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AimsCardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort.Methods and resultsThis multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death.ConclusionThe primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.

Objectives: The goal of this study was to demonstrate that intravascular ultrasound (IVUS) examination of native coronary arteries does not result in an acceleration of the atherosclerotic process. Background: Intravascular ultrasound is increasingly used to assess the effects of pharmacologic agents on atherosclerosis. Methods: Intravascular ultrasound examinations of one coronary artery and coronary angiography were performed in 525 patients at baseline. Patients then underwent a follow-up angiogram 18 to 24 months later. All end points were evaluated in IVUS-related and non-IVUS arteries using quantitative coronary analysis. The study end points were the coronary change score (per-patient mean of minimum lumen diameter changes for all lesions measured), occurrence of new coronary lesions, and progression of preexistent lesions at follow-up. Acute angiographic and clinical complications were also analyzed. Results: Coronary change score was -0.06 +/- 0.23 mm and -0.05 +/- 0.21 mm for IVUS-related and non-IVUS arteries, respectively (p = 0.35). The increase in percent diameter stenosis from baseline to follow-up was 0.8 +/- 6.7% and 1.2 +/- 7.0% in the IVUS-related and non-IVUS arteries (p = 0.29). New lesions occurred in 3.6% and 3.9% of IVUS-related and non-IVUS arteries, respectively (p = 0.84). When all coronary lesions were considered, the incidence of lesion progression was not significantly different between IVUS-related (11.6%) and non-IVUS (9.8%) arteries. Coronary spasm occurred in 1.9% of IVUS procedures, and there was one case of acute occlusion with no long-term sequelae. Conclusions: Intravascular ultrasound does not significantly accelerate atherosclerosis in native coronary arteries and can be used safely to assess progression/regression in clinical trials. [ABSTRACT FROM AUTHOR]

Patients with coronary artery disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, cost-efficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease. The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronary intervention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months. The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI. Trial registration: ClinicalTrials.gov: NCT06095765., Competing Interests: Declaration of competing interest The authors have no conflict of interest related to the content of this paper., (Copyright © 2024. Published by Elsevier Inc.)

Background: CK-MB levels exceeding 3 times the upper limit of normal (ULN) following percutaneous coronary intervention (PCI), defining periprocedural myocardial infarction (PMI), are associated with worse outcomes. This study assessed the incidence and mechanisms of PMI and their impact on in-hospital stay., Methods and Results: Over a 12-year period (1996-2007), 272 cases of PMI (overall incidence, 3.5%) were analyzed among 310 consecutive cases of periprocedural myocardial necrosis (PMN; CK-MB > ULN). Mean numbers of treated segments and stents per procedure were 1.87 ± 0.99 and 1.43 ± 1.01, respectively. Mean stent length per procedure was 29.50 ± 19.30 mm. Following analysis of angiogram, procedural data, delay between PCI and necrosis, and mechanisms of PMN were classified as follows: cryptogenic (by exclusion, 41.5%), immediate failure, side-branch occlusion (14.0% each), stent thrombosis (10.6%), prolonged ischemia (9.2%), delayed failure (8.1%), post coronary artery bypass graft (1.5%), and non-target lesion related MI (1.1%). Significantly more stents were used in stent thrombosis, prolonged ischemia during PCI, and cryptogenic cases. In-hospital mortality was 8.1% for PMN and 8.8% for periprocedural MI, decreasing from non-target lesion related MI (25.0%) to mechanisms linked to stent thrombosis (20.7%), immediate failure (17.5%), delayed failure (7.7%), cryptogenic causes (6.1%), and prolonged ischemia (3.4%). Multivariate analysis confirms that in-hospital mortality is influenced by stent thrombosis, age, ejection fraction, and extent of coronary artery disease., Conclusions: The precise mechanism of PMI was determined in about 60% of our series. Stent thrombosis and immediate failure had the poorest in-hospital outcomes.

Aims: Despite a proven safety profile, the transradial approach (TRA) for coronary procedures is regarded by many as complicated and the second-choice arterial access, with a high conversion rate to transfemoral access (TFA). This study reports causes of failure and the contemporary success rate of TRA when both radial arteries are attempted first before converting to TFA., Methods: This prospective, single-center study included 1,826 consecutive patients referred for cardiac catheterization, which was performed by two trained operators between January 2005 and June 2007. Procedural data were reported in a specific database., Results: The procedural success rate through TRA (attempting one or both radial arteries) was 98.8%. One hundred and thirty-five radial attempts failed. Inability to puncture or to wire the artery accounted for 52.6% of failures, inability to reach coronary or graft ostia accounted for 20.7% and the remaining failures were related to the inability to reach a contralateral mammary graft. By multivariate analysis, the best predictors for failures were peripheral artery disease (PAD) (odds ratio [OR] 1.8, 95% confidence interval [CI] 1.1-2.8; p = 0.016), bedside clinical assessment of either a "small radial artery" size (OR 2.6, 95% CI 1.4 to 5.0; p = 0.003) or a "difficult access" (OR 2.5, 95% CI 1.3-4.9; p = 0.006). The number of failed attempts regresses annually by about 40% (OR 0.6, 95% CI 0.4-0.8; p < 0.001), thus demonstrating a continuous learning curve. Although rare, hematoma combined with swelling (3.8%) arises more frequently in females (OR 2.4, 95% CI 1.4-3.9; p = 0.001) and elderly patients (OR 1.9, 95% CI 1.0- 3.7; p = 0.040)., Conclusion: The TRA can be safely proposed for all patients, with a low conversion rate to TFA when an attempt on both radial arteries is considered first.