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1.
Curr Cardiol Rep ; 24(5): 519-528, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35286663

RESUMO

PURPOSE OF REVIEW: To provide a review of recent literature on the treatment of moderate-to-severe calcification in coronary and peripheral vasculature with intravascular lithotripsy (Shockwave Medical, Santa Clara, CA). RECENT FINDINGS: Moderate-to-severe calcific plaques constitute a significant proportion of lesions treated with transcatheter interventions in the coronary and peripheral vascular beds and portend lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared to non-calcific plaques. Intravascular lithotripsy (IVL) is a new technique that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits to facilitate luminal gain and stent expansion. IVL demonstrated high procedural success and low complication rates in the management of moderate-to-severe calcification in coronary and peripheral vascular beds and led to large luminal gain by modification of calcific plaque as assessed by optical coherence tomography. Further studies will determine the role of IVL in an integrated, protocolized approach to the treatment of severely calcified plaques in the coronary and peripheral vascular beds.


Assuntos
Litotripsia , Calcificação Vascular , Acústica , Humanos , Litotripsia/efeitos adversos , Stents , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/etiologia , Calcificação Vascular/terapia
2.
Cardiovasc Revasc Med ; 37: 112-117, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34607786

RESUMO

Effective treatment strategies and medical devices continue to be needed in Japan and the United States of America (US) to mitigate the growing burden of cardiovascular disease and coronary heart disease. Unfortunately, there can be a delay in gaining cardiovascular device approval in Japan after a device has already been approved and is in use in the US. The Harmonization by Doing (HBD) program; however, can eliminate this delay and reduce the cost of completing a clinical trial in Japan. The HBD proof-of-concept study, COAST, resulted in approval of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown simultaneously in Japan and the US on the same day. Subsequently, the Diamondback 360® Coronary OAS Classic Crown also received approval in Japan. The COAST study provides further evidence that global clinical trials via HBD for medical devices are practical and advantageous.


Assuntos
Aterectomia Coronária , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Calcificação Vascular , Aterectomia , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Japão , Índice de Gravidade de Doença , Resultado do Tratamento , Estados Unidos , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia
4.
EuroIntervention ; 17(2): e105-e123, 2021 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-34110288

RESUMO

Optical coherence tomography (OCT) has been increasingly utilised to guide percutaneous coronary intervention (PCI). Despite the diagnostic utility of OCT, facilitated by its high resolution, the impact of intracoronary OCT on clinical practice has thus far been limited. Difficulty in transitioning from intravascular ultrasound (IVUS), complex image interpretation, lack of a standardised algorithm for PCI guidance, and paucity of data from prospective clinical trials have contributed to the modest adoption. Herein, we provide a comprehensive up-do-date overview on the utility of OCT in coronary artery disease, including technical details, device set-up, simplified OCT image interpretation, recognition of the imaging artefacts, and an algorithmic approach for using OCT in PCI guidance. We discuss the utility of OCT in acute coronary syndromes, provide a summary of the clinical trial data, list the work in progress, and discuss the future directions.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Humanos , Estudos Prospectivos , Tomografia de Coerência Óptica , Ultrassonografia de Intervenção
5.
JACC Cardiovasc Interv ; 14(12): 1337-1348, 2021 06 28.
Artigo em Inglês | MEDLINE | ID: mdl-33939604

RESUMO

OBJECTIVES: The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL). BACKGROUND: The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628]). METHODS: Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days. RESULTS: Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow. CONCLUSIONS: In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success.


Assuntos
Doença da Artéria Coronariana , Litotripsia , Intervenção Coronária Percutânea , Calcificação Vascular , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia
6.
Curr Cardiol Rep ; 23(4): 33, 2021 03 05.
Artigo em Inglês | MEDLINE | ID: mdl-33666772

RESUMO

PURPOSE OF REVIEW: Moderate or severe calcification is present in approximately one third of coronary lesions in patients with stable ischemic heart disease and acute coronary syndromes and portends unfavorable procedural results and long-term outcomes. In this review, we provide an overview on the state-of-the-art in evaluation and treatment of calcified coronary lesions. RECENT FINDINGS: Intravascular imaging (intravascular ultrasound or optical coherence tomography) can guide percutaneous coronary intervention of severely calcified lesions. New technologies such as orbital atherectomy and intravascular lithotripsy have significantly expanded the range of available techniques to effectively modify coronary calcium and facilitate stent expansion. Calcium fracture improves lesion compliance and is essential to optimize stent implantation. Intravascular imaging allows for detailed assessment of patterns and severity of coronary calcium that are integrated into scoring systems to predict stent expansion, identifying which lesions require atherectomy for lesion modification. Guided by intravascular imaging, older technologies such as rotational atherectomy and excimer laser can be incorporated with newer technologies such as orbital atherectomy and intravascular lithotripsy into an algorithmic approach for the safe and effective treatment of patients with heavily calcified coronary lesions.


Assuntos
Aterectomia Coronária , Doença da Artéria Coronariana , Tecnologia Disruptiva , Intervenção Coronária Percutânea , Calcificação Vascular , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia
7.
Circ Cardiovasc Interv ; 14(1): e009354, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32907343

RESUMO

Constituting a significant proportion of lesions treated with transcatheter interventions in the coronary arteries, moderate-to-severe calcification portends lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared with noncalcific plaques. Adapted from the lithotripsy technology for treatment of nephrolithiasis, intravascular lithotripsy is a new technique for treatment of severely calcific lesions that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits to facilitate luminal gain and stent expansion. Herein, we summarize the physics and characteristics of the currently available intravascular lithotripsy system (Shockwave Medical, Santa Clara, CA), the clinical data on intravascular lithotripsy use in the coronary arteries, and future directions for adoption of the technique in percutaneous coronary intervention.


Assuntos
Doença da Artéria Coronariana , Litotripsia , Calcificação Vascular , Acústica , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Humanos , Litotripsia/efeitos adversos , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia
8.
EuroIntervention ; 17(4): e294-e300, 2021 07 20.
Artigo em Inglês | MEDLINE | ID: mdl-32364503

RESUMO

BACKGROUND: A large, prospective, multicentre trial recently showed that fractional flow reserve (FFR) derived from coronary angiography (FFRangio) has an accuracy of 92% compared with conventional guidewire-based FFR (FFRwire); however, little is known about whether specific patient/lesion characteristics affect the diagnostic performance. AIMS: The primary goal of the present study was to investigate whether specific patient or lesion characteristics such as high body mass index (BMI), presentation with an acute coronary syndrome, or lesion location affect the diagnostic performance of FFRangio in patients enrolled in the FAST-FFR study. METHODS: FFRangio was measured in a blinded fashion in 301 patients (319 vessels) who were undergoing FFRwire assessment. Using an FFRwire ≤0.80 as a reference, the diagnostic performance of FFRangio was compared in pre-specified subgroups. RESULTS: The mean FFRwire and FFRangio were 0.81±0.13 and 0.80±0.12. Overall, FFRangio had a sensitivity of 93.5% and specificity of 91.2% for predicting FFRwire. Patient characteristics including age, sex, clinical presentation, body mass index, and diabetes did not affect sensitivity or specificity (p>0.05 for all). Similarly, lesion characteristics including calcification and tortuosity did not affect sensitivity or specificity (p>0.05 for all), nor did lesion location (proximal, middle, versus distal). Sensitivity was equally high across all target vessels, while specificity was highest in the LAD and lower (~85%) in the RCA and LCx (p<0.05). CONCLUSIONS: FFRangio derived from coronary angiography has a high diagnostic performance regardless of patient and most lesion characteristics. The interaction of vessel on the specificity will need to be confirmed in larger cohorts.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Humanos , Valor Preditivo dos Testes , Estudos Prospectivos , Índice de Gravidade de Doença
9.
EuroIntervention ; 16(13): 1085-1091, 2021 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-32540793

RESUMO

AIMS: In the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact on clinical outcomes is unknown. The aim of the present study was to report the 12-month clinical follow-up data from the ILUMIEN III study. METHODS AND RESULTS: OCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes among the groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT. CONCLUSIONS: In this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12 months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit of OCT-guided PCI. TRIAL REGISTRATION: NCT02471586.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Stents , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de Intervenção
10.
Catheter Cardiovasc Interv ; 98(3): 483-491, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-32915510

RESUMO

OBJECTIVES: We sought to evaluate the severity and patterns of calcifications in the left main coronary artery (LMCA) and proximal segments of left anterior descending coronary artery (LAD) and left circumflex artery (LCX) using optical coherence tomography (OCT) in patients with and without prior coronary artery bypass grafting (CABG). BACKGROUND: CABG may accelerate upstream calcium development. METHODS: OCT images (n = 76) of the LMCA bifurcation from either the LAD or LCX in 76 patients with at least one patent left coronary graft, on average 7.0 ± 5.6 years post-CABG, were compared with 148 OCT images in propensity-score-matched non-CABG controls. RESULTS: Minimum lumen areas in the LMCA, LAD, and LCX in post-CABG patients were smaller than non-CABG controls. Maximum calcium arc and thickness as well as calcium length were greater in the LMCA and LCX, but not in the LAD in post-CABG patients versus non-CABG controls. Calcium located at the carina of a bifurcation, calcified nodules (CN), thin intimal calcium, and lobulated calcium were more prevalent in post-CABG patients. After adjusting for multiple covariates, prior CABG was an independent predictor of calcification at the carina of a bifurcation (odds ratio [OR] 5.77 [95% confidence interval, CI: 1.5-21.6]), thin intimal calcium (4.7 [1.5-14.4]), and the presence of a CN (15.60 [3.2-76.2]). CONCLUSIONS: Prior CABG is associated with greater amount of calcium in the LMCA and the proximal LCX, as well as higher prevalence of atypical calcium patterns, including CN, thin or lobulated calcium, and calcifications located at the carina of a bifurcation, compared with non-CABG controls.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Angiografia Coronária , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Humanos , Tomografia de Coerência Óptica , Resultado do Tratamento
11.
EuroIntervention ; 16(13): 1092-1099, 2021 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-32863246

RESUMO

AIMS: Randomised trials have demonstrated improvement in clinical outcomes with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI. The ILUMIEN III trial demonstrated non-inferiority of an optical coherence tomography (OCT)- versus IVUS-guided PCI strategy in achieving similar post-PCI lumen dimensions. ILUMIEN IV is a large-scale, multicentre, randomised trial designed to demonstrate the superiority of OCT- versus angiography-guided stent implantation in patients with high-risk clinical characteristics (diabetes) and/or complex angiographic lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes. METHODS AND RESULTS: ILUMIEN IV is a prospective, single-blind clinical investigation that will randomise between 2,490 and 3,656 patients using an adaptive design to OCT-guided versus angiography-guided coronary stent implantation in a 1:1 ratio. The primary endpoints are: (1) post-PCI minimal stent area assessed by OCT in each randomised arm, and (2) target vessel failure, the composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation. Clinical follow-up will continue for up to two years. The trial is currently enrolling, and the principal results are expected in 2022. CONCLUSIONS: The large-scale ILUMIEN IV randomised controlled trial will evaluate the effectiveness of OCT-guided versus angiography-guided PCI in improving post-PCI lumen dimensions and clinical outcomes in patients with diabetes and/or with complex coronary lesions. TRIAL REGISTRATION: NCT03507777.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Estudos Prospectivos , Método Simples-Cego , Stents , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de Intervenção
12.
Eur Heart J Cardiovasc Imaging ; 22(7): 753-759, 2021 06 22.
Artigo em Inglês | MEDLINE | ID: mdl-33167000

RESUMO

AIMS: Optical coherence tomography (OCT)-guided external elastic lamina (EEL)-based stent sizing is safe and as effective as intravascular ultrasound in achieving post-procedural lumen dimensions. However, when compared with automated lumen diameter (LD) measurements, this approach is time-consuming. We aimed to compare vessel diameter measurements and stent diameter selection using either of these approaches and examined whether applying a correction factor to automated LD measurements could result in selecting similar stent diameters to the EEL-based approach. METHODS AND RESULTS: We retrospectively compared EEL-based measurements vs. automated LD in reference segments in 154 OCT acquisitions and derived a correction factor for stent sizing using the ratio of EEL to LD measurements. We then prospectively applied the correction factor in 119 OCT acquisitions. EEL could be adequately identified in 100 acquisitions (84%) at the distal reference to allow vessel diameter measurement. Vessel diameters were larger with EEL-based vs. LD measurements at both proximal (4.12 ± 0.74 vs. 3.14 ± 0.67 mm, P < 0.0001) and distal reference segments (3.34 ± 0.75 vs. 2.64 ± 0.65 mm, P < 0.0001). EEL-based downsizing led to selection of larger stents vs. an LD-based upsizing approach (3.33 ± 0.47 vs. 2.70 ± 0.44, P < 0.0001). Application of correction factors to LD [proximal 1.32 (IQR 1.23-1.37) and distal 1.25 (IQR 1.19-1.36)] resulted in discordance in stent sizing by >0.25 mm in 63% and potentially hazardous stent oversizing in 41% of cases. CONCLUSION: EEL-based stent downsizing led to selection of larger stent diameters vs. LD upsizing. While applying a correction factor to automated LD measurements resulted in similar mean diameters to EEL-based measurements, this approach cannot be used clinically due to frequent and potentially hazardous stent over-sizing.


Assuntos
Doença da Artéria Coronariana , Tomografia de Coerência Óptica , Vasos Coronários/diagnóstico por imagem , Humanos , Estudos Retrospectivos , Stents , Resultado do Tratamento , Ultrassonografia de Intervenção
13.
Clin Cardiol ; 43(12): 1547-1554, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33280140

RESUMO

BACKGROUND: Cardiac injury is common in COVID-19 patients and is associated with increased mortality. However, it remains unclear if reduced cardiac function is associated with cardiac injury, and additionally if mortality risk is increased among those with reduced cardiac function in COVID-19 patients. HYPOTHESIS: The aim of this study was to assess cardiac function among COVID-19 patients with and without biomarkers of cardiac injury and to determine the mortality risk associated with reduced cardiac function. METHODS/RESULTS: This retrospective cohort study analyzed 143 consecutive COVID-19 patients who had an echocardiogram during hospitalization between March 1, 2020 and May 5, 2020. The mean age was 67 ± 16 years. Cardiac troponin-I was available in 131 patients and an increased value (>0.03 ng/dL) was found in 59 patients (45%). Reduced cardiac function, which included reduced left or right ventricular systolic function, was found in 40 patients (28%). Reduced cardiac function was found in 18% of patients without troponin-I elevation, 42% with mild troponin increase (0.04-5.00 ng/dL) and 67% with significant troponin increase (>5 ng/dL). Reduced cardiac function was also present in more than half of the patients on mechanical ventilation or those deceased. The in-hospital mortality of this cohort was 28% (N = 40). Using logistic regression analysis, we found that reduced cardiac function was associated with increased mortality with adjusted odds ratio (95% confidence interval) of 2.65 (1.18 to 5.96). CONCLUSIONS: Reduced cardiac function is highly prevalent among hospitalized COVID-19 patients with biomarkers of myocardial injury and is independently associated with mortality.


Assuntos
COVID-19/mortalidade , Traumatismos Cardíacos/mortalidade , Troponina I/sangue , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , COVID-19/sangue , Causas de Morte , Ecocardiografia Doppler de Pulso , Feminino , Traumatismos Cardíacos/sangue , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Estudos Retrospectivos
14.
J Am Coll Cardiol ; 76(22): 2635-2646, 2020 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-33069849

RESUMO

BACKGROUND: Coronary calcification hinders stent delivery and expansion and is associated with adverse outcomes. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhancing vessel compliance and optimizing stent deployment. OBJECTIVES: The purpose of this study was to assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions. METHODS: Disrupt CAD III (NCT03595176) was a prospective, single-arm multicenter study designed for regulatory approval of coronary IVL. The primary safety endpoint was freedom from major adverse cardiovascular events (cardiac death, myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared with a pre-specified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) substudy. RESULTS: Patients (n = 431) were enrolled at 47 sites in 4 countries. The primary safety endpoint of the 30-day freedom from major adverse cardiovascular events was 92.2%; the lower bound of the 95% confidence interval was 89.9%, which exceeded the PG of 84.4% (p < 0.0001). The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% confidence interval was 90.2%, which exceeded the PG of 83.4% (p < 0.0001). Mean calcified segment length was 47.9 ± 18.8 mm, calcium angle was 292.5 ± 76.5°, and calcium thickness was 0.96 ± 0.25 mm at the site of maximum calcification. OCT demonstrated multiplane and longitudinal calcium fractures after IVL in 67.4% of lesions. Minimum stent area was 6.5 ± 2.1 mm2 and was similar regardless of demonstrable fractures on OCT. CONCLUSIONS: Coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Procedimentos Endovasculares , Desenho de Equipamento , Litotripsia , Intervenção Coronária Percutânea , Calcificação Vascular , Idoso , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/cirurgia , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/métodos , Feminino , Humanos , Litotripsia/instrumentação , Litotripsia/métodos , Masculino , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Índice de Gravidade de Doença , Stents , Tomografia de Coerência Óptica/métodos , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/cirurgia
16.
J Am Coll Cardiol ; 75(19): 2403-2413, 2020 05 19.
Artigo em Inglês | MEDLINE | ID: mdl-32240760

RESUMO

BACKGROUND: P2Y12 inhibitor monotherapy with ticagrelor after a brief period of dual antiplatelet therapy can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with diabetes mellitus (DM) remains unknown. OBJECTIVES: The purpose of this study was to examine the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with DM undergoing PCI. METHODS: This was a pre-specified analysis of the DM cohort in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. After 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The primary endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke. RESULTS: Patients with DM comprised 37% (n = 2,620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of Bleeding Academic Research Consortium 2, 3, or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (hazard ratio: 0.65; 95% confidence interval: 0.47 to 0.91; p = 0.012). Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs. 5.9%; hazard ratio: 0.77; 95% confidence interval: 0.55 to 1.09; p = 0.14). In the overall trial population, there was no significant interaction between DM status and treatment group for the primary bleeding or ischemic endpoints. CONCLUSIONS: Compared with ticagrelor plus aspirin, the effect of ticagrelor monotherapy in reducing the risk of clinically relevant bleeding without any increase in ischemic events was consistent among patients with or without DM undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).


Assuntos
Aspirina/administração & dosagem , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/cirurgia , Intervenção Coronária Percutânea/tendências , Inibidores da Agregação Plaquetária/administração & dosagem , Ticagrelor/administração & dosagem , Aspirina/efeitos adversos , Diabetes Mellitus/epidemiologia , Método Duplo-Cego , Quimioterapia Combinada , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Fatores de Risco , Ticagrelor/efeitos adversos
18.
EuroIntervention ; 16(4): e335-e343, 2020 07 17.
Artigo em Inglês | MEDLINE | ID: mdl-31403461

RESUMO

AIMS: The aim of this study was to use optical coherence tomography (OCT) to predict newly implanted stent expansion for treatment of in-stent restenosis (ISR). METHODS AND RESULTS: With OCT guidance, 143 ISR lesions were treated with a new stent. Stent underexpansion was defined as minimum stent area (MSA) <4.5 mm2 and MSA/average of reference lumen area <70%. New stent underexpansion was found in 33 lesions (23%). These had a smaller old stent MSA (4.13 [3.32-4.62] versus 5.18 [4.01-6.38] mm2, p=0.001), and had a higher prevalence of multiple old stent layers (51.5% versus 10.9%, p<0.001) and neointimal or peri-stent calcium (69.7% versus 37.3%, p=0.001) compared to those without new stent underexpansion. Old stent underexpansion, multiple layers of old stent, maximum calcium angle >180°, and maximum calcium thickness >0.5 mm were independently associated with new stent underexpansion. Patients with new stent underexpansion had a higher prevalence of major adverse cardiac events (35.5% vs 14.3%, p=0.009), mainly driven by a higher rate of myocardial infarction and target vessel revascularisation at two years. CONCLUSIONS: When re-stenting an ISR lesion, old stent underexpansion, the amount of neointimal or peri-stent calcium, and multiple old stent strut layers are important determinants of new stent underexpansion which is then associated with adverse long-term outcomes.


Assuntos
Reestenose Coronária/diagnóstico por imagem , Neointima , Stents , Tomografia de Coerência Óptica , Angiografia Coronária , Reestenose Coronária/cirurgia , Vasos Coronários , Humanos
19.
EuroIntervention ; 15(8): 714-721, 2019 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-31062700

RESUMO

Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher rates of target lesion revascularisation (TLR). High-pressure non-compliant balloon angioplasty may be of insufficient force to modify calcium and, even when successful, may be limited in its ability to modify the entire calcified lesion. Scoring and cutting balloons hold theoretical value but data to support their efficacy are lacking and, because of their high lesion crossing profile, they often fail to reach the target lesion. Rotational and orbital atherectomy target superficial calcium; however, deep calcium, which may still impact on vessel expansion and luminal gain, is not affected. Intravascular lithotripsy (IVL), based on lithotripsy for renal calculi, is a new technology which uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue. Energy is delivered via a balloon catheter, analogous to contemporary balloon catheters, with transmission through diluted ionic contrast in a semi-compliant balloon inflated at low pressure with sufficient diameter to achieve contact with the vessel wall. With coronary and peripheral balloons approved in Europe, peripheral balloons approved in the USA and multiple new trials beginning, we review the indications for these recently introduced devices, summarise the clinical outcomes of the available trials and describe the design of ongoing studies.


Assuntos
Artérias/diagnóstico por imagem , Aterectomia Coronária/métodos , Calcinose/cirurgia , Litotripsia , Calcificação Vascular/terapia , Aterectomia Coronária/efeitos adversos , Calcinose/diagnóstico , Constrição Patológica , Europa (Continente) , Humanos , Tomografia de Coerência Óptica , Ultrassonografia de Intervenção , Calcificação Vascular/diagnóstico por imagem
20.
Cardiovasc Revasc Med ; 20(6): 454-460, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30982659

RESUMO

BACKGROUND: Direct stenting offers many potential advantages in appropriately selected lesions. Coronary artery calcification increases the complexity and risk of adverse events associated with percutaneous coronary intervention. This study aimed to examine the feasibility of direct stenting after treatment with orbital atherectomy (OA). METHODS: ORBIT II was a single-arm trial enrolling 443 subjects with de novo severely calcified coronary lesions treated with OA; direct stenting was utilized in 59.0% of cases. Procedural outcomes and 3-year major adverse cardiac event (MACE) rates were compared in subjects treated with pre-stent balloon dilatation versus direct stenting after OA. RESULTS: Procedural success (84.2% vs. 93.3%; p = 0.004) was significantly higher in the direct stenting cohort. 3-year MACE occurred less frequently in the direct stenting cohort (29.9% vs. 19.1%; p = 0.006), driven by lower rates of myocardial infarction and target lesion revascularization. In a propensity matched analysis, procedural success and 3-year MACE rates were similar in the pre-stent balloon dilatation and direct stenting groups (85.0% vs. 91.8%; p = 0.122 and 28.2% vs. 19.6%; p = 0.078, respectively). CONCLUSIONS: Orbital atherectomy facilitates direct stenting and is associated with high procedural success and favorable 3-year outcomes in carefully selected patients. Randomized studies are needed to assess the optimal strategy after lesion preparation with OA.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Aterectomia Coronária , Doença da Artéria Coronariana/terapia , Stents , Calcificação Vascular/terapia , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/mortalidade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/mortalidade
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