Impact of Total Coronary Revascularization Via Left Anterior Thoracotomy (TCRAT) vs. Robotic-Assisted Harvesting of LIMA (ITcrats)

NCT ID: NCT06988735

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2027-08-31

Brief Summary

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The two types of total coronary revascularization via left anterior thoracotomy (TCRAT) might have their potential benefits and disadvantages. The proposed randomized clinical trial here will compare 'RA-TCRAT' with 'Nonrobotic TCRAT' procedures concerning effects on hospital stays, overall healthcare costs, safety, and feasibility. If the two TCRAT procedures are comparably effective and safe, the 'Nonrobotic TCRAT' procedure is probably preferred as it seems easier to use. However, if the 'Nonrobotic TCRAT' procedure is less effective and less safe than the "robotic TCRAT,' that procedure should be preferred.

Detailed Description

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Rationale

A recent study involving 1,195 patients from the Society of Thoracic Surgeons Registry undergoing robotic-assisted-minimally-invasive direct coronary artery bypass (RA-MIDCAB) by 114 surgeons between 2014 and 2019 showed that surgeons can quickly reduce complication rates by building up the learning curve. It is yet unclear if robotic-assisted harvesting of the left internal thoracic artery (RA-LITA) would offer a benefit over total coronary revascularization via left anterior thoracotomy (TCRAT) in terms of the postoperative hospital stay and cost of healthcare. That raises the need to examine the impact of RA-LITA compared with TCRAT on these crucial clinical outcomes.

Objective

The primary objective of this prospective randomized clinical trial (RCT) is, compared with TCRAT, to examine the impact of robotic-assisted coronary artery bypass graft (RA-CABG) on the length of hospital stay in diverse patients scheduled for elective surgical coronary revascularization.

Secondary objectives include identifying the overall costs and charges of healthcare, operating room and intensive care unit (ICU) stays, postoperative bleeding, need for re-explorative surgery or transfusion, postoperative major adverse cardiovascular and cerebrovascular events (MACCE)\], acute kidney injury (AKI), and surgical related complications and 30-days and 3-months need for hospital re-admission and survival after adult cardiac surgical coronary revascularization using cardiopulmonary bypass (CPB).

Hypothesis

It is hypothesized that RA-total coronary revascularization via left anterior thoracotomy (TCRAT) might have shorter hospital stays than the nonrobotic assisted TCRAT in adult patients undergoing elective coronary revascularization surgery.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness

There is no expected patient burden or risk other than the estimated risks for the coronary revascularization surgery. Patient burden and risks are low, and the two surgical approaches (nonrobotic TCRAT and RA-CABG/TCRAT) are being used widely and interchangeably. The collection of patients' outcome data from hospital charts and (electronic) medical records systems causes no harm to the patients; patients will not experience any discomfort from any of the study interventions because they will be performed during general anesthesia.

INTRODUCTION AND RATIONALE

3.1 TCRAT has a significant impact on outcomes.

The main goals of minimally invasive cardiac surgery (MICS) are to avoid sternotomy, reduce postoperative blood product transfusion, shorten ventilation times, shorten intensive care and hospital stays, improve the quality of postoperative analgesia, and expedite physical recovery.

TECRAT emerged as a promising MICS procedure. TCRAT has been shown to have a likely success rate of 95%, defined as complete revascularization in a cohort of 102 multivessel coronary artery disease (MV-CAD) patients with diverse age, body mass index (BMI), and left-ventricular ejection fraction (LVEF) in conjunction with low incidences of in-hospital mortality, CVA, AMI and need for revascularization in 2%. Muliarterial TCRAT increased the aortic cross-clamping and operating room times without further improving these outcomes or shortening hospital stays.

3.2 Robotic totally endoscopic CABG (TE-CABG)

Robotic TE-CABG is technically more challenging than RA-CABG. Kofer et al. compared the 12 years of single-center experience performing conventional CABG or TE-CABG in a propensity score-matched retrospective study. They identified similar age groups, log European System for Cardiac Operative Risk Evaluation (EuroSCORE), perioperative mortality, AMI, and stroke rate, and long-term survival and freedom from major adverse cardiac and cerebral events at 1, 5, and 10 years after surgery between the two groups. TE-CABG took 40% longer CPB and 67% cross-clamp times. That doubts the superiority of TE-CABG over the RA-MIDCAB or RA-TCRAT.

3.3. RA-MIDCAB

MIDCAB is performed without the use of CPB with associated fewer complications such as perioperative CVA due to avoidance of aortic manipulation. CPB might be required in rare cases during MIDCAB procedures that necessitate peripheral cannulation to avoid a sternotomy, which could be challenging in patients with severe peripheral vascular disease and morbidly obese patients who would benefit the most from avoiding a sternotomy. A RA-MIDCAB procedure may be possible in such patients.

Patrick et al. demonstrated a growing learning curve after the 10th RA-MIDCAB procedure in terms of reduced rates of approach conversion (odds ratio, 0.27; 95% CI, 0.09-0.84) and improved procedural success (odds ratio, 1.96; 95% CI, 1.00-3.84). A cohort of 605 RA-MIDCAB patients performed at a single center over 18 years showed a reduced conversion rate to sternotomy for any cause, from 16.0% of the first 200 cases to 6.9% of the last 405 patients. The mortality rate was 0.3%, the patency rate of the LITA-to-left anterior descending (LAD) coronary artery anastomosis was 97.4%, surgical re-exploration for bleeding in 1.8% of patients, and the transfusion rate was 9.2%.

A previous study found that compared with those who underwent conventional CABG (n=235), patients who received RA-CABG (n=281) had fewer risk factors, lower in-hospital and long-term mortality but had comparable incidences of target lesion revascularization (TLR), target vessel revascularization (TVR), AMI, and stroke. Interestingly, neither the residual Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score nor completeness of revascularization were related to the long-term mortality.

3.4. RA-CABG: An emerged approach to improve outcomes

A retrospective study demonstrated that compared with MIDCAB, RA-CABG had comparable complete revascularization, one-year graft patency, surgical conversion, mortality rates, more extended operating room stays, and shorter ICU stays. To our knowledge, no RCT compares the impacts of TCRAT and RA-TCRAT CABG on successful revascularization, mortality, and postoperative CVA and AMI.

3.5. Feasibility

The two types of TCRAT (nonrobotic or R.A.) have never been compared in terms of feasibility. 'RA-TCRAT' procedures are more complex to perform and might take longer durations to be accomplished, increasing the overall healthcare costs, which could be unacceptable for both the stakeholders. 'Non-RA-TCRAT' procedures are more straightforward to perform and are thus easier to learn, but most importantly, they take much less time.

Conditions

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Minimally Invasive Coronary Revascularization Surgery Elective Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-center prospective randomized controlled clinical trial- and patient-blinded comparative trial in patients scheduled for surgical coronary revascularization. The RCT will be conducted according to Good Clinical Practice (GCP) Guidelines and comply with the principles of the Declaration of Helsinki. The RCT will be registered in a public registry, and the study protocol with its statistical analysis plan will be published before the enrollment of the first patient.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Further minimization of bias will be achieved by involving two independent investigators. The researcher responsible for performing the surgery will perform the Randomization directly before the start of anesthesia. A second investigator, who will not be blinded for the randomization arm, will score the primary and secondary postoperative outcome measures.

Study Groups

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Nonrobotic TCRAT

Nonrobotic TCRAT for CABG

Group Type PLACEBO_COMPARATOR

Nonrobotic TCRAT

Intervention Type PROCEDURE

Nonrobotic TCRAT for CABG

Robotic TCRAT

Robotic TCRAT for CABG

Group Type ACTIVE_COMPARATOR

Robotic TCRAT

Intervention Type PROCEDURE

Robotic TCRAT for CABG

Interventions

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Nonrobotic TCRAT

Nonrobotic TCRAT for CABG

Intervention Type PROCEDURE

Robotic TCRAT

Robotic TCRAT for CABG

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Scheduled for any type of elective minimally invasive coronary revascularization surgery.
* Using CPB.
* General anesthesia is provided in an endotracheally intubated patient

Exclusion Criteria

* Planned for coronary revascularization surgery without CPB;
* Planned for a combined coronary revascularization surgery and a valve or intra-cardiac surgery;
* LVEF less than 35%;
* Preoperative cardiogenic shock;
* Pregnancy;
* Scheduled for re-do or emergency surgery;
* Consent for another interventional study during anesthesia;
* No written informed consent;
* Preoperative need for mechanical circulatory support;
* Preoperative need for invasive ventilatory support;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohamed R El Tahan

OTHER

Sponsor Role lead

Responsible Party

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Mohamed R El Tahan

Consultant in Cardiac Anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed R El Tahan, MD

Role: STUDY_CHAIR

Consultant in Cardiac Anesthesia

Fahad Makhdoum, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Cardiac Surgery

Yasser F ElGhoneimy, MD

Role: STUDY_DIRECTOR

Professor, Cardiac Surgery

Locations

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Imam Abdulrahamn Bin Faisal University (Former, Dammam University)

Dammam, Eastern, Saudi Arabia,, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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Moahmed R El Tahan, MD

Role: CONTACT

0096569371849

Yasser f ElGhoneimy, MD

Role: CONTACT

+966 59 777 7012

Facility Contacts

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Mohamed R El Tahan, MD

Role: primary

00966569371849

Fahad Makhdoum, MD

Role: backup

References

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Gong W, Cai J, Wang Z, Chen A, Ye X, Li H, Zhao Q. Robot-assisted coronary artery bypass grafting improves short-term outcomes compared with minimally invasive direct coronary artery bypass grafting. J Thorac Dis. 2016 Mar;8(3):459-68. doi: 10.21037/jtd.2016.02.67.

Reference Type BACKGROUND
PMID: 27076941 (View on PubMed)

Lin TH, Wang CW, Shen CH, Chang KH, Lai CH, Liu TJ, Chen KJ, Chen YW, Lee WL, Su CS. Clinical outcomes of multivessel coronary artery disease patients revascularized by robot-assisted vs conventional standard coronary artery bypass graft surgeries in real-world practice. Medicine (Baltimore). 2021 Jan 22;100(3):e23830. doi: 10.1097/MD.0000000000023830.

Reference Type BACKGROUND
PMID: 33545949 (View on PubMed)

Giambruno V, Chu MW, Fox S, Swinamer SA, Rayman R, Markova Z, Barnfield R, Cooper M, Boyd DW, Menkis A, Kiaii B. Robotic-assisted coronary artery bypass surgery: an 18-year single-centre experience. Int J Med Robot. 2018 Jun;14(3):e1891. doi: 10.1002/rcs.1891. Epub 2018 Jan 19.

Reference Type BACKGROUND
PMID: 29349908 (View on PubMed)

Marin-Cuartas M, Sa MP, Torregrossa G, Davierwala PM. Minimally invasive coronary artery surgery: Robotic and nonrobotic minimally invasive direct coronary artery bypass techniques. JTCVS Tech. 2021 Oct 13;10:170-177. doi: 10.1016/j.xjtc.2021.10.008. eCollection 2021 Dec. No abstract available.

Reference Type BACKGROUND
PMID: 34984377 (View on PubMed)

Kofler M, Stastny L, Reinstadler SJ, Dumfarth J, Kilo J, Friedrich G, Schachner T, Grimm M, Bonatti J, Bonaros N. Robotic Versus Conventional Coronary Artery Bypass Grafting: Direct Comparison of Long-Term Clinical Outcome. Innovations (Phila). 2017 Jul/Aug;12(4):239-246. doi: 10.1097/IMI.0000000000000393.

Reference Type BACKGROUND
PMID: 28777131 (View on PubMed)

Babliak O, Demianenko V, Melnyk Y, Revenko K, Babliak D, Stohov O, Pidgayna L. Multivessel Arterial Revascularization via Left Anterior Thoracotomy. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):655-662. doi: 10.1053/j.semtcvs.2020.02.032. Epub 2020 Feb 28.

Reference Type BACKGROUND
PMID: 32114114 (View on PubMed)

Sellin C, Asch S, Belmenai A, Mourad F, Voss M, Dorge H. Early Results of Total Coronary Revascularization via Left Anterior Thoracotomy. Thorac Cardiovasc Surg. 2023 Sep;71(6):448-454. doi: 10.1055/s-0042-1758149. Epub 2022 Nov 11.

Reference Type BACKGROUND
PMID: 36368676 (View on PubMed)

Babliak O, Demianenko V, Melnyk Y, Revenko K, Pidgayna L, Stohov O. Complete Coronary Revascularization via Left Anterior Thoracotomy. Innovations (Phila). 2019 Aug;14(4):330-341. doi: 10.1177/1556984519849126. Epub 2019 May 20.

Reference Type BACKGROUND
PMID: 31106625 (View on PubMed)

Caynak B, Sicim H. Routine minimally invasive approach via left anterior mini-thoracotomy in multivessel coronary revascularization. J Card Surg. 2022 Apr;37(4):769-776. doi: 10.1111/jocs.16259. Epub 2022 Jan 20.

Reference Type BACKGROUND
PMID: 35060197 (View on PubMed)

Marin Cuartas M, Javadikasgari H, Pfannmueller B, Seeburger J, Gillinov AM, Suri RM, Borger MA. Mitral valve repair: Robotic and other minimally invasive approaches. Prog Cardiovasc Dis. 2017 Nov-Dec;60(3):394-404. doi: 10.1016/j.pcad.2017.11.002. Epub 2017 Nov 9.

Reference Type BACKGROUND
PMID: 29128572 (View on PubMed)

Smilowitz NR, Gupta N, Ramakrishna H, Guo Y, Berger JS, Bangalore S. Perioperative Major Adverse Cardiovascular and Cerebrovascular Events Associated With Noncardiac Surgery. JAMA Cardiol. 2017 Feb 1;2(2):181-187. doi: 10.1001/jamacardio.2016.4792.

Reference Type BACKGROUND
PMID: 28030663 (View on PubMed)

Patrick WL, Iyengar A, Han JJ, Mays JC, Helmers M, Kelly JJ, Wang X, Ghoreishi M, Taylor BS, Atluri P, Desai ND, Williams ML. The learning curve of robotic coronary arterial bypass surgery: A report from the STS database. J Card Surg. 2021 Nov;36(11):4178-4186. doi: 10.1111/jocs.15945. Epub 2021 Aug 29.

Reference Type BACKGROUND
PMID: 34459029 (View on PubMed)

Other Identifiers

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IABF-16-05-25

Identifier Type: -

Identifier Source: org_study_id

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