The safety and efficacy of Firesorb bioresorbable scaffold in first-in-man study for coronary artery disease: the four-year outcomes / 中华心血管病杂志

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.

Clinical outcome of patients undergoing emergent coronary artery bypass grafting following failed percutaneous coronary intervention in stent era / 中华心血管病杂志

<p><b>OBJECTIVE</b>To explore clinical outcomes of patients undergoing emergent coronary artery bypass grafting (CABG) following failed percutaneous coronary intervention (PCI) in the stent era.</p><p><b>METHODS</b>Eleven patients who underwent emergent CABG following failed PCI from January, 2002 to December 2010 were enrolled. The in-hospital follow-up included cardiac deaths, Q-wave myocardial infarction, kidney failure, and cerebrovascular events. The clinical end-point of out-hospital follow-up was the major adverse cardiac events including death, myocardial infarction, and target lesion revascularization.</p><p><b>RESULTS</b>The patients were (61 ± 5) years old. Coronary angiography showed 5 patients had triple vessel lesions. There were 9 target lesions on left anterior descending artery. There were 3 (27.3%) severe calcified, 4 (36.4%) chronic total occlusion, and 4 (36.4%) diffused long lesions. Reasons for emergent CABG were dissection (n = 5, 45.5%), perforation (n = 3, 27.3%), failure to sufficient predilation (n = 1, 9.1%), acute closure (n = 1, 9.1%) and stent loss (n = 1, 9.1%). The average duration of follow-up was (47 ± 33) months. During in-hospital follow-up, there were 1 (9.1%) cardiac death and 2 (18.2%) Q wave myocardial infarction. During follow-up after hospital discharge, 1 patient (9.1%) died of kidney failure, and there was no rehospitalization due to cardiac events.</p><p><b>CONCLUSIONS</b>Emergent CABG after failed PCI often happened in patients with complex coronary lesions. The long term outcome of patients requiring emergent CABG after failed PCI was favorable in this cohort.</p>

The in-hospital outcome and predictors of major adverse cardiac events after transradial intervention in patients with coronary artery disease / 中华心血管病杂志

<p><b>OBJECTIVE</b>The purpose of this study is to evaluate the in-hospital clinical outcome of patients with coronary artery disease who underwent transradial intervention (TRI) and analyze the predictors of clinical outcome.</p><p><b>METHODS</b>From May 2004 to May 2009, there were 16 281 patients who underwent transradial intervention, as well as 5388 patients who underwent transfemoral intervention (TFI) at our institution. The clinical characteristics, procedural characteristics, and in-hospital clinical adverse events were compared between TRI and TFI groups. Multivariable logistic regression analysis was performed to determine predictors of in-hospital major adverse cardiac events (composite of death, myocardial infarction, or target lesion revascularization) of TRI.</p><p><b>RESULTS</b>The annulations time was significantly longer for TRI than TFI (P < 0.01), fluoroscopy time, amount of contrast agent and procedural success rate (95.5% for TRI and 96.2% for TFI) were similar between the two groups. However, the rates of vascular complications (0.1% for TRI group and 1.3% for TFI group, P < 0.01), incidence of in-hospital major adverse cardiac events (1.6% vs. 3.8%, P < 0.01) and in-hospital death (0.2% vs. 0.4%, P < 0.01) were all significantly lower in TRI group compared with TFI group. The following characteristics were identified as independent multivariate predictors of in-hospital major adverse cardiac events of TRI: age ≥ 65 (OR: 1.98, 95%CI: 1.50 - 2.61, P < 0.01), prior myocardial infarction (OR: 2.14, 95%CI: 1.63 - 2.82, P < 0.01), use of drug-eluting stent (DES) (OR: 0.68, 95%CI: 0.47 - 0.98, P = 0.04), dissection during procedure (OR: 4.08, 95%CI: 2.28 - 7.33, P < 0.01), left main lesion (OR: 2.12, 95%CI: 1.09 - 4.13, P = 0.03), number of implanted stents (OR: 1.25, 95%CI: 1.09 - 1.43, P < 0.01), and total stented length (OR: 1.01, 95%CI: 1.00 - 1.02, P = 0.03).</p><p><b>CONCLUSIONS</b>In this large single-centre patient cohort, the transradial intervention is superior to transfemoral intervention in terms of in-hospital safety and efficacy. Age ≥ 65, prior myocardial infarction, use of DES, dissection during procedure, left main lesion, number of implanted stents and total stented length were identified as independent multivariate predictors of in-hospital major adverse cardiac events of TRI.</p>

Coronary intervention in patients>or=75 years old with ST-elevation myocardial infarction: in-hospital and 6-month clinical outcomes / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>ST-segment elevation myocardial infarction (STEMI) in elderly patients presents specific clinical characteristics. The study on percutaneous coronary intervention (PCI) in elderly patients (>or=75 years) with STEMI, however, has less been performed.</p><p><b>METHODS</b>In the present study, 522 consecutive STEMI patients undergoing PCI within 12 hours from symptom onset were investigated, and clinical characteristics and in-hospital and 6-month outcomes of 66 elderly patients (>or=75 years, group A) were compared to those of 456 younger patients (<75 years, group B).</p><p><b>RESULTS</b>Compared to younger patients, elderly ones had more females (42.4% vs. 17.8%, P<0.005), a history of cerebral vascular events (7.6% vs. 0.9%, P<0.05), higher serum creatinine level ((96.48+/-31.65) mmol/L vs. (84.87+/-19.81) mmol/L, P<0.005) and fewer smokers (28.8% vs. 45.4%, P<0.05). The elderly ones had worse Killip class (Killip I class: 69.7% vs. 85.7%, P<0.05), less drug-eluting stent implantation and lower rates of TIMI flow 3 following PCI (33.3% vs. 47.1%, and 84.8% vs. 94.7%, P<0.05 respectively). Additionally, both in-hospital mortality and myocardial infarction rate were found to be higher in elderly patients (16.7% vs. 1.5%, and 7.6% vs. 2.6%, P<0.05 respectively), which were also observed until 6-month follow-up (9.1% vs. 0, and 6.1% vs. 0, P<0.05 respectively). In multivariable Cox regression analysis, serum creatinine level, history of hypertension, left anterior descending coronary artery as infarct-related artery and Killip class were independent predictors of 6-month overall death in elderly patients.</p><p><b>CONCLUSIONS</b>The clinical characteristics of elderly patients with STEMI after PCI are different from those of younger patients. Although PCI in this population is with a low rate of PCI failure, it is still associated with a worse outcome.</p>

Clinical and angiographic outcome in coronary artery disease patients with type-II diabetes mellitus undergoing elective bare-metal stenting or drug-eluting stenting / 中华心血管病杂志

<p><b>OBJECTIVE</b>To compare the clinical and angiographic outcome in patients with type-II diabetes mellitus undergoing drug-eluting stent (DES) or bare-metal stent (BMS).</p><p><b>METHODS</b>A total of 139 consecutive diabetic patients (114 males) with coronary disease who underwent successful elective percutaneous coronary intervention with DES (n = 83 with 151 lesions) or BMS (n = 56 with 70 lesions) on native coronary arteries from April 2004 to August 2005 at our institution were included in this study. All patients were treated according to guidelines and coronary angiography was repeated at 6 months post procedure in all patients. Aspirin (300 mg/d) and clopidogrel (75 mg/d) were administered till 6 months after the procedure.</p><p><b>RESULTS</b>There were 42.5% C type by ACC/AHA and 19.0% total occlusion lesions. The average stent length of each lesion was 26.53 +/- 14.72 mm, and mean reference diameter was 2.80 +/- 0.43 mm. Baseline characteristics were similar between DES and BMS groups except lower mean reference vessel diameter in DES than that of BMS group (2.71 +/- 0.41 mm vs. 2.98 +/- 0.53 mm, P < 0.001). The in stent restenosis rate at 6 months (10.6% vs. 38.6%, P < 0.001) and in-segment late loss (0.24 +/- 0.56 mm vs. 0.91 +/- 0.77 mm, P < 0.001) were significantly lower in DES group than those of BMS group. The target lesion revascularization (TLR) incidence was also significantly lower in DES group compared to BMS group (8.6% vs. 30.0%, P < 0.001). However, 4 late in-stent thrombosis were seen in DES group and none in BMS group of DES (P = 0.148).</p><p><b>CONCLUSION</b>DES implantation in patients with diabetes mellitus is associated with lower in-stent restenosis and TLR rates compared to BMS implantation 6 months after procedure and attention should be paid on late in-stent thrombosis after DES implantation.</p>

Clinical and angiographic outcome in patients undergoing elective bare- metal stenting or drug-eluting stenting for total occlusion lesion / 中华心血管病杂志

<p><b>OBJECTIVE</b>To compare the clinical and angiographic outcome in patients with total occlusion lesion treated with drug-eluting stent (DES) or bare-metal stent (BMS).</p><p><b>METHODS</b>A total of 155 (138 males) consecutive patients with total occlusion lesion underwent successful revascularization with DES (n = 74) or BMS (n = 81) in our hospital were included in this study. All patients received aspirin 300 mg and clopidogrel 75 mg once daily for at least 3 months after the procedure. Clinical and angiographic follow-up were completed in all patients at 6 months post stenting.</p><p><b>RESULTS</b>Demographic data between the two groups were similar except there was more diabetic patients in DES group (33.8% vs. 18.5%, P < 0.05). A total of 232 stents for 159 target lesions (77 treated with DES, 82 treated with BMS) were implanted. There were 85.4% C ACC/AHA type lesions and 17.0% lesions were treated with overlapping stents. Six months post stenting, the incidence of restenosis (15.6% vs. 41.5%, P < 0.001), the cumulative rate of major adverse cardiac events (MACE) (1.4% vs. 11.1%, P = 0.032) and TLR (5.8% vs. 19.9%, P = 0.001) were significantly lower in DES group than that of BMS group. The incidence of local restenosis in DES group is higher in DES group than that in BMS group (58.3%, 17.6%, P < 0.001). Two DES treated patients developed late in-stent thrombosis.</p><p><b>CONCLUSION</b>For patients with total occlusion lesion, the clinical and angiographic outcome 6 months post DES stenting is clearly superior to that of BMS stenting.</p>

Compare drug-eluting stent to bare-metal stent in prognosis on treating diffuse coronary lesions / 中华心血管病杂志

<p><b>OBJECTIVE</b>Compare drug-eluting stent (DES) to bare-metal stent (BMS) in prognosis on treating diffuse coronary lesions and analysis risk factor of treating complex and diffuse lesions in PCI.</p><p><b>METHODS</b>205 consecutive patients with complex and diffuse coronary lesions enrolled our hospital, who were treated with more than 25 mm long DES or BMS. We exclude unsuccessful operation and location. All patients received medical treatment by guideline, and aspirin 300 mg and clopidogrel 75 mg once daily were continued at 6 months after the procedure. The patients were followed up after 6 months.</p><p><b>RESULTS</b>The study population were consisted of 205 patients that there were 181 man, and 24 women, who got 382 stents for 227 target lesions in coronary. There were 93.8% C and 6.2% B2 ACC/AHA type lesion. There were 86.8% patients with binary or above vessel treated. The average reference vessel diameter was 2.88 +/- 0.43 mm. The average stent length of per lesion was 40.09 +/- 12.94 mm. There were 54.2% lesions treated with overlapping stent. There were not different between DES and BMS in patients baseline characteristics, but RVD of group DES less than of group BMS (2.80 +/- 0.37 mm, 3.10 +/- 0.48 mm, P = 0.005) in lesion baseline characteristics. After 6 months, restenosis rate in group DES was less than in group BMS (15.4%, 48.4%, P < 0.001). There were obvious superiority TVR of DES than of BMS (11.6%, 38.5%, P < 0.001). The rate of local restenosis in group of DES was higher than that in group of BMS (33.3%, 18.2%, P = 0.029). We analyzed the risk factors for diffuse lesion by a logistic regression model, the significant univariate clinical and angiographic predictors of restenosis were treating with overlapping stent (OR = 2.82, P = 0.017) and drug-eluting stent (OR = 5.71, P < 0.001).</p><p><b>CONCLUSIONS</b>We find that implantation of DES in patients with diffuse lesions in coronary is relatively more safe and associated with more good clinical outcomes, than of BMS.</p>