Introduction

Atherosclerotic plaque distribution in the coronary vascular bed can take on a very intricate pattern in ostial left anterior descending (LAD) coronary artery disease.¹ Despite invasive coronary angiography identifying these diseases as simple Medina 0.1.0, it is typically difficult to predict the inclusion of distal left main coronary artery (LMCA) disease.^2-4 The complex morphological features of ostial lesions and the requirement of high technical skill make the application of interventional techniques for these lesions difficult.² Three revascularization options are available in the modern intervention era for these difficult anatomic lesions: surgery, crossover stenting (CS), and accurate ostial stent implantation (OSI).^1-7 The therapy of the stenosis of the ostial LAD artery is challenging owing to the complicated effects of the distal LMCA, as shown by previous studies.^1,2,5-7 Previously, OSI, CS, and other solutions have been tested. However, the findings have not been convincing owing to controversial data in the literature.^5-7 Several investigators have probed the performance of the OSI technique for ostial LAD artery disease;^5-7 however, especially in lesions that are not mapped in detail by intravascular imaging modalities, the proximal stent segment may protrude into the ostium of the side branch, cause progressive restenosis with postdilatation-induced distal LMCA injury, or may not completely cover the atherosclerotic plaque.² Apart from this, the side branch (mostly the left circumflex artery) may be influenced by plaque or carina shift.^1,2 Even though percutaneous coronary intervention (PCI) with the CS technique is associated with better clinical results, CS may lead to severe stenosis, occlusion, or side branch loss due to plaque or carina displacement.¹ Once this complication occurs, it inevitably requires side branch intervention or bail-out 2-stent techniques.^1,2,5-7 Furthermore, implantation of a drug-eluting stent with the CS technique into the left main without atherosclerotic disease has the potential to increase the risk of in-stent restenosis or stent thrombosis.² There is a dearth of large-sample size data and randomized controlled trials (RCTs) regarding PCI techniques (CS and OSI). Therefore, the European Bifurcation Club (EBC) consensus report and expert opinions emphasize that the best way to revascularize ostial LAD lesions is still a debatable issue.¹

Conventional CABG is an efficient revascularization method for complex coronary artery disease; however, it is an extremely invasive procedure that necessitates sternum dissection to access the heart. Consequently, it causes extensive scarring, a lengthy recovery period after surgery, and morbidity.^8,9 Recent developments in coronary surgery have shown that robotic-assisted coronary artery bypass grafting (RA-CABG) has fewer short-term complications, a shorter hospital stay, and reduced rates of morbidity and mortality compared to traditional on-pump coronary artery bypass grafting.¹⁰ Given that there is a dearth of data comparing RA-CABG with OSI and CS in terms of mid-term clinical outcomes for patients with ostial LAD disease (so-called Medina 0.1.0 left main bifurcation disease), this study aimed to compare the mid-term results of RA-CABG, CS, and OSI revascularization options in patients with this complex issue.

Methods

Study Design and Population

This retrospective observational study included 439 patients who underwent PCI or RA-CABG for ostial LAD disease between January 2011 and March 2024 in our institute. Demographic information, clinical and angiographic aspects of the patients, and cardinal symptoms were collected retrospectively. Individuals diagnosed with ST-segment elevation myocardial infarction, significant LMCA disease (30-50%), incomplete revascularization, a bare metal stent, end-stage kidney disease requiring hemodialysis, cardiogenic shock status, premature discontinuation of dual antiplatelet therapy, lost to follow-up, <1-year life expectancy, and absence of medical records were excluded from the study. We allocated the patient population into 3 groups based on the proposed revascularization strategy, including RA-CABG (group 1) as surgical intervention, and PCI therapies including either CS (group 2) or OSI (group 3). The final analysis comprised 439 patients, of which 157 were assigned to group 1, 104 to group 2, and 178 to group 3. Figure 1 depicts the flow chart for patient selection and the exclusion criteria. The heart team examined the different intervention approaches (RA-CABG, CS, or OSI), considering the operators’ skills, current guidelines, institutional experience, and the clinical choice reached after consulting with the patient. The patient and physician were involved in a collaborative decision-making process. Moreover, the revascularization technique or strategy employed for intervention was non-randomized and reviewed by multiple operators. It may have been chosen due to several clinical and anatomical factors that made operators feel they would be more successful with one technique over the other. This could have resulted in significant uncontrolled bias. After receiving approval from the Institutional Ethics Committee, this study followed all protocols outlined in the Declaration of Helsinki (number#2024.06-61, date: 19.11.2024). Additionally, no artificial intelligence (AI)-enabled technologies (such as llarge language models [LLM], chatbots, or image generators) were used in the production of the submitted work.

Interventional Procedures

Participating primary operators were required to perform 300 PCI per year for 3 years. The stents that were implanted with OSI or CS technique in the LMCA to LAD position were second- or third-generation DES, such as Firehawk (MicroPort Scientific Inc., Shanghai, China), Promus (Boston Scientific Inc., Galway, Ireland), Xience (Abbott Inc., Abbott Park, Illinois, USA), and Biomime (Meril Inc., Vapi, Gujarat, India), according to current recommendations from the EBC and at the operators’ discretion.^11,12 The CS procedure without intravascular ultrasonography (IVUS) guidance determined the main vessel (LMCA) stent size using Finet’s law.¹³ Furthermore, stent enhancement is a useful imaging technique for improving operation settings, which was used in all patients.¹⁴ The interventional cardiologist exercised their discretion in conducting IVUS assessments, by current recommendations, utilizing the 3 F Opticross coronary IVUS catheter (Boston Scientific, Fremont, CA, USA) and an automatic pull-back system (0.5 mm/sec).¹⁵ Considerations such as stenosis severity, plaque evaluation, and ideal landing zone were taken into account when deciding between angiography and intravascular ultrasound-optimized stent placement.¹⁶ Before and after the ostial LAD lesions had stents implanted, standard measures were taken.

Under general anesthesia, the second, fourth, and sixth intercostal gaps were used to establish 3 ports in the anterior axillary line, and the da Vinci Xi robotic system (Intuitive Surgical, Inc., Sunnyvale, CA, USA) was introduced to begin the RA-CABG procedure. A camera equipped with surgical tools was introduced into the left pleural space along with 2 lateral arms. Under constant carbon dioxide insufflation, the left internal thoracic artery (LITA) was correctly collected. The side branches of the LITA graft were harvested using bipolar cautery forceps and a low-energy monopolar electrocautery spatula. In a semi-skeletonized fashion, the LITA and its associated veins were extracted. Using a suction stabilizer (Octopus Nuvo Tissue Stabilizer, Medtronic, Minneapolis, USA), the pericardial fat was removed under endoscopic control. The LAD was then located and an optimal anastomosis site was determined. The beating heart underwent the off-pump anastomosis to the LAD. In circumstances where many veins were involved, the appropriate harvesting vessels were the great saphenous vein or the radial artery. Anastomosing the target vessel to the venous graft or radial artery followed the same procedure. Upon arrival at the intensive care unit, the patient was intubated and will be extubated within the next several hours. Following interventional procedures, the duration of dual antiplatelet therapy, including a P2Y12 receptor inhibitor, was determined depending on the clinical status of the patient, by current major cardiovascular guidelines.⁹

Clinical Assessment

Intraprocedural or in-hospital major adverse events (including death) were assessed at the time of the event or before hospital discharge. At 1, 6, and 12 months following the index procedure (RA-CABG, CS, or OSI), in addition to yearly clinic visits thereafter, all patients were routinely evaluated. Exercise stress testing, myocardial perfusion scintigraphy, or echocardiography was routinely done 6 to 12 months following the intervention to measure induced myocardial ischemia, and all patients were expected to comply with routine clinic visits. Invasive coronary angiography (coronary computed tomography angiography if needed) was performed on all patients who had clinical symptoms or instrumental evidence of myocardial ischemia during the follow-up period. Clinic visits, phone calls (for event confirmation from medical records), and referrals from other doctors all contributed to in-depth evaluations of patients’ health. We also checked the National Death Database to make sure the patients’ lives or deaths were accurately recorded.

Definitions and Study Outcomes

All-cause/cardiac death, clinically driven target vessel revascularization (TVR), spontaneous target vessel myocardial infarction (TVMI), stent thrombosis, symptomatic graft occlusion, stroke, contrast-induced acute kidney injury, and major bleeding were defined according to the EXCEL trial.¹⁷ The primary outcome was measured as major adverse cardiovascular and cerebral events (MACCE), which were cardiac death, spontaneous TVMI, TVR, stroke, and stent thrombosis or symptomatic graft occlusion under mid-term follow-up.

Statistical Analysis

Descriptive statistics were reported using mean ± standard deviation for continuous variables, and frequency with percentages for categorical data. The Shapiro–Wilk and Kolmogorov–Smirnov tests were used to determine the normality of the distribution of continuous variables. All continuous variables did not show normal distribution, and therefore non-parametric tests were used. For 2-group comparisons, continuous variables were compared across groups using the Mann–Whitney U test and for 3-group comparisons the Kruskal–Wallis H test was used. Simultaneously, post-hoc comparisons of the groups’ means were made with the Bonferroni–Dunn test. Besides, categorical variables were contrasted using the Chi-squared and Fisher’s exact tests. To identify independent predictors of MACCE in patients with ostial LAD disease, the characteristics that were discovered using univariate analyses were subsequently put into the Cox regression analysis using backward selection.

To account for treatment selection bias, the Cox proportional hazard regression model for mid-term MACCE was adjusted using the inverse probability weighted (IPW) approach to account for treatment selection bias. A multivariable logistic regression model was built to estimate the probability (propensity) of a patient being included in the OSI group versus others, given a set of measured covariates that would be predictive of the binary outcome (age, hypertension, EuroSCORE II, active side branch protection, and side branch narrowing > 50%). The standard errors of the hazard ratios from the IPW-adjusted Cox proportional hazard models are based on the robust sandwich variance estimator. Adjustment variables for both standard and IPW-adjusted Cox proportional hazard regression models were treatment (OSI), current smoker, EuroSCORE-II score, SYNTAX score, and in-hospital non-fatal major adverse events. The association between treatment and outcomes was quantified by univariate Cox regression and multiple Cox regression analyses hazard ratio (HR) and 95% confidence interval obtained by IPW-adjusted regression models. The Kaplan–Meier survival curve was used to demonstrate the cumulative incidence of MACCE, and log-rank tests were employed for group comparisons. The significance level was accepted as P < .05 in all statistical analyses. All statistical analyses were performed using R software v. 4.2.2 (R statistical software, Institute for Statistics and Mathematics, Vienna, Austria).

Results

A total of 439 consecutive patients [male: 341 (77.6%), mean age: 59.58 ± 9.35] with ostial LAD disease were enrolled in this study. The baseline demographic, clinical, medications, and lesion characteristics of the groups are depicted in Table 1. The prevalence of older age (60.50 ± 6.30 vs. 59.04 ± 10.54 years, P = .023) and hypertension (81.5 vs. 62.9%, P = 0.001) was significantly higher in group 1 than in group 3 (Table 1). Besides, the prevalence of hypertension was significantly greater in group 1 compared to group 2 (81.5 vs. 67.3%, P = .009). Groups 1 and 2 had substantially higher EuroSCORE-II scores (1.13 ± 0.78 vs. 0.99 ± 0.61, P = .003 and 1.11 ±. 80 vs. 0.99 ± 0.61, P = .020, respectively) compared to group 3 (Bonferroni: group 1 > group 3) (Table 1). Other demographic, clinical, and lesion parameters were comparable between the 3 groups.

Procedural details of the MICS-CABG and PCI arms are summarized in Tables 2 and 3, respectively. The majority of cases (99.4%) utilized LITA, while a small percentage (7% of all cases) had multiarterial CABG (Table 2). In PCI groups, arterial access was predominantly femoral, and IVUS was performed in approximately one-fourth of all patients (Table 3). Besides, group 2 had a significantly higher maximum post-dilatation balloon diameter (4.70 ± 0.27 vs. 3.98 ± 0.29 mm, P < .001), active side branch protection rate (4.8 vs. 0%, P = .006), and side branch (circumflex artery) intervention (14.4 vs. 6.7%, P = .034) compared to group 3 (Table 3).

In-hospital complications and mid-term clinical outcomes are presented in Table 4. The length of hospital stay in group 1 was higher than in groups 2 (5.06 ± 1.36 vs 2.20 ± 2.24 days, P < .001) and group 3 (5.06 ± 1.36 vs 2.27 ± 1.70 days, P < 0.001) (Bonferroni: group 1 > group 2 and group 1 > group 3) (Table 4). The rates of MACCE (26.4 vs 15.9%, P = .020 for groups 3 vs 1; 26.4 vs 13.5%, P = .011 for groups 3 vs 2, P = .011 for the 3-group) and clinically driven TVR (15.7 vs 4.5%, P = .001 for groups 3 vs 1; 15.7 vs 5.8%, P = .014 for groups 3 vs 2, P = .001 for the 3-group) were significantly higher in group 3 than in groups 1 and 2 (Table 4). Although 3-group comparisons were similar (P = .181 for 3-group), group 2 had a numerically lower mortality rate than group 3 but did not differ significantly (5.8 vs 12.4%, P = .098) (Table 4).

In the IPW-Cox proportional hazard analysis, the mid-term MACCE [(unadjusted HR: 1.706, [95% CI: 1.115-2.611], P = .014 and adjusted HR (IPW) = 2.129 [95% CI: 1.360-3.334], P = .001)] in the overall population notably differed between the group 3 and the others (Table 5).

Kaplan–Meier analysis showed that mid-term MACCE-free survival was found to be significantly decreased in patients with the treated OSI (Log Rank P = .032) (Figure 2).

Discussion

This is the first investigation comparing mid-term outcomes of RA-CABG, CS, and OSI revascularization options for ostial LAD disease, thereby most effectively reflecting real-world practice. The 4 major findings of the present study are: (1) the primary endpoint (MACCE) developed in 86 cases (19.6%) during the mean follow-up time of 39.41 ± 21.1 months; (2) RA-CABG and CS revascularization strategies had lower ischemia-driven combined outcome (MACCE) and TVR rates compared with the OSI under mid-term follow-up; (3) RA-CABG had longer hospital lengths of stays and a higher rate of procedural complications (i.e., pneumothorax) than PCI techniques; and (4) being in group 3 (OSI) was found to be one of the independent predictors of the mid-term MACCE.

The management algorithm of ostial LAD disease remains a controversial issue, especially in the rapidly developing stent technology and RA-CABG. The decision to use one revascularization technique over the other may depend on a better understanding of the lesion complexity of the atherosclerotic plaques.^2,4,7,18,19 For the PCI strategies, the prevailing option is between OSI and CS from LMCA to LAD disease.^1,2,5 The “keep it simple” 1-stent strategy has strong evidence as the “gold standard” approach for the management of most bifurcation lesions.^1,2,20 Additionally, the majority of published investigations focus on a provisional approach (CS) and OSI for ostial LAD disease.^5-7,21,22 The procedure of accurate ostial LAD stenting has some concerns. The risk of longitudinal geographic miss is particularly high.¹ Placing it too close to the circumflex artery ostium increases the risk of stent thrombosis and in-stent restenosis; meanwhile, putting it too far away raises the risk of missing the sick ostium. Spasm, dissection, or displacement of the distal LMCA bifurcation carina or plaque into the circumflex artery ostium can happen even with the best stent placement.^2,5 Hence, the optimal stent positioning for the OSI technique is a quite challenging issue.² Additionally, the concern with the CS technique is the possibility of plaque shifting to the side branch or the need for intervention for the side branch and the procedure being converted to a bail-out 2-stent technique. Several investigators reported that the bail-out 2-stent procedure has a high incidence of poor clinical outcomes.^2,5,7 In the past 10 years, RA-CABG may be considered a promising intervention due to all these drawbacks of PCI techniques for ostial LAD disease.^3,10,19 The RA-CABG and other minimally invasive coronary surgery options have grown in popularity due to the projected lower mortality, perioperative morbidity, and short-term major adverse events compared to conventional CABG.^3,10,18,19 The other major advantages of RA-CABG over conventional CABG are: (1) a shorter length of hospital stay, (2) a lower incidence of acute care facility discharge, (3) skeletonized LITA, (4) tiny incision, (5) faster recovery, and (6) good cosmetic effect [3]. Several studies regarding the comparison of minimally invasive approaches including RA-CABG vs conventional CABG in patients with coronary artery disease have been tested in recent years.^18,23-26 However, a limited number of investigations were reported regarding the mid-term outcomes of patients with isolated LAD disease who underwent RA-CABG or PCI with DES,^3,4 and there is no data in the literature comparing RA-CABG with PCI strategies (CS or OSI) for ostial LAD disease. Hence, we believe that the present study provides novel insights to clarify this uncertainty.

We observed that MACCE and clinically driven TVR occurred more frequently in the OSI group compared to the RA-CABG and CS groups. However, other endpoints were comparable between the groups. Several investigators previously indicated that minimally invasive surgical approaches and PCI had no significant difference in the combined ischemia-driven outcomes in patients with isolated LAD lesions (ostial or proximal localization) under mid- to long-term follow-up.^4,27,28 Whereas, several investigators reported that minimally invasive surgical approaches, including RA-CABG, improve clinical symptoms (angina pectoris) and reduce the rate of ischemia-driven outcomes and TVR compared to PCI in patients with isolated proximal LAD stenosis.^3,29 The several concerns in all these publications should be addressed: (1) LAD lesions were revascularized with minimally invasive direct coronary bypass grafting (not RA-CABG), (2) bare-metal stents or first-generation drug-eluting stents were used with PCI in several investigations, and (3) most studies did not include specific analysis for ostial LAD lesions.^{3-7,18,19,27-30} Accurate OSI and CS techniques are considered the 2 essential PCIs for ostial LAD lesions.^1,2,5 Recently, several publications have demonstrated that the CS technique was associated with lower long-term combined outcomes, TVR, and mortality rates compared with OSI in patients with ostial LAD disease.^5,21,31 Likewise, a recent meta-analysis showed that CS from LAD to LMCA emerges as a promising revascularization strategy for ostial LAD lesions.³² Conversely, Soylu et al⁷ suggest that the PCI with OSI was associated with better long-term major adverse cardiac events compared to CS.

The major drawback of a minimally invasive approach (RA-CABG) is its limited indication for revascularization. Specifically, young patients with proximal LAD disease, chronic total occlusion of the ostial LAD, advanced age or comorbidities (e.g., end-stage chronic kidney disease) with ostial LAD disease, and (4) special situations in which patients decline conventional CABG with sternotomy despite the heart team's favorable opinion regarding the benefits of conventional CABG over PCI. These concerns prevent the clinical outcomes of this surgical approach (RA-CABG) from being generalized to all coronary artery lesions.^10,19 Additionally, the lack of RCTs, the paucity of large-scale prospective studies comparing PCI techniques for ostial LAD lesions, and the quite low use of intravascular imaging tools in published studies prevent a strong conclusion regarding which PCI technique would have better clinical outcomes than other techniques. The best way to solve this uncertainty is for prospective studies with routine use of intravascular imaging to decide which revascularization strategy would improve the clinical outcomes of patients with ostial LAD disease.

SYNTAX score and EuroSCORE-II are well-established scoring systems for predicting preoperative adverse events.^33-37 Likewise, in the present study, we found these scores to be independent predictors of the mid-term MACCE.

Study Limitations

Several limitations should be addressed in the present study. First of all, the non-RCT and retrospective design could be considered a major limitation that might have introduced selection bias. Therefore, we used an IPW-Cox method to minimize such a possibility. Second, this was a single-center study; therefore, these results should be cautiously generalized to other centers. Third, the sample size of the study was relatively small. However, it is still remarkable for its size within each group. Fourth, the relatively low rate of imaging in the current complex PCI climate is also a significant limitation. Fifth, preoperative coronary computed tomography angiography for LAD assessment was not routinely performed. Lastly, the determination of the severity of lesions through quantitative coronary angiographic study and regular physiological examinations is lacking.

Conclusıon

In conclusion, for patients with ostial LAD lesions, the CS and RA-CABG strategies may result in fewer mid-term combined ischemia-driven outcomes (MACCE) and clinically driven TVR rates. However, there is no appreciable difference in mid-term survival for all revascularization options. Although RA-CABG is less invasive and has better clinical outcomes than other surgical revascularization options, PCI with CS has comparable ischemia-driven outcomes and more favorable outcomes in terms of length of hospital stay and procedural complications compared to RA-CABG. Therefore, we advocate revascularization with the CS strategy in Medina 0.1.0 left main bifurcation patients with low and intermediate SYNTAX scores and emphasize the evaluation of the multidisciplinary cardiac team in the decision-making process. Our findings provide more accurate and generalizable estimates with new insights regarding patients with ostial LAD lesions. Nevertheless, large-scale prospective RCTs with the routine use of intravascular imaging tools are warranted to address the best revascularization option in complex groups of patients.

Footnotes

Ethics Committee Approval:

This study was approved by the Ethics Committee of İstanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital (Approval No: 2024.06-61, Date: 19.11.2024).

Informed Consent: Due to the retrospective nature of the study, informed consent is not required.

Peer-review: Externally peer-reviewed.

Author Contributions: Concept – M.K., C.A., A.G.; Design –C.A., M.K., K.Ç., Supervision – F.U. Y.A.; Resources –B.S., Ü.A., A.Y.Ç., E.K., T.İ.; Materials –C.C., A.R.D., F.F.B., E.G.G.; Data Collection and/or Processing – A.D., C.C., C.A., B.S., K.Ç., E.G.G., Analysis and/or Interpretation – A.G. Literature Search – C.A, M.K., A.D. K.Ç.,B.S.; Writing – M.K., C.A., A.G. Critical Review – Y.A., F.U.

Declaration of Interests : The authors have no conflict of interests to declare.

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