Impact of stenting and abciximab in patients with diabetes mellitus undergoing primary angioplasty in acute myocardial infarction (the CADILLAC trial)

We sought to determine the benefits of stent implantation and abciximab in patients with diabetes mellitus and acute myocardial infarction (AMI) who underwent primary angioplasty. In a 2-by-2 factorial design, 2,082 patients with AMI were randomly assigned to balloon angioplasty versus stenting, with or without abciximab. Diabetes was present in 346 patients (16.6%). The primary end point was the composite incidence of death, disabling stroke, reinfarction, and ischemic target vessel revascularization (TVR). The primary end point at 1 year occurred significantly more frequently in diabetic than nondiabetic patients (21.9% vs 16.8%, p <0.02), driven by increased rates of death (6.1% vs 3.9%, p = 0.04) and TVR (16.4% vs 12.7%, p = 0.07). Among patients with diabetes, TVR at 1 year was significantly reduced with routine stenting compared with balloon angioplasty (10.3% vs 22.4%, p = 0.004), with no differences in death, reinfarction, or stroke. Angiographic restenosis was also greatly reduced in diabetics randomized to stenting (21.1% vs 47.6%, p = 0.009). No beneficial effects were apparent with abciximab in diabetic patients at 1 year. Despite the improved outcomes with stenting in patients with diabetes, 1-year mortality remained increased in diabetic patients who received stents compared with nondiabetics (8.2% vs 3.6%, p = 0.005). Thus, routine stent implantation in diabetic patients with AMI significantly reduces restenosis and enhances survival free from TVR, independent of abciximab use, although survival remains reduced compared with survival in nondiabetic patients regardless of reperfusion modality.     

Intracoronary thrombectomy improves myocardial reperfusion in patients undergoing direct angioplasty for acute myocardial infarction

OBJECTIVES: We sought to evaluate the effects of mechanical thrombectomy on myocardial reperfusion during direct angioplasty for acute myocardial infarction (AMI). BACKGROUND: Embolization of thrombus and plaque debris may occur during direct angioplasty for AMI. This may lead to distal vessel or side branch occlusion and to obstructions in the microvascular system, resulting in impaired myocardial reperfusion. Mechanical thrombectomy is used to reduce distal embolization. METHODS: Ninety-two patients with AMI and angiographic evidence of intraluminal thrombus were randomized to either intracoronary thrombectomy followed by stenting or to a conventional strategy of stenting. Thrombectomy was performed using the X-Sizer catheter (EndiCOR Inc., San Clemente, California). Myocardial reperfusion was assessed by myocardial blush and ST resolution. RESULTS: Postprocedure Thrombolysis in Myocardial Infarction-3 flow was not different between groups (93.5% vs. 95.7%, p = 0.39). Myocardial blush-3 was observed in 71.7% of patients undergoing thrombectomy and in 36.9% of patients undergoing conventional strategy (p = 0.006). ST-segment resolution >or=50% occurred more often in patients undergoing thrombectomy (82.6% vs. 52.2%, p = 0.001). By multivariate analysis, adjunctive thrombectomy was an independent predictor of blush-3 (odds ratio, 3.27; 95% confidence interval, 1.06 to 10.05; p = 0.039). CONCLUSIONS: Intracoronary thrombectomy as adjunct to stenting during direct angioplasty for AMI improves myocardial reperfusion as assessed by myocardial blush and ST resolution.     

A randomized trial of coronary stenting versus balloon angioplasty as a rescue intervention after failed thrombolysis in patients with acute myocardial infarction

OBJECTIVES: This study was conducted to assess whether coronary stenting produces better results compared with balloon angioplasty in patients with acute myocardial infarction (AMI) after failed thrombolysis. BACKGROUND: Little evidence exists on the value of rescue mechanical reperfusion after failed thrombolysis. METHODS: This open-label, randomized study enrolled 181 patients with AMI referred for failed thrombolysis performed within the previous 24 h. The patients had to have a Thrombolysis In Myocardial Infarction (TIMI) flow grade of 相似文献   

Usefulness of routine unfractionated heparin infusion following primary percutaneous coronary intervention for acute myocardial infarction in patients not receiving glycoprotein IIb/IIIa inhibitors

We evaluated the utility of a routine postprocedure course of unfractionated heparin after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in patients not receiving glycoprotein IIb/IIIa inhibitors. In the CADILLAC study, 2,082 patients with AMI who underwent primary PCI were randomized to receive stents versus percutaneous transluminal coronary angioplasty (PTCA), each with or without abciximab. In a subset of 976 patients who did not receive abciximab, we compared outcomes of patients who received postprocedural heparin (n = 758; 78%; median duration 2 days) with those who did not. In 421 patients treated with PTCA, postprocedural heparin use was associated with lower in-hospital major adverse cardiac events (MACEs; 5.3% vs 11.4%, p = 0.069), 1-year MACEs (22% vs 31%, p = 0.08), and decreased in-hospital moderate/severe bleeding (2.3% vs 8.9%, p = 0.01). By multivariate analyses, heparin use correlated with freedom from in-hospital and 1-year MACEs in patients after PTCA. In contrast, in 555 patients who underwent stenting, postprocedural heparin use was associated with increased bleeding and hospitalization costs without a decrease in early or late MACEs. In conclusion, in patients with AMI treated with coronary stenting without glycoprotein IIb/IIIa inhibitors, routine postprocedural heparin was not associated with any significant benefits and may be safely omitted. However, in a subset of patients treated with PTCA, postprocedural heparin use was independently associated with fewer in-hospital and 1-year MACEs.     

Predictors of and outcomes of early thrombosis following balloon angioplasty versus primary stenting in acute myocardial infarction and usefulness of abciximab (the CADILLAC trial)

We sought to identify the predictors and clinical outcomes of early thrombosis after primary angioplasty and stenting for acute myocardial infarction (AMI). Little is known about the correlates and prognosis of acute and subacute thromboses after percutaneous coronary intervention (PCI) for AMI. We therefore studied the frequency, clinical determinants, and implications of early thrombosis in a large trial of patients who had primary PCI. In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications trial, 2,082 patients who had AMI were randomized in a 2 x 2 factorial design to primary stenting or to balloon angioplasty, each with and without abciximab. Early thrombosis occurred in 19 patients (0.9%) at a median of 2 days (range 0 to 23). Maximal balloon diameter was smaller, and aneurysmal and bifurcation lesions were more prevalent in the group with early thrombosis. Early thrombosis occurred in 0.4% of patients who had been randomized to receive abciximab versus 1.5% of control patients (p <0.01) and in 0.5% of patients who had been randomized to undergo stenting versus 1.4% of those who underwent balloon angioplasty (p = 0.04). By multivariate analysis, abciximab use was an independent predictor of no thrombosis (hazard ratio 0.27, 95% confidence interval 0.09 to 0.86, p = 0.026). Within 30 days, 5.3% of patients who had early thrombosis died, 32.9% developed reinfarction, and 89.5% required repeat target vessel revascularization (including bypass surgery in 11.1%). As a result, patients who had versus those who did not have early thrombosis had markedly higher rates of major adverse cardiac events at 30 days (94.7% vs 5.0%, p <0.0001) and at 1 year (94.7% vs 16.9%, p <0.0001). Patients who develop early thrombosis after primary PCI have a very high rate of major adverse cardiac events, including death and reinfarction, and usually require repeat coronary angioplasty or surgery for management. Complex baseline angiographic morphology and smaller maximal balloon diameter are predictors of early thrombosis after primary PCI for AMI. The incidence of early thrombosis after primary angioplasty and stenting is decreased by abciximab use.     

Evolution in the practice of primary angioplasty: effect of adjunctive coronary stenting and glycoprotein IIb/IIIa inhibitors on long-term outcomes.

Primary angioplasty strategies have evolved dramatically, including increasing adjunctive use of stents and glycoprotein (GP) IIb/IIIa inhibitors. The purpose of this study was to examine the specific effects of these adjunctive therapies on long-term outcomes after primary angioplasty. From 1996 to 1998, 257 unselected, consecutive patients underwent primary PTCI at our institution. In-hospital mortality was 5.4% (2.9% for patients without cardiogenic shock). The remaining 243 patients were followed for 2.0 +/- 0.7 years. Adjunctive stenting was associated with increased late mortality (8.7% vs. 2.3%, P = 0.02). GP IIb/IIIa inhibitors were associated with reduced late mortality among patients receiving stents (6.9% vs. 21.4%, P = 0.07), but not in those patients treated with balloon angioplasty alone (2.9% vs. 0%, P > 0.20). Coronary stenting remained a significant predictor of late mortality (hazard ratio 5.6, 95% CI 1.5-21.2) after adjustment for other established risk factors. In this unselected series, adjunctive coronary stenting was associated with higher late mortality among hospital discharge survivors. Concomitant GP IIb/IIIa inhibitors partially corrected for this increase. These results are limited by the small sample size and retrospective design of this study. Additional long-term studies are required to test these findings and evaluate for possible mechanisms.     

Impact of normalized myocardial perfusion after successful angioplasty in acute myocardial infarction

OBJECTIVES: We sought to evaluate and validate the ability of the angiographic myocardial blush grade to risk stratify patients after successful angioplasty in acute myocardial infarction (AMI). BACKGROUND: Although epicardial Thrombolysis In Myocardial Infarction (TIMI)-3 flow is restored in >90% of patients undergoing primary percutaneous coronary intervention (PCI), normal myocardial perfusion may be present less frequently and may detrimentally impact survival. METHODS: A cohort of 173 consecutive patients undergoing intervention within 24 h of AMI onset were studied. High-risk features of this population included failed thrombolysis in 39%, cardiogenic shock in 17% and saphenous vein graft culprit in 11% of patients. RESULTS: Despite the restoration of TIMI-3 flow in 163 (94.2%) patients, myocardial perfusion, as evidenced by normal contrast opacification of the myocardial bed subtended by the infarct artery (myocardial blush), was normal in only 29.4% of patients with TIMI-3 flow following PCI, and in no patient with TIMI 0 to 2 flow. In patients in whom TIMI-3 flow was restored, survival was strongly dependent on the myocardial perfusion grade; one-year cumulative mortality was 6.8% with normal myocardial blush, 13.2% with reduced myocardial blush and 18.3% in patients with absent myocardial blush (p = 0.004). CONCLUSIONS: Abnormal myocardial perfusion is present in most patients following primary or rescue PCI in AMI, despite restoration of brisk epicardial coronary flow. In high risk patients achieving TIMI-3 flow after intervention, the myocardial blush score may be used to stratify prognosis into excellent, intermediate and poor survival. Further study is warranted to examine whether adjunctive mechanical or pharmacologic strategies can further improve myocardial perfusion and survival of patients with acute myocardial infarction undergoing intervention.     

Early abciximab administration in acute myocardial infarction treated with primary coronary intervention

BACKGROUND: Glycoprotein IIb/IIIa inhibitors improve myocardial reperfusion and clinical outcomes of patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI), but optimal timing of administration remains unclear. In this prospective randomized trial, we evaluated the impact of early abciximab administration on angiographic findings, myocardial salvage and left ventricular function. METHODS AND RESULTS: Fifty-five consecutive patients with first AMI, undergoing primary PCI, were randomized to abciximab administration either in the emergency room (early group: 27 patients) or in the catheterization laboratory after coronary angiography (late group: 28 patients). The primary outcome measures were initial Thrombolysis In Myocardial Infraction (TIMI) grade flow, corrected TIMI frame count and myocardial blush grade as well as salvage index and left ventricular function recovery as assessed by serial scintigraphic scans performed at admission, and 7 days and 1 month after PCI. Angiographic analysis showed a significant difference in initial TIMI grade 3 flow, corrected TIMI frame count and myocardial blush grade favouring early group. Moreover, salvage index and left ventricular function recovery were significantly greater in the early group (P=0.007; and P=0.043, respectively). CONCLUSIONS: In patients with AMI, treated with primary PCI, early abciximab administration improves myocardial salvage and left ventricular function recovery probably by starting early recanalization of the infarct-related artery.     

Impact of advanced age on myocardial perfusion, distal embolization, and mortality patients with ST-segment elevation myocardial infarction treated by primary angioplasty and glycoprotein IIb–IIIa inhibitors

Despite mechanical reperfusion, the outcome is still unsatisfactory in elderly patients with ST-segment elevation myocardial infarction (STEMI). The vast majority of studies have been conducted without extensive use of glycoprotein (Gp) IIb–IIIa inhibitors, which have been associated with improved perfusion and survival. Thus the aim of the current study was to evaluate the impact of age on the angiographic and clinical outcome patients with STEMI undergoing primary angioplasty with Gp IIb–IIIa inhibitors. Our population is represented by a total of 1,662 patients undergoing primary angioplasty for STEMI included in 11 randomized trials comparing early versus late administration of Gp IIb–IIIa inhibitors. Myocardial perfusion was evaluated by myocardial blush grade and ST-segment resolution. Follow-up data were collected between 30 days and 1 year after primary angioplasty. A total of 231 (13.9 %) patients were older than 75 years. Elderly patients showed a larger prevalence of female gender, hypertension, and diabetes, more advanced Killip class at presentation and longer time to treatment, but a smaller prevalence of smoking. All patients were treated with GP IIb–IIIa inhibitors. Elderly patients showed a significantly impaired postprocedural thrombolysis in myocardial infarction (TIMI) flow (TIMI 0–2: 17.7 vs 10.3 %, P = 0.002) and myocardial perfusion (myocardial blush grade 0–1: 38.3 vs 26.5 %, P = 0.001), and higher prevalence of distal embolization (19.2 vs 9.8 %, P < 0.001), whereas no difference was observed in terms of ST-segment resolution. At follow-up, elderly patients showed a significantly higher mortality (3.2 vs 11.0 %, hazard ratio (HR) (95 % confidence interval (CI)) = 3.78 (2.31–6.16), P < 0.001), which was confirmed after adjustment for baseline confounding factors (HR (95 % CI) = 5.01 (2.63–9.55), P < 0.0001). This study showed that among patients with STEMI undergoing primary angioplasty, advanced age is an independent predictor of mortality after primary angioplasty. Higher rates of distal embolization and poor myocardial perfusion, in addition to the worse risk profile, contribute toward explaining the impact of aging on mortality.     

Glycoprotein IIb/IIIa inhibitors in patients undergoing percutaneous mechanical intervention for acute myocardial infarction

Limitations in study designs and adoption of rigid criteria for randomization in clinical trials on acute myocardial infarction (AMI) may result in the enrollment of artificial populations, and subsequent trial results may be misleading in many ways rendering problematic the generalization of the trial results to a "real world population" of AMI. Furthermore, the "frequentist" approach in study designs with inclusion of thousands of low-risk patients and high statistical inference have produced inconclusive or negative results despite the high potential for a strong impact on outcome of the study drug, or device, or strategy. The investigative approaches to the use of IIb/IIIa inhibitors as adjunctive treatment to primary coronary intervention (PCI) for AMI are a clear instance of this crucial problem in the evidence-based medicine era. Five concluded randomized trials comparing abciximab with placebo in patients undergoing primary PCI for AMI have produced different and conflicting results with a broad spectrum of possibilities. No benefit of the drug in patients receiving infarct artery stenting, benefit of the drug only in patients undergoing conventional balloon angioplasty with provisional stenting and limited to the early phase, and mainly driven by the decrease in the need for urgent target vessel revascularization, benefit in terms of decreased mortality, reinfarction and target vessel revascularization at 1-month but not maintained at 6 months, long-term benefit in the composite of death, reinfarction and target vessel revascularization, improved early and late outcome including long-term survival. This review of the trials of abciximab and other IIb/IIIa inhibitors in patients undergoing PCI for AMI tries to put the studies and their results into a proper perspective for the correct use of adjunctive IIb/IIIa inhibitor use in patients with AMI.     

Randomized early versus late abciximab in acute myocardial infarction treated with primary coronary intervention (RELAx-AMI Trial).

OBJECTIVES: This prospective randomized trial evaluates the impact of early abciximab administration on angiographic and left ventricular function parameters. BACKGROUND: Glycoprotein IIb/IIIa inhibitors improve myocardial reperfusion in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI), but optimal timing of administration remains unclear. METHODS: Two-hundred ten consecutive patients with first AMI undergoing primary PCI were randomized to abciximab administration either in the emergency room (early group: 105 patients) or in the catheterization laboratory, after coronary angiography (late group: 105 patients). Primary end points were initial Thrombolysis In Myocardial Infarction (TIMI) flow grade, corrected TIMI frame count (cTFC), and myocardial blush grade (MBG), as well as left ventricular function recovery as assessed by serial echocardiographic evaluations. RESULTS: Angiographic pre-PCI analysis showed a significantly better initial TIMI flow grade 3 (24% vs. 10%; p = 0.01), cTFC (78 +/- 30 frames vs. 92 +/- 21 frames; p = 0.001), and MBG 2 or 3 (15% vs. 6%; p = 0.02) favoring the early group. Consistently, post-PCI tissue perfusion parameters were significantly improved in the early group, as assessed by 60-min ST-segment reduction > or =70% (50% vs. 35%; p = 0.03) and MBG 2 or 3 (79% vs. 58%; p = 0.001). Left ventricular function recovery at 1 month was significantly greater in the early group (mean gain ejection fraction 8 +/- 7% vs. 6 +/- 7%, p = 0.02; mean gain wall motion score index 0.4 +/- 0.3 vs. 0.3 +/- 0.3, p = 0.03). CONCLUSIONS: In patients with AMI treated with primary PCI, early abciximab administration improves pre-PCI angiographic findings, post-PCI tissue perfusion, and 1-month left ventricular function recovery, possibly by starting early recanalization of the infarct-related artery.     

Optimizing the percutaneous interventional outcomes for patients with diabetes mellitus: results of the EPISTENT (Evaluation of platelet IIb/IIIa inhibitor for stenting trial) diabetic substudy

BACKGROUND: Stenting likely decreases the need for target-vessel revascularization procedures in diabetic patients compared with balloon angioplasty. However, the efficacy of stenting with platelet glycoprotein IIb/IIIa blockade has not yet been assessed in diabetics. METHODS AND RESULTS: We analyzed the outcomes of 491 diabetic patients within the multicenter Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial (EPISTENT). Diabetic patients were a prospectively defined subset: 173 were randomized to stent-placebo, 162 to stent-abciximab, and 156 to balloon angioplasty-abciximab. The main end point for this analysis was combined 6-month death, myocardial infarction (MI), or target-vessel revascularization (TVR). The composite end point occurred in 25.2% of stent-placebo, 23.4% of balloon-abciximab, and 13.0% of stent-abciximab patients (P=0.005). Abciximab therapy, irrespective of revascularization strategy (stent or balloon angioplasty), resulted in a significant reduction in the 6-month death or MI rate: 12.7% for stent-placebo, 7.8% for balloon angioplasty-abciximab, and 6.2% for the stent-abciximab group (P=0.029). The 6-month TVR rate was 16.6% for stent-placebo, 18.4% for balloon-abciximab, and 8.1% for stent-abciximab (P=0.021). Compared with stent-placebo, stent-abciximab therapy was associated with a significant increase in angiographic net gain (0.88 versus 0.55 mm; P=0.011) and a decrease in the late loss index (0.40 versus 0.60 mm; P=0.061). The 1-year mortality rate for diabetics was 4.1% for stent-placebo and 1. 2% for stent-abciximab patients (P=0.11). CONCLUSIONS: The combination of stenting and abciximab therapy among diabetics resulted in a significant reduction in 6-month rates of death, MI, and TVR compared with stent-placebo or balloon-abciximab therapy.     

Effect of abciximab on angiographic complications during percutaneous coronary stenting in the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT)

In the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT), abciximab reduced ischemic complications of stent implantation at 30 days and 6 months. The responsible mechanisms remain unclear. We sought to determine if abciximab decreases ischemic complications by decreasing the incidence of angiographic complications during coronary stenting. In EPISTENT, patients were randomized to stenting with abciximab (abciximab group), stenting with placebo (placebo group), or balloon angioplasty with abciximab. Angiographic complications (including major or minor dissection, distal embolization, thrombus postprocedure, side branch or other vessel occlusion, residual stenosis >50%, transient coronary occlusion, and Thrombolysis In Myocardial Infarction final flow <3) were recorded prospectively. Creatine kinase (CK)-MB enzyme levels after intervention were measured at 6-hour intervals. We analyzed angiographic complications and CK-MB elevations in the abciximab group (n = 784) and the placebo group (n = 803). Angiographic complications were 29% less frequent in the abciximab group compared with the placebo group (17.0% vs 23.8%; p = 0.001). In patients with angiographic complications, there was a nonsignificant reduction in the incidence of CK-MB elevation >3 times normal with abciximab therapy (19.7% vs 24.5% in placebo group; p = 0.314). Abciximab (compared with placebo) significantly reduced the incidence of CK-MB elevation >3 times normal in those without any angiographic complications (6.5% vs 10.7%; p = 0.007). In summary, abciximab (compared with placebo) significantly reduced angiographic complications during coronary stenting. Abciximab also prevented CK-MB elevations in patients without angiographic complications.     

Usefulness of myocardial blush grade early and late after primary coronary angioplasty for acute myocardial infarction in predicting left ventricular function

This study sought to analyze the evolution of myocardial perfusion during follow-up after primary angioplasty for acute myocardial infarction (AMI) and relate it to final left ventricular (LV) function. In 101 patients with a first AMI, angiographic myocardial blush grade (MBG) was analyzed immediately after intervention and at follow-up 7.5 +/- 5.6 months later. Cine ventriculography was performed at follow-up angiography to define LV function. Five patients had occluded stents or flow-limiting restenosis. In the remaining patients, myocardial perfusion at follow-up, as defined by MBG, was persistently abnormal in 19 patients (20%), had become normalized from previously abnormal MBG in 30 patients (31%), remained normal in 40 patients (42%), and deteriorated from normal to abnormal in 7 patients (7%). Patients with improvement of abnormal blush determined immediately after intervention to normal blush at follow-up (n = 30) compared with patients with persistently abnormal blush (n = 19) had a better LV ejection fraction at follow-up (53.7 +/- 11.1 vs. 37.4 +/- 9.7%, p <0.001). Evolution of MBG had a better predictive value for LV ejection fraction at follow-up than acute MBG only. Multivariate analysis proved evolution of MBG from AMI to follow-up to be an independent predictor of LV function (R(2) = 0.177, p <0.001) in addition to the initial size of jeopardized myocardium as defined by the sum of ST-segment elevation (R(2) = 0.138, p = 0.001) and infarct location (R(2) = 0.044, p = 0.033). In conclusion, tissue reperfusion after angioplasty for AMI is characterized by frequent improvement over time, as indicated by repeated MBG analysis. Patients with recovery of perfusion have better, final LV function.     

Comparison of primary balloon angioplasty with bailout stenting strategy to primary coronary stenting strategy in the treatment of patients with ST-segment elevation myocardial infarction (STEMI)

BACKGROUND: In recent years significant progress has been made in invasive treatment of patients with acute myocardial infarction (AMI). Primary coronary stenting is currently a routine strategy which replaced primary balloon angioplasty with bailout stenting preferred in the past. Studies comparing these two strategies of stenting in AMI are scarce. AIM: To compare the immediate and long-term outcomes after primary angioplasty strategy and bailout stenting versus primary stent placement strategy in patients with AMI. METHODS: We analysed data from a single-centre registry of consecutive patients with ST segment elevation myocardial infarction admitted between January 1998 and October 2003. In our centre in years 1998-2000 stenting was used only after failed or suboptimal balloon angioplasty. Starting from year 2001 we used routine primary stenting strategy. We compared these two angioplasty strategies applied in different time intervals with regard to in-hospital outcome and long-term mortality. Patients with cardiogenic shock at admission were excluded. RESULTS: Out of a total of 1602 patients treated invasively for AMI (cardiogenic shock excluded) 479 underwent primary balloon angioplasty strategy with bailout stenting - group 1 (years 1998-2000) and 1123 were treated with primary stenting strategy - group 2 (years 2001-2003). In group 1 bailout stenting occurred in 34.4% of patients whereas in group 2 stents were implanted in 83% of patients. Patients in the balloon angioplasty group were younger, had shorter time from the onset of symptom to hospital arrival and more frequently underwent rescue coronary intervention after failed thrombolysis. In-hospital mortality was 2.9 vs. 2.4% in groups 1 and 2, respectively (p=NS). Twenty-four month mortality rate was 9.8% in group 1 and 10.06% in group 2 (p=NS). CONCLUSIONS: 1. Effectiveness of coronary angioplasty is high and comparable in both groups. 2. In-hospital and long-term mortality and procedure-related complication rate are all low and comparable with both stenting strategies. 3. Independent factors increasing long-term mortality include: culprit vessel reocclusion, multivessel coronary disease, older age and hypertension. 4. Patients with complete patency of culprit vessel restored and with higher left ventricular ejection fraction presented lower 2-year mortality rate. 5. Bailout stenting did not increase 2-year mortality.     

Preservation of myocardial microcirculation during mechanical reperfusion for myocardial ischemia with either abciximab or eptifibatide

Myocardial Blush Grade (MBG) is an angiographic method of assessing myocardial microcirculation and provides independent risk stratification among patients with normal TIMI 3 flow. Although the beneficial effect of abciximab on microvascular perfusion is well established, the efficacy of eptifibatide in the prevention of platelet aggregation and distal microembolization is less proven. After a pharmacologic shift by our institution towards the use of eptifibatide in patients with unstable angina presenting for PCI, we sought to evaluate our experience by retrospectively comparing the effect on myocardial perfusion between abciximab and eptifibatide following PCI in stable angina or acute coronary syndrome. Microcirculatory perfusion was reviewed in 101 consecutive patients (23 stable angina, 61 unstable angina, 17 non-q MI) undergoing PTCA/stenting. This comparison was between the last group of 51 patients who routinely received standard bolus and infusion of abciximab and the first group of 50 patients who began receiving standard bolus and infusion of eptifibatide. Baseline characteristics between the two groups were balanced, except for more patients with previous CABG in the eptifibatide group. Angiograms were evaluated by 2 blinded independent reviewers for MBG as follows: 0, no blush; 1, minimal blush; 2, moderate blush; and 3, normal blush. TIMI 3 flow was seen in 98 patients. MBG scores were not significantly different in the abciximab group (67% MBG 3; 31% MBG 2; 2.0% MBG 0 1) than in the eptifibatide group (58% MBG 3; 36% MBG 2; 6.0% MBG 0 1); p = 0.34. Patients with prior PTCA/stenting had lower MBG scores (0 2) compared to patients without prior PTCA (58% vs 31%; p = 0.03). There were significantly lower MBG scores in all patients with prior PTCA or CABG compared to patients without (55% vs 30%; p = 0.03). MBG scores significantly and inversely correlated with peak troponin I levels (r = -0.18, one-tailed p = 0.04). The similarity in myocardial perfusion between abciximab and eptifibatide suggests that both compounds are equally effective in reducing platelet aggregation and microembolization during mechanical reperfusion. Lower MBG scores in patients with prior PTCA or revascularization may be explained by irreversible microvascular dysfunction resulting from distal microembolization during the previous procedure. Lower MBG scores in patients with higher troponin I levels may reflect more frequent microemboli and microinfarcts during an ischemic event. Larger prospective studies need to be performed to validate these findings.     

A comparison of systematic stenting and conventional balloon angioplasty during primary percutaneous transluminal coronary angioplasty for acute myocardial infarction

OBJECTIVES

In a multicenter, randomized trial, systematic stenting using the Wiktor stent was compared to conventional balloon angioplasty with provisional stenting for the treatment of acute myocardial infarction (AMI).

BACKGROUND

Primary angioplasty in AMI is limited by in-hospital recurrent ischemia and a high restenosis rate.

METHODS

A total of 211 patients with AMI <12 h from symptom onset, with an occluded native coronary artery, were randomly assigned to systematic stenting (n = 101) or balloon angioplasty (n = 110). The primary end point was the binary six-month restenosis rate determined by core laboratory quantitative angiographic analysis.

RESULTS

Angiographic success (Thrombolysis in Myocardial Infarction [TIMI] flow grade 3 and residual diameter stenosis <50%) was achieved in 86% of the patients in the stent group and in 82.7% of those in the balloon angioplasty group (p = 0.5). Compared with the 3% cross-over in the stent group, cross-over to stenting was required in 36.4% of patients in the balloon angioplasty group (p = 0.0001). Six-month binary restenosis (≥50% residual stenosis) rates were 25.3% in the stent group and 39.6% in the balloon angioplasty group (p = 0.04). At six months, the event-free survival rates were 81.2% in the stent group and 72.7% in the balloon angioplasty group (p = 0.14), and the repeat revascularization rates were 16.8% and 26.4%, respectively (p = 0.1). At one year, the event-free survival rates were 80.2% in the stent group and 71.8% in the balloon angioplasty group (p = 0.16), and the repeat revascularization rates were 17.8% and 28.2%, respectively (p = 0.1).

CONCLUSIONS

In the setting of primary angioplasty for AMI, as compared with a strategy of conventional balloon angioplasty, systematic stenting using the Wiktor stent results in lower rates of angiographic restenosis.     

A randomized comparison of direct stenting with conventional stent implantation in selected patients with acute myocardial infarction.

OBJECTIVES: We sought to determine whether direct stenting might prevent the adverse events associated with stent implantation during primary angioplasty and to compare it with conventional stent implantation in patients with acute myocardial infarction (AMI). BACKGROUND: No trial has demonstrated that stents favorably influence mortality rate. Recent studies have even suggested a negative impact of stents on coronary blood flow and clinical outcome. METHODS: Of 409 patients treated by primary angioplasty with stent implantation in our center, 206 (50%) were enrolled in this randomized, single-center trial and allocated to direct stent implantation (n = 102) or stent implantation after balloon pre-dilation (n = 104). The study end points included angiographic results (final corrected Thrombolysis In Myocardial Infarction [TIMI] frame count and a composite end point of slow and no-reflow or distal embolization), an electrocardiogram marker of myocardial reperfusion assessment (ST-segment resolution) and in-hospital clinical outcome (death and recurrent infarction). RESULTS: Direct stent implantation failed in eight patients but succeeded after pre-dilation in all. A non-significant increase in TIMI flow grade 3 was achieved after direct stenting (95.1% vs. 93.3%, p = 0.74) without significant difference in the corrected TIMI frame count (31.5 +/- 17 and 35.2 +/- 20 frames after direct and conventional stent, respectively, p = 0.42). The composite angiographic end point was significantly reduced by direct stent implantation (11.7% vs. 26.9%, p = 0.01). ST-segment resolution was also significantly improved after direct stent (no ST-segment resolution in 20.2% vs. 38.1% after direct and conventional stent, respectively, p = 0.01). Death and/or recurrent infarction occurred in six patients after conventional stent implantation and in two patients after direct stenting (p = 0.28). CONCLUSIONS: In selected patients with AMI, direct stenting can be applied safely and effectively. This strategy may result in a significant reduction of microvascular injury, as suggested by improved ST-segment resolution after reperfusion with major potential clinical consequences.     

Glycoprotein IIb/IIIa inhibition and long-term benefit: the stuff of dreams?

This editorial refers to "Five-year outcome of patients withacute myocardial infarction enrolled in a randomised trial assessingthe value of abciximab during coronary artery stenting" by G.Ndrepepa et al. on page 1635 Over the years, several controversies have surrounded the choicesmade before and during the reperfusion process of acute ST-elevationmyocardial infarction (STEMI). Among many others, questionshave been raised over the value of percutaneous coronary intervention(PCI) versus thrombolysis, of stenting versus balloon angioplasty,of filters or thrombectomy devices versus no distal protection,and of course, of glycoprotein (GP) IIb/IIIa inhibitors versusno GP IIb/IIIa inhibitors. Among the dozen of randomized trialsevaluating these drugs in primary PCI of evolving STEMI, onlyfive were big enough to look at clinical endpoints and wereperformed with abciximab.     

Effect of glycoprotein IIb/IIIa receptor blockade on platelet-leukocyte interaction and surface expression of the leukocyte integrin Mac-1 in acute myocardial infarction.

OBJECTIVES: This prospective randomized study investigated platelet-induced upregulation of Mac-1 on monocytes and its inhibition by glycoprotein (GP) IIb/IIIa blockage in patients with acute myocardial infarction (AMI). BACKGROUND: In experimental AMI, Mac-1 on leukocytes is the pivotal adhesion molecule for detrimental inflammatory responses. In vitro, platelet adhesion to monocytes upregulates Mac-1. METHODS: Patients undergoing stenting in AMI within 48 h after onset of symptoms were randomly assigned to receive either standard-dose heparin (n = 50) or abciximab plus low-dose heparin (n = 50). In serial blood samples, we assessed platelet-monocyte interaction and Mac-1 surface expression by triple color immunofluorescence flow cytometry. RESULTS: Compared with platelet-negative monocytes, Mac-1 surface expression on monocytes with attached platelets was upregulated (median fluorescence intensity [interquartile range]: 259 [179 to 367] vs. 135 [78 to 195] arbitrary units, p < 0.001). As an indicator of platelet-monocyte interaction, mean fluorescence of the platelet marker GP Ib alpha in the monocytes population decreased after abciximab, although it remained unaffected by heparin alone. Abciximab achieved this effect by a reduction in platelet mass attached to monocytes (GP Ib alpha fluorescence intensity of heterotypic aggregates at 24 h [arbitrary units]: 187 [143 to 236] after abciximab vs. 228 [156 to 332] after heparin, p = 0.02), whereas it did not affect the percentage of monocytes with adherent platelets. Reduction of platelet-monocyte interaction resulted in decreased Mac-1 surface expression (fluorescence intensity at 24 h [arbitrary units]: 116 [68 to 153] after abciximab vs. 162 [117 to 239] after heparin, p = 0.001). CONCLUSIONS: In patients with AMI, platelet-leukocyte interactions modulate Mac-1 expression on monocytes. Glycoprotein IIb/IIIa blockade is a therapeutic option to interfere with this mechanism.