Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention: a report from the Acute Catheterization and Urgent Intervention Triage Strategy trial.

OBJECTIVES: There are limited data on bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) with positive biomarkers of myocardial necrosis (troponin and/or creatine kinase-myocardial band isoenzyme). We sought to evaluate the safety and efficacy of bivalirudin monotherapy in patients with positive biomarkers from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. PATIENTS AND METHODS: We compared the net adverse clinical events [composite ischemia - (death, myocardial infarction, or unplanned ischemic revascularization) - or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy. RESULTS: Among 13 819 patients with NSTE-ACS enrolled in ACUITY, 4728 patients presented with positive biomarkers and underwent an early invasive strategy. Of those, 1547 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), 1555 to bivalirudin plus GPI, and 1626 to bivalirudin monotherapy. Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14.0 vs. 12.4%; P = 0.04), all-cause death (1.3 vs. 0.5%; P = 0.001), cardiac death (1.1 vs. 0.5%; P = 0.005), and non-CABG-related major bleeding (6.5 vs. 5.2%, P = 0.03). At 30 days, bivalirudin monotherapy was associated with significantly less non-CABG-related major bleeding (bivalirudin monotherapy 4.1% vs. bivalirudin plus GPI 8.4% vs. heparin plus GPI 7.1%) with comparable rates of composite ischemia (bivalirudin monotherapy 9.2% vs. bivalirudin plus GPI 9.9% vs. heparin plus GPI 8.4%). In a multivariable model, bivalirudin monotherapy was associated with a significant reduction in non-CABG-related major bleeding but was not associated with an increased risk of death, myocardial infarction, unplanned revascularization or stent thrombosis. CONCLUSION: Compared with heparin plus GPI or bivalirudin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding at 30 days among patients with NSTE-ACS and positive biomarkers.

Validity time of normal results of preoperative tests for surgical reintervention and the impact on postoperative outcomes / Tempo de validade dos exames pré-operatórios normais para uma reintervenção cirúrgica e o impacto nos desfechos pós-operatórios

Abstract Background and objective: There are few data defining the period of time in which preoperative tests can be considered valid. The purpose of this study was to determine the likelihood of changes in the results of preoperative tests previously normal in relation to time, and the impact of these changes on postoperative outcomes. Methods: A total of 970 patients with normal preoperative tests before the first surgery and who required a new intervention were included. The preoperative tests performed for the first procedure were compared with those performed for the second procedure. The following variables were assessed regarding their potential to induce changes in test results: sex, age, surgical risk, previous chemotherapy or radiotherapy, and presence of comorbidities. In-hospital outcomes were analyzed. Results: The median time between procedures was 27 months (6-84). The probability of change in at least one of the preoperative exams was 1.7% (95% CI: 0.5-2.9), 3.6% (95% CI: 1.8-5.4), and 6.4% (95% CI: 3.9-8.9) during the 12, 24, and 36-month intervals, respectively, for patients aged <50 years and 2.1% (95% CI: 0.7-3.5), 9.2% (95% CI: 5.9-12.5), and 13.4% (95% CI: 9.3-17.5), respectively, for patients ≥50 years of age. Age (p = 0.009), surgical risk (p < 0.001), chemotherapy (p = 0.001), radiotherapy (p = 0.012), and comorbidities (p < 0.001) were associated with the likelihood of changes in test results. Test changes were not significantly associated with in-hospital adverse outcomes (p = 0.426). Conclusion: For patients undergoing a second surgical procedure, the probability of change in previously normal preoperative tests is low during the first years after the first surgical intervention, and when changes occurred, they did not adversely affect the in-hospital postoperative outcomes.

Resumo Justificativa e objetivo: Existem poucos dados que delimitam o período de tempo em que os exames pré-operatórios podem ser considerados válidos. O objetivo deste estudo foi determinar a probabilidade de mudanças nos resultados de exames pré-operatórios previamente normais em relação ao tempo e o impacto dessas alterações nos desfechos pós-operatórios. Métodos: Foram incluídos 970 pacientes com exames pré-operatórios normais antes da primeira cirurgia e que requereram uma nova intervenção. Os exames pré-operatórios feitos para o primeiro procedimento foram comparados com aqueles feitos para o segundo procedimento. As seguintes variáveis foram analisadas em relação ao seu potencial para induzir alterações nos resultados dos exames: sexo, idade, risco cirúrgico, quimioterapia ou radioterapia prévia e presença de comorbidades. Desfechos intra-hospitalares foram analisados. Resultados: A mediana temporal entre os procedimentos foi de 27 meses (6-84). A probabilidade de alteração em pelo menos um dos exames pré-operatórios foi de 1,7% (IC 95%: 0,5-2,9), 3,6% (IC 95%: 1,8-5,4) e 6,4% (IC 95%: 3,9-8,9) nos intervalos 12, 24 e 36 meses, respectivamente, para pacientes < 50 anos e 2,1% (IC 95%: 0,7-3,5), 9,2% (IC 95%: 5,9-12,5) e 13,4% (IC 95%: 9,3-17,5), respectivamente, para pacientes ≥ 50 anos. Idade (p = 0,009), risco cirúrgico (p < 0,001), quimioterapia (p = 0,001), radioterapia (p = 0,012) e presença de comorbidades (p < 0,001) estavam associadas com a probabilidade de mudanças nos resultados dos exames. Alterações nos exames não se associaram significativamente a desfechos intra-hospitalares adversos (p = 0,426). Conclusão: Para pacientes submetidos a um segundo procedimento cirúrgico, a probabilidade de alteração nos exames pré-operatórios previamente normais é baixa durante os primeiros anos após a primeira intervenção cirúrgica e quando ocorreram mudanças não afetaram adversamente os desfechos pós-operatórios intra-hospitalares.

[Validity time of normal results of preoperative tests for surgical reintervention and the impact on postoperative outcomes]. / Tempo de validade dos exames pré­operatórios normais para uma reintervenção cirúrgica e o impacto nos desfechos pós­operatórios.

BACKGROUND AND OBJECTIVE: There are few data defining the period of time in which preoperative tests can be considered valid. The purpose of this study was to determine the likelihood of changes in the results of preoperative tests previously normal in relation to time, and the impact of these changes on postoperative outcomes. METHODS: A total of 970 patients with normal preoperative tests before the first surgery and who required a new intervention were included. The preoperative tests performed for the first procedure were compared with those performed for the second procedure. The following variables were assessed regarding their potential to induce changes in test results: sex, age, surgical risk, previous chemotherapy or radiotherapy, and presence of comorbidities. In-hospital outcomes were analyzed. RESULTS: The median time between procedures was 27 months (6-84). The probability of change in at least one of the preoperative exams was 1.7% (95% CI: 0.5-2.9), 3.6% (95% CI: 1.8-5.4), and 6.4% (95% CI: 3.9-8.9) during the 12, 24, and 36-month intervals, respectively, for patients aged <50 years and 2.1% (95% CI: 0.7-3.5), 9.2% (95% CI: 5.9-12.5), and 13.4% (95% CI: 9.3-17.5), respectively, for patients ≥ 50 years of age. Age (p=0.009), surgical risk (p <0.001), chemotherapy (p=0.001), radiotherapy (p=0.012), and comorbidities (p <0.001) were associated with the likelihood of changes in test results. Test changes were not significantly associated with in-hospital adverse outcomes (p=0.426). CONCLUSION: For patients undergoing a second surgical procedure, the probability of change in previously normal preoperative tests is low during the first years after the first surgical intervention, and when changes occurred, they did not adversely affect the in-hospital postoperative outcomes.

Tissue characterization and phenotype classification in patients presenting with acute myocardial infarction: Insights from the iWonder study.

OBJECTIVES: We sought to assess a new modality of radiofrequency intravascular ultrasound (IVUS) called iMAP-IVUS (Boston Scientific, Santa Clara, California) during the evaluation of patients presenting with high-risk acute coronary syndromes. BACKGROUND: There are limited data on plaque tissue characterization and phenotype classification using iMAP-IVUS. METHODS: In the iWonder study patients presenting with ST-elevation myocardial infarction (STEMI) or non-STEMI underwent three-vessel grayscale IVUS and iMAP-IVUS tissue characterization prior to percutaneous intervention. In total 385 lesions from 100 patients were divided into culprit (n = 100) and nonculprit (n = 285) lesions. Lesion phenotype was classified as (i) thin-cap fibroatheroma (iMAP-derived TCFA); (ii) thick-cap fibroatheroma; (iii) pathological intimal thickening; (iv) fibrotic plaque; and (v) fibrocalcific plaque. RESULTS: Culprit lesions had smaller minimum lumen cross-sectional area (MLA) with greater plaque burden compared to non-culprit lesions. Volumetric analysis showed that culprit lesions had longer length and larger vessel and plaque volumes compared to non-culprit lesions. iMAP-IVUS revealed that culprit lesions presented more NC and fibrofatty volume, both at lesion level and at the MLA site (all P < 0.001). Any fibroatheroma was more frequently identified in culprit lesions compared with non-culprit lesions (93% vs. 78.9%, P = 0.001), anywhere within the lesion 19.0%, P < 0.001) as well as at the MLA site (18.0% vs. 9.5%, P = 0.07). CONCLUSIONS: Three-vessel radiofrequency iMAP-IVUS demonstrated a greater plaque burden and higher prevalence of any fibroatheroma as well as iMAP-derived TCFAs in culprit versus non-culprit lesions in patients presenting with STEMI or non-STEMI undergoing percutaneous coronary intervention. © 2017 Wiley Periodicals, Inc.

Impact of chronic statin therapy on clinical presentation and underlying lesion morphology in patients undergoing percutaneous intervention: an ADAPT-DES IVUS substudy.

OBJECTIVE: Previous intravascular ultrasound (IVUS) studies have not established a relationship between chronic statin use and plaque morphology and composition in patients undergoing percutaneous coronary intervention (PCI). We sought to use pre-PCI grayscale and virtual histology (VH)-IVUS to assess plaque morphology and composition in patients treated with chronic statin therapy compared with patients who were not taking statins before admission and PCI. METHODS: In a prespecified substudy of the Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents study, pre-PCI grayscale and VH-IVUS were performed in 780 patients with 916 culprit and 765 nonculprit lesions. RESULTS: Overall, 338 patients were treated with chronic statin therapy before admission. Statin-treated patients were older and had a higher prevalence of coronary risk factors. Statin-treated patients were more likely to present with stable angina, whereas non-statin-treated patients more frequently presented with acute myocardial infarction. Grayscale and VH-IVUS findings showed that lesions in statin-treated patients had a smaller plaque burden, but more dense calcium. Statin-treated patients had more calcified thick-cap fibroatheromas (9.2 vs. 3.7%, P=0.0007), but fewer VH-defined thin-cap fibroatheromas (45.2 vs. 56.1%, P=0.001) or plaque ruptures (26.6 vs. 38.4%, P=0.0001). In a propensity-matched population (n=249 in each group), similar results were obtained as regards clinical presentation and grayscale and VH-IVUS findings. CONCLUSION: Chronic statin use in patients with coronary artery disease was associated with more stable clinical presentation and IVUS findings consistent with greater lesion stability (fewer VH-thin-cap fibroatheromas and plaque ruptures and more calcified thick-cap fibroatheromas).

Predictors and Long-Term Clinical Impact of Acute Stent Malapposition: An Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) Intravascular Ultrasound Substudy.

BACKGROUND: The impact of acute stent malapposition (ASM) on long-term clinical outcomes in patients undergoing percutaneous coronary intervention is still controversial. We sought to evaluate predictors and long-term clinical outcomes of ASM. METHODS AND RESULTS: ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective multicenter study of 8663 patients undergoing percutaneous coronary intervention using drug-eluting stents. In a prespecified intravascular ultrasound-guided substudy, 2072 patients with 2446 culprit lesions had post-percutaneous coronary intervention intravascular ultrasound and were classified according to the presence or absence of ASM. After intravascular ultrasound-guided percutaneous coronary intervention, the overall prevalence of ASM after successful drug-eluting stents implantation was 14.4% per patient and 12.6% per lesion. Compared to lesions without ASM, lesions with ASM had larger in-stent lumen areas, larger stent areas, and larger in-stent vessel areas. A larger mean plaque area along with more attenuated plaque was observed in lesions with ASM versus lesions without ASM. Lesions with ASM had greater proximal and distal reference lumen areas and more distal, but not proximal, reference calcium compared to lesions without ASM. At 2-year follow-up, there was no significant difference in the incidence of cardiac death; myocardial infarction; early, late, or very late stent thrombosis; or clinically driven target lesion revascularization in patients with ASM versus those without ASM. Furthermore, ASM was not an independent predictor of 2-year major adverse cardiac events or target lesion revascularization even when forced into the multivariate model. CONCLUSIONS: In patients treated with intravascular ultrasound-guided drug-eluting stents implantation, ASM was not associated with adverse clinical events during long-term follow-up including, but not limited to, stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00638794.

Morphological changes and clinical impact of unstable plaques within untreated segments of acute myocardial infarction patients during a 3-year follow-up: an analysis from the HORIZONS-AMI trial.

OBJECTIVES: Plaque ruptures and attenuated plaques are considered to be unstable and have been identified in both culprit and nonculprit lesions of patients with ST-segment elevation myocardial infarction (STEMI). However, there are limited data available on the natural evolution of these plaques and their long-term clinical outcome. We investigated the natural evolution and long-term impact of plaque ruptures and attenuated plaques in untreated segments of infarct-related arteries in patients with STEMI. METHODS: In the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial, 389 patients with 429 lesions underwent intravascular ultrasound (IVUS) at baseline. Follow-up IVUS at 13 months was conducted in 245 patients. Three-year follow-up data were available for all patients. RESULTS: Segments not treated between baseline and follow-up were compared. Baseline IVUS identified 29 plaque ruptures in 27 patients (7%). Of 11 plaque ruptures with follow-up IVUS, four healed and seven persisted. Conversely, through follow-up IVUS, nine new plaque ruptures in nine patients (4%) were identified. Attenuated plaques were identified in 31 of 38 plaque ruptures (81.5%), of which 24 were in the same circumferential segment as the ruptured cavity and seven were within 5 mm proximal or distal to the plaque rupture. Morphologic changes during follow-up, including new plaque ruptures and changes in the attenuated plaque frequency and distribution, were not accompanied by either serious lumen compromise or clinical events. CONCLUSION: Serial IVUS analysis demonstrated that the morphology of unstable plaques within untreated segments in STEMI patients treated with optimal systemic therapies markedly changed during the 13-month follow-up period, without lumen compromise or clinical events at the 3-year follow-up.

Catheter-induced in-stented segment coronary dissection.

Coronary angiography can lead to different kinds of complications. Catheter-induced coronary dissection is one of the most feared of them. It is uncommonly reported and may result in ischemic events ranging from angina to death. We report a case of a woman admitted to the hospital due to progressive effort angina who had a complication during percutaneous coronary intervention not previously reported. It is a usual thinking that a coronary artery stented segment would not be prone to dissect either spontaneously or catheter-induced. This report describes a catheter-induced in-stented segment coronary dissection and a discussion if the dissection line involving the left anterior descending coronary artery stented segment occurred between the stent and the intimal hyperplasia or between the stent and the adventitia.