Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention.

BACKGROUND: Drug-eluting coronary-artery stents have been shown to decrease restenosis and therefore the likelihood that additional procedures will be required after percutaneous coronary intervention (PCI). We evaluated the use of a drug-eluting stent in patients undergoing PCI for acute myocardial infarction with ST-segment elevation. METHODS: We randomly assigned 619 patients presenting with an acute myocardial infarction with ST-segment elevation to receive either a paclitaxel-eluting stent or an uncoated stent. The primary end point was a composite of death from cardiac causes, recurrent myocardial infarction, or target-lesion revascularization at 1 year. RESULTS: Baseline clinical and angiographic characteristics in both groups were well matched. There was a trend toward a lower rate of serious adverse events in the paclitaxel-stent group than in the uncoated-stent group (8.8% vs. 12.8%; adjusted relative risk, 0.63; 95% confidence interval, 0.37 to 1.07; P=0.09). A nonsignificant trend was also detected in favor of the paclitaxel-stent group, as compared with the uncoated-stent group, in the rate of death from cardiac causes or recurrent myocardial infarction (5.5% vs. 7.2%, P=0.40) and in the rate of target-lesion revascularization (5.3% vs. 7.8%, P=0.23). The incidence of stent thrombosis during 1 year of follow-up was the same in both groups (1.0%). CONCLUSIONS: Although the use of paclitaxel-eluting stents in acute myocardial infarction with ST-segment elevation reduced the incidence of serious adverse cardiac events at 1 year by 4.0 percentage points, as compared with uncoated stents, the difference was not statistically significant. (Current Controlled Trials number, ISRCTN65027270 [controlled-trials.com].).

Early discharge is feasible following primary percutaneous coronary intervention with transradial stent implantation under platelet glycoprotein IIb/IIIa receptor blockade. Results of the AGGRASTENT Trial.

BACKGROUND: Primary percutaneous coronary intervention (PCI) with stent implantation demonstrated to be superior to both PCI with balloon angioplasty and to thrombolysis for acute ST-elevation myocardial infarction (STEMI). The use of glycoprotein (GP) IIb-IIIa blockers in this setting may be beneficial. However, GP IIb-IIIa receptor blocker treatment is frequently accompanied by femoral entry site-related bleeding complications, resulting in additional morbidity and prolonged hospitalization. These complications are minimized by using the transradial approach (TRA). METHODS: This study prospectively explored the feasibility of early discharge (within 4 days) following primary PCI with transradial stent implantation under GP IIb-IIIa blockade with tirofiban in the setting of STEMI. One-hundred patients with STEMI eligible for PCI were included. RESULTS: Of these 100 patients, 62% received treatment according to the protocol, e.g., TRA, successful PCI with stent implantation, full-dose GP IIb/IIIa receptor blocker infusion and early discharge. The PCI was successful in 95%. Early discharge was achieved in 75 patients of the total study population. Major adverse cardiac and cerebral events (MACCE) did not occur in the early discharge group, with a 1-year event-free survival rate of 91%. The combined MACCE rates in the total study population at 1, 6, and 12 months were 8%, 15% and 20%, respectively. CONCLUSION: Early discharge is feasible following primary PCI with stent implantation via the radial artery under GP IIb-IIIa blockade for STEMI, however a larger study is needed to prove the efficacy of this strategy.

Lack of efficacy of clopidogrel pre-treatment in the prevention of myocardial damage after elective stent implantation.

OBJECTIVES: The object of this study was to determine the effect of pre-treatment with clopidogrel in patients undergoing elective stent implantation. BACKGROUND: The treatment of patients with adenosine diphosphate receptor blockers after percutaneous coronary intervention (PCI) with stent implantation has been shown to decrease the incidence of subacute stent thrombosis. Furthermore, non-randomized studies on pre-treatment with clopidogrel among patients undergoing stent implantation have suggested a reduction in myocardial damage and clinical events. The effect of pre-treatment with clopidogrel has been studied in only a few randomized trials. METHODS: In a randomized trial, three days of pre-treatment with clopidogrel was compared with standard post-procedural treatment in 203 patients undergoing elective stent implantation. The primary end point was a rise in troponin I or creatine kinase-MB fraction (CK-MB) serum levels at 6 to 8 and 16 to 24 h after PCI. Secondary end points were death, stroke, myocardial infarction, coronary bypass grafting, repeated PCI, and subacute stent thrombosis at one and six months after PCI. RESULTS: No difference was found between non-pre-treated and pre-treated patients in the post-procedural elevation of troponin I (42 [43.3%] vs. 48 [51.1%], respectively, p = 0.31) or CK-MB (6 [6.3%] vs. 7 [7.4%], respectively, p = 0.78). Adjustment for possible confounding factors did not change these findings. Patient follow-up at one and six months showed no significant difference between the treatment groups in death, stroke, myocardial infarction, coronary artery bypass grafting, repeated PCI, or subacute stent thrombosis. CONCLUSIONS: In this randomized study, no beneficial effect of pre-treatment with clopidogrel on post-procedural elevation of troponin I and CK-MB or on clinical events after one and sixth months could be demonstrated. The study suggests that among patients with stable coronary syndromes in whom coronary stent implantation is planned, pre-treatment may not be beneficial in reducing early myocardial damage.