Aim Current guidelines recommend the use of Vitamin K Antagonist (VKA) for up to 3–6 months for the treatment of LV thrombus post- acute myocardial infarction (AMI). However based on evidence supporting the non-inferiority and potential superiority of Direct Oral Anti-Coagulation's (DOAC) compared to VKA for other indications such as atrial fibrillation, DOACs are being increasingly used off licence for the treatment of left ventricular (LV) thrombus post AMI. In this study we investigated the effect of DOACs compared to VKA on LV thrombus resolution and their safety profile in patients presenting with AMI. Methods and results This was a prospective observational study of 2,328 consecutive patients undergoing Percutaneous Coronary Intervention (PCI) for AMI between 2015- 2018, at a UK cardiac centre. Patients' details were collected from the hospital electronic database. The primary end-point was the rate of resolution of LV thrombus with bleeding rates as a secondary outcome. Left ventricular (LV) thrombus was diagnosed by echocardiography, or cardiac magnetic resonance imaging in 98 (5.1%) patients. Sixty patients (61.2%) were started on VKA and 38 patients (38.8%) on DOAC therapy (Rivaroxaban: 57.9%, Apixaban, 36.8% and Edoxaban: 5.3%). Both groups were well matched in terms of baseline characteristics including age, previous cardiac history (previous MI, PCI, CABG), and cardiovascular risk factors (Hypertension, Diabetes, Hypercholesterolaemia). Over the follow up period (median 1.8 years), overall rates of LV thrombus resolution were 86%. There was greater and earlier LV thrombus resolution in the DOAC group compared to patients treated with warfarin (75% vs 53%, p=0.0018, at 1 year), which persisted after adjusting for baseline variables (OR 1.8 95% CI 1.2–2.9). Major bleeding such as intracranial bleed, major GI bleed and bleed requiring hospital admission were lower in DOAC group, compared with VKA group (0% vs 5%, p=0.030) with no difference in rates of systemic thromboembolism (p=0.388). Conclusion This data suggests improved thrombus resolution in post ACS LV thrombosis in patient treated with DOACs compared to vitamin K antagonists. This improvement in thrombus resolution was accompanied with a better safety profile for the DOAC patients' vs VKA treated patients. This supports the need for randomised controlled trials to confirm this observational data. Acknowledgement/Funding None
Rationale: Cell-based therapies are a novel potential treatment for refractory angina and have been found to improve markers of angina. However, the effects on mortality and major adverse cardiac events (MACE) have not been definitively investigated. Objective: To investigate the efficacy and safety of stem cell treatment compared with optimal medical treatment for refractory angina by conducting an updated meta-analysis, looking at clinical outcomes. Methods and Results: We performed a systematic review and meta-analysis of randomized controlled trials using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. A comprehensive search was performed of PubMed, EMBASE (Excerpta Medica database), Cochrane, ClinicalTrials.gov , Google Scholar databases of randomized controlled trials, and scientific session abstracts. Studies were deemed eligible if they met the following criteria: (1) full-length publications in peer-reviewed journals; (2) evaluated cell therapy use in patients with no further revascularisation options while on optimal medical treatment; (3) patients had ongoing angina, Canadian Cardiovascular Society class II—IV; and (4) included a placebo/control arm. We calculated risk ratios for all-cause mortality, combined MACE events. We assessed heterogeneity using χ 2 and I 2 tests. We identified 1191 citations with 8 randomized controlled trials meeting inclusion criteria involving 526 patients. Outcomes pooled were MACE, mortality, and indices of angina (angina episodes, Canadian Cardiovascular Society angina class, exercise tolerance, and antianginal medications). Our analysis showed a decreased risk of both MACE (odds ratio, 0.41; CI, 0.25−0.70) and mortality (odds ratio, 0.24; 95% CI, 0.10−0.60) in cell-treated patients compared with patients on maximal medical therapy. This was supported by improvements in surrogate end points of anginal episodes, use of antianginal medications, Canadian Cardiovascular Society class, and exercise tolerance. Conclusions: In addition to improvements in indices of angina, cell-based therapies improve cardiovascular outcomes (mortality/MACE) in patients with refractory angina. Given the premature termination of the phase III study, this supports the need for further definitive trials. Prospero Registration : URL: https://www.crd.york.ac.uk/prospero/ . Unique identifier: CRD42018084257.
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