Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions. Methods: This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups. Results: (1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1-5 years were similar in Firehawk stent group and Xience V stent group (5.7% and 6.6% respectively, HR=0.88, 95%CI 0.42-1.84, P=0.72). Land-Mark analysis showed that TLF rates bewteen 1-5 years were similar in Firehawk stent group and Xience V stent group (3.6% and 4.4% respectively, HR=0.83, 95%CI 0.34-2.00, P=0.67). Kaplan-Meier analysis showed that PoCE rates between 1-5 years were also similar in Firehawk stent group and Xience V stent group (11.4% and 17.3% respectively, HR=0.64, 95%CI 0.39-1.04, P=0.07). Land-Mark analysis showed that PoCE rates after 5 years were similar in Firehawk stent group and Xience V stent group (8.4% and 10.0% respectively, HR=0.66, 95%CI 0.40-1.10, P=0.11). (5) No stent thrombosis was documented in Firehawk stent group during the 5 years follow-up period, and there was 1 case of stent thrombosis in Xience V stent group after 3 years of stent implantation. Conclusion TARGETⅠ trial results of 5 years follow up indicate the novel Firehawk stent have a durable safety and efficacy profile which is comparable to the Xience V stent in treating patients with single de novo coronary lesion. Clinical Trial Registration North American Clinical Trial Registration Center, NCT01196819.

Objective: To investigate the prognostic value of SYNTAX score on 1 year outcome in coronary heart disease patients underwent percutaneous coronary intervention(PCI). Methods: The present study (PANDA Ⅲ trial) was a perspective, multi-center, randomized controlled trial. Between December 2013 and August 2014, 2 348 patients who underwent PCI from 46 centers were enrolled. SYNTAX score was calculated from all patients. Patients were divided into 3 groups based on SYNTAX score: lower risk group (SYNTAX score≤22, 1 777 patients), intermediate risk group (SYNTAX score 23-32, 412 patients), and higher risk group (SYNTAX score≥33, 159 patients). The patients were followed up after the procedure for one year.Primary endpoint was target lesion failure (TLF), including cardiac death, target vessel myocardial infarction,and ischemia driven target lesion revascularization. Secondary endpoints included stent thrombosis and major adverse cardiac events were defined as a composite of all-cause death, myocardial infarction and any revascularization. Results: (1) A total of 1 766 (99.2%), 411 (99.8%),and 159 (100%) patients in the lower risk group, intermediate risk and higher risk group completed the 1 year follow up. (2) Incidence of TLF were 5.6%(99/1 763) in lower risk group, 8.8%(36/411) in intermediate risk group,and 8.8%(14/159) in higher risk group(P=0.03). The incidence of target vessel myocardial infarction in lower risk group was 3.9%(68/1 763), 6.6%(27/411) in intermediate risk group,and 7.5% (12/159) in higher risk group(P=0.01).Prevalence of cardiac death and ischemia driven target lesion revascularization was similar among the 3 groups(P>0.05).(3) The probable stent thrombosis events rate was 0.1% (1/1 763), 0.7% (3/411), and 0.6% (1/159) in the lower, intermediate,and higher risk groups respectively (P=0.02). The incidence of major adverse cardiac events was 8.1% (142/1 763) in lower-risk group, 11.7% (48/411) in intermediate risk group, and 14.5% (23/159) in higher risk group (P<0.01). The incidence of all-cause death was 1.7%(30/1 763) in lower-risk group, 1.7%(7/411) in intermediate risk group, and 6.3%(10/159)in higher risk group (P<0.01). The incidence of myocardial infarction was 4.2% (74/1 763) in lower-risk group, 6.6% (27/411) in intermediate risk group, and 8.2% (13/159) in higher risk group(P=0.02).Incidence of any revascularization was similar among groups(P=0.59). (4) The multivariable Cox analysis showed that age (HR=1.04, 95%CI 1.02-1.06, P<0.01), total implanted stent length (HR=1.01, 95%CI 1.00-1.02, P=0.03), and baseline SYNTAX score (HR=1.02, 95%CI 1.02-1.04, P=0.02) were independent risk factors of TLF after PCI in this patient cohort. Conclusion The SYNTAX score is a valuable tool for predicting prognosis on 1 year in coronary heart disease patients underwent PCI. Trial Registration www.clinicaltrials.gov, NCT02017275.

Objectives:To analyze the efficacy and safety of drug coated balloon for coronary de novo lesions in real world. Methods:We enrolled consecutive patients with coronary de novo lesions treated with drug coated balloons from January 2020 to June 2021 in Fuwai Hospital.The baseline data,procedure data and in-hospital cardiac events were collected through case query.All patients were followed up by clinical visit or telephone call.Major adverse cardiac events(MACE)were defined as the composite of the cardiac death,acute myocardial infarction,target lesion revascularization.According to the diameter of the blood vessels,the patients are divided into the large vessel lesion group(vessel diameter≥2.75 mm,n=337),and the small vessel lesion group(vessel diameter<2.75 mm,n=575). Results:There were 940 coronary de novo lesions in 912 patients.A total of 974 drug balloons were used,average diameter was(2.6±0.8)mm,average length was(21.0±6.0)mm,average pressure was(10.0±3.8)atm.Among the 940 primary coronary artery lesions,343 lesions had a diameter≥2.75 mm,and 597 lesions had a diameter<2.75 mm.During hospitalization,two patients with acute ST-segment elevation myocardial infarction died of cardiac rupture after emergency coronary interventional treatment,acute vessel closure because of coronary hematoma occurred in 1 patient and bailout drug-eluting stent was used in this patient,five patients received salvage stent treatment due to type C dissection immediately after drug coated balloon treatment.During follow-up,Target lesion revascularization(TLR)occurred in 15(1.6%)patients(including coronary artery bypass grafting in 1 patient).Nonfatal acute myocardial infarction occurred in 1 patient,cardiac death occurred in 1 patient,2 patients died of cerebral hemorrhage,1 patient died of cerebral infarction,MACE rate was 1.9%(17/912).MACE rate during follow-up was similar between large vessels group and small vessels group(1.8%vs.1.9%,P>0.05). Conclusions:Our study indicates that drug coated balloon for coronary de novo lesion is safe and effective.There is no difference of MACE rate between large vessel group and small vessel group.

Objectives:To evaluate the efficacy and safety of drug-coated balloon in the treatment of de novo coronary chronic occlusive lesions. Methods:Consecutive patients with de novo coronary chronic occlusive lesions treated with drug-coated balloons only were included in this study.The general information,medical history,and surgical information of the patients were recorded,and major adverse cardiovascular events(MACE,including cardiac death,myocardial infarction,and target vessel revascularization)were recorded by telephone or outpatient follow-up. Results:A total of 160 patients were included.There were 26 ostial lesions(16.3%),42 bifurcated lesions(26.3%),117 diffuse lesions(73.1%),and 87 calcified lesions(54.4%).The reference vessel diameter was(2.3±0.4)mm.During hospitalization,there were no acute myocardial infarction,cardiac death,target lesion revascularization,or acute coronary thrombosis.Cardiac death occurred in 1 case and target vessel revascularization occurred in 6 cases during follow-up.The MACE rate is 4.4%. Conclusions:Drug balloon therapy for de novo coronary chronic occlusive lesions is safe and effective,and the prognosis is satisfactory.

Objective: To compare the long-term outcomes in ST-elevation myocardial infarction (STEMI) patients who underwent early or late delayed percutaneous coronary intervention (PCI) using drug-eluting stents (DES). Methods: This study was a retrospective, observational and single-center study. Consecutive STEMI patients (n=977), who admitted to Fuwai Hospital in 2013 and underwent successful selective PCI using drug-eluting stents (DES) within 3 to 35 days after symptom onset were enrolled and divided into the early delayed PCI (3-14 d) group (n=495) and the late delayed PCI (15-35 d) group (n=482). General clinical data of the patients and related data of coronary angiography and interventional therapy were collected, and the endpoint events were followed up. The primary endpoint was 2-year major adverse cardiac and cerebrovascular events (MACCE) including cardiac death, recurrent myocardial infarction, definite or probable stent thrombosis and ischemic stroke. The secondary endpoint was 2-year ischemia-driven target vessel revascularization. The incidence of endpoint events of the two groups was compared, and it was compared again after the primary baseline characteristics such as age and gender were matched by the propensity scoring method at a 1∶1 ratio. Results: A total of 910 (93.1%) patients who underwent delayed PCI were transferred from other hospitals, and 292 (29.9%) patients received thrombolysis before PCI. The time interval before PCI was 14 (10, 20) days. The incidence of 2-year MACCE (3.0%(15/495) vs. 2.3%(11/482), P=0.468) and ischemia-driven target vessel revascularization (3.8%(19/495) vs. 5.0%(24/482), P=0.385) were similar between the two groups. The incidence of 2-year MACCE (3.3%(15/453 vs. 2.4%(11/453), P=0.426) and ischemia-driven target vessel revascularization (4.2% (19/453) vs. 4.9%(22/453), P=0.632) were also similar between the two groups after matching propensity score. Conclusion The long-term clinical outcomes after early delayed PCI using DES is statistically equivalent to those of late delayed PCI using DES for STEMI patients who missed the time window for emergency PCI.