Key result
MiStent reduces 9-month in-stent late lumen loss by ~32% versus TIVOLI.
Why the study?
Data directly comparing the angiographic efficacy and clinical outcomes of the MiStent microcrystalline biodegradable polymer SES with the TIVOLI BP-SES were rare.
Does the MiStent microcrystalline biodegradable polymer sirolimus-eluting stent reduce in-stent late lumen loss compared to the TIVOLI biodegradable polymer sirolimus-eluting stent in patients with de novo coronary lesions?
RCT (n=428)
Single-blind
1:1
Yes
Does the MiStent microcrystalline biodegradable polymer sirolimus-eluting stent reduce in-stent late lumen loss compared to the TIVOLI biodegradable polymer sirolimus-eluting stent in patients with de novo coronary lesions?
The MiStent microcrystalline biodegradable polymer sirolimus-eluting stent provided superior angiographic efficacy in terms of late lumen loss at 9 months compared to the TIVOLI stent.
May guide stent choice toward MiStent in de novo lesions; extends comparative data on microcrystalline polymer sirolimus-eluting stents.
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.
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Wang et al. (2022) conducted an RCT in de novo coronary lesions (n=428). MiStent vs. TIVOLI was evaluated on in-stent late lumen loss (LLL) by quantitative coronary angiography at 9 months (p=<0.001 for non-inferiority, 0.02 for superiority). MiStent was superior to TIVOLI for in-stent late lumen loss at 9 months (0.23 mm vs. 0.34 mm; P=0.02 for superiority) in patients with de novo coronary lesions.
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