Study Design

Study Design:

Patients Enrolled: 381
Mean Follow Up: Six-month clinical follow-up and repeat angiogram
Mean Patient Age: Mean 62
Female: 24

Patient Populations:

Symptomatic ischemic heart disease (angina pectoris, objective evidence of myocardial ischemia, or both) with de novo lesions in small native coronary arteries. Angiographic inclusion criteria were a lesion with ≥50% stenosis in a coronary segment with a diameter <3 mm after intracoronary administration of nitroglycerin, and a lesion <15 mm long, able to be covered by a single stent crimped over a ≤2.5 mm or a noncompliant 2.75 mm diameter balloon.

Exclusions:

Ostial and/or bifurcation lesion, MI within three days, ejection fraction of ≤30%, or contraindication to aspirin or ticlopidine. A maximum of two lesions located in two different main native coronary arteries or branches could be treated in the same patient. Additional angioplasty of other lesions in coronary segments >3 mm in diameter was allowed if located in other coronary artery branches.

Primary Endpoints:

Restenosis rate defined as a stenosis ≥50% measured by quantitative coronary angiography (QCA) on the follow-up angiogram

Secondary Endpoints:

Clinical procedural success defined as angiographic success (reduction in stenosis to <50% by QCA and TIMI 3 flow in the absence of dissection >D1 according to National Heart, Lung, and Blood Institute [NHLBI] criteria) without MACE defined as death, myocardial infarction (MI), or revascularization by repeat angioplasty or coronary bypass surgery; and rate of MACE during the six-month follow-up period

Drug/Procedures Used:

Stenting arm: Stenting with the BeStent Small stent (Medtronic Inc.) designed for 2.5 to 3.0 mm diameter vessels. Before stenting, each lesion was predilated with a 2.5 mm or noncompliant 2.75 mm balloon, 20 mm in length. Balloon size was chosen to reach a balloon to artery ratio close to 1.

Balloon angioplasty arm: Similar balloons were used for percutaneous transluminal coronary angioplasty (PTCA). An optimal angiographic result was defined as a residual stenosis ≤30%. A crossover to stent placement was restricted to a “bail-out” procedure and in the case of a suboptimal result, defined by a residual stenosis >50%.

Concomitant Medications:

Bolus heparin (80 U/kg) administered before the procedure, supplemented according to the investigator. Most patients were pretreated with aspirin (160 to 325 mg daily). In other cases, a dose of 500 mg of aspirin was administered intravenously before the procedure.

After the procedure, patients assigned to stenting received a daily dose of aspirin (100 mg) and an additional daily dose of ticlopidine (500 mg) for one month and a daily dose of aspirin (250 mg) thereafter. Patients assigned to PTCA received a daily dose of aspirin (250 mg).