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1.
Cardiol J ; 2024 Sep 03.
Artículo en Inglés | MEDLINE | ID: mdl-39225322

RESUMEN

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.

2.
Artículo en Inglés | MEDLINE | ID: mdl-39279142

RESUMEN

BACKGROUND: The role of intra-coronary imaging in patients with stent failure undergoing intravascular lithotripsy (IVL) is unclear. We aimed to assess clinical outcomes in patients undergoing IVL treatment for stent failure stratified according to the use of intra-coronary imaging and lesion complexity. METHODS: This is a pre-specified subgroup analysis of patients who were included in the coronary intravascular lithotripsy in patients with stent failure (COIL) registry (international multi-centre study assessing IVL treatment for stent failure in 6 European centres). A complex lesion was defined if IVL treatment was used in the left main, true bifurcation, long lesion, or coupled with athero-ablative therapy. The primary endpoint was the composite of cardiac death, spontaneous myocardial infarction, or target vessel revascularization (TVR) at 12 months. RESULTS: There were 102 patients analyzed, of whom 27 (26%) patients had complex anatomy. The use of intra-coronary imaging following IVL in stent failure was more frequent in patients with complex versus Noncomplex anatomy (56% vs. 31%, p = 0.022). IVL treatment was effective in both groups, however, patients with complex anatomy had worse clinical outcomes (30% vs. 11%, p = 0.02), driven by a higher rate of TVR (26% vs. 8%, p = 0.017). In the complex group, patients who underwent intracoronary imaging post intervention had lower event rate compared to those without imaging (13% vs. 50%, p = 0.038). CONCLUSIONS: In patients undergoing IVL treatment for stent failure with complex coronary anatomy, the use of intra-coronary imaging was associated with fewer adverse events compared to angiography guided intervention.

3.
Cardiol J ; 2024 Aug 07.
Artículo en Inglés | MEDLINE | ID: mdl-39110126

RESUMEN

BACKGROUND: The coexistence of mitral regurgitation (MR) and severe aortic stenosis (AS) has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Herein, the aim was to assess the etiology and degree of MR in an unselected TAVI population and investigate the impact of MR reduction at mid-term follow-up. METHODS: Patients subjected to TAVI as a treatment for severe AS in a single center were retrospectively analyzed. The primary endpoint was the MR reduction after TAVI. The secondary endpoint was all-cause mortality and heart failure hospitalization at a 3-year follow-up. RESULTS: Patients undergoing TAVI (n = 283) in the years 2017-2019 were screened for the presence of hemodynamically significant MR. Sixty-nine subjects (24.4%) with severe (16, 23.2%) and moderate (53, 76.8%) MR were included. The primary MR was predominant (39 subjects, 56.5%). The median age of the patients was 82 years. MR improved in 25 patients (36.2%, p < 0.001). Baseline severe MR was more prone to reduce (8 subjects, 50%) than moderate (17 subjects, 32.1%, p = 0.04). The primary MR improved in 14 patients (35.9%), while secondary in 11 patients (36.7%, p = 1). Patients showing MR reduction had lower mortality (8 vs. 29.55%, p = 0.047) and were less frequently hospitalized (20 vs. 45.45%, p = 0.03) at 3-year follow-up. CONCLUSIONS: Hemodynamically significant MR improves after TAVI regardless of its etiology. Moreover, MR reduction after TAVI is associated with better clinical outcomes.

4.
Eur J Cardiothorac Surg ; 66(2)2024 Aug 02.
Artículo en Inglés | MEDLINE | ID: mdl-39142801

RESUMEN

Myocardial revascularization in coronary artery disease via percutaneous coronary intervention or coronary artery bypass graft (CABG) surgery effectively relieves symptoms, significantly improves prognosis and quality of life when combined with guideline-directed medical therapy. Hybrid coronary revascularization is a promising alternative to percutaneous coronary intervention or CABG in selected patients and is defined as a planned and/or intended combination of consecutive CABG surgery using at least 1 internal mammary artery to the left anterior descending (LAD), and catheter-based coronary intervention to the non-LAD vessels for the treatment of multivessel disease. The main indications for hybrid coronary revascularization are (i) to achieve complete revascularization in patients who cannot undergo conventional CABG, (ii) to treat patients with acute coronary syndromes and multivessel disease with a non-LAD vessel as the culprit lesion that needs revascularization and (iii) in highly select patients with multivessel disease with complex LAD lesions and simple percutaneous coronary intervention targets for all other vessels. Hybrid coronary revascularization patients receive a left internal mammary artery graft to the LAD artery through a minimal incision along with percutaneous coronary intervention to the remaining diseased coronary vessels using latest generation drug-eluting stents. A collaborative environment with a dedicated heart team is the optimal platform to perform such interventions, which aim to improve the quality and outcome of myocardial revascularization. This position paper analyses the rationale of hybrid coronary revascularization and the currently available evidence on the various techniques and delves into the sequence of the interventions and pharmacological management during and after the procedure.


Asunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/cirugía , Puente de Arteria Coronaria/métodos , Revascularización Miocárdica/métodos , Revascularización Miocárdica/normas , Europa (Continente)
8.
J Clin Med ; 13(14)2024 Jul 10.
Artículo en Inglés | MEDLINE | ID: mdl-39064067

RESUMEN

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.

10.
Pol Arch Intern Med ; 2024 Jul 30.
Artículo en Inglés | MEDLINE | ID: mdl-39077927

RESUMEN

INTRODUCTION: Ischemia and non-obstructive coronary arteries (INOCA) remains a significant clinical issue. Recent guidelines underscore the importance of comprehensive coronary physiology assessments to make specific diagnoses and implement tailored treatment strategies. OBJECTIVES: The primary objective was to implement the comprehensive invasive diagnostics. The secondary objective was to determine the pathomechanism of INOCA in consecutive adult patients with symptomatic chronic coronary syndrome, non-invasive evidence of myocardial ischemia, and non-obstructive coronary artery disease included in the prospective MOSAIC-COR registry, and therefore, to define new INOCA subgroups. PATIENTS AND METHODS: All patients underwent comprehensive coronary physiological assessments, including resting full-cycle ratio (RFR), fractional flow reserve (FFR), index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) using a pressure wire and thermodilution method. Coronary artery reactivity was assessed with acetylcholine in a provocative test. RESULTS: A total of 173 patients were enrolled (median age 66 years, 66% female). A high prevalence of typical cardiovascular risk factors was registered. According to physiological assessment, patients were divided into the following subgroups: epicardial vasospastic angina (EVSA) (19%), microvascular vasospastic angina (MVSA) (19%), coronary microcirculatory disease (CMD) (11%), EVSA+CMD (21%), MVSA+CMD (18%), and non-coronary disorder (12%). The diagnosis of MVSA and MVSA+CMD had a higher representation of females (76% and 94%, respectively). CONCLUSIONS: Patients diagnosed with INOCA in the MOSAIC-COR registry exhibit significant symptomatology and a high prevalence of typical cardiovascular risk factors. Myocardial ischemia in this population may be generated by various pathomechanisms which may overlap.

11.
J Clin Med ; 13(11)2024 May 25.
Artículo en Inglés | MEDLINE | ID: mdl-38892807

RESUMEN

Atherosclerosis is the predominant underlying etiopathology of coronary artery disease. Changes in plaque phenotype from stable to high risk may spur future major adverse cardiac events (MACE). Different pharmacological therapies have been implemented to mitigate this risk. Over the last two decades, intravascular imaging modalities have emerged in clinical studies to clarify how these therapies may affect the composition and burden of coronary plaques. Lipid-lowering agents, such as statins, ezetimibe, and proprotein convertase subtilisin/kexin type 9 inhibitors, were shown not only to reduce low-density lipoprotein levels and MACE but also to directly affect features of coronary plaque vulnerability. Studies have demonstrated that lipid-lowering therapy reduces the percentage of atheroma volume and number of macrophages and increases fibrous cap thickness. Future studies should answer the question of whether pharmacological plaque stabilization may be sufficient to mitigate the risk of MACE for selected groups of patients with atherosclerotic coronary disease.

12.
EuroIntervention ; 20(15): e915-e926, 2024 Aug 05.
Artículo en Inglés | MEDLINE | ID: mdl-38752714

RESUMEN

The 2023 European Bifurcation Club (EBC) meeting took place in Warsaw in October, and the latest evidence for the use of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to optimise percutaneous coronary interventions (PCI) on coronary bifurcation lesions (CBLs) was a major focus. The topic generated deep discussions and general appraisal on the potential benefits of IVUS and OCT in PCI procedures. Nevertheless, despite an increasing recognition of IVUS and OCT capabilities and their recognised central role for guidance in complex CBL and left main PCI, it is expected that angiography will continue to be the primary guidance modality for CBL PCI, principally due to educational and economic barriers. Mindful of the restricted access/adoption of intracoronary imaging for CBL PCI, the EBC board decided to review and describe a series of tips and tricks which can help to optimise angiography-guided PCI for CBLs. The identified key points for achieving an optimal angiography-guided PCI include a thorough analysis of pre-PCI images (computed tomography angiography, multiple angiographic views, quantitative coronary angiography vessel estimation), a systematic application of the technical steps suggested for a given selected technique, an intraprocedural or post-PCI use of stent enhancement and a low threshold for bailout use of intravascular imaging.


Asunto(s)
Consenso , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Intervención Coronaria Percutánea/métodos , Angiografía Coronaria/métodos , Ultrasonografía Intervencional/métodos , Ultrasonografía Intervencional/normas , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Tomografía de Coherencia Óptica/métodos , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía
13.
Pol Arch Intern Med ; 134(7-8)2024 08 08.
Artículo en Inglés | MEDLINE | ID: mdl-38752580

RESUMEN

INTRODUCTION: Intricate management of heart failure (HF), especially in the context of reduced ejection fraction, is further complicated by an elevated risk of thromboembolic events. Studies published so far offer inconclusive insight into the interplay between mitral regurgitation (MR) and the coagulation system. OBJECTIVES: This study aimed to investigate the impact of transcatheter edge­to­edge repair (TEER) on specific coagulation parameters in HF patients. PATIENTS AND METHODS: A cohort of 31 HF patients with severe MR treated with TEER underwent a systematic evaluation at 3 visits (V1, V2, and V3). Coagulation parameters, including fibrinogen concentration, thrombin generation, fibrin clot permeability, and clot lysis time (CLT) were assessed (n = 27 at V2; n = 25 at V3). RESULTS: TEER induced changes in fibrinogen levels (P = 0.01; V3 vs V2) and improved fibrin clot properties over 50­day follow­up (P = 0.01; V3 vs V2). No significant differences were observed between time points in the analyzed blood clot parameters. Correlation analysis showed that baseline CLT was associated with ΔN­terminal pro-B­type natriuretic peptide (NT­proBNP) level (P = 0.049; r = 0.4). Multivariable analysis identified baseline CLT as an independent predictor of early post­TEER NT­proBNP change (R2 = 0.55; P = 0.02). CONCLUSIONS: We found decreased level of fibrinogen and increased permeation coefficient over a median 50 (interquartile range, 32.5-75.5)-day post­TEER follow­up, as compared with early postprocedural assessments. Other blood coagulation parameters remained unchanged from baseline at both follow­up time points after TEER. Finally, CLT was an independent predictor of early NT­proBNP increase, emphasizing its role as an indicator of hemodynamic response to TEER.


Asunto(s)
Fibrina , Insuficiencia de la Válvula Mitral , Trombina , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/sangre , Femenino , Masculino , Anciano , Trombina/metabolismo , Fibrina/metabolismo , Persona de Mediana Edad , Válvula Mitral/cirugía , Fibrinógeno/análisis , Fibrinógeno/metabolismo , Tiempo de Lisis del Coágulo de Fibrina , Coagulación Sanguínea
14.
Kardiol Pol ; 82(2): 166-174, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38493472

RESUMEN

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.


Asunto(s)
Síndrome Coronario Agudo , Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Choque Cardiogénico/etiología , Oclusión Coronaria/complicaciones , Oclusión Coronaria/cirugía , Síndrome Coronario Agudo/complicaciones , Síndrome Coronario Agudo/cirugía , Resultado del Tratamiento , Estudios Prospectivos , Vasos Coronarios , Polonia , Pronóstico , Sistema de Registros , Enfermedad Crónica
15.
Medicina (Kaunas) ; 60(2)2024 Feb 05.
Artículo en Inglés | MEDLINE | ID: mdl-38399564

RESUMEN

Background and Objectives: The assessment of coronary microcirculation may facilitate risk stratification and treatment adjustment. The aim of this study was to evaluate patients' clinical presentation and treatment following coronary microcirculation assessment, as well as factors associated with an abnormal coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) values. Materials and Results: This retrospective analysis included 223 patients gathered from the national registry of invasive coronary microvascular testing collected between 2018 and 2023. Results: The frequency of coronary microcirculatory assessments in Poland has steadily increased since 2018. Patients with impaired IMR (≥25) were less burdened with comorbidities. Patients with normal IMR underwent revascularisation attempts more frequently (11.9% vs. 29.8%, p = 0.003). After microcirculation testing, calcium channel blockers (CCBs) and angiotensin-converting enzyme inhibitors were added more often for patients with IMR and CFR abnormalities, respectively, as compared to control groups. Moreover, patients with coronary microvascular dysfunction (CMD, defined as CFR and/or IMR abnormality), regardless of treatment choice following microcirculation assessment, were provided with trimetazidine (23.2%) and dihydropyridine CCBs (26.4%) more frequently than those without CMD who were treated conservatively (6.8%) and by revascularisation (4.2% with p = 0.002 and 0% with p < 0.001, respectively). Multivariable analysis revealed no association between angina symptoms and IMR or CFR impairment. Conclusions: The frequency of coronary microcirculatory assessments in Poland has steadily increased. Angina symptoms were not associated with either IMR or CFR impairment. After microcirculation assessment, patients with impaired microcirculation, expressed as either low CFR, high IMR or both, received additional pharmacotherapy treatment more often.


Asunto(s)
Vasos Coronarios , Reserva del Flujo Fraccional Miocárdico , Humanos , Microcirculación , Resistencia Vascular , Estudios Retrospectivos , Sistema de Registros , Angiografía Coronaria
16.
Cardiol J ; 31(1): 133-146, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-37964649

RESUMEN

Cangrelor is the only intravenous P2Y12 receptor antagonist. It is an adenosine triphosphate analog that selectively, directly, and reversibly binds to the platelet P2Y12 receptors exerting its antiaggregatory effect. Cangrelor is characterized by linear, dose-dependent pharmacokinetics and rapid onset of action providing potent platelet inhibition exceeding 90%. Cangrelor is rapidly metabolized by endothelial endonucleotidase; thus, its half-life is 2.9 to 5.5 min, and its antiplatelet effect subsides within 60 to 90 min. Data originating from three pivotal cangrelor trials (CHAMPION PLATFORM, CHAMPION PCI, and CHAMPION PHOENIX) indicate that cangrelor reduces the risk of periprocedural thrombotic complications during percutaneous coronary intervention at the expense of mild bleedings. Its unique pharmacological properties allow it to overcome the limitations of oral P2Y12 receptor inhibitors, mainly related to the delayed and decreased bioavailability and antiplatelet effect of these agents, which are often observed in the setting of acute coronary syndrome. Subgroups of patients who could theoretically benefit the most from cangrelor include those in whom pharmacokinetics and pharmacodynamics of oral P2Y12 receptor antagonists are most disturbed, namely patients with ST-segment elevation myocardial infarction, those treated with opioids, with mild therapeutic hypothermia, or in cardiogenic shock. Cangrelor could also be useful if bridging is required in patients undergoing surgery. According to the current guidelines cangrelor may be considered in P2Y12 receptor inhibitor-naïve patients undergoing percutaneous coronary intervention in both acute and stable settings.


Asunto(s)
Síndrome Coronario Agudo , Adenosina Monofosfato/análogos & derivados , Intervención Coronaria Percutánea , Humanos , Inhibidores de Agregación Plaquetaria/efectos adversos , Síndrome Coronario Agudo/tratamiento farmacológico , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento
17.
Hellenic J Cardiol ; 76: 31-39, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-37295667

RESUMEN

OBJECTIVES: The study aimed to compare pre- and postoperative resting as well as postprocedural resting and exertional right ventricular speckle-tracking echocardiographic parameters at a mid-term follow-up after left ventricular assist device (LVAD) implantation. METHODS: Patients with implanted third-generation LVADs with hydrodynamic bearings were prospectively enrolled (NCT05063006). Myocardial deformation was evaluated before pump implantation and at least three months after the procedure, both at rest and during exercise. RESULTS: We included 22 patients, 7.3 months (IQR, 4.7-10.2) after the surgery. The mean age was 58.4 ± 7 years, 95.5% were men, and 45.5% had dilated cardiomyopathy. The RV strain analysis was feasible in all subjects both at rest and during exercise. The RV free wall strain (RVFWS) worsened from -13% (IQR, -17.3 to -10.9) to -11.3% (IQR, -12.9 to -6; p = 0.033) after LVAD implantation with a particular decline in the apical RV segment [-11.3% (IQR, -16.4 to -6.2) vs -7.8% (IQR, -11.7 to -3.9; p = 0.012)]. The RV four-chamber longitudinal strain (RV4CSL) remained unchanged [-8.5% (IQR, -10.8 to -6.9) vs -7.3% (IQR, -9.8 to -4.7; p = 0.184)]. Neither RVFWS (-11.3% (IQR, -12.9 to -6) vs -9.9% (IQR, -13.5 to -7.5; p = 0.077) nor RV4CSL [-7.3% (IQR, -9.8 to -4.7) vs -7.9% (IQR, -9.8 to -6.3; p = 0.548)] changed during the exercise test. CONCLUSIONS: In patients who are pump-supported, the right ventricular free wall strain tends to worsen after LVAD implantation and remains unchanged during a cycle ergometer stress test.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Disfunción Ventricular Derecha , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ecocardiografía/métodos , Corazón Auxiliar/efectos adversos , Estudios Retrospectivos , Disfunción Ventricular Derecha/diagnóstico por imagen , Disfunción Ventricular Derecha/etiología , Función Ventricular Izquierda , Función Ventricular Derecha
19.
Kardiol Pol ; 81(11): 1103-1112, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37937354

RESUMEN

BACKGROUND: Impella is a percutaneous mechanical circulatory support device for treatment of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCIs). IMPELLA-PL is a national retrospective registry of Impella-treated CS and HR-PCI patients in 20 Polish interventional cardiological centers, conducted from January 2014 until December 2021. AIMS: We aimed to determine the efficacy and safety of Impella using real-world data from IMPELLA-PL and compare these with other registries. METHODS: IMPELLA-PL data were analyzed to determine primary endpoints: in-hospital mortality and rates of mortality and major adverse cardiovascular and cerebrovascular events (MACCE) at 12 months post-discharge. RESULTS: Of 308 patients, 18% had CS and 82% underwent HR-PCI. In-hospital mortality rates were 76.4% and 8.3% in the CS and HR-PCI groups, respectively. The 12-month mortality rates were 80.0% and 18.2%, and post-discharge MACCE rates were 9.1% and 22.5%, respectively. Any access site bleeding occurred in 30.9% of CS patients and 14.6% of HR-PCI patients, limb ischemia in 12.7% and 2.4%, and hemolysis in 10.9% and 1.6%, respectively. CONCLUSIONS: Impella is safe and effective during HR-PCIs, in accordance with previous registry analyses. The risk profile and mortality in CS patients were higher than in other registries, and the potential benefits of Impella in CS require investigation.


Asunto(s)
Corazón Auxiliar , Intervención Coronaria Percutánea , Humanos , Choque Cardiogénico/terapia , Polonia , Intervención Coronaria Percutánea/efectos adversos , Estudios Retrospectivos , Cuidados Posteriores , Alta del Paciente , Sistema de Registros , Resultado del Tratamiento
20.
Circulation ; 148(13): 989-999, 2023 09 26.
Artículo en Inglés | MEDLINE | ID: mdl-37624364

RESUMEN

BACKGROUND: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. METHODS: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. RESULTS: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P<0.0001 for noninferiority for both tests). CONCLUSIONS: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04137510.


Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Trombosis , Humanos , Everolimus , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Polímeros , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Resultado del Tratamiento , Implantes Absorbibles , Sirolimus/efectos adversos , Infarto del Miocardio/tratamiento farmacológico , Stents/efectos adversos , Trombosis/etiología
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