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1.
Lancet ; 404(10456): 937-948, 2024 Sep 07.
Artículo en Inglés | MEDLINE | ID: mdl-39226909

RESUMEN

BACKGROUND: Dual antiplatelet therapy (DAPT) for 12 months is the standard of care after coronary stenting in patients with acute coronary syndrome (ACS). The aim of this individual patient-level meta-analysis was to summarise the evidence comparing DAPT de-escalation to ticagrelor monotherapy versus continuing DAPT for 12 months after coronary drug-eluting stent implantation. METHODS: A systematic review and individual patient data (IPD)-level meta-analysis of randomised trials with centrally adjudicated endpoints was performed to evaluate the comparative efficacy and safety of ticagrelor monotherapy (90 mg twice a day) after short-term DAPT (from 2 weeks to 3 months) versus 12-month DAPT in patients undergoing percutaneous coronary intervention with a coronary drug-eluting stent. Randomised trials comparing P2Y12 inhibitor monotherapy with DAPT after coronary revascularisation were searched in Ovid MEDLINE, Embase, and two websites (www.tctmd.com and www.escardio.org) from database inception up to May 20, 2024. Trials that included patients with an indication for long-term oral anticoagulants were excluded. The risk of bias was assessed using the revised Cochrane risk-of-bias tool. The principal investigators of the eligible trials provided IPD by means of an anonymised electronic dataset. The three ranked coprimary endpoints were major adverse cardiovascular or cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction, or stroke) tested for non-inferiority in the per-protocol population; and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding and all-cause death tested for superiority in the intention-to-treat population. All outcomes are reported as Kaplan-Meier estimates. The non-inferiority was tested using a one-sided α of 0·025 with the prespecified non-inferiority margin of 1·15 (hazard ratio [HR] scale), followed by the ranked superiority testing at a two-sided α of 0·05. This study is registered with PROSPERO (CRD42024506083). FINDINGS: A total of 8361 unique citations were screened, of which 610 records were considered potentially eligible during the screening of titles and abstracts. Of these, six trials that randomly assigned patients to ticagrelor monotherapy or DAPT were identified. De-escalation took place a median of 78 days (IQR 31-92) after intervention, with a median duration of treatment of 334 days (329-365). Among 23 256 patients in the per-protocol population, MACCE occurred in 297 (Kaplan-Meier estimate 2·8%) with ticagrelor monotherapy and 332 (Kaplan-Meier estimate 3·2%) with DAPT (HR 0·91 [95% CI 0·78-1·07]; p=0·0039 for non-inferiority; τ2<0·0001). Among 24 407 patients in the intention-to-treat population, the risks of BARC 3 or 5 bleeding (Kaplan-Meier estimate 0·9% vs 2·1%; HR 0·43 [95% CI 0·34-0·54]; p<0·0001 for superiority; τ2=0·079) and all-cause death (Kaplan-Meier estimate 0·9% vs 1·2%; 0·76 [0·59-0·98]; p=0·034 for superiority; τ2<0·0001) were lower with ticagrelor monotherapy. Trial sequential analysis showed strong evidence of non-inferiority for MACCE and superiority for bleeding among the overall and ACS populations (the z-curve crossed the monitoring boundaries or the required information size without crossing the futility boundaries or approaching the null). The treatment effects were heterogeneous by sex for MACCE (p interaction=0·041) and all-cause death (p interaction=0·050), indicating a possible benefit in women with ticagrelor monotherapy, and by clinical presentation for bleeding (p interaction=0·022), indicating a benefit in ACS with ticagrelor monotherapy. INTERPRETATION: Our study found robust evidence that, compared with 12 months of DAPT, de-escalation to ticagrelor monotherapy does not increase ischaemic risk and reduces the risk of major bleeding, especially in patients with ACS. Ticagrelor monotherapy might also be associated with a mortality benefit, particularly among women, which warrants further investigation. FUNDING: Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale.


Asunto(s)
Síndrome Coronario Agudo , Terapia Antiplaquetaria Doble , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Ensayos Clínicos Controlados Aleatorios como Asunto , Ticagrelor , Humanos , Ticagrelor/uso terapéutico , Ticagrelor/administración & dosificación , Síndrome Coronario Agudo/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Terapia Antiplaquetaria Doble/métodos , Hemorragia/inducido químicamente , Stents Liberadores de Fármacos , Resultado del Tratamiento
3.
EuroIntervention ; 20(17): e1086-e1097, 2024 Sep 02.
Artículo en Inglés | MEDLINE | ID: mdl-39219363

RESUMEN

BACKGROUND: The clinical benefits of optical frequency domain imaging (OFDI)-guided percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) remain unclear. AIMS: We sought to compare intravascular ultrasound (IVUS)- and OFDI-guided PCI in patients with ACS. METHODS: OPINION ACS is a multicentre, prospective, randomised, non-inferiority trial that compared OFDI-guided PCI with IVUS-guided PCI using current-generation drug-eluting stents in ACS patients (n=158). The primary endpoint was in-stent minimum lumen area (MLA), assessed using 8-month follow-up OFDI. RESULTS: Patients presented with ST-segment elevation myocardial infarction (55%), non-ST-segment elevation myocardial infarction (29%), or unstable angina pectoris (16%). PCI procedural success was achieved in all patients, with comparably low periprocedural complications rates in both groups. Immediately after PCI, the minimum stent area (p=0.096) tended to be smaller for OFDI versus IVUS guidance. Proximal stent edge dissection (p=0.012) and irregular protrusion (p=0.03) were significantly less frequent in OFDI-guided procedures than in IVUS-guided procedures. Post-PCI coronary flow, assessed using corrected Thrombolysis in Myocardial Infarction frame counts, was significantly better in the OFDI-guided group than in the IVUS-guided group (p<0.001). The least squares mean (95% confidence interval [CI]) in-stent MLA at 8 months was 4.91 (95% CI: 4.53-5.30) mm2 and 4.76 (95% CI: 4.35-5.17) mm2 in the OFDI- and IVUS-guided groups, respectively, demonstrating the non-inferiority of OFDI guidance (pnon-inferiority<0.001). The average neointima area tended to be smaller in the OFDI-guided group. The frequency of major adverse cardiac events was similar. CONCLUSIONS: Among ACS patients, OFDI-guided PCI and IVUS-guided PCI were equally safe and feasible, with comparable in-stent MLA at 8 months. OFDI guidance may be a potential option in ACS patients. This study was registered in the Japan Registry of Clinical Trials (jrct.niph.go.jp: jRCTs052190093).


Asunto(s)
Síndrome Coronario Agudo , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Ultrasonografía Intervencional , Humanos , Ultrasonografía Intervencional/métodos , Intervención Coronaria Percutánea/métodos , Masculino , Síndrome Coronario Agudo/terapia , Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/cirugía , Femenino , Persona de Mediana Edad , Anciano , Resultado del Tratamiento , Estudios Prospectivos , Tomografía de Coherencia Óptica/métodos , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/terapia , Infarto del Miocardio con Elevación del ST/cirugía , Angina Inestable/terapia , Angina Inestable/diagnóstico por imagen , Angina Inestable/cirugía
4.
EuroIntervention ; 20(18): e1184-e1194, 2024 Sep 16.
Artículo en Inglés | MEDLINE | ID: mdl-39279513

RESUMEN

BACKGROUND: Recent observations in silico and in vivo reported that, during proximal optimisation technique, drug-eluting stents (DES) elongate, challenging conventional wisdom. The interaction between plaque morphology and radial expansion is well established, but little is known about the impact of plaque morphology on elongation. AIMS: We aimed to assess the longitudinal mechanical behaviour of contemporary DES in vivo and evaluate the relationship between post-percutaneous coronary intervention (PCI) stent elongation and lesion morphology, as assessed with optical coherence tomography (OCT). METHODS: Patients treated with OCT-guided PCI to left main or left anterior descending artery bifurcations, between July 2017 and March 2022, from the King's Optical coherence Database Analysis Compendium were included. Patients were excluded if there were overlapping stents, if they had undergone prior PCI, or if there was inadequate image quality. Lesions were characterised as fibrocalcific, fibrous or lipid-rich by pre-PCI OCT. Following stent post-dilatation, stent expansion and final stent length were assessed. The primary outcome was the percentage change in stent length from baseline. RESULTS: Of 501 eligible consecutive patients from this period, 116 were included. The median age was 66 years (interquartile range [IQR] 57-76), 31% were female, and 53.4% were treated for an acute coronary syndrome. A total of 50.0% of lesions were classified as fibrocalcific, 6.9% were fibrous, and 43.1% were lipid-rich. The change in relative stent length was 4.4% (IQR 1.0-8.9), with an increase of 3.1% (IQR 0.5-6.3) in fibrocalcific lesions, 3.3% (IQR 0.5-5.9) in fibrous lesions, and 6.4% (IQR 3.1-11.1) in lipid-rich plaque (p=0.006). In multivariate regression modelling, lipid-rich plaque was an independent predictor of stent elongation (odds ratio 3.689, 95% confidence interval: 1.604-8.484). CONCLUSIONS: Contemporary DES elongate following implantation and post-dilatation, and this is significantly mediated by plaque morphology. This is an important consideration when planning a strategy for DES implantation.


Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Placa Aterosclerótica , Tomografía de Coherencia Óptica , Humanos , Femenino , Tomografía de Coherencia Óptica/métodos , Masculino , Anciano , Persona de Mediana Edad , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Resultado del Tratamiento , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología
5.
EuroIntervention ; 20(18): e1173-e1183, 2024 Sep 16.
Artículo en Inglés | MEDLINE | ID: mdl-39279514

RESUMEN

BACKGROUND: The 12-month outcomes of BIOMAG-I - the first-in-human study investigating the third-generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) - showed promising results regarding clinical outcomes and late lumen loss. AIMS: The current study aimed to investigate vascular healing parameters assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on strut visibility, vessel and scaffold areas, and neointimal growth patterns. METHODS: This is a BIOMAG-I substudy including patients with available serial OCT and IVUS data. We conducted a frame-based analysis of OCT findings in conjunction with IVUS-derived vessel and scaffold areas, evaluating the qualitative and quantitative aspects of vascular healing. RESULTS: Among the 116 patients enrolled in this trial, 56 patients treated with DREAMS 3G were included in the analysis. At 12 months, OCT imaging revealed that 99.0% of the struts were invisible, and no malapposed struts were depicted. While the vessel area showed no significant difference between the timepoints, the minimum lumen area significantly decreased from post-percutaneous coronary intervention to 6 months (6.88 mm2 to 4.75 mm2; p<0.0001), but no significant changes were observed between 6 and 12 months. Protruding neointimal tissue (PNT) - a unique neointimal presentation observed following resorbable magnesium scaffold implantation - was observed in 89.3% of the study patients at 12 months, and its area exhibited a 47.4% decrease from 6 to 12 months. CONCLUSIONS: This imaging substudy revealed that, at 12-month follow-up, virtually all struts of the DREAMS 3G scaffold became invisible, without evident malapposition. The vascular healing response to DREAMS 3G implantation also appeared favourable up to 12 months, which is indicated by advanced strut degradation and spontaneous regressing PNT between 6 and 12 months.


Asunto(s)
Implantes Absorbibles , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Stents Liberadores de Fármacos , Magnesio , Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Tomografía de Coherencia Óptica/métodos , Masculino , Femenino , Persona de Mediana Edad , Ultrasonografía Intervencional/métodos , Anciano , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/instrumentación , Vasos Coronarios/diagnóstico por imagen , Resultado del Tratamiento , Neointima , Andamios del Tejido
6.
EuroIntervention ; 20(18): e1136-e1153, 2024 Sep 16.
Artículo en Inglés | MEDLINE | ID: mdl-39279515

RESUMEN

Peripheral arterial disease is the third leading cause of cardiovascular morbidity after coronary artery disease and stroke. Lower limb peripheral arterial disease commonly involves infrainguinal arteries, may impair walking ability (intermittent claudication) and may confer a significant risk of limb loss (chronic limb-threatening ischaemia), depending on the severity of ischaemia. Endovascular treatment has become the mainstay revascularisation option in both the femoropopliteal and the below-the-knee arterial segments. After crossing and preparing the lesion, treatment results in these arterial segments can be enhanced by using drug-coated devices (drug-eluting stents and drug-coated balloons) that mitigate the occurrence of restenosis. As for other medical devices, the use of drug-eluting devices is based on their demonstrated safety and efficacy profiles when applied in the distinct segments of the lower limb vasculature. In this state-of-the-art narrative review we provide an overview of the safety and efficacy of drug-coated devices when used in the femoropopliteal and below-the-knee arterial segments.


Asunto(s)
Stents Liberadores de Fármacos , Extremidad Inferior , Enfermedad Arterial Periférica , Humanos , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Extremidad Inferior/irrigación sanguínea , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/métodos , Arteria Poplítea , Resultado del Tratamiento , Arteria Femoral
12.
Medicine (Baltimore) ; 103(22): e38071, 2024 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-39259115

RESUMEN

BACKGROUND: Patients undergoing percutaneous coronary intervention mainly receive antiplatelet therapy. However, limited data are available regarding the optimal dual antiplatelet therapy (DAPT) following the implantation of new-generation drug-eluting stent (DES). OBJECTIVE: This study aimed to compare the clinical outcomes of short-term (1-3 months) DAPT and standard (12 months) DAPT after the implantation of a new-generation of DES. METHODS: We systematically searched PubMed, The Cochrane Library Database, Embase for trials that compared short-term (1-3 months) and standard DAPT after the implantation of next-generation DES were retrieved from all published studies in English until December 31, 2021. The primary endpoint was major bleeding. The secondary endpoints included all-cause mortality, cardiac death, myocardial infarction, stroke, stent thrombosis, and all bleeding. RESULTS: This study included a total of 7 randomized controlled trials, comprising 28,344 subjects. Regarding primary endpoints, short-term DAPT exhibited a significantly lower incidence of major bleeding compared with standard DAPT [relative risk (RR): 0.66, 95% confidence interval (CI): (0.54, 0.81), P < .0001]. For secondary endpoints, there were significant differences between short-term and standard DAPT in all bleeding [RR: 0.59, 95% CI: (0.50, 0.69), P < .00001]. However, no significant differences were identified in all-cause mortality [RR: 0.96, 95% CI: (0.77, 1.18), P = .27], myocardial infarction [RR: 0.98, 95% CI: (0.82, 1.18), P = .86], cardiac death [RR: 0.83, 95% CI: (0.63, 1.10), P = .20], stroke [RR: 1.08, 95% CI: (0.79, 1.47), P = .63], cerebrovascular [RR: 1.08, 95% CI: (0.79, 1.47), P = .63], and stent thrombosis [RR: 1.13, 95% CI: (0.80, 1.57), P = .49] between the 2 groups. CONCLUSION: In patients undergoing implantation of a new-generation of DES, short-term (1-3 months) DAPT exhibited no inferiority compared with standard (12 months) DAPT in terms of all-cause mortality, cardiac death, myocardial infarction, stroke, and definite or probable stent thrombosis compared with standard (12 months) DAPT. However, short-term DAPT appeared superior to standard DAPT in terms of major bleeding and all bleeding.


Asunto(s)
Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Intervención Coronaria Percutánea/métodos , Terapia Antiplaquetaria Doble/métodos , Hemorragia/epidemiología , Hemorragia/inducido químicamente , Hemorragia/prevención & control
13.
Sci Rep ; 14(1): 21173, 2024 09 11.
Artículo en Inglés | MEDLINE | ID: mdl-39256427

RESUMEN

Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach.Clinical Trial Registration: NCT02748226.


Asunto(s)
Stents Liberadores de Fármacos , Arteria Femoral , Arteria Poplítea , Humanos , Masculino , Femenino , Anciano , Arteria Poplítea/cirugía , Arteria Femoral/cirugía , Resultado del Tratamiento , Persona de Mediana Edad , Enfermedad Arterial Periférica/terapia , Angioplastia de Balón/métodos , Anciano de 80 o más Años , Estudios Retrospectivos , Grado de Desobstrucción Vascular
14.
Acta Cir Bras ; 39: e397324, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39258620

RESUMEN

PURPOSE: To compare the endothelial coverage of different stents in porcine carotid arteries. Research problem: How effective are polyurethane stents (PU) and PU + rapamycin (PU + RAPA) compared to bare-metal stents on endothelial coverage by neointima in pigs after 28 days? METHODS: The methodology had two phases for an interventional, experimental, prospective study, with three Moura pigs, 12 weeks old and weighing between 19 and 22.5 kg. In phase I, eight stents were implanted in carotid arteries; three stents coated with PU, three coated with PU + RAPA, and two without coating. After 28 days, phase II was carried out, consisting of euthanasia, removal of the stents, to evaluate the exposed area of the stent struts, and the percentage of endothelialization through optical microscopy and scanning electron microscopy. RESULTS: The eight stents implanted with ultrasound sizing and post-dilation with a larger diameter balloon were analyzed by Doppler ultrasound, intravascular ultrasound, and angiography after 28 days. CONCLUSIONS: This study showed complete endothelial coverage by the endoluminal neointima of the stent struts, good integration and coverage with the arterial wall, with no exposed struts showing the presence of intimal hyperplasia (whitish tissue).


Asunto(s)
Stents Liberadores de Fármacos , Sirolimus , Animales , Sirolimus/administración & dosificación , Sirolimus/farmacología , Porcinos , Arterias Carótidas/cirugía , Arterias Carótidas/efectos de los fármacos , Neointima/patología , Microscopía Electrónica de Rastreo , Poliuretanos , Estudios Prospectivos , Endotelio Vascular/efectos de los fármacos , Reproducibilidad de los Resultados , Polímeros , Modelos Animales , Factores de Tiempo , Materiales Biocompatibles Revestidos
15.
Lancet ; 404(10457): 1029-1039, 2024 Sep 14.
Artículo en Inglés | MEDLINE | ID: mdl-39236729

RESUMEN

BACKGROUND: Despite the detailed imaging information provided by optical coherence tomography (OCT) during percutaneous coronary intervention (PCI), clinical benefits of this imaging technique in this setting remain uncertain. The aim of the OCCUPI trial was to compare the clinical benefits of OCT-guided versus angiography-guided PCI for complex lesions, assessed as the rate of major adverse cardiac events at 1 year. METHODS: This investigator-initiated, multicentre, randomised, open-label, superiority trial conducted at 20 hospitals in South Korea enrolled patients aged 19-85 years for whom PCI with drug-eluting stents was clinically indicated. After diagnostic angiography, clinical and angiographic findings were assessed to identify patients who met the criterion of having one or more complex lesions. Patients were randomly assigned 1:1 to receive PCI with OCT guidance (OCT-guidance group) or angiography guidance without OCT (angiography-guidance group). Web-response permuted-block randomisation (mixed blocks of four or six) was used at each participating site to allocate patients. The allocation sequence was computer-generated by an external programmer who was not involved in the rest of the trial. Outcome assessors were masked to group assignment. Patients, follow-up health-care providers, and data analysers were not masked. PCI was done according to conventional standard methods with everolimus-eluting stents. The primary endpoint was major adverse cardiac events (a composite of cardiac death, myocardial infarction, stent thrombosis, or ischaemia-driven target-vessel revascularisation), 1 year after PCI. The primary analysis was done in the intention-to-treat population. The margin used to establish superiority was 1·0 as a hazard ratio. This trial is registered with ClinicalTrials.gov (NCT03625908) and is completed. FINDINGS: Between Jan 9, 2019, and Sept 22, 2022, 1604 patients requiring PCI with drug-eluting stents for complex lesions were randomly assigned to receive either OCT-guided PCI (n=803) or angiography-guided PCI (n=801). 1290 (80%) of 1604 patients were male and 314 (20%) were female. The median age of patients at randomisation was 64 years (IQR 57-70). 1588 (99%) patients completed 1-year follow-up. The primary endpoint occurred in 37 (5%) of 803 patients in the OCT-guided PCI group and 59 (7%) of 801 patients in the angiography-guided PCI group (absolute difference -2·8% [95% CI -5·1 to -0·4]; hazard ratio 0·62 [95% CI 0·41 to 0·93]; p=0·023). Rates of stroke, bleeding events, and contrast-induced nephropathy were not significantly different across the two groups. INTERPRETATION: Among patients who required drug-eluting stent implantation for complex lesions, OCT guidance resulted in a lower incidence of major adverse cardiac events at 1 year compared with angiography guidance. These findings indicate the existence of a therapeutic benefit of OCT as an intravascular imaging technique for PCI guidance in patients with complex coronary lesions. FUNDING: Abbott Vascular and Cardiovascular Research Center. TRANSLATION: For the Korean translation of the abstract see Supplementary Materials section.


Asunto(s)
Angiografía Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica , Humanos , Intervención Coronaria Percutánea/métodos , Femenino , Masculino , Persona de Mediana Edad , Anciano , República de Corea , Tomografía de Coherencia Óptica/métodos , Angiografía Coronaria/métodos , Adulto , Anciano de 80 o más Años , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/terapia , Resultado del Tratamiento
16.
Lancet ; 404(10457): 1040-1050, 2024 Sep 14.
Artículo en Inglés | MEDLINE | ID: mdl-39236727

RESUMEN

BACKGROUND: The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions. METHODS: REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing. FINDINGS: Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; pnon-inferiority=0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group. INTERPRETATION: In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years, which indicates that DES should remain the preferred treatment for this patient population. FUNDING: Xijing Hospital and Shenqi Medical. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.


Asunto(s)
Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Paclitaxel , Humanos , Masculino , Femenino , Persona de Mediana Edad , Angioplastia Coronaria con Balón/métodos , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Enfermedad de la Arteria Coronaria/terapia , Anciano , Sirolimus/uso terapéutico , Sirolimus/administración & dosificación , Resultado del Tratamiento , Materiales Biocompatibles Revestidos , China/epidemiología , Intervención Coronaria Percutánea/métodos
17.
Int J Mol Sci ; 25(16)2024 Aug 11.
Artículo en Inglés | MEDLINE | ID: mdl-39201436

RESUMEN

Multiple clinical trials have reported favorable outcomes after drug-coated balloon therapy for peripheral artery disease in above-the-knee and below-the-knee lesions and in both de novo and in-stent restenosis. However, there are still insufficient data to identify and tackle the risk factors associated with a higher risk of restenosis, which is the primary concern for patients who are treated with an endovascular approach. A modern armamentarium, which includes improved lesion preparation techniques such as plaque modification balloons, mechanical atherectomy, intravascular lithotripsy, and imaging, is crucial for obtaining better long-term clinical outcomes. Moreover, a better understanding of the molecular properties of drug-coated balloons has led to improved devices that could tackle the shortcomings of previous generations. This comprehensive review focuses on drug-coated balloon technology as a tool to treat peripheral artery disease and the effects of the molecular mechanisms involved in preventing vascular restenosis.


Asunto(s)
Angioplastia de Balón , Enfermedad Arterial Periférica , Humanos , Enfermedad Arterial Periférica/terapia , Angioplastia de Balón/métodos , Materiales Biocompatibles Revestidos/química , Stents Liberadores de Fármacos
18.
Medicine (Baltimore) ; 103(32): e39161, 2024 Aug 09.
Artículo en Inglés | MEDLINE | ID: mdl-39121283

RESUMEN

BACKGROUND: Spinal cord infarction is an uncommon nervous system disorder. We present a case of high cervical cord infarction caused by stenting of the origin of the left vertebral artery (VA). The incidence of spinal cord infarction is minimal, and it must be distinguished from a number of other disorders. The diagnosis is primarily based on imaging, clinical symptoms, and history. Currently, there is no focused treatment for spinal cord infarction. Thrombolysis, high-dose glucocorticoid shocks, tube dilatation to promote circulation, and nutritional neurotropic medicines given early in the course of the disease can all help to slow the disease's progression. There is no agreement on the etiology, diagnosis, or therapy options for these people. CASE PRESENTATION: On October 7, 2023, an 81-year-old man was admitted to the hospital primarily for recurrent chest tightness and pain that had persisted for more than 2 years and 1 month. Cerebral angiography upon admission revealed significant blockage of the right VA and stenosis of the left vertebral arterial origin. Six days following admission, a drug-eluting stenting procedure was carried out under local anesthesia to open the left VA origin via the femoral artery. Following the procedure, the patient experienced a progressive loss of muscle strength in all 4 limbs and paraplegia below the cervical 3 spinal cord. One week following the procedure, the patient was released from the hospital. After the procedure, the patient was released 1 week later. After the procedure, the patient's symptoms persisted for a month. CONCLUSION: High awareness for high cervical cord infarction is required when neck discomfort and limb weakness with progressive progression arises after surgery. Complications of high cervical cord infarction following stenting for stenosis of VA origin are uncommon in clinical settings. Patients' prognoses can be improved by prompt diagnosis and care.


Asunto(s)
Infarto , Humanos , Anciano de 80 o más Años , Masculino , Infarto/etiología , Insuficiencia Vertebrobasilar/etiología , Insuficiencia Vertebrobasilar/diagnóstico por imagen , Insuficiencia Vertebrobasilar/cirugía , Arteria Vertebral/diagnóstico por imagen , Stents/efectos adversos , Stents Liberadores de Fármacos/efectos adversos , Vértebras Cervicales/cirugía , Médula Cervical/diagnóstico por imagen , Isquemia de la Médula Espinal/etiología
20.
Am Heart J ; 277: 1-10, 2024 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-39098754

RESUMEN

BACKGROUND: Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI). METHODS: The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients. SUMMARY: The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.


Asunto(s)
Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Sistema de Registros , Sirolimus , Humanos , Sirolimus/farmacología , Sirolimus/análogos & derivados , Método Simple Ciego , Intervención Coronaria Percutánea/métodos , Diseño de Prótesis , Enfermedad de la Arteria Coronaria/terapia , Resultado del Tratamiento , Masculino , Femenino , Implantes Absorbibles
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