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BACKGROUND: The Cardiology Complex Structure of the Azienda Socio Sanitaria Territoriale (ASST) of Lodi, Italy, assists patients with clinical conditions ranging from emergency to chronicity. The model of Homogeneous Waiting Groups should guide the appropriateness of prescriptions categorized as U (urgent), B (brief), D (deferrable), and P (programmable). This study aims to describe and analyze the characteristics of prescription and delivery of clinical and instrumental cardiology outpatient services with U and B priority during the November 2023-January 2024 quarter, paying particular attention to the clinical appropriateness of prescribing. METHODS: A prospective observational study was conducted. Computerized data were anonymously extracted from the company's Management Control and provided with the authorization of the Data Protection Officer. RESULTS: During the observed quarter, the Cardiology Complex Structure provided 7379 services for outpatients. Out of 123 U services, 94 (76.4%) were managed through SBC (Single Booking Center) and 29 (23.6%) were managed outside the SBC. From 529 services with B priority, 504 (95%) were managed through SBC and 25 (5%) outside the SBC. Requests with U priority mainly referred to ECG (n = 50; 40.6%) and first cardiological visit (n = 46; 37.4%). Fifty percent of U and B requests were prescribed by 4% and 8% of general practitioners, respectively. The prescribed priority was correct for 13% of requests (n = 64). CONCLUSIONS: This study shows a vastly inappropriate use of resources allocated to urgent outpatient cardiological services. Actions aimed at promoting the adherence to the Homogeneous Waiting Groups Manual and enhancing telemedicine services, currently limited to heart failure, are necessary for resource optimization in cardiology within the ASST of Lodi.
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Atención Ambulatoria , Listas de Espera , Humanos , Estudios Prospectivos , Atención Ambulatoria/estadística & datos numéricos , Italia , Cardiología , Pacientes Ambulatorios/estadística & datos numéricosRESUMEN
We present the case of an 82-year-old woman with history of bivalvular replacement (mitral mechanical prothesis and tricuspid bioprothesis) and subsequent tricuspid percutaneous valve-in-valve bioprothesis implantation. The patient developed an indication for pacemaker implantation. We describe the feasibility of leadless pacemaker implantation across the tricuspid prothesis when all other techniques fail.
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BACKGROUND: Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary or inoperable primary mitral regurgitation (MR). The relatively recent approval of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences) has expanded the options of TEER devices. However, evidence comparing PASCAL with MitraClip systems is still limited. METHODS: We conducted a systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies comparing PASCAL and MitraClip systems. RESULTS: Four observational studies and 1 randomized controlled trial, involving 1315 patients total, were eligible for inclusion. All patients exhibited symptomatic (NYHA II-IV) MR grades 3+ or 4+. Baseline characteristics were comparable across all included studies. The clinical outcomes were assessed according to the Mitral Valve Academic Research Consortium consensus. The procedural success rates for the 2 devices were comparable in terms of achieving post-procedural MR grades of less than or equal to 2+ and less than or equal to 1+. Furthermore, most patients improved their clinical status, with no significant differences between patients treated with PASCAL and those treated with MitraClip. In terms of safety, both procedures exhibited low overall mortality rates and occurrence of major adverse events (MAE), without significant difference between the 2 devices. These findings remained consistent in both short- and long-term follow-up assessments. CONCLUSIONS: Our study revealed similar effectiveness and safety profiles between the PASCAL and MitraClip devices in patients experiencing significant symptomatic MR.
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Procedimientos Quirúrgicos Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Cateterismo Cardíaco/métodos , Catéteres , Implantación de Prótesis de Válvulas Cardíacas/métodos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/etiología , Resultado del TratamientoRESUMEN
Background: In the setting of coronary artery dissection, both spontaneous and iatrogenic, fixing the intimal tear, usually with stent implantation, can be extremely challenging if the distal wire position has been lost. Common complications are mainly related to the inadvertent subintimal tracking of the guidewire while attempting to gain the distal true lumen. Aims: To report the registry results of using the SUOH 0.3 guidewire for managing coronary artery dissection in a real-world multicenter setting. Methods: The study population in this retrospective, multicenter, international registry included 75 consecutive patients who underwent PCI and required an antegrade wiring of a dissected coronary artery. Results: Successful use of SUOH 0.3 was achieved in 69 (92%) patients. The use of a microcatheter was associated with a significantly higher rate of TIMI 3 flow at the end of the procedure (no microcatheter: n = 17, 81%; microcatheter: n = 52, 96.3%; p = 0.017). The first recanalization attempt was made with the SUOH 03 guidewire in 48 (64%) cases, and it was successful in 42 (87%). The overall PCI success rate was reported in 72 (96%) patients, with no significant differences among patients with different origins, mechanisms, and locations of dissection. Conclusions: In this setting, the SUOH 0.3 guidewire provides high procedural success without additional complex techniques.
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Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Resultado del Tratamiento , Oclusión Coronaria/etiología , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Estudios Retrospectivos , Angiografía Coronaria , Enfermedad Crónica , Sistema de RegistrosRESUMEN
OBJECTIVES AND BACKGROUND: Coronary artery perforation (CAP) is a potentially life-threatening complication during percutaneous coronary interventions (PCI) and the best strategy for its management is yet to be proved. We aimed to analyze the safety, efficacy, and long-term clinical outcomes of the block and deliver (BAD) technique, as only anecdotal cases are reported in literature. METHODS: From January 2016 to January 2020, all consecutive patients treated with the BAD technique at five high-volume centers in Italy were retrospectively identified. RESULTS: 25 CAPs treated with the BAD technique were included. The most frequently perforated artery was the left anterior descending artery (32%) and spring-coil wires with a hydrophilic coating were the most common culprit wires (68%). Mean sealing time was 46.9 ± 60.1 min, with no significant differences between CTO-PCIs and non-CTO PCIs (p = .921). Acute successful sealing of the CAP was achieved in 96% of the cases. Immediate cardiac tamponade occurred in 28% of patients, four during CTO PCI and three during non-CTO PCI (p = .55). Two patients required pericardiocentesis during hospitalization, one patient developed acute kidney injury, and one patient underwent cardiac surgery due to severe mitral regurgitation. At 1-year follow-up no significant differences were observed between groups in terms of POCE (25 vs 25%, p = .628) and its individual components. CONCLUSION: The BAD technique proved to be effective for the management of CAP, showing high successful sealing rates. Rates of in-hospital events and at 1-year follow-up did not significantly differ between patients suffering CAP during CTO revascularization or during non-CTO PCI.
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Oclusión Coronaria , Intervención Coronaria Percutánea , Enfermedad Crónica , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Humanos , Intervención Coronaria Percutánea/efectos adversos , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Equipment delivery in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can be challenging and it is associated with a higher risk of device entrapment. Data regarding the incidence of device entrapment during CTO PCI are lacking. AIMS: The aim of this study was to describe the incidence and procedural characteristics of device entrapment in patients undergoing PCI for CTOs and discuss management strategies for dealing with it. METHODS: Device entrapment was characterised in a large consecutive series of 2,361 CTO PCI cases performed by five high-volume CTO Italian operators between January 2015 and January 2020. RESULTS: Device entrapment occurred in 36 out of 2,361 cases (1.5%) and consisted of coronary guidewires in 13 (0.5%), microcatheters in 6 (0.2%), balloons in 6 (0.2%), rotational atherectomy burrs in 10 (0.4%) and guiding catheter extension in 1 patient (0.04%). Complete device retrieval was achieved in 63.9%, with at least partial removal of material in 97.2%. Vessel recanalisation was still possible in 86.1% of cases even after device entrapment. Intraprocedural myocardial infarction occurred in 3 patients (8.3%), tamponade with urgent pericardiocentesis in 1 (2.8%) and emergency surgical removal of the entrapped device in 1 patient (2.8%). Mean radiation dose was 4.7±2.3 Gy. At 30-day follow-up, one patient died with stent thrombosis of a non-target vessel and another required repeat percutaneous revascularisation. CONCLUSIONS: Device entrapment during CTO revascularisations is a rare but potentially severe complication. We describe and discuss current techniques of percutaneous retrieval that can be employed to achieve procedural success safely.
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Aterectomía Coronaria , Oclusión Coronaria , Infarto del Miocardio , Intervención Coronaria Percutánea , Enfermedades Vasculares , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/epidemiología , Oclusión Coronaria/cirugía , Humanos , Incidencia , Intervención Coronaria Percutánea/efectos adversos , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: To report our initial experience of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/acute coronary syndrome (ACS) patients undergoing standard of care invasive management. BACKGROUND: The rapid diffusion of the SARS-CoV-2 together with the need for isolation for infected patients might be responsible for a suboptimal treatment for SARS-CoV-2 ACS patients. Recently, the group of Sichuan published a protocol for COVID/ACS infected patients that see the thrombolysis as the gold standard of care. METHODS: We enrolled 31 consecutive patients affected by SARS-COV-2 admitted to our emergencies room for suspected ACS. RESULTS: All patients underwent urgent coronary angiography and percutaneous coronary intervention (PCI) when required except two patients with severe hypoxemia and unstable hemodynamic condition that were conservatively treated. Twenty-one cases presented diffuse ST-segment depression while in the remaining cases anterior and inferior ST-elevation was present in four and six cases, respectively. PCI was performed in all cases expect two that were diagnosed as suspected myocarditis because of the absence of severe coronary disease and three with apical ballooning at ventriculography diagnostic for Tako-Tsubo syndromes. Two patients conservatively treated died. The remaining patients undergoing PCI survived except one that required endotracheal intubation (ETI) and died at Day 6. ETI was required in five more patients while in the remaining cases CPAP was used for respiratory support. CONCLUSIONS: Urgent PCI for ACS is often required in SARS-CoV-2 patients improving the prognosis in all but the most advanced patients. Complete patient history and examination, routine ECG monitoring, echocardiography, and careful evaluation of changes in cardiac enzymes should be part of the regular assessment procedures also in dedicated COVID positive units.
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Síndrome Coronario Agudo/terapia , COVID-19/complicaciones , Servicio de Urgencia en Hospital , Hospitalización , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/virología , Anciano , Anciano de 80 o más Años , COVID-19/diagnóstico , COVID-19/terapia , Angiografía Coronaria , Electrocardiografía , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
Coronary artery dissection is a well-known complication of percutaneous coronary interventions. In this setting, coronary artery dissection is caused by mechanical injury of the arterial wall. However, dissection may also occur spontaneously. In both situations, an intimal tear or dissection allows blood entering and separating the layers of the coronary arterial wall. Despite percutaneous approach is still the preferred and the quickest way to restore coronary flow, it remains challenging. One of the main reasons for procedural failure is due to the difficult advancement of a guidewire into the true lumen. In such situation, the ideal wire should have a soft tip, high torque control, and excellent flexibility. Assuming that, the "new rope coil" composite core Suoh 0.3 guidewire, with its unique combination of characteristics, could allow better orientation insight into a dissected coronary artery increasing the chance of procedural success. We collected a case series of nine consecutive patients in which the Suoh 0.3 guidewire was able to gain the true lumen distally to a dissected segment.
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Angioplastia Coronaria con Balón/instrumentación , Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos , Anomalías de los Vasos Coronarios/terapia , Enfermedades Vasculares/congénito , Anomalías de los Vasos Coronarios/diagnóstico por imagen , Diseño de Equipo , Humanos , Stents , Resultado del Tratamiento , Enfermedades Vasculares/diagnóstico por imagen , Enfermedades Vasculares/terapiaRESUMEN
AIMS: Our aim was to assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in males and females with acute coronary syndrome (ACS) undergoing invasive management. METHODS AND RESULTS: In the MATRIX programme, 7,213 patients were randomised to bivalirudin or UFH. Patients in the bivalirudin group were subsequently randomly assigned to receive or not a post-PCI bivalirudin infusion. The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding. The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target vessel revascularisation (TVR), definite stent thrombosis (ST), or NACE. The rate of MACE was not significantly lower with bivalirudin than with heparin in male (rate ratio [RR] 0.90, 95% confidence interval [CI]: 0.75-1.07; p=0.22) and female patients (RR 1.06, 95% CI: 0.80-1.40; p=0.67) without significant interaction (pint=0.31), nor was the rate of NACE (males: RR 0.85, 95% CI: 0.72-1.01; p=0.07; females: RR 0.98, 95% CI: 0.76-1.28; p=0.91; pint=0.38). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent TVR, definite ST, or NACE (males: RR 0.84, 95% CI: 0.66-1.07; p=0.15; females: RR 1.06, 95% CI: 0.74-1.53; p=0.74; pint=0.28). CONCLUSIONS: In ACS patients, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH in both sexes. The rate of the composite of urgent TVR, definite ST, or NACE was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion in both sexes.
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Síndrome Coronario Agudo , Heparina/uso terapéutico , Fragmentos de Péptidos/uso terapéutico , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/terapia , Anticoagulantes , Antitrombinas , Femenino , Hirudinas , Humanos , Masculino , Proteínas Recombinantes/uso terapéutico , Resultado del TratamientoRESUMEN
OBJECTIVES: To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. BACKGROUND: BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. METHODS: RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. RESULTS: Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). CONCLUSIONS: Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.
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Implantes Absorbibles , Síndrome Coronario Agudo/terapia , Angina Inestable/terapia , Angioplastia Coronaria con Balón/instrumentación , Infarto del Miocardio sin Elevación del ST/terapia , Infarto del Miocardio con Elevación del ST/terapia , Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/mortalidad , Anciano , Angina Inestable/diagnóstico por imagen , Angina Inestable/mortalidad , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Trombosis Coronaria/mortalidad , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Infarto del Miocardio sin Elevación del ST/diagnóstico por imagen , Infarto del Miocardio sin Elevación del ST/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Sistema de Registros , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: The objective of this study was to investigate mid-term clinical outcomes of patients treated with 'full-plastic jacket' (FPJ) everolimus-eluting Absorb bioresorbable vascular scaffold (BRS) implantation. BACKGROUND: FPJ with BRS may represent an interesting option for patient with diffuse coronary artery disease (CAD), but data on the clinical impact of FPJ using the Absorb BRS are scant. METHODS: FPJ was defined as the implantation of >56â¯mm of overlapping BRS in at least one vessel. We compared outcomes of patients receiving Absorb FPJ vs. non-FPJ within the multicenter prospective RAI Registry. RESULTS: Out of 1505 consecutive patients enrolled in the RAI registry, 1384 were eligible for this analysis. Of these, 143 (10.3%) were treated with BRS FPJ. At a median follow-up of 649â¯days, no differences were observed between FPJ and non-FPJ groups in terms of the device-oriented composite endpoint (DoCE) (5.6% vs. 4.4%, pâ¯=â¯0.675) or the patient-related composite endpoint (PoCE) (20.9% vs. 15.9%, pâ¯=â¯0.149). Patients receiving FPJ had higher rates of target vessel repeat revascularization (TVR) (11.2% vs. 6.3%, pâ¯=â¯0.042). In the FPJ group, there was no cardiac death and only one (very late) stent thrombosis (ST) (0.7%). CONCLUSIONS: Mid-term outcomes of a FPJ PCI strategy in the setting of diffuse CAD did not show a significant increase in composite device- and patient-related events, with rates of cardiac death and ST comparable to non-FPJ Absorb BRS implantation. However, these findings are hypothesis generating and requiring further validation.
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Implantes Absorbibles , Prótesis Vascular/tendencias , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos/tendencias , Everolimus/administración & dosificación , Sistema de Registros , Implantes Absorbibles/tendencias , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Andamios del Tejido/tendencias , Resultado del TratamientoRESUMEN
Coronary perforation is a rare but potentially lethal complication of percutaneous coronary intervention. Management of coronary perforations is mainly conditioned by the extension of coronary rupture and location of the perforation. Successful treatment is highly affected by the operator's familiarity with tools and dedicated techniques to achieve prompt sealing of the disruption. We report a case of an epicardial collateral channel perforation occurred during a retrograde chronic total occlusion revascularization procedure that was promptly managed with bilateral coils embolization in the target and in the donor vessel. Based on medical literature an overview of the most helpful techniques to treat these complications is provided.
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Circulación Colateral , Circulación Coronaria , Oclusión Coronaria/terapia , Vasos Coronarios/lesiones , Embolización Terapéutica/instrumentación , Lesiones Cardíacas/terapia , Intervención Coronaria Percutánea/efectos adversos , Anciano , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/diagnóstico , Oclusión Coronaria/fisiopatología , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/fisiopatología , Lesiones Cardíacas/diagnóstico por imagen , Lesiones Cardíacas/etiología , Lesiones Cardíacas/fisiopatología , Humanos , Masculino , Resultado del TratamientoRESUMEN
BACKGROUND: The bioresorbable vascular scaffold (BVS) technology may be an appealing option in ST-segment elevation myocardial infarction (STEMI) patients. However, the available evidence on its use in this challenging subset is limited. METHODS: Registro Absorb Italiano (RAI) is a multicenter, prospective registry that aims to assess BVS performance through a 5-year follow-up of all consecutive patients who undergone at least 1 successful BVS implantation. As a part of it, a subgroup analysis in STEMI patients was performed and the outcomes of this cohort compared to the remaining population (defined as "non-STEMI") are reported here. RESULTS: Among the 1505 patients enrolled, 317 (21.1%) had STEMI on admission. Among those, 232 (73.2%) underwent primary percutaneous coronary intervention (PCI) within 12â¯h from symptom onset; 64 (20.2%) were late-comers (>12â¯h); 16 (5%) underwent PCI after successful thrombolysis while 5 (1.6%) underwent rescue-PCI. At a median follow-up time of 12â¯months (IQR 6-20â¯months) no differences were noticed between STEMI and "non-STEMI" groups in terms of device-oriented composite endpoint (4.1% vs. 5.6%; pâ¯=â¯0.3) and its singular components: ischemia-driven target lesion revascularization (3.2% vs. 3.6%; pâ¯=â¯0.7), target-vessel myocardial infarction (3.2% vs. 2.8%; pâ¯=â¯0.7) and cardiac death (0.6% vs. 0.6%; pâ¯=â¯0.9). The rate of definite/probable scaffold thrombosis (ScT) was numerically higher but not significant in the STEMI group (2.5% vs. 1.3%; pâ¯=â¯0.1). CONCLUSIONS: BVS implantation in an unrestricted cohort of STEMI patients is associated with a numerically higher rate of ScT compared to the non-STEMI group. Further studies exploring the potential clinical impact of a pre-specified BVS implantation strategy in this high-risk clinical setting are needed.
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Implantes Absorbibles/tendencias , Prótesis Vascular/tendencias , Sistema de Registros , Infarto del Miocardio con Elevación del ST/cirugía , Injerto Vascular/tendencias , Anciano , Estudios de Cohortes , Femenino , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/tendencias , Estudios Prospectivos , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/epidemiología , Andamios del Tejido/tendencias , Injerto Vascular/métodosRESUMEN
OBJECTIVES: To compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS. BACKGROUND: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. METHODS: We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry. RESULTS: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints. CONCLUSIONS: Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. © 2017 Wiley Periodicals, Inc.
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Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Everolimus/administración & dosificación , Isquemia Miocárdica/cirugía , Intervención Coronaria Percutánea/instrumentación , Anciano , Fármacos Cardiovasculares/efectos adversos , Angiografía Coronaria , Everolimus/efectos adversos , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Recurrencia , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
AIMS: The aim of this study was to assess outcomes following Absorb bioresorbable scaffold (BVS) implantation in an unrestricted clinical practice according to an "on-label" versus "off-label" indication. METHODS AND RESULTS: RAI is a prospective registry, investigating BVS performance in different lesion subsets. No specific exclusion criteria were applied. Co-primary endpoints were target lesion revascularisation (TLR) and definite/probable scaffold thrombosis (ScT) at one year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients, BVS was implanted in at least one off-label subset according to the manufacturer's instructions for use. Predilatation was performed in 98.5% of the cases, and post-dilatation in 96.8%. At one-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% vs. 2.2%, HR 1.8, 95% CI: 1.0-3.4; p=0.05) while a trend towards a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%, HR 2.7, 95% CI: 0.9-8.2; p=0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR. CONCLUSIONS: Our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcomes when meticulously implanted. However, a higher rate of adverse events was observed when this device was used in off-label lesions.
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Implantes Absorbibles , Intervención Coronaria Percutánea , Humanos , Estudios Prospectivos , Sistema de Registros , Resultado del TratamientoRESUMEN
The Absorb biovascular scaffold (BVS) is a bioresorbable, everolimus-eluting scaffold whose data on real-world patients with complex lesions are limited. Short-term follow-up from recent studies point to a higher rate of 30-day thrombosis than observed with drug-eluting stents. We aimed to understand the short-term safety and efficacy of BVS. Registro Absorb Italiano (RAI, ClinicalTrials.gov:NCT02298413) is an Italian, prospective, multicenter registry not funded, whose aim is to investigate BVS performance through a 5-year follow-up of all consecutive patients who have undergone successful implantation of ≥1 BVS in different clinical/lesion subsets. Co-primary end points were target lesion revascularization and definite/probable thrombosis. Secondary end point was the occurrence of device-oriented cardiac events. The registry involved 23 centers, with patient enrollment from October 2012 to December 2015. We here report the 30-day outcomes of the whole population of the registry. We enrolled 1,505 consecutive patients, of which 82% were men and 22.4% diabetic. At presentation, 59.6% of the patients had an acute coronary syndrome, including 21% ST-elevation myocardial infarction. All lesions were pre-dilated and in 96.8% of the cases BVS was post-dilated. At 30 days, the co-primary study end point target lesion revascularization occurred in 0.6% of patients and definite/probable BVS thrombosis in 0.8%. There were 2 cases of cardiac and overall death (0.13%). Device-oriented cardiac events occurred in 1% of the patients. In conclusion, our data of consecutive patients suggest that current use of BVS in a wide spectrum of coronary narrowings and clinical settings is associated with good outcome at 30 days.