Invasive versus medical management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome: a pilot randomized controlled trial

Background: The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials. Methods: In a multicenter trial, non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (invasive group) or noninvasive management (medical group). The primary outcome was adherence with the randomized strategy by 30 days. A blinded, independent Clinical Event Committee adjudicated predefined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function). Results: Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29). One-third (n=10) of the participants in the invasive group initially received percutaneous coronary intervention. In the medical group, 1 participant crossed over to invasive management on day 30 but percutaneous coronary intervention was not performed. During 2-years’ follow-up (median [interquartile range], 744 [570–853] days), the composite outcome for efficacy occurred in 13 (42%) subjects in the invasive group and 13 (45%) subjects in the medical group. The composite safety outcome occurred in 8 (26%) subjects in the invasive group and 9 (31%) subjects in the medical group. An efficacy or safety outcome occurred in 17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group. Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months. Conclusions: More than half of the population experienced a serious adverse event. An initial noninvasive management strategy is feasible. A substantive health outcomes trial of invasive versus noninvasive management in non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts appears warranted. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01895751

Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations

Background: Coronary artery bypass graft (CABG) patients are under-represented in acute coronary syndrome (ACS) trials. We compared characteristics and outcomes for patients who did and did not participate in a randomised trial of invasive versus non-invasive management (CABG-ACS). Methods: ACS patients with prior CABG in four hospitals were randomised to invasive or non-invasive management. Non-randomised patients entered a registry. Primary efficacy (composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, myocardial infarction (MI), heart failure) and safety outcomes (composite of bleeding, stroke, procedure-related MI, worsening renal function) were independently adjudicated. Results: Of 217 patients screened, 84 (39%) screenfailed, of whom 24 (29%) did not consent and 60 (71%) were ineligible. Of 133 (61%) eligible, 60 (mean±SD age, 71±9 years, 72% male) entered the trial and 73 (age, 72±10 years, 73% male) entered a registry (preferences: physician (79%), patient (38%), both (21%)). Compared with trial participants, registry patients had more valve disease, lower haemoglobin, worse New York Heart Association class and higher frailty. At baseline, invasive management was performed in 52% and 49% trial and registry patients, respectively, of whom 32% and 36% had percutaneous coronary intervention at baseline, respectively (p=0.800). After 2 years follow-up (694 (median, IQR 558–841) days), primary efficacy (43% trial vs 49% registry (HR 1.14, 95% CI 0.69 to 1.89)) and safety outcomes (28% trial vs 22% registry (HR 0.74, 95% CI 0.37 to 1.46)) were similar. EuroQol was lower in registry patients at 1 year. Conclusions: Compared with trial participants, registry participants had excess morbidity, but longer-term outcomes were similar. Trial registration number: NCT01895751

Dynamic modulation of coronary arterio-venous communications

A 62 year-old man with multiple coronary risk factors – including uncontrolled hypertension, smoking habit, abdominal obesity and family history of ischemic heart disease – was admitted to our Emergency Department for a prolonged episode of chest pain occurring at rest. He had no relevant past medical history except recently diagnosed chronic obstructive pulmonary disease; however, in the last year he suffered from sporadic episodes of effort angina (Canadian Class II–III) with spontaneous regression after few minutes of rest. During the last week he experienced worsening angina, with daily episodes of chest pain, mainly occurring during mild exertion but with some episodes occurring even at rest in the last two days. On admission the patient was symptomatic for angina. Physical examination was unremarkable, except for rhonchi and wheezing sounds in the chest, the blood pressure was 200/95 mmHg and the ECG revealed sinus tachycardia with ST segment elevation and QS waves in V1–V4 leads. Pharmacological treatment was immediately started with loading doses of Aspirin and Clopidogrel, iv. morphine, i.v. nitroglycerin and i.v. beta-blockers, with partial pain resolution. Cath lab team was promptly alerted for urgent coronary angiography. In the meantime, a trans-thoracic echocardiogram was performed, showing a hypertrophic and mildly dilated left ventricle with regional wall motion abnormalities in the left anterior descending (LAD) coronary artery territory: apical and mid septal akinesia, anterior wall hypokinesia. The estimated left ventricular ejection fraction was 35–40%. No other relevant findings. Fifteen minutes after the admission the patient was still mildly symptomatic for angina and ST segment elevation was still present on the ECG, although reduced, thus the patient was transferred directly to the cath lab to undergo coronary angiography. The selective right coronary angiography revealed significant stenosis of the posterolateral branch of the right coronary artery (RCA) and, more importantly, the presence of collaterals to the LAD and three artero-venous fistulae, which allowed the RCA to communicate with the pulmonary artery, the coronary sinus and a posterolateral branch of the cardiac venous system (Fig. 1A ). Prior to the selective angiography of the left coronary artery, the patient's chest pain resolved together with the concomitant resolution of the ST segment elevation. The left coronary angiography (Fig. 2C ) was performed and showed the presence of significant proximal LAD stenosis, likely representing the culprit lesion, which appeared spontaneously reperfused. Angiography also revealed sub-occlusion of the first diagonal and significant stenosis of the first obtuse marginal (OM) branch. Due to these findings, a new right coronary angiography was performed, which documented the disappearance of both arterial and venous communications (Fig. 1 B). Because of the spontaneous reperfusion of the culprit lesion, together with the total regression of symptoms and ST segment elevation, urgent revascularization was not deemed necessary. Furthermore, considering the presence of multivessel disease, a joint clinical case meeting with cardiac surgeons and invasive cardiologists was arranged and a staged PCI was felt to be the best treatment option and thus was scheduled the following day. A successful revascularization procedure was performed with the implantation of two everolimus eluting stents (EES), 2.75×23 mm on LAD and 2.75×32 mm on OM, and a POBA of the first diagonal branch with a 2.5×25 mm balloon. The patient was discharged with the indication to complete the percutaneous revascularization later. The pre-discharge echocardiogram confirmed global left ventricular dysfunction (LVEF 35–40%) with the above described regional wall motion abnormalities. One month later the revascularization was completed with an elective PCI of the posterolateral branch of the RCA with the implantation of another EES 2.75×16 mm and the angiography confirmed the complete disappearance of collateral circulation and arterio-venous fistulae (Fig. 2 D,E)

Physiological assessment after percutaneous coronary intervention: the hard truth

Physiologically guided revascularization, using fractional flow reserve (FFR) or instantaneous wave free ratio (iFR) has been demonstrated to be associated with better long-term outcomes compared to an angiographically-guided strategy, mainly avoiding inappropriate coronary stenting and its associated adverse events. On the contrary, the role of invasive physiological assessment after percutaneous coronary intervention (PCI) is much less well established. However, a large body of evidence suggests that a relevant proportion of patients undergoing PCI with a satisfying angiographic result show instead a suboptimal functional product with a potentially negative prognostic impact. For this reason, many efforts have been focused to identify interventional strategies to physiologically optimize PCI. Measuring the functional result after as PCI, especially when performed after a physiological assessment, implies that the operator is ready to accept the hard truth of an unsatisfactory physiological result despite angiographically optimal and, consequently, to optimize the product with some additional effort. The aim of this review was to bridge this gap in knowledge by better defining the paradigm shift of invasive physiological assessment, from a simple tool for deciding whether an epicardial stenosis must be treated, to a thoroughly physiological approach to PCI with the suggestion of a practical flow chart. coronary intervention: the hard truth. Panminerva Med 2021;63:519-28. DOI: 10.23736/S0031-0808.21.04363-9

Fractional Flow Reserve-Guided Coronary Revascularization: Evidence from Randomized and Non-Randomized Studies

Simple visual estimation of coronary angiography is limited by several factors that can hinder the proper classification of coronary lesions. Fractional flow reserve (FFR) is the most widely used tool to perform a physiological evaluation of coronary stenoses. Compared to isolated angiography, FFR has been demonstrated to be more effective in selecting those lesions associated with myocardial ischemia and, accordingly, impaired outcomes. At the same time, deferring coronary intervention in those lesions that do not show ischemic FFR values has proven safe and not associated with adverse events. Despite a major randomized clinical trial (RCT) and several non-randomized studies showing that FFR-guided revascularization could be superior to isolated angiography in improving clinical outcomes, subsequent RCTs have reported conflicting results. In this review, we summarize the principles behind FFR and the data currently available in the literature, highlighting the main differences between randomized and non-randomized studies that investigated this topic

Stent malapposition, strut coverage and atherothrombotic prolapse after percutaneous coronary interventions in ST-segment elevation myocardial infarction

Stent implantation in ST-segment elevation myocardial infarction (STEMI) patients can be challenging and sometimes associated with immediate and long-term suboptimal results. Stent malapposition and strut uncoverage, predictors of stent thrombosis, are frequently detected in STEMI patients at medium/long-term follow-up. Nevertheless, data at a short follow-up are missing. We aimed to assess the extent of stent malapposition and struts coverage in the subacute phase of STEMI after stent implantation in primary or rescue percutaneous coronary intervention (PCI)

Hard Events AfteR Orsiro Sirolimus-Eluting Stent (HEROES) in STEMI: A Multicenter Registry

To evaluate the safety and efficacy of the Orsiro sirolimus-eluting stent (Biotronik) in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (pPCI). Specific drug-eluting stent (DES) platforms might influence pPCI success rate in the mid-to-long term. Orsiro, a hybrid sirolimus DES with thin struts and a biodegradable polymer, may potentially cause less stent malapposition, stent-induced inflammation, and mechanical damage, improving clinical outcomes

Hard Events AfteR Orsiro Sirolimus-Eluting Stent (HEROES) in STEMI: A Multicenter Registry

Objectives: To evaluate the safety and efficacy of the Orsiro sirolimus-eluting stent (Biotronik) in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (pPCI). Specific drug-eluting stent (DES) platforms might influence pPCI success rate in the mid-to-long term. Orsiro, a hybrid sirolimus DES with thin struts and a biodegradable polymer, may potentially cause less stent malapposition, stent-induced inflammation, and mechanical damage, improving clinical outcomes. Methods: We retrospectively enrolled all patients who received 1 or more Orsiro DES in the target vessel of pPCI at 9 Italian centers from January 2012 to March 2016. The primary endpoint was a device-oriented composite endpoint (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel (TVMI), and ischemic-driven target-lesion revascularization (ID-TLR) at 1-year follow-up. Secondary endpoints were: (1) DOCE at 6-month and 3-year follow-up; (2) any definite/probable stent thrombosis; and (3) any major bleeding. Results: The study cohort comprised 353 patients. At 1-year follow-up, we observed a 3.7% cumulative incidence of DOCE, consisting of 11 cardiac deaths (3.1%), 2 TVMIs (0.6%), and 2 ID-TLRs (0.6%). There was only 1 definite stent thrombosis (0.3%) and 8 bleedings (2.4%). Kaplan-Meier analysis showed DOCE-free survival rates of 96.6% at 6 months, 96.3% at 1 year, and 93.8% at 3 years. Conclusions: Our findings support the real-world safety and efficacy of the Orsiro stent for pPCI