Introduction
Methods
Study design and patient selection
Interventional procedure
DIOR | IN.Pact Falcon | |
---|---|---|
Manufacturer | EuroCor GmbH, Germany | Medtronic Vascular Inc., USA |
Balloon type | Semi-compliant | Semi-compliant |
Balloon diameters available, mm | 2.0, 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 | 2.0, 2.25, 2.5, 2.75, 3.0, 3.25, 3.5, 3.75, 4.0 |
Balloon lengths available, mm | 15, 20, 25, 30 | 14, 20, 30, 40 |
Coated drug | Paclitaxel | Paclitaxel |
Drug | Paclitaxel | Paclitaxel |
Loading dose | 3 µg/mm2
| 3 µg/mm2
|
Excipient | Shellac | Urea |
Coating procedure | Micro-pipetting | Not specified |
Inflation time, s | 30–60 | 30–60 |
CE marking | 2007 | 2009 |
Follow-up and endpoints
Statistical analysis
Results
DIOR (n = 20) | IN.Pact Falcon (n = 25) |
p value | |
---|---|---|---|
Patient characteristics | |||
Age, years | 66.6 ± 10.27 | 65.3 ± 9.69 | 0.66 |
Male gender | 14 (70) | 17 (68) | 0.89 |
Diabetes mellitus | 4 (20) | 6 (24) | 0.75 |
Hypertension | 11 (55) | 14 (56) | 0.95 |
Hyperlipidemia | 13 (65) | 7 (28) | 0.01 |
Current smoker | 3 (15) | 4 (16) | 0.93 |
Family history of cardiovascular disease | 10 (50) | 12 (48) | 0.89 |
Previous myocardial infarction | 10 (50) | 14 (56) | 0.69 |
Previous coronary artery bypass grafting | 3 (15) | 3 (12) | 0.77 |
Lesion characteristics | |||
Target vessel | 0.22 | ||
Left anterior descending | 10 (50) | 12 (48) | |
Ramus circumflex | 6 (30) | 3 (12) | |
Right coronary artery | 4 (20) | 10 (40) | |
Pattern of restenosisa
| 0.47 | ||
Focal body | 8 (40) | 5 (20) | |
Multifocal | 0 | 0 | |
Diffuse in-stent | 8 (40) | 15 (60) | |
Proliferative | 3 (15) | 3 (12) | |
Occlusive | 1 (5) | 2 (8) | |
Index stent type | 0.44 | ||
Bare-metal stent | 15 (75) | 22 (88) | |
Drug-eluting stent | 5 (25) | 3 (12) | |
Index stent diameter, mm | 2.97 ± 0.38 | 3.01 ± 0.47 | 0.64 |
Index stent length, mm | 33.5 ± 14.5 | 28.6 ± 13.3 | 0.26 |
DIOR (n = 20) | IN.Pact Falcon (n = 25) |
p value | |
---|---|---|---|
Predilatation with standard balloon | 20 (100) | 24 (96) | 0.37 |
Predilatation balloon diameter, mm | 3.1 ± 0.4 | 2.9 ± 0.4 | 0.07 |
Predilatation balloon length, mm | 17.4 ± 5.4 | 20.7 ± 7.9 | 0.26 |
Predilatation pressure, ATM | 14.8 ± 4.5 | 14.2 ± 5.0 | 0.71 |
>1 DEB used per lesion | 2 (10) | 6 (24) | 0.27 |
DEB diameter, mm | 3.2 ± 0.4 | 3.1 ± 0.3 | 0.34 |
2.50 | 2 (10) | 1 (4) | |
2.75 | 0 | 3 (12) | |
3.00 | 9 (45) | 13 (52) | |
3.50 | 8 (40) | 8 (32) | |
4.00 | 1 (5) | 0 | |
DEB length, mm | 27.3 ± 9.4 | 32.4 ± 12.0 | 0.10 |
DEB inflation pressure, ATM | 10.8 ± 3.0 | 11.3 ± 3.0 | 0.54 |
DEB inflation time, s | 58.0 ± 5.3 | 52.0 ± 13.2 | 0.18 |
Postdilatation with standard balloon | 3 (15) | 1 (4) | 0.31 |
Maximum balloon diameter to index stent diameter ratio | 1.09 ± 0.08 | 1.07 ± 0.09 | 0.34 |
Additional stenting | 1 (5) | 2 (8) | 0.69 |
Angiographic success | 20 (100) | 25 (100) | |
Device success | 18 (90) | 23 (92) | 0.69 |
Procedural success | 20 (100) | 25 (100) |
Angiographic outcomes and clinical follow-up
DIOR (n = 20) | IN.Pact Falcon (n = 25) |
p value | |
---|---|---|---|
Preprocedural | |||
Reference vessel diameter, mm | 2.32 ± 0.51 | 2.35 ± 0.46 | 0.82 |
Minimal lumen diameter, mm | 0.59 ± 0.28 | 0.58 ± 0.38 | 0.98 |
Diameter stenosis, % | 75.0 ± 12.5 | 75.3 ± 16.1 | 0.94 |
Lesion length, mm | 23.7 ± 9.5 | 26.4 ± 12.6 | 0.52 |
Fractional flow reserve | 18 (90) | 22 (88) | |
Distal of the stent | 0.65 ± 0.11 | 0.58 ± 0.17 | 0.31 |
In-stent gradient | 0.33 ± 0.12 | 0.37 ± 0.18 | 0.54 |
Postprocedural | |||
Minimal lumen diameter, mm | 1.88 ± 0.62 | 1.83 ± 0.47 | 0.79 |
Diameter stenosis, % | 20.3 ± 9.17 | 27.5 ± 15.9 | 0.20 |
Acute gain, mm | 1.29 ± 0.50 | 1.26 ± 0.61 | 0.85 |
Residual binary stenosis | 0 | 2 (8) | 0.50 |
Fractional flow reserve | 20 (100) | 25 (100) | |
Distal of the stent | 0.93 ± 0.05 | 0.92 ± 0.05 | 0.35 |
In-stent gradient | 0.05 ± 0.03 | 0.06 ± 0.04 | 0.40 |
Follow-up | 18 (90) | 23 (92) | |
Minimal lumen diameter in-stent, mm | 1.46 ± 0.68 | 1.83 ± 0.62 | 0.064 |
Minimal lumen diameter in-segment, mm | 1.41 ± 0.66 | 1.69 ± 0.56 | 0.11 |
Diameter stenosis in-stent, % | 40.1 ± 23.9 | 26.0 ± 18.3 | 0.049 |
Diameter stenosis in-segment, % | 41.3 ± 22.6 | 30.7 ± 16.2 | 0.083 |
Late lumen loss in-stent, mm | 0.41 ± 0.54 | 0.01 ± 0.43 | 0.026 |
Late lumen loss in-segment, mm | 0.36 ± 0.48 | -0.03 ± 0.43 | 0.014 |
Binary restenosis in-stent | 7 (39) | 4 (17) | 0.16 |
Binary restenosis in-segment | 7 (39) | 4 (17) | 0.16 |
Fractional flow reserve | 18 (90) | 23 (92) | |
Distal of the stent | 0.84 ± 0.13 | 0.92 ± 0.07 | 0.029 |
In-stent gradient | 0.13 ± 0.12 | 0.05 ± 0.05 | 0.002 |
6-months clinical outcome | 20 (100) | 25 (100) | |
Cardiac death | 0 | 0 | |
Myocardial infarction | 0 | 0 | |
Stent thrombosis | 0 | 0 | |
Target lesion revascularization | 7 (35) | 2 (8) | 0.057 |
Fractional flow reserve and optical coherence tomography
DIOR (n = 20) | IN.pact falcon (n = 25) |
p value | |
---|---|---|---|
Preprocedure | 16 (80) | 19 (76) | |
Stent length analyzed, mm | 23.9 [20.1–30.0] | 22.0 [15.4–35.7] | 0.29 |
Mean lumen area, mm2
| 3.1 [2.3–4.5] | 3.6 [2.7–4.5] | 0.32 |
Minimal lumen area, mm2
| 1.1 [0.7–1.4] | 1.3 [0.9–1.8] | 0.13 |
Mean stent area, mm2
| 6.5 [5.6–8.5] | 7.2 [6.2–8.9] | 0.31 |
Minimal stent area, mm2
| 5.3 [3.6–7.2] | 5.4 [4.4–7.1] | 0.32 |
Mean neointimal area stenosis, % | 50.7 [35.4–66.1] | 53.0 [43.7–58.9] | 0.90 |
Maximum neointimal area stenosis, % | 80.4 [74.2–88.7] | 82.8 [73.6–85.9] | 0.79 |
Lumen volume, mm3
| 89.7 [45.8–103.4] | 77.4 [60.5–129.1] | 0.92 |
Stent volume, mm3
| 156 [132–227] | 176 [124–217] | 0.92 |
Neointimal volume, mm3
| 66.4 [53.8–134] | 87.4 [69.4–102] | 0.53 |
Neointima occupied stent volume, % | 51.5 [34.9–65.1] | 53.2 [40.8–58.1] | 0.95 |
Postprocedure | 20 (100) | 25 (100) | |
Stent length analyzed, mm | 23.9 [19.7–29.9] | 21.8 [15.6–32.0] | 0.40 |
Mean lumen area, mm2
| 5.0 [4.1–6.8] | 6.2 [5.5–7.1] | 0.093 |
Minimal lumen area, mm2
| 3.3 [2.6–4.7] | 4.7 [3.0–5.4] | 0.10 |
Mean stent area, mm2
| 7.4 [6.0–9.7] | 9.8 [8.8–11.0] | 0.016 |
Minimal stent area, mm2
| 6.1 [4.1–8.5] | 8.2 [7.5–9.2] | 0.024 |
Mean neointimal area stenosis, % | 28.3 [24.4–40.4] | 33.5 [30.3–36.8] | 0.58 |
Maximum neointimal area stenosis, % | 47.8 [37.8–55.2] | 48.3 [43.1–50.8] | 0.96 |
Neointima occupied stent volume, % | 28.2 [24.8–40.2] | 33.6 [29.0–37.4] | 0.38 |
Follow-up | 17 (85) | 22 (88) | |
Stent length analyzed, mm | 23.8 [21.2–31.7] | 22.4 [18.1–32.8] | 0.28 |
Mean lumen area, mm2
| 4.6 [3.4–6.1] | 6.0 [5.2–7.8] | 0.008 |
Minimal lumen area, mm2
| 2.4 [1.8–3.7] | 4.0 [3.1–6.0] | 0.009 |
Mean stent area, mm2
| 7.6 [6.1–9.5] | 9.1 [7.5–11.5] | 0.066 |
Minimal stent area, mm2
| 6.5 [4.4–8.0] | 7.7 [5.3–9.8] | 0.16 |
Mean neointimal area stenosis, % | 42.8 [23.7–55.3] | 31.6 [24.9–37.5] | 0.011 |
Maximum neointimal area stenosis, % | 66.4 [49.9–76.6] | 47.7 [37.3–60.7] | 0.010 |
Neointima occupied stent volume, % | 41.7 [26.0–55.1] | 30.5 [23.7–36.5] | 0.047 |
DIOR (n = 20) | IN.pact falcon (n = 25) | Crude p value | Adjusted p value* | |
---|---|---|---|---|
Quantitative coronary angiography | 18 (90) | 23 (92) | ||
Minimal lumen diameter change, % | –10.4 [–42.3 to 4.7] | 4.8 [−7.7 to 16.8] | 0.034 | 0.26 |
Diameter stenosis change, % | 28.6 [−7.1 to 187] | 2.6 [−49.7 to 67.6] | 0.032 | 0.32 |
Optical coherence tomography | 17 (85) | 21 (84) | ||
Minimal lumen area change, % | −30.2 [−49.5 to 2.6] | −13.4 [−21.8 to 19.4] | 0.048 | 0.097 |
Maximal neointimal area change, % | 33.8 [6.2 to 72.0] | −8.9 [−21.0 to 33.0] | 0.002 | 0.007 |
Maximal neointimal area stenosis change, % | 35.8 [8.7 to 59.1] | 14.6 [−21.7 to 36.6] | 0.014 | 0.009 |
Lumen volume change, % | −14.6 [−34.0 to 1.7] | 2.89 [−14.0 to 18.6] | 0.011 | 0.026 |
Stent volume change, % | −0.7 [−3.0 to 2.7] | −1.6 [−6.9 to 5.9] | 0.67 | 0.77 |
Neointimal volume change, % | 27.2 [1.1 to 58.6] | −15.8 [−36.7 to 28.3] | 0.006 | 0.028 |
Fractional flow reserve | 17 (85) | 22 (88) | ||
FFR stent gradient change, % | 69.0 [0.0 to 238] | −40.8 [−58.9 to 18.8] | 0.003 | 0.46 |