Coronary Artery Healing Process after Bioresorbable Scaffold in Patients with Non-ST-Segment Elevation Myocardial Infarction: Rationale, Design, and Methodology of the HONEST Study

Cardiology ◽  
2021 ◽  
pp. 1-11
Author(s):  
Christian Oliver Fallesen ◽  
Akiko Maehara ◽  
Lisbeth Antonsen ◽  
Kirstine Nørregaard Hansen ◽  
Manijeh Noori ◽  
...  

<b><i>Background:</i></b> Bioresorbable scaffolds (BRSs) is a relatively new approach in treating coronary artery stenosis. The initial results of the first commercially available scaffolds consisting of a backbone of poly-L-lactide raised safety concerns related to delayed resorption and healing. The magnesium alloy-based scaffold degrades via bio-corrosion within months, whereas it often takes several years for polymer scaffolds to degrade. The aim of the study was to assess the healing stage by optical coherence tomography (OCT) after 6 months in patients with non-ST-segment elevation myocardial infarct (NSTEMI) randomized to OCT or angiography-guided percutaneous coronary intervention with implantation of a magnesium sirolimus-eluting Magmaris scaffold (Magmaris; Biotronik, Bülach, Switzerland). <b><i>Methods:</i></b> We analyzed the healing process by comparing OCT at baseline and after 6 months. Five stages of healing were defined with stage 1 being the least healed and stage 5 demonstrating complete resorption and healing with no visible scaffold/remnant. The primary end point is a calculated healing score that is based on 5 subtypes of healing stage: (1) malapposed, (2) uncovered with no detection of smooth surface tissue on top of struts or remnants, (3) covered protruding, (4) covered embedded, and (5) complete healing with a smooth neointimal surface and no sign of struts or visible remnants assessed by OCT 6 months after the index procedure. <b><i>Results:</i></b> The impact of OCT-guided compared to angiography-guided scaffold implantation will be illuminated. <b><i>Conclusion:</i></b> The present study will provide new information on midterm healing properties of the magnesium BRS in patients with NSTEMI.

2020 ◽  
Vol 16 ◽  
Author(s):  
George Kassimis ◽  
Grigoris V. Karamasis ◽  
Athanasios Katsikis ◽  
Joanna Abramik ◽  
Nestoras Kontogiannis ◽  
...  

Coronary artery disease (CAD) remains the leading cause of cardiovascular death in octogenarians. This group of patients represents nearly a fifth of all patients treated with percutaneous coronary intervention (PCI) in real-world practice. Octogenarians have multiple risk factors for CAD and often greater myocardial ischemia than younger counterparts, with a potential of an increased benefit from myocardial revascularization. Despite this, octogenarians are routinely under-treated and belittled in clinical trials. Age does make a difference to PCI outcomes in older people, but it is never the sole arbiter of any clinical decision, whether in relation to the heart or any other aspect of health. The decision when to perform revascularization in elderly patients and especially in octogenarians is complex and should consider the patient on an individual basis, with clarification of the goals of the therapy and the relative risks and benefits of performing the procedure. In ST-segment elevation myocardial infarction (MI), there is no upper age limit regarding urgent reperfusion and primary PCI must be the standard of care. In non-ST-segment elevation acute coronary syndromes, a strict conservative strategy must be avoided; whereas the use of a routine invasive strategy may reduce the occurrence of MI and need for revascularization at follow-up, with no established benefit in terms of mortality. In stable CAD patients, invasive therapy on top of the optimal medical therapy seems better in symptom relief and quality of life. This review summarizes the available data on percutaneous revascularization in the elderly patients and particularly in octogenarians, including practical considerations on PCI risk secondary to ageing physiology. We also analyse technical difficulties met when considering PCI in this cohort and the ongoing need for further studies to ameliorate risk stratification and eventually outcomes in these challenging patients.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Dariusz Dudek ◽  
Petr Widimsky ◽  
Leonardo Bolognese ◽  
Patrick Goldstein ◽  
Christian Hamm ◽  
...  

Objectives: We evaluated the impact of prasugrel pretreatment and timing of coronary artery bypass grafting (CABG) on clinical outcomes of patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing CABG based on data from ACCOAST. Methods: We evaluated the impact of troponin, prasugrel pretreatment and CABG timing on clinical outcomes of NSTEMI patients undergoing CABG through 30 days from ACCOAST. Results: CABG patients versus PCI or medically managed patients were more often male, diabetic, had peripheral arterial disease and a higher GRACE score. By randomization assignment, 157 patients received a 30-mg loading-dose of prasugrel before CABG; 157 patients did not. CABG patients were grouped by tertiles of time from randomization to CABG; baseline characteristics in the Table. Patients in the lowest tertile had significantly more events (cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa bailout) and all TIMI major bleeds than those in the other 2 groups (p<0.045, p<0.002 respectively), but the patients in the higher 2 groups were not significantly different from each other. No difference was detected in all cause death among the 3 groups (p>0.39). A multivariate model evaluated 5 possible predictors of the composite endpoint of all cause death, MI, stroke and TIMI major bleeding. Time from randomization to CABG (HR 0.84 for each 1 hour of delay), left main disease presence (HR 1.76), and region of enrollment (Eastern Europe vs other, HR 3.83) were significant predictors but not prasugrel pretreatment or baseline troponin level ≥3xULN. Conclusions: In this group of high-risk patients presenting with NSTEMI, early surgical revascularization carried an increased risk of bleeding and ischemic complications, without impact on all-cause mortality. No impact of baseline troponin or prasugrel pretreatment (important factors influencing time of CABG) on clinical outcomes was confirmed.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Yader Sandoval ◽  
David F Miranda ◽  
Steven R Goldsmith ◽  
Bradley A Bart ◽  
Stephen W Smith ◽  
...  

Background: Emerging data have supported a strategy of earlier access to cardiac catheterization in patients with out-of-hospital cardiac arrest (OHCA). However, there are as yet no randomized controlled trials (RCT) addressing the issue, and the impact of percutaneous coronary intervention (PCI) on outcome is unclear in the absence of STEMI. We report here the characteristics and outcomes of patients with OHCA without STEMI undergoing coronary angiography (CA) with PCI vs. no PCI, in contrast to patients not undergoing CA. Methods: Single center, retrospective study of 195 patients with OHCA without STEMI between July 2007 and April 2014. Patients were categorized into CA vs. no CA (control), and among those undergoing CA we compared those treated with PCI vs. no PCI. Mortality was assessed along with key relevant clinical and angiographic variables in each group (Table). Results: 195 cases with OHCA without STEMI were reviewed, among which 102 (52%) did not undergo CA. 93 (48%) patients underwent CA, of which 21 (23%) underwent PCI, whereas 72 (77%) did not require PCI. Acute culprit lesion was identified in only 19 out of 93 (20.4%) Inpatient mortality was similar in those undergoing PCI vs. no PCI (19% vs. 14%, p=0.56). Patients that did not undergo CA had a significantly worse mortality, in comparison to patients undergoing CA (p<0.001). Conclusions: In this series of consecutive patients with OHCA without STEMI, culprit lesions were uncommon when CA was performed. Overall outcomes in patients receiving CA were better than in those not receiving CA, likely reflecting referral bias based on disease severity. However, successful PCI in patients with obstructive CAD and culprit lesions was not associated with improved inpatient survival. These findings emphasize the need for RCTs to guide the need for CA and/or PCI in these patients.


Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001432
Author(s):  
Callum D Little ◽  
Tushar Kotecha ◽  
Luciano Candilio ◽  
Richard J Jabbour ◽  
George B Collins ◽  
...  

ObjectivesTo understand the impact of COVID-19 on delivery and outcomes of primary percutaneous coronary intervention (PPCI). Furthermore, to compare clinical presentation and outcomes of patients with ST-segment elevation myocardial infarction (STEMI) with active COVID-19 against those without COVID-19.MethodsWe systematically analysed 348 STEMI cases presenting to the PPCI programme in London during the peak of the pandemic (1 March to 30 April 2020) and compared with 440 cases from the same period in 2019. Outcomes of interest included ambulance response times, timeliness of revascularisation, angiographic and procedural characteristics, and in-hospital clinical outcomesResultsThere was a 21% reduction in STEMI admissions and longer ambulance response times (87 (62–118) min in 2020 vs 75 (57–95) min in 2019, p<0.001), but that this was not associated with a delays in achieving revascularisation once in hospital (48 (34–65) min in 2020 vs 48 (35–70) min in 2019, p=0.35) or increased mortality (10.9% (38) in 2020 vs 8.6% (38) in 2019, p=0.28). 46 patients with active COVID-19 were more thrombotic and more likely to have intensive care unit admissions (32.6% (15) vs 9.3% (28), OR 5.74 (95%CI 2.24 to 9.89), p<0.001). They also had increased length of stay (4 (3–9) days vs 3 (2–4) days, p<0.001) and a higher mortality (21.7% (10) vs 9.3% (28), OR 2.72 (95% CI 1.25 to 5.82), p=0.012) compared with patients having PPCI without COVID-19.ConclusionThese findings suggest that PPCI pathways can be maintained during unprecedented healthcare emergencies but confirms the high mortality of STEMI in the context of concomitant COVID-19 infection characterised by a heightened state of thrombogenicity.


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