| ObjectiveTo compare the efficacy and safety of Neovas bioabsorbable scaffolds and XIENCE V drug-eluting stents in patients with coronary artery disease.MethodsWe performed a retrospective study of 101 consecutive patients diagnosed with coronary heart disease who had single target vessel and lesion,met the indications for PCI treatment and received single stent in our hospital from 2015 to 2016,including 45 patients in the BRS group and 56 patients in the DES group.The baseline data included age,gender,complications,smoke,past history,diagnosis,cardiac function grade and left ventricular ejection fraction;characteristics of coronary artery lesions included the distribution of coronary artery lesions,lesion length,diameter stenosis rate,reference vessel diameter;and percutaneous coronary intervention detailes,included the scaffold’s/stent’s length,diameter,the ratio of scaffold’s/stent’s diameter to reference vessel’s,whether doing predilation and the pressure and time,scaffold/stent release pressure and time,whether doing post-dilation and the pressure and time,the residual stenosis after the operation,complications and success rate of the operation were recorded.We recorded by a combination of telephone follow-up and outpatient follow-up,the patient’s total follow-up timeMACE,target lesion restenosis and device thrombosis,dual anti-platelet therapy.MACE was defined as cardiogenic death,target vessel myocardial infarction and target lesion rerevascularization.All the data of the study was analyzed by SPSS23.0 and R 4.0.0.Results1.There were no statistically significant differences in age,BMI,gender,hypertension,diabetes mellitus,hyperlipidemia,previous medical history,type of coronary heart disease,NYHA class,and left ventricular ejection fraction between BRS and DES groups（p>0.05）.2.There were no statistically significant differences in lesion length,stenosis rate,reference vessel diameter of target lesion,lesion classification,stent length,diameter,stent/reference vessel diameter ratio between BRS and DES groups（p>0.05）;The dilatation time in BRS group was longer than DES group（18.90 ± 5.18 vs 11.88 ± 7.07 sec,p=0.015）.There were no complications such as residual vascular stenosis,coronary artery dissection and stent rupture and peeling.3.The mean follow-up time of 101 patients was（52.6±16.0）months.Among them,seventeen patients（16.8%）had target lesion restenosis events,eleven target lesion revascularization,three target lesion myocardial infarction,one advanced thrombosis,and one cardiac death.There were no statistically significant differences in major cardiovascular events（15.56%vs 14.29%）,target lesion myocardial infarction（4.44%vs 1.79%）,cardiogenic death（0.00%vs 1.79%）,target lesion revascularization（11.11%vs 10.71%）,restenosis（17.78%vs 16.07%）and the incidence of stent thrombosis（2.22%vs 0.00%）between BRS and DES groups（p>0.05）.4.The 101 patients were followed up for dual antiplatelet drug therapy.Among them,100 patients received double antiplatelet drug therapy for 1 year,only 1 patient was less than 6 months,and 20 patients persisted in double antiplatelet drug therapy for 2 years.5.There were no statistically significant differences in the risks of the major cardiovascular events（HR:0.96,95%CI:0.35,2.64）,target lesion myocardial infarction（HR:0.43,95%CI:0.04,4.69）,target lesion revascularization（HR:1.00,95%CI:0.31,3.29）and target vessel restenosis（HR:0.94,95%CI:0.36,2.43）between the two groups（p>0.05）.Sensitivity analysis found that other factors did not affect the stent relationship between the stent and the outcome（p for interaction>0.05）.ConclusionCompared with XIENCE V DES,Neovas BRS showed no significant difference in immediate and long-term clinical outcomes in patients with coronary heart disease requiring PCI intervention.Further validation of this study is required in a large,randomized controlled trial. |
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