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Evaluation of a Novel Laser-assisted Coronary Anastomotic Connector - the Trinity Clip - in a Porcine Off-pump Bypass Model
Published on: November 24, 2014
Single-blind, randomized study comparing clinical equivalence of trulene and prolene polypropylene sutures in
Ravi Shankar Shetty1, Ajay Kaul2, Aayush Goyal3
1Department of Cardio-Thoracic and Vascular Surgery, M S Ramaiah Medical College and Hospitals, Bangalore, Karnataka, 560054, India.
Insights
Trulene® and Prolene® polypropylene sutures are clinically equivalent for coronary artery bypass graft surgery (CABG). Both sutures demonstrated safety and effectiveness in anastomosis construction, with no major adverse cardiac or cerebrovascular events (MACCE) observed.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Trials
Background:
- Coronary artery bypass graft (CABG) surgery is a primary treatment for coronary artery disease, improving survival and quality of life (QoL).
- Polypropylene sutures, known for tensile strength and minimal tissue trauma, are standard for vascular and cardiac anastomosis.
- This study evaluated the clinical equivalence of Trulene® and Prolene® polypropylene sutures in CABG procedures.
Purpose of the Study:
- To compare the clinical equivalence of Trulene® and Prolene® polypropylene sutures.
- To assess the incidence of major adverse cardiac or cerebrovascular events (MACCE) up to 26 weeks post-CABG.
- To evaluate secondary endpoints including anastomotic revision, surgical site infection, and patient-reported outcomes.
Main Methods:
- A multicenter, prospective, randomized (1:1), single-blind study involving 89 participants.
- Primary endpoint: cumulative incidence of MACCE within 26 weeks post-surgery.
- Secondary endpoints: anastomotic revision, surgical site infection (SSI), operative time, hospital stay, QoL, and adverse events.
Main Results:
- No MACCE events were recorded in either treatment group.
- No significant differences were found between Trulene® and Prolene® for most secondary endpoints, including anastomotic revision, SSI, operative time, and QoL.
- Both sutures demonstrated comparable intraoperative handling characteristics, with minor differences noted in ease of passage.
Conclusions:
- Trulene® polypropylene suture is clinically equivalent to Prolene® polypropylene suture for anastomosis in CABG surgery.
- Both sutures are safe and effective for routine CABG procedures.
- The study supports Trulene® as a viable alternative for CABG anastomosis construction.
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).
