Table 1.
Baseline Characteristics of Randomized Bare Metal Stent-Treated Patients.*
| Characteristics | Continued Thienopyridine N=842 |
Placebo N=845 |
|---|---|---|
|
| ||
| % (N) reported for non-continuous variable | ||
| Patients | ||
| Age (years), mean ±SD | 58.9 ±10.5 | 59.2 ±11.1 |
| Female | 25.5% (215) | 21.8% (184) |
| Race- non-White** | 7.5% (62) | 7.3% (61) |
| Weight (kg), mean ±SD | 88.0 ±18.4 | 88.5 ±18.8 |
| BMI(Kg/m2), mean ±SD | 29.5 ±5.2 | 29.6 ±5.6 |
| Diabetes mellitus | 21.7% (181) | 20.7% (173) |
| Hypertension | 64.0% (534) | 64.6% (543) |
| Cigarette smoker | 43.3% (360) | 43.3% (350) |
| Stroke/TIA | 5.1% (43) | 4.0% (34) |
| Congestive heart failure | 4.2% (35) | 3.3% (28) |
| Peripheral arterial disease | 4.2% (35) | 5.5% (46) |
| Prior PCI | 17.9% (150) | 20.3% (171) |
| Prior CABG | 6.0% (50) | 5.9% (50) |
| Prior MI | 19.4% (160) | 21.5% (178) |
| Indication for PCI | 58.8% | 58.3% |
| ACS | 58.8% (495) | 58.3% (493) |
| STEMI | 36.9% (311) | 38.3% (324) |
| NSTEMI | 21.9% (184) | 20.0% (169) |
| Unstable Angina*** | 9.1% (77) | 9.6% (81) |
| Stable Angina | 23.6% (199) | 23.4% (198) |
| Other | 8.4% (71) | 8.6% (73) |
| Any risk factor for stent thrombosis | 69.2% (568) | 69.0% (569) |
| Any Clinical | 64.0% (525) | 63.2% (521) |
| Enzyme positive ACS (STEMI or NSTEMI) | 58.8% (495) | 58.3% (493) |
| Renal insufficiency/failure | 3.4% (28) | 2.4% (20) |
| LVEF < 30% | 4.0% (32) | 3.6% (29) |
| Any Lesion-Related | 38.7% (325) | 37.5% (316) |
| > 2 vessels stented | 0.0% (0) | 0.1% (1) |
| > 2 lesions per vessel | 1.1% (9) | 1.0% (8) |
| Lesion length ≥ 30 mm | 6.5% (55) | 6.6% (56) |
| Bifurcation lesion sidebranch ≥ 2.5 mm | 4.5% (38) | 4.0% (34) |
| In-stent restenosis of a DES | 0.4% (3) | 0.7% (6) |
| Vein bypass graft stented | 2.6% (22) | 2.4% (20) |
| Unprotected left main stented | 0.0% (0) | 0.1% (1) |
| Thrombus-containing lesion | 28.9% (243) | 25.9% (219) |
| Prior Brachytherapy | 0.1% (1) | 0.1% (1) |
| Region | ||
| North America | 60.5% (509) | 61.4% (519) |
| Europe | 36.1% (304) | 35.5% (300) |
| Australia or New Zealand | 3.4% (29) | 3.1% (26) |
| Thienopyridine drug at randomization | ||
| Clopidogrel | 86.7% (730) | 86.6% (732) |
| Prasugrel | 13.3% (112) | 13.4% (113) |
| Number of treated lesions, mean ±SD | 1.2 ±0.4 | 1.12 ±0.4 |
| Number of treated vessels, mean ±SD | 1.0 ±0.2 | 1.1 ±0.2 |
| Number of stents, mean ±SD | 1.3 ±0.6 | 1.3 ±0.6 |
| Minimum stent diameter (per subject) | ||
| <3 | 23.9% (201) | 24.4% (206) |
| ≥3 | 76.1% (641) | 75.6% (639) |
| Total stent length (mm), mean ±SD | 24.0 ±13.0 | 23.9 ±13.1 |
| Lesions† | ||
| Treated Vessel | ||
| Left main | 0.0% (0) | 0.1% (1) |
| LAD | 31.6% (308) | 30.9% (306) |
| Right | 44.8% (437) | 45.6% (452) |
| Circumflex | 21.1% (206) | 20.9% (207) |
| Venous graft | 2.5% (24) | 2.5% (25) |
| Arterial graft | 0.0% (0) | 0.0% (0) |
| Modified ACC/AHA lesion class B2 or C | 47.6% (440) | 47.8% (450) |
Abbreviations: ACC, American College of Cardiology; ACS, acute coronary syndrome; AHA, American Heart Association; BMI, body mass index; CABG, coronary artery bypass graft; DES, drug-eluting stent; LAD, left anterior descending; LVEF, left ventricular ejection fraction; MI, myocardial infarction; NSTEMI, non-ST elevation MI; PCI, percutaneous coronary intervention; STEMI, ST-elevation MI; TIA, transient ischemic attack.
For all variables, 0-4% of subjects had missing values.
Race was self-reported.
This category included unstable angina without reported elevation of cardiac enzymes.
A total of 975 lesions were treated in the continued thienopyridine group and 991 in the placebo group.
The definitions of class B2 and class C lesions according to the modified American College of Cardiology (ACC)–American Heart Association (AHA) criteria.23