We did not find a significant difference in the rate of slow flow/no-reflow between the traditional rota-flush group and heparin rota-flush group (19.6% vs. 29.1%, P = 0.117), and the procedural success was also comparable. |
The incidence of coronary spasm was significantly higher in the heparin rota-flush group compared to the traditional rota-flush group (42.7% vs. 22.7%, P = 0.003). |
Although the incidence of systolic blood pressure (SBP) drop ≥ 20 mmHg was significantly higher in the traditional rota-flush group, severe hypotension (SBP < 90 mmHg) was not significantly different (P = 0.841), indicating that vasodilators in the flush did not severely impact hemodynamic stability. |
Introduction
Methods
Study Design and Patient Selection
Randomization
Revascularization Protocol
Definitions and Endpoints
Sample Size
Statistical Analysis
Results
Variables | All (n = 200) | Heparin rota-flush (n = 103) | Traditional rota-flush (n = 97) | P value |
---|---|---|---|---|
Age, years | 71.8 ± 8.8 | 71.8 ± 9.1 | 71.9 ± 8.6 | 0.931 |
Male | 114 (57.0) | 61 (59.2) | 53 (54.6) | 0.513 |
UA | 158 (79.0) | 78 (75.7) | 80 (82.5) | 0.242 |
Hypertension | 148 (74.0) | 74 (71.8) | 74 (76.3) | 0.474 |
Diabetes mellitus | 80 (40.0) | 41 (39.8) | 39 (40.2) | 0.954 |
Dyslipidemia | 187 (93.5) | 95 (92.2) | 92 (94.8) | 0.454 |
Smoking | 72 (36.0) | 42 (40.8) | 30 (30.9) | 0.147 |
Chronic heart failure | 49 (24.5) | 25 (24.3) | 24 (24.7) | 0.938 |
CKD | 9 (4.5) | 2 (1.9) | 7 (7.2) | 0.093 |
Dialysis | 3 (1.5) | 1 (0.9) | 2 (2.1) | 0.612 |
Pre-MI | 35 (17.5) | 21 (20.4) | 14 (14.4) | 0.268 |
Pre-PCI | 81 (40.5) | 48 (46.6) | 33 (34.0) | 0.070 |
Stroke | 67 (33.5) | 35 (33.9) | 32 (32.9) | 0.882 |
LVEF (%) | 58.3 ± 11.7 | 58.0 ± 11.9 | 58.6 ± 11.7 | 0.747 |
Medication | ||||
ACEI/ARB | 100 (50.0) | 49 (47.6) | 51 (52.6) | 0.479 |
CCB | 51 (25.5) | 30 (29.1) | 21 (21.6) | 0.225 |
Nitrates | 101 (50.5) | 54 (52.4) | 47 (48.5) | 0.574 |
β-blocker | 112 (56.0) | 58 (56.3) | 54 (55.7) | 0.927 |
SBP just before RA (mmHg) | 138.6 ± 22.4 | 138.4 ± 22.0 | 138.8 ± 22.9 | 0.903 |
DBP just before RA (mmHg) | 72.3 ± 12.4 | 72.5 ± 11.8 | 72.1 ± 13.0 | 0.823 |
Heart rate just before RA (bpm) | 76.2 ± 13.5 | 76.5 ± 13.1 | 75.8 ± 13.9 | 0.690 |
Target coronary vessel | 0.712 | |||
LAD | 165 (82.5) | 84 (81.6) | 81 (83.5) | |
LCX | 13 (6.5) | 6 (5.8) | 7 (7.2) | |
RCA | 22 (11.0) | 13 (12.6) | 9 (9.3) | |
No. of diseased vessels | 0.072 | |||
1 | 20 (10.0) | 9 (8.7) | 11 (11.3) | |
2 | 49 (24.5) | 19 (18.4) | 30 (30.9) | |
3 | 131 (65.5) | 75 (72.8) | 56 (57.7) | |
CTO lesion | 9 (4.5) | 5 (4.9) | 4 (4.1) | 1.000 |
Calcification | 0.250 | |||
None/mild | 21 (10.5) | 10 (9.7) | 11 (11.3) | |
Moderate | 31 (15.5) | 12 (11.7) | 19 (19.6) | |
Severe | 148 (74.0) | 81 (78.6) | 67 (69.1) | |
Angulation > 45° | 101 (50.5) | 56 (54.4) | 45 (46.4) | 0.259 |
Diffuse lesion | 145 (72.5) | 75 (72.8) | 70 (72.2) | 0.918 |
Initial TIMI flow < 3 | 40 (20.0) | 25 (24.3) | 15 (15.5) | 0.120 |
Lesion length (mm) | 32.0 ± 10.0 | 32.1 ± 9.8 | 31.9 ± 10.4 | 0.933 |
Reference diameter (mm) | 2.86 ± 0.37 | 2.87 ± 0.36 | 2.85 ± 0.38 | 0.867 |
MLD (mm) | 0.51 ± 0.32 | 0.52 ± 0.31 | 0.51 ± 0.34 | 0.726 |
Stenosis, % | 81.8 ± 12.6 | 81.6 ± 13.4 | 82.1 ± 11.6 | 0.755 |
Variables | All (n = 200) | Heparin rota-flush (n = 103) | Traditional rota-flush (n = 97) | P value |
---|---|---|---|---|
Access | 0.068 | |||
Radial artery | 147 (73.5) | 70 (67.9) | 77 (79.4) | |
Brachial artery | 17 (8.5) | 13 (12.6) | 4 (4.1) | |
Femoral artery | 36 (18.0) | 20 (19.4) | 16 (16.5) | |
Guiding catheter | 0.056 | |||
6Fr | 160 (80.0) | 77 (74.8) | 83 (85.6) | |
7Fr | 40 (20.0) | 26 (25.2) | 14 (14.4) | |
IABP supported | 23 (11.5) | 16 (15.5) | 7 (7.2) | 0.065 |
IVUS guided | 26 (13.0) | 13 (12.6) | 13 (13.4) | 0.870 |
Primary RA | 128 (64.0) | 64 (62.1) | 64 (65.9) | 0.571 |
Burr number | 0.690 | |||
1 | 187 (93.5) | 97 (94.2) | 90 (92.8) | |
2 | 13 (6.5) | 6 (5.8) | 7 (7.2) | |
Final burr size | 0.990 | |||
1.25 mm | 43 (21.5) | 22 (21.4) | 21 (21.6) | |
1.5 mm | 141 (70.5) | 73 (70.9) | 68 (70.1) | |
1.75 mm | 16 (8.0) | 8 (7.8) | 8 (8.2) | |
Initial burr-to-artery ratio (%) | 51.5 ± 7.0 | 51.7 ± 7.3 | 51.3 ± 6.7 | 0.670 |
Total run time(s) | 39.0 (26.0, 62.0) | 38.0 (26.0, 62.0) | 40.0 (27.0, 64.0) | 0.478 |
Mean run time(s) | 14.5 ± 4.2 | 14.1 ± 4.0 | 14.9 ± 4.4 | 0.217 |
Mean rotational speed (× 10,000 rpm) | 14.9 ± 1.5 | 15.1 ± 1.5 | 14.8 ± 1.4 | 0.138 |
DES | 194 (97.0) | 101 (98.1) | 93 (95.9) | 0.434 |
Variables | All (n = 200) | Heparin rota-flush (n = 103) | Traditional rota-flush (n = 97) | P value |
---|---|---|---|---|
Procedural success | 191 (95.5) | 100 (97.1) | 91 (93.8) | 0.320 |
Complications | ||||
Slow flow/no-reflow | 49 (24.5) | 30 (29.1) | 19 (19.6) | 0.117 |
Slow flow | 28 (14.0) | 16 (15.5) | 12 (12.4) | 0.519 |
No-flow | 21 (10.5) | 14 (13.6) | 7 (7.2) | 0.142 |
Coronary spasm | 66 (33.0) | 44 (42.7) | 22 (22.7) | 0.003 |
Hypotension | 123 (61.5) | 56 (54.4) | 67 (69.1) | 0.033 |
SBP drop ≥ 20 mmHg | 112 (56.0) | 50 (48.5) | 62 (63.9) | 0.029 |
SBP < 90 mmHg | 32 (16.0) | 17 (16.5) | 15 (15.5) | 0.841 |
Vasopressor usage | 21 (10.5) | 12 (11.7) | 9 (9.3) | 0.584 |
Bradycardia | 45 (22.5) | 21 (20.4) | 24 (24.7) | 0.461 |
Atropine usage | 6 (3.0) | 3 (2.9) | 3 (3.1) | 1.000 |
Complete AV block | 2 (1.0) | 2 (1.9) | 0 (0) | 0.498 |
Sinus arrest | 2 (1.0) | 2 (1.9) | 0 (0) | 0.498 |
Dissection | 27 (13.5) | 12 (11.7) | 15 (15.5) | 0.430 |
Perforation | 6 (3.0) | 2 (1.9) | 4 (4.1) | 0.434 |
Burr entrapment | 1 (0.5) | 0 (0) | 1 (1.0) | 0.485 |
Transection of RA guidewire | 0 (0) | 0 (0) | 0 (0) | – |
MACE | ||||
ST | 1 (0.5) | 0 (0) | 1 (1.0) | 1.000 |
TLR | 5 (2.5) | 2 (1.9) | 3 (3.1) | 0.675 |
Stroke | 0 (0) | 0 (0) | 0 (0) | – |
Cardiac death | 2 (1.0) | 1 (1.0) | 1 (1.0) | 1.000 |
Univariate analysis | Multivariate analysis | |||
---|---|---|---|---|
OR (95% CI) | P value | OR (95% CI) | P value | |
Angulation > 45° | 2.24 (1.15–4.37) | 0.018 | 2.15 (1.01–4.62) | 0.049 |
Lesion length | 1.06 (1.02–1.93) | 0.002 | 1.05 (1.01–1.09) | 0.027 |
SBP just before RA | 0.79 (0.68–0.92) | 0.003 | 0.82 (0.67–0.99) | 0.040 |
Reference diameter | 0.42 (0.16–1.07) | 0.068 | 0.12 (0.02–0.59) | 0.010 |
Heparin rota-flush | 1.69 (0.87–3.26) | 0.089 | 1.66 (0.78–3.52) | 0.186 |
Initial TIMI flow < 3 | 2.57 (1.23–5.38) | 0.013 | 0.70 (0.29–1.65) | 0.418 |
LVEF | 0.97 (0.95–0.99) | 0.044 | 0.98 (0.95–1.01) | 0.143 |
Mean RA speed | 1.19 (0.98–1.47) | 0.100 | 1.01 (0.98–1.03) | 0.673 |
Mean single run time | 0.96 (0.92–1.00) | 0.056 | 0.94 (0.86–1.03) | 0.177 |
Initial burr-to-artery ratio | 0.89 (0.68–1.05) | 0.098 | 0.48 (0.22–1.04) | 0.064 |
Univariate analysis | Multivariate analysis | |||
---|---|---|---|---|
OR (95% CI) | P value | OR (95% CI) | P value | |
Heparin rota-flush | 2.54 (1.37–4.70) | 0.003 | 2.68 (1.43–5.05) | 0.002 |
Lesion length | 1.03 (0.99–1.06) | 0.068 | 1.03 (0.99–1.06) | 0.076 |
Reference diameter | 0.83 (0.37–1.06) | 0.086 | 1.12 (0.3–4.19) | 0.864 |
Mean RA speed | 0.98 (0.81–1.01) | 0.093 | 0.99 (0.97–1.01) | 0.492 |
Mean single run time | 1.07 (0.99–1.09) | 0.054 | 1.03 (0.95–1.11) | 0.479 |
Initial burr-to-artery ratio | 1.54 (0.95–1.74) | 0.083 | 1.02 (0.60–2.36) | 0.610 |