Single-blind, randomized study comparing clinical equivalence of trulene and prolene polypropylene sutures in elective primary coronary artery bypass graft surgery

Abstract

Background: Coronary artery bypass graft surgery (CABG) is one of the principle therapies for coronary artery disease, as it improves survival rate and quality of life (QoL). Polypropylene suture is commonly used in vascular and cardiac surgeries for anastomosis due to its long-term tensile strength and minimal tissue trauma. This study compared the clinical equivalence of Trulene® (Healthium Medtech Limited) and Prolene® (Ethicon-Johnson & Johnson) polypropylene sutures regarding incidence of myocardial infarction, stroke, renal failure and cardiac death (MACCE) occurring up to 26 weeks' period post-CABG surgery.

Methods: This multicenter, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (n = 89) was conducted between August 2020 and September 2021. The primary endpoint, post-surgery cumulative incidence of MACCE was evaluated. In addition, anastomotic revision, surgical site infection (SSI), operative time, length of post-operative hospital stay, repeat revascularization, intraoperative suture handling characteristics, time taken to return to work and resume normal day to day activities, subject satisfaction score and QoL, and other adverse events were also recorded.

Results: A total of 80 (89.89%) males and 9 (10.11%) females participated in the study. No incidence of MACCE was recorded in any of the study participants. Non-significant difference was observed in anastomotic revision, SSI, operative time, post-operative hospital stay, revascularization, return to work and normal day-to-day activities, subject satisfaction score and QoL, and intraoperative handling parameters (except ease of passage) between the treatment groups, Trulene® and Prolene®. Compared to screening visit, proportion of subjects with 'no problems' for each QoL dimension and the mean visual analogue scale increased with each subsequent follow-up visit.

Conclusion: Trulene® polypropylene suture is clinically equivalent to Prolene® polypropylene suture and is safe and effective for anastomosis construction in CABG surgery during a routine clinical procedure. Trial registration CTRI Registration No.: CTRI/2020/05/025157 (Registered on: 13/05/2020).

Keywords: Coronary anastomosis; Coronary artery bypass graft surgery; Coronary artery disease; Major adverse cardiac and cerebrovascular events; Polypropylene suture.