BACKGROUND The risk-benefit ratio of the Absorb bioresorbable vascular scaffold (BVS) may vary before and after 3 years, the time point of complete bioresorption of the poly-L-lactic acid scaffold. OBJECTIVES The aim of this study was to determine the time-varying outcomes of the Absorb BVS compared with cobalt-chromium everolimus-eluting stents (EES) from a large individual-patient-data pooled analysis of randomized trials. METHODS The individual patient data from 5 trials that randomized 5,988 patients undergoing percutaneous coronary intervention to the Absorb BVS vs EES with 5-year follow-up were pooled. The primary effectiveness and safety endpoints were target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis (DT). RESULTS Between 0 and 5 years, TLF occurred in 15.9% BVS patients vs 13.1% EES patients (HR: 1.25; 95% CI: 1.08-1.43; P = 0.002), and DT occurred in 2.2% vs 1.0%, respectively (HR: 2.38; 95% CI: 1.49-3.79; P = 0.0002). Between 0 and 3 years, TLF occurred in 12.4% BVS patients vs 9.3% EES patients (HR: 1.35; 95% CI: 1.15-1.59; P = 0.0002), and DT occurred in 2.0% vs 0.6%, respectively (HR: 3.58; 95% CI: 2.01-6.36; P < 0.0001). Between 3 and 5 years, TLF occurred in 4.5% BVS patients vs 4.7% EES patients (HR: 0.99; 95% CI: 0.76-1.27; P = 0.91), and DT occurred in 0.2% vs 0.4%, respectively (HR: 0.49; 95% CI: 0.18-1.38; P = 0.17). By spline analysis, the TLF hazard by 5 years was lower with BVS than EES. CONCLUSIONS Compared with EES treatment, BVS increased TLF and DT rates through 5-year follow-up. However, the period of excess risk for the first-generation Absorb BVS ended at 3 years, when poly-L-lactic acid bioresorption is complete. Thereafter event rates were comparable or lower with BVS. (ABSORB II Randomized Controlled Trial, NCT01425281; A Clinical Evaluation of AbsorbTM Bioresorbable Vascular Scaffold [AbsorbTM BVS] System in Chinese Population - ABSORB CHINA Randomized Controlled Trial [ABSORB CHINA], NCT01923740; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [AbsorbTM BVS] in Japanese Population [ABSORB JAPAN], NCT01844284; ABSORB III Randomized Controlled Trial [ABSORB III], NCT01751906; Absorb IV Randomized Controlled Trial, NCT02173379) (JACC Cardiovasc Interv. 2025;18:1-11) (c) 2025 by the American College of Cardiology Foundation.
Purpose In ductal carcinoma in situ, whole breast radiation therapy (WBRT) reduces local recurrence rates, but ipsilateral breast events at 10 years were observed in 15% to 19% of 50-year-old patients. The BONBIS trial (NCT00907868) assessed the effect of an additional localized radiation boost on local recurrence-free survival (primary endpoint). Methods and Materials This large multicenter (n = 53), randomized, open-label phase 3 trial was conducted from November 2008 to July 2014. In total, 2004 patients with complete ductal carcinoma in situ resection underwent postsurgery WBRT followed or not by a 16-Gy boost in the tumor bed. Only late radiation therapy-induced toxicity occurrence (National Cancer Institute Common Terminology Criteria for Adverse Events v3.0), health-related quality of life European Organisation for Research and Treatment Of Cancer (EORTC) Quality of life Cancer Patients (QLQ-C30) v3.0 and EORTC Quality of life Breast Cancer Patients (QLQ-BR23), and potential predictive factors of breast subcutaneous fibrosis (BSCF) (ie, secondary endpoints) will be reported here because the primary endpoint has not been reached yet. Results After a median follow-up of 66.9 months (95% CI, 65.1-67.8), grade ≥2 BSCF was observed in 4.9% of patients (7.0% in the WBRT + boost vs 2.8% in the WBRT arm; P < .001). Grade ≥2 acute and late toxicities were positively correlated (P = .005). Grade ≥2 BSCF was correlated with the boost (odds ratio = 2.6; 95% CI, 1.62-4.30) and breast clinical target volume ≥500 cm3 (odds ratio = 1.6; 95% CI, 1.01-2.51). Among the QLQ-C30 and QLQ-BR23 domain and symptom scores, only the breast symptom scores exhibited an arm-by-time interaction effect (P = .001) with a greater long-term breast symptom experience in the WBRT + boost arm. Time to first deterioration analysis showed a statically significant deterioration for body image in the WBRT + boost arm (hazard ratio = 1.19; 95% CI, 1.00-1.41). Conclusions The boost significantly increased grade ≥2 BSCF occurrence and persistent breast symptoms.
For most patients with stable ischemic cardiomyopathy (SICM), PCI neither improves LVEF nor heart failure outcomes. We sought to ascertain if specific subgroups of SICM patients might have a LVEF and clinical benefit from PCI. From a cohort of 1702 consecutive SICM patients with LVEF ≤50% treated between 2009 and 2023, patients were randomly selected for screening to meet final inclusion criteria including target vessel subtending ≥20% of the LV, hibernation+ischemia>scar, timely pre- and post PCI echos and no intercurrent treatment that might influence change in LVEF, until a cohort of 200 patients was available. Parsimoniously selected variables were then assessed for correlation with change in LVEF, with 1000-fold bootstrapping to minimize overfitting. Correlation of change in LVEF with freedom from cardiac death or heart failure admission was assessed with Cox multivariable analysis. Mean age was 69 ± 10 yrs, 76% were male, 52% had diabetes and baseline LVEF obtained a median 9 days before PCI was 35% ± 11%. Post-PCI LVEF obtained at a median 132 days was 39% ± 11%. Median follow-up was 35 months. After consideration of medication usage, the presence of an ICD, baseline LVEF >35%, prior CABG and scar all were independently and negatively correlated with improvement in LVEF (p ≤0.035). Patients with none of these factors had an improvement in LVEF of 5.5% ± 7.4%. Post-PCI LVEF and change in LVEF were independently correlated with reduced risk of clinical events (p = 0.003 and p = 0.032, respectively). If validated, these data will change the paradigm that no patients with SICM have a heart failure or mortality benefit from PCI.
BACKGROUND:The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) CathPCI Registry reports bleeding events within 72-h of percutaneous coronary intervention (PCI) as a quality metric. It is plausible that NCDR post-PCI bleeding events may be influenced by markers of intensity of patient care not related to PCI quality. The relationship between iatrogenic phlebotomy, intravenous fluid input, and post-PCI bleeding events is unknown. METHODS:This is a patient-level, observational study of 13,553 PCI procedures at a single center between 6/11/2009 and 6/14/2017. Multivariable logistic regression determined associations between NCDR bleeding events, total oral and intravenous fluid volume input, and number of lab tubes drawn on day of PCI up to 72-h post PCI. Improvement in discriminatory ability of adding these variables to a bleeding risk model was assessed with C-statistic. RESULTS:There were 767 (5.7%) bleeding events. Every 100 mL input was independently associated with 2.0% increased odds of bleeding (odds ratio [OR] 1.01-1.03, p < 0.001). Every 3 mL lab tube drawn was independently associated with 8.1% increased odds (OR 1.07-1.09, p < 0.001). A multivariable model including baseline patient characteristics and PCI variables achieved good discriminatory ability (C-statistic 0.858), but with addition of input, number of lab draws, and length of stay (LOS) achieved an excellent discriminatory ability (C-statistic 0.927, p < 0.001 comparing C-statistics). CONCLUSIONS:Variables reflecting intensity of patient illness including frequency of lab draws and fluid intake within 72-h of PCI significantly improve the ability of models to predict NCDR post-PCI bleeding events. Consideration should be given to risk-adjusting for lab draws and fluid administration when nationally reporting bleeding event rates.
Approximately half of all coronary angiograms performed for angina do not show obstructive coronary artery disease, and many of these patients have coronary microvascular dysfunction (CMD). Invasive testing for CMD has increased with the advent and wider availability of thermodilution systems. We review CMD pathophysiology and invasive diagnostic testing using the Doppler and thermodilution systems. We report the results of a PubMed search of invasive microvascular testing and discuss limitations of current diagnostic algorithms in the diagnosis of CMD, including controversies regarding the optimal cutoff value for abnormal coronary flow reserve, use of microvascular resistance indices, and options for increasing sensitivity of testing.
Increasing evidence has shown that coronary spasm and vasomotor dysfunction may be the underlying cause in more than half of myocardial infarctions with non-obstructive coronary arteries (MINOCA) as well as an important cause of chronic chest pain in the outpatient setting. We review the contemporary understanding of coronary spasm and related vasomotor dysfunction of the coronary arteries, the pathophysiology and prognosis, and current and emerging approaches to diagnosis and evidence-based treatment.
BACKGROUND Monomorphic ventricular tachycardia (VT) electrical storm (ES) in patients with coronary artery disease is dependent on scarred myocardium. The role of routine ischemic or coronary evaluations before ablation in patients presenting with monomorphic VT storm, without acute coronary syndrome (ACS), remains unknown. OBJECTIVES This study sought to assess the impact of ischemic or coronary evaluations on procedural outcomes and post-ablation mortality in monomorphic VT storm patients. METHODS All patients undergoing VT ablation at the Cleveland Clinic from 2014 to 2020 after presenting with monomorphic VT storm were enrolled in a prospectively maintained registry. The associations among ischemic or coronary evaluations and short-term procedural efficacy, acute outcomes, and mortality during follow-up were assessed. RESULTS A total of 97 consecutive patients with monomorphic VT storm in the absence of ACS underwent VT ablations. This cohort was characterized by severe LV systolic dysfunction (mean left ventricular ejection fraction 30.3%, 67% with known ischemic cardiomyopathy) with moderately severe heart failure (median NYHA functional class II); 45% of patients underwent ischemic or coronary evaluations via coronary angiography (10%), noninvasive myocardial perfusion (26%), or both (9%). The yield of these evaluations was low: No acute coronary occlusions were identified. There was no associ-ation between ischemic evaluation and acute ablation outcomes or mortality during follow-up. Similarly, in a secondary analysis, the yield of ischemic or coronary evaluations in patients with monomorphic VT storm and known coronary disease (regardless of ablation status) was found to be low. CONCLUSIONS Ischemic evaluations in patients with monomorphic VT storm without ACS may not improve procedural outcomes or mortality after ablation. (J Am Coll Cardiol EP 2023;9:1890-1899) (c) 2023 Published by Elsevier on behalf of the American College of Cardiology Foundation.
Coronary chronic total occlusion percutaneous coronary intervention treatment algorithms have helped to standardize crossing strategy sequence to improve efficacy and efficiency of CTO interventions based on angiographic criteria. Unfortunately, advanced crossing techniques such as a retrograde and subintimal guidewire tracking and reentry that have accelerated procedural success in more difficult lesions are associated with higher major adverse cardiac event rates as compared with traditional antegrade and intimal guidewire tracking. In this regard, antegrade wire escalation (AWE) remains the most common CTO crossing strategy. In this state of the art review, we outline the techniques employed to maximize the clinical utility of AWE crossing strategy for both novice operators as well as those experienced with the advanced crossing strategies. For the less experienced operator, these techniques may provide a framework to treat more patients safely and effectively without the need to refer to a more advanced operator. Whereas these same techniques may be employed by an advanced operator to improve the technical success in procedures requiring more advanced crossing strategies.
BackgroundThis study aimed to report outcomes of intracoronary brachytherapy (ICBT) in treating drug-eluting stent (DES) in-stent restenosis (ISR) and identify correlated factors.MethodsPatients who underwent ICBT for DES ISR from 2010 to 2021 were included in this single-institution retrospective PCI registry. Patients were treated with balloon angioplasty, laser atherectomy, and/or rotational atherectomy, followed by ICBT at a dose of 18.4-25 Gy delivered at the site of ISR with dose determined by the reference vessel size. The primary outcome was 3-year target lesion failure rate (TLF). Secondary end points were 1-year TLF, target lesion revascularization (TLR), all-cause mortality, and cardiac mortality.ResultsIn total, 330 consecutive patients presented with 345 treated lesions; 70% were male, age was 66 ± 11 years, 55% were diabetic patients, 62% underwent previous bypass surgery, and 89% were placed with at least 2 stent layers at the treated site. The rate of TLF was 18% at 1 year and 46% at 3 years. All-cause mortality and cardiac mortality rates were 19.8% and 12.3% at 3 years. The number of stent layers was associated with 3-year TLF (1 layer, 33.3%; 2 layers, 47.0%, >3 layers, 60.2%; P = .045). Diabetes, repeat ICBT, final percent stenosis, lesion length, and intravascular imaging use were not correlated with the primary outcome. Lower ICBT dose (P = .035) and restenosis <1 year from previous percutaneous coronary intervention (P = .044) were correlated with early (1-year) TLF.ConclusionICBT for recurrent DES ISR provided low recurrence rates at 1 year, which increased substantially by 3 years. Outcomes were most closely correlated with the number of stent layers, but early restenosis and lower ICBT dose adversely affected early TLF.