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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

Postal Subscription Code 80-967

2018 Impact Factor: 1.847

Front. Med.    2023, Vol. 17 Issue (1) : 75-84    https://doi.org/10.1007/s11684-022-0950-1
RESEARCH ARTICLE
Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation
Sanna Uskela1(), Antti Eranti1, Jussi M. Kärkkäinen2, Tuomas T. Rissanen2
1. North Karelia Central Hospital-Heart Center Tikkamaentie 16, Joensuu 80210, Finland
2. Kuopio University Hospital Puijonlaaksontie 2, Kuopio, Pohjois-Savo 70210, Finland
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Abstract

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.

Keywords drug-coated balloon      left main      high bleeding risk      predilatation      calcifield lesion      percutaneous coronary intervention     
Corresponding Author(s): Sanna Uskela   
Just Accepted Date: 08 November 2022   Online First Date: 25 December 2022    Issue Date: 15 March 2023
 Cite this article:   
Sanna Uskela,Antti Eranti,Jussi M. Kärkkäinen, et al. Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation[J]. Front. Med., 2023, 17(1): 75-84.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-022-0950-1
https://academic.hep.com.cn/fmd/EN/Y2023/V17/I1/75
Fig.1  Patient flow in the study.
All procedures N = 66 (%)Acceptable predilatation N = 52 (%)Suboptimal predilatation N = 14 (%)P value acceptable/suboptimal predilatation
Patient characteristics
Age (years)74.874.874.80.985
Sex
Male48 (72)39 (75)9 (64)0.503
Female18 (27)13 (25)5 (36)
Smoking
Current smoker8 (12)5 (10)3 (21)0.481
Ex-smoker20 (30)16 (31)4 (29)
Diabetes26 (39)23 (44)3 (21)0.217
Hypertension43 (65)34 (65)9 (64)1
Hypercholesterolemia62 (94)48 (92)14 (100)0.571
Prior myocardial infarction16 (24)9 (17)7 (50)0.03
Acute coronary syndrome34 (52)26 (50)6 (43)0.766
CCS-class0.511
I4 (6)4 (8)0
II9 (14)8 (15)1 (7)
III18 (27)13 (25)5 (36)
IV31 (47)23 (44)8 (57)
Not known4 (6)4 (8)
Ejection fraction (%)0.774
< 304 (6)4 (8)0
30–4912 (18)9 (17)3 (21)
≥ 6014 (21)10 (19)4 (29)
Not known36 (55)29 (56)7 (50)
Bleeding risk factors
At least one (%)51 (77)38 (73)13 (93)0.161
Anticoagulation20 (30)15 (29)5 (36)0.745
Anemia or thrombocytopenia29 (43)21 (40)8 (57)0.365
Age ≥ 80 years25 (38)20 (38)5 (36)11
Active malignant disease3 (5)2 (4)1 (7)0.517
Prior stroke14 (21)13 (25)1 (7)0.269
Severe renal dysfunction1 (1.5)1 (2)01
Planned elective surgery < 12 months after PCI2 (3)1 (2)1 (7)0.382
Prior bleeding requiring intervention10 (15)8 (15)2 (14)1
Tab.1  Patient characteristics and bleeding risk factors
Left main PCI characteristicsn (%)
Unprotected51 (77)
Protected15 (23)
DCB-only PCI done according to the international consensus guidelines
Yes52 (79)
No14 (21)
Lesions treated
LM only23 (35)
LM + 122 (33)
LM + 213 (20)
LM + 38 (12)
Other vessels treated
LAD30 (45)
LCX20 (30)
RCA5 (8)
Diag2 (3)
Marg12 (18)
Bifurcation42 (66)
Significant calcification33 (50)
Rotational atherectomy32 (48)
Cutting balloon33 (50)
Rotational atherectomy and cutting balloon19 (29)
At least 1 stent in other vessel13 (20)
Access
Radial22 (33)
Femoral40 (60)
Brachial3 (5)
Not known1 (1.5)
Diameter of the largest predilatation balloon (mm)
2.54 (6)
317 (26)
3.253 (5)
3.519 (29)
417 (26)
4.51 (1.5)
52 (3)
Not known3 (5)
Number of the DCBs used
158 (88)
28 (12)
Diameter of the largest DCB used (mm)
2.53 (5)
2.751 (1.5)
317 (26)
3.525 (38)
420 (30)
Length of the DCB used (mm)
< 151 (1.5)
15?2058 (88)
> 206 (9)
The reason for DCB-only strategy
Bleeding risk18 (27)
Anatomical17 (26)
Urgent elective surgery2 (3)
Poor predilatation result2 (3)
Later optimization1 (1.5)
Not known26 (39)
Tab.2  Procedural characteristics
n (%)
Anticoagulant66 (100)
Enoxaparin64 (97)
Unfractionated heparin1 (1.5)
Bivalirudin1 (1.5)
Aspirin65 (98)
P2PY12 inhibitor59 (89)
Clopidogrel39 (59)
Prasugrel9 (14))
Ticagrelol9 (14)
Kangrelor2 (3)
Aspirin “only”7 (11)
Tab.3  Procedural antithrombotics and anticoagulation
Duration of DAPT (months)n (%)
014 (21)
0.52 (3)
119 (29)
24 (6)
314 (21)
610 (15)
121 (1.5)
241 (1.5)
Lifelong1 (1.5)
Tab.4  Duration of DAPT after PCI
Fig.2  Kaplan–Meier plots for survival free of MACE in all patients, and according to the predilatation result.
All subjects (n = 66/61)aAcceptable predilatation (n = 52/47)aSuboptimal predilatation (n = 14/14)aP (acceptable vs suboptimal predilatation)
Death
12 months12 (18.2)8 (15.4)4 (28.6)0.264
24 months15 (24.6)9 (19.1)6 (42.9)0.087
Cardiovascular death
12 months8 (12.1)6 (11.5)2 (14.3)0.674
24 monthsc7 (11.5)5 (10.6)2 (14.3)0.655
Myocardial infarction
12 months6 (9.1)4 (7.7)2 (14.3)0.6
24 months7 (11.5)4 (8.5)3 (21.4)0.335
Target lesion revascularization
12 months4 (6.1)1 (1.9)3 (21.4)0.028
24 months4 (6.6)1 (2.1)3 (21.4)0.035
Subjects with at least one MACEb
12 months16 (24.2)11 (21.2)5 (35.7)0.3
24 months16 (26.2)10 (21.3)6 (42.9)0.164
BARC 2 + bleeding
12 months14 (21.2)9 (17.3)5 (35.7)0.154
24 months14 (23.0)9 (19.1)5 (35.7)0.277
Tab.5  Adverse events (n (%)) among subjects with LM DCB PCI
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