Table 1

Baseline Clinical Characteristics of Randomized Patients

Tryton Stent
(N = 355)
Provisional
(N = 349)
p Value
Age, yrs64.5 ± 10.664.6 ± 9.40.92
Male255/355 (71.8)256/349 (73.4)0.67
Smoking history0.62
 Current smoker62/355 (17.5)53/348 (15.2)
 Former smoker123/355 (34.6)125/348 (35.9)
 Never170/355 (47.9)170/348 (48.9)
Diabetes mellitus85/355 (23.9)98/349 (28.1)0.23
Hypertension260/355 (73.2)256/348 (73.6)0.93
Hyperlipidemia260/351 (74.1)266/344 (77.3)0.33
Family history of premature CAD114/309 (36.9)101/311 (32.5)0.27
Prior MI105/350 (30.0)131/347 (37.8)0.03
Prior PCI135/355 (38.0)146/349 (41.8)0.32
Prior CABG9/353 (2.5)7/349 (2.0)0.80
History of congestive heart failure6/355 (1.7)3/349 (0.9)0.51
Prior stroke8/350 (2.3)13/343 (3.8)0.28
Prior transient ischemic attack10/351 (2.8)8/346 (2.3)0.81
Renal insufficiency on dialysis0/355 (0.0)1/348 (0.3%)0.49
Atrial fibrillation38/354 (10.7)24/348 (6.9)0.08
Mean left ventricular ejection fraction, %57.7 ± 9.657.5 ± 9.90.81
Clinical presentation0.94
 Stable angina262/355 (73.8)261/349 (74.8)
 ACS-UA71/355 (20.0)69/349 (19.8)
 Silent ischemia20/355 (5.6)18/349 (5.2)
 No angina2/355 (0.6)1/349 (0.3)
Functional test showing ischemia126/201 (62.7)117/185 (63.2)0.92
Access site0.60
 Femoral231/355 (65.1)225/349 (64.5)
 Radial123/355 (34.6)124/349 (35.5)
 Other1/355 (0.3)0/349 (0.0)
Number of vessels with ≥50% stenosis0.12
 1-vessel disease239/355 (67.3)217/349 (62.2)
 2-vessel disease98/355 (27.6)105/349 (30.1)
 3-vessel disease18/355 (5.1)27/349 (7.7)
Medina classification (site reported)0.51
 1,1,1260/355 (73.2)239/348 (68.7)
 1,0,141/355 (11.5)43/348 (12.4)
 0,1,152/355 (14.6)65/348 (18.7)
 1,1,0 or 1,0,0 or 0,1,0 or 0,0,12/355 (0.6)1/348 (0.3)
Antiplatelet therapy pre-loading before index procedure298/355 (83.9)299/349 (85.7)0.53

Values are mean ± SD or n/N (%).

ACS-UA = acute coronary syndrome-unstable angina; CABG = coronary artery bypass graft; CAD = coronary artery disease; MI = myocardial infarction; PCI = percutaneous coronary intervention.

  • Site reported.

  • Not true bifurcation.