Five-year follow-up of the Argentine randomized trial of coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II).

OBJECTIVES: The purpose of the present study is to report the five-year follow-up results of the ERACI II trial. BACKGROUND: Immediate and one-year follow-up results of the ERACI II study showed a prognosis advantage of percutaneous coronary intervention (PCI) with stents over coronary artery bypass grafting (CABG). METHODS: A total of 450 patients were randomly assigned to undergo either PCI (n = 225); or CABG (n = 225). Only patients with multi-vessel disease were enrolled. Clinical follow-up during five years was obtained in 92% of the total population after hospital discharge. The primary end point of the study was to compare freedom from major adverse cardiovascular events (MACE) at 30 days, 1 year, 3 years, and 5 years of follow-up. RESULTS: At five years of follow-up, patients initially treated with PCI had similar survival and freedom from non-fatal acute myocardial infarction than those initially treated with CABG (92.8% vs. 88.4% and 97.3% vs. 94% respectively, p = 0.16). Freedom from repeat revascularization procedures (PCI/CABG) was significantly lower with PCI compared with CABG (71.5% vs. 92.4%, p = 0.0002). Freedom from MACE was also significantly lower with PCI compared with CABG (65.3% vs. 76.4%; p = 0.013). At five years similar numbers of patients randomized to each revascularization procedure were asymptomatic or with class I angina. CONCLUSIONS: At five years of follow-up, in the ERACI II study, there were no survival benefits from any revascularization procedure; however patients initially treated with CABG had better freedom from repeat revascularization procedures and from MACE.

Latin American randomized trial of balloon angioplasty vs coronary stenting for small vessels (LASMAL): immediate and long-term results.

PURPOSE: To assess the potential role of coronary stent to improved acute success and reduce late restenosis in lesions with reference diameter <2.9 mm using a bare metal stent specifically designed for small coronary vessels. There is controversy on the results among previous studies comparing bare metal stent implantation with conventional balloon percutaneous transluminal coronary angioplasty (PTCA). Differences in baseline characteristics, inclusion and exclusion criteria, and stent design may account for these discrepancies. METHODS: The population of this multicenter, multinational randomized study (LASMAL) consisted of 246 patients undergoing percutaneous coronary intervention of small vessel reference diameter. They were randomized into 2 strategies of percutaneous revascularization: elective primary stent (n = 124) or conventional balloon PTCA with provisional stenting (n = 122) in the presence of acute, threatened closure or flow-limiting dissections. RESULTS: The clinical success rate was significantly better for the stent group (98.3% vs 91.8%; P = 0.038). At 30 days follow-up, requirements of target vessel revascularization (TVR) (6.6% vs 0.8%; P = 0.018) and incidence of major adverse cardiac and cerebrovascular events (MACCE) (9.8% vs 2.4%; P = 0.01) was significantly lower in the stent strategy. Postpercutaneous coronary intervention minimal luminal diameter (MLD) was significantly larger in the stent group (2.3 +/- 0.2 mm vs 2.2 +/- 0.2 mm; P = 0.003). At follow-up, MLD in the stent group was larger than with PTCA (1.7 +/- 0.7 mm vs 1.5 +/- 0.7 mm, respectively; P = 0.035). Net gain was also significantly better with stent strategy (1.1 +/- 0.7 mm vs 0.8 +/- 0.7 mm, respectively; P = 0.002). Stenting resulted in a significant lower angiographic binary restenosis (20% vs 31%; P = 0.02) than PTCA. Furthermore, patients treated with stent were more frequently free from MACCE at 9-month follow-up (death, acute myocardial infarction [AMI], stroke, repeat revascularization procedures) than those treated initially with PTCA (82.2% vs 72% of PTCA, P = 0.046). CONCLUSIONS: The use of a specifically designed bare metal coronary phosphoril choline-coated stent as primary device during percutaneous interventions in small coronary arteries was associated with high procedural success and low in-hospital and 30-day follow-up complications. At long-term follow-up, patients initially treated with stents had lower angiographic restenosis rate and were more frequently free from major adverse cardiac events.

A randomized trial comparing primary infarct artery stenting with or without abciximab in acute myocardial infarction.

OBJECTIVES: We sought to evaluate the efficacy of abciximab as adjunctive therapy to routine infarct-related artery (IRA) stenting. BACKGROUND: The impact of abciximab on the efficacy of myocardial reperfusion and the outcome of patients with acute myocardial infarction (AMI) undergoing IRA stenting have not yet been defined. METHODS: In a randomized trial, we assigned 400 patients with AMI to undergo IRA stenting alone or stenting plus abciximab. The primary end point was a composite of death, reinfarction, target vessel revascularization (TVR), and stroke at one month. RESULTS: The incidence of the primary end point was lower in the abciximab group than in the stent only group (4.5% and 10.5%, respectively; p = 0.023), and randomization to abciximab was independently related to the risk of the primary end point (odds ratio 0.41, 95% confidence interval 0.17 to 0.97; p = 0.041). Early ST-segment resolution was more frequent in the abciximab group (85% vs. 68%, p < 0.001). Infarct size, as assessed by one-month technetium-99m sestamibi scintigraphy, revealed smaller infarcts in the abciximab group. At six months, the cumulative difference in mortality between the groups increased (4.5% vs. 8%), and the incidence of the composite of six-month death and reinfarction was lower in the abciximab group than in the stent only group (5.5% and 13.5%, respectively; p = 0.006). Six-month repeat TVR and restenosis rates were similar in the two groups. CONCLUSIONS: Abciximab plus IRA stenting should be considered the routine reperfusion strategy in patients with AMI undergoing primary percutaneous mechanical revascularization, especially in high-risk patients.