ABSTRACT
Background
In patients with acute coronary syndrome (ACS) and multivessel disease (MVD), complete revascularization (CR) improves clinical outcomes compared with culprit‐only percutaneous coronary intervention (PCI). However, the optimal timing of CR, immediate (ICR) versus staged (SCR), remains debated.
Aims
This post hoc analysis of the BIOVASC trial aimed to evaluate whether unresolved culprit‐lesion‐related complications influence outcomes of ICR compared with SCR and to identify predictors of procedural complications.
Methods
Among 1525 patients enrolled in BIOVASC, 1487 index coronary angiographies were analyzed. Coronary complications related to culprit lesion PCI were classified and assessed for resolution status. Clinical outcomes were evaluated at 2‐year follow‐up according to randomized treatment strategy (ICR vs. SCR). Logistic regression was used to identify independent predictors of complications.
Results
Culprit‐lesion‐related complications occurred in 153 of 1487 procedures (10.3%), with 125 (81.7%) unresolved at the end of the index procedure. The most frequent complications were side branch occlusion or slow flow and distal slow reflow. Among patients with unresolved complications, the 2‐year rate of major adverse cardiovascular events (MACE: death, myocardial infarction, unplanned revascularization, or stroke) was similar between ICR and SCR (10.6% vs. 17.2%; HR 0.58, 95% CI 0.22–1.52; p = 0.27). Independent predictors of procedural complications were complex culprit lesion morphology (class B2/C) (OR 1.68, 95% CI 1.07–2.63; p = 0.023) and STEMI presentation (OR 1.45, 95% CI 1.00–2.11; p = 0.049).
Conclusions
In patients with unresolved culprit lesion complications during index PCI, ICR showed comparable 2‐year outcomes to the staged approach. Complex lesion morphology and STEMI presentation independently predicted procedural complications. These findings suggest that ICR remains a safe and viable strategy in hemodynamically stable patients, even in the presence of procedural challenges.
1. Introduction
Up to 50% of patients with acute coronary syndrome (ACS) present with multivessel disease (MVD) [1, 2]. The presence of MVD has been associated with higher in‐hospital and long‐term mortality [3, 4, 5]. Complete revascularization (CR) using percutaneous coronary intervention (PCI) of both the infarct‐related artery (IRA) and non‐culprit vessels with significant stenosis is currently guideline‐recommended in patients with ACS presenting with MVD without cardiogenic shock [6, 7]. CR was shown to be safe and to reduce the risk of major adverse cardiovascular events (MACE) in both patients presenting with non‐ST‐segment elevation ACS (NSTE‐ACS) and ST‐segment elevation myocardial infarction (STEMI) [8, 9, 10, 11, 12, 13, 14].
Although the optimal timing for the staged procedure remains unclear, recent trials have suggested a benefit of immediate complete revascularization (ICR) over staged complete revascularization (SCR) [15, 16, 17, 18]. Specifically, the recently published BIOVASC trial observed a reduction in risk of myocardial infarction and unplanned ischemia‐driven revascularization in patients randomized to ICR compared with SCR, confirmed by the 2‐year follow‐up outcomes [15]. The MULTISTARS AMI and SMILE trials also showed a reduction in MACE with ICR [16, 17].
Unresolved complications arising during culprit PCI could impact the choice between ICR and SCR, potentially benefiting the staged strategy, as a consequence of the increased complexity of index procedure. Given the established effectiveness of ICR as a revascularization strategy, this post hoc analysis of the BIOVASC trial aimed to determine whether unresolved index PCI complications influence clinical outcomes in patients undergoing ICR compared with SCR. To provide a clearer view on which patients may be at risk of periprocedural complications, we also explored potential predictors, as this may affect treatment strategy.
2. Methods
The BIOVASC was a multicenter, prospective, randomized trial enrolling 1525 patients (18−85 years) presenting with NSTE‐ACS or STEMI with MVD and a clearly identifiable culprit lesion. MVD was defined as one or more non‐culprit‐related lesions in coronary arteries with a diameter of 2.5 mm or more and at least 70% stenosis by visual estimation or positive coronary physiology testing. The use of intracoronary coronary physiology or invasive imaging was left to the decision of the operator. Exclusion criteria consisted of the absence of a clear culprit lesion, the presence of single‐vessel coronary disease, cardiogenic shock, a chronic total occlusion in a major coronary artery, previous coronary artery bypass surgery, and prior PCI in the previous 30 days. After informed consent and angiographic confirmation of MVD with a clear culprit, patients were randomly allocated to receive ICR or SCR, within 6 weeks after the index procedure, before performing PCI. Treatment was assigned on the basis of a 1:1 ratio, using random block size randomization. Clinical follow‐up was conducted at 30 days, 1 year, and 2 years after the index procedure, with an additional follow‐up planned at 5 years. Details regarding the rationale and design of the BIOVASC trial were previously reported [19]. In the BIOVASC trial, ICR was non‐inferior to SCR for the composite outcome of death, myocardial infarction, unplanned ischemia‐driven revascularization, or cerebrovascular events at both 1 and 2 years. ICR resulted in significantly fewer myocardial infarctions and unplanned revascularizations compared with SCR, mainly due to a reduction in early post‐procedural events, while overall mortality and cerebrovascular event rates were similar between the two strategies [15, 18].
2.1. Angiographic Evaluation
In this post hoc analysis, coronary angiography films (CAGs) of all randomized patients were evaluated, if available, and coronary complications related to culprit lesion treatment occurring during the index procedure were classified. A detailed list of definitions of all complications is provided in the Supporting Information Appendix. It was reported whether complications were resolved during the index procedure.
SYNTAX score was calculated with the use of the SYNTAX score calculator, online version 2.28 (https://syntaxscore.org/) [20]. Lesion complexity was classified into four groups (A, B1, B2, C) based on the American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology classification, updated in 1990 [21]. Lesions were categorized as non‐complex (class A or B1) and complex (class B2 or C) [22]. All the CAGs were observed by two analysts (W.C. and A.G.), who were blinded to clinical outcomes but not to treatment allocation. In case of disagreement, a third reviewer (J.J.E.) was consulted, and consensus was reached after joint review.
2.2. Endpoints
Clinical outcomes were defined in accordance with the BIOVASC trial protocol and the analyses reported at 1‐ and 2‐year follow‐up [15, 18, 19]. The primary endpoint was MACE, a composite of all‐cause death, any myocardial infarction, unplanned ischemia‐driven revascularization, or cerebrovascular event at 2 years. Secondary endpoints included the individual components of the primary outcome, stent thrombosis, major bleeding (BARC type 3 or 5), cardiovascular mortality, and a composite of death, myocardial infarction, cerebrovascular event, or major bleeding [23, 24, 25].
2.3. Statistical Analysis
Baseline characteristics were represented as means with standard deviations or medians and quartiles (Q1–Q3) for continuous variables and counts with percentages for categorical variables. Categorical variables were compared with the use of the Pearson chi‐square test or Fisher's exact test, if there was an expected cell value < 5. Gaussian distribution of continuous data was tested with the use of the Shapiro−Wilk test and consequently compared with the independent samples T‐test or Mann−Whitney U test, in the presence of a Gaussian or non‐normal distribution, respectively. Comparisons were performed both between patients with and without coronary complications and between immediate and staged revascularization groups within the complicated cohort.
The Kaplan−Meier method was employed to estimate cumulative incidences of outcomes during follow‐up and to compute cumulative time‐to‐event curves. In the absence of an event, patients were censored at their last known alive status. Among patients with unresolved culprit‐lesion complications, Cox proportional hazards regression was used to compare time‐to‐event outcomes according to their original randomized assignment to ICR or SCR. Assessment of the log‐minus‐log survival functions indicated adherence to the proportional hazards assumptions.
Logistic regression analysis was performed to investigate the predictors of coronary complications. Variables were selected for the multivariable analysis if presenting with p values < 0.1 in the univariable analysis (STEMI presentation, complex culprit lesion morphology [class B2/C], and pre‐procedural SYNTAX score).
Statistical tests were considered significant with a two‐sided p < 0.05. Odds ratios (OR) and hazard ratios (HR) were presented with 95% confidence intervals (CI). Data were analyzed using IBM SPSS Statistics software version 28 (IBM Corp, Armonk, New York).
3. Results
Among 1525 patients enrolled in the BIOVASC trial, a total of 1487 index CAGs were evaluated. Coronary complications were not reported for 38 (2.5%) patients enrolled, mainly due to missing angiographic data (Supporting Information S1: Figure 1).
A total of 153/1487 (10.3%) procedures with complications related to culprit lesion treatment were observed, and 28/153 of complicated procedures (18.3%) were resolved at the end of the procedure. Within complicated procedures, 175 culprit‐lesion‐related complications were reported, and at least two complications occurred in 21 (1.4%) procedures. Among patients randomized to ICR, 82 of 744 (11.0%) experienced coronary complications, whereas among those randomized to SCR, 71 of 743 (9.6%) experienced complications; the difference was not statistically significant (p = 0.35).
Of the total, 125 procedures ended with unresolved culprit‐lesion‐related complications, accounting for 81.7% of all 153 complicated procedures. Among these, coronary complications were classified as coronary dissections in five cases (including three type A and one type F dissections), aortocoronary dissection in one case, side branch occlusions in 32 cases, side branch slow flow in 32 cases, both in branches > 1.5 mm, no‐reflow in one case and distal slow reflow in 69 cases (classified as TIMI 1 or TIMI 0 flow). Perforations, stent thrombosis, and equipment entrapment were not observed. Each type of complication occurred without significant differences between the revascularization strategies. Overall, 18.3% of complicated procedures (28 cases) were resolved, with equal rates in both revascularization strategies. A detailed list of complications characteristics is shown in Supporting Information S1: Table 1.
Regarding patients in whom an unresolved culprit lesion‐related complication occurred, the median age of the patients was 65.7 years (59.0−72.0), 102 (81.6%) were male, 28 (22.4%) had diabetes, 56 (44.8%) had hypercholesterolemia, 60 (48.0%) had hypertension, and 62 (49.6%) were current or former smokers. STEMI was the presentation in 64 (51.2%) patients, NSTEMI in 54 (43.2%) patients, and unstable angina in 7 (5.6%) patients. Complicated culprit lesions were mostly classified as complex, namely as Type A/B1 in 30 (24.0%) cases and Type B2/C in 95 (76.0%) cases. The median pre‐procedural SYNTAX score was 17 [12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23]. Baseline clinical and procedural characteristics of patients with complicated index PCI procedure are reported in Tables 1 and 2.
Table 1.
Clinical baseline characteristics.
| Characteristics | Total (N = 125) | ICR group (N = 67) | SCR group (N = 58) | p value |
|---|---|---|---|---|
| Age, years | 65.7 (59.0−72.0) | 65.7 (58.4−72.2) | 65.0 (59.2−71.6) | 0.62 |
| Sex | 0.44 | |||
| Male | 102 (81.6%) | 53 (79.1%) | 49 (84.5%) | |
| Female | 23 (18.4%) | 14 (20.9%) | 9 (15.5%) | |
| BMI, kg/m2 | 26.4 (24.6−29.7) | 26.2 (24.2−29.6) | 26.6 (24.7−30.1) | 0.86 |
| Presentation | 0.75 | |||
| STEMI | 64 (51.2%) | 36 (53.7%) | 28 (48.3%) | |
| NSTEMI | 54 (43.2%) | 28 (41.8%) | 26 (44.8%) | |
| Unstable angina | 7 (5.6%) | 3 (4.5%) | 4 (6.9%) | |
| Previous PCI | 16 (12.8%) | 10 (14.9%) | 6 (10.3%) | 0.45 |
| History of MI | 10 (8.0%) | 8 (11.9%) | 2 (3.4%) | 0.10 |
| Peripheral artery disease | 2 (1.6%) | 1 (1.5%) | 1 (1.7%) | > 0.99 |
| COPD | 9 (7.2%) | 5 (7.5%) | 4 (6.9%) | > 0.99 |
| Atrial fibrillation or flutter | 4 (3.2%) | 3 (4.5%) | 1 (1.7%) | 0.62 |
| Renal insufficiency | 5 (4.0%) | 2 (3.0%) | 3 (5.2%) | 0.66 |
| History of stroke | 2/124 (1.6%) | 1/66 (1.5%) | 1/58 (1.7%) | > 0.99 |
| Hypertension | 60 (48.0%) | 32 (47.8%) | 28 (48.3%) | 0.95 |
| Hypercholesterolemia | 56 (44.8%) | 33 (49.3%) | 23 (39.7%) | 0.28 |
| Diabetes | 28 (22.4%) | 15 (22.4%) | 13 (22.4%) | > 0.99 |
| Family history of CVD | 35 (28.0%) | 19 (28.4%) | 16 (27.6%) | 0.92 |
| Smoking behavior | 0.53 | |||
| Never | 63 (50.4%) | 36 (53.7%) | 27 (46.6%) | |
| Current | 39 (31.2%) | 21 (31.3%) | 18 (31.0%) | |
| Former | 23 (18.4%) | 10 (14.9%) | 13 (22.4%) |
Note: Data are reported as median and quartiles (Q1–Q3) or n (%).
Abbreviations: BMI = body mass index, CI = confidence interval, COPD = chronic obstructive pulmonary disease, CVD = cardiovascular disease, ICR = immediate complete revascularization, MI = myocardial infarction, NSTEMI = non‐ST‐segment elevation myocardial infarction, PCI = percutaneous coronary intervention, SCR = staged complete revascularization, STEMI = ST‐segment elevation myocardial infarction.
Table 2.
Procedural baseline characteristics.
| Characteristics | Total (N = 125) | ICR group (N = 67) | SCR group (N = 58) | p value |
|---|---|---|---|---|
| Systolic blood pressure, mmHg | 122 (110−141) | 127 (110−145) | 120 (109−137) | 0.16 |
| Diastolic blood pressure, mmHg | 75 (66–82) | 80 (66–90) | 72 (62–81) | 0.074 |
| Radial access | 122 (97.6%) | 64 (95.5%) | 58 (100%) | 0.25 |
| Culprit lesion complexitya | 0.65 | |||
| Type A/B1 | 30 (24.0%) | 15 (25.9%) | 15 (22.4%) | |
| Type B2/C | 95 (76.0%) | 43 (74.1%) | 52 (77.6%) | |
| Location of culprit lesion | 0.57b | |||
| LAD | 46 (36.8%) | 24 (35.8%) | 22 (37.9%) | |
| LCX | 36 (28.8%) | 22 (32.8%) | 14 (24.1%) | |
| RCA | 42 (33.6%) | 21 (31.3%) | 21 (36.2%) | |
| LM | 1 (0.8%) | 0 (0.0%) | 1 (1.7%) | |
| Pre‐procedural SYNTAX score | 17 (12–23) | 17.5 (12.0−24.0) | 16.0 (11.0−22.0) | 0.63 |
Note: Data are reported as median and quartiles (Q1–Q3) or n (%).
Abbreviations: ACC/AHA = American College of Cardiology/American Heart Association, ICR = immediate complete revascularization, LAD = left anterior descending artery, LCX = left circumflex artery, LM = Left main artery, OR = odds ratio, RCA = right coronary artery, SCR = staged complete revascularization, SYNTAX score = Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery score.
Lesion complexity was assessed based on the ACC/AHA lesion morphology classification.
p value calculated with use of the Fisher−Freeman−Halton exact test.
At 2 years follow‐up, there was no significant difference in primary outcome among patients with unresolved culprit lesion‐related complications (Table 3). The primary composite outcome occurred in 7 (10.6%) patients in the ICR group and in 10 (17.2%) patients in the SCR group (HR 0.58, 95% CI 0.22−1.52, p = 0.27; Table 3). Regarding secondary outcomes at 2 years after the index procedure, no statistically significant differences were observed between the ICR and SCR groups (Table 3).
Table 3.
Clinical outcomes at 2 years.
| Outcomes | ICR group (N = 67) | SCR group (N = 58) | HR (95% CI) | p value |
|---|---|---|---|---|
| Primary outcome | ||||
| All‐cause death, any myocardial infarction, any unplanned ischemia‐driven revascularization, or cerebrovascular events | 7 (10.6%) | 10 (17.2%) | 0.58 (0.22−1.52) | 0.27 |
| Secondary outcomes | ||||
| All‐cause mortality | 2 (3.0%) | 2 (3.4%) | 0.87 (0.12−6.19) | 0.89 |
| Myocardial infarction | 2 (3.1%) | 4 (6.9%) | 0.43 (0.08−2.32) | 0.32 |
| Unplanned ischemia‐driven revascularization | 4 (6.2%) | 7 (12.2%) | 0.48 (0.14−1.62) | 0.24 |
| Probable or definite stent thrombosis | 1 (1.5%) | 1 (1.7%) | 0.86 (0.05−13.81) | 0.92 |
| All‐cause death, myocardial infarction, stroke, or major bleeding (BARC 3 or 5) | 6 (9.0%) | 7 (12.1%) | 0.74 (0.25−2.19) | 0.58 |
| Major bleeding (BARC 3 or 5) | 2 (3.0%) | 1 (1.8%) | 1.75 (0.16−19.35) | 0.65 |
| Cardiovascular mortality | 1 (1.5%) | 2 (3.4%) | 0.44 (0.04−4.82) | 0.50 |
| Any revascularization | 4 (6.2%) | 7 (12.2%) | 0.48 (0.14−1.62) | 0.24 |
| Cerebrovascular events | 1 (1.6%) | 0 (0.0%) |
Note: Data are reported as the number of events. Cumulative incidence according to the Kaplan−Meier method is reported as a percentage.
Abbreviation: BARC = Bleeding Academic Research Consortium.
Between complicated group and non‐complicated group, clinical and procedural baseline differences were observed in terms of STEMI presentation (64 [51.2%] vs. 536 [39.4%], p = 0.0031), diastolic blood pressure (75 [66−82] vs. 71 [62−80], p = 0.010), culprit lesion complexity Type B2/C (95 [76.0%] vs. 836 [61.7%], p = 0.0015), and pre‐procedural SYNTAX score (17.0 [12.0−23.0] vs. 14.0 [10.0−20.0], p = 0.0010) (Supporting Information S1: Tables 2 and 3).
To investigate potential predictors of coronary complications, univariable and multivariable logistic regression analyses were performed. Both complex culprit lesion (class B2 or C) (OR 1.68, 95% CI 1.07−2.63, p = 0.023) and STEMI presentation (OR 1.45, 95% CI 1.00−2.11, p = 0.049) were independent predictors of coronary complications (Table 4).
Table 4.
Predictors of coronary complications.
| Variables | Univariable analysis | Multivariable analysis | ||
|---|---|---|---|---|
| OR (95% CI) | p value | OR (95% CI) | p value | |
| Age, years | 1.00 (0.98−1.02) | 0.96 | ||
| Sex, male | 1.29 (0.81−2.07) | 0.29 | ||
| BMI, kg/m2 | 1.00 (0.96−1.04) | > 0.99 | ||
| STEMI presentation | 1.62 (1.12−2.33) | 0.010 | 1.45 (1.00−2.11) | 0.049 |
| Hypertension | 0.79 (0.55−1.14) | 0.21 | ||
| Diabetes | 1.12 (0.72−1.73) | 0.63 | ||
| Complex culprit lesiona | 1.97 (1.29−3.01) | 0.0018 | 1.68 (1.07−2.63) | 0.023 |
| Pre‐procedural SYNTAX score | 1.03 (1.01−1.06) | 0.0026 | 1.02 (1.00−1.05) | 0.086 |
Abbreviations: ACC/AHA = American College of Cardiology/American Heart Association, BMI = body mass index, CI = confidence interval, OR = odds ratio, STEMI = ST‐segment elevation myocardial infarction, SYNTAX score = Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery score.
Complex culprit lesion was defined as class B2 or C based on the ACC/AHA lesion morphology classification.
4. Discussion
This is the first study comparing clinical outcomes in patients with index PCI coronary complications related to culprit lesion treatment, stratified by initial randomization to ICR or SCR. At 2‐year follow‐up, there were no statistically significant differences in primary or secondary outcomes between the ICR and SCR groups among patients with unresolved culprit lesion complications. Importantly, randomization in the BIOVASC trial occurred prior to PCI and the occurrence of complications, minimizing selection bias in the overall population.
In recent guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA), ICR is recommended for selected hemodynamically stable patients with STEMI and NSTE‐ACS [6]. Although recent studies indicate that ICR is associated with a lower risk of MACE, mainly due to reduced rates of recurrent ischemia and myocardial infarction, the interpretation of these results should consider that the enrolled populations predominantly consisted of patients with uncomplicated culprit lesion PCI and overall favorable procedural profiles [15, 16, 17, 18]. The current analysis, focusing on patients with procedural complications, provides novel insights into a subgroup generally underrepresented in randomized trials. Despite the procedural complexity introduced by these complications, no statistically significant differences in long‐term outcomes were observed between ICR and SCR. However, given the limited sample size and number of events, these findings should be considered exploratory and warrant confirmation in larger studies.
In current clinical practice, the choice between ICR and SCR depends on hemodynamic stability, anatomical complexity, and operator judgment. Although ICR was not associated with an increased risk among hemodynamically stable patients with unresolved culprit lesion‐related complications, the limited number of events precludes definitive conclusions. This perspective is aligned with recent guideline recommendations encouraging ICR in patients with MVD and ACS [6], given its potential to reduce the risk of MACE, along with practical advantages such as shorter hospitalization and fewer repeat interventions [6, 7].
In recent decades, the incidence of complications has decreased, although there has been an increase in complexity and procedural risk in the interventions performed [26]. In our study, coronary complications occurred in 10.3% of procedures, a rate consistent with historical data despite improvements in devices and operator expertise [26]. The most prevalent complications included side branch occlusions and slow flow in branches > 1.5 mm, and distal slow reflow. Particularly, there was no significant difference in the occurrence of complicated procedures between the ICR and SCR groups, suggesting that the timing of revascularization did not significantly impact the likelihood of procedural complications. This observation is consistent with the findings from a single‐center retrospective study involving 1400 patients with STEMI and NSTEMI‐ACS and MVD undergoing PCI, where the rates of complications during the index procedure did not significantly differ between the ICR and SCR groups (4.2% vs. 2.0%, p = 0.1) [27].
No stent thrombosis was found, presumably because of the evaluation being limited to peri‐procedural stent thrombosis during the index procedure. However, in the BIOVASC trial [15, 18], stent thrombosis was evaluated regardless of the time after the index procedure until 2 years of follow‐up. The disparity in event definitions is in accordance with the purpose of this study to evaluate complications of treating culprit lesions occurring before treatment of non‐culprit lesions.
Distal slow reflow was observed mainly in lesions with high thrombus burden, caused by downstream embolization of thrombus with microvascular obstruction, or, in rare cases, by air embolization. In most cases, slow flow did not resolve with additional stents or post‐dilatation, as these interventions are limited to epicardial circulation. In a minority of cases (0.4% out of 1487 procedures), no‐reflow occurred, which results in a worsening prognosis and is not self‐limiting in about half of the cases [28, 29]. Although most complications observed were distal slow reflow or side branch slow flow, these phenomena are not necessarily benign, as they may reflect distal embolization and microvascular obstruction and have been associated with impaired myocardial perfusion and worse clinical outcomes [28, 29]. Nonetheless, their clinical impact may differ from that of more severe complications such as coronary perforation or major dissection, which were not observed in this cohort, and the limited number of events precluded a sensitivity analysis excluding minor flow disturbances.
Furthermore, the study explored potential predictors of coronary complications. The assessment of the likelihood of procedural complications is challenging and can be based on lesion characteristics or on risk stratification tools, which combine patient and lesion characteristics [30, 31]. The most widely known is the ACC/AHA lesion morphology classification, updated in 1990 [21]. It is based on angiographic characteristics, and it predicts clinical outcomes but has not been tested for coronary complications [22]. In our study, patients with complicated index procedure showed higher rates of STEMI presentation, lower rates of hypertension, higher pre‐procedural SYNTAX score, and a more complex culprit lesion. Among patients included in this analysis, a culprit complex lesion (class B2 or C) and a STEMI presentation predict coronary complications within the index procedure. These findings should be interpreted as exploratory and mainly confirm previously reported associations between STEMI presentation, complex culprit lesion morphology, and adverse procedural outcomes [32, 33].
From a pathophysiological standpoint, the presence of complex lesions, characterized by severe calcifications, tortuosity, or high thrombotic burden, increases the risk of distal embolization, no‐reflow phenomenon, or vessel dissection during PCI. Likewise, STEMI presentation, typically associated with a prothrombotic and inflammatory milieu [32, 33], may further amplify procedural vulnerability, predisposing to acute complications and suboptimal reperfusion. While complex lesion morphology and STEMI presentation have been previously associated with adverse procedural outcomes, our findings extend this knowledge by confirming their role as predictors of culprit lesion‐related complications specifically within a contemporary, randomized multivessel PCI population, thereby providing additional context for procedural risk stratification in patients considered for ICR.
4.1. Limitations
Complications were identified primarily through angiography, with invasive imaging performed in only a minority of procedures, potentially underestimating subtle events. The present subanalysis was conducted to evaluate the relationship between revascularization strategies and the incidence of patient complications. Given its post‐randomization nature, this analysis is inherently exploratory and may be subject to selection bias. Consequently, the findings should be interpreted as hypothesis‐generating. In addition, the study was not formally powered to assess the safety of ICR specifically in patients with complicated index PCI; although multivariable adjustment was considered, it was not performed given the limited number of events and the risk of model overfitting, particularly in the absence of significant differences in the unadjusted analysis.
5. Conclusion
Among patients with unresolved culprit lesion‐related complications during the index procedure, no difference in 2‐year outcomes was observed between immediate and staged complete revascularization. However, the limited sample size and event rate warrant cautious interpretation of these findings, which should be considered hypothesis‐generating pending confirmation in future studies.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Figure S1: Study flowchart.
Table S1: Coronary culprit lesion related Complications Characteristics.
Table S2: Clinical Baseline Characteristics between Complicated and Non‐Complicated Groups.
Table S3: Procedural Baseline Characteristics between Complicated and Non‐Complicated Groups.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Figure S1: Study flowchart.
Table S1: Coronary culprit lesion related Complications Characteristics.
Table S2: Clinical Baseline Characteristics between Complicated and Non‐Complicated Groups.
Table S3: Procedural Baseline Characteristics between Complicated and Non‐Complicated Groups.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.