Pooled Analysis of CREDIT Trials Investigate JW Medical's Excel 2 DES
January 31, 2017—Geng Wang, MD, et al published a pooled analysis of the CREDIT II and CREDIT III trials evaluating the efficacy and safety of Excel 2, a second-generation, biodegradable-polymer, cobalt-chromium, sirolimus-eluting stent (JW Medical LLC, a China-based subsidiary of Biosensors International), in treating de novo coronary artery disease. In addition, the investigators conducted an objective performance criterion study from the CREDIT II and CREDIT III trials to meet the China Food and Drug Administration requirements. The findings are available online in Catheterization and Cardiovascular Interventions.
CREDIT II is a randomized trial comparing the Excel 2 versus the first-generation Excel stent in patients with up to two de novo coronary lesions. CREDIT III is a prospective, single-arm study evaluating the efficacy and safety of Excel 2 in broad types of de novo coronary artery lesions.
As summarized in Catheterization and Cardiovascular Interventions, this pooled analysis included patients in CREDIT III and in the Excel 2 arm of the CREDIT II trials. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed. The analysis was composed of 833 patients, including 625 in the CREDIT III trial and 208 in the Excel 2 arm of the CREDIT II trial.
The investigators reported that 12-month TLF occurred in 6.1% patients, cardiac death in 0.4%, TV-MI in 5%, and CI-TLR in 1.1%. In addition, they recorded 64 (7.7%) PoCE events and three probable late stent thromboses (0.4%).
The Excel 2 stent met the objective performance criterion on efficacy and safety with a low level of 12-month TLF, as well as stent thrombosis, when treating patients with de novo coronary lesions, concluded the investigators in Catheterization and Cardiovascular Interventions.