of both decreasing with longer time intervals between stent implantation and presentation. The most frequent dominant observation varied according to time intervals from index stenting: uncovered struts and underexpansion in acute/subacute ST and neoatherosclerosis and uncovered struts in late/very late ST.
Subject(s)
Coronary Thrombosis/diagnostic imaging , Coronary Thrombosis/prevention & control , Drug-Eluting Stents/trends , Percutaneous Coronary Intervention/trends , Research Report/trends , Tomography, Optical Coherence/trends , Aged , Coronary Thrombosis/epidemiology , Drug-Eluting Stents/adverse effects , Europe/epidemiology , Female , Humans , Male , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Registries , Tomography, Optical Coherence/methodsSubject(s)
Coronary Restenosis/diagnosis , Drug-Eluting Stents/adverse effects , Percutaneous Coronary Intervention/adverse effects , ST Elevation Myocardial Infarction/surgery , Thrombosis/diagnosis , Aged , Coronary Restenosis/etiology , Follow-Up Studies , Humans , Imaging, Three-Dimensional , Male , Prosthesis Failure , ST Elevation Myocardial Infarction/diagnosis , Thrombosis/etiology , Time Factors , Tomography, Optical CoherenceSubject(s)
Cardiomyopathy, Hypertrophic/diagnostic imaging , MELAS Syndrome/diagnostic imaging , Mitochondrial Diseases/diagnostic imaging , Multimodal Imaging/methods , Biopsy, Needle , Cardiomyopathy, Hypertrophic/complications , Cardiomyopathy, Hypertrophic/pathology , Dyspnea/diagnosis , Dyspnea/etiology , Echocardiography, Doppler , Electrocardiography/methods , Humans , Hypertrophy, Left Ventricular/diagnostic imaging , Hypertrophy, Left Ventricular/pathology , Hypertrophy, Right Ventricular/diagnostic imaging , Hypertrophy, Right Ventricular/pathology , Immunohistochemistry , MELAS Syndrome/complications , MELAS Syndrome/pathology , Magnetic Resonance Imaging, Cine/methods , Male , Middle Aged , Mitochondrial Diseases/pathology , Prognosis , Radiography, Thoracic/methods , Rare DiseasesABSTRACT
AIMS: Our aim was to evaluate the five-year clinical impact of side branch (SB) stenting with a drug-eluting stent (DES) following Axxess stent implantation in coronary bifurcation lesions. METHODS AND RESULTS: Four hundred patients treated with Axxess were pooled from the AXXESS Plus and DIVERGE five-year follow-up studies. We compared unadjusted and propensity-adjusted major adverse clinical events (MACE) between Axxess with no SB stenting ("Axxess provisional") versus Axxess with SB stenting ("Axxess additional"). "Axxess additional" had no impact on the MACE rate, with unadjusted and adjusted HR 1.59 (95% CI: 0.95-2.64) and 1.37 (95% CI: 0.88-2.13), respectively. No differences were seen in the individual components of death, myocardial infarction and ischaemia-driven target lesion revascularisation, respectively, both in unadjusted (HR 0.92 [95% CI: 0.38-2.19]; HR 1.73 [95% CI: 0.78-3.82]; HR 1.65 [95% CI: 0.84-3.26]) and adjusted analysis (HR 0.92 [95% CI: 0.41-2.09]; HR 1.13 [95% CI: 0.59-2.17]; HR 1.31 [95% CI: 0.74-2.31]). No differences in definite stent thrombosis were seen with unadjusted HR 2.1 (95% CI: 0.45-9.88) and adjusted HR 1.0 (95% CI: 0.32-3.1). CONCLUSIONS: Stenting the SB following Axxess implantation does not impact on long-term clinical outcomes compared to MV stenting only. The Axxess stent system offers a safe and tailored alternative for the treatment of coronary bifurcation lesions.