ABSTRACT
Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. Design, Setting, and Participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. Main Outcomes and Measures: The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority. Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively. Conclusions and Relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT04647253.
Subject(s)
Coronary Restenosis , Myocardial Infarction , Female , Humans , Aged , Paclitaxel , Coronary Restenosis/etiology , Coronary Restenosis/therapy , Stents , Treatment Outcome , DeathABSTRACT
An 84-year-old man developed angina while watching televised coverage of the President Trump impeachment hearings and presented to the emergency department with positive cardiac biomarkers and EKG changes indicative of ST-elevation myocardial infarction. Echocardiogram and coronary angiography were consistent with non-ischemic, 3 vessel coronary artery disease with apical hypokinesis resulting in the diagnosis of Takotsubo Cardiomyopathy. This case is the first report of politically-induced cardiomyopathy and warrants further evaluation of political stress as an etiology of cardiac events.
ABSTRACT
The worldwide prevalence of cardiovascular disease in general and atherosclerotic coronary artery disease in particular is a health and economic concern of unparalleled proportion. Despite a long history of astute observations beginning in 1575 made by Fallopius, followed by those of von Rokatansky, Virchow, Osler, and Ross, and incremental knowledge of the pathobiology of atherosclerosis to include varying stages of inflammation, response to internally and externally mediated vascular injury, and impaired homeostasis, gaps in the field's understanding persist. Here, we summarize the current scope of the problem for coronary artery disease, emerging constructs in its pathobiology and common clinical phenotypes, potentially useful biomarkers, clinical trials designed specifically to test the 'inflammation hypothesis' of disease, and the interface of pathobiology and precision medicine as a foundation for diagnosis, management, and future advances in the diagnosis, prognosis, natural history, prevention, and optimal management.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Coronary Artery Disease/drug therapy , Inflammation Mediators/antagonists & inhibitors , Inflammation/drug therapy , Animals , Anti-Inflammatory Agents/adverse effects , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized , Clinical Trials as Topic , Coronary Artery Disease/immunology , Coronary Artery Disease/metabolism , Coronary Artery Disease/physiopathology , Evidence-Based Medicine , Humans , Inflammation/immunology , Inflammation/metabolism , Inflammation/physiopathology , Inflammation Mediators/immunology , Inflammation Mediators/metabolism , Risk Factors , Signal Transduction/drug effects , Treatment OutcomeABSTRACT
BACKGROUND: Exercise is the AHA/ACC guideline-recommended stress modality for myocardial perfusion imaging, but many patients are unable to exercise to target heart rate on a conventional treadmill. We examined the feasibility and safety of stress imaging using an anti-gravity treadmill in patients with perceived poor exercise capacity. METHODS AND RESULTS: 49 patients were recruited for stress testing by anti-gravity treadmill (n = 29) or to a regadenoson control group (n = 20). Seventeen anti-gravity test patients (59%) reached target heart rate obviating the need for a pharmacologic stress agent. Adverse effects of the anti-gravity treadmill were limited to minor muscle aches in 5 subjects. Stress myocardial perfusion image quality judged by 3 blinded readers on a 5-point scale was comparable for the anti-gravity treadmill (4.30 ± SD 0.87) vs pharmacologic stress (4.28 ± SD 0.66). CONCLUSION: Stress testing using an anti-gravity treadmill is feasible and may help some patients safely achieve target heart rate.
