Safety and efficacy of Everolimus‐Eluting bioabsorbable Polymer‐Coated stent in patients with long coronary lesions: The EVOLVE 48 study

Abstract

Objectives The EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions. Background Clinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long‐term data in a broad population of patients undergoing PCI. Methods Patients with lesion length >34‐ ≤44 mm and reference vessel diameter (RVD) ≥2.5‐ ≤ 4.0 mm were enrolled in this prospective, multicenter, single‐arm study. The primary endpoint was 12‐month target lesion failure (TLF; composite of target lesion revascularization [TLR], target‐vessel myocardial infarction [TV‐MI], or cardiac death) compared to a prespecified performance goal (PG). Results A total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre‐TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One‐year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV‐MI in two patients treated with SYNERGY 48 mm stent. Between the 1‐2‐year timeframe, TV‐MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years. Conclusions PCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.

Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions

“…We compared our results with some additional studies on long coronary lesions as shown in Table 5 . The incidences of ST were 0% in our study, which was noted in very few studies like Karmpaliotis et al [ 28 ] and PtCr-EES, Re-ZES groups of Kang et al [ 23 ]. It is also worth noting that in almost all previous publications, the TLR and TVR rates were higher than our study (0%).…”

“…Kang et al previously compared the 12-month outcomes of three randomized clinical trials of the LONG-DES (LONG-DES III, IV, and V trials) in percutaneous treatment of LONG native coronary lesions with DES. The comparison of their findings with those of our study is shown in Table 5 [23,[26][27][28][29][30][31][32]. Our MACE outcomes are superior to all studies compared by Kang et al [23].…”