Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial using optical coherence tomography

doi:10.5847/wjem.j.1920-8642.2020.02.004

Abstract

Abstract:

BACKGROUND: Stent failure is more likely in the lipid rich and thrombus laden culprit lesions underlying ST-segment elevation myocardial infarction (STEMI). This study assessed the effectiveness of post-dilatation in primary percutaneous coronary intervention (pPCI) for acute STEMI.

METHODS: The multi-center POST-STEMI trial enrolled 41 consecutive STEMI patients with symptom onset <12 hours undergoing manual thrombus aspiration and Promus Element stent implantation. Patients were randomly assigned to control group (n=20) or post-dilatation group (n=21) in which a non-compliant balloon was inflated to >16 atm pressure. Strut apposition and coverage were evaluated by optical coherence tomography (OCT) after intracoronary verapamil administration via thrombus aspiration catheter, post pPCI and at 7-month follow-up. The primary endpoint was rate of incomplete strut apposition (ISA) at 7 months after pPCI.

RESULTS: There were similar baseline characteristics except for stent length (21.9 [SD 6.5] mm vs. 26.0 [SD 5.8] mm, respectively, P=0.03). In post-dilatation vs. control group, ISA rate was lower (2.5% vs. 4.5%, P=0.04) immediately after pPCI without affecting final TIMI flow 3 rate (95.2% vs. 95.0%, P>0.05) or corrected TIMI frame counts (22.6±9.4 vs. 22.0±9.7, P>0.05); and at 7-month follow-up (0.7% vs. 1.8%, P<0.0001), the primary study endpoint, with similar strut coverage (98.5% vs. 98.4%, P=0.63) and 1-year rate of major adverse cardiovascular events (MACE).

CONCLUSION: In STEMI patients, post-dilatation after stent implantation and thrombus aspiration improved strut apposition up to 7 months without affecting coronary blood flow or 1-year MACE rate. Larger and longer term studies are warranted to further assess safety (ClinicalTrials.gov identifier: NCT02121223).

Key words: ST-segment elevation myocardial infarction, Post-dilatation, Incomplete strut apposition, Optical coherence tomography

Jun Jiang, Nai-liang Tian, Han-bin Cui, Chang-ling Li, Xian-bao Liu, Liang Dong, Yong Sun, Xiao-min Chen, Shao-liang Chen, Bo Xu, Jian-an Wang. Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial using optical coherence tomography[J]. World Journal of Emergency Medicine, 2020, 11(2): 87-92.

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Parameters	Control group (n=20)	Post-dilatation group (n=21)	P value
Age (years)	64.8±9.7	61.6±12.4	0.37
Men	18 (90)	15 (71.4)	0.24
Body mass index (kg/m²)	24.1±3.8	24.1±2.3	0.99
Diabetes mellitus	3 (16.7)	4 (19.1)	1.00
Arterial hypertension	9 (50)	10 (47.6)	0.88
Hypercholesterolemia	4 (22.2)	4 (19.1)	1.00
Current smoker	9 (50)	8 (38.1)	0.45
Family history of CAD	2 (11.1)	0 (0)	0.21
Prior myocardial infarction	0 (0)	0 (0)	-
Previous PCI	0 (0)	0 (0)	-

Parameters	Control group (n=20)	Post-dilatation group (n=21)	P value
QCA immediately after PCI
Target lesion coronary artery			0.89
LAD	7 (35)	9 (42.9)
LCx	2 (10)	2 (9.5)
RCA	11 (55)	10 (47.6)
Thrombus	15 (75)	14 (66.7)	0.55
Bifurcation	4 (20)	4 (19.1)	1.0
Pre-procedural TIMI flow			0.36
0	14 (70)	18 (85.7)
1	1 (5)	0 (0)
2	1 (5)	2 (9.5)
3	4 (20)	1 (4.8)
Lesion length (mm)	22.7±7.1	17.8±8.3	0.05
Pre-procedure RVD (mm)	2.9±0.4	2.9±0.5	0.79
Pre-procedure MLD (mm)	0.05±0.12	0.07±0.19	0.79
Post-procedure RVD (mm)	2.9±0.4	2.9±0.4	0.92
Post-procedure MLD (mm)	2.7±0.4	2.7±0.4	0.92
Total stent length (mm)	26.0±5.8	21.9±6.5	0.03
Post-procedural TIMI flow			1.0
0	0 (0)	0 (0)
1	0 (0)	0 (0)
2	1 (5)	1 (4.8)
3	19 (95)	20 (95.2)
Post-procedural CTFC	22.0±9.7	22.6±9.4	0.85
Side branch involvement			0.53
Yes	3 (15)	4 (19.1)
No	0 (0)	2 (9.5)
Without side branch	17 (85)	15 (71.4)
QCA at 7-month follow-up	Control group (n=14)	Post-dilatation group (n=20)	P value
Thrombus	0 (0)	0 (0)
TIMI flow			1.0
0	0 (0)	0 (0)
1	0 (0)	0 (0)
2	2 (14.3)	3 (14.3)
3	12 (85.7)	18 (85.7)
MLD (mm)	2.6±0.5	2.6±0.4	1.0
In-stent stenosis (%)	14.7± 8.9	12.0±7.8	0.45
Post-procedural CTFC	26.7±11.1	27.0±13.7	0.95

Parameters	Control group (n=20)	Post-dilatation group (n=21)	P value
OCT immediately after PCI
Mean stent area (mm²)	7.62±1.99	8.70±2.09	0.06
Minimal stent area (mm²)	6.35±1.71	7.35±1.85	0.07
Mean lumen area (mm²)	8.06±2.10	8.74±2.04	0.24
Minimal lumen area (mm²)	6.32±1.60	7.28±1.74	0.06
Distal reference lumen area (mm²)	7.79±2.23	7.15±2.17	0.3
Proximal reference lumen area (mm²)	9.82±3.01	9.25±2.53	0.56
Area stenosis (%)	21.01±7.66	16.44±6.21	0.06
Intimal healing index	204.60±5.60	202.60±6.70	0.25
ISA (%)	4.5	2.5	0.04
OCT at 7-month follow-up	Control group (n=14)	Post-dilation group (n=20)
Mean stent area (mm²)	8.39±2.20	8.38±2.42	0.69
Minimal stent area (mm²)	7.15±2.00	6.96±2.19	0.63
Mean lumen area (mm²)	7.92±2.32	7.80±2.44	0.73
Minimal lumen area (mm²)	6.09±2.28	6.07±2.19	0.85
Distal reference lumen area (mm²)	8.83±1.46	6.81±2.57	0.03
Proximal reference lumen area (mm²)	10.61±3.70	8.05±2.89	0.06
Area stenosis (%)	25.09±9.94	22.76±9.04	0.49
Intimal healing index	5.93±10.38	3.29±4.32	0.49
Intima coverage (%)	98.4	98.5	0.63
Late-acquired malapposition	0.21	0.12	0.37
Neointima volume	0.7±0.4	0.7±0.3	0.78
ISA (%)	1.8	0.7	<0.0001

Parameters	Control group (n=20)	Post-dilatation group (n=21)	P value
MACE
Death	0 (0)	0 (0)	_
Recurrent MI	0 (0)	0 (0)	_
Heart failure	1 (5.9)	1 (4.8)	1.00
Stroke	0 (0)	0 (0)	_
TLR	0 (0)	0 (0)	_
Non-target lesion revascularization	5 (25)	3 (14.3)	0.45