RESUMO
OBJECTIVES: To compare the efficacy and safety of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (O-SES) in patients with and without acute coronary syndrome (ACS) included in the SORT OUT X study. BACKGROUND: The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with ACS when compared to patients without ACS. Whether the results from the SORT OUT X study apply to patients with and without ACS remains unknown. METHODS: In total, 3146 patients were randomized to stent implantation with DTS (n = 1578; ACS: n = 856) or O-SES (n = 1568; ACS: n = 854). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year. RESULTS: At 1 year, the rate of TLF was higher in the DTS group compared to the O-SES group, both among patients with ACS (6.7% vs. 4.1%; incidence rate ratio: 1.65 [95% confidence interval, CI: 1.08-2.52]) and without ACS (6.0% vs. 3.2%; incidence rate ratio: 1.88 [95% CI: 1.13-3.14]). The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without ACS CONCLUSION: Compared to the O-SES, the DTS was associated with a higher risk of TLF at 12 months in patients with and without ACS. The differences were mainly explained by higher rates of TLR.
Assuntos
Síndrome Coronariana Aguda , Fármacos Cardiovasculares , Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Sirolimo/efeitos adversos , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/terapia , Síndrome Coronariana Aguda/complicações , Doença da Artéria Coronariana/terapia , Fatores de Risco , Resultado do Tratamento , Intervenção Coronária Percutânea/efeitos adversos , Implantes Absorvíveis , Fármacos Cardiovasculares/efeitos adversos , Fatores de Tempo , Desenho de Prótese , Infarto do Miocárdio/etiologia , Stents Farmacológicos/efeitos adversosRESUMO
BACKGROUND: Target lesion failure remains an issue with contemporary drug-eluting stents. Thus, the dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo stent (DTS) was designed to further improve early healing. This study aimed to investigate whether the DTS is noninferior to the sirolimus-eluting Orsiro stent (SES) in an all-comers patient population. METHODS: The SORT OUT X (Combo Stent Versus Orsiro Stent) trial, was a large-scale, randomized, multicenter, single-blind, 2-arm, noninferiority trial with registry-based follow-up. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction, or target lesion revascularization within 12 months, analyzed using intention-to-treat. The trial was powered for assessing target lesion failure noninferiority of the DTS compared with the SES with a predetermined noninferiority margin of 0.021. RESULTS: A total of 3146 patients were randomized to treatment with the DTS (1578 patients; 2008 lesions) or SES (1568 patients; 1982 lesions). At 12 months, intention-to-treat analysis showed that 100 patients (6.3%) assigned the DTS and 58 patients (3.7%) assigned the SES met the primary end point (absolute risk difference, 2.6% [upper limit of 1-sided 95% CI, 4.1%]; P (noninferiority)=0.76). The SES was superior to the DTS (incidence rate ratios for target lesion failure, 1.74 [95% CI, 1.26-2.41]; P=0.00086). The difference was explained mainly by a higher incidence of target lesion revascularization in the DTS group compared with the SES group (53 [3.4%] vs. 24 [1.5%]; incidence rate ratio, 2.22 [95% CI, 1.37-3.61]; P=0.0012). CONCLUSIONS: The DTS did not confirm noninferiority to the SES for target lesion failure at 12 months in an all-comer population. The SES was superior to the DTS mainly because the DTS was associated with an increased risk of target lesion revascularization. However, rates of death, cardiac death, and myocardial infarction at 12 months did not differ significantly between the 2 stent groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03216733.
Assuntos
Antibacterianos/uso terapêutico , Antígenos CD34/metabolismo , Stents Farmacológicos/normas , Intervenção Coronária Percutânea/métodos , Sirolimo/uso terapêutico , Idoso , Antibacterianos/farmacologia , Feminino , Humanos , Masculino , Sirolimo/farmacologia , Resultado do TratamentoRESUMO
OBJECTIVES: To compare the efficacy and safety of the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study. BACKGROUND: The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown. METHODS: In total 3146 patients were randomized to stent implantation with DTS (n = 1578; DM: n = 279) or SES (n = 1568; DM: n = 271). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year. RESULTS: At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02-3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15-2.42). The differences were mainly explained by higher rates of TLR. CONCLUSION: Compared to the SES, the DTS was associated with an increased risk of TLF at 12 months in patients with and without DM. The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without DM.
Assuntos
Doença da Artéria Coronariana , Diabetes Mellitus , Infarto do Miocárdio , Intervenção Coronária Percutânea , Implantes Absorvíveis , Antígenos CD34/imunologia , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/terapia , Morte , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiologia , Humanos , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Sirolimo/efeitos adversos , Stents , Resultado do TratamentoRESUMO
BACKGROUND: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention. METHODS: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021. RESULTS: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; Pnoninferiority=0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; P<0.0001). CONCLUSIONS: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.
Assuntos
Implantes Absorvíveis , Anti-Inflamatórios , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/efeitos adversos , Polímeros , Sirolimo/análogos & derivados , Idoso , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/etiologia , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
OBJECTIVES: In this substudy of the SORT OUT VII trial, the clinical outcomes among patient with diabetes mellitus treated with Orsiro sirolimus-eluting stent (O-SES; Biotronik, Bülach, Switzerland) or Nobori biolimus-eluting stent (N-BES; Terumo, Tokyo, Japan) were compared. BACKGROUND: Diabetes is associated with increased risk of target lesion failure (TLF) after percutaneous coronary intervention. METHODS: In total, 2525 patients were randomized to stent implantation with O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). The primary endpoint, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 2 years. RESULTS: At 2 year, TLF did not differ between O-SES vs N-BES in diabetic (9.3% vs 9.4%; RR 0.98, 95% CI 0.54-1.78) patients. The individual components of the primary endpoint did not differ among stent type. In diabetics, cardiac death occurred in 3% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.77, 95% CI 0.29-2.08), MI occurred in 3.0% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.76, 95% CI 0.28-2.06) and TLR occurred in 5,5% of O-SES-treated and in 6.0% of N-BES-treated patients (RR 0.91, 95% CI 0.43-1.95). CONCLUSION: TLF did not differ between O-SES- and N-BES-treated diabetic patients.
Assuntos
Implantes Absorvíveis , Síndrome Coronariana Aguda/terapia , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Diabetes Mellitus , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Polímeros , Sirolimo/análogos & derivados , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/mortalidade , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Medição de Risco , Fatores de Risco , Sirolimo/administração & dosagem , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing. AIMS: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention. METHODS: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR). RESULTS: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups. CONCLUSIONS: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years. CLINICALTRIALS: gov: NCT03216733.
RESUMO
OBJECTIVE: To evaluate the difference in early vascular healing between the ultrathin-strut biodegradable-polymer sirolimus-eluting Orsiro stent (O-SES) and the polymer-free biolimus-A9-eluting BioFreedom stent (BF-BES), assessed with optical coherence tomography (OCT) after primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarctions (STEMIs). METHODS: Eighty patients with STEMI who underwent primary PCI were randomly allocated 1:1 to treatment with BF-BES or O-SES. OCT was acquired after PCI and at 1-month follow-up. The primary endpoint was 1-month OCT-assessed vascular healing index based on the presence of uncovered and malapposed stent struts and intraluminal filling defects where low vascular healing index indicated favorable vascular healing. RESULTS: At 1-month, the vascular healing index was similar in O-SES 11.5 [interquartile range (IQR) 9.5-17.5], compared to BF-BES 11.5 (IQR 7.1-12.5; P = 0.14). Percentage of uncovered struts [O-SES 31.5% (IQR 20.7-41.9), P = 0.43] vs. BF-BES 27.8% (IQR 19.4-41.9; P = 0.44), and median volume of neointimal hyperplasia [O-SES 4.9 mm3 (IQR 1.4-13.1) vs. BF-BES 7.1 mm3 (IQR 2.8-17.0), P = 0.18] did not differ significantly between the two stent groups. Complete coverage was not observed in any of the stents. The percentages of stents with malapposition did not differ significantly (O-SES 87.1% vs. BF-BES 71.4%, P = 0.14) whereas percentage of malapposed struts [O-SES 3.5% (IQR 0.8-5.5) vs. BF-BES 0.8% (IQR 0.0-1.8), P = 0.003] was lower in the BF-BES group. CONCLUSION: In patients with STEMI, the drug-coated BF-BES and the thin strut O-SES had similar vascular healing index at 1-month. However, the thin O-SES struts were more often malapposed.
Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Implantes Absorvíveis , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Polímeros , Desenho de Prótese , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Sirolimo , Stents , Tomografia de Coerência Óptica/métodos , Resultado do TratamentoRESUMO
BACKGROUND: The purpose of a bioresorbable scaffold (BRS) is to provide radial support during coronary healing. In this study, coronary artery healing after optical coherence tomography (OCT)- versus angiography-guided magnesium BRS (MBRS) implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) is compared. METHODS: 75 patients were randomized 1:1 to OCT- or angiography-guided implantation of a MBRS with protocolled pre- and post-dilation. In the OCT-guided group, prespecified criteria indicating additional intervention were (1) scaffold under-expansion, (2) strut malapposition, (3) edge dissection, and (4) residual stenosis at distal or proximal reference segments. The primary endpoint was OCT-derived healing stage at 6 months. RESULTS: At 6 months, there was no difference in average healing stage between OCT- and angiography-guided intervention (4.6 [interquartile range (IQR): 4.5-4.7] versus 4.5 [IQR: 4.3-4.7]; p = 0.54). The MBRSs were completely resolved in 77.0% [IQR: 68.5-85.5] versus 76.5% [IQR: 67.9-85.5]; (p = 0.97). Minimal lumen area (MLA) was reduced at 6 months in both the OCT- (32.3%; p < 0.01) and the angiography-guided group (21.3%; p < 0.01), however OCT-guided implantation was associated with a greater reduction of total lumen volume (-27.1 ± 32.5 mm3 versus -5.0 ± 32.9 mm3; p < 0.01) and MLA (-2.3 ± 1.6 mm2 vs. -1.4 ± 1.4 mm2; p = 0.02). CONCLUSIONS: In NSTEMI patients, OCT-guidance with protocolled pre- and post-dilation of MBRS implantation showed similar healing pattern at 6 months compared to angiography-guidance alone. CLINICAL TRIAL REGISTRATION: The Coronary Artery Healing Process after Optical Coherence Tomography Guided Percutaneous Coronary Intervention with Magmaris Bioresorbable Scaffold in Patients with Non-ST-Segment-Elevation Myocardial Infarction: (HONEST) trial is registered with ClinicalTrials.gov, NCT03016624.
Assuntos
Infarto do Miocárdio sem Supradesnível do Segmento ST , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Implantes Absorvíveis , Angiografia Coronária/métodos , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Humanos , Magnésio , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Desenho de Prótese , Tomografia de Coerência Óptica/métodos , Resultado do TratamentoRESUMO
OBJECTIVES: To compare the early vascular healing of ruptured plaques (RP) and non-ruptured plaques (NRP) one month after primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI), using optical coherence tomography (OCT). BACKGROUND: Vascular healing and strut coverage are important factors in reducing the risk of stent thrombosis after PCI. Influence of underlying lesion characteristics and differences in healing response between RP and NRP are unknown. METHODS: Twenty-six STEMI-patients underwent PCI and implantation of a polymer-free drug-coated Biofreedom stent (BF-BES). OCT was performed pre-PCI, post-PCI and at 1-month follow-up. The patients were divided into two groups: RP = 15 and NRP = 11. OCT analyses of culprit lesion, post stent implantation at baseline and follow-up were performed to determine the difference in vascular healing based on presence of uncovered and/or malapposed stent struts and intraluminal filling defects. RESULTS: The stent coverage did not differ significantly between the two groups at 1-month follow-up with percentage of uncovered struts: RP 26.5% [IQR 15.0-49.0] and NRP 28.1% [IQR 15.5-38.8] for NRP (p = 0.78). At 1-month, RP showed an increased percentage of late acquired malapposed struts (1.4% [IQR 0.8-2.4] vs. 0.0% [IQR 0.0-1.4], p = 0.03) and a larger total malapposition area (1.3 mm2 [IQR 0.4-2.5] vs. 0.0 mm2 [IQR 0.0-0.9], p = 0.01), compared to NRP. CONCLUSION: Three out of four struts were covered within one month after stenting. The vascular healing was comparable in RP and NRP on stent coverage. However, RP had more and larger late acquired malapposition areas.
Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Placa Aterosclerótica , Infarto do Miocárdio com Supradesnível do Segmento ST , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Tomografia de Coerência Óptica , Resultado do TratamentoRESUMO
AIMS: To assess the incidence, timing, and relation of drug-eluting stent (DES) thrombosis to discontinuation of clopidogrel therapy. METHODS AND RESULTS: This prospective observational cohort study included 6816 consecutive patients that underwent successful DES implantation. Primary endpoint was definite stent thrombosis (ST). During 4 years of follow-up, definite ST was observed in 73 patients, corresponding to a cumulative incidence of 1.2%. Cumulative incidence of ST at 30 days was 0.5 and 0.8% at 1 year, respectively. Discontinuation of clopidogrel therapy was significantly associated with ST only in the first 6 months after the procedure (P < 0.001). During that period, the median time interval from clopidogrel discontinuation to ST was 9 days [interquartile range (IQR) 5.5-22.5] while thereafter it was 104.3 days (IQR 7.4-294.8). CONCLUSION: The 4 year incidence of ST after DES implantation is low. A relevant number of ST occur early after discontinuation of clopidogrel therapy. The dependence of ST on discontinuation of clopidogrel therapy seems to be mostly confined to the first 6 months after DES implantation. However, specifically designed randomized studies are required to establish the optimal length of clopidogrel therapy after DES implantation.
Assuntos
Prótese Vascular , Stents Farmacológicos , Oclusão de Enxerto Vascular/etiologia , Inibidores da Agregação Plaquetária/administração & dosagem , Ticlopidina/análogos & derivados , Idoso , Clopidogrel , Angiografia Coronária , Feminino , Oclusão de Enxerto Vascular/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Estudos Prospectivos , Ticlopidina/administração & dosagemRESUMO
BACKGROUND: Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis. METHODS: The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization. RESULTS: A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups. CONCLUSION: At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.
Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Revascularização Miocárdica/métodos , Polímeros , Sirolimo/análogos & derivados , Sirolimo/farmacologia , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Método Simples-Cego , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: This study sought to evaluate the incidence of ruptured plaques and nonruptured plaques (NRP) and to compare patient characteristics and detailed plaque morphology features between the two culprit types in ST-segment elevation myocardial infarction (STEMI) patients, using optical coherence tomography (OCT). METHODS AND RESULTS: Using OCT, the culprit lesions in patients with STEMI were assessed prior to stent implantation. The culprit lesion was categorized as ruptured plaques or NRP, and the plaque components were evaluated. Fifty-two patients (69.3%) presented with ruptured plaques and 23 (30.7%) with NRP. Patients with NRP were younger (58.0 ± 10.4 vs 64.7 ± 9.9 years, P = 0.01) and more often smokers (72.7% vs 37.1%, P = 0.001), compared to ruptured plaques. NRP contained significantly more fibrotic plaque (20.0% [interquartile range (IQR) 13.7-29.8] vs 11.3% [IQR 6.9-18.1], P = 0.005), but less lipidic plaque (44.0% ± 13.7 vs 59.3% ± 13.6, P < 0.001), less superficial [5.0% (IQR 2.8-7.5) vs 8.1% (IQR 5.7-11.0), P = 0.005] and profound macrophages [0.9% (IQR 0.0-1.7) vs 2.2% (IQR 0.9-4.7), P = 0.003]. The prevalence, numbers and lengths of thin-cap fibroatheroma (TCFA) were significantly lower in NRP, compared to ruptured plaques [47.8% vs 88.5%, 0 (IQR 0-1) vs 1 (IQR 1-2) and 0 mm (IQR 0-2.7) vs 4.5 mm (IQR 2.3-7.7), P < 0.001]. CONCLUSIONS: One-third of STEMI patients had culprit lesions without an OCT-detectable ruptured plaque. Culprit lesions with NRP contained less vulnerable plaque components, such as lipid plaque, TCFAs and macrophages compared to ruptured plaques.
Assuntos
Vasos Coronários , Placa Aterosclerótica , Cuidados Pré-Operatórios/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST , Tomografia de Coerência Óptica/métodos , Fatores Etários , Angiografia Coronária/métodos , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Dinamarca/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Placa Aterosclerótica/diagnóstico por imagem , Placa Aterosclerótica/patologia , Fatores de Risco , Ruptura Espontânea , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Índice de Gravidade de Doença , Fumar/epidemiologiaRESUMO
An 81-year-old male patient with a severe de novo coronary artery stenosis in the proximal left anterior descending artery was treated with a BioFreedom stent (3.5×11mm), three months later, the patient was re-admitted with chest pain and slightly increased troponin. The angiogram showed a significant in-stent restenosis in the recently treated lesion. Optical coherence tomography revealed a fully expanded stent without areas of incomplete stent apposition. Severe immature neointimal hyperplasia without formation of thrombosis was visualized, causing a severe in-stent restenosis. An underlying plaque rupture within the mid-proximal part of the in-stent restenosis was evident.
Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Reestenose Coronária/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Tomografia de Coerência Óptica , Idoso de 80 Anos ou mais , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/etiologia , Reestenose Coronária/patologia , Vasos Coronários/patologia , Humanos , Hiperplasia , Masculino , Neointima , Placa Aterosclerótica , Valor Preditivo dos Testes , Desenho de Prótese , Ruptura Espontânea , Sirolimo/administração & dosagem , Fatores de Tempo , Resultado do TratamentoAssuntos
Coração Auxiliar , Parada Cardíaca Extra-Hospitalar/terapia , Choque Cardiogênico/terapia , Função Ventricular Esquerda , Função Ventricular Direita , Idoso , Angiografia Coronária , Stents Farmacológicos , Ecocardiografia , Humanos , Masculino , Parada Cardíaca Extra-Hospitalar/diagnóstico por imagem , Parada Cardíaca Extra-Hospitalar/fisiopatologia , Intervenção Coronária Percutânea/instrumentação , Desenho de Prótese , Recuperação de Função Fisiológica , Choque Cardiogênico/diagnóstico por imagem , Choque Cardiogênico/fisiopatologia , Resultado do TratamentoRESUMO
Clopidogrel is a prodrug that is converted via the hepatic cytochrome P450 system into its active thiol metabolite. Evidence is accumulating that proton pump inhibitors (PPIs) inhibit this enzymatic pathway and may therefore attenuate the antiplatelet effect of clopidogrel. The objective of this study was to investigate whether patients on clopidogrel therapy after drug-eluting stent (DES) placement who also receive a PPI are at higher risk of stent thrombosis (ST). This is a retrospective analysis of patients who received dual antiplatelet treatment including clopidogrel after DES placement. Outcomes were compared according to PPI therapy. The primary endpoint was the incidence of definite ST at 30 days. Secondary endpoints were death, combined death or ST and myocardial infarction (MI). The study population included 3,338 patients and 698 patients (20.9%) received PPIs. Patients receiving a PPI had a higher risk profile at baseline. Multivariate analysis showed that PPI treatment was not independently associated with the occurrence of ST [adjusted HR 1.8 (95% CI: 0.7-4.7), p=0.23] or MI [adjusted HR 1.3 (0.8-2.3), p=0.11]. PPI treatment was significantly associated with death [adjusted HR 2.2 (1.1-4.3), p=0.02] and death or ST [adjusted HR 3.3(1.7-6.7), p=0.02]. Concomitant treatment with a PPI in patients receiving dual antiplatelet treatment after coronary stenting is not an independent predictor of ST. The higher mortality is probably due to confounding as patients on PPIs had a higher risk profile at baseline.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Aspirina/uso terapêutico , Stents Farmacológicos , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Bomba de Prótons/uso terapêutico , Trombose/prevenção & controle , Ticlopidina/análogos & derivados , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Distribuição de Qui-Quadrado , Clopidogrel , Comorbidade , Fatores de Confusão Epidemiológicos , Interações Medicamentosas , Quimioterapia Combinada , Feminino , Alemanha , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Modelos de Riscos Proporcionais , Inibidores da Bomba de Prótons/efeitos adversos , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombose/etiologia , Trombose/mortalidade , Ticlopidina/uso terapêutico , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION AND OBJECTIVES: The relationship between microcirculatory myocardial perfusion grade (MPG), myocardial salvage and long-term mortality after acute ST-segment elevation myocardial infarction (STEMI) and full restoration of epicardial blood flow by primary percutaneous coronary intervention (PCI) remains poorly understood. METHODS: This study included 1213 patients with STEMI and Thrombolysis in Myocardial Infarction (TIMI) grade-3 flow after primary PCI. The MPG was determined and paired scintigraphic studies (before and 7-14 days after the intervention) were performed. The primary outcome was 5-year mortality. RESULTS: The MPG was 0-1 in 217 patients, 2 in 195, and 3 in 801. In patients with an MPG of 0-1, 2 and 3, respectively, the median infarct size was 13% (interquartile range [IQR] 5.6-28%), 12% (IQR 4-27%) and 7% (IQR 1-19%) of the left ventricle, respectively (P< .001), the myocardial salvage index (i.e. the proportion of the initial area at risk that recovered) was 0.44 (IQR 0.22-0.73), 0.46 (IQR 0.25-0.75) and 0.58 (IQR 0.31-0.85), respectively (P< .001), and the Kaplan-Meier estimated 5-year mortality was 16.6% (i.e. 28 deaths), 15.3% (i.e. 25 deaths) and 7.8% (i.e. 48 deaths), respectively. The odds ratio (OR) for death for an MPG of 0-1 vs. 3 was 2.32 (95% confidence interval [CI] 1.42-3.8; P< .001) and for an MPG of 2 vs. 3, 2.3 (95% CI 1.38-3.85; P=.001). The Cox proportional hazards model identified MPG as independently associated with mortality at 5 years: the hazard ratio for an MPG of 3 vs. 0-2 was 0.65 (95% CI 0.41-0.97; P=.037). CONCLUSIONS: In patients with STEMI and TIMI grade-3 flow after primary PCI, suboptimal microcirculatory myocardial perfusion (i.e. MPG < or =2) was associated with poorer myocardial salvage, a larger infarct, and higher 5-year mortality than observed in patients whose tissue perfusion was reestablished (i.e. MPG=3).
Assuntos
Angioplastia Coronária com Balão , Circulação Coronária/fisiologia , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Reperfusão Miocárdica , Pericárdio/fisiologia , Terapia de Salvação , Idoso , Angiografia Coronária , Eletrocardiografia , Determinação de Ponto Final , Feminino , Seguimentos , Humanos , Masculino , Microcirculação/fisiologia , Pessoa de Meia-Idade , Infarto do Miocárdio/patologia , Miocárdio/patologia , Tomografia Computadorizada de Emissão de Fóton Único , Resultado do TratamentoRESUMO
Introducción y objetivos. La relación entre el grado de perfusión miocárdica (GPM), el rescate miocárdico y la mortalidad a largo plazo tras el infarto agudo de miocardio con elevación del segmento ST (IAMEST) y restablecimiento pleno del flujo sanguíneo epicárdico con una intervención coronaria percutánea (ICP) primaria continúa sin conocerse bien. Métodos. Participaron en el estudio 1.213 pacientes con IAMEST y un flujo de grado Thrombolysis in Myocardial Infarction (TIMI) 3 tras la ICP primaria. Se realizaron determinaciones del GPM y dos exploraciones gammagráficas (antes y 7-14 días después de la intervención). La variable de valoración principal fue la mortalidad a 5 años. Resultados. Se observó un GPM de 0-1, 2 o 3 en un total de 217, 195 y 801 pacientes, respectivamente. En los grupos con un GPM 0-1, 2 y 3, los tamaños del infarto (mediana [cuartiles 25-75]) fueron del 13% [5,6%- 28%], el 12% [4%-27%] y el 7% [1%-19%] del ventrículo izquierdo, respectivamente (p < 0,001); los índices de rescate (proporción del área inicial en riesgo que se rescata) fueron 0,44 [0,22-0,73], 0,46 [0,25-0,75] y 0,58 [0,31-0,85], respectivamente (p < 0,001); las estimaciones de Kaplan-Meier de la mortalidad a 5 años fueron del 16,6% (28 muertes), el 15,3% (25 muertes) y el 7,8% (48 muertes); con una odds ratio (OR) = 2,32 (intervalo de confianza [IC] del 95%, 1,42-3,8) (p < 0,001) para GPM 0-1 frente a GPM 3, y OR = 2,3 (IC del 95%, 1,38-3,85) (p = 0,001) para GPM 2 frente a GPM 3. El modelo de riesgos proporcionales de Cox identificó el GPM como factor independiente correlacionado con la mortalidad a 5 años (razón de riesgos = 0,65 [0,41-0,97]; p = 0,037 para el GPM 3 frente a GPM 0-2). Conclusiones. En los pacientes con IAMEST y un flujo de grado TIMI 3 tras una ICP primaria, la reperfusión miocárdica subóptima (GPM <= 2) se asoció a una reducción del rescate miocárdico, un mayor tamaño del infarto y un aumento de la mortalidad a 5 años en comparación con los pacientes con restablecimiento de la perfusión tisular (GPM = 3) (AU)
Introduction and objectives. The relationship between microcirculatory myocardial perfusion grade (MPG), myocardial salvage and long-term mortality after acute ST-segment elevation myocardial infarction (STEMI) and full restoration of epicardial blood flow by primary percutaneous coronary intervention (PCI) remains poorly understood. Methods. This study included 1213 patients with STEMI and Thrombolysis in Myocardial Infarction (TIMI) grade-3 flow after primary PCI. The MPG was determined and paired scintigraphic studies (before and 714 days after the intervention) were performed. The primary outcome was 5-year mortality. Results. The MPG was 0-1 in 217 patients, 2 in 195, and 3 in 801. In patients with an MPG of 0-1, 2 and 3, respectively, the median infarct size was 13% (interquartile range [IQR] 5.6-28%), 12% (IQR 4-27%) and 7% (IQR 1-19%) of the left ventricle, respectively (P<.001), the myocardial salvage index (i.e. the proportion of the initial area at risk that recovered) was 0.44 (IQR 0.22-0.73), 0.46 (IQR 0.25-0.75) and 0.58 (IQR 0.31-0.85), respectively (P<.001), and the Kaplan-Meier estimated 5-year mortality was 16.6% (i.e. 28 deaths), 15.3% (i.e. 25 deaths) and 7.8% (i.e. 48 deaths), respectively. The odds ratio (OR) for death for an MPG of 0-1 vs. 3 was 2.32 (95% confidence interval [CI] 1.42-3.8; P<.001) and for an MPG of 2 vs. 3, 2.3 (95% CI 1.38-3.85; P=.001). The Cox proportional hazards model identified MPG as independently associated with mortality at 5 years: the hazard ratio for an MPG of 3 vs. 0-2 was 0.65 (95% CI 0.41-0.97; P=.037). Conclusions. In patients with STEMI and TIMI grade-3 flow after primary PCI, suboptimal microcirculatory myocardial perfusion (i.e. MPG <=2) was associated with poorer myocardial salvage, a larger infarct, and higher 5-year mortality than observed in patients whose tissue perfusion was reestablished (i.e. MPG=3) (AU)