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 Tratamiento

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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: 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 imagen

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 Balón

Asunto(s)

Estenosis Coronaria , Humanos , Estenosis Coronaria/cirugía , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/terapia , Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria/terapia

RESUMEN

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

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 Seguimiento

Asunto(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/cirugía

RESUMEN

We characterized the performance as well as safety of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), deployed in the acute coronary syndrome (ACS) setting. We enrolled patients who were subjected to percutaneous coronary intervention (PCI) between July 2015 and March 2016 and took into consideration demographics, clinical and laboratory data, and clinical outcomes. 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 88 ACS and 144 chronic coronary syndrome (CCS) patients. The mean age of the ACS population was 67 ± 13 years old, and 32% of it consisted of females. Patients with ACS were characterized by lower rates of arterial hypertension (85.2% vs. 95.8%, p = 0.004), dyslipidemia (67% vs. 81.9%, p = 0.01), prior MI (34.1% vs. 57.6%, p < 0.001), and prior PCI (35.2% vs. 68.8%, p < 0.001). At 48 months, among the ACS patients, the rates of MACE, death, cardiac death, MI, and TLR were 23.9%, 11.4%, 7.9%, 9.1%, and 10.2%, respectively. No stent thrombosis cases were reported. Multivariable Cox regression revealed that the statistically significant MACE predictors were massive calcifications in coronary arteries (HR 9.0, 95% CI 1.75-46.3, p = 0.009), post-dilatation (HR 3.78, 95% CI 1.28-11.2, p = 0.016), prior CABG (HR 6.64, 95% CI 1.62-27.1, p = 0.008), vitamin K antagonist use (HR 5.99, 95% CI 1.29-27.8, p = 0.022), and rivaroxaban use (HR 51.7, 95% CI 4.48-596, p = 0.002). The study findings show that Alex Plus was effective and safe in a contemporary cohort of real-world ACS patients undergoing primary PCI. The outcomes were comparable between the ACS and chronic coronary syndrome patients, with a trend of lower TLR in ACS patients at 4 years.

RESUMEN

We aimed to characterize the performance and safety of percutaneous coronary intervention (PCI) in complex, high-risk indicated procedure (CHIP) and high-bleeding-risk (HBR) patients at a 4-year follow up. We included all consecutive patients who underwent PCI with the sirolimus-eluting coronary stent Alex Plus (Balton, Poland) between July 2015 and March 2016. We analyzed various baseline demographic and clinical characteristics, laboratory data, and clinical outcomes. We enrolled 232 patients in whom 282 stents were implanted, including 81 patients meeting the CHIP criteria and 76 patients meeting the HBR criteria. In the whole population, the mean age was 68 ± 11 years, and 23.7% were females. Most procedures were performed from radial access (83.2%) using a 6F guiding catheter (95.7%). The lesions were mostly predilated (61.6%), and postdilatation was performed in 37.9%. The device success was 99.6% (in one case, a second stent was required due to heavy calcifications). Additional stents were deployed in 39% of cases due to edge dissection (6.9%), side branch stenting (5.2%), or diffuse disease (26.9%). Myocardial infarction (MI) type 4a was revealed in 2.2% of cases. At 4 years, the MACE rates for the whole population and for CHIP and HBR patients were 23.3%, 29.6%, and 27.6%, respectively. CHIP patients had a higher risk of MACEs (29.6% vs. 19.9%, HR 1.69, p = 0.032) and cardiac death (11.1% vs. 4.6%, HR 2.50, p = 0.048). There were no differences for MI (7.4% vs. 6.6%, p = 0.826) and TLR (18.5% vs. 12.6%, p = 0.150). HBR patients were also characterized by a higher risk of MACEs (27.6% vs. 21.2%, HR 1.84, p = 0.049) and cardiac death (17.1% vs. 1.9%, HR 9.61, p < 0.001). There were no differences for MI (7.9% vs. 6.4%, p = 0.669) and TLR (11.8% vs. 16.0%, p = 0.991). PCI in CHIP and HBR patients is feasible with a low rate of periprocedural complications. Nevertheless, CHIP and HBR patients are at a high risk of future adverse events and require strict surveillance to improve outcomes.

RESUMEN

The long-term outcomes of patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) are still not well known. This study aimed to compare the characteristics and outcomes between MINOCA and STEMI patients in a 5-year follow-up. Between 2010 and 2015 we identified 3171 coronary angiography procedures performed due to acute coronary syndrome, from which 153 had a working MINOCA diagnosis, and the final diagnosis of MINOCA was ascribed to 112 (5.8%) patients. Additionally, we matched 166 patients with STEMI and obstructive coronary arteries as the reference group. In MINOCA patients (mean age of 63 years), there were more females (60% vs. 26%, p < 0.001), and patients presented most frequently with NSTEMI (83.9%). Patients with MINOCA had more frequent atrial fibrillation (22% vs. 5.4%, p < 0.001) and higher left ventricular ejection fraction (59 ± 10% vs. 54 ± 10%, p < 0.001) compared to STEMI patients. We observed only a trend for a higher rate of MACE in STEMI patients at 5 years (11.6% vs. 18.7%, HR 1.82, 95% CI 0.91-3.63, p = 0.09). In multivariable Cox regression, only beta-blocker use was a protective factor (a trend observed), with HR 0.33, 95% CI 0.10-1.15, p = 0.082 of future MACE. The outcomes of MINOCA and STEMI patients were comparable in the 5-year follow-up.

RESUMEN

Introduction: Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-in-man registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods: In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results: The study population consisted of 95 patients (mean age: 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in 4 (4.2%) cases. At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions: Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.

RESUMEN

INTRODUCTION: SARS­CoV­2 infection is associated with an increased risk of thromboembolic complications. Thromboembolism is one of the possible causes of myocardial infarction with nonobstructive coronary arteries (MINOCA). OBJECTIVES: We aimed to compare the characteristics and 12­month clinical outcomes of patients with MINOCA treated before and during the COVID­19 pandemic. PATIENTS AND METHODS: We retrospectively analyzed data of 51 734 patients with acute myocardial infarction registered in the nationwide Polish Registry of Acute Coronary Syndromes database in 2019 and 2020. The final study group included 3178 patients with MINOCA. We compared the baseline characteristics, management strategies, and 12­month clinical outcomes of the MINOCA patients treated before (2019) and during the COVID­19 pandemic (2020). RESULTS: The rate of MINOCA was higher in 2019 than in 2020 (6.3% vs 5.9%; P = 0.03). The only difference between the groups was a higher hypercholesterolemia rate before the pandemic (33.9% vs 28.2%; P <0.001). In­hospital stroke was observed more frequently during the pandemic (0% vs 0.3%; P = 0.01), whereas other in­hospital complications were similar between the groups. Most patients were discharged on aspirin (85.6%), a ß­blocker (73.1%), an angiotensin­converting enzyme inhibitor / angiotensin receptor blocker (70.2%), and a statin (62.7%), but only 50.6% of the participants received a P2Y12 inhibitor. There was no difference in 12­month all­cause mortality between the patients with MINOCA treated before and during the pandemic (9.2% vs 11%; P = 0.09). CONCLUSIONS: We observed a lower percentage of MINOCA cases and higher in­hospital stroke rates in the MINOCA patients treated during the COVID­19 pandemic (2020). The possible association between worse clinical outcomes of the MINOCA patients treated during the pandemic and the increased risk for thromboembolic complications of SARS­CoV­2 infection needs further evaluation.

Asunto(s)

COVID-19 , Infarto del Miocardio , Accidente Cerebrovascular , Humanos , MINOCA , Pandemias , Estudios Retrospectivos , Angiografía Coronaria , COVID-19/complicaciones , SARS-CoV-2 , Infarto del Miocardio/epidemiología

RESUMEN

BACKGROUND: Optimal duration of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. METHODS: We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of major adverse cardiac and cardiovascular events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as Bleeding Academic Research Consortium (BARC) ≥3 were evaluated too. RESULTS: Patients were divided into 3 groups: short DAPT (<6-months, N.=375); standard DAPT (≥6-months but ≤12-months, N.=636); prolonged DAPT (>12-months, N.=1273). At 24 months follow-up MACCE-free survival was significantly lower in short DAPT patients (Log-Rank: 45.23, P for trend <0.001). MACCE occurred less frequently in the prolonged DAPT group (148 [11.6%]) as compared with both the short (83 [22.1%] HR: 0.48 [0.37-0.63], P<0.001) and standard DAPT groups (137 [21.5%] HR:0.51 [0.41-0.65], P<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 [0.20-0.36] and HR: 0.44 [0.34-0.57]). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC≥3 bleedings were 0.3% in the standard DAPT, 1.6% in short and 1.9% in prolonged DAPT groups. CONCLUSIONS: In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.

Asunto(s)

Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Intervención Coronaria Percutánea/efectos adversos , Constricción Patológica , Resultado del Tratamiento , Hemorragia/inducido químicamente , Hemorragia/tratamiento farmacológico , Sistema de Registros , Quimioterapia Combinada

RESUMEN

BACKGROUND: Percutaneous coronary interventions (PCI) of bifurcation lesions poses a technical challenge with a high complication rate. Kissing balloon inflation (KBI) and proximal optimization technique (POT) are used to correct bifurcation carina after stenting. However, both may still lead to uncomplete strut apposition to the side branch (SB) lateral wall. Proposed herein, is a new stent-optimization technique following bifurcation stenting consisting of a combination of POT and KBI called proximal optimization with kissing balloon inflation (POKI). METHODS: Bench and in-vivo evaluations were performed. For the bench visualization bifurcated silicone mock vessel was used. The POKI technique was simulated using a 3.5 mm POT balloon. For the in-vivo evaluation patients with angiographic bifurcation lesions in a native coronary artery with diameter ≥ 2.5 mm and ≤ 4.5 mm, SB diameter ≥ 2.0 mm, and percentage diameter stenosis (%DS) more than 50% in the main vessel (MV) were included. Provisional stenting was the default strategy. RESULTS: In total 41 vessels were evaluated. The target vessel was left main in 9 (22.0%) patients, left anterior descending artery - in 26 (63.4%), left circumflex artery - in 4 (9.8%) and right coronary artery - in 2 (4.9%). The predominant type of bifurcation was Medina 1-1-1 (61.8%). Baseline proximal MV DS% was 60.0 ± 23.7%, distal MV DS% - 58.8 ± 28.9% and SB DS% 53.0 ± 32.0%. The application of POKI was feasible in 41 (100%) of the vessels. Post-PCI residual DS at proximal MV was 11.5 ± 15.4%, distal MV - 6.6 ± 9.3%, and SB - 22.9 ± 28.5%. Both procedural and angiographic success was 100%. CONCLUSIONS: POKI is a novel stent-optimization technique for bifurcation lesions. It showed excellent feasibility and success rate both in bench and in-vivo evaluation.

Asunto(s)

Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Angioplastia Coronaria con Balón/métodos , Intervención Coronaria Percutánea/métodos , Angiografía Coronaria/métodos , Resultado del Tratamiento , Stents , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía

RESUMEN

Introduction: Data regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous. Aim: To evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES. Material and methods: Overall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs. > 3 and ≤ 6 vs. > 6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes. Results: Pairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs. > 6 months) before PSM revealed superiority of DES + DAPT > 6 months vs. DEB + DAPT > 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Also, DES + DAPT ≤ 6 months was found to be superior compared to DEB + DAPT ≤ 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Kaplan-Meier estimate analysis confirmed that DAPT > 6 months is related to a higher stroke rate (p = 0.01) when compared to ≤ 6 months. Conclusions: Treatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT > 6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.