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BACKGROUND: Rotational atherectomy (RA) is traditionally administered for patients with heavily calcified lesions and is thereby characterized by a high risk of the performed intervention. However, the prevalence characteristics of cardiac arrest are poorly studied in this group of patients. We aimed to evaluate the frequency and risk factors of cardiac arrest during percutaneous coronary interventions (PCI) performed with RA and preceding coronary angiography (CA). METHODS: Based on the data collected in the Polish Registry of Invasive Cardiology Procedures (ORPKI) from 2014 to 2021, we included 6522 patients who were treated with RA-assisted PCI. We scrutinized patient and procedural characteristics, as well as periprocedural complications, subsequently comparing groups in terms of cardiac arrest incidence with the use of univariable and multivariable analyses. RESULTS: Thirty-five (0.5%) patients suffered from cardiac arrest during RA-PCI or preceding CA. They were characterized by significantly higher rates of prior stroke, acute coronary syndromes (ACS) as indications and higher Killip class (P < 0.001) at the admission time. Among the confirmed independent predictors of in-procedure cardiac arrest, the following can be noted: factors related to patients' clinical characteristics (e.g., older age, female sex, and disease burden), periprocedural characteristics (e.g., PCI within left main coronary artery [LMCA]), and periprocedural complications (e.g., coronary artery perforation and no-reflow phenomenon). CONCLUSIONS: Severe clinical condition at baseline, expressed by ACS presence and Killip class IV, as well as RA-PCI performed within LMCA and other periprocedural complications, were the strongest predictors of cardiac arrest during RA-assisted PCI and CA.
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BACKGROUND AND AIMS: Long-term safety and efficacy of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) are unknown. MAVA-LTE (NCT03723655) is an ongoing, 5-year, open-label extension study designed to evaluate the long-term effects of mavacamten. METHODS: Participants from EXPLORER-HCM (NCT03470545) could enrol in MAVA-LTE upon study completion. RESULTS: At the latest data cut-off, 211 (91.3%) of 231 patients originally enrolled in MAVA-LTE still received mavacamten. Median (range) time on study was 166.1 (6.0-228.1) weeks; 185 (80.1%) and 99 (42.9%) patients had completed the week 156 and 180 visits, respectively. Sustained reductions from baseline to week 180 occurred in left ventricular outflow tract gradients (mean [standard deviation]: resting, -40.3 [32.7] mmHg; Valsalva, -55.3 [33.7] mmHg), NT-proBNP (median [interquartile range]: -562 [-1162.5, -209] ng/L), and EQ-5D-5L score (mean [standard deviation]: 0.09 [0.17]). Mean left ventricular ejection fraction (LVEF) decreased from 73.9% (baseline) to 66.6% (week 24) and 63.9% (week 180). At week 180, 74 (77.9%) of 95 patients improved by at least one New York Heart Association class from baseline. Over 739 patient-years exposure, 20 patients (8.7%; exposure-adjusted incidence: 2.77/100 patient-years) experienced 22 transient reductions in LVEF to <50% resulting in temporary treatment interruption (all recovered LVEF of ≥50%). Five (2.2%) patients died (all considered unrelated to mavacamten). CONCLUSIONS: Long-term mavacamten treatment resulted in sustained improvements in cardiac function and symptoms in patients with obstructive HCM, with no new safety concerns identified. Transient, reversible reductions in LVEF were observed in a small proportion of patients during long-term follow-up.
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BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. OBJECTIVES: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization. RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06). CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.
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AIMS: There is a paucity of data on the performance of angiography-derived vessel fractional flow reserve (vFFR) in coronary artery lesions of patients presenting with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). Optical coherence tomography (OCT) allows for visualization of lumen dimensions and plaque integrity with high resolution. The aim of the present study was to define the association between vFFR and OCT findings in intermediate coronary artery lesions in patients presenting with NSTE-ACS. METHODS AND RESULTS: The FAST OCT study was a prospective, multicenter, single-arm study. Patients presenting with NSTE-ACS with intermediate to severe coronary artery stenosis in one or multiple vessels with TIMI 3 flow suitable for OCT imaging were eligible. Complete pre-procedural vFFR and OCT data were available in 226 vessels (in 188 patients). A significant association between vFFR and minimal lumen area (MLA) was observed, showing an average decrease of 20.4% (95% CI -23.9% - -16.7%) in MLA per 0.10 decrease in vFFR (adjusted p<0.001). vFFR≤0.80 showed a sensitivity of 56.7% and specificity of 92.5% to detect MLA≤2.5 mm². Conversely, vFFR had a poor to moderate discriminative ability to detect plaque instability (sensitivity, 46.9% specificity 71.6%). CONCLUSIONS: In patients with NSTE-ACS, vFFR is significantly associated with OCT-detected MLA and a vFFR≤0.80 is highly predictive for the presence of significant disease based on OCT. Conversely, the sensitivity of vFFR≤0.80 to detect OCT-assessed significant disease was low, indicating that the presence of significant OCT findings cannot be ruled out based on a negative vFFR. CLINICALTRIALS.GOV ID: NCT04683133.
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Background Quantifying the fibrotic and calcific composition of the aortic valve at CT angiography (CTA) can be useful for assessing disease severity and outcomes of patients with aortic stenosis (AS); however, it has not yet been validated against quantitative histologic findings. Purpose To compare quantification of aortic valve fibrotic and calcific tissue composition at CTA versus histologic examination. Materials and Methods This prospective study included patients who underwent CTA before either surgical aortic valve replacement for AS or orthotopic heart transplant (controls) at two centers between January 2022 and April 2023. At CTA, fibrotic and calcific tissue composition were quantified using automated Gaussian mixture modeling applied to the density of aortic valve tissue components, calculated as [(volume/total tissue volume) × 100]. For histologic evaluation, explanted valve cusps were stained with Movat pentachrome as well as hematoxylin and eosin. For each cusp, three 5-µm slices were obtained. Fibrotic and calcific tissue composition were quantified using a validated artificial intelligence tool and averaged across the aortic valve. Correlations were assessed using the Spearman rank correlation coefficient. Intermodality and interobserver variability were measured using the intraclass correlation coefficient (ICC) and Bland-Altman plots. Results Twenty-nine participants (mean age, 63 years ± 10 [SD]; 23 male) were evaluated: 19 with severe AS, five with moderate AS, and five controls. Fibrocalcific tissue composition strongly correlated with histologic findings (r = 0.92; P < .001). The agreement between CTA and histologic findings for fibrocalcific tissue quantification was excellent (ICC, 0.94; P = .001), with underestimation of fibrotic composition at CTA (bias, -4.9%; 95% limits of agreement [LoA]: -18.5%, 8.7%). Finally, there was excellent interobserver repeatability for fibrotic (ICC, 0.99) and calcific (ICC, 0.99) aortic valve tissue volume measurements, with no evidence of a difference in measurements between readers (bias, -0.04 cm3 [95% LoA: -0.27 cm3, 0.19 cm3] and 0.02 cm3 [95% LoA: -0.14 cm3, 0.19 cm3], respectively). Conclusion In a direct comparison, standardized quantitative aortic valve tissue characterization at CTA showed excellent concordance with histologic findings and demonstrated interobserver reproducibility. Clinical trial registration no. NCT06136689 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Almeida in this issue.
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Estenosis de la Válvula Aórtica , Válvula Aórtica , Calcinosis , Angiografía por Tomografía Computarizada , Fibrosis , Humanos , Masculino , Estudios Prospectivos , Femenino , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/patología , Persona de Mediana Edad , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/patología , Estenosis de la Válvula Aórtica/cirugía , Calcinosis/diagnóstico por imagen , Calcinosis/patología , Fibrosis/diagnóstico por imagen , Angiografía por Tomografía Computarizada/métodos , AncianoRESUMEN
Background: Fractional flow reserve (FFR) is an established method to guide decisions on revascularization; however, in patients with diabetes mellitus (DM), FFR-negative lesions carrying an optical coherence tomography-detected thin-cap fibroatheroma (TCFA) remain at high risk for adverse cardiac events. Methods: In this prespecified subanalysis of the COMBINE OCT-FFR trial, DM patients with ≥1 FFR-negative, TCFA-positive medically treated target lesions referred to as vulnerable plaque (VP group), were compared to patients with exclusively FFR-positive target lesions who underwent complete revascularization (CR group). The primary endpoint was first and recurrent event analysis for target lesion failure and the secondary endpoint was a composite of cardiac death, target vessel myocardial infarction, target lesion revascularization, or hospitalization due to unstable angina. Results: Among 550 patients enrolled, 98 belonged to the VP group while 93 to the CR group and were followed up to 5 years. The VP group had a higher occurrence of the primary endpoint (20.4% vs 8.6%; HR, 2.22; 95% CI, 0.98-5.04; P = .06). Recurrent event analysis showed that the VP group had significantly higher rates of the primary and secondary endpoints (9.17 vs 3.76 events per 100 PY; RR, 2.44; 95% CI, 1.16-5.60; P = .01 and 13.45 vs 5.63 events per 100 PY; RR, 2.39; 95% CI, 1.30-4.62; P < .01). Conclusions: In a population with DM, medically treated nonischemic, TCFA-carrying target lesions were associated with higher risk of reoccurring adverse cardiac events compared to target lesions that underwent complete revascularization, opening the discussion about whether a focal preventive revascularization strategy could be contemplated for highly vulnerable lesions.
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BACKGROUND: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain. METHODS: We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status). RESULTS: A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%). CONCLUSIONS: Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.).
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AIMS: A paucity of studies addressed sex-related differences in clinical outcomes in the long term following acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). In these patients, it remains uncertain whether heart failure (HF) might exert a differential impact on the prognosis in the long term. METHODS: We queried a large-scale database of ACS patients undergoing PCI. The primary endpoint was new-onset HF. Secondary endpoints included mortality, myocardial infarction, re-PCI and ischaemic stroke. Propensity score matching was generated to balance group characteristics. A total of 3334 patients after propensity score matching were analysed. Follow-up was assessed at the 5 year term. RESULTS: At 5 year follow-up, HF risk increased significantly in males versus females {17.9% vs. 14.8%, hazard ratio [HR] [95% confidence interval (CI)] = 1.22 [1.03-1.44], P = 0.02}. At 5 year follow-up, mortality was significantly higher in the male cohort as compared with the female cohort [HR (95% CI) = 1.23 (1.02-1.47), P = 0.02]. On landmark analysis, differences in mortality emerged after the first year and were maintained thereafter. Ischaemic outcomes were comparable between cohorts. CONCLUSIONS: Following ACS, males experienced a greater long-term risk of developing new-onset HF as compared with females. This difference remained consistent across all prespecified subgroups. Mortality was significantly higher in males. No differences were observed in ischaemic outcomes. New-onset HF emerges as a primary contributor to long-term gender disparities after ACS and a strong predictor of mortality in men with HF.
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AIMS: To evaluate the individual as well as combined impact of OCT-detected vulnerability features (OCT-VFs) in the prediction of major adverse cardiovascular events (MACE) in non-ischemic lesions in patients with diabetes mellitus (DM). METHODS AND RESULTS: The COMBINE OCT-FFR (NCT02989740) was a prospective, double-blind, international, natural history study that included patients with DM having ≥1 lesions with a fractional flow reserve >0.80, undergoing systematic OCT assessment. Pre-specified OCT-VFs included TCFA, r-MLA, h-PB, and CP. The primary endpoint (MACE) was a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or hospitalization for unstable angina up to 5 years, analyzed according to the presence of these OCT-VFs, both individually and in combination. TCFA, r-MLA, h-PB and CP were identified in 98 (25.1%), 159 (40.8%), 56 (14.4%), and 116 (29.8%) patients, respectively. The primary endpoint rate increased progressively from 6.9% to 50.0% (HR=10.10; 95%CI, 3.37 to 30.25, p<0.001) in patients without OCT-VFs compared to those with concomitant h-PB, r-MLA, CP, and TCFA. Importantly, while TCFA, h-PB, r-MLA and CP were individually associated with the primary endpoint, the presence of two or more OCT-VFs significantly increased the likelihood of adverse events at 5 years. CONCLUSIONS: In patients with DM and non-ischemic lesions, TCFA, h-PB, r-MLA and CP were predictors of adverse events. However, the presence of two or more OCT-VFs significantly increased the likelihood of MACE at 5 years. Further studies are warranted to confirm these findings and their potential clinical implications in a randomized fashion.
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Background: Due to its high resolution, optical coherence tomography (OCT) is the most suitable modality for neointimal coverage assessments. Evaluation of stent healing seems crucial to accurately define their safety profile since delayed healing is connected with stent thrombosis. This study aimed to present an algorithm for automated quantitative analysis of stent strut coverage at the early stages of vessel healing in intravascular OCT. Methods: A set of 592 OCT frames from 24 patients one month following drug-eluting stent implantation was used to assess the algorithm's effectiveness. Struts not covered on any side or covered but only on one side were categorized as uncovered. The algorithm consists of several key steps: preprocessing, vessel lumen segmentation, automatic strut detection, and measurement of neointimal thickness. Results: The proposed algorithm proved its efficiency in lumen and stent area estimation versus manual reference. It showed a high positive predictive value (PPV) (89.7%) and true positive rate (TPR) (91.4%) in detecting struts. A qualitative assessment for covered and uncovered struts was characterized by high TPR (99.1% and 80%, respectively, for uncovered and covered struts) and PPV (77.3% and 87%). Conclusions: The proposed algorithm demonstrated good agreement with manual measurements. Automating the stent coverage assessment might facilitate imaging analysis, which might be beneficial in experimental and clinical settings.
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Background: The rate of in-stent restenosis (ISR) is decreasing; however, it is still a challenge for contemporary invasive cardiologists. Therapeutic methods, including drug-eluting balloons (DEBs), intravascular lithotripsy, excimer laser coronary atherectomy, and imaging-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES), have been implemented. Patients with diabetes mellitus (DM) are burdened with a higher risk of ISR than the general population. Aims: DM-Dragon is aimed at evaluating the clinical outcomes of ISR treatment with DEBs vs. DES, focusing on patients with co-existing diabetes mellitus. Methods: The DM-Dragon registry is a retrospective study comprising data from nine high-volume PCI centers in Poland. A total of 1117 patients, of whom 473 individuals had DM and were treated with PCI due to ISR, were included. After propensity-score matching (PSM), 198 pairs were created for further analysis. The primary outcome of the study was target lesion revascularization (TLR). Results: In DM patients after PSM, TLR occurred in 21 (10.61%) vs. 20 (10.1%) in non-diabetic patients, p = 0.8690. Rates of target vessel revascularization (TVR), target vessel myocardial infarction, device-oriented composite endpoint (DOCE), and cardiac death did not differ significantly. Among diabetic patients, the risk of all-cause mortality was significantly lower in the DEB group (2.78% vs. 11.11%, HR 3.67 (95% confidence interval, CI) [1.01-13.3), p = 0.0483). Conclusions: PCI with DEBs is almost as effective as DES implantation in DM patients treated for ISR. In DM-Dragon, the rate of all-cause death was significantly lower in patients treated with DEBs. Further large-scale, randomized clinical trials would be needed to support these findings.
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BACKGROUND: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. METHODS: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. RESULTS: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. CONCLUSIONS: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.
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Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Reestenosis Coronaria , Stents Liberadores de Fármacos , Sistema de Registros , Sirolimus , Humanos , Masculino , Femenino , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Reestenosis Coronaria/etiología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/mortalidad , Reestenosis Coronaria/terapia , Factores de Tiempo , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Factores de Riesgo , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Europa (Continente) , Infarto del Miocardio/mortalidad , Infarto del Miocardio/etiología , Catéteres Cardíacos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagenRESUMEN
Background: The literature review shows that female patients are more frequently underdiagnosed or suffer from delayed diagnosis. Recognition of sex-related differences is crucial for implementing strategies to improve cardiovascular outcomes. We aimed to assess sex-related disparities in the frequency of fractional flow reserve (FFR)-guided procedures in patients who underwent angiography and/or percutaneous coronary intervention (PCI). Methods: We have derived the data from the national registry of percutaneous coronary interventions and retrospectively analyzed the data of more than 1.4 million angiography and/or PCI procedures [1,454,121 patients (62.54% men and 37.46% women)] between 2014 and 2022. The logistic regression analysis was conducted to explore whether female sex was associated with FFR utilization. Results: The FFR was performed in 61,305 (4.22%) patients and more frequently in men than women (4.15% vs. 3.45%, p < 0.001). FFR was more frequently assessed in females with acute coronary syndrome than males (27.75% vs. 26.08%, p < 0.001); however, women with chronic coronary syndrome had FFR performed less often than men (72.25% vs. 73.92%, p < 0.001). Females with FFR-guided procedures were older than men (69.07 (±8.87) vs. 65.45 (±9.38) p < 0.001); however. less often had a history of myocardial infarction (MI) (24.79% vs. 36.73%, p < 0.001), CABG (1.62% vs. 2.55%, p < 0.005) or PCI (36.6% vs. 24.79%, p < 0.001) compared to men. Crude comparison has shown that male sex was associated with a higher frequency of FFR assessment (OR = 1.2152-1.2361, p < 0.005). Conclusions: Despite a substantial rise in FFR utilization, adoption in women remains lower than in men. Female sex was found to be an independent negative predictor of FFR use.
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AIM: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. METHODS AND RESULTS: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. CONCLUSION: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.
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Insuficiencia Cardíaca , Insuficiencia de la Válvula Mitral , Índice de Severidad de la Enfermedad , Volumen Sistólico , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/complicaciones , Femenino , Masculino , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/complicaciones , Anciano , Estudios Prospectivos , Volumen Sistólico/fisiología , Resultado del Tratamiento , Persona de Mediana Edad , Fragmentos de Péptidos/sangre , Válvula Mitral/cirugía , Péptido Natriurético Encefálico/sangre , Implantación de Prótesis de Válvulas Cardíacas/métodos , Función Ventricular Izquierda/fisiologíaRESUMEN
BACKGROUND: The long-term outcomes for patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. AIMS: We aimed to investigate the outcomes for patients with drug-eluting stents (DES)-ISR and CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES. METHODS: A total of 846 consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin (strut thickness <100 µm) strut-DES (381 [45%]) or paclitaxel-DCB (465 [55%]) for DES-ISR were enrolled between February 2008 and October 2021. The median follow-up was 1006 (IQR 426-1770) days. The primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint (DOCE: cardiac death, TLR, or target vessel myocardial infarction [TV-MI]). RESULTS: Patients who received DES, compared with those who received DCB, had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74]; P <0.001), TVR (HR, 0.56 [95% CI, 0.39-0.86]; P <0.001), and DOCE (HR, 0.63 [95% CI, 0.45-0.88]; P = 0.007). The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33-0.88]; P = 0.013), TVR (HR, 0.57 [95% CI, 0.41-0.80]; P = 0.009) and DOCE (HR, 0.65 [95% CI, 0.42-0.99]; P = 0.046) between the DES and DCB groups, respectively. CONCLUSIONS: In long-term follow-up of CCS patients undergoing PCI of ISR, the use of DES was associated with reduced rates of TLR, TVR, and DOCE compared with patients treated with DCB.
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Reestenosis Coronaria , Stents Liberadores de Fármacos , Paclitaxel , Sistema de Registros , Humanos , Masculino , Femenino , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Persona de Mediana Edad , Anciano , Reestenosis Coronaria/etiología , Resultado del Tratamiento , Intervención Coronaria Percutánea , Angioplastia Coronaria con BalónRESUMEN
BACKGROUND: Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been shown to improve the clinical outcomes of percutaneous coronary interventions (PCIs) in selected subsets of patients. AIM: The aim was to investigate whether the use of OCT or IVUS during a PCI with rotational atherectomy (RA-PCI) will increase the odds for successful revascularization, defined as thrombolysis in myocardial infarction (TIMI) 3 flow. METHODS: Data were obtained from the national registry of PCIs (ORPKI) maintained by the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The dataset includes PCIs spanning from January 2014 to December 2021. RESULTS: A total of 6522 RA-PCIs were analyzed, out of which 708 (10.9%) were guided by IVUS and 86 (1.3%) by OCT. The postprocedural TIMI 3 flow was achieved significantly more often in RA-PCIs guided by intravascular imaging (98.7% vs. 96.6%, p < 0.0001). Multivariable analysis revealed that using IVUS and OCT was independently associated with an increased chance of achieving postprocedural TIMI 3 flow by 67% (odds ratio (OR), 1.67; 95% confidence interval (CI): 1.40-1.99; p < 0.0001) and 66% (OR, 1.66; 95% CI: 1.09-2.54; p = 0.02), respectively. Other factors associated with successful revascularization were as follows: previous PCI (OR, 1.72; p < 0.0001) and coronary artery bypass grafting (OR, 1.09; p = 0.002), hypertension (OR, 1.14; p < 0.0001), fractional flow reserve assessment during angiogram (OR, 1.47; p < 0.0001), bifurcation PCI (OR, 3.06; p < 0.0001), and stent implantation (OR, 19.6, p < 0.0001). CONCLUSIONS: PCIs with rotational atherectomy guided by intravascular imaging modalities (IVUS or OCT) are associated with a higher procedural success rate compared to angio-guided procedures.
RESUMEN
BACKGROUND: Thin-cap fibroatheroma (TCFA) lesions are associated with a high risk of future major adverse cardiovascular events. However, the impact of other optical coherence tomography-detected vulnerability features (OCT-VFs) and their interplay with TCFA in predicting adverse events remains unknown. AIMS: We aimed to evaluate the individual as well as the combined prognostic impact of OCT-VFs in predicting the incidence of the lesion-oriented composite endpoint (LOCE) in non-ischaemic lesions in patients with diabetes mellitus (DM). METHODS: COMBINE OCT-FFR (ClinicalTrials.gov: NCT02989740) was a prospective, double-blind, international, natural history study that included DM patients with ≥1 non-culprit lesions with a fractional flow reserve>0.80 undergoing systematic OCT assessment. OCT-VFs included the following: TCFA, reduced minimal lumen area (r-MLA), healed plaque (HP), and complicated plaque (CP). The primary endpoint, LOCE - a composite of cardiac mortality, target vessel myocardial infarction, or clinically driven target lesion revascularisation up to 5 years - was analysed according to the presence of these OCT-VFs, both individually and in combination. RESULTS: TCFA, r-MLA, HP and CP were identified in 98 (25.3%), 190 (49.0%), 87 (22.4%), and 116 (29.9%) patients, respectively. The primary endpoint rate increased progressively from 6.3% to 55.6% (hazard ratio 15.2, 95% confidence interval: 4.53-51.0; p<0.001) in patients without OCT-VFs as compared to patients with concomitant HP, r-MLA, CP, and TCFA. The coexistence of TCFA with other OCT-VFs resulted in an increased risk of the LOCE at 5 years. CONCLUSIONS: In DM patients with non-ischaemic lesions, TCFA was the strongest predictor of future LOCE events. However, lesions that present additional OCT-VFs are associated with a higher risk of adverse events than OCT-detected TCFA alone. Further randomised studies are warranted to confirm these findings and their potential clinical implications.
Asunto(s)
Enfermedad de la Arteria Coronaria , Placa Aterosclerótica , Tomografía de Coherencia Óptica , Humanos , Tomografía de Coherencia Óptica/métodos , Placa Aterosclerótica/diagnóstico por imagen , Femenino , Masculino , Persona de Mediana Edad , Anciano , Estudios Prospectivos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/terapia , Diabetes Mellitus/epidemiología , Método Doble Ciego , Reserva del Flujo Fraccional Miocárdico , Intervención Coronaria Percutánea/efectos adversos , Factores de Riesgo , Pronóstico , Vasos Coronarios/diagnóstico por imagenRESUMEN
Opinions on the effects of osteoprotegerin (OPG) have evolved over the years from a protein protecting the vasculature from calcification to a cardiovascular risk factor contributing to inflammation within the vascular wall. Nowadays, the link between OPG and angiotensin II (Ang II) appears to be particularly important. In this study, the endothelial function was investigated in OPG-knockout mice (B6.129.S4-OPG, OPG-) and wild-type (C57BL/6J, OPG+) mice under basic conditions and after Ang II exposure by assessing the endothelium-dependent diastolic response of aortic rings to acetylcholine in vitro. A further aim of the study was to compare the effect of Ang II on the expression of cytokines in the aortic wall of both groups of mice. Our study shows that rings from OPG- mice had their normal endothelial function preserved after incubation with Ang II, whereas those from OPG+ mice showed significant endothelial dysfunction. We conclude that the absence of OPG, although associated with a pro-inflammatory cytokine profile in the vascular wall, simultaneously protects against Ang II-induced increases in pro-inflammatory cytokines in the murine vascular wall. Our study also demonstrates that the absence of OPG can result in a decrease in the concentration of pro-inflammatory cytokines in the vascular wall after Ang II exposure. The presence of OPG is therefore crucial for the development of Ang II-induced inflammation in the vascular wall and for the development of Ang II-induced endothelial dysfunction.