Search

Background: It is unclear whether the beneficial effects of intravascular imaging-guided stent optimization vary by clinical presentation during complex percutaneous coronary intervention (PCI)., Objectives: In this prespecified, stratified subgroup analysis from RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex PCI), we sought to compare the outcomes between intravascular imaging vs angiography guidance according to clinical presentation., Methods: Patients with complex coronary artery lesions were randomly assigned to undergo either intravascular imaging-guided PCI or angiography-guided PCI in a 2:1 ratio. The primary endpoint was target vessel failure (TVF), which is a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization., Results: Of 1,639 patients, 832 (50.8%) presented with acute coronary syndrome (ACS) and 807 (49.2%) with chronic coronary syndrome. During a median follow-up of 2.1 years (Q1-Q3: 1.4-3.0 years), there was no significant interaction between the treatment effect of intravascular imaging and clinical presentation (P for interaction = 0.19). Among patients with ACS, the incidences of TVF were 10.4% in the intravascular imaging group and 14.6% in the angiography group (HR: 0.74; 95% CI: 0.48-1.15; P = 0.18). Among patients with CCS, the incidences of TVF were 5.0% in the intravascular imaging group and 10.4% in the angiography group (HR: 0.46; 95% CI: 0.27-0.80; P = 0.006). Achieving stent optimization by intravascular imaging resulted in a reduced risk of TVF among patients with ACS who were randomly assigned to intravascular imaging-guided PCI for complex coronary lesions (optimized vs unoptimized, 6.5% vs 14.1%; HR: 0.49; 95% CI: 0.27-0.87; P = 0.02) but not those with CCS (5.4% vs 4.7%, HR: 1.18; 95% CI: 0.53-2.59; P = 0.69)., Conclusions: No significant interaction was observed between the benefits of intravascular imaging and clinical presentation in the risk of TVF. Stent optimization by intravascular imaging was particularly important for ACS patients. (Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease [RENOVATE]; NCT03381872)., Competing Interests: Funding Support and Author Disclosures This trial is investigator initiated with grant support from Abbott Vascular and Boston Scientific. The sponsors were not involved with the protocol development or study process, including site selection, management, data collection, or analysis of the results. Dr Chan Joon Kim has received research grants from Basic Science Research Program, National Research Foundation of Korea, Ministry of Education, Hanmi Pharmaceutical, Chong Keun Dang Pharm, Handoc Kalos Medical, Donga-ST, and Boryung Corporation. Dr Joo Myung Lee has received institutional research grants from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Zoll Medical, and Donga-ST. Dr Hyeon-Cheol Gwon has received institutional research grants from Abbott Vascular, Boston Scientific, and Medtronic Inc. Dr Joo-Yong Hahn has received institutional research grants from the National Evidence-based Healthcare Collaborating Agency, Ministry of Health and Welfare (Korea), Abbott Vascular, Biosensors, Boston Scientific, Daiichi-Sankyo, Donga-ST, Hanmi Pharmaceutical, and Medtronic Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Data regarding prognosis and management after nuisance bleeding (NB) is limited. The purpose was to examine the prognostic significance of NB in patients receiving potent dual antiplatelet treatment (DAPT) after acute myocardial infarction and the impact of de-escalation of DAPT on clinical outcomes thereafter., Methods: From the TALOS-AMI trial (Ticagrelor Versus Clopidogrel in Stabilized Patients With Acute Myocardial Infarction)' 2583 patients were used to investigate the clinical impact of NB (defined as Bleeding Academic Research Consortium [BARC] 1 bleeding) during 1-month treatment with ticagrelor-based DAPT after acute myocardial infarction. We assessed the associations between NB within 1 month and BARC 2, 3, or 5 bleeding and major adverse cardiovascular event (a composite of cardiovascular death, myocardial infarction, stroke) from 1 to 12 months. We also evaluated the effect of de-escalation to clopidogrel in patients with or without NB., Results: NB occurred in 416 patients (16.7%) after 1 month of ticagrelor-based DAPT. At 1 year, NB was not associated with increase in BARC 2, 3, or 5 bleeding (hazard ratio [HR]' 1.29 [95% CI' 0.7-2.14]) and major adverse cardiovascular event (HR' 1.72 [95% CI' 0.87-3.39]). However, patients with NB had an increased risk of BARC 2, 3, or 5 bleeding at 6 months (HR, 1.94 [95% CI, 1.08-3.48]; P =0.026), which diminished over the next 6 months. De-escalation from ticagrelor to clopidogrel reduced the incidence of BARC 2, 3, or 5 bleeding compared with ticagrelor plus aspirin in NB (HR' 0.31 [95% CI' 0.10-0.92]) and non-NB patients (HR' 0.58 [95% CI' 0.37-0.90]) without heterogeneity ( P interaction=0.291). There was no increase in major adverse cardiovascular event after DAPT de-escalation, irrespective of NB., Conclusions: NB was frequent in patients with acute myocardial infarction on 1-month ticagrelor-based DAPT and was associated with an early increase of bleeding. DAPT de-escalation after NB may reduce bleeding without increasing ischemic events., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT02018055.

Background: Antiplatelet therapy deescalation has been suggested as an alternative to standard treatment with potent dual antiplatelet therapy (DAPT) for 1 year in low bleeding risk patients with acute coronary syndromes undergoing percutaneous coronary intervention to mitigate the increased risk of bleeding. Whether this strategy preserves the ischemic and survival benefits of potent DAPT is uncertain., Methods: We performed a pairwise meta-analysis in patients with acute coronary syndrome undergoing percutaneous coronary intervention treated with either 1-year standard potent DAPT versus deescalation therapy (potent DAPT for 1-3 months followed by either reduced potency DAPT or ticagrelor monotherapy for up to 1 year). Randomized trials comparing standard DAPT versus deescalation therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary end point was 1-year all-cause mortality., Results: The meta-analysis included 6 trials in which 20 837 patients were randomized to potent DAPT for 1 to 3 months followed by deescalation therapy for up to 1 year (n=10 392) or standard potent DAPT for 1 year (n=10 445). Deescalation therapy was associated with lower 1-year rates of all-cause mortality compared with standard therapy (odds ratio, 0.75 [95% CI, 0.59-0.95]; P =0.02). Deescalation therapy was also associated with lower rates of major bleeding (odds ratio, 0.59 [95% CI, 0.48-0.72]; P <0.0001), with no significant difference in major adverse cardiac events (major adverse cardiovascular events; odds ratio, 0.89 [95% CI, 0.77-1.04]; P =0.14)., Conclusions: In low bleeding risk patients with acute coronary syndrome undergoing percutaneous coronary intervention, compared with 1-year of potent DAPT, antiplatelet therapy deescalation therapy after 1 to 3 months was associated with decreased mortality and major bleeding with similar rates of major adverse cardiovascular events.

Aims: In patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI), the risk of ischaemic complications is highest in the early phase (during the first 30 days), while most bleeding events occur predominantly during the maintenance phase of treatment (after the first 30 days). Data on the de-escalation of dual antiplatelet therapy by switching from ticagrelor to clopidogrel in stabilised AMI patients are limited. The aim of this study is to investigate the efficacy and safety of switching from ticagrelor to clopidogrel in AMI patients with no adverse event during the first month after the index PCI with newer-generation DES., Methods and Results: TALOS-AMI is a multicentre, randomised, open-label study enrolling 2,590 AMI patients with no adverse events during the first month after the index PCI. One month after the index PCI, eligible patients are randomly assigned either to 1) aspirin 100 mg plus clopidogrel 75 mg daily, or to 2) aspirin 100 mg plus ticagrelor 90 mg twice daily, in a 1:1 ratio. The primary endpoint is a composite of cardiovascular death, MI, stroke, and bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria from 1 to 12 months after the index PCI., Conclusions: The TALOS-AMI trial is the first large-scale, multicentre, randomised study exploring the efficacy and safety of the de-escalation of antiplatelet therapy by switching from ticagrelor to clopidogrel in stabilised AMI patients undergoing PCI.

Background: Asian patients with acute coronary syndrome (ACS) are frequently prescribed moderate- -intensity statin in real practice, even during the early stage of ACS. Under assessment herein was the effect of moderate-intensity statin therapy on the resolution of plaque inflammation during the first month after ACS, a period with highest recurrent ischemic events, using dual time point 18F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT)., Methods: This prospective study included statin-naïve patients with ACS and non-calcified carotid plaques (≥ 3 mm on ultrasound images). Baseline FDG PET/CT images of the carotid arteries of the patients were obtained. Then, all patients received atorvastatin (20 mg/day); follow-up FDG PET/CT images of the carotid arteries were then obtained after 1 month of therapy. The primary endpoint measurement was the change in the target-to-background ratio (TBR) of the carotid artery between the initial and follow-up FDG PET/CT scans., Results: Thirteen ACS patients completed the initial and follow-up FDG PET/CT scans. Moderate-intensity statin therapy failed to reduce plaque inflammation at 1 month after ACS (TBR 1.60 ± 0.20 at baseline vs. 1.50 ± 0.40 after therapy; p = 0.422) but significantly reduced serum low-density lipoprotein cholesterol (LDL-C) levels (mean LDL-C 101.2 ± 21.1 mg/dL at baseline vs. 70.7 ± 12.4 mg/dL after therapy; p < 0.001). Changes in the TBR and serum LDL-C levels were not correlated (r = -0.27, p = 0.243)., Conclusions: Dual time point FDG PET/CT imaging demonstrates that moderate-intensity statin therapy was insufficient in suppressed plaque inflammation within the first month after ACS in Asian patients, even though achieving target LDL levels.

Background: Ticagrelor is an intriguing antiplatelet agent with a potentially beneficial impact on endothelial dysfunction and confers a mortality benefit beyond 1 month after acute coronary syndrome (ACS). However, little data exist on whether ticagrelor improves endothelial dysfunction in stable patients who survive the acute period and receive guideline-directed medical therapy., Methods and Results: This study is a prospective, randomized, parallel, open-labeled study that enrolled 30-day survivors of non-ST-segment elevation ACS (NSTE-ACS). Forty patients with NSTE-ACS were randomly assigned to ticagrelor or clopidogrel groups. The primary end point was the change in the percentage brachial artery flow-mediated dilation (baFMD) from baseline. Baseline characteristics were not different between the 2 groups. The median time from the stent implantation to screening was 269 days. After 30 days of study medication administration, the change in the percentage baFMD value was similar between the ticagrelor and clopidogrel groups (-0.08 [1.42] vs 0.30 [1.69], P = .66). There was no difference in the change in high-sensitive C-reactive protein (-0.61 [1.48] vs -0.01 [0.57], P = .28); however, the change in platelet inhibition significantly differed (P2Y 12 reaction units, -140.5 [49.5] vs -3.9 [51.4], P < .001)., Conclusions: This dual time point baFMD study demonstrated that treatment with ticagrelor was not superior to clopidogrel for improving endothelial dysfunction in stabilized patients with NSTE-ACS.