Impact of Side Branch Lesion Length on Clinical Outcome after Coronary Stenting Techniques in Patients with Coronary Artery Bifurcation Disease: A Meta-Analysis : Cardiology Discovery

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Special Issue for Coronary Bifurcation Lesions, Guest Editor, Shaoliang Chen: Meta Analysis

Impact of Side Branch Lesion Length on Clinical Outcome after Coronary Stenting Techniques in Patients with Coronary Artery Bifurcation Disease: A Meta-Analysis

Kan, Junyan1,2; Luo, Shuai2; Wang, Dongchen2; Cai, Dandan2; Zhang, Xiaojuan2; Kan, Jing2,*

Author Information
doi: 10.1097/CD9.0000000000000066

Abstract

CLINICAL PERSPECTIVE

WHAT IS NEW?

  • Provisional stenting remains the main technique for simple coronary bifurcation lesions. In a pooled analysis and sub-group analysis, 2-stent techniques (mostly double-kissing crush) resulted in significant improvement in 1-year target lesion revascularization and myocardial infarction rates compared to provisional stenting in patients with complex bifurcation lesions defined by a side branch lesion length >10 mm.

WHAT ARE THE CLINICAL IMPLICATIONS?

  • A 2-stent approach was associated with fewer target lesion revascularization and myocardial infarction cases than provisional stenting in patients with long side branch lesions.
  • Further clinical trials are warranted to identify the treatment effect on clinical outcome among different upfront 2-stent strategies.

Introduction

Among epicardial coronary stenosis cases, 1 in 5 patients present with bifurcation lesions.[1] Percutaneous coronary intervention (PCI) therapy is preferred for bifurcation lesions despite it being technically challenging and leading to a worse prognosis in contrast to when it is used for non-bifurcation lesions.[2] Even with standard dual anti-platelet therapy (DAPT), the long-term outcomes are often unsatisfactory, owing to target lesion state deterioration.[3] As such, bifurcation PCI technique selection is controversial for patients with coronary bifurcation disease, requiring comprehensive consideration of numerous clinical factors.

Although several clinical trials comparing bifurcation PCI techniques have been conducted, the best choice is still a matter of debate. Currently, provisional stenting (PS) is recognized as effective in most bifurcation cases, superior to the more complex 2-stent techniques.[4] Recent randomized controlled trials have proposed a PS strategy integrating the procedure time, X-ray dose, and consumables.[5] However, 2-stent approaches, such as double-kissing (DK) crush, have shown advantages in complex left main distal bifurcation lesions, significantly reducing the rate of target lesion failure.[6] The widely used Medina classification depicts the existence of lesions in the proximal main vessel, distal main branch, and side branch (SB), neglecting the anatomic variability and complexity of bifurcation lesions.[7] However, parameters such as the lesion length and diameter of the SB could have a significant impact on technique selection and major cardiac events (MACEs).[8,9]

In this meta-analysis, we reviewed existing randomized controlled trials comparing clinical outcomes after PCI with bifurcation lesions, providing evidence for bifurcation PCI technique selection and its influencing factors.

Methods

Search strategy

The current meta-analysis study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.[10] Two individual reviewers precisely searched the PubMed, Cochrane, Web of Science, and EBSCO literature databases for studies assessing outcomes after PCI in bifurcation cases. The search terms “PCI,” “bifurcation,” and “random” were jointly used for paper retrieval on February 4, 2022. No language, sample size, or date of publishing limitation was applied. The complete search formula deployed in PubMed was as follows: random AND (coronary AND bifurcation AND (stenting OR PCI)) AND ((single stent) OR (one stent) OR (1 stent) OR (complex stent) OR (2 stent) OR (two stent) OR complex OR simple OR (double stent) OR provisional OR (T stenting) OR TAP OR crush OR DK crush OR mini-crush OR culotte OR (V stenting) OR (Y stenting)). Studies retrieved by both reviewers were preliminarily included. Disagreements about literature search results were judged by a third reviewer.

Study selection

Studies meeting the following criteria were regarded as eligible for inclusion: (1) randomized controlled trials with ≥2 arms; (2) participants underwent PCI for bifurcation lesions; and (3) follow-up was >6 months with quantitative outcome indicators. In the case of multicenter studies reported by different institutions that used the same study population, we prioritized the latest version. Participants with chronic total occlusion were defined as the exclusion standard.

Two independent investigators completed study selection by reviewing study titles and abstracts. Divergences were resolved by a third investigator. Studies that fulfilled inclusion criteria were retrieved for full-text review and retained for further inspection. Finally, studies with complete ethnology and bifurcation PCI technique information were included for meta-analysis.

Data extraction

We extracted the following data from the included studies: the last name of the first author, publication year, multicenter or single-center study, PCI technique used, sample size among techniques, drug-eluting stent (DES) generation, follow-up duration, mean duration of DAPT, percentages of patients with acute coronary syndrome and intracoronary imaging, crossover between techniques, baseline cardiovascular risk profile (mean age for each sex; ratio of male patients; percentages with smoking, diabetes mellitus, hypertension, and hyperlipidemia; family history of coronary artery disease), previous myocardial infarction (MI), previous PCI, stable angina, left ventricular ejection fraction (LVEF), location of treated bifurcation (left main coronary artery (LMCA), left anterior descending artery, left circumflex artery, or right coronary artery), count and percentage of true bifurcation, Medina classification, lesions with calcification, severe tortuosity, the use of final kissing balloon, procedural success, and mean lesion length in the main branch and SB. Contiguous variables were extracted and calculated from tables, quantitative figures, or exact text descriptions and kept to the decimal point. The percentage of categorical variables was kept to 1 digit.

Recorded bifurcation PCI techniques were classified as 1-stent or 2-stent for pairwise meta-analysis in general. The 1-stent technique was referred to the PS strategy, which is also described as simple stenting. Two-stent techniques included crush, DK crush, T-stenting/T and protrusion (T/TAP), and Culotte approaches were recorded as “complex stenting” or “systematic stenting” in a few studies.

MACEs defined by every single study were regarded as the primary outcomes of our work. Through aggregating the included studies, we deemed MACEs to be a combination of all-cause death, cardiovascular death, target vessel revascularization (TVR), target lesion revascularization (TLR), MI, and probable or definite stent thrombosis (ST). Outcomes were affirmed according to the included study protocol. Endpoint data were extracted by the longest follow-up duration.

Statistical analysis

The correlation between PCI techniques with MACEs and the fine-sorted 6 secondary outcomes was assessed. We analyzed the proportion of participants achieving MACEs, all-cause death, cardiovascular death, TVR, TLR, MI, and ST after bifurcation PCI as binary variables, calculating the relative risk (RR) and 95% confidence interval (CI) values. Sub-group analyses for the same outcomes were performed depending on the SB lesion length.

We employed the R software (version 4.0.2; R Foundation for Statistical Computing, Vienna, Austria) for the integral statistical analysis procedure and the “meta” package was used for construction and visualization of meta-analysis models. Both a fixed-effects model (Mantel-Haenszel method) and a random-effects model (DerSimonian-Laird method) were constructed and used to evaluate potential variability among the study populations. We used the statistic Cochrane Q test to estimate between-study heterogeneity. I2 testing was also employed to assess the degree of heterogeneity with a moderate-to-high boundary value of 50%. The risk of bias for every single trial was estimated in accordance with the Cochrane risk-of-bias tool. We measured possible publication bias by means of a funnel plot, weighing the capacity of a trial’s effect size against the standard error. Begg and Egger tests were applied to assess funnel plot asymmetry, and significant publication bias was recognized if P < 0.1. We further estimated possible publication bias with the trim-and-fill method and framed the corresponding funnel plots after adjustment. To investigate the source of heterogeneity among included studies, we conducted a meta-regression with publication year, SB lesion length, and generation of DES as covariables, respectively.

Results

Study characteristics

We identified 908 studies, of which 23 were ultimately considered eligible for inclusion.[5,6,11–31] The search strategy and exclusion reasons are shown as a flowchart in Figure 1, and the characteristics of included studies are presented in Table 1.[5,6,11–31] The total 23 trials were published from 2004 to 2021. Patients received DAPT ranging from 3 to 12 months and were followed up for a median of 12 months (range, 6–60 months). Five trials compared specific 2-stent approaches.[12,14,18,19,26] All 23 studies declared adequate randomization, and 14 were multicenter investigations.

Table 1 - Design and characteristics of studies included in the meta-analysis.
Study Interventions Number of centers Sample size DES generation Follow-up duration (month) Mean duration of DAPT (month) ACS, % Intracoronary imaging use, % Crossover
Pan et al[25] 2004 PS Multi-centered 47 First 6 12 88 ND 2% crossed from PS to T/TAP
T/TAP 44 9% crossed from T/TAP to PS
Colombo et al[21] 2004 PS Multi-centered 23 First 6 3 17 100 4.7% crossed from T/TAP to PS
T/TAP 63 51.2% crossed from PS to T/TAP
DK-Crush I[26] 2008 Crush Multi-centered 156 First 8 12 85.8 ND 0 crossed from crush to DK crush
DK crush 155 0 crossed from DK crush to crush
CACTUS[27] 2009 Crush Multi-centered 177 First 6 6 46 ND 31% crossed from PS to crush
PS 173 0 crossed from crush to PS
Ye et al[28] 2010 DK Single-centered 25 First 8 ≥12 86 ND 0 crossed from crush to DK crush
PS 26 0 crossed from DK crush to crush
Lin et al[30] 2010 PS Single-centered 54 First 8 12 42 ND 16.7% crossed from PS to 2-stent
2-stent 54 5.6% crossed from 2-stent to PS
Hildick-Smith et al[29] 2010 PS Multi-centered 250 First 9 9 34 ND 2.8% crossed from PS to 2-stent
2-stent 250 3.6% crossed from 2-stent to PS
Ye et al[31] 2012 DK crush Single-centered 38 First 12 12 68 ND 0 crossed from DK crush to PS
PS 30 0 crossed from PS to DK crush
NSTS[12] 2013 Crush Single-centered 209 First 36 6–12 22.87 ND 0 crossed from crush to Culotte
left 215 0 crossed from Culotte to crush
NBS[11] 2013 PS Multi-centered 202 First 60 6–12 16 ND 0 crossed from PS to 2-stent
2-stent 202 0 crossed from 2-stent to PS
RuizSalmerón et al[13] 2013 PS Single-centered 33 Second 9 12 ND ND 9.1% crossed from PS to 2-stent
T-stenting 36 25% crossed from 2-stent to PS
Dk-CrushⅢ[14] 2015 DK crush Multi-centered 210 Second 36 12 90.2 71.4 0 crossed from Dk crush to Culotte
left 209 0 crossed from Culotte to DK crush
BBK I[15] 2015 PS Single-centered 101 First 60 6 0 ND 18.8% crossed from PS to T-stenting
T-stenting 101 3.0% crossed from T-stenting to PS
PERFECT[16] 2015 Crush Multi-centered 213 First and second 12 12 38.4 95.7 0.5% crossed from crush to PS
PS 206 25.9% crossed from PS to crush
Zhang et al[20] 2016 left Single-centered 52 First and second 9 12 66.4 ND 3.8% crossed from PS to 2-stent
PS 52 0 crossed from 2-stent to PS
Hildick-Smith et al[17] 2016 left Multi-centered 97 Second 12 12 31.5 ND 16% crossed from PS to 2-stent (T-stenting)
PS 103 2% crossed from 2-stent to PS
BBK II[19] 2016 left Single-centered 150 First and second 12 Clopidogrel 6 20 ND 0.7% crossed from TAP to Culotte
TAP 150 Prasugrel or ticagrelor 12 0 crossed from Culotte to TAP
Zheng et al[18] 2016 Crush Single-centered 150 NA 12 12 91.4 ND ND
left 150
DK-Crush II[22] 2017 DK crush Multi-centered 183 First 60 12 84 47 28% crossed from PS to 2-stent
PS 183 0 crossed from 2-stent to PS
Dk-Crush V[23] 2019 DK crush Multi-centered 240 Second 36 12 72.2 41 47.1% crossed from PS to 2-stent
PS 242 0 crossed from 2-stent to PS
NBBS IV[24] 2020 PS Multi-centered 218 First and second 24 12 14.8 ND 3.7% crossed from PS to 2-stent
2-stent 228 4% crossed from 2-stent to PS
DEFINITION II[6] 2020 PS Multi-centered 325 First and second 12 12 72 27.7 22.5% crossed from PS to 2-stent
2-stent 328 7.9% crossed from 2-stent to PS
EBC Main[5] 2021 PS Multi-centered 230 Second 12 Aspirin Long-term 37 33 22% crossed from PS to 2-stent
2-stent 237 Clopidogrel, prasugrel, or ticagrelor 6 5% crossed from 2-stent to PS
ACS: Acute coronary syndrome; BBK: Bifurcations Bad Krozingen; CACTUS: Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents; DAPT: Dual anti-platelet therapy; DEFINITION II: Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes after Percutaneous Coronary Intervention Using Drug-Eluting Stents; DES: Drug-eluting stent; DK: Double-kissing; EBC: European Bifurcation Club; NA: Not available; NBBS IV: Nordic-Baltic Bifurcation Study IV; NBS: Nordic Bifurcation Study; ND: Not declared; NSTS: Nordic Stent Technique Strategy; PERFECT: Optimal Stenting Strategy for True Bifurcation Lesions; PS: Provisional stenting; T: T-stenting; TAP: T and protrusion.

F1
Figure 1::
Flowchart of the search strategy for studies.

Baseline and procedural characteristics

The 23 included studies involved a total of 6830 participants with coronary bifurcation lesions treated by PCI. Table 2[5,6,11–31] profiles the baseline characteristics of the study population in all 23 trials. Most studies did not report a significant difference between groups in the composition of participants’ age or sex. Risk factors such as smoking history, complications, and family history were reported, but none of the trials showed a notable difference. Considering symptom status, the existence of stable angina before PCI was recorded, whereas inconsistency in baseline stable angina status of patients appeared across studies. In addition, the mean LVEFs of participants were all >50% across reported trials. Procedural details and angiographic characteristics are shown in Table 3,[5,6,11–31] revealing a wide variance in main branch and SB lesion lengths among trials.

Table 2 - Baseline characteristics of the study populations.
Study Interventions Sample size Age (years), mean ± SD Male sex, n (%) Smoking, n (%) DM, n (%) HTN, n (%) HLP, n (%) Family history of CAD Previous MI, n (%) Previous PCI, n (%) Stable angina, n (%) LVEF (%), mean ± SD
Pan et al[25] 2004 PS 47 61 ± 10 34 (72) 18 (38) 20 (42) 28 (59) 25 (53) ND 9 (19) ND ND 60 ± 11
T/TAP 44 58 ± 11 38 (86) 23 (52) 17 (39) 25 (57) 18 (41) 17 (39) 55 ± 11
Colombo et al[21] 2004 PS 23 62 ± 9 21 (91) ND 6 (26) ND ND ND ND ND 19 (83) 59 ± 9
T/TAP 63 63 ± 10 48 (76) 13 (21) 52 (82) 59 ± 10
DK-Crush I[26] 2008 Crush 156 64 ± 9 109 (70) 98 (63) 13 (8) 119 (77) 98 (63) ND 19 (12) 17 (11) 47 (30) 63 ± 13
DK crush 155 64 ± 9 118 (76) 99 (64) 42 (27) 118 (76) 106 (69) 13 (9) 18 (11) 45 (31) 62 ± 11
CACTUS[27] 2009 Crush 177 65 ± 10 142 (80) 36 (20) 42 (24) 125 (71) 113 (64) 83 (47) 79 (45) 55 (31) 86 (49) 55 ± 9
PS 173 67 ± 10 132 (76) 29 (17) 38 (22) 138 (80) 122 (70) 62 (36) 61 (35) 46 (27) 86 (50) 57 ± 8
Ye et al[28] 2010 DK 25 64 ± 11 16 (64) ND 4 (16) 19 (73) 3 (11) ND ND ND 6 (23) 57 ± 10
PS 26 63 ± 10 19 (73) 5 (19) 19 (76) 4 (16) 1 (4) 59 ± 10
Lin et al[30] 2010 PS 54 61 ± 7 45 (83) 16 (30) 10 (18) 49 (91) ND ND 12 (22) 13 (24) 31 (57) 56 ± 6
2-stent 54 59 ± 7 41 (76) 13 (24) 7 (13) 45 (83) 10 (18) 13 (24) 32 (59) 57 ± 6
Hildick-Smith et al[29] 2010 PS 250 64 ± 10 192 (77) 42 (17) 31 (13) 142 (57) 188 (76) 104 (42) 57 (23) 42 (17) ND ND
2-stent 250 64 ± 11 193 (77) 43 (17) 28 (11) 154 (62) 189 (76) 103 (41) 63 (25) 40 (16)
Ye et al[31] 2012 DK crush 38 63 ± 10 24 (63) ND 7 (18) 29 (76) 7 (18) ND 4 (10) ND 11 (29) 61 ± 10
PS 30 62 ± 9 23 (77) 4 (13) 20 (67) 6 (20) 2 (7) 11 (37) 64 ± 6
NSTS[12] 2013 Crush 209 65 ± 10 149 (71) 42 (20) 28 (13) 130 (62) 176 (84) 118 (57) ND 84 (40) 164 (80) 57 ± 11
left 215 65 ± 11 154 (71) 58 (27) 31 (15) 129 (60) 159 (74) 134 (62) 72 (34) 161 (75) 57 ± 12
NBS[11] 2013 PS 202 63 ± 10 159 (77) 57 (28) 27 (13) 110 (53) 161 (78) 119 (58) ND 52 (25) 139 (67) 58 ± 11
2-stent 202 63 ± 10 162 (79) 48 (23) 24 (12) 119 (58) 149 (73) 111 (54) 53 (26) 136 (66) 58 ± 10
RuizSalmerón et al[13] 2013 PS 33 63 ± 13 28 (85) 20 (61) 15 (45) 22 (67) 17 (51) ND ND 7 (21) 33 (100) ND
T-stenting 36 64 ± 13 28 (78) 18 (50) 12 (33) 26 (72) 23 (64) 9 (25) 36 (100)
Dk-Crush III[14] 2015 DK crush 210 64 ± 10 162 (77) 58 (28) 67 (32) 148 (70) 87 (41) ND 32 (15) 47 (22) 27 (13) 59 ± 11
left 209 63 ± 9 167 (80) 54 (26) 63 (30) 128 (61) 88 (42) 29 (14) 31 (15) 23 (11) 59 ± 11
BBK I[15] 2015 PS 101 67 ± 9 80 (79) ND 26 (26) 93 (92) ND ND 19 (19) 45 (45) 101 (100) 59 (12)
T-stenting 101 67 ± 10 79 (78) 19 (19) 90 (89) 21 (21) 52 (51) 101 (100) 61 (12)
PERFECT[16] 2015 Crush 213 61 ± 9 160 (75) 54 (25) 55 (26) 118 (55) 132 (62) 30 (14) 9 (4) 20 (9) 130 (61) 60 ± 7
PS 206 61 ± 9 155 (75) 67 (32) 60 (29) 114 (55) 118 (57) 26 (13) 9 (4) 11 (5) 127 (62) 59 ± 7
Zhang et al[20] 2016 left 52 64 ± 7 43 (83) 27 (52) 11 (21) 33 (63) 6 (11) ND 10 (19) 12 (23) 20 (38) ND
PS 52 64 ± 11 48 (92) 31 (60) 10 (19) 35 (67) 6 (11) 12 (23) 13 (25) 15 (29)
Hildick-Smith et al[17] 2016 left 97 63 ± 12 76 (78) 49 (50) 30 (31) 66 (68) 70 (70) 48 (49) 40 (41) 40 (41) 66 (68) ND
PS 103 63 ± 11 87 (85) 58 (56) 26 (25) 65 (63) 72 (70) 49 (48) 40 (39) 41 (40) 71 (69)
BBK II[19] 2016 left 150 66 ± 11 107 (71) 17 (11) 41 (27) 132 (88) ND 61 (41) 24 (16) 57 (38) 118 (78) 56 ± 7
TAP 150 69 ± 10 114 (76) 17 (11) 42 (28) 128 (85) 59 (39) 32 (21) 48 (32) 121 (81) 57 ± 6
Zheng et al[18] 2016 Crush 150 63 ± 8 109 (73) 58 (39) 33 (22) 106 (71) 114 (76) 45 (30) ND 40 (27) 26 (17) ND
left 150 64 ± 9 111 (74) 67 (45) 37 (25) 109 (73) 105 (70) 52 (35) 34 (23) 21 (14)
DK-Crush II[22] 2017 DK crush 183 64 ± 11 145 (79) 57 (31) 36 (20) 120 (65) 62 (34) ND 32 (17) 39 (21) 32 (15) ND
PS 183 65 ± 10 138 (76) 44 (24) 42 (23) 111 (61) 53 (29) 24 (14) 38 (21) 27 (15)
Dk-Crush V[23] 2019 DK crush 240 65 ± 9 199 (83) 78 (32) 69 (29) 175 (73) 114 (47) ND 52 (22) 33 (14) 41 (17) 59 ± 9
PS 242 64 ± 10 188 (78) 82 (34) 62 (26) 156 (64) 115 (47) 51 (21) 43 (18) 36 (14) 60 ± 9
NBBS IV[24] 2020 PS 218 64 ± 12 ND 42 (19) 36 (16) 155 (70) 181 (82) 112 (51) ND 78 (35) ND ND
2-stent 228 63 ± 11 48 (21) 35 (15) 150 (66) 186 (81) 109 (47) 77 (33)
DEFINITION II[6] 2020 PS 325 64 ± 10 250 (77) 98 (30) 116 (36) 230 (70) 223 (69) ND 42 (13) 54 (17) 71 (22) 60 ± 10
2-stent 328 63 ± 11 255 (78) 93 (28) 112 (34) 215 (66) 227 (69) 39 (12) 65 (20) 79 (24) 59 ± 10
EBC Main[5] 2021 PS 230 71 ± 10 182 (79) 36 (16) 66 (29) 180 (79) 158 (70) 74 (33) 60 (26) 93 (41) 149 (66) ND
2-stent 237 71 ± 10 177 (74) 30 (13) 62 (27) 190 (82) 166 (72) 75 (33) 66 (28) 99 (43) 139 (60)
Data are presented for each arm. BBK: Bifurcations Bad Krozingen; CACTUS: Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents; CAD: Coronary artery disease; DEFINITION II: Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents; DM: Diabetes mellitus; EBC: European Bifurcation Club; HLP: Hyperlipidemia; HTN: Hypertension; LVEF: Left ventricular ejection fraction; MI: Myocardial infarction; NBBS IV: Nordic-Baltic Bifurcation Study IV; NBS: Nordic Bifurcation Study; ND: Not declared; NSTS: Nordic Stent Technique Strategy; PCI: Percutaneous coronary intervention; PERFECT: Optimal Stenting Strategy for True Bifurcation Lesions; PS: Provisional stenting; SD: Standard deviation; T: T-stenting; TAP: T and protrusion.

Table 3 - Procedural details and angiographic characteristics.
Study Interventions Bifurcation treated, n (%)* True Bifurcation, n (%)* Medina, n (%) Calcification, n (%)* Severe tortuosity, n (%)* MB lesion length (mm), mean ± SD SB lesion length (mm), mean ± SD Final KB, n (%)* Procedural success, n (%)*
LMCA LAD LCX RCA 1,1,1 1,0,1 0,1,1
Pan et al[25]2004 PS 3 (6) 33 (71) 8 (17) 3 (6) 47 (100) ND ND ND ND ND ND ND 28 (60) 44 (94)
T/TAP 2 (5) 33 (75) 6 (13) 3 (7) 44 (100) 34 (77) 43 (97)
Colombo et al[21] 2004 PS 0 (0) 64 (74) 15 (17) 7 (8) 22 (100) ND ND ND ND ND ND ND 18 (82) 17 (77)
T/TAP 0 (0) 63 (100) 57 (90) 58 (92)
DK-Crush I[26] 2008 Crush (16) (62) (14) (8) (100) ND ND ND 0 (0) 20 (12) 20.0 ± 9.0 10.5 ± 7.5 124 (76) (91)
DK (15) (66) (11) (8) (100) 1 (1) 14 (9) 21.3 ± 11.3 10.3 ± 6.3 161 (100) (92)
CACTUS[27] 2009 Crush 0 (0) 131 (74) 34 (19) 12 (7) 328 (94) OA 262 (75) 10 (3) 56 (16) ND ND 15.8 ± 8.7 5.9 ± 4.7 163 (92) 160 (90)
PS 0 (0) 121 (70) 43 (25) 9 (5) 14.7 ± 8.2 5.7 ± 4.2 156 (90) 158 (91)
Ye et al[28] 2010 DK ND ND ND ND 25 (100) ND ND ND ND ND 29.3 ± 8.3 17.1 ± 8.0 25 (100) 25 (100)
PS 26 (100) 25.3 ± 7.7 11.5 ± 6.9 ND 26 (100)
Lin et al[30] 2010 PS 0 (0) 45 (83) 5 (9) 4 (7) 54 (100) 26 (48) 9 (17) 19 (35) 14 (26) ND 23.8 ± 2.6 12.9 ± 3.1 51 (94) ND
2-stent 0 (0) 43 (80) 6 (11) 5 (9) 54 (100) 23 (43) 13 (24) 18 (33) 15 (28) 23.6 ± 2.1 12.7 ± 2.8 49 (91)
Hildick-Smith et al[29] 2010 PS 0 (0) 201 (81) 35 (14) 9 (4) 202 (81) 150 (60) 19 (8) 33 (13) 21 (8) 25 (10) ND ND 72 (29) 235 (94)
2-stent 0 (0) 209 (84) 28 (11) 12 (5) 209 (84) 149 (60) 26 (10) 34 (14) 28 (11) 27 (11) 189 (76) 234 (94)
Ye et al[31] 2012 DK 0 (0) (78) OA (15) OA (7) OA 38 (100) (80) OA 0 (0) OA (20) OA 0 (0) ND 28.9 ± 11.1 16.9 ± 8.2 38 (100) 38 (100)
PS 0 (0) 37 (100) 0 (0) 25.5 ± 11.1 10.2 ± 8.4 26 (87) 37 (100)
NSTS[12] 2013 Crush 20 (10) 132 (63) 42 (20) 15 (7) 153 (73) ND ND ND (27) OA (6) OA 17.4 ± 10.3 7.3 ± 5.8 177 (85) 205 (98)
Culotte 21 (10) 142 (66) 43 (20) 9 (4) 177 (82) 17.4 ± 10.1 7.5 ± 6.0 197 (92) 210 (98)
NBS[11] 2013 PS (2) OA (73) OA (18) OA (7) OA ND ND ND ND (60) (4) 16 (12-24) 5 (3-8) 65 (32) 200 (97)
2-stent (47) (8) 16 (12-20) 5 (4-8) 152 (74) 194 (97)
Ruiz-Salmerón et al[13] 2013 PS 0 (0) 24 (71) 9 (26) 1 (3) 27 (79) 24 (71) 3 (9) 0 (0) ND ND ND ND 14 (42) 34 (100)
T-stenting 0 (0) 26 (72) 6 (17) 4 (11) 33 (92) 29 (81) 3 (8) 1 (3) 23 (64) 34 (94)
Dk-Crush III[14] 2015 DK 210 (100) 0 (0) 0 (0) 0 (0) 210 (100) 207 (99) 0 (0) 3 (1) ND 63 (30) ND ND 209 (99) 203 (97)
Culotte 209 (100) 0 (0) 0 (0) 0 (0) 209 (100) 198 (95) 0 (0) 11 (5) 73 (35) 208 (99) 201 (96)
BBK I[15] 2015 PS 0 (0) 76 (75) 16 (16) 9 (9) 69 (69) 36 (36) 8 (8) 25 (25) 0 (0) 0 (0) ND ND 101 (100) ND
T-stenting 0 (0) 74 (73) 21 (21) 6 (6) 69 (69) 31 (31) 6 (6) 32 (32) 0 (0) 0 (0) 101 (100)
PERFECT[16] 2015 Crush 0 (0) 200 (94) 10 (5) 3 (1) 194 (91) 137 (66) 18 (9) 39 (19) 25 (12) 0 (0) 28.9 ± 14.6 10.3 ± 8.2 ND ND
PS 0 (0) 190 (92) 15 (7) 1 (0) 169 (82) 126 (62) 18 (9) 25 (12) 25 (12) 0 (0) 27.8 ± 13.1 8.3 ± 7.3
Zhang et al[20] 2016 left 14 (27) 34 (65) 2 (4) 2 (4) 52 (100) 34 (65) 7 (14) 11 (21) 3 (6) 9 (17) 15.8 ± 8.6 14.1 ± 7.1 48 (92) 51 (98)
PS 16 (31) 33 (63) 3 (6) 0 (0) 52 (100) 30 (58) 6 (11) 16 (31) 5 (10) 11 (21) 14.7 ± 7.7 12.8 ± 4.9 43 (83) 48 (92)
Hildick-Smith et al[17] 2016 left 0 (0) 75 (77) 18 (19) 4 (4) 97 (100) 66 (68) 7 (7) 23 (24) 17 (17) 15 (15) 18 ± 8.8 10.8 ± 7.3 93 (96) 95 (98)
PS 0 (0) 80 (78) 16 (15) 6 (6) 103 (100) 83 (81) 6 (6) 12 (12) 20 (19) 10 (10) 18 ± 6.7 9.7 ± 7.1 97 (94) 100 (97)
BBK II[19] 2016 left 28 (19) 82 (55) 36 (24) 4 (3) 147 (98) 101 (67) 12 (8) 34 (23) 0 (0) 0 (0) 23.9 ± 7.6 13.8 ± 6.6 150 (100) 150 (100)
TAP 23 (15) 83 (55) 38 (25) 6 (4) 143 (95) 99 (66) 12 (8) 32 (21) 0 (0) 0 (0) 22.7 ± 7.3 15.5 ± 6.9 150 (100) 148 (99)
Zheng et al[18] 2016 Crush 13 (9) 96 (64) 35 (23) 6 (4) 150 (100) 109 (73) 27 (18) 14 (9) ND ND 16.1 ± 6.3 7.9 ± 4.1 107 (71) 145 (97)
Culotte 19 (13) 102 (68) 26 (17) 3 (2) 150 (100) 111 (74) 32 (21) 7 (5) 18.5 ± 7.6 7.4 ± 4.3 129 (86) 148 (99)
DK-Crush II[22] 2017 DK 32 (17) 112 (61) 23 (12) 17 (9) 183 (100) 154 (84) 0 (0) 29 (16) 2 (1) 17 (9) 28.5 ± 12.9 15.3 ± 11.1 183 (100) 183 (100)
PS 29 (16) 107 (59) 30 (16) 16 (9) 183 (100) 144 (79) 0 (0) 39 (21) 5 (3) 20 (11) 25.8 ± 14.5 14.6 ± 11.9 144 (79) 180 (99)
Dk-Crush V[23] 2019 DK 240 (100) 0 (0) 0 (0) 0 (0) 240 (100) 204 (85) 0 (0) 36 (15) 89 (37) ND average 16.4 total 239 (100) 236 (98)
PS 242 (100) 0 (0) 0 (0) 0 (0) 242 (100) 190 (79) 0 (0) 52 (21) 96 (40) 191 (79) 235 (97)
NBBS IV[24] 2020 PS (3) (74) (17) (6) (100) ND ND ND ND ND 20.8 ± 9.9 6.4 ± 4.1 (36) (98)
2-stent (1) (77) (18) (4) (100) 19.5 ± 8.9 7.7 ± 4.9 (91) (99)
DEFINITION II[6] 2020 PS 94 (29) 197 (61) 25 (8) 9 (3) 315 (97) 268 (83) ND 47 (15) 131 (40) 218 (67) 42.2 ± 15.4 19.9 ± 9.3 70 (22) 319 (98)
2-stent 94 (29) 205 (63) 17 (5) 12 (4) 324 (99) 283 (86) 41 (13) 127 (39) 213 (65) 41.0 ± 13.2 20.7 ± 10.1 287 (99) 323 (99)
EBC Main[5] 2021 PS 226 (99) 61 (27) 29 (13) 13 (6) 230 (100) 204 (90) 0 (0) 23 (10) 101 (44) 43 (19) 8.4 ± 6.1 5.8 ± 4.0 202 (88) 224 (97)
2-stent 229 (99) 80 (34) 22 (9) 16 (7) 237 (100) 206 (89) 0 (0) 25 (11) 125 (54) 56 (24) 8.0 ± 5.1 7.9 ± 5.7 211 (89) 219 (92)
*Data presented as (%) without n is due to the fact that the original study provided only patient proportion data and no count data. BBK: Bifurcations Bad Krozingen; CACTUS: Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents; DEFINITION II: Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents; DK: Double-kissing; EBC: European Bifurcation Club; KB: Kissing balloon; LAD: Left anterior descending artery; LCX: Left circumflex artery; LMCA: Left main coronary artery; MB: Main branch; NBBS IV: Nordic-Baltic Bifurcation Study IV; NBS: Nordic Bifurcation Study; ND: Not declared; NSTS: Nordic Stent Technique Strategy; OA: Overall; RCA: Right circumflex artery; PERFECT: Optimal Stenting Strategy for True Bifurcation Lesions; PS: Provisional stenting; SB: Side branch; SD: Standard deviation; NBBSIV: Nordic-Baltic Bifurcation.

Risk of bias

The risk of bias for each study was estimated according to the Cochrane tool [Supplementary Table 1, https://links.lww.com/CD9/A27].[5,6,11–32] Due to the particularity of PCI, biases from blinding the participants and personnel were of a high risk in all trials. In addition, 6 studies were at high risk for bias from the blinding of outcome assessments.[13,21,24,25,28,31]

Pairwise meta-analysis

Eighteen studies reported MACEs during follow-up, comparing PS and complex 2-stent approaches,[5,6,11,13,15–17,20–25,27–31] with 2498 participants having undergone a 1-stent approach and 2568 having undergone a 2-stent approach. There were 383 (15.3% rate) and 358 (13.9% rate) MACEs that occurred in the 1-stent and 2-stent groups, respectively. We analyzed the extracted data from both the fixed-effects model and random-effects model, and no significant difference in MACEs (RR, 1.16; 95% CI, 0.90–1.48; I2 = 62%) was found between the 1-stent and 2-stent techniques [Figure 2].[5,6,11,13,15–17,20–25,27–31] Analyses for secondary outcomes were performed [Figure 3],[5,6,11,13,15–17,20–25,27–31] revealing no significant difference in all-cause mortality, cardiovascular mortality, TVR, MI, or ST between the 1-stent and 2-stent groups. Interestingly, the 2-stent technique was associated with less TLR using a fixed-effects model (RR, 1.27; 95% CI, 1.03–1.56; I2 = 47%) [Figure 3C]. However, a discrepancy arose given the result of the random-effects model (RR, 1.29; 95% CI, 0.93–1.79; I2 = 47%).

F2
Figure 2::
Forest plot for the risk of MACEs with 1-stent versus 2-stent techniques. CI: Confidence interval; RR: Relative risk.
F3
Figure 3::
Forest plots for the following secondary outcomes of interest. (A) All-cause mortality; (B) cardiovascular mortality; (C) target lesion revascularization; (D) target vessel revascularization; (E) myocardial infarction; (F) stent thrombosis. CI: Confidence interval; RR: Relative risk.

Sub-group analysis

According to an SB lesion length of 10 mm, we sub-divided the included studies into 2 groups. The sub-group analysis of 11 studies that assessed the incidence of MACEs showed that the 2-stent approach has an advantage when the SB lesion length is >10 mm (RR, 1.87; 95% CI, 1.46–2.41; I2 = 70%) [Figure 4].[5,6,11,20,22–24,27,28,30,31] When the SB lesion length ≤ 10mm, a non-significant difference was found between the 1-stent and 2-stent techniques (RR, 0.87; 95% CI, 0.70–1.08; I2 = 0). Furthermore, similar sub-group analyses were performed for secondary outcomes [Figure 5],[5,6,11,20,22–24,27,28,30,31] revealing that the 2-stent technique led to relatively fewer cases of TLR (RR, 2.13; 95% CI, 1.50–3.02; I2 = 59%) [Figure 5C] and MI (RR, 2.17; 95% CI, 1.19–3.95; I2 = 52%) [Figure 5E] when the SB lesion length is >10 mm. In contrast, results of the 1-stent and 2-stent approaches were indistinguishable in TLR and MI cases when the SB lesion length ≤ 10 mm. Sub-group analysis did not reveal a significant difference between 1-stent and 2-stent techniques in all-cause mortality, cardiovascular mortality, TVR, or ST. What’s more, when a sub-group analysis with stratification of first-generation DES and second-generation DES was performed [Supplementary Figure 1, https://links.lww.com/CD9/A27],[5,11,13,15,17,21–23,25,27–31] no disparity was found.

F4
Figure 4::
Forest plot showing sub-group analysis for the risk of MACEs depending on side branch lesion length. CI: Confidence interval; RR: Relative risk.
F5
Figure 5::
Forest plot showing sub-group analysis for the following secondary outcomes depending on side branch lesion length. (A) All-cause mortality; (B) cardiovascular mortality; (C) target lesion revascularization; (D) target vessel revascularization; (E) myocardial infarction; (F) stent thrombosis. CI: Confidence interval; RR: Relative risk.

Publication bias

Publication bias was evaluated using a visual inspection of the funnel plot for MACEs [Supplementary Figure 2, https://links.lww.com/CD9/A27], indicating that 5 included trials might exhibit heterogeneity. Results from Begg (P = 0.21) and Egger (P = 0.19) tests confirmed the potential bias. We also employed the trim-and-fill method for further evaluation of potential publication bias [Supplementary Figure 3, https://links.lww.com/CD9/A27], 3 potential missing studies were displayed as hollow circles.

Meta-regression analysis

A SB lesion length of >10 mm was identified to be the only significant (P < 0.05) source of heterogeneity [Supplementary Figure 4, https://links.lww.com/CD9/A27]. Publication year [Supplementary Figure 5, https://links.lww.com/CD9/A27] and generation of DES [Supplementary Figure 6, https://links.lww.com/CD9/A27] were not significantly correlated with MACEs.

Discussion

Our study revealed that no significant difference existed in MACEs or secondary outcomes (all-cause mortality, cardiovascular mortality, TVR, TLR, MI, and ST) between 1-stent and 2-stent approaches. Nevertheless, patients with an SB lesion length of >10 mm might benefit from comparatively more complex 2-stent PCI bifurcation techniques, which are associated with lower MACE occurrence rates. This advantage might be derived from reductions in TLR and MI. While considering patients with SB lesion lengths ≤10 mm, neither the 1-stent technique nor 2-stent technique had a significant advantage.

In the management of coronary bifurcation disease, the optimal PCI operating method has been debated. A provisional bifurcation stenting strategy is recommended for almost all bifurcation lesions, including in the distal LMCA.[4] A recent meta-analysis including only randomized controlled trials reported no significant difference between 1-stent and 2-stent strategies.[8] The most recent randomized multicenter trial confirmed this result, indicating comparable primary and secondary outcomes in the 1-stent and 2-stent groups.[5] A definition for complex bifurcation lesions in the distal LMCA has been raised, including the variability of SB, and applied in PCI technique selection.[14] The importance of the lesion in the SB has been concerned by several studies. Over the years, several trials have been conducted to compare PS and 2-stent approaches, involving participants with longer SB lesions.[6,22,23] A recent pairwise meta-analysis showed that the 2-stent approach gained advantages in MACEs when the SB lesion length is >10 mm.[33]

As shown in Figures 2 and 3, we obtained results similar to those of earlier meta-analyses supporting the idea that a vested stent in the SB does not benefit patients with bifurcation lesions. The provisional strategy is a classical PCI technique and recognized as a fundamental option. Our study determined that the 1-stent technique is a non-inferior solution compared to 2-stent approaches. When comprehensively considering consumables, procedural duration, etc, our findings lend support to the consensus that the provisional strategy is widely applicable. This consistency might be derived from its gradual update and improvement as the latest randomized trial reached a relatively low MACE ratio (14.8%).

A recent guideline suggested that the presence of a large SB (>2.75 mm) with a long ostial SB lesion (>5 mm) favors a 2-stent strategy. Furthermore, findings from our sub-group analysis reassured us that patients with SB lesion lengths of > 10 mm may benefit from a 2-stent strategy in terms of MACEs. Then, we concentrated on the composition of MACEs, revealing that the 2-stent strategy ameliorated TLR and MI cases during follow-up. This benefit indicated that upfront SB stenting might have a protective effect against target lesion failure. In addition, bifurcation, as a specific lesion subset, is still a complicated system with a high degree of internal heterogeneity. The optimal intervention strategy for various bifurcation lesions relies on more delicate classification.

Limitations

The present study suffers from some limitations. First, we only performed a pairwise meta-analysis comparing 1-stent and 2-stent strategies, skipping a network meta-analysis between different 2-stent approaches, such as crush, DK crush, Culotte, and T/TAP. Therefore, we could not track the beneficial impact of a 2-stent technique on complex bifurcation lesions to a fine-sorted degree. Second, the SB lesion length for separation depended on the mean values of groups in individual trials, disrupting the chance for a realistic correlation between SB lesion length, PCI technique, and participant outcomes. Third, although most included trials were multicenter investigations, the country where each study was performed remained a turbulent factor. The stepwise provisional technique was pioneered by the European Bifurcation Club, while DK crush, an upfront 2-stent technique, was initiated and adopted by Chinese cardiology teams. Likewise, a discrepancy in the stent platform adopted in each trial might interfere with the results. Finally, there was a non-negligible risk of bias among the included studies. Statistical heterogeneity between trials may weaken our findings.

Conclusions

Although further studies are needed to ascertain the optimal specific 2-stent strategy for bifurcation lesions with an SB lesion length of >10 mm, our findings clearly provide evidence in favor of a 2-stent technique in this context. What’s more, we explored the derivation of advantages in 2-stent procedures, serving as hypothesis facilitating subsequent research to shed light on the possible effect of upfront SB stenting in complex bifurcation lesions.

Acknowledgment

We deeply acknowledge the Cooperative Innovational Center of Nanjing Medical University for data analysis.

Funding

This study was funded by grants from the Nanjing Health Science and Technology Development Special Fund Project (ZKX20034) and the Jiangsu Provincial Special Program of Medical Science (BE2019615).

Author contributions

Jing Kan made substantial contributions to the initial conception and design of the whole study and to the revision of the manuscript. Junyan Kan wrote the first draft. Junyan Kan and Shuai Luo contributed data management and statistical expertise. Dongchen Wang, Dandan Cai, and Xiaojuan Zhang provided comments and suggestions for critical revision of the article. All authors approved the final version of the article.

Conflicts of interest

None.

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Keywords:

Percutaneous coronary intervention; Complex coronary bifurcation lesions; Provisional stenting; Two-stent strategy; Major adverse cardiovascular events; Stent thrombosis

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