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Four-Year Outcomes of Unprotected Left Main Lesion PCI with Self-Apposing Stents versus Balloon-Expandable Stents Cover

Four-Year Outcomes of Unprotected Left Main Lesion PCI with Self-Apposing Stents versus Balloon-Expandable Stents

Open Access
|Apr 2022

Figures & Tables

Figure 1

Unadjusted comparisons of mortality, TLR and MACE at 4 years according to the type of the stent in patients with unprotected left main coronary artery disease. Curves represent Kaplan-Meier failure function.
Unadjusted comparisons of mortality, TLR and MACE at 4 years according to the type of the stent in patients with unprotected left main coronary artery disease. Curves represent Kaplan-Meier failure function.

SYNTAX, SYNTAX II (for PCI and CABG, with respective predicted mortality) and EuroSCORE II scores of patients with unprotected left main coronary artery disease according to the stent strategy

Balloon-expandable stentsSelf-apposing stentsTotalp value
SYNTAX23.5 (16.5–30.5)17.5 (11–25.5)21 (13–29)0.004
SYNTAX-2 PCI34.1 (25.6–45.4)28.9 (22.1–40.7)32.2 (23.6–43.6)0.04
Estimated PCI mortality9.8 (4.9–22.7)6.2 (3.6–15.9)8.3 (4.1–19.9)0.03
SYNTAX-2 CABG31.5 (23.3–40.9)25.3 (16.4–33.6)28.9 (19.4–38)0.01
Estimated CABG mortality7.7 (3.9–16.2)4.6 (2.2–10.3)6.2 (2.9–13.6)0.01
EUROSCORE II1.6 (1–3.3)1.1 (0.8–2.5)1.3 (0.9–2.8)0.1

Angiographic findings of patients with unprotected left main coronary artery disease according to the type of implanted stent (LM – left main; LAD – left anterior descending artery; LCX – left circumflex artery; RCA – right coronary artery)

Balloon-expandable stentsSelf-apposing stentsTotalp value
Arterial access site
Radial16 (19.1)18 (29)34 (23.3)0.2
Femoral68 (80.9)44 (71)112 (76.6)0.2
Left main lesion localization
Ostial10 (11.9)0 (0)10 (6.9)
Middle segment1 (1.2)0 (0)1 (0.7)
Distal58 (69)54 (87.1)112 (76.7)
Ostial and distal1 (1.2)3 (4.8)4 (2.7)
Whole length14 (16.7)5 (8.1)19 (13)0.009
Bifurcation63 (75)52 (83.9)115 (78.8)0.2
Trifurcation21 (25)10 (16.1)31 (21.2)0.2
Other lesions
None24 (28.6)25 (40.3)49 (33.6)
One vessel27 (32.1)17 (27.4)44 (30.1)
Two vessels23 (27.4)16 (25.8)39 (26.7)
Three vessels10 (11.9)4 (6.5)14 (9.6)0.4
Chronic total occlusion17 (20.2)14 (22.6)31 (21.2)0.8
LAD ostium involved45 (53.6)50 (80.6)95 (65.1)0.001
LCX ostium involved36 (42.9)24 (38.7)60 (41.1)0.7
LAD non-ostial lesion41 (48.8)23 (37.1)64 (43.8)0.2
LCX non-ostial lesion27 (312.1)13 (21)40 (27.4)0.2
RCA lesion28 (33.3)20(32.3)48 (32.9)0.5
Left main lesion characteristics
Diffuse lesion49 (5.3)27 (43.5)76 (52.1)0.09
Eccentric lesion64 (76.2)43 (69.4)107 (73.3)0.4
Calcified lesion29 (34.5)14 (22.6)43 (29.4)0.1
Ulcerated lesion21 (25)15 (24.2)26 (25.7)0.5
Carina involved4 (4.8)5 (8.1)9 (6.2)0.5
Medina classification (only distal Left main lesions)
1/1/122 (30.1)12 (19.4)34 (25.2)
1/0/017 (23.3)6 (9.7)23 (17.1)
1/1/010 (13.7)6 (9.7)16 (11.9)
1/0/16 (8.2)3 (4.8)6 (6.7)
0/1/011 (15.1)26 (41.9)37 (27.4)
0/1/14 (5.5)6 (9.8)10 (7.4)
0/0/13 (4.1)3 (4.8)6 (4.4)0.01
True bifurcation (1/1/1, 0/1/1)26 (35.6)18 (29)44 (32.6)0.5
Left main take-off angle >70022 (32.8)22 (37.9)44 (35.2)0.6
Bifurcation angle
>90 degrees5 (8.1)7 (12.1)12 (10)
70–9024 (38.7)24 (41.4)48 (40)
45–6911 (17.7)10 (17.2)21 (17.5)
<4522 (35.5)17 (29.3)39 (32.5)0.8
LM stenosis, % (median, IQR)67 (45–89)30 (11–57)55 (20–80)<0.001
LAD stenosis, % (median, IQR)83 (58–90)86 (71–93)85 (66–92)0.006
LCX stenosis, % (median, IQR)71 (43–84)63 (18–86)70 (30–86)0.4

Procedural outcomes and post-procedural complications according to the type of implanted stent in patients with unprotected left main coronary artery disease (LM – left main; SB – side branch; TIA – transient ischemic attack; PCI – percutaneous coronary intervention; CIN – contrast induced nephropathy)

Balloon-expandable stentsSelf-apposing stentsTotalp value
Unaffected LM ostium covered by implanted stent12 (14.3)6 (9.7)18 (13.3)0.4
LM lesion covered84 (100)60 (96.8)133 (98.5)0.2
SB residual stenosis
None50 (67.5)36 (58.1)83 (62.4)
<50%17 (23)21 (33.9)38 (28.6)
>50%7 (9.5)5 (8)12 (9)0.4
Procedural success81 (96.4)57 (91.9)138 (94.5)0.3
Complete revascularization63 (75)46 (74)109 (74.7)0.5
TIMI flow at the of the procedure
11 (1.2)3 (4.8)4 (2.7)
23 (3.6)1 (1.6)4 (2.7)
380 (95.2)58 (93.6)138 (94.5)0.4
Peri-procedural complications
Hematoma3 (3.6)3 (4.8)6 (4.1)0.7
Stroke/TIA1 (1.2)0 (0)1 (0.7)0.6
MI1 (1.2)3 (4.8)4 (2.7)0.2
Afib1 (1.2)1 (1.6)2 (1.5)0.8
Need for external electric shock1 (1.2)3 (4.8)4 (2.7)0.3
Bradi-arrhythmia3 (3.6)7 (11.3)10 (6.9)0.1
Death during PCI1 (1.2)2 (3.2)3 (2)0.6
CIN*9 (16.4)5 (13.2)14 (15.1)0.8

Procedural characteristics according to the type of implanted in patients with unprotected left main coronary artery disease (PCI – percutaneous coronary intervention; IABP – intra-aortic balloon pump; LAD – left anterior descending artery; LCX – left circumflex artery; POT – proximal optimization technique; KBPD – kissing balloon post dilatation; TKBPD – triple kissing balloon post dilatation; MV – main vessel; SB – side branch; iFR - instantaneous wave-free ratio; IVUS – intravascular ultrasound)

Balloon-expandable stentsSelf-apposing stentsTotalp value
Time from coronary angiogram to PCI, days (median, IQR)2 (0–22.5)2.5 (0–20)2 (0–20)0.8
Arterial acces site
Femoral81 (96.4)50 (80.6)131 (89.7)0.004
Radial3 (3.6)12 (19.4)15 (10.3)0.004
Pre-PCI IABP5 (5.9)1 (1.6)6 (4.1)0.2
Guide catheter
6F47 (55.9)31 (50)78 (53.4)
7F37 (44.1)29 (46.8)66 (45.2)
8F0 (0)2 (3.2)2 (1.4)0.2
Rotational atherectomy2 (2.4)1 (1.6)3 (2.1)0.6
Two stent technique35 (41.7)25 (40.3) 0.5
Provisional stenting1 (3.1)0 (0)1 (1.7)
TAP10 (31.2)10 (40)20 (35.1)
Minicrush14 (43.7)4 (16)18 (31.6)
DK-Crush3 (9.4)0 (0)3 (5.3)
Cullotte3 (9.4)10 (40)13 (22.8)
V-stenting1 (3.1)1 (4)2 (3.5)0.03
MV predilatation62 (78.5)49 (79)111 (78.7)0.5
SB predilatation*29 (40.9)19 (30.7)48 (36.1)0.4
Predilatation at nominal pressure**21 (30.4)24 (46.1)40 (36)0.3
Dissection19 (26.4)9 (17.3)26 (23.4)0.2
POT*57 (81.4)28 (45.2)87 (64.4)<0.001
POT after first stent***46 (78)22 (78.6)68 (50.4)0.6
POT after KBPD***32 (54.2)6 (21.4)38 (28.2)0.005
POT balloon diameter*, mm (median, IQR)4 (4–4.5)4 (4–4.5)4 (4–4.5)0.9
KBPD*42 (62.7)19 (30.6)62 (45.9)<0.001
TKBPD*5 (7.2)0 (0)5 (3.7)0.03
MV stent diameter
314 (16.7)18 (29.3)32 (21.9)
3.553 (63.1)44 (71)97 (66.4)
417 (20.2)0 (0)17 (11.6)<0.001
MV stent length, mm (median, IQR)24 (16–29)22 (18–25)22 (18–28)
SB stent diameter, mm (median, IQR)3 (3–3.5)3.5 (3–3.5)N/A0.5
SB stent length, mm (median, IQR)19 (13–23)22 (18–27)N/A0.06
Under expansion of >30%6 (7.1)8 (12.9)14 (9.6)0.3
IFR used pre-PCI2 (2.4)4 (6.5)6 (4.1)0.4
IFR used post-PCI0 (0)4 (6.5)4 (2.8)0.03
IVUS used pre-PCI2 (2.4)0 (0)2 (1.4)0.5
IVUS used post-PCI12 (14.3)14 (22.6)26 (17.8)0.3

Demographic and baseline clinical characteristics according to the type of the implanted stent in patients with unprotected left main coronary artery disease (ACS – acute coronary syndrome; NSTEMI – non-ST segment elevation myocardial infarction; STEMI – ST segment elevation myocardial infarction; PCI – percutaneous coronary intervention; TIA – transient ischemic attack; COPD - chronic obstructive pulmonary disease; PAD – peripheral artery disease; LBBB – left bundle branch block; RBBB – right bundle branch block; LVEF – left ventricular ejection fraction; HB – hemoglobin)

Balloon-expandable stentsSelf-apposing stentsTotalp value
Age, y (median, IQR)63 (56–72)62 (52–70)63 (55–71)0.2
Male58 (69.1)44 (71)102 (69.9)0.8
Cardiovascular risk factors
Hypertension71 (84.5)51 (83.6) 0.5
Dyslipidemia73 (86.9)53 (86.9)126 (86.9)0.6
Diabetes25 (29.8)17 (27.9)42 (29)0.8
Obesity21 (25)17 (27.4)38 (26)0.8
Smoking status
Active smoker25 (30.1)18 (29.5)43 (29.9)0.8
Former smoker16 (19.3)10 (16.4)26 (18.1)0.8
Patient history
ACS32 (38.1)26 (42.6)58 (40)0.6
Unstable angina3 (9.4)3 (11.5)6 (10.3)
NSTEMI11 (34.4)5 (19.2)16 (27.6)
STEMI18 (56.2)18 (69.3)36 (62.1)0.4
PCI20 (23.8)14 (22.6)34 (23.3)0.5
Atrial fibrillation11 (13.1)8 (13.1)19 (13.1)0.6
Stroke/TIA10 (11.9)5 (8.1)15 (10.3)0.6
Bleeding2 (2.4)3 (4.9)5 (3.4)0.6
COPD1 (1.2)1 (1.6)2 (1.4)0.7
PAD21 (25)4 (6.6)25 (17.2)0.004
Neoplasm9 (10.7)0 (0)9 (6.2)0.01
Clinical presentation
Stable angina40 (47.6)30 (48.4)70 (47.9)
Unstable angina19 (22.6)11 (17.7)30 (20.5)
NSTEMI9 (10.7)7 (11.3)16 (11)
STEMI10 (11.9)8 (12.9)18 (12.3)
ACS with cardiogenic shock6 (7.2)6 (9.7)12 (8.2)0.9
Atrial fibrillation7 (8.6)5 (8.1)12 (8.4)0.6
LBBB6 (7.4)3 (4.8)9 (6.3)0.4
RBBB7 (8.6)4 (6.4)11 (7.7)0.4
Ventricular tachycardia0 (0)2 (3.2)2 (1.4)0.2
LVEF, % (median, IQR)50 (35–55)50 (38–60)50 (35–57.5)0.6
LV systolic disfunction
None (>=50%)42 (50.6)32 (52.5)74 (51.4)
Mild (40–49%)16 (19.3)13 (21.3)29 (20.1)
Moderate (30–39%)15 (18.1)10 (16.4)25 (17.4)
Severe (<30%)10 (12)6 (9.8)16 (11.1)0.9
Diastolic disfunction71 (92.2)49 (84.4)120 (88.9)0.2
Regional wall motion abnormality58 (71.6)38 (62.3)96 (67.6)0.3
LV aneurysm5 (6.1)4 (6.6)9 (6.3)0.6
LV thrombus2 (2.4)0 (0)2 (1.4)0.5
LV hypertrophy31 (41.3)14 (24.6)45 (30.1)0.06
Dilated cardiomyopathy4 (4.8)3 (4.9)7 (4.9)0.6
Mitral regurgitation
None/Trivial12 (14.5)2 (3.3)14 (9.8)
Mild51 (61.4)45 (75)96 (67.1)
Moderate12 (14.5)10 (16.7)22 (15.4)
Severe8 (9.6)3 (5)11 (7.7)0.09
Aortic regurgitation
None/Trivial61 (73.5)40 (66.7)101 (70.6)
Mild15 (18.1)20 (33.3)35 (24.5)
Moderate7 (8.4)0 (0)7 (4.9)
Severe0 (0)0 (0)0 (0)0.01
Ascending aorta diameter, mm (median, IQR)32 (30–34)34 (31–37)32 (30–35)0.02
Moderate/severe aortic stenosis3 (3.6)0 (0)6 (4.2)0.3
Tricuspid regurgitation50 (60.2)40 (65.6)90 (62.5)0.6
Pulmonary hypertension15 (20)4 (7)19 (14.4)0.04
Blood samples pre-PCI
HB, g/dl (median, IQR)13.4 (12.2–14.4)13.9 (12.5–15)13.5 (12.3–14.7)0.1
CK-MB, U/L (median, IQR)25 (18–63)22 (16–37)22 (17–50)0.2
Troponin, ng/ml (median, IQR)0.24 (0.03–1.3)1 (0.07–4.8)0.3 (0.03–2.9)0.2
Creatinine, mg/dl (median, IQR)0.9 (0.8–1.2)0.9 (0.8–1.2)0.9 (0.8–1.2)0.9
Creatinine clearance, ml/min/1.73m2 (median, IQR)80 (62–97)80 (65–95)80 (64–96)0.9
DOI: https://doi.org/10.2478/rjc-2022-0004 | Journal eISSN: 2734-6382 | Journal ISSN: 1220-658X
Language: English
Page range: 2 - 9
Published on: Apr 22, 2022
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2022 Lucian Predescu, Adrian Bucsa, Marian Croitoru, Adrian Mereuta, Pavel Platon, Marin Postu, Lucian Zarma, Dan Dorobantu, Leonard Lichiardopol, Alexandra Predescu, Carmen Ginghina, Dan Deleanu, published by Romanian Society of Cardiology
This work is licensed under the Creative Commons Attribution 4.0 License.