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Importance: Patients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI)., Objective: To investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease., Design, Setting, and Participants: This was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document., Interventions: Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy., Main Outcomes and Measures: The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5., Results: Among 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points., Conclusions and Relevance: HBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI., Trial Registration: ClinicalTrials.gov Identifier: NCT03772743.

Background: The resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population., Methods: SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization., Results: Overall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%-5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6-4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%-7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%-1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis., Conclusions: These results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interests. All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Intravenous unfractionated heparin (UFH) is recommended in ST-elevation acute myocardial infarction (STEMI), following thrombolysis with fibrin-specific agents. Subcutaneous low-molecular-weight heparins (LMWH), previously proven effective in non-ST-elevation acute coronary syndromes, have been recently investigated in the setting of STEMI. We aimed at evaluating the current level of evidence supporting the use of LMWH in STEMI., Methods: A Medline search of the English language literature between January 1995 and December 2005 was performed and randomized clinical trials comparing LMWH to either placebo or UFH in conjunction with thrombolysis were selected., Results: About 26,800 patients treated with various thrombolytic regimens were included in 12 randomized clinical trials. Dalteparin was superior to placebo on left ventricular thrombosis/arterial thromboembolism, with no significant effect on the early patency rate of the infarct-related artery (IRA). Compared to UFH, dalteparin had no significant effect on clinical events and on the IRA late patency, although less thrombus was present. Enoxaparin was superior to placebo on the medium-term death/reinfarction/angina rate and late IRA patency, and superior also to UFH on in-hospital and medium-term occurrence of death/reinfarction/angina. The effect of enoxaparin on IRA patency rate was not univocal. Compared to placebo, reviparin significantly reduced early and medium-term mortality and reinfarction rates, without a substantial increase in overall stroke rate. As regards safety, bleedings were more frequent than placebo and comparable to UFH in LMWH groups, with the exception of the pre-hospital ASSENT-3 PLUS trial, where in elderly patients, enoxaparin had an incidence of intracranial hemorrhage twice higher than UFH., Conclusions: In-hospital subcutaneous administration of dalteparin, enoxaparin or reviparin, as an adjunct to various thrombolytics in STEMI, appears feasible and at least as effective and safe as intravenous UFH. Before LMWH might be recommended, however, some yet unresolved issues (i.e. use in elderly patients, in severe renal insufficiency, in association with glycoprotein IIb/IIIa inhibitors and during interventional procedures), need to be addressed., (Copyright 2007 S. Karger AG, Basel.)

The use of enoxaparin in conjunction with thrombolysis in ST-elevation acute myocardial infarction (STEMI), has been recently investigated in several clinical trials. In 8 published open-label studies including about 10,000 patients, in which enoxaparin was compared to either placebo or unfractionated heparin (UFH), a general superiority of enoxaparin on both reinfarction/recurrent angina and patency of the infarct-related artery, was observed. Overall, bleeding rate with enoxaparin was higher than with placebo and comparable to UFH, with the exception of one study where pre-hospital administration induced a doubled incidence of intracranial bleeding in patients older than 75 years. In a recent double-blind, randomized, mega-trial including over 20,000 patients, the superior efficacy on in-hospital and 30-day adverse cardiac events (namely reinfarction), and comparable safety on intracranial bleedings of enoxaparin compared to UFH, was definitively proven. In conclusion, initial intravenous bolus of enoxaparin followed by twice daily subcutaneous administration for about 1 week should be considered instead of intravenous UFH for the treatment of patients with STEMI receiving thrombolysis. Along with its easiness of use, not requiring laboratory monitoring, the subcutaneous administration of enoxaparin allows extended antithrombotic treatment, while permitting early mobilization (and rehabilitation) of patients.

BACKGROUND: The FIRE trial (Functional Assessment in Elderly Myocardial Infarction Patients With Multivessel Disease) enrolled 1445 older (aged =75 years) patients with myocardial infarction and multivessel disease in Italy, Spain, and Poland. Patients were randomized to physiology-guided complete revascularization or treatment of the only culprit lesion. Physiologyguided complete revascularization significantly reduced ischemic adverse events at 1 year. This prespecified analysis investigated the changes between the 2 study groups in angina status, quality of life, physical performance, and frailty. METHODS: Patients underwent validated scales at hospital discharge (baseline) and 1 year later. Angina status was evaluated using the Seattle Angina Questionnaire, health-related quality of life by EQ visual analog scale, physical performance by short physical performance battery, and frailty by the clinical frailty scale. Mixed models for repeated measures analysis were used to study the association between the treatment arms, time, and scales. RESULTS: Baseline and 1-year Seattle Angina Questionnaire, EQ visual analog scale, short physical performance battery, and clinical frailty scale were collected in around two-thirds of the entire FIRE study population. The mean age was 80.9±4.6 years (female sex, 35.9%). Overall, 35.3% were admitted for ST-segment-elevation myocardial infarction, whereas the others were admitted for non-ST-segment-elevation myocardial infarction. Physiology-guided complete revascularization, compared with culprit-only revascularization, was associated with greater improvement in terms of angina status (Seattle Angina Questionnaire summary score, 7.3 [95% CI, 6.1-8.6] points), health-related quality of life (EQ visual analog scale, 6.2 [95% CI, 4.4-8.1] points), and physical performance (short physical performance battery, 1.1 [95% CI, 0.9-1.3] points). After 1 year, patients randomized to culprit-only revascularization experienced a deterioration in frailty status (clinical frailty scale, 0.2 [95% CI, 0.1-0.3] points), which was not observed in patients randomized to physiology-guided complete revascularization. CONCLUSIONS: The present analysis suggested that a physiology-guided complete revascularization is associated with consistent benefits in terms of angina status, quality of life, physical performance, and the absence of further deterioration of the frailty status. [ABSTRACT FROM AUTHOR]