Direct Coronary Stenting Versus Stenting With Balloon Predilation: Immediate and Follow-Up Results - DISCO

Description:

Direct Stenting of Coronary Arteries (DISCO) was a randomized, multicenter trial of direct stenting compared to conventional predilation with a balloon catheter in patients with coronary artery stenoses.

Hypothesis:

Direct stenting will be as safe and effective for treatment of selected coronary artery stenoses as predilation.

Study Design

Study Design:

Patients Enrolled: 416
Mean Follow Up: One year
Mean Patient Age: 20-75
Female: 15

Patient Populations:

Presence of one or two lesions in different coronary arteries, vessel reference diameter >2.7 mm, stenosis >60%, and lesion length <15 mm by visual evaluation

Exclusions:

Acute MI within the last 48 hours, contraindication to antithrombotic therapy, ejection fraction <30%, left main lesion, severe tortuosity or calcification, totally occluded vessel, bifurcation lesions, or restenotic lesions

Primary Endpoints:

Procedural success rate; restenosis rate; and adverse events at one, six, and 12 months

Drug/Procedures Used:

Patients with angina or objective evidence of ischemia (excluding myocardial infarctions [MIs]) were randomized to direct stenting or conventional predilation with a balloon catheter followed by stenting. Second generation tubular premounted stents (nondrug-eluting) were used. Postdilation was performed if deemed necessary by the operator.

Principal Findings:

At baseline, the groups were well matched in terms of age, gender, indication of percutaneous transluminal coronary angioplasty (PTCA), comorbidities, and lesion characteristics (location, type tortuosity). Direct stenting was successful in 97% of cases. In 3% of cases (seven patients), the lesion had to be predilated to deliver the stent. All patients in the predilation arm were successfully stented. There were no major procedural complications in the direct stenting arm. The predilation arm had four patients that developed thrombotic occlusion of the stent (p=0.04). There were no in-hospital deaths in either arm. Maximum creatine kinase (CK) level and rates of CK elevation were similar between arms.

At one-year follow-up, rates of MI, death, and major adverse cardiac events (MACE) were similar between groups. MACE was 15.2% for direct stenting versus 16.9% for predilation (p=0.89). MI was 1.5% for direct stenting versus 3.7% for predilation (p=0.18).

Follow-up angiography was performed for 409 lesions at a mean follow-up time of 6.3 months. There were no significant differences between groups for minimum luminal diameter, percentage stenosis, acute gain, late loss, net gain, or loss index.

Interpretation:

Among patients with coronary artery stenoses, direct stenting was associated with similar rates of procedural success and adverse events compared to predilation for selected coronary lesions. A major limitation of the study is that only simple coronary lesions (<15 mm in length, no calcification, minimal tortuosity, and reference diameter >2.7 mm in patients not having an acute MI) were evaluated. These results may not apply to more complex stenoses.

References:

Martinez-Elbal L, Ruiz-Nodar JM, Zueco J, et al. Direct coronary stenting versus stenting with balloon pre-dilation: immediate and follow-up results of a multicentre, prospective, randomized study. The DISCO trial. DIrect Stenting of COronary Arteries. Eur Heart J 2002;23:633-40.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Follow-Up Studies, Creatine Kinase, Coronary Stenosis, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Stents


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