Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenT...Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenTech,Beijing,China)are rare.This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent(SES)system MiStent and those of TIVOLI BP-SES.Methods::The DESSOLVE-C trial was a prospective,single-blinded,multicenter,randomized trial(NCT02448524),which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio.The primary endpoint was a non-inferiority comparison of in-stent late lumen loss(LLL)by quantitative coronary angiography at 9 months.The secondary endpoint was device-related clinical cardiovascular composite events(target lesion failure(TLF),composite of cardiac death,target vessel myocardial infarction(MI),and clinically driven target lesion revascularization)and 1-year outcomes.Results::A total of 428 patients(216 patients in the MiStent group and 212 patients in the TIVOLI group)were enrolled and included in an intention-to-treat analysis.MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months((0.23±0.37)mm vs.(0.34±0.48)mm,P for non-inferiority<0.001,P for superiority=0.02).Although without significant difference,the rate of TLF in MiStent was quantitatively lower than that in TIVOLI(3.70%vs.6.60%;P=0.17).Conclusion::Compared with TIVOLI BP-SES,the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.展开更多
文摘Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenTech,Beijing,China)are rare.This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent(SES)system MiStent and those of TIVOLI BP-SES.Methods::The DESSOLVE-C trial was a prospective,single-blinded,multicenter,randomized trial(NCT02448524),which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio.The primary endpoint was a non-inferiority comparison of in-stent late lumen loss(LLL)by quantitative coronary angiography at 9 months.The secondary endpoint was device-related clinical cardiovascular composite events(target lesion failure(TLF),composite of cardiac death,target vessel myocardial infarction(MI),and clinically driven target lesion revascularization)and 1-year outcomes.Results::A total of 428 patients(216 patients in the MiStent group and 212 patients in the TIVOLI group)were enrolled and included in an intention-to-treat analysis.MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months((0.23±0.37)mm vs.(0.34±0.48)mm,P for non-inferiority<0.001,P for superiority=0.02).Although without significant difference,the rate of TLF in MiStent was quantitatively lower than that in TIVOLI(3.70%vs.6.60%;P=0.17).Conclusion::Compared with TIVOLI BP-SES,the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.
