What does this research mean for the field?

Long-term clopidogrel administration (24 weeks) significantly reduces neointimal formation and restenosis rates compared to a 4-week regimen in patients undergoing percutaneous coronary intervention. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

September 1, 2004

The effect of long-term clopidogrel use on neointimal formation after percutaneous coronary intervention

Structured PICO

Does long-term clopidogrel use reduce neointimal formation in patients undergoing percutaneous coronary intervention for stable angina?

Population

78 patients with typical stable angina pectoris or documented myocardial ischaemia, and with only one angiographic lesion in one native coronary artery undergoing successful stent implantation without predilatation with C-reactive protein levels ≤5 mg/l at 72 h after the procedure.

Intervention

Clopidogrel 75 mg/day and aspirin 300 mg/day continued for 24 weeks total (initial 4 weeks, then maintained for 20 weeks).

Comparator

Placebo and aspirin 300 mg/day for 20 weeks (after an initial 4 weeks of clopidogrel 75 mg/day and aspirin 300 mg/day).

Outcome

In-stent neointimal formation evaluated by intravascular ultrasound imaging (neointimal cross sectional area) at week 24.surrogate

Long-term clopidogrel administration beyond 4 weeks reduces neointimal formation and restenosis after stent implantation in patients without a high-risk systemic inflammatory response.

Abstract

In Brief Objective The purpose of this study was to evaluate the long term effect of clopidogrel-based antiplatelet therapy on neointimal formation. Methods This study comprised 78 patients with typical stable angina pectoris or documented myocardial ischaemia, and with only one angiographic lesion in one native coronary artery undergoing successful stent implantation without predilatation with C-reactive protein levels ≤5 mg/l at 72 h after the procedure. All patients received dual antiplatelet therapy with 75 mg/day clopidogrel and 300 mg/day aspirin for four weeks. Clopidogrel was switched to isochronous placebo in half of the patients (n=39) at the end of the fourth week. This allocation was maintained for 20 weeks, and at week 24 of the study, coronary angiography and intravascular ultrasound imaging were performed again in all cases in order to evaluate the changes that had occurred in the in-stent neointimal formation; rates of restenosis were also recorded Results At the end of the follow-up period, angiographic stenosis diameter and restenosis rates were smaller in the clopidogrel group than in the placebo group (23.3% versus 35.6%, p=0.05 and 5.12% versus 10.25%; p=0.03 respectively); the intravascular ultrasonographic neointimal cross sectional area was also smaller in the clopidogrel group (3.6±2.7 mm2 versus 5.2±2.5 mm2, p=0.03). Conclusions Long-term clopidogrel administration significantly reduced neointimal formation at the stent site as well as reducing major clinical events in patients who did not develop high-risk systemic inflammatory response after percutaneous coronary intervention. We evaluated 78 patients with stable angina pectoris or documented myocardial ischemia, and with only one angiographic lesion in one coronary artery undergoing stent implantation. Dual antiplatelet therapy were applied with 75 mg/day clopidogrel and 300 mg/day aspirin for 4 weeks. Clopidogrel was switched to placebo in half of the patients (n=39), and 20 weeks later, angiography and intravascular ultrasound were repeated. Angiographic stenosis diameter, restenosis rate and intravascular ultrasonographic neointimal cross sectional area were smaller in clopidogrel group than placebo group (23.3% vs 35.6%, P: 0.05; 5.12% vs 10.25%, P: 0.03; 3.6±2.7 mm2 vs 5.2±2.5 mm2, P: 0.03 respectively).

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