The impact of routine angiographic follow-up on 3-year clinical outcomes in older patients following percutaneous coronary intervention with drug-eluting stents

doi:10.21203/rs.3.rs-4906216/v1

Objectives

This study aimed to investigate the impact of routine angiographic follow-up (RAF) on 3-year clinical outcomes in older patients (≥ 65 years) following percutaneous coronary intervention (PCI) with drug-eluting stents (DES) as compared with those of patients with clinical follow-up (CF).

Methods

This study enrolled a total of 3,147 patients aged 65 years and older, who had undergone PCI with DES. Among these patients, 1,313 (%) underwent RAF at 6–9 months post - PCI, while the remaining 1,834 patients were clinically followed. To address baseline clinical and angiographic differences between the two groups, propensity score matching (PSM) analysis was performed. The primary endpoint was major adverse cardiac events (MACE), which include cardiac death (CD), non-fatal myocardial infarction (MI), and target lesion revascularization (TLR). Additionally, we assessed the secondary endpoints that included CD, non-fatal MI, TLR, target vessel revascularization (TVR), non-target vessel revascularization (non - TVR), and stent thrombosis (ST).

Results

Following PSM, the 3-year cumulative incidence for TLR (hazard ratio [HR], 3.415; 95% confidence interval [CI], 2.120–5.500; p < 0.001), TVR (HR, 2.801; 95% CI, 1.890–4.151; p < 0.001), non-TVR (HR, 2.180; 95% CI, 1.413–3.364; p < 0.001) and MACE (HR, 2.383; 95% CI, 1.659–3.423, p < 0.001) were significantly higher in the RAF group. However, there were no significant differences observed in the incidence of CD, non-fatal MI, or ST between the two groups.

Conclusions

In older patients who underwent PCI with DES, RAF was associated with higher incidences of revascularization and MACE, despite of similar incidence of CD, non-fatal MI, or ST between the RAF and CF groups. These findings suggest that the implementation of the RAF strategy may not be necessary for older patients following PCI with DESs.

routine coronary angiography

percutaneous coronary intervention

drug-eluting stent

older patients

The impact of routine angiographic follow-up (RAF) after percutaneous coronary intervention (PCI) has been a topic of ongoing debate. A prospective, multicenter, open-label, randomized trial reported that there were no clinical benefits associated with RAF following PCI, and it even showed increased rates of early coronary revascularization within the RAF strategy ^[1]. Similarly, Yong Hoon Kim et al. found consistent results among patients with multivessel coronary artery diseases (CAD) and acute myocardial infarction (MI), respectively^{[2, 3]}. Conversely, Cristina Aurigemma et al.^[4] reported that RAF after unprotected left main PCI was associated with reduced risk of cardiac death (CD), MI, and urgent target vessel revascularization (TVR). Considering that age is a major cardiovascular risk factor, and CAD is a leading cause of death in the elderly, it is crucial to pay special attention to older patients after PCI^[5]. Compared to the younger populations, older patients often present with more complex lesions, such as calcified lesions, multi-vessel diseases and left main stenosis^[6], and their atypical symptoms can result in delayed or missed diagnoses^[7]. In light of these considerations, the most suitable follow-up method for the elderly after PCI, whether RAF or clinical follow-up (CF), remains unclear. Therefore, our study aims to compare 3-year clinical outcomes between RAF and CF in older patients who underwent PCI with drug-eluting stents (DES).

This study is a single-center, prospective, all-comer registry designed to reflect the real-world practice since 2004. Data were collected using a standardized de-identified case report form by a trained study-coordinator. The study received approval from the local ethics committee, and all subjects provided informed written consent in accordance with the ethical standards set forth in the 1964 declaration of Helsinki.

Study population

Between January 2004 and June 2021, a total of 6,760 patients underwent PCI with DES. For this study, we enrolled patients aged 65 years or older and excluded those who experienced recurrent events, including death, MI, and unplanned revascularization, within 6 months after the index PCI. Subsequently, we categorized the eligible patients into either the RAF group (n = 1,313) or the CF group (n = 1,834) based on the two different follow-up strategies. The choice of follow-up modality after the index PCI was determined by physician’s preference.

Percutaneous coronary intervention procedure and medical treatment

PCI were performed via either the femoral or radial artery following the administration of unfractionated heparin (70–100 IU/kg) to maintain an activated clotting time (ACT) above 250 seconds during the procedure. Revascularization was considered clinically indicated if the patient exhibited typical angina and/or signs of ischemia, along with ≥ 70% diameter restenosis, or if there was ≥ 70% diameter restenosis in a coronary artery as assessed by visual estimation, even in the absence of overt signs and symptoms. The decision to use cilostazol or platelet glycoprotein IIb/IIIa receptor blockers was left to the discretion of the individual operators.

A successful PCI was defined as achieving an angiographic residual stenosis of less than 30% and a final thrombolysis in myocardial infarction (TIMI) blood flow grade of 3. During hospitalization, enrolled patients received cardiovascular beneficial medications, including beta-blockers (BB), angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and lipid lowering agents. After discharge, patients were encouraged to continue the same medications they received during hospitalization. Especially dual antiplatelet therapy, which consists of aspirin (100 mg/day) and clopidogrel (75 mg/day), was recommended for at least 12 months to patients who had undergone PCI.

Study definitions and follow-up

Cardiovascular risk factors and past medical histories were recorded based on patients’ self-report. RAF was defined as a scheduled coronary angiogram at 6–9 months after index PCI. CD was defined as any death without a clear non-cardiac cause. Non-fatal MI was characterized by the presence of clinical symptoms, electrocardiographic changes, or abnormal imaging findings indicative of MI, accompanied by an increase in the creatine kinase myocardial band fraction above the upper normal limits or an increase in troponin-T/troponin-I levels exceeding the 99th percentile of the upper normal limit. Target lesion revascularization (TLR) referred to the revascularization of the target lesion caused due to restenosis or re-occlusion occurring within the stent or within 5 mm of either the distal or proximal segment. TVR was defined as the revascularization of the target vessel or any segment of the coronary artery that contains the target lesion. Non-TVR included the revascularization of any segment of the non-target coronary artery. Major adverse cardiac events (MACE) were defined as the composite of CD, non-fatal MI, and TLR. Stent thrombosis (ST) was defined according to the criteria established by the Academic Research Consortium^[8].

All participants were required to visit the cardiology outpatient department at the end of the first month and subsequently every 3 to 6 months after the index PCI procedure, in addition to seeking medical attention whenever angina-like symptoms occurred. The cumulative incidence of individual and composite endpoints over the course of 3 years was compared between the two groups.

Statistical analysis

Continuous variables were presented as mean ± SD and compared using the Mann-Whitney rank test. Categorical variables were expressed as percentages and analyzed using either Chi-square test or Fisher exact test, as appropriate. The Multifactor Cox regression was employed to assess the prognosis and propensity score matching (PSM) was performed to account for potential confounders.

The covariates adjusted in the multifactor cox regression and PSM analyses included gender (men), age, acute MI (AMI), smoking, prior MI, prior coronary artery bypass grafting (CABG), hypertension, diabetes, chronic kidney disease (CKD), ischemic stroke, creatinine, LDL cholesterol (LDL-c), total cholesterol (TC), triglyceride (TG), multivessel disease, left main disease (LM), chronic total occlusion (CTO), diffuse long lesion (> 3 cm), length of stent, diameter of stent, and post-PCI medications (aspirin, clopidogrel, prasugrel, ticagrelor, beta blockers, and statins).

Subsequently, patients in the RAF group were matched one-to-one with those in the CF group based on their propensity scores, using the nearest available pair matching method with a caliper width of 0.01. This process yielded 1,199 well-matched pairs. Kaplan-Meier analysis and univariate Cox regression were employed to access the prognosis in PSM population. For all statistical analyses, a two-sided p-value of less than 0.05 was considered statistically significant. All data were processed using SPSS (version 26.0, SPSS-PC, Inc. Chicago, Illinois).

Patient enrollment

The study enrolled a total of 3,147 patients aged 65 years or older who underwent PCI with DES, comprising 1,313 patients in the RAF group and 1,834 patients in the CF group. After performing PSM analysis, two well-matched PSM groups consisting of 1,199 pairs each (total n = 2,398) were generated (Fig. 1).

Baseline characteristics

The study enrolled a total of 3,147 patients aged 65 years or older who underwent PCI with DES, comprising 1,313 patients in the RAF group and 1,834 patients in the CF group. The baseline clinical characteristics and laboratory findings were summarized in Table 1. The mean age in the RAF group was 72.3 ± 5.4 years, while in the CF group, it was 74.0 ± 6.3 years (p < 0.001). A comparison of the baseline characteristics between the two groups revealed that the RAF group had lower proportions of patients with CKD, diabetes, and peripheral vascular disease. Additionally, the RAF group exhibited higher levels of TC, TG, and LDL-c.

Table1. Clinical characteristics and laboratory tests between the RAF and CF groups

Variables	Entire patients		p value
Variables	RAF (n=1,313)	CF (n=1,834)	p value
Men, n (%)	803 (58.3)	1,109 (58.9)	0.758
Age (years)	72.3 ± 5.4	74.0 ± 6.3	<0.001
Indication for PCI
Unstable angina, n (%)	575 (43.8)	806 (43.9)	0.931
Stable angina, n (%)	384 (29.2)	486 (26.5)	0.089
Myocardial infarction, n (%)	354 (27.0)	542 (29.6)	0.112
ST segment elevation MI, n (%)	186 (14.2)	267 (14.6)	0.757
Non-ST segment elevation MI, n (%)	167 (12.7)	275 (15.0)	0.070
Previous history
Previous PCI, n (%)	15 (1.1)	14 (0.8)	0.272
Previous CABG, n (%)	5 (0.4)	5 (0.3)	0.595
Previous MI, n (%)	8(0.6)	5 (0.3)	0.147
Hypertension, n (%)	933 (71.1)	1293 (70.5)	0.735
Diabetes, n (%)	489 (37.2)	752 (41.0)	0.033
Cerebrovascular accident, n (%)	111 (8.5)	183 (10.0)	0.147
Ischemic stroke, n (%)	90 (6.9)	154 (8.4)	0.111
Hemorrhagic stroke, n (%)	21 (1.6)	29 (1.6)	0.968
Peripheral vessel disease, n (%)	60 (4.6)	126 (6.9)	0.007
smokers, n (%)	508 (38.7)	657 (35.8)	0.101
Chronic kidney disease, n (%)	50 (3.8)	162 (8.8)	<0.001
Laboratory test
Creatinine (mg/dL)	1.01 ± 1.19	1.15 ± 1.31	0.119
HDL cholesterol (mg/L)	45.04 ± 11.04	44.41 ± 11.57	0.087
Total cholesterol (mg/L)	171.15 ± 43.49	165.70 ± 41.59	0.001
Triglyceride (mg/L)	129.38 ± 77.08	119.60 ± 65.39	0.001
LDL cholesterol (mg/L)	107.03 ± 38.18	100.55 ± 35.60	<0.001
Troponin I (ng/dL)	0.39 ± 1.32	0.34 ± 1.08	0.097

Abbreviations: RAF, routine angiographic follow-up; CF, clinical follow-up; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; HDL, high-density lipoprotein; LDL, low-density lipoprotein.

Angiographic characteristics

The RAF group showed a higher proportion of patients who received treatment for left circumflex and right coronary artery lesions, in addition to those with diffuse long lesions, bifurcation lesions, CTO lesions, ostial lesions and multi-vessel disease. Furthermore, the lengths of stents were longer and the diameters of stents were larger in the RAF group (Table 2).

Table 2. Angiographic characteristics

Variables	Entire patients		p value
Variables	RAF (n=1,313)	CF (n=1,834)	p value
Treated vessels
Left main, n (%)	73 (5.6)	80 (4.4)	0.123
Left anterior descending, n (%)	786 (59.9)	1069 (58.3)	0.376
Left circumflex, n (%)	462 (35.2)	583 (31.8)	0.046
Right coronary artery, n (%)	514 (39.1)	639 (34.8)	0.013
Ramus, n (%)	20 (1.5)	27 (1.5)	0.907
ACC/AHA lesion type
Type A, n (%)	23 (1.8)	31 (1.7)	0.896
Type B, n (%)	474 (36.1)	691 (37.7)	0.366
Type C, n (%)	816 (62.1)	1,112 (60.6)	0.390
Diffuse long lesion (>3 cm), n (%)	599 (45.6)	750 (40.9)	0.008
Left main disease, n (%)	101 (7.7)	110 (6.0)	0.061
Bifurcation lesion, n (%)	440 (33.5)	442 (24.1)	<0.001
Chronic total occlusion lesion, n (%)	116 (8.8)	109 (5.9)	0.002
Multi vessel disease, n (%)	446 (34.0)	506 (27.6)	<0.001
Ostial lesion, n (%)	286 (21.8)	311 (17.0)	0.001
Length of stent (mm)	42.15 ± 29.90	38.00 ± 26.44	<0.001
Diameter of stent (mm)	3.06 ± 0.41	3.00 ± 0.43	<0.001

Abbreviations: RAF, routine angiographic follow-up; CF, clinical follow-up; ACC/AHA, American college of cardiology/American heart association.

Post-percutaneous coronary intervention medications

Compared with the CF group, the RAF group had a higher proportion of patients prescribed oral medications, including cilostazol, ticagrelor, beta blockers, statins and ACEI after PCI (Table 3). After performing PSM analysis, two well-matched PSM groups, each consisting of 1,199 pairs (total n = 2,398) were generated. Consequently, the baseline characteristics of the two groups were balanced, as shown in Table 4, Table 5 and Table 6.

Table 3. Post-percutaneous coronary intervention medications

Variables	Entire patients		p value
Variables	RAF (n=1,313)	CF (n=1,834)	p value
Aspirin, n (%)	1,307 (99.5)	1,807 (99.6)	0.947
Clopidogrel, n (%)	1,285 (97.9)	1,786 (98.4)	0.270
Cilostazol, n (%)	412 (31.4)	468 (25.8)	0.001
Prasugrel, n (%)	31 (2.4)	39 (2.1)	0.692
Ticagrelor, n (%)	22 (1.7)	12 (0.7)	0.007
Beta blockers, n (%)	917 (69.8)	1,120 (61.7)	<0.001
ARBs, n (%)	607 (46.2)	785 (43.3)	0.098
ACEIs, n (%)	481 (36.6)	560 (30.9)	0.001
Diuretics, n (%)	428 (32.6)	608 (33.5)	0.597
Statins, n (%)	1,229 (93.6)	1,649 (90.9)	0.005

Abbreviations: RAF, routine angiographic follow-up; CF, clinical follow-up; ARBs, angiotensin receptor blockers; ACEI, angiotensin converting enzyme inhibitors.

Table 4. Clinical characteristics and laboratory findings of propensity score-matched patients

Variables	Entire patients		p value
Variables	RAF (n=1,199)	CF (n=1,199)	p value
Men, n (%)	708 (59.0)	683 (57.0)	0.301
Age (years)	72.6 ± 5.4	73.0 ± 5.8	0.213
Indication for PCI
Unstable angina, n (%)	527 (44.0)	537 (44.8)	0.681
Stable angina, n (%)	347 (28.9)	325 (27.1)	0.317
Myocardial infarction, n (%)	325 (27.1)	337 (28.1)	0.584
ST segment elevation MI, n (%)	173 (14.4)	170 (14.2)	0.861
Non-ST segment elevation MI, n (%)	151 (12.6)	167 (13.9)	0.335
Previous PCI, n (%)	10 (0.8)	13 (1.1)	0.530
Previous CABG, n (%)	4 (0.3)	3 (0.3)	0.705
Previous MI, n (%)	3 (0.3)	3 (0.3)	1.000
Hypertension, n (%)	849 (70.8)	864 (72.1)	0.498
Diabetes, n (%)	455 (37.9)	459 (38.3)	0.866
Cerebrovascular accident, n (%)	106 (8.8)	103 (8.6)	0.828
Ischemic stroke, n (%)	86 (7.2)	86 (7.2)	1.000
Hemorrhagic stroke, n (%)	20 (1.7)	17 (1.4)	0.619
Peripheral vessel disease, n (%)	59 (4.9)	56 (4.7)	0.774
smokers, n (%)	459 (38.3)	452 (37.7)	0.768
Chronic kidney disease, n (%)	50 (4.2)	57 (4.8)	0.489
Laboratory test
Creatinine (mg/dL)	1.02 ± 1.24	1.06 ± 1.20	0.620
HDL cholesterol (mg/L)	45.28 ± 11.01	44.51 ± 11.08	0.105
Total cholesterol (mg/L)	169.32 ± 42.55	170.11 ± 41.56	0.596
Triglyceride (mg/L)	124.47 ± 70.80	124.70 ± 70.71	0.861
LDL cholesterol (mg/L)	105.10 ± 36.85	105.70 ± 35.44	0.571
Troponin I (ng/dL)	0.40 ± 1.37	0.37 ± 1.15	0.374

Abbreviations: RAF, routine angiographic follow-up; CF, clinical follow-up; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; HDL, high-density lipoprotein; LDL, low-density lipoprotein.

Table 5. Angiographic characteristics of propensity score-matched patients

Variables	Entire patients		p value
Variables	RAF (n=1,199)	CF (n=1,199)	p value
Treated vessels
Left main, n (%)	50 (4.2)	52 (4.3)	0.840
Left anterior descending, n (%)	712 (59.4)	732 (61.1)	0.404
Left circumflex, n (%)	404 (33.7)	393 (32.8)	0.633
Right coronary artery, n (%)	457 (38.1)	429 (35.8)	0.236
Ramus, n (%)	17 (1.4)	19 (1.6)	0.737
ACC/AHA lesion type
Type A, n (%)	20 (1.7)	15 (1.3)	0.395
Type B, n (%)	446 (37.2)	440 (36.7)	0.800
Type C, n (%)	733 (61.1)	744 (62.1)	0.644
Diffuse long lesion (>3 cm), n (%)	517 (43.1)	540 (45.0)	0.344
Left main disease, n (%)	71 (5.9)	78 (6.5)	0.554
Bifurcation lesion, n (%)	379 (31.6)	371 (30.9)	0.725
Chronic total occlusion lesion, n (%)	87 (7.3)	85 (7.1)	0.874
Multi vessel disease, n (%)	372 (31.0)	372 (31.0)	1.000
Ostial lesion, n (%)	244 (20.4)	249 (20.8)	0.801
Length of stent (mm)	39.91 ± 27.91	40.53 ± 28.03	0.469
Diameter of stent (mm)	3.05 ± 0.41	3.05 ± 0.43	0.588

Abbreviations: RAF, routine angiographic follow-up; CF, clinical follow-up; ACC/AHA, American college of cardiology/American heart association.

Table 6. Post-percutaneous coronary intervention medications of propensity score-matched patients

Variables	Entire patients		p value
Variables	RAF (n=1,199)	CF (n=1,199)	p value
Aspirin, n (%)	1,193 (99.5)	1,193 (99.5)	1.000
Clopidogrel, n (%)	1,177 (98.2)	1,173 (97.8)	0.560
Cilostazol, n (%)	362 (30.2)	393 (32.8)	0.173
Prasugrel, n (%)	28 (2.3)	33 (2.8)	0.517
Ticagrelor, n (%)	11 (0.9)	12 (1.0)	0.834
Beta blockers, n (%)	820 (68.4)	861 (71.8)	0.067
ARBs, n (%)	555 (46.3)	514 (42.9)	0.092
ACEIs, n (%)	441 (36.8)	444 (37.0)	0.899
Diuretics, n (%)	398 (33.2)	422 (35.2)	0.302
Statin, n (%)	1,122 (93.6)	1,123 (93.7)	0.933

Abbreviations: RAF, routine angiographic follow-up; CF, clinical follow-up; ARBs, angiotensin receptor blockers; ACEI, angiotensin converting enzyme inhibitors.

Clinical outcomes

The 3-year cumulative clinical outcomes are presented in Table 7. There was no significant difference in the incidence of CD or non-fatal MI between the two groups. However, the RAF group exhibited a significantly higher incidence of repeat revascularization, including TLR, TVR, and non-TVR compared to the CF group (TLR: hazard ratio [HR], 2.992; 95% confidence interval [CI], 1.978–4.525; p < 0.001. TVR: HR, 2.592; 95% CI, 1.824–3.683; p < 0.001; non-TVR: HR, 2.302; 95% CI, 1.555–3.407; p < 0.001). Additionally, the incidence of MACE was higher in the RAF group than in the CF group (HR, 2.464; 95% CI, 1.775–3.419; p < 0.001). Consistent results were observed even after performing PSM, as depicted in Table 8. Figure 2-5 display the Kaplan-Meier analysis results of CD, non-fatal MI, TLR, and MACE up to 3 years in the PSM cohort, providing insights into the clinical outcomes between the two groups.

Table 7. Three-year follow-up outcomes

	RAF (n=1,313)	CF (n=1,834)	p value	Multivariable Cox regression
	RAF (n=1,313)	CF (n=1,834)	p value	HR (95%CI)	p value
Cardiac death, n (%)	17 (1.3)	21 (1.1)	0.705	1.370 (0.706, 2.657)	0.352
Myocardial infarction, n (%)	23 (1.8)	19 (1.0)	0.084	1.729 (0.922, 3.245)	0.088
Revascularizations, n (%)	149 (11.3)	81 (4.4)	<0.001	2.577 (1.948, 3.410)	<0.001
TLR, n (%)	79 (6.0)	35 (1.9)	<0.001	2.992 (1.978, 4.525)	<0.001
TVR, n (%)	98 (7.5)	51 (2.8)	<0.001	2.592 (1.824, 3.683)	<0.001
Non-TVR, n (%)	69 (5.3)	44 (2.4)	<0.001	2.302 (1.555, 3.407)	<0.001
MACE, n (%)	105 (8.0)	61 (3.3)	<0.001	2.464 (1.775, 3.419)	<0.001
Stent Thrombosis, n (%)	11 (0.8)	6 (0.3)	0.054	2.740 (0.865, 8.683)	0.087

Abbreviations: RAF, routine angiographic follow-up; CF, clinical follow-up; CI, confidence interval; TLR, target lesion revascularization; TVR, target vessel revascularization; MACE, major adverse cardiovascular events.

Table 8. Three-year follow-up outcomes of propensity score-matched patients

	RAF (n=1199)	CF (n=1199)	P value	Univariate cox regression
	RAF (n=1199)	CF (n=1199)	P value	HR (95% CI)	p value
Cardiac death, n (%)	16 (1.3)	16 (1.3)	1.000	0.997 (0.499, 1.995)	0.994
Myocardial infarction, n (%)	21 (1.8)	16 (1.3)	0.407	1.314 (0.686, 2.518)	0.408
Revascularizations, n (%)	138 (11.5)	54 (4.5)	<0.001	2.692 (1.965, 3.687)	<0.001
TLR, n (%)	73 (6.1)	22 (1.8)	<0.001	3.415 (2.120, 5.500)	<0.001
TVR, n (%)	92 (7.7)	34 (2.8)	<0.001	2.801 (1.890, 4.151)	<0.001
Non-TVR, n (%)	64 (5.3)	30 (2.5)	<0.001	2.180 (1.413, 3.364)	<0.001
MACE, n (%)	97 (8.1)	42 (3.5)	<0.001	2.383 (1.659, 3.423)	<0.001
Stent Thrombosis, n (%)	9 (0.8)	3 (0.3)	0.082	3.006 (0.814, 11.103)	0.076

Abbreviations: RAF, routine angiographic follow-up; CF, clinical follow-up; CI, confidence interval; TLR, target lesion revascularization; TVR, target vessel revascularization; MACE, major adverse cardiovascular events.

The main findings of our study showed that the RAF strategy for elderly patients after PCI with DES was associated with higher incidences of revascularization, including TLR, TVR, non-TVR, and MACE, when compared to the CF strategy. However, no significant differences were observed in the incidence of CD, non-fata MI or ST between the RAF and CF groups.

Restenosis remains a significant concern after PCI, occurring in approximately 10% to 30% of patients treated with bare metal stents (BMS) and 5% to 15% of patients treated with DES^[9]. The use of RAF was common practiced back in the 1990s to identify angiographically significant restenosis^[10]. However, the potential of RAF to improve patient prognosis has been a topic of ongoing debate^[3,11,12]. Presently, U.S. and European guidelines recommend clinical follow-up after PCI, with angiography reserved for patients who exhibit recurrent symptoms or objective evidence of myocardial ischemia^[13,14]. Furthermore, considering that age is a major cardiovascular risk factor and that coronary lesions in older patients tend to be more complex, it is essential to explore the necessity of RAF for older individuals after PCI, particularly to prevent sudden CD.

Based on our findings, the RAF group exhibited a higher incidence of revascularization, which aligns with previous research results ^[2,3]. The higher incidence of revascularization observed after follow-up angiography can be attributed to the operator’s decision to perform repeat PCI based on ‘oculo-stenotic or oculo-occlusive reflex’, despite the absence of atypical symptom in patients. Additionally, the higher incidence of TVR was related to a higher tendency to treat even intermediate stenotic lesions (40%–70% stenosis as assessed by quantitative angiography), which typically regress within 2 to 5 years^[15]. While restenosis and ST were common contributor to TLR in general. However, the incidence of ST was relatively low in our study (0.9% vs 0.5%). This may be attributed to limitations inherent in a single-center study and the relatively large proportion of patients with one-vessel disease.

Despite the higher incidence of revascularization in the RAF group, we observed no significant differences in the incidence of CD or non-fatal MI between the two groups. It is essential to note that clinical restenosis and angiographic restenosis do not always coincide, as stenotic lesions may not consistently cause sufficient compromise of the lumen area to induce ischemic symptoms. Repeated revascularization in asymptomatic and ischemia-free patients may not necessarily lead to a reduction in myocardial infarction or cardiovascular mortality^[16,17]. These results were consistent with previous reports by Yong Hoon Kim et al, who observed similar outcomes from our PCI registry among patients with multivessel CAD, AMI and diabetes, respectively^[2,3,18].

This study had several limitations. First, it employed a non-randomized design and was conducted at a single center study. Second, despite utilizing multifactorial Cox regression and PSM to adjust for potential confounders, some important variables may have been overlooked. Third, the follow-up strategy was determined at the discretion of individual physicians, which may introduce selection bias.

In conclusion, our study indicated that RAF at 6 to 9 months for older patients following PCI with DES was associated with higher incidences of revascularization including TLR, TVR, non-TVR, and MACE without significant differences in the incidence of CD, non-fatal MI or ST. Consequently, a mid-term RAF strategy for older patients (≥ 65 years) may not be necessary following PCI with DES.

Acknowledgements

This work was funded by Tianjin Key Medical Discipline (Specialty) Construction Project (TJYXZDXK-029A) and Key project of Tianjin Natural Science Foundation(21JCZDJC01080).

Author contributions

Study conception and design:Su-Tao Hu and Kang-Yin Chen; data collection: Su Jin Hyun, Jin Ah Cha, Se Yeon Choi, Soohyung Park, Cheol Ung Choi, Dong Joo Oh and Byoung Geol Choi; analysis and interpretation of results: Su-Tao Hu, Jing-Kun Zhang and Xue Wu; draft manuscript preparation: Su-Tao Hu, Xian Shao, Xing Liu, Kang-Yin Chen and Seung-Woon Rha. All authors reviewed the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Data availability

Data are available by contacting the corresponding author on reasonable requests.

Competing interests

The authors declare no competing interests.

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No competing interests reported.

The impact of routine angiographic follow-up on 3-year clinical outcomes in older patients following percutaneous coronary intervention with drug-eluting stents

Status:

Version 1

Abstract

Objectives

Methods

Results

Conclusions

Figures

Introductions

Methods

Study population

Percutaneous coronary intervention procedure and medical treatment

Study definitions and follow-up

Statistical analysis

Results

Patient enrollment

Baseline characteristics

Discussion

Conclusions

Declarations

References

Additional Declarations

Status:

Version 1