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1.
Am J Cardiol ; 2019 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-31474326

RESUMO

Patients referred for transcatheter aortic valve implantation (TAVI) are typically elderly with several co-morbidities, which might limit prognosis despite successful procedural outcome. To date, the prevalence and clinical impact of iron deficiency (ID) in patients with severe aortic stenosis who underwent TAVI remains poorly defined. This study included 495 patients who underwent transfemoral TAVI for severe symptomatic aortic stenosis. ID was defined as ferritin <100 ng/ml or ferritin 100 to 300 ng/ml, when transferrin saturation was <20%. The primary end point of the study was a composite of all-cause mortality, unplanned readmission for worsening heart failure or red blood cell transfusions during the first year after TAVI, which occurred in 22% (109 of 495) of the population. ID was present in 54% (268 of 495) of the entire cohort and was associated with a higher rate of the primary end point (27.6% [74 of 268] vs 15.4% [35 of 227]; p = 0.001). After multivariable adjustment, the association of ID with the primary end point remained significant (hazard ratio 1.64, 95% confidence interval [1.08 to 2.48]; p = 0.019). In a subgroup of ferropenic patients (n = 56), treatment with intravenous iron before TAVI was feasible, resulting in a considerable improvement of ferritin, transferrin saturation and symptoms at 30-day follow-up. In conclusion, ID is common in TAVI patients and is associated with adverse clinical outcome after TAVI. Correction of ID with intravenous iron seems feasible in contemporary TAVI patients. Whether this reduces transfusion rates and impacts clinical outcome after TAVI remains to be investigated in future prospective trials.

2.
N Engl J Med ; 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31475799

RESUMO

BACKGROUND: The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. METHODS: In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. RESULTS: A total of 4018 patients underwent randomization. A primary-end point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). CONCLUSIONS: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

3.
EuroIntervention ; 2019 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-31498111

RESUMO

AIMS: Elevated gradients have been proposed to be associated with hemodynamic structural valve deterioration (SVD) after transcatheter aortic valve implantation (TAVI) and data regarding their characterization remain scarce. METHODS AND RESULTS: 691 patients undergoing transfemoral TAVI were enrolled. The primary endpoint was moderate or severe hemodynamic SVD during 12-month follow-up after TAVI, defined as (I) mean transvalvular gradient ≥20 mmHg or (II) mean transvalvular gradient change ≥10 mmHg. The primary endpoint was observed in 10.3% after TAVI. Use of 20mm valve, valve-in-valve procedure and oral anticoagulation (OAC) were independently associated with hemodynamic SVD, whereas valve-in-valve procedure and OAC were the only significant variables after accounting for death as a competing event. OAC was significantly associated with both, hemodynamic SVD (RR 8.65; p=0.004) and death (RR 3.57; p=0.06), whereas valve-in-valve procedure was only associated with hemodynamic SVD (RR 52.76; p<0.001). Valve thrombosis was present in 0.87% (6/691) of all patients. CONCLUSIONS: The prevalence of moderate or greater hemodynamic SVD during the first 12 months after TAVI is 10.3%. Procedural factors and pharmacotherapy seem to play a key role during manifestation. Future studies should focus on the underlying mechanisms.

4.
Eur Heart J ; 2019 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-31511862

RESUMO

AIMS: Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited. METHODS AND RESULTS: The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02-1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58-1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71-1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53-1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80-2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments. CONCLUSIONS: In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.

7.
Artigo em Inglês | MEDLINE | ID: mdl-31448867

RESUMO

OBJECTIVES: We sought to compare the procedural and clinical performance of dual- versus single-catheter strategy for transradial coronary angiography. BACKGROUND: The radial artery (RA) is recommended as the vascular access of choice in patients undergoing coronary angiography and intervention. The procedural and clinical performance of dual- versus single-catheter strategy in patients undergoing transradial coronary angiography remains a matter of debate. METHODS: This is a study-level meta-analysis of randomized trials. The primary outcome was procedure time. The main secondary outcome was fluoroscopy time. Other outcomes of interest were contrast volume, crossover to other catheter strategy and RA spasm. RESULTS: A total of 2,062 patients (978 randomly assigned to dual-catheter and 1,084 to single-catheter strategy) included in seven trials were available for the quantitative synthesis. A dual-catheter strategy was associated with procedure time (standardized mean difference [95% confidence intervals (CI)], 0.55 [-0.69, 1.78]; p = .32), fluoroscopy time (-0.36 [-2.39, 1.67]; p = .68) and contrast volume (-0.93 [-3.79, 1.94]; p = .44) comparable to a single-catheter strategy. The risk for crossover was lower (risk ratio [95% CI], 0.14 [0.03, 0.70]; p = .025) while the risk for RA spasm was higher (1.81 [1.54, 2.12]; p < .001) among patients assigned to dual- versus single-catheter strategy. CONCLUSIONS: This meta-analysis provides evidence for a comparable procedural performance of either dual- or single-catheter strategy for transradial coronary angiography. The fewer crossovers with dual-catheter strategy occur at the expense of more frequent radial artery spasm.

8.
EuroIntervention ; 2019 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-31355753

RESUMO

AIMS: To assess the incidence and predictors of superficial femoral artery (SFA) stent thrombosis (ST) in a large patient cohort. METHODS AND RESULTS: 984 stented SFA-lesions were retrospectively analysed in 717 patients. We observed an overall ST rate of 7.5% (74/984) while 14% occurred early within 30 days after stenting, 51% during the first year thereafter and 35% later than one year. The estimated 5-year probability of ST was 13.4% [95% confidence interval CI: 10.0% to 16.7%]. Significant predictors of ST were stent-length (hazard ratio HR: 1.09 [95% CI: 1.06 to1.11], p<0.001), lesion-length (HR: 1.10 [1.08 to 1.13], p<0.001) female gender (HR: 1.79 [1.12 to 2.86], p=0.015), chronic total occlusion (CTO) (HR: 4.21 [2.51 to 7.05], p<0.001), implantation of more than one stent (2 stents: HR:6.06 [3.35 to 11.0], p<0.001), (3 or more stents: HR:16.83 [9.43 to 30.0], p<0.001) as well as lesion complexity criteria as expressed by TASC-II C/D (HR: 17.7 [5.56 to 56.1], p<0.001). CONCLUSIONS: ST after SFA stenting was a common adverse event in our cohort and peaked during the first year after stent implantation. Independent predictors of ST included lesion- and stent-length, female gender, presence of CTO, number of implanted stents and lesion complexity.

9.
Eur. heart j ; 40(25)Jul. 1, 2019. ilus
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1009597

RESUMO

Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs. Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications. Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s). The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug. Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval. The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the U.S. Food and Drug Administration and physician-scientists from the USA and Europe. One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials. The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies. These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.(AU)


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10.
Circ Cardiovasc Interv ; 12(7): e007734, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31288561

RESUMO

BACKGROUND: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new- versus early-generation DES vary by DM status. METHODS AND RESULTS: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively ( Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization. CONCLUSIONS: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

11.
Artigo em Inglês | MEDLINE | ID: mdl-31155492

RESUMO

PURPOSE: Bifurcation stenting is thought to be associated with delayed healing and a subsequent risk of stent failure. The aim of this study was to further evaluate healing of thin-strut bioabsorbable polymer everolimus-eluting stents (EES) post bifurcation stenting by optical coherence tomography (OCT) including grey-scale signal intensity (GSI) analysis. METHODS: Patients undergoing bifurcation stenting with a planned two-stent approach using EES with OCT follow-up at 3-6 months post-stenting were included in this study. Morphometric analysis of contiguous cross-sections was performed at 1 mm longitudinal intervals within the stented segment. GSI analysis of neointimal regions of interest (ROI) overlying stent struts was performed for each of these cross-sections. Tissue coverage was classified as mature or immature. RESULTS: Data on a total of 31 lesions (17 cases) was available at a median of 168 days post stenting. Mean length of stented segments was 27.7 ±â€¯16.6 mm. The mean minimum stent area was 6.50 ±â€¯2.71 mm2 while the mean stent area was 8.69 ±â€¯3.08 mm2. Amongst a total of 847 assessed frames, 9716 struts were visible. Overall strut coverage was 95.9%; 0.3% of struts were malapposed. The mean thickness of neointimal coverage was 100.95 ±â€¯42.03 µm and the mean percentage area stenosis was 9.03 ±â€¯7.80%. A total of 53.79% of ROIs were classified as mature. CONCLUSIONS: After implantation of EES in bifurcation lesions, rates of uncovered and malapposed struts were low. GSI analysis showed that more than half of neointimal areas analyzed were classified as mature in keeping with advanced vessel healing.

12.
Heart Lung Circ ; 2019 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-31182269

RESUMO

AIM: Psoas muscle cross-sectional area (CSA) is a proposed marker of frailty associated with mortality after transcatheter aortic valve implantation (TAVI). We assessed the impact of psoas CSA on medium-term mortality over 5 years in a large cohort, adjusted for pre-procedural variables. METHOD: This single-centre registry-derived analysis assessed 1,731 consecutive TAVI patients between 2007 and 31 April 2015 with available abdominal computed tomography scans. Sex-stratified, height-adjusted psoas CSA was measured mid-body of the fourth lumbar vertebra. Kaplan-Meier survival distributions across psoas CSA quartiles were compared. Cox and logistic regression models were used to assess baseline variables associated with the primary outcome, which was mortality within 5 years. RESULTS: Median age was 81 years (interquartile range, 77 - 85); 52.5% were women. The primary end point occurred in 555 patients over a mean follow-up of 775 days. Lower psoas CSA quartile patients were older, had a lower body mass index, lower creatinine clearance, and lower rates of previous cardiac surgery, with higher rates of diabetes, coronary artery disease, pacemaker, anaemia, hypoalbuminaemia, and higher European System for Cardiac Operative Risk Evaluation. Unadjusted survival by psoas CSA quartile was significantly different in men (log rank p=0.041) but not women (p=0.099). In Bonferroni-adjusted multivariate analysis, psoas CSA quartiles were not significantly associated with mortality. Hypoalbuminaemia (hazard ratio [HR], 2.10; 95% confidence interval [CI], 1.53 - 2.87 [p<0.001]) and increasing age (HR, 1.03 per year; 95% CI, 1.01 - 1.05 [p=0.002]) were associated with increased risk; female sex (HR, 0.63; 95% CI 0.51 - 0.78 [p<0.001]), and hypercholesterolaemia (HR, 0.67; 95%, CI 0.54 0.83 [p<0.001]) with reduced risk. CONCLUSIONS: Psoas CSA was not significantly associated with mortality after adjusting for pre-procedural variables. Hypoalbuminaemia, sex, hypercholesterolaemia, and age were significantly associated with mortality after TAVI.

13.
Artigo em Inglês | MEDLINE | ID: mdl-31231028

RESUMO

PURPOSE: Everolimus-eluting bioresorbable scaffolds (BRS) demonstrated an increased risk of very late scaffold thrombosis (VLScT) in comparison with conventional drug-eluting stents. However, characterization of VLScT cases remains scant and the role of interim angiographic surveillance in identifying patients at risk of VLScT is unclear. We therefore set out to identify angiographic predictors of VLScT in our present case series. METHODS: We analyzed a series of consecutive patients with VLScT presenting to two centers in Munich, Germany. Of interest, all patients had undergone interim planned surveillance angiography. Angiographic films were collected and reviewed and quantitative coronary angiography analysis was done at a core laboratory. Optical coherence tomography (OCT) images at presentation with VLScT were analyzed in patients with available data. RESULTS: Nine patients presented with 10 VLScT events. Mean age was 62.6 years. Surveillance angiography (between 159 and 476 days) were unremarkable in all cases. Time from index intervention to VLScT ranged from 393 to 1494 days. Nine of 10 events occurred after discontinuation of dual antiplatelet therapy. Four patients underwent OCT. The dominant finding at the time of VLScT was scaffold discontinuity. CONCLUSIONS: In a series of patients with VLScT after treatment with BRS, routine interim surveillance angiography was available in all patients and failed to identify features predictive of subsequent adverse events.

14.
Clin Chim Acta ; 496: 55-61, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31254501

RESUMO

BACKGROUND: Data regarding the association between alanine aminotransferase (ALT) and prognosis of patients with coronary artery disease (CAD) are limited. The aim of this study was to assess the association of ALT with the prognosis of patients with CAD. METHODS: The study included 9523 patients with angiography-proven CAD who underwent percutaneous coronary intervention. Baseline ALT activity measurements were available for analysis in all patients. The primary outcome was 3-year cardiac mortality. RESULTS: Patients were divided into three groups: a group with ALT within the 1st tertile (ALT 2.0 U/L to ≤17.0 U/L; n = 3276 patients), a group with ALT within the 2nd tertile (ALT >17.0 U/L to ≤26.0 U/L; n = 3075 patients) and a group with ALT within 3rd tertile (>26 U/L to ≤50.0 U/L; n = 3172 patients). Cardiac death (primary outcome) occurred in 441 patients: 201 (7.1%), 126 (4.7%) and 114 (4.0%) of these occurring in patients in the 1st, 2nd and 3rd ALT tertiles, respectively (with percentages representing Kaplan-Meier estimates of 3-year cardiac mortality); adjusted hazard ratio = 1.43, 95% confidence interval 1.11 to 1.85, P = 0.006 calculated for 1 unit decrement in the logarithmic scale of ALT. The multivariable model for cardiac mortality with baseline variables without ALT had a C-statistic of 0.827 [0.801-0.853], P < 0.001, which increased to 0.832 [0.806-0.857], P < 0.001 after incorporation of ALT (P = 0.020). CONCLUSIONS: In patients with CAD, ALT was inversely and independently associated with the risk of 3-year cardiac mortality. Low ALT may reflect cardiovascular risk that is poorly mediated by traditional cardiovascular risk factors.

15.
Eur Heart J ; 2019 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-31170283

RESUMO

AIMS: Genetic disposition and lifestyle factors are understood as independent components underlying the risk of multiple diseases. In this study, we aim to investigate the interplay between genetics, educational attainment-an important denominator of lifestyle-and coronary artery disease (CAD) risk. METHODS AND RESULTS: Based on the effect sizes of 74 genetic variants associated with educational attainment, we calculated a 'genetic education score' in 13 080 cases and 14 471 controls and observed an inverse correlation between the score and risk of CAD [P = 1.52 × 10-8; odds ratio (OR) 0.79, 95% confidence interval (CI) 0.73-0.85 for the higher compared with the lowest score quintile]. We replicated in 146 514 individuals from UK Biobank (P = 1.85 × 10-6) and also found strong associations between the 'genetic education score' with 'modifiable' risk factors including smoking (P = 5.36 × 10-23), body mass index (BMI) (P = 1.66 × 10-30), and hypertension (P = 3.86 × 10-8). Interestingly, these associations were only modestly attenuated by adjustment for years spent in school. In contrast, a model adjusting for BMI and smoking abolished the association signal between the 'genetic education score' and CAD risk suggesting an intermediary role of these two risk factors. Mendelian randomization analyses performed with summary statistics from large genome-wide meta-analyses and sensitivity analysis using 1271 variants affecting educational attainment (OR 0.68 for the higher compared with the lowest score quintile; 95% CI 0.63-0.74; P = 3.99 × 10-21) further strengthened these findings. CONCLUSION: Genetic variants known to affect educational attainment may have implications for a health-conscious lifestyle later in life and subsequently affect the risk of CAD.

16.
Thromb Haemost ; 119(9): 1539-1545, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31226721

RESUMO

Despite dual antiplatelet therapy patients undergoing percutaneous coronary intervention (PCI) continue to experience periprocedural ischemic events. In addition, all currently used antithrombotic drugs increase the bleeding risk. Thus, there is an unmet clinical need for antithrombotic strategies with improved efficacy and no increase in bleeding. Revacept is a novel, lesion-directed antithrombotic drug that does not interfere with the function of circulating platelets. This dimeric fusion protein of the extracellular domain of glycoprotein VI (the major platelet collagen receptor) and the human Fc-fragment inhibits collagen-mediated platelet adhesion and subsequent aggregation at the site of vascular injury. The randomized, double-blinded, phase II ISAR-PLASTER trial is based on extensive preclinical evaluation of Revacept and a favorable first-in-man trial. A total of 332 patients with stable coronary artery disease undergoing elective PCI will be randomized to either Revacept 160 mg, Revacept 80 mg, or placebo administered as single intravenous infusion directly before the intervention, on top of standard dual antiplatelet therapy and either heparin or bivalirudin, based on local practice and current guidelines. The primary endpoint is the composite of death or myocardial injury (defined as increase in high sensitivity troponin T ≥ 5 times the upper limit of normal) at 48 hours. The safety endpoint is bleeding of class 2 or higher according to the Bleeding Academic Research Consortium at 30 days. This phase II randomized, double blind trial will assess for the first time the efficacy and safety of Revacept-a lesion-directed inhibitor of platelet adhesion-in patients undergoing elective PCI.

17.
Clin Res Cardiol ; 2019 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-31049679

RESUMO

AIMS: To evaluate 1-year outcome after transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (S3) prosthesis with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety" proposed by the updated Valve Academic Research Consortium (VARC-2). METHODS AND RESULTS: Four hundred and two consecutive patients undergoing transfemoral TAVI with the S3 were enrolled. Mean age was 81 ± 6 years, 43% were female and median logistic EuroSCORE I was 12% [8-19]. Device success was achieved in 93% (374/402) with moderate or severe paravalvular leakage (PVL) in 2%. At 1 year all-cause mortality was 8.9% [95% CI 6.4-12.2] and new permanent pacemaker implantation rate was 16% [95% CI 12.7-20.4]. The composite endpoint time-related valve safety occurred in 29% with structural valve deterioration, defined as elevated gradients or more than moderate PVL, occurring in 13%. The clinical efficacy endpoint after 30 days was observed in 37% of patients with the main contributor symptom worsening with New York Heart Association functional class III + in 17% of cases. CONCLUSIONS: For the first time, VARC-2-defined composite endpoints at 1 year are reported and reveal a considerable proportion of patients experiencing the endpoint of time-related valve safety (29%) and clinical efficacy after 30 days (37%).

18.
Eur Heart J ; 2019 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-31145798

RESUMO

AIMS: The antiplatelet treatment strategy providing optimal balance between thrombotic and bleeding risks in patients undergoing coronary artery bypass grafting (CABG) is unclear. We prospectively compared the efficacy of ticagrelor and aspirin after CABG. METHODS AND RESULTS: We randomly assigned in double-blind fashion patients scheduled for CABG to either ticagrelor 90 mg twice daily or 100 mg aspirin (1:1) once daily. The primary outcome was the composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG. The main safety endpoint was based on the Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings. The study was prematurely halted after recruitment of 1859 out of 3850 planned patients. Twelve months after CABG, the primary endpoint occurred in 86 out of 931 patients (9.7%) in the ticagrelor group and in 73 out of 928 patients (8.2%) in the aspirin group [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group. The main safety endpoint was also not significantly different (ticagrelor 3.7% vs. aspirin 3.2%, hazard ratio 1.17, CI 0.71-1.92; P = 0.53). CONCLUSION: In this prematurely terminated and thus underpowered randomized trial of ticagrelor vs. aspirin in patients after CABG no significant differences in major cardiovascular events or major bleeding could be demonstrated. CLINICALTRIALS.GOV IDENTIFIER: NCT01755520.

19.
J Transl Med ; 17(1): 180, 2019 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-31142323

RESUMO

BACKGROUND: ST-segment elevation myocardial infarction (STEMI) displays circadian variability with the highest incidence in the morning hours. Data on whether the time-of-day at symptom onset affects infarct size or patients' long-term prognosis are conflicting. We sought to investigate the association of time-of-day at symptom onset with infarct size or long-term mortality in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI). METHODS: This study included 1206 STEMI patients undergoing PPCI. All patients underwent single photon emission computed tomography (SPECT) imaging with 99mTc-sestamibi before and 7-14 days after PPCI. The co-primary endpoints were final infarct size on day 10 after STEMI and all-cause mortality at 5-year follow-up. Time-of-day at symptom onset of STEMI was categorized in 6-h intervals. RESULTS: In patients presenting from 0 to 6 h, 6 to 12 h, 12 to 18 h, and 18 to 24 h, the infarct sizes (median [25th-75th percentiles]) were 10.0 [3.0-24.7], 10.0 [3.0-24.0], 10.0 [3.0-22.0], and 9.0 [3.0-21.0] of the left ventricle, respectively (p = 0.87); the Kaplan-Meier estimates of 5-year all-cause mortality were 13.6%, 8.7%, 13.7% and 9.3%, respectively (log-rank test p = 0.30). After adjustment, time-of-day was not associated with infarct size (p ≥ 0.76 for comparisons with infarct size from reference [6-12 h] time interval) or 5-year all-cause mortality (p ≥ 0.25 for comparisons with mortality from reference [6-12 h] time interval). Time-of-day at symptom onset of STEMI was not associated with differences in the recovery of left ventricular ejection fraction 6 months after STEMI. CONCLUSIONS: In patients with STEMI undergoing PPCI, time-of-day at symptom onset was neither associated with scintigraphic infarct size, left ventricular ejection fraction recovery at 6 months nor with 5-year mortality.

20.
Int J Cardiol ; 287: 7-12, 2019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-31003796

RESUMO

The local inflammatory response following acute myocardial infarction (AMI) is increasingly being recognized as a central factor determining infarct healing. Myocardial inflammation can be visualized in patients using fasting 18F-FDG PET/MRI. Although this novel biosignal correlates with long-term functional outcome, the corresponding cellular substrate is not well understood. Here we present a retrospective analysis of 29 patients with AMI who underwent revascularization, suggesting a connection between post infarction myocardial fasting 18F-FDG uptake, monocyte platelet aggregates (MPA), and P2Y12 inhibition. In detail, patients with high MPA percentages of CD14highCD16+ and CD14lowCD16+ monocytes had significantly higher local 18F-FDG uptake (SUVmean) in the infarcted myocardium than patients with low MPA (p < 0.05). Furthermore, there was an association of high MPA percentage in all monocyte subpopulations with deteriorating ΔLV-EF after 6 months (p < 0.01), which was confirmed in an extended analysis with additional 29 patients without PET/MRI data available. In this analysis, administration of Ticagrelor was associated with lower MPA percentage of CD14high monocyte subpopulations than Clopidogrel (p < 0.01) or Prasugrel (p < 0.05). Taken together, the findings from this analysis suggest that platelet aggregability may affect monocyte extravasation into the infarcted myocardium and influence long-term functional outcome. P2Y12 inhibition may intervene in this pathophysiologic process. Prospective studies are needed to further examine this important relationship.

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