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Introduction: Significant advances have been made in the diagnosis and treatment of coronary artery disease over the years. New generations of scaffolds containing novel material and eluting drug have produced one of the most significant advancements in coronary intervention. The newest generation would be Magmaris with a magnesium frame and a sirolimus cover. Methods: From July 2018 to August 2020, 58 patients treated with Magmaris at the University Medical Center Ho Chi Minh City were enrolled in this study. Results: A total of 60 lesions were stented, 60.3% of which were left anterior descending (LAD) lesions. There was no in-hospital event. Within 1â year after discharge, we noted one myocardial infarction event that required target-lesion revascularization, one stroke event, one non-target-lesion revascularization patient, two target-vessel revascularization patients, and one in-stent thrombosis. Among them, one myocardial infarction occurrence, one non-target-lesion revascularization, and one in-stent thrombosis event were recorded within the first 30â days after discharge. Conclusion: In conclusion, the Magmaris scaffold is a safe and effective option for structural procedures performed with imaging device support, particularly intravascular ultrasound.
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BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the standard of care after coronary stenting, including coronary stenting involving bioresorbable scaffolds (BRSs). Current clinical guidelines recommend at least 12 months of DAPT after BRS implantation. However, the correlation between prolonged DAPT and net clinical benefits remains unknown. METHODS: The SPARTA trial is designed to be a prospective, randomized, parallel-group, clinical trial. It aims to compare the benefits and risks of DAPT applied for either 12 or 36 months after XINSORB BRS implantation. The primary endpoints are the incidence of the composite endpoint of major adverse cardiac events (MACEs), including all-cause death, any myocardial infarction (MI), and all revascularizations, as well as Bleeding Academic Research Consortium Definition (BARC) type 3 or 5 bleeding events. The secondary endpoints of the study include the device-oriented composite endpoint of target lesion failure (defined as cardiac death, target vessel-related MI, or ischemia-driven target lesion revascularization), target vessel failure (defined as cardiac death, MI, or ischemia-driven target vessel revascularization), scaffold thrombosis, and minor bleeding events. This trial will enroll 2106 subjects treated with the XINSORB BRS only. All subjects will receive DAPT after the index procedure for 12 (± 1) months. Subjects without MACEs or major bleeding will be randomized to receive either 24 additional months of DAPT or aspirin alone. DISCUSSION: This trial is designed to investigate the impact of extending the duration of DAPT up to 3 years after XINSORB BRS implantation by investigating the balance of risks and benefits in a broad population of treated patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04501900 . Registered on 6 August 2020.
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Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Inhibidores de Agregación Plaquetaria/efectos adversos , Implantes Absorbibles , Estudios Prospectivos , Aspirina/efectos adversos , Infarto del Miocardio/etiología , Infarto del Miocardio/tratamiento farmacológico , Hemorragia/inducido químicamente , Hemorragia/prevención & control , Hemorragia/tratamiento farmacológico , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Quimioterapia Combinada , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Background: The magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>2 years) in all-comer populations remain scarce. Methods: We analyzed data from a single-center registry, including patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), who had undergone percutaneous coronary intervention (PCI) using the Mg-BRS. The primary outcome comprised the device-oriented composite endpoint (DoCE) representing a hierarchical composite of cardiac death, ScT, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) up to 5 years. Results: In total, 84 patients [mean age 62 ± 11 years and 63 (75%) men] were treated with the Mg-BRS devices between June 2016 and March 2017. Overall, 101 lesions had successfully been treated with the Mg-BRS devices using 1.2 ± 0.4 devices per lesion. Pre- and postdilatation using dedicated devices had been performed in 101 (100%) and 98 (97%) of all the cases, respectively. After a median follow-up time of 62 (61-64) months, 14 (18%) patients had experienced DoCEs, whereas ScT was encountered in 4 (4.9%) patients [early ScTs (<30 days) in three cases and two fatal cases]. In 4 (29%) of DoCE cases, optical coherence tomography confirmed the Mg-BRS collapse and uncontrolled dismantling. Conclusion: In contradiction to earlier studies, we encountered a relatively high rate of DoCEs in an all-comer cohort treated with the Mg-BRS. We even observed scaffold collapse and uncontrolled dismantling. This implicates that this metal-based BRS requires further investigation and may only be used in highly selected cases.
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Bioresorbable scaffolds (BRS) emerged as an alternative to conventional stents with a fundamental idea, to avoid a permanent metallic cage with all its harmful effects on the vessel. The Absorb BVS was the first widely studied device with the promising concept of performing a percutaneous coronary intervention, giving the necessary initial support to maintain vessel integrity and avoid acute vessel thrombosis. After a period, complete resorption of the device without leaving in the vessel any metallic structure would theoretically offer several benefits as the reduction of the inflammatory response and recovering normal vasomotor function, recovering access of jailed side-branches and segments for surgical revascularization, and the reduction of very late stent thrombosis derived from late acquired malapposition. However, cumulative evidence from the different absorb randomized trials (ABSORB II, ABSORB III, ABSORB China, ABSORB Japan) raised significant concerns, due to an elevated rate of scaffold thrombosis, target lesion failure and target vessel failure, when compared to contemporary everolimus drug-eluting stents. Several mechanisms arose explaining scaffold failure; some were strictly related to the device itself, and others related to the operator and the lesion itself. Newer generation BRS are under development targeting the main limitations of the ABSORB BVS, mainly focusing on reducing strut thickness, improving the mechanical structure with faster resorption times, and a better crossing profile. The story of BRS is not over yet, with ongoing refinements in the quest for the ideal stent.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Trombosis , Implantes Absorbibles , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Intervención Coronaria Percutánea/efectos adversos , Diseño de Prótesis , Stents , Resultado del TratamientoRESUMEN
BACKGROUND: Magnesium Reabsorbable Scaffold (MRS), is the newest reabsorbable technology with low thrombogenicity, short scaffolding time and almost complete resorption at 12-months (95%). Preliminary 12-months data in selected patients has shown that safety and efficacy are comparable with second generation Drug Eluting Stent (DES). Magmaris Multicenter registry showed 1-and 2-years clinical outcome on the first patients suitable for MRS enrolled in 4 Italian centers. METHODS: We evaluated 12- and 24-months clinical results in "real world" experience with Magnesium Reabosrbable Scaffold in terms of Target Lesion Failure (TLF) and scaffold thrombosis (ST). TLF is the primary endpoint and was defined as composite of cardiac mortality, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). 4P's strategy (Patient/lesion selection, Pre-dilatation, Proper scaffold sizing and Post-dilatation) was strongly recommended. Dual Antiplatelet Therapy (DAPT) has been recommended for 12 months. RESULTS: Data from 207 patients, including initial experience, have been collected. Patients were 83% male, 20% diabetic and Acute Coronary Syndrome (ACS) in 23%. Lesion type were A-B1 in 54% and B2C in 46%. 4P's strategy was respected in 94%. Procedural success was 98% (2% peri-procedural MI). Compliance at 12-months follow up was 97.6%, TLF rate was 5.4% (including 1 case of myocardial infarction with late scaffold thrombosis (ST), all patients were successfully treated with in-scaffold segment DES implantation). At 24-months compliance was 92.8% (192 patients) and TLF was 7.4%. In the period between 13 and 24 months only 4 patients had TLF (including 1 case of myocardial infarction, all patients were successfully treated with in-scaffold segment DES implantation). None of the patients died for a cardiac reason. CONCLUSION: Our 2-years results confirm safety and efficacy showed at 12-months, reinforcing long-term performance with only 2% rate of TLF increase and no ST after 1 year.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Trombosis , Implantes Absorbibles , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Magnesio , Masculino , Infarto del Miocardio/etiología , Infarto del Miocardio/terapia , Diseño de Prótesis , Sistema de Registros , Trombosis/etiología , Resultado del TratamientoRESUMEN
BACKGROUND: Permanent drug-eluting stents are associated with a steady increase in late complications attributed to persistent inflammation and poor vessel remodelling. Bioresorbable scaffolds have been developed to overcome such long-term limitations by providing temporary vessel support and disappearing thereafter. We aimed to assess the long-term outcomes of an absorbable metallic scaffold at 5 years. METHODS: BIOSOLVE-II is an international, multi-centre, first-in-human study assessing the safety and performance of the sirolimus-eluting absorbable metal scaffold DREAMS 2G (commercial name Magmaris) in patients with a maximum of two de novo lesions. After 3 years, follow-up was extended to 5 years with the endpoints of target lesion failure and rate of definite or probable stent thrombosis. RESULTS: A total of 123 patients with 123 lesions were enrolled. Lesions were 12.6 ± 4.5 mm long and 2.7 ± 0.4 mm in diameter, 43.4% were class B2/C lesions, and calcification was moderate to severe in 10.6%. At 5 years, 5.4% of patients had stable angina and 94.6% had no symptoms or ischaemia. Target lesion failure rate was 8.0% [95% confidence interval:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarctions, and 6 clinically driven target lesion revascularizations (TLRs). Only one target lesion failure occurred beyond 3 years: a target-vessel myocardial infarction with clinically driven TLR on post-procedure day 1157. One additional non-cardiac death beyond 3 years due to renal failure was reported on day 1777. No definite or probable scaffold thrombosis was observed. CONCLUSION: The Magmaris scaffold showed favourable long-term safety and clinical performance with low target lesion failure rates and absence of definite or probable scaffold thrombosis throughout 5 years.
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Enfermedad de la Arteria Coronaria , Infarto del Miocardio , Intervención Coronaria Percutánea , Implantes Absorbibles , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Humanos , Metales , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Estudios Prospectivos , Sirolimus/efectos adversos , Resultado del TratamientoRESUMEN
AIMS: We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure. METHODS AND RESULTS: A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT. CONCLUSION: Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Implantes Absorbibles , Austria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Diseño de Prótesis , Sistema de Registros , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The in-stent restenosis (ISR) rates are reportedly inconsistent despite the increased use of second-generation drug eluting stent (DES). Although bioresorbable vascular scaffold (BVS) have substantial advantages with respect to vascular restoration, the rate of scaffold thrombosis is higher with BVS than with DES. Optimal treatment strategies have not been established for DES-ISR to date. CASE SUMMARY: We report on a case of a 60-year-old man patient with acute coronary syndrome. He had a history of ST-segment elevation myocardial infarction associated with very late scaffold thrombosis and treated with a DES. Coronary angiography revealed significant stenosis, suggesting DES-ISR on the previous BVS. Optical coherence tomography (OCT) identified a plaque rupture and a disrupted scaffold strut in the neointimal proliferation of DES. To treat the DES-ISR on the previous BVS, we opted for a drug-coated balloon (DCB) after a balloon angioplasty using a semi-compliant and non-compliant balloon. The patient did not experience adverse cardiovascular events on using a DCB following the use of intensive dual antiplatelet therapy and statin for 24 mo. CONCLUSION: This case highlights the importance of OCT as an imaging modality for characterizing the mechanism of target lesion failure. The use of a DCB following the administration of optimal pharmacologic therapy may be an optimal strategy for the treatment and prevention of recurrent BVS thrombosis and DES-ISR.
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Although a domestic trial in Japan revealed that Absorb bioresorbable vascular scaffold (BVS) has no inferiority to everolimus-eluting stent (EES) cohort in the primary endpoint of the target lesion failure at 12 months, the scaffold/stent thrombosis (ST) rates with the BVS at 24 months were higher than those with the EES (Absorb BVS 3.1% vs. EES 1.5%), the ST rate of 3.1% with Absorb BVS is not an acceptable level in Japan. A cause-of-ST analysis revealed that cases in which diagnostic imaging and ensuing post-dilatation had been performed appropriately had lower ST rates than those without such management (within 1 year: 1.37% vs. 7.69%, from 1 to 2 years: 0.00% vs. 8.33%). Therefore, a further evaluation was needed to confirm that the ST rate with the Absorb BVS would be reduced by a proper implementation procedure. Regulatory approval was given conditionally to initiate rigorous post-marketing data collection in order to ensure the proper use of this device in limited facilities. The One-year Use-Result Survey in Japan for the Absorb BVS revealed no instances of ST. This approach to reducing the premarket regulatory burden of clinical trials and enhancing the post-marketing commitments of medical device regulation is useful for expediting patient access to innovative medical devices.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Implantes Absorbibles , Everolimus , Humanos , Japón , Diseño de Prótesis , Resultado del TratamientoRESUMEN
Percutaneous coronary intervention, which is safe, effective, and timely, has become an important treatment for coronary artery diseases and has been widely used in clinical practice. However, there are still some problems that urgently need to be solved. Permanent vessel caging through metallic implants not only prevents the process of positive vessel remodeling and the restoration of vascular physiology but also makes the future revascularization of target vessels more difficult. Bioresorbable scaffolds (BRSs) have been developed as a potential solution to avoid the above adverse reactions caused by permanent metallic devices. BRSs provide temporary support to the vessel wall in the short term and then gradually degrade over time to restore the natural state of coronary arteries. Nonetheless, long-term follow-up of large-scale trials has drawn considerable attention to the safety of BRSs, and the significantly increased risk of late scaffold thrombosis (ScT) limits its clinical application. In this review, we summarize the current status and clinical experiences of BRSs to understand the application prospects and limitations of these devices. In addition, we focus on ScT after implantation, as it is currently the primary drawback of BRS. We also analyze the causes of ScT and discuss improvements required to overcome this serious drawback and to move the field forward.
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BACKGROUND: Device underexpansion is associated with late adverse outcomes after bioresorbable vascular scaffold (BVS) implantation. This study, representing official IVUS results of the ABSORB Japan trial, aimed to characterize IVUS findings, focusing specifically on acute device expansion, and to investigate its impact on late lumen loss (LLL) with Absorb-BVS compared with cobalt-chromium everolimus-eluting stents (CoCr-EES). METHODS: ABSORB Japan enrolled 148 patients (2:1 randomization) in the IVUS cohort. Serial IVUS was prescheduled at post-procedure and 3 years. Acute device expansion was evaluated with respect to the degree and uniformity of the implanted device. RESULTS: Overall, Absorb-BVS showed smaller and more nonuniform device expansion at post-procedure, compared with CoCr-EES, which was particularly prominent in small-vessel lesions. In serial analysis, Absorb-BVS showed unique associations of smaller device expansion (r = 0.40, p = 0.001) and more nonuniformity (r = 0.29, p = 0.007) at post-procedure with greater LLL at 3 years, primarily attributable to greater negative remodeling (r = 0.39, p = 0.006). In contrast, acute device expansion showed no relation with subsequent lumen change in CoCr-EES. In Absorb-BVS, ischemic-driven target lesion or vessel revascularization (ID-TLR or ID-TVR) at 3 years occurred more frequently in small- versus large-vessel lesions (12.5% vs. 0%, p = 0.04 for ID-TLR and 15.6% vs. 2.3%, p = 0.08 for ID-TVR). Conversely, Absorb BVS had no target lesion nor vessel failure, even in small-vessel lesions, when adequate device expansion was achieved at post-procedure. CONCLUSIONS: Unlike CoCr-EES, underexpansion was associated with greater negative remodeling and LLL in Absorb-BVS. This may in part account for the poorer outcomes of Absorb-BVS than CoCr-EES when under-expanded.
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INTRODUCTION: The technology of bioresorbable scaffold (BRS) spread out after the success of the first-in-man trials of the Absorb. However, the randomized trials demonstrated that major adverse cardiac events and scaffold thrombosis rates of the first-generation Absorb were higher than those of the metallic everolimus-eluting stent. To overcome the shortcoming of the firstly commercialized Absorb, novel technologies have been developed. AREAS COVERED: In this review, we overviewed the field of BRS in the treatment of coronary, peripheral artery and gastrointestinal fields. To date, 10 BRS devices developed by 6 manufacturers have acquired the CE mark in coronary artery disease. Currently 8 BRS are in clinical trial phase, whereas 7 BRS are in preclinical assessment phase. Most new-generation devices have a strut thickness of less than 100 µm. However, late favorable outcome might be achieved not only by device refinement but also by a proper technique of implantation using intra vascular imaging guidance, as well as with a careful patient and lesion selection. EXPERT OPINION: New-generation BRS will be soon tested in the clinical arena to demonstrate improved acute and long-term of safety and efficacy.
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Implantes Absorbibles , Stents Liberadores de Fármacos , Enfermedad Arterial Periférica/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Everolimus/administración & dosificación , Humanos , Andamios del Tejido , Resultado del TratamientoRESUMEN
AIMS: The ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (MACE). Therefore, we evaluated the impact of SScD compared to large scaffold diameter (LScD, ≥3 mm) of ≤18 mm device length on 2 year outcome in the all-comer real life GABI-R cohort. METHODS AND RESULTS: We compared patients with implanted LScD (1341 patients) vs. SScD (444 patients) of ≤18 mm device length. Patients with LScD more often presented with ST-elevation myocardial infarction (35.8% vs. 20.6%, p < 0.0001) and single-vessel disease (50.6% vs. 36.5% p < 0.0001). After a 24 months follow-up, there was no difference in regard of MACE (9.66% vs. 12.31%, p = 0.14) or definite/probable ST (2.47% vs. 2.82%, p = 0.71). Despite no difference in target lesion revascularisations (TLR) (5.81% vs. 7.71%, p = 0.18), there was a higher need for target vessel revascularisation (TVR) in the SScD-group (11.57% vs. 7.51%, p < 0.05). CONCLUSION: Compared to LScD, SScD of ≤18 mm device length demonstrated comparable safety in regard to MACE and ScT as well as efficacy in regard to TLR. Resorbable scaffold technology should not be restricted to large vessel diameters. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02066623.
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BACKGROUND: In bioresorbable vascular scaffolds (BVSs), there is some concern about a possible increase in the rate of scaffold thromboses (ScTs). Although several characteristics similarly contribute to the development of both early and late ScTs, there are also clearly different pathomechanisms between the two time-dependent types of thromboses, especially with BVSs. CASE PRESENTATION: We recently experienced a very rare case of a 69-year-old man who had recurrent early and late ScTs with somewhat differing pathomechanisms as assessed by optical coherence tomography (OCT). For the late ScT, OCT identified a scaffold dismantling in the same place that a peri-strut low intensity area (PLIA) was observed in the previous OCT finding. CONCLUSION: We report the management of an ScT in a case with findings such as a heterogeneous a BVS degradation, peri-strut low intensity area (PLIA), intraluminal scaffold dismantling, and under-sizing and/or stent malapposition observed in OCT.
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Implantes Absorbibles , Angioplastia Coronaria con Balón/instrumentación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Trombosis Coronaria/diagnóstico por imagen , Stents , Tomografía de Coherencia Óptica , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Trombosis Coronaria/etiología , Trombosis Coronaria/terapia , Humanos , Masculino , Valor Predictivo de las Pruebas , Recurrencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Bioresorbable scaffolds have been introduced to overcome the shortcomings of drug-eluting stents. Higher rates of device thrombosis, however, have been reported up to 3 years after implantation of the Absorb bioresorbable vascular scaffold (BVS). In the current article, we therefore report long-term clinical outcomes of the AMC Absorb Registry. METHODS AND RESULTS: In the AMC Absorb Registry, all patients who underwent a percutaneous coronary intervention with Absorb BVS implantation between 30 August 2012 and 5 August 2013â¯at the Amsterdam University Medical Centre-Academic Medical Centre were included. The composite endpoint of this analysis was target-vessel failure (TVF). The median follow-up of the study cohort of the AMC Absorb Registry was 1534 days. At the time of the cross-sectional data sweep the clinical status at 4 years was known in 124 of 135 patients (91.9%). At long-term follow-up, the composite endpoint of TVF had occurred in 27 patients. The 4year Kaplan-Meier estimate of TVF was 19.8%. At 4 years cardiac death had occurred in 4 patients (3.2%) and target-vessel myocardial infarction in 9 (6.9%) patients. Definite scaffold thrombosis occurred in 5 (3.8%) patients. We found 1 case of very late scaffold thrombosis that occurred at 911 days after device implantation in a patient who was not on dual anti-platelet therapy. CONCLUSION: In a patient population reflecting routine clinical practice, we found that cases of TVF continued to accrue beyond 2 years after Absorb BVS implantation.
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PURPOSE: Everolimus-eluting bioresorbable scaffolds (BRS) demonstrated an increased risk of very late scaffold thrombosis (VLScT) in comparison with conventional drug-eluting stents. However, characterization of VLScT cases remains scant and the role of interim angiographic surveillance in identifying patients at risk of VLScT is unclear. We therefore set out to identify angiographic predictors of VLScT in our present case series. METHODS: We analyzed a series of consecutive patients with VLScT presenting to two centers in Munich, Germany. Of interest, all patients had undergone interim planned surveillance angiography. Angiographic films were collected and reviewed and quantitative coronary angiography analysis was done at a core laboratory. Optical coherence tomography (OCT) images at presentation with VLScT were analyzed in patients with available data. RESULTS: Nine patients presented with 10 VLScT events. Mean age was 62.6â¯years. Surveillance angiography (between 159 and 476â¯days) were unremarkable in all cases. Time from index intervention to VLScT ranged from 393 to 1494â¯days. Nine of 10 events occurred after discontinuation of dual antiplatelet therapy. Four patients underwent OCT. The dominant finding at the time of VLScT was scaffold discontinuity. CONCLUSIONS: In a series of patients with VLScT after treatment with BRS, routine interim surveillance angiography was available in all patients and failed to identify features predictive of subsequent adverse events.
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Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Trombosis Coronaria/diagnóstico por imagen , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Tomografía de Coherencia Óptica , Anciano , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Trombosis Coronaria/etiología , Terapia Antiplaquetaria Doble , Everolimus/efectos adversos , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Valor Predictivo de las Pruebas , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Diabetes mellitus (DM) patients show higher rates of repeat revascularisation even in the era of modern drug-eluting stents (DES). The concept of bioresorbable scaffolds is becoming captivating, as it might allow for repeat interventions, prolonging the time span during which patients can be treated by percutaneous coronary intervention (PCI). AIMS: We intend to evaluate the short- and long-term safety and efficacy of Absorb bioresorbable vascular scaffolds (Absorb BVS) in the treatment of coronary artery disease (CAD) in DM patients for any indication. METHODS: The ABSORB DM Benelux is an international prospective study in DM patients who have undergone PCI with ≥1 Absorb BVS. Major adverse cardiac events (MACE) at 1 year was the primary endpoint, defined as a composite of all-cause death, any myocardial infarction (MI) and ischaemia-driven target vessel revascularisation (TVR). Secondary endpoints were target lesion failure (TLF) and definite or probable scaffold thrombosis (ScT). RESULTS: Between April 2015 and March 2017, 150 DM patients and 188 non-complex lesions were treated. Device implantation was successful in 100%. MACE occurred in 14 (9.5%) patients, with all-cause death occurring in 4 (2.7%), any MI in 6 (4.1%) and ischaemia-driven TVR in 7 (4.8%) respectively. TLF was reported in 11 (7.5%). Definite and probable ScT was observed in 2 (1.4%). CONCLUSION: Absorb BVS for treatment of anatomically low-risk patients with DM show acceptable safety and efficacy outcomes at 1 year. If these promising results are confirmed after a longer follow-up period, new-generation bioresorbable scaffolds combined with refinement of implantation techniques might open new horizons for CAD treatment in DM patients.
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The Academic Research Consortium (ARC) and the Standardized Data Collection for Cardiovascular Trials Initiative have recently published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials. The aim of this document is to provide practical guidance to facilitate and harmonize the implementation of those definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees. The authors compared the ARC-2 and Standardized Data Collection for Cardiovascular Trials Initiative definitions to identify areas of consistency, complex scenarios, and definitions in need of further standardization. Furthermore, the authors compared the fourth universal definition of myocardial infarction with the ARC-2 definition of myocardial infarction. The Society for Cardiovascular Angiography and Interventions definition of periprocedural myocardial infarction was also compared with the ARC-2 definition and the fourth universal definition of myocardial infarction. An in-depth assessment was done for each individual clinical endpoint to guide clinical investigators on reporting and classifying clinical adverse events. Finally, the authors propose standard streamlined data capture templates for reporting and adjudicating death, myocardial infarction, stroke, revascularization, stent or scaffold thrombosis, and bleeding.
Asunto(s)
Enfermedad Coronaria/terapia , Determinación de Punto Final/normas , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Proyectos de Investigación/normas , Angiografía Coronaria/normas , Enfermedad Coronaria/diagnóstico por imagen , Enfermedad Coronaria/mortalidad , Trombosis Coronaria/etiología , Trombosis Coronaria/mortalidad , Hemorragia/etiología , Hemorragia/mortalidad , Humanos , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/mortalidad , Recurrencia , Medición de Riesgo , Factores de Riesgo , Stents/normas , Terminología como Asunto , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options. METHODS: The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT). RESULTS: Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT. CONCLUSION: EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registered.