Trial Outcomes & Findings for Comparison of Bidirectional Palpation Test and Transit Time Flow Measurement for LIMA-LAD Graft Patency (NCT NCT06934993)

Last Updated: 2025-07-08

Results Overview

The reliability of the Bilateral Palpation Test (BPT) in evaluating LIMA-LAD graft patency was assessed. As detailed in the Study Description section, participants were evaluated intraoperatively as BPT-positive or BPT-negative. Grafts were considered patent in BPT-positive participants and occluded in those with negative findings. In the early postoperative period, contrast-enhanced coronary CT angiography (CCTA), a validated method for assessing graft patency, was performed. The correlation between CCTA and BPT results was then analyzed to evaluate the reliability of the BPT.

Recruitment status

COMPLETED

Target enrollment

116 participants

Primary outcome timeframe

Postoperative first month.

Results posted on

2025-07-08

Participant Flow

A total of 116 patients who underwent elective isolated CABG surgery or CABG in combination with other procedures such as valve surgery or ascending aorta surgery and gave informed consent were included in the study. The first patient was enrolled in the study on August 31, 2023 while the last patient was enrolled on August 27, 2024.

Patients were excluded for reasons such as refusing to participate postoperatively, death in the early postoperative period , or conditions like elevated postoperative creatinine that precluded CTCA.

Participant milestones

Participant milestones
Measure	Elective CABG Patients With LIMA-to-LAD Grafts This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.
Overall Study STARTED	116
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Elective CABG Patients With LIMA-to-LAD Grafts This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.
Overall Study Withdrawal by Subject	29
Overall Study elevated postoperative creatinine level	11
Overall Study Death	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elective CABG Patients With LIMA-to-LAD Grafts n=73 Participants This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.
Age, Continuous	58 years n=73 Participants
Sex: Female, Male Female	14 Participants n=73 Participants
Sex: Female, Male Male	59 Participants n=73 Participants
Region of Enrollment Turkey	73 participants n=73 Participants
Diabetes Mellitus (DM)	40 Participants n=73 Participants
Peripheral Artery Disease (PAD)	6 Participants n=73 Participants
Smoking	50 Participants n=73 Participants
Body Mass Index (BMI)	27.72 kg/m² n=73 Participants
Hypertension	53 Participants n=73 Participants

PRIMARY outcome

Timeframe: Postoperative first month.

Population: The number of patients with graft occlusion among 73 patients who participated in the study was examined. Then, BPT negativity in patients with graft occlusion and BPT positivity in patients with patent grafts were evaluated.

Outcome measures

Outcome measures
Measure	Elective CABG Patients With LIMA-to-LAD Grafts n=73 Participants This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.
Reliability of Bidirectional Palpation Test (BPT) in Evaluating LIMA-LAD Graft Patency Patients with LIMA-LAD graft occlusion (CCTA)	2 Participants
Reliability of Bidirectional Palpation Test (BPT) in Evaluating LIMA-LAD Graft Patency Patients with negative BPT	2 Participants
Reliability of Bidirectional Palpation Test (BPT) in Evaluating LIMA-LAD Graft Patency Patients with BPT negativity and LIMA-LAD graft occlusion (CCTA)	2 Participants
Reliability of Bidirectional Palpation Test (BPT) in Evaluating LIMA-LAD Graft Patency BPT negativity in patients with LIMA-LAD graft occlusion (CCTA)	2 Participants
Reliability of Bidirectional Palpation Test (BPT) in Evaluating LIMA-LAD Graft Patency BPT positivity in patients with patent LIMA-LAD grafts (CCTA)	71 Participants

PRIMARY outcome

Timeframe: Postoperative first month

Population: While evaluating graft patency in the 73 patients included in the study, the correlation of MGF \<10 ml/min and PI \>4.5 measurements was analyzed both individually and in combination among patients with graft occlusion.

Mean Graft Flow (MGF) and Pulsatility Index (PI) were used in this study as TTFM parameters for evaluating graft patency. In the literature, there is no clear consensus on cut-off values for these parameters. Therefore, the values commonly used in the literature were statistically analyzed, and the values that gave the most significant results with our data were accepted as cut-off values. These cut-off values were determined to be 10 ml/min for MGF and 4.5 for PI.

Outcome measures

Outcome measures
Measure	Elective CABG Patients With LIMA-to-LAD Grafts n=73 Participants This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with LIMA-LAD graft occlusion	2 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured MGF<10ml/min	3 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured PI>4,5	23 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured MGF<10ml/min and PI>4,5	3 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured MGF<10ml/min and PI<4,5 or MGF>10 and PI>4,5	20 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured MGF<10ml/min with LIMA-LAD graft occlusion	2 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured MGF>10ml/min with patent LIMA-LAD graft	70 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured PI>4,5 with LIMA-LAD graft occlusion	2 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured PI<4,5 with patent LIMA-LAD graft	50 Participants
Reliability of TTFM in Evaluating LIMA-LAD Graft Patency Patients with measured MGF<10ml/min and PI>4,5 with LIMA-LAD graft occlusion	2 Participants

SECONDARY outcome

Timeframe: postoperative first month.

Population: This outcome was assessed only in a subgroup of 2 patients who had negative BPT. Therefore, the number of participants analyzed is lower than the total study population (N=73).

Outcome measures

Outcome measures
Measure	Elective CABG Patients With LIMA-to-LAD Grafts n=2 Participants This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.
Correlation Between Intraoperative TTFM and BPT Results The rate of MGF <10 mL/min among patients with a negative BPT.	2 Participants
Correlation Between Intraoperative TTFM and BPT Results The rate of PI>4.5 among patients with a negative BPT.	2 Participants

SECONDARY outcome

Timeframe: postoperative first month.

Population: The distributions of SYNTAX I and II scores were analyzed in patients with occluded grafts, MGF \<10 ml/min and negative BPT.

The correlation between preoperatively calculated SYNTAX 1 and SYNTAX 2 risk scores and LIMA-LAD graft patency, TTFM measurements and BPT was demonstrated. The SYNTAX I and SYNTAX II scores are risk assessment tools used to guide treatment decisions in patients with complex coronary artery disease. The SYNTAX I score is based solely on the anatomical complexity of coronary lesions observed during angiography. It categorizes patients into three risk groups: low (0-22), intermediate (23-32), and high (≥33).Higher SYNTAX I scores are associated with more complex coronary artery disease and worse clinical outcomes, often favoring coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI). The SYNTAX II score combines anatomical factors with clinical variables such as age, gender, left ventricular ejection fraction, creatinine clearance, and the presence of comorbidities like COPD and peripheral artery disease. This comprehensive score provides a personalized risk

Outcome measures

Outcome measures
Measure	Elective CABG Patients With LIMA-to-LAD Grafts n=73 Participants This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score · Low score	18 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score · Interm score	29 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score · High score	26 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX II score · Low score	33 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX II score · Interm score	28 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX II score · High score	12 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with occluded LIMA-LAD grafts · Low score	2 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with occluded LIMA-LAD grafts · Interm score	0 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with occluded LIMA-LAD grafts · High score	0 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX II score distribution in patients with occluded LIMA-LAD grafts · Low score	1 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX II score distribution in patients with occluded LIMA-LAD grafts · Interm score	1 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX II score distribution in patients with occluded LIMA-LAD grafts · High score	0 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with MGF<10 ml/min · Low score	3 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with MGF<10 ml/min · Interm score	0 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with MGF<10 ml/min · High score	0 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with BPT negativity · Low score	2 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with BPT negativity · Interm score	0 Participants
The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated. SYNTAX I score distribution in patients with BPT negativity · High score	0 Participants

Adverse Events

Elective CABG Patients With LIMA-to-LAD Grafts

Serious events: 0 serious events

Other events: 11 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Elective CABG Patients With LIMA-to-LAD Grafts n=116 participants at risk This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.
Renal and urinary disorders Renal dysfunction	9.5% 11/116 • Number of events 11 • Adverse event data were collected for 6 months postoperatively. Adverse events were monitored in all 116 participants who underwent CABG surgery and were enrolled in the study. No serious or non-serious adverse events were observed during the postoperative period. However, 3 early postoperative deaths occurred before CT angiography could be performed. These were reported under all-cause mortality

Additional Information

Dr. Abdulgani Orhun YENİGÜN

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Phone: +90 05346214600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place