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Complex versus non-complex percutaneous coronary intervention in patients with atrial fibrillation: a real-world study

BMC Cardiovascular Disorders volume 25, Article number: 285 (2025) Cite this article

Abstract

Background

Patients with atrial fibrillation (AF) often underwent percutaneous coronary intervention (PCI), and the complexity of PCI has risen in recent years. However, there is limited data available on clinical outcomes in patients with AF who underwent complex PCI.

Methods

This was a prospective, observational study. Complex PCI was defined as PCI performed to ≥ 3 separate major coronary vessels; ≥3 stents implanted; ≥3 lesions treated; or total stented length > 60 mm. The primary outcome was defined as major adverse cardiovascular event (MACE) including all-cause death, spontaneous myocardial infarction (MI), stroke/ transient ischemic attack (TIA), systemic embolism or ischemia-driven revascularization. The secondary outcome was defined as net adverse clinical events (NACE), which included major adverse cardiovascular events (MACE) and major bleeding.

Results

A total of 1132 patients who underwent PCI with AF were enrolled consecutively. The mean age was 67 ± 9, and 75.1% were male. 320 participants (28.2%) underwent complex PCI. During a median follow-up of 1045 days (interquartile range: 666–1327), the primary outcome occurred in 52 out of 320 patients (16.2%), while the secondary outcome was observed in 55 out of 320 patients (17.2%) in the complex PCI group. MACE showed no differences between groups (hazard ratio [HR], 1.30; 95% confidence interval [CI], 0.93–1.82), nor did NACE (HR:1.34, 95%CI: 0.97–1.85). Patients with complex PCI still had a higher likelihood of experiencing spontaneous MI (HR, 2.17, 95%CI, 1.00-4.70) and ischemic driven revascularization (HR, 1.86, 95%CI, 1.01–3.45) after adjusted for confounders.

Conclusion

The complexity of PCI was an independent risk factor for adverse clinical outcomes, particularly for myocardial infarction and revascularization events in patients with atrial fibrillation. However, it was not associated with major bleeding, all-cause mortality, or stroke/TIA.

Clinical trial number

Not applicable

Peer Review reports

Introduction

Percutaneous coronary intervention (PCI), the most frequent modality of coronary revascularization [1], was commonly employed to alleviate symptoms and reduce cardiovascular events in patients with obstructive coronary artery diseases (CAD) [2, 3]. Whereby, the prevalence of comorbidities and increasing age have contributed to the continued growth of complex PCI [4], which is used to describe the challenging characteristics of the intervention lesions. Recent studies indicated that complex PCI was associated with an increased risk of target lesion failure (TLF), including cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization as well as probable/definite stent thrombosis at three years post-PCI [5, 6]. Moreover, a previous study reported that as the number of complex features increases (3–6 vs. 1–2 vs. none), the risk of all outcomes also rises [6]. Apart from ischemic events, patients with complex PCI were found to be more susceptible to bleeding events compared to non-complex PCI [7].

Atrial fibrillation (AF) frequently coexisted with CAD and/or PCI in clinical practice [8, 9], posing challenges for antithrombotic therapy. Determining the risk of developing bleeding or thrombotic complications in these patients is crucial for defining the appropriate intensity and duration of antithrombotic therapy [9]. In patients with complex PCI, a known risk factor for ischemic outcomes, evidence supports prolonged treatment with dual antiplatelet therapy (DAPT) for an extended duration [10]. Subsequent monotherapy with P2Y12 inhibitors in these patients has been associated with a lower risk of major bleeding events compared to DAPT, and a reduced risk of myocardial infarction [11]. Given the need to tailor antiplatelet therapy, the development of several scoring systems has provided a foundation for guiding treatment decisions [12]. The guideline recommends that patients who undergo complex PCI complicated by atrial fibrillation be treated with aspirin, a P2Y12 inhibitor, and anticoagulant therapy for up to one month following the intervention [13]. However, in the real world, the combination of antithrombotic therapy raises concerns about bleeding events, while insufficient antithrombotic therapy may lead to ischemic events [14]. Additionally, real-world data on the prescription of antithrombotic therapy according to the complexity of PCI is scarce. There was a lack of evidence regarding clinical outcomes in patients with AF who undergo complex versus non-complex PCI.

In this study, we aimed to investigate the impact of complex PCI and discharge antithrombotic therapy on safety and efficacy outcomes in patients with AF who underwent PCI in real-world.

Methods

Study population

This study was an observational, prospective, single center study of adults with AF who underwent PCI from 2017 to 2019 in Fuwai Hospital, Beijing, China. Participants aged over 18 with AF and who underwent PCI and implanted stents were able to get eligibility. Patients who lacked of PCI details were excluded. Due to the analysis of antithrombotic therapy, we excluded patients with CHA2DS2-VASc score less than 1 point apart from gender. Finally, a total of 1132 participants were included (Supplementary Fig. 1). The study design and protocol have been approved by the Ethics Committee of Fuwai Hospital and conformed to the Declaration of Helsinki. All the patients had signed informed consents to participate in this study.

Data collection and definition

Baseline data including demographic information, medical history, physical measurements, laboratory tests, discharge medications, and ultrasound results, were gathered based on medical records confirmed by their physicians. Details regarding antithrombotic therapy were collected at discharge, comprising antiplatelet therapy alone, dual antithrombotic therapy (DAT, single antiplatelet drug plus oral anticoagulant) and triple antithrombotic therapy (TAT, dual antiplatelet drug plus oral anticoagulant). Only continuous variables were identified to have missing data, which were imputed using the mean or median value (missing details were presented in supplementary).

We defined complex PCI as the following criteria: PCI performed to ≥ 3 separate major coronary vessels; ≥3 stents implanted; ≥3 lesions treated; or total stented length > 60 mm [15]. Based on the complexity of PCI intervention, we divided participants into two groups, complex PCI and non-complex PCI.

Subgroup analysis was performed based on CHA2DS2-VASc score combined with the complexity of PCI. Previous studies have demonstrated that CHA2DS2-VASc score can predict mortality in AF patients undergoing coronary artery angiography, with a cut-off at 4 points [16]. Therefore, were divided into 4 groups according to their stroke risk (CHA2DS2-VASc score 1–3 vs. 4–9) and the complexity of PCI (complex vs. non-complex).

Follow up and outcomes

Primary outcome was major adverse cardiovascular event (MACE), which was defined as a composite of all-cause death, stroke/transient ischemic attack (TIA), systemic embolism (SE), spontaneous myocardial infarction (MI) and ischemic driven revascularization. Other outcomes included Thrombolysis in Myocardial Infarction (TIMI) [17] major bleeding and individual components of the MACE. The secondary endpoint was net adverse clinical outcome events (NACE), defined as a composite of MACE events and major bleeding events (not related to coronary artery bypass graft) [18]. All clinical outcomes were adjudicated by an independent clinical event adjudication committee. Definitions of endpoints and risk scores are presented in the Supplemental Appendix [19]. Follow-up with a mean duration of 1045 days and information was gathered through telephone calls, re-hospitalization, and outpatient visits facilitated by trained research personnel.

Statistics analysis

Continuous variables were presented as mean ± standard deviation (SD) or as median with lower and upper quartiles and tested by using Mann-Whitney U test or t test, while categorical variables were tabulated as counts and percentages and tested with χ2 test or Fisher’s exact test. Cumulative events rates were estimated by Kaplan-Meier (KM) curves. Multivariate proportional-hazards Cox analysis was used to adjust confounding factors and found out factors associated with MACE events, spontaneous MI, ischemic driven revascularization, and major TIMI bleeding events. Variables adjusted in multivariate proportional-hazards Cox analysis were presented in Supplementary Tables 3–4. The results expressed as hazard ratio (HR) with a 95% confidence interval (CI). All the analyses were performed using software packages R (4.3.1, R Project for Statistical Computing, Vienna, Austria) and SPSS (version 25.0, IBM Corporation, New York, NY, USA). All statistical tests were two-sided and a value of P < 0.05 was considered significant.

Results

Baseline characteristics and antithrombotic therapy status

PCI was performed on a total of 1293 patients with AF. 11 patients without PCI details, 55 patients with CHA2DS2-VASc score lower than 1, and 95 patients lost during follow-up were excluded. Finally,1132 patients were included for analysis, 320 (28.2%) of whom were classified as undergoing complex PCI (Supplementary Fig. 1). Details on the composing of complex PCI were showed in supplementary Table 1. The average age was 67 ± 9, with males accounting for 75.1% of the participants. Baseline characteristics were presented in Table 1. Clinical characteristics were similar between the two groups, while patients who underwent complex PCI were more likely to have a higher peak cTnI level (4.25 versus 2.70, p = 0.01).

All the patients were under antiplatelet therapy. Antiplatelet therapy without OAC was administered in 769 (67.9%) patients. DAT was applied in 32 (2.8%) patients and TAT was given to 331 (29.2%) patients. Among patients who underwent complex PCI, 202 (63.1%) received antiplatelet therapy, while DAT and TAT were prescribed in 10 (3.1%) and 108 (33.8%) patients, respectively (Fig. 1 and Supplementary Table 2). It is worth noting that TAT (33.8% vs. 27.5%, p = 0.04) and oral anticoagulant (OAC) usage (36.9% vs. 30.2%, p = 0.04) was more common in patients who underwent complex PCI compared to those who had non-complex PCI.

Table 1 Baseline clinical characteristics in patients with AF who undergoing complex or non-complex PCI
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Fig. 1
figure 1

Rate of antithrombotic therapy in complex and non-complex PCI. DAT: dual antithrombotic therapy; OAC usage: oral anticoagulant usage; TAT: triple antithrombotic therapy. * indicates p<0.05

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Clinical outcomes according to complexity of PCI

During a median follow-up of 1045 days (interquartile range: 666–1327), the primary outcome occurred in 157 (13.9%) patients, which included all-cause death in 66 (5.8%) patients, stroke/TIA in 49 (4.3%) patients, SE in 3 (0.3%) patients, spontaneous MI in 27 (2.4%) patients, and ischemic driven revascularization in 43 (3.8%) patients (Table 2). KM curves presented conformable rate of MACE (p = 0.12) and NACE (p = 0.08) but higher rate of MI (p = 0.03) and revascularization (p = 0.03) in complex PCI group compared to non-complex PCI. (Figures 2 and 3) We observed similar incidence of MACE (16.2% vs. 12.9%, HR: 1.30; 95%CI, 0.93–1.82) and NACE (17.2% vs. 13.4%, HR:1.34, 95%CI: 0.97–1.85) among patients who underwent complex PCI throughout the follow-up period, without statistical significance. Spontaneous MI (3.8% vs. 1.8%, HR, 2.26; 95%CI, 1.05–4.87) and ischemia-driven revascularization (5.6% vs. 3.1%, HR, 1.91; 95%CI, 1.04–3.50) demonstrated an increased risk associated with the complexity of PCI. (Table 3) There were no significant differences between the two groups in terms of all-cause death, SE, stroke/TIA or TIMI major bleeding. (Supplementary Fig. 2, supplementary Fig. 3, supplementary Fig. 4, supplementary Fig. 5)

Table 2 Clinical outcomes during follow-up in AF patients underwent complex PCI versus non-complex PCI
Full size table

After adjusted confounding factors, compared to patients with non-complex PCI, patients with complex PCI were still more likely to experience spontaneous MI (HR = 2.17, 95%CI, 1.00-4.70) and ischemic driven revascularization (HR = 1.86, 95%CI, 1.01–3.45). (Table 3)

Fig. 2
figure 2

Cumulative rate of clinical events (a) MACE events (b) NACE events. MACE: major adverse cardiovascular events

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Fig. 3
figure 3

Cumulative rate of events on (a) spontaneous MI (b) ischemic driven revascularization. MI: myocardial infarction; TIMI: Thrombolysis in Myocardial Infarction

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Table 3 Cox analysis on clinical outcomes based on the complexity of PCI
Full size table

Subgroup analysis of clinical outcomes according to CHA2DS2-VASc score and the complexity of PCI

In the subgroup analysis, antithrombotic therapy showed no discrepancy between low and high CHA2DS2-VASc score groups. (Supplementary Table 5) MACE presented differences among four groups (p < 0.001). (Fig. 4) However, among patients with a high CHA2DS2-VASc score, those who underwent complex PCI were more likely to receive both antiplatelet therapy and anticoagulant therapy, particularly TAT (p = 0.02). Complex PCI led to higher rate of MACE (p = 0.04) in patients with low CHA2DS2-VASc score, while no differences were observed in patients with high CHA2DS2-VASc score (p = 0.76). Among patients with non-complex PCI, patients with high CHA2DS2-VASc score had a higher incidence of MACE than those with low CHA2DS2-VASc score (p < 0.001). On the contrary, among patients with complex PCI, the cumulative risk of MACE was similar between groups with low and high CHA2DS2-VASc score(p = 0.17). (Supplementary Fig. 6)

Fig. 4
figure 4

Subgroup analysis of the complexity of PCI with CHA2DS2-VASc score. Low score complex: CHA2DS2-VASc score from 1 to 3 and complex PCI. High score complex: CHA2DS2-VASc score from 4 to 9 and complex PCI. High score non- complex: CHA2DS2-VASc score from 4 to 9 and non-complex PCI

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Discussion

Current study drew conclusions from a total of 1132 participants and the main results were as follows. 1)Among participants with AF who underwent PCI, 28.2% were performed to complex PCI, and 13.9% experienced MACE and 17.2% experienced NACE during follow-up. 2) It appears that patients who underwent complex PCI were more likely to be prescribed OAC and TAT at discharge. 3) Complex PCI was identified as an independent risk factor for ischemic driven revascularization and MI in patients with AF. However, MACE, NACE, all-cause death and TIMI major bleeding were similar between groups divided by complexity of PCI. 4)The occurrence of MACE among participants varied according to the complexity of PCI and CHA2DS2-VASc score.

The incidence of MACE was 5.6% from the HOST-REDUCE-POLYTECH-ACS Trial among patients who underwent complex PCI [20]. This rate was similar to that observed in our study, despite the fact that our participants were diagnosed with AF. Another trial indicated that rate of NACE didn’t differ between complex PCI and non-complex PCI [21], which is consistent with our findings. Previous studies had detected patients underwent complex PCI were older and diagnosed with more cardiac-related complications [6, 22]. However, there were no statistically significant differences between groups in our study, which may be explained by the different definition of complex PCI. Besides, our study found out that patients underwent complex PCI had a higher level of peak cTnI, because of the concentration of cTnI level was related with the injured area without reperfusion [23], as well as peri-procedure myocardial injury.

It is well-established that complex PCI is associated with a higher risk of both ischemic and bleeding events [24,25,26]. To our knowledge, our research is the first one to illustrate the clinical outcomes in patients with both AF and complex PCI. Our research showed that patients who underwent complex PCI with AF were more likely to be prescribed with OAC, as well as TAT, consisting of dual antiplatelet therapy and anticoagulant. Although the most recent guidelines recommend that patients with CAD and AF should be prescribed OAC [13], in real-world clinical practice, healthcare providers often reduce the intensity of antithrombotic therapy [27], particularly in patients who require both OAC and antiplatelet therapy according to standard treatment strategies, primarily due to concerns regarding bleeding complications. In this context, concerns about ischemic events outweighed concerns about bleeding events, leading to preference for OAC therapy and TAT regimens. Nonetheless, the relatively low usage of OAC remains an unresolved issue that should be addressed in future clinical practice.

A real-word analysis revealed that complex PCI was an independent risk factor for spontaneous MI and TLF, while it wasn’t associated with stroke and all-cause death in patients without AF [28]. Another trial concentrated on patients with chronic coronary syndrome proved consistent result that complex PCI presented higher rate of primary endpoint of periprocedural MI or major myocardial injury was higher than in the population without complex PCI (45.6% vs. 26.6%; P < 0.001) [29]. Similarly, our study indicated that the impact of the complexity of PCI on coronary-related ischemic events was consistent in AF patients. However, there were no significant differences between groups in terms of MACE, stroke/TIA and all-cause death, indicating that the coronary lesion itself was the primary factor for outcomes in this population. On the other hand, complex PCI was also associated with a higher incidence of Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events (2.49% vs. 1.96%; HR: 1.28, 95% CI: 1.02–1.61; P = 0.034) in patients without AF [7] and in AF patients based on this study. Our study did not demonstrate the same tendency, which may be attributed to the limited number of major bleeding events during follow-up. Therefore, this result should be interpreted with caution.

The CHA2DS2-VASc score is a widely recognized predictive model for clinical outcomes in AF patients [30, 31]. In our analysis, we found that patients underwent complex PCI with a low CHA2DS2-VASc score (1–3), had a significantly higher rate of MACE, primarily driven by an increased risk of spontaneous MI. Unlike the aforementioned, in patients with non-complex PCI, a higher CHA2DS2-VASc score (4–9) led to a higher incidence of MACE due to a higher rate of stroke and all-cause death. This result may indicate that among patients with a low CHA2DS2-VASc score who underwent complex PCI, antiplatelet therapy should be considered initially to protect patients from MI events. For patients who underwent uncomplicated PCI, a high CHA2DS2-VASc score should remind practitioners of the importance of using anticoagulant therapy to prevent stroke events. Combining the complexity of PCI and CHA2DS2-VASc score could only distinguish several groups under high risk. Therefore, there is a need of a risk score specifically focused on patients with AF and ACS who underwent PCI. In addition, there were no differences in antithrombotic therapy between groups. This finding suggested that antithrombotic therapy in patients with a high CHA2DS2-VASc score and undergoing complex PCI may be ineffective in real-world.

This study observed divergent preferences between patients who underwent complex PCI and those who underwent non-complex PCI. Furthermore, the insufficient use of OAC highlights the need for practitioners to dynamically assess bleeding risks in order to increase the rate of OAC prescriptions in accordance with guideline recommendations. Additionally, in patients undergoing complex PCI, greater attention should be given to ischemic events related to coronary related adverse events. While the CHA2DS2-VASc score can differentiate the risk of MACE events in this population, future studies are required to develop a novel scoring system that more accurately predicts adverse events by balancing both bleeding and ischemic risks.

Limitations

Firstly, our study was limited by the lack of details of PCI procedure, including stent selection and vascular access. Secondly, we only collected data on antithrombotic therapy at discharge and did not conduct a dynamic analysis of changes over time. Thirdly, while there is currently no standardized definition of complex PCI, our study employed one of the recognized definitions. As a result, the findings may not be generalizable to a broader population. Finally, our study design was not sufficiently powered to determine whether increasing antithrombotic therapy in patients with a higher ischemic risk would result in a net clinical benefit.

Conclusion

The complexity of PCI was an independent risk factor for adverse clinical outcomes, particularly for myocardial infarction and revascularization events in patients with atrial fibrillation. However, it was not associated with major bleeding, all-cause mortality, or stroke/TIA. Antithrombotic therapy showed a preference of adding antithrombotic regimen according to the complexity of PCI in real world.

Data availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

AF:

Atrial fibrillation

BRAC:

Bleeding academic research consortium

CI:

Confidence interval

DAT:

Dual antithrombotic therapy

HR:

Hazard ratio

MACE:

Major adverse cardiovascular event

MI:

Myocardial infarction

NACE:

Net adverse clinical events

OAC:

Oral anticoagulant

PCI:

Percutaneous coronary intervention

SE:

Systemic embolism

TAT:

Triple antithrombotic therapy

TLF:

Target lesion failure

TIA:

Transient ischemic attack

TIMI:

Thrombolysis in myocardial infarction

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Acknowledgements

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Funding

This research article was supported by National Clinical Medical Research Center for Cardiovascular Diseases (NCRC2020015) and High-Level Hospital Clinical Research Funding (2022-GSP-GG-26).

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Author notes

  1. Yimeng Wang and Han Zhang contributed equally to this work.

Authors and Affiliations

  1. Emergency and Intensive Care Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases of China, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishilu, Xicheng District, Beijing, 100037, China

    Yimeng Wang, Han Zhang, Jiang-shan Tan, Lulu Wang, Jingyang Wang, Yuyuan Shu & Yanmin Yang

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  1. Yimeng Wang
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Contributions

YM Wang and H Zhang wrote the manuscript. JY Wang, JS Tan, LL Wang and YY Shu collected the data.

Corresponding author

Correspondence to Yanmin Yang.

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Ethics approval and consent to participate

The study design and protocol have been approved by the Ethics Committee of Fuwai Hospital (Approved No. 2017 − 923) and conformed to the Declaration of Helsinki. All the patients had signed informed consents to participate in this study.

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Wang, Y., Zhang, H., Tan, Js. et al. Complex versus non-complex percutaneous coronary intervention in patients with atrial fibrillation: a real-world study. BMC Cardiovasc Disord 25, 285 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12872-025-04748-y

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BMC Cardiovascular Disorders

ISSN: 1471-2261

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