Table 1.
Baseline characteristics in patients with or without primary outcome at 30 days
| Stroke or death at 30 days (N = 30) | Non-Stroke or death at 30 days (N = 183) | P-value | |
|---|---|---|---|
| Patient associated variables | |||
| Age (mean SD) | 64.7 ± 9.4 | 60.4 ± 10.8 | 0.042 |
| Sex (% women) | 56.7% (17) | 39.3% (72) | 0.109 |
| Body Mass Index (mean +/− SD) | 30.0 ± 5.2 | 30.6 ± 6.3 | 0.636 |
| Ethnicity (% Hispanic/Latino) | 10.0%% (3) | 8.7% (16) | 0.736 |
| Race | 0.231 | ||
| Caucasian (%) | 86.7% (26) | 69.9% (128) | |
| African American (%) | 10.0% (3) | 25.7% (47) | |
| Asian | 0% (0) | 2.2% (4) | |
| History of Hypertension (%) | 90.0% (27) | 89.1% (163) | 1.000 |
| History of Diabetes (%) | 60.0% (18) | 39.3% (72) | 0.045 |
| History of Hyperlipidemia (%) | 90.0% (27) | 86.9% (159) | 1.000 |
| Active or Ex-smoking (%) | 33.3% (10/30) | 65.4% (119/182) | 0.001 |
| Moderate/Vigorous Physical activity (%) | 16.7% (5/30) | 23.2% (42/181) | 0.488 |
| Infection within 30 days (%) | 6.7% (2) | 13.1% (24) | 0.546 |
| History of coronary artery disease (%) | 23.3% (7) | 19.1% (35) | 0.622 |
| History of congestive heart failure (%) | 10.0% (3) | 1.1% (2) | 0.021 |
| History of peripheral vascular disease* (%) | 3.3% (1) | 3.8% (7) | 1.000 |
| History of ischemic stroke (%) | 46.7% (14) | 24.0% (44) | 0.014 |
| Taking aspirin at the time of event (%) | 63.3% (19) | 52.5% (96) | 0.325 |
| Taking Plavix at the time of event (%) | 20.0% (6) | 21.3% (39) | 1.000 |
| Statin within 7 days of enrollment (%) | 83.3% (25) | 84.2% (154) | 0.611 |
| Baseline modified Rankin Scale (median, IQR) | 1 (2) | 1 (2) | 0.912 |
| NIHSS score (median, IQR) | 0 (3) | 1 (2) | 0.960 |
| Glucose (mean +/− SD) | 141.7 ± 66.3 | 122.9 ± 48.8 | 0.066 |
| HbA1C (mean +/− SD) | 7.9 ± 2.4 | 6.9 ± 1.8 | 0.051 |
| Total Cholesterol (mean +/− SD) | 164.4 ± 65.3 | 152.3 ± 41.8 | 0.191 |
| LDL cholesterol (mean +/− SD) | 102.9 ± 51.5 | 95.1 ± 35.9 | 0.318 |
| HDL cholesterol (mean +/− SD) | 37/5 ± 11.5 | 37.6 ± 10.5 | 0.953 |
| Systolic Blood Pressure (mean +/− SD) | 146.4 ± 23.4 | 143.3 ± 19.6 | 0.458 |
| Diastolic Blood Pressure (mean +/− SD) | 76.3 ± 10.1 | 78.0 ± 10.6 | 0.458 |
| Stroke as qualifying event (%) | 53.3% (16) | 64.5% (118) | 0.308 |
| Time from qualifying event to enrollment | 10.9 ± 8.0 | 10.3 ± 7.8 | 0.693 |
| Acute or subacute infarcts in the arterial territory (%) | 53.6% (15/28) | 63.8% (113/177) | 0.302 |
| Lesion related variables | |||
| Symptomatic artery | 0.522 | ||
| ICA | 20.0% (6) | 18.6% (34) | |
| MCA (M1 segment) | 30.0% (9) | 43.7% (80) | |
| Vertebral | 20.0% (6) | 16.4% (30) | |
| Basilar | 30.0% (9) | 21.3% (39) | |
| Affected side (% left) | 65.2% (14/21) | 54.9% (79/144) | 0.354 |
| Perforator segment involved (%) | 63.3% (19/30) | 50.6% (92/182) | 0.238 |
| Degree of stenosis by central reader (mean +/− SD) | 75.4 ± 9.0 | 73.9 ± 9.3 | 0.120 |
| Length of lesion (mean +/− SD) | 8.2 ± 3.3 | 7.0 ± 2.8 | 0.036 |
| Lesion length > 10 mm (%) | 33.3% (10) | 11.5% (21) | 0.004 |
| Diameter of lesion (mean +/− SD) | 0.58 ± 0.27 | 0.63 ± 0.30 | 0.390 |
| Procedure related variables | |||
| Type of anesthesia (% conscious sedation) | 0.0% (0/33) | 1.1% (2/183) | 1.00 |
| Time from enrollment to stent | 1.4 ± 1.3 | 1.6 ± 2.4 | |
| Time from qualifying event to stent | 11.7 ± 8.2 | 11.9 ± 8.4 | 0.764 |
| Stent Diameter (mean +/− SD) | 3.5 ± 0.7 | 3.4 ± 0.7 | 0.595 |
| Stent length (mean +/− SD) | 16.7 ± 3.2 | 15.6 ± 3.3 | 0.117 |
| Balloon Diameter (mean +/− SD) | 2.4 ± 0.6 | 2.4 ± 0.6 | 0.927 |
| Balloon Length (mean +/− SD) | 13.4 ± 4.1 | 12.8 ± 3.5 | 0.339 |
| First inflation pressure (mean +/− SD) | 6.5 ± 1.4 | 6.3 ± 1.6 | 0.666 |
| Last inflation pressure (mean +/− SD) | 8.1 ± 1.8 | 7.2 ± 2.9 | 0.350 |
| Number of Stents Placed (median, IQR) | 1 (0) | 1 (0) | 0.280 |
| Number of Balloons Introduced (median IQR) | 1 (0) | 1 (0) | 0.923 |
| Number of Inflations (median IQR) | 1 (1) | 1 (1) | 0.858 |
| Activated clotting time within target (%) | 55.2% (16/29) | 49.4% (87/176) | 0.689 |
| Percent stenosis after stenting (mean +/− SD) | 36.1 ± 17.0 | 37.0 ± 14.0 | 0.748 |
| Duration of procedure (mean +/− SD) | 99.8 ± 54.8 | 102.3 ± 54.1 | 0.818 |
| FDA approved indications | |||
| Age 22–80 years | 100% (30) | 100% (183) | 1.000 |
| Baseline mRS 3 or less | 100% (30) | 100% (183) | 1.000 |
| Stent 7 days or more from event | 66.7% (20) | 69.9% (128) | 0.831 |
| 70–99% stenosis on central adjudication | 86.7% (26) | 73.8% (135) | 0.169 |