BeStent in Small Arteries Trial - BESMART
BeStent in Small Arteries Trial (BESMART) was a multicenter randomized trial designed to evaluate the efficacy of stenting versus balloon angioplasty in patients undergoing percutaneous coronary intervention of de novo focal lesions in small coronary artery vessels.
Compared to balloon angioplasty alone in small coronary arteries, stenting would be associated with reduced rates of angiographic restenosis at six months compared to standard balloon angioplasty.
Patients Enrolled: 381
Mean Follow Up: Six-month clinical follow-up and repeat angiogram
Mean Patient Age: Mean 62
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.
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.
Restenosis rate defined as a stenosis ≥50% measured by quantitative coronary angiography (QCA) on the follow-up angiogram
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
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%.
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).
Data from 381 patients were analyzed. There was a greater prevalence of diabetes and hypertension in the stent group, with a greater prevalence of multivessel disease in the angioplasty group; the majority of lesions were ACC/AHA type A or B1 lesions, and angiographic lesion characteristics were well-balanced across study groups. There were no differences in angiographic procedural success between the two groups, although 22.7% (45/198) of lesions in the angioplasty group required crossover to stents (analyzed by intention-to-treat).
Minimum lumen diameter (MLD) was greater, and percentage of stenosis was less in the stent group versus the angioplasty group both acutely and at six months (six-month MLD: 1.43 mm vs. 1.19 mm; six-month percent stenosis 38% vs. 50%, p=0.0001 for both). The restenosis rate was lower in the stent group (21% vs. 47%, risk reduction [RR] 55%, p=0.0001), and the RR was independent of vessel size.
Rates of in-hospital major adverse cardiac events (MACE), bleeding, and clinical procedural success were similar in both groups. At six months, repeat target vessel revascularization was less frequent in the stent group (13% vs. 25%, p=0.006), with an overall lower MACE rate (24% vs. 45%, p=0.002).
Among patients with a de novo lesion in arteries <3 mm, treatment with stenting compared to standard balloon angioplasty was associated with lower rates of restenosis and repeat target vessel revascularization. Although other studies (e.g., ISAR-SMART) have demonstrated similar rates of restenosis with stents versus angioplasty in small coronary arteries, this trial enrolled patients with less complex, focal lesions in larger vessels, which may explain in part the differences in outcome between the studies.
Koning R, Eltchaninoff H, Commeau P, et al., on behalf of the BESMART (BeStent in Small Arteries) Trial Investigators. Stent placement compared with balloon angioplasty for small coronary arteries: in-hospital and 6-month clinical and angiographic results. Circulation 2001;104:1604-8.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Prevention, Hypertension
Keywords: Prevalence, Risk Reduction Behavior, Intention to Treat Analysis, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Hypertension, Diabetes Mellitus, Stents, Nitroglycerin
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