RESUMEN
Background and Objectives: Patients with atrial fibrillation and coronary artery disease represent a group with a greater risk of mortality. To evaluate patients with atrial fibrillation (AF) and a significant coronary bifurcation lesion and compare the clinical outcomes between the patients on anticoagulant treatment with Vitamin K antagonist (VKA) and those on direct anticoagulant (DOAC). Materials and Methods: This is a prospective study of patients with AF and stable coronary artery disease, who had evidence of a significant coronary bifurcation lesion. A log-rank test was used to assess the difference in mortality between patients taking VKA and those on DOAC. The primary endpoint was the incidence of all-cause and cardiovascular death at mid-term. Results: A total of 226 patients with AF and a significant bifurcation lesion were included. The mean age was 70.9 ± 9.2, and 70% were males. Of the patients, 123 (54.7%) were on VKA treatment, and 103 (45.3%) were taking DOAC. For a median follow-up time of 55 (39-96) months, overall mortality was 40%, whereas CV mortality was 31%. Both all-cause (28.2% versus 50.4%, p = 0.020) and CV death (12.7% versus 24.9%, p = 0.032) were significantly lower in patients taking DOAC versus those on VKA. In patients treated with PCI, CV mortality was significantly lower in patients taking DOAC (21.4% versus 40.5%, p = 0.032). VKA therapy was an independent predictor of cardiovascular death (HR 1.88; 95% CI 1.11-3.18; p = 0.01), together with chronic kidney disease (HR 1.81; 95% CI 1.13-2.92; p = 0.01). Conclusions: Treatment with DOAC in patients with atrial fibrillation and coronary bifurcation lesion was associated with significantly lower mortality independently of the treatment approach. VKA was an independent predictor of CV mortality.
Asunto(s)
Anticoagulantes , Fibrilación Atrial , Enfermedad de la Arteria Coronaria , Sistema de Registros , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Masculino , Femenino , Anciano , Anticoagulantes/uso terapéutico , Estudios Prospectivos , Sistema de Registros/estadística & datos numéricos , Persona de Mediana Edad , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/complicaciones , Bulgaria/epidemiología , Vitamina K/antagonistas & inhibidores , Resultado del TratamientoRESUMEN
Percutaneous coronary interventions(PCI) are the cornerstone of treatment in patients with coronary artery disease, generating substantial costs for the healthcare system. Considerable improvement in PCI technique, stent technology and antiplatelet therapy led to a complication rate of <5%, a success rate of >95% and lack of routine cardiothoracic surgical support. Thereby, the concept of same-day discharge following PCI has been proposed due to comparable efficacy, safety, and socioeconomic benefits to inpatient PCI. Although single-vessel disease was the primary indication for outpatient (OP) PCI, more complex scenarios such as multivessel disease, left main disease and chronic total occlusions were shown to be feasible and safe in OP setting as well. Currently available data shows that OP PCI leads to cost optimization, increased PCI center capacity, decrease in nosocomial infections rate and increased patient satisfaction, along with good clinical outcomes. Although OP PCI seems promising in a subset of well-prepared and compliant patients without severe comorbidities, there are some challenges to overcome before its routine implementation. To prevent unnecessary hospitalizations and unsafe same-day discharges, interventional cardiology teams should be trained to perform reliable risk-benefit assessments. Standardized forms should be created to obtain informed consent and instruct OP PCI patients and their relatives about postprocedural management. Here, we summarize the available data on OP and inpatient PCI outcomes, discuss the opportunities and challenges of OP PCI and propose a periprocedural patient management checklist, with the goal of facilitating OP PCI implementation in interventional cardiology centers.
RESUMEN
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.
RESUMEN
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.
Asunto(s)
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
According to the latest guidelines of European and American medical societies, genetic testing (GT) is essential in cardiovascular diseases for establishing diagnosis, predicting prognosis, enabling initiation of disease-modifying therapy, and preventing sudden cardiac death. The GT result may be relevant for cascade GT in the patient's relatives, for planning his/her profession and physical activity, and for procreative counseling. This position statement has been prepared due to the scarcity of GT in cardiovascular diseases in Poland and the need to expand its availability. We give a concise description of the genetic background of cardiomyopathies, channelopathies, aortopathies, familial hypercholesterolemia, pheochromocytomas, and paragangliomas. The article discusses various aspects of GT in specific populations, such as children or athletes, and also presents prenatal genetic diagnostics. We propose recommendations for GT and counselling, which take into account Polish needs and capabilities. We give an outline of legal regulations, good clinical practice in GT with respect for patient rights, the role of cardiologists and clinical geneticists in GT planning and post-test counseling, and the requirements for laboratories performing genetic tests. The Polish Cardiac Society and Polish Society of Human Genetics experts speak with one voice with cardiovascular patient communities to underline the need for a law on GT and increasing the availability of GT for cardiovascular patients.
Asunto(s)
Enfermedades Cardiovasculares , Pruebas Genéticas , Sociedades Médicas , Humanos , Polonia , Enfermedades Cardiovasculares/genética , Enfermedades Cardiovasculares/diagnóstico , Cardiología/normas , Asesoramiento Genético , FemeninoRESUMEN
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.
RESUMEN
OBJECTIVES: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018. BACKGROUND: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes. METHODS: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality. RESULTS: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]). CONCLUSION: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.
RESUMEN
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.
Asunto(s)
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
We characterized the performance, as well as the safety, of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), implanted in patients with type 2 diabetes (DM) with a 4-year follow-up. We defined the primary endpoint as the 48-month rate of major cardiovascular adverse events (MACE), including cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were all-cause death, cardiac death, MI, and TLR rates at 12, 24, 36, and 48 months. We enrolled 232 patients in whom 282 stents were implanted, including 97 DM and 135 non-DM patients. The mean age of the DM patients was 69.5 ± 10.1 years and females accounted for 30% of the patients. DM patients had higher rates of arterial hypertension (97% vs. 88%, p = 0.016), dyslipidemia (86% vs. 70%, p = 0.005), prior MI (61% vs. 40%, p = 0.002), prior PCI (65% vs. 50%, p = 0.020), and prior CABG (14% vs. 5.9%, p = 0.029). We recorded statistically significant differences for MACE (HR 1.85, 95% CI 1.01-3.41, p = 0.046), cardiac death (HR 4.46, 95% CI 1.44-13.8, p = 0.010), and MI (HR 3.17, 95% CI 1.10-9.12, p = 0.033), but not for TLR, between DM and non-DM patients in terms of the analyzed endpoints at 4 years. Our study showed that Alex Plus was efficient and safe in a contemporary cohort of real-world DM patients undergoing percutaneous revascularization.
RESUMEN
This multicenter, randomized study aimed to compare the sirolimus-eluting BiOSS LIM C dedicated coronary bifurcation stent with second-generation -limus drug-eluting stents (rDESs) in the treatment of non-left main (non-LM) coronary bifurcation. The deployment of a single stent in the main vessel-main branch across a side branch was the default strategy in all patients. The primary endpoint was the rate of major cardiovascular events (cardiac death, myocardial infarction, and target lesion revascularization) at 48 months. We enrolled 230 patients, allocating 116 patients to the BiOSS LIM C group and 114 patients to the rDES group. Most procedures were elective (BiOSS vs. rDES: 48.3% vs. 59.6%, p = 0.09) and performed in bifurcations within the left anterior descending/diagonal branch (BiOSS vs. rDES: 51.7% vs. 61.4%, p = 0.15). At 48 months, there were no statistically significant differences between the BiOSS and rDES groups in terms of major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) as follows: MACEs-18.1% vs. 14.9%, HR 1.36, 95% CI 0.62-2.22, and p = 0.33; cardiac death-4.3% vs. 3.5%, HR 1.23, 95% CI 0.33-4.56, and p = 0.75; MI-2.6% vs. 3.5%, HR 0.73, 95% CI 0.17-3.23, and p = 0.68; and TLR-11.2% vs. 7.9%, HR 1.66, 95% CI 0.75-3.71, and p = 0.21. The implantation success rate of the BiOSS LIM C stent was very high, and the cumulative MACE rates were promising. The POLBOS 3 trial sets an important benchmark for treating non-LM coronary bifurcations (ClinicalTrials.gov NCT03548272).
RESUMEN
According to the latest guidelines of European and American medical societies, genetic testing (GT) is essential in cardiovascular diseases for establishing diagnosis, predicting prognosis, enabling initiation of disease-modifying therapy, and preventing sudden cardiac death. The GT result may be relevant for cascade GT in the patient's relatives, for planning his/her profession and physical activity, and for procreative counseling. This position statement has been prepared due to the scarcity of GT in cardiovascular diseases in Poland and the need to expand its availability. We give a concise description of the genetic background of cardiomyopathies, channelopathies, aortopathies, familial hypercholesterolemia, pheochromocytomas, and paragangliomas. The article discusses various aspects of GT in specific populations, such as children or athletes, and also presents prenatal genetic diagnostics. We propose recommendations for GT and counselling, which take into account Polish needs and capabilities. We give an outline of legal regulations, good clinical practice in GT with respect for patient rights, the role of cardiologists and clinical geneticists in GT planning and post-test counseling, and the requirements for laboratories performing genetic tests. The Polish Cardiac Society and Polish Society of Human Genetics experts speak with one voice with cardiovascular patient communities to underline the need for a law on GT and increasing the availability of GT for cardiovascular patients.
Asunto(s)
Enfermedades Cardiovasculares , Pruebas Genéticas , Sociedades Médicas , Humanos , Polonia , Enfermedades Cardiovasculares/genética , Enfermedades Cardiovasculares/diagnóstico , Cardiología/normas , Asesoramiento Genético , FemeninoRESUMEN
BACKGROUND: Side branch predilatation (SBPD) during coronary bifurcation interventions is a technique that is not recommended by the latest guidelines. However, the data about the clinical outcomes after SBPD are surprisingly few. AIMS: The current study aimed to explore the association between SBPD and mortality in long-term follow-up. METHODS: All patients with coronary bifurcation stenoses revascularized with percutaneous coronary intervention were included in a prospective registry. Patients with stable angina and a bifurcation lesion with ≥50% diameter stenosis were included in the current analysis. Patients were assigned to two groups - those with SBPD(+) and those without SBPD(-). Propensity score matching was performed to equalize the risk factors and severity of coronary artery disease between the groups. A Kaplan-Meier analysis with a log-rank test for between-group differences was also performed. RESULTS: From January 2013 to June 2021, 813 patients were included in the final study population. The mean age was 67 (10) years. After propensity score matching, 648 patients remained for analysis - 324 in each group. At a median follow-up of 57 months patients in the SBPD(+) group had a higher all-cause mortality (n = 107 (33%) vs. n = 98 [30.2%]; P = 0.045) and cardiovascular mortality (n = 82 [25.3%] vs. n = 70 [21.6%]; P = 0.03) when compared with SBPD(-) patients. SBPD was independently associated with all-cause and cardiovascular mortality. CONCLUSION: SBPD treatment of coronary bifurcation stenoses is associated with worse patient survival in the follow-up of up to 8 years. SBPD treatment gives better angiographic results, but this did not translate into better clinical outcomes.
Asunto(s)
Intervención Coronaria Percutánea , Humanos , Masculino , Femenino , Anciano , Persona de Mediana Edad , Estenosis Coronaria/cirugía , Estenosis Coronaria/terapia , Estenosis Coronaria/mortalidad , Estenosis Coronaria/diagnóstico por imagen , Sistema de Registros , Resultado del Tratamiento , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/terapia , Estudios Prospectivos , Estudios de SeguimientoAsunto(s)
Ablación por Catéter , Cicatriz , Atrios Cardíacos , Humanos , Proyectos Piloto , Femenino , Masculino , Atrios Cardíacos/diagnóstico por imagen , Atrios Cardíacos/patología , Persona de Mediana Edad , Cicatriz/etiología , Neoplasias/cirugía , Neoplasias/complicaciones , Anciano , Arritmias Cardíacas/etiología , Fibrilación Atrial/cirugíaRESUMEN
BACKGROUND: Notwithstanding readily available revascularization, significant advancements in mechanical circulatory support, and pharmacological progress, cardiogenic shock (CS) secondary to unprotected left main culprit lesion-related acute myocardial infarction (ULMCL-related AMI) is associated with very high mortality. In this population, chronic total occlusion (CTO) is relatively frequent. AIMS: This study sought to assess the association between the presence of CTO and 12-month mortality in patients with CS due to ULMCL-related AMI. RESULTS: The study included consecutive patients admitted for AMI-related CS with ULMCL who underwent percutaneous coronary intervention (PCI) and were enrolled in the prospective Polish Registry of Acute Coronary Syndromes (PL-ACS) between January 2017 and December 2021. The patients were stratified into two groups based on the presence of at least one CTO. The primary endpoint was all-cause death at 12 months. Of the 250 included patients, 60 (24%) patients had one or more CTOs of a major coronary artery (+CTO), and in 190 (76%) patients, the presence of CTO was not observed (-CTO). The 12-month mortality rates for the +CTO and -CTO patients were 85% and 69.8%, respectively (P log-rank = 0.03). After multivariable adjustment for differences in the baseline characteristics, the presence of CTO remained significantly associated with higher 12-month mortality (hazard ratio, 1.423; 95% CI, 1.027-1.973; P = 0.034). CONCLUSIONS: Our analysis showed that in patients with CS due to ULMCL-related AMI treated with PCI, the presence of CTO is associated with worse 12-month prognosis.