ABSTRACT
Objective: To evaluate the 4-year clinical outcomes of patients following Firesorb bioresorbable scaffold (BRS) implantation. Methods: The study reported the 4-year follow-up results of the FUTURE I study. FUTURE I was a prospective, single-center, open-label, first-in-man study which evaluated the feasibility, preliminary safety, and efficacy of Firesorb stent in the treatment of coronary artery stenosis. A total of 45 patients with single de novo lesions in native coronary arteries ,who hospitalized in Fuwai Hospital from January to March 2016 were enrolled. After successfully stent implantation these patients were randomized in a 2∶1 ratio into cohort 1 (n=30) or cohort 2 (n=15). The patients in cohort 1 underwent angiographic, IVUS or OCT examination at 6 months and 2 years; and cohort 2 underwent angiographic, IVUS or OCT at 1 and 3 years. All patients underwent clinical follow-up at 1, 6 months and 1 year and annually thereafter up to 5 years. The primary endpoint was target lesion failure (TLF, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization). Secondary endpoints included patient-oriented composite endpoint (PoCE, defined as composite of all death, all miocardial infarction, or any revascularization). Results: A total of 45 patients were enrolled and implanted with Firesorb BRS, including 35 males (77.8%), and the age was (54.4±9.3) years. At 4 years, 10 patients in cohort 1 were reexamined by coronary angiography and OCT examination. Among them, 2 patients' stents were completely degraded and absorbed. Compared with the OCT images of the other 8 patients in cohort 2 at 3 years, the degree of stent degradation was increased, and no stent adherence was found. The 4-year clinical follow-up rate was 100%. In 4-year clinical following up, 2 patients suffered PoCE (4.4%): 1 patient underwent non-target vessel revascularization the day after index procedure and target vessel revascularization (Non-target lesion revascularization) at 2-year imaging follow-up; the other patient underwent target lesion revascularization during imaging follow-up at 4 years but not due to ischemic driven. There was no scaffold thrombosis or TLF events through 4 years. Conclusions: Four years after the implantation, complete degradation and absorption of the Firsorb stent are evidenced in some patients. Firesorb stent is feasible and effective in the treatment of patients with non-complex coronary lesions.
Subject(s)
Humans , Male , Middle Aged , Absorbable Implants , Cardiovascular Agents , Coronary Artery Disease/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention , Prospective Studies , Sirolimus , Treatment OutcomeABSTRACT
Objective To investigate the risk factors of short-term and long-term mortality in elderly patients with ST-segment elevation myocardial infarction(STEMI) after primary percutaneous coronary intervention(PPCI).Methods From Sept. 2011 to Jan. 2014, there were 27397 PCI cases performedin the Fuwai Hospital. 108 consecutive patients(0.39％) who aged over 75 diagnosed as acute myocardial infarction and underwent PCI were enrolled into this study. Cox proportional hazards model was used to analysis the risk factors of mortality during follow up.Results In the study population, 5 patients (4.63％) died during in-hospital stay, 7 patients(6.5％) died within 30 days after PPCI and 17 patients (15.7％)died during follow up[averaged follow up duration was (51.17±17.75) months] . Independent risk factors of 1-year mortality included female(HR 5.482, 95％CI1.099-27.333,P=0.038) and cardiac shock(HR 11.283, 95％CI 2.841-44.805,P=0.001). Stent implantation was found to be a protective factor(HR 0.173, 95％CI 0.032-0.943,P=0.043). Independent risk factors of long-term mortality included age(HR 1.146,95％CI 1.010-1.300,P=0.034)and cardiac shock(HR 4.928, 95％ CI1.718-14.130, P=0.003).Conclusions Old age, female, low LVEF, cardic shock and not having stent implantation were independent risk factors for mortality in elderly STEMI patients(≥75 years) who underwent primary PCI.
ABSTRACT
<p><b>OBJECTIVE</b>To investigate the neointimal coverage at the very early phase after drug-eluting stent (DES) implantation using optical coherence tomography (OCT).</p><p><b>METHODS</b>OCT examination was performed immediately after stent deployment and about one week post stenting in 12 patients with coronary artery disease to detect neointimal coverage and stent thrombus. Sirolimus eluting stent implantation was also performed in 5 healthy Chinese minipigs, OCT and histopathology examination were made one week later in these minipigs.</p><p><b>RESULTS</b>(1) Twenty-nine DES were implanted in 12 patients. There was no major cardiovascular event post stenting. The mean time of follow-up was (7.7 ± 2.6) d, the mean percentage of stent coverage was (21.8 ± 17.7)%, and neointimal hyperplasia thickness was (42.9 ± 32.2) µm and the percentage of malapposition struts was (1.5 ± 3.0)%, respectively. Mural stent thrombus was found in 2 of the 12 patients (the percentage is 16.7%). (2) In the minipigs model, OCT evidenced that (43.2 ± 11.5)% struts were covered by neointima with a mean neointimal hyperplasia thickness of (24.0 ± 8.5) µm at one week. Histopathology examination illustrated that the neointima was mainly consisted of proteoglycan, inflammation cells, fibrin and organized thrombus at the very early phase after DES implantation, while endothelial cells were barely found on the neointima.</p><p><b>CONCLUSIONS</b>Neointimal coverage is found as early as one week after DES implantation by OCT. The covered struts rate is very low and the main components of neointima are proteoglycan, inflammation cells, fibrin and organized thrombus. Re-endothelialization is rather poor at the very early phase post DES implantation.</p>