强化阿托伐他汀对急性冠状动脉综合征患者选择性介入治疗围手术期的影响

目的探讨负荷剂量阿托伐他汀对非ST段抬高急性冠状动脉综合征(NSTEACS)患者PCI围手术期的影响。方法将81例NSTEACS患者随机分为负荷治疗组41例和标准治疗组40例,负荷治疗组PCI术前12 h顿服阿托伐他汀80 mg,PCI术前2 h追加阿托伐他汀40 mg。2组术前、术后8和24 h抽取肘静脉血,检测血清肌酸激酶同工酶(CK-MB)、血浆肌钙蛋白(cTnI)和高敏C反应蛋白(hs-CRP)等。随访30 d主要不良心脏事件发生率。结果与PCI术前比较,2组PCI术后CK-MB、cTnI和hs CRP均明显升高(P0.01),但负荷治疗组CK-MB、cTnI和hs-CRP升高水平显著低于标准治疗组(P0.01)。负荷治疗组心肌损伤标记物升高发生率较标准治疗组显著降低(7.3%vs 32.5%,P=0.003;24.4%vs 47.5%,P=0.030)。负荷治疗组主要不良心脏事件发生率较标准治疗组低(2.4% vs 22.5%,P=0.01 61),心肌梗死发生率下降(2.4%vs20.0%,P=0.0307)。结论 NSTEACS患者PCI术前应用阿托伐他汀负荷剂量,能减少PCI术对患者造成的心肌损伤及炎性反应,还可降低PCI术后不良心脏事件的发生,而且安全有效。     

Short-term, high-dose Atorvastatin pretreatment to prevent contrast-induced nephropathy in patients with acute coronary syndromes undergoing percutaneous coronary intervention (from the ARMYDA-CIN [atorvastatin for reduction of myocardial damage during angioplasty--contrast-induced nephropathy] trial

Contrast-induced nephropathy (CIN) impairs clinical outcome in patients undergoing angiographic procedures. The aim of this study was to investigate whether short-term high-dose atorvastatin load decreases the incidence of CIN after percutaneous coronary intervention (PCI). Statin-naive patients with acute coronary syndrome undergoing PCI (n = 241) randomly received atorvastatin (80 mg 12 hours before intervention with another 40-mg preprocedure dose, n = 120) or placebo (n = 121). All patients had long-term atorvastatin treatment thereafter (40 mg/day). Primary end point was incidence of CIN defined as postintervention increase in serum creatinine ≥0.5 mg/dl or >25% from baseline. Five percent of patients in the atorvastatin arm developed CIN versus 13.2% of those in the placebo arm (p = 0.046). In the atorvastatin group, postprocedure serum creatinine was significantly lower (1.06 ± 0.35 vs 1.12 ± 0.27 mg/dl in placebo, p = 0.01), creatinine clearance was decreased (80.1 ± 32.2 vs 72.0 ± 26.6 ml/min, p = 0.034), and C-reactive protein peak levels after intervention were decreased (8.4 ± 10.5 vs 13.1 ± 20.8 mg/l, p = 0.01). Multivariable analysis showed that atorvastatin pretreatment was independently associated with a decreased risk of CIN (odds ratios 0.34, 95% confidence interval 0.12 to 0.97, p = 0.043). Prevention of CIN with atorvastatin was paralleled by a shorter hospital stay (p = 0.007). In conclusion, short-term pretreatment with high-dose atorvastatin load prevents CIN and shortens hospital stay in patients with acute coronary syndrome undergoing PCI; anti-inflammatory effects may be involved in this renal protection. These results lend further support to early use of high-dose statins as adjuvant pharmacologic therapy before percutaneous coronary revascularization.     

Protection from procedural myocardial injury by atorvastatin is associated with lower levels of adhesion molecules after percutaneous coronary intervention: results from the ARMYDA-CAMs (Atorvastatin for Reduction of MYocardial Damage during Angioplasty-Cell Adhesion Molecules) substudy.

OBJECTIVES: The goal of this work was to investigate whether protection from myocardial injury during percutaneous coronary intervention (PCI) by atorvastatin is related to reduction of endothelial inflammatory response. BACKGROUND: In the randomized ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) trial, 7-day pre-treatment with atorvastatin before PCI significantly reduced procedural myocardial injury; mechanisms underlying this effect are not characterized. METHODS: In a planned subanalysis of the ARMYDA trial, a subgroup of 76 patients was blind-tested for measurement of plasma levels of vascular cell adhesion molecule-1 (VCAM-1), intercellular cell adhesion molecule-1 (ICAM-1), and E-selectin: 38 patients belonged to atorvastatin (40 mg/day) and 38 to the placebo arm. Adhesion molecules were evaluated 7 days before intervention, immediately before PCI, and after 8 and 24 h. RESULTS: Reduction of procedural myocardial injury after statin pre-treatment was also confirmed in this subgroup. Intercellular cell adhesion molecule-1, E-selectin, and VCAM-1 levels were not different at randomization and before intervention in either arm. At 8 h, increase of ICAM-1 levels was similar in the 2 arms, whereas 24-h levels were significantly lower in the atorvastatin versus placebo group (282 +/- 56 vs. 325 +/- 70 ng/ml; p = 0.007). Attenuation of E-selectin elevation occurred at 8 h in the atorvastatin group (50 +/- 8 vs. 59 +/- 13 ng/ml; p = 0.002) and became even more significant at 24 h (57 +/- 9 vs. 73 +/- 18 ng/ml; p = 0.0008). Vascular cell adhesion molecule-1 levels were not different at any time point in the 2 arms. CONCLUSIONS: In patients undergoing PCI, reduction of procedural myocardial injury after 7-day pre-treatment with atorvastatin is paralleled by concomitant attenuation of post-procedural increase of ICAM-1 and E-selectin levels; thus, reduction of endothelial inflammatory response may explain this protective effect of statins.     

Beneficial Effects of High-Dose Atorvastatin Pretreatment on Renal Function in Patients with Acute ST-Segment Elevation Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention

Objectives: To investigate whether preprocedural high-dose atorvastatin decreases the incidence of contrast-induced nephropathy (CIN) and protects the renal function after emergency percutaneous coronary intervention (PCI). Methods: Statin-naive patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing emergency PCI (n = 161) randomly received atorvastatin (80 mg, n = 78, ATOR group) or placebo [n = 83, control (CON) group] followed by long-term atorvastatin (40 mg/day). The primary end point was incidence of CIN. Results: In the ATOR group, 2.6% of the patients developed CIN versus 15.7% in the CON group (p = 0.01). In the ATOR group, postprocedural serum creatinine was significantly lower (93.4 ± 17.1 vs. 112.6 ± 23.3 μmol/l at 48 h and 84.2 ± 14.2 vs. 95.3 ± 17.7 μmol/l at 72 h, both p < 0.0001) and in the CON group, peak serum cystatin C was lower (0.51 ± 0.14 vs. 0.61 ± 0.13 mg/l, p < 0.0001). Atorvastatin pretreatment was independently associated with a decreased risk of CIN (OR 0.084, 95% CI 0.015-0.462, p = 0.004). The proportion of alanine aminotransferase >3 × upper limit of the normal value within 1 month was 3.85 versus 1.20% (ATOR vs. CON group, p = 0.57). Conclusion: Preprocedural high-dose atorvastatin prevents CIN and protects the renal function in patients with acute STEMI undergoing emergency PCI.     

Effects of high-dose statin administered prior to coronary angioplasty on the incidence of cardiac events in patients with acute coronary syndrome

INTRODUCTION: Statins given after acute coronary syndrome without ST elevation (NSTE-ACS) reduce the incidence of major adverse cardiac events (MACE) in long-term follow-up. AIM: To evaluate the effects of high-dose statin administered in patients with NSTE ACS and increased CRP level prior to percutaneous coronary intervention (PCI) on the incidence of MACE in long-term follow-up. METHODS: The study involved 140 consecutive patients with NSTE ACS and increased CRP level at baseline. Patients from group A (n=54) did not receive statin before PCI, whereas subjects in group B (n=86) were given 80 mg of atorvastatin. Patients in both groups received typical cardiological therapy including aspirin, thienopyridine and low molecular weight heparin. After PCI all patients received 40 mg of atorvastatin. Incidence of MACE (death, myocardial infarction (MI), re-PCI) during long-term followup was evaluated in both groups. RESULTS: Study groups did not differ with respect to demographic parameters and rate of ischaemic heart disease risk factors. Also, no differences occurred regarding CRP level (group A vs. B: hsCRP 10.8+/-1.8 mg/l vs. 8.2+/-2.8 mg/l; p=NS) and TIMI Risk Score (group A vs. B: 4.3+/-0.71 vs. 4.37+/-0.79; p=NS). During long-term follow-up the incidence of MI (9.25% vs. 1.2%, p=0.03), composite endpoint: death + MI (14.8% vs. 2.32%, p=0.013) and death + MI + re PCI (25.9% vs. 8.1%, p=0.006) was significantly higher in group A than group B. CONCLUSIONS: Administration of high-dose statin in NSTE ACS patients before PCI was associated with significant reduction of MACE in long-term follow-up. This effect was observed despite the same therapy given after PCI.     

Comparison of myocardial reperfusion in patients undergoing percutaneous coronary intervention in ST-segment elevation acute myocardial infarction with versus without diabetes mellitus (from the EMERALD Trial)

Diabetes mellitus is strongly associated with increased cardiovascular morbidity and mortality in patients with ST-segment elevation myocardial infarction. It is unknown whether myocardial perfusion is decreased in diabetic compared with nondiabetic patients after primary percutaneous coronary intervention (PCI), which may contribute to their worse prognosis. We compared myocardial perfusion and infarct sizes between diabetic and nondiabetic patients undergoing PCI for acute ST-segment elevation myocardial infarction in the EMERALD trial. EMERALD was a prospective, randomized, multicenter study evaluating distal embolic protection during primary PCI in ST-segment elevation myocardial infarction. End points included final myocardial blush grade, complete ST-segment resolution (STR) 30 minutes after PCI, and final infarct size as determined by technetium-99m single proton emission computed tomography measured between days 5 and 14. Of 501 patients, 62 (12%) had diabetes mellitus. Diabetic patients had impaired myocardial perfusion after PCI as measured by myocardial blush grade 0/1 (34% vs 16%, p = 0.002) and lower rates of complete 30-minute STR (45% vs 65%, p = 0.005). Infarct size (median 20% vs 11%, p = 0.005), development of new onset severe congestive heart failure (12% vs 4%, p = 0.016), and 30-day mortality (10% vs 1%, p <0.0001) were also greater in diabetic patients. After multivariate adjustment, diabetes remained associated with lack of complete STR and mortality at 6 months. Use of distal protection devices did not improve outcomes in diabetic or nondiabetic patients. In conclusion, in patients with ST-segment elevation myocardial infarction undergoing primary PCI, diabetes is independently associated with decreased myocardial reperfusion, larger infarct, development of congestive heart failure, and decreased survival.     

Randomized comparison of upstream tirofiban versus downstream high bolus dose tirofiban or abciximab on tissue-level perfusion and troponin release in high-risk acute coronary syndromes treated with percutaneous coronary interventions: the EVEREST trial.

OBJECTIVES: We aimed to compare the effects of upstream tirofiban versus downstream high-dose bolus (HDB) tirofiban and abciximab on tissue level perfusion and troponin I release in high-risk non-ST-segment elevation acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI). BACKGROUND: Optimal timing and dosage of glycoprotein IIb/IIIa inhibitors for ACS remain to be explored. METHODS: We randomized 93 high-risk ACS patients undergoing PCI to receive upstream (in the coronary care unit) tirofiban, downstream (just prior to PCI) HDB tirofiban, and downstream abciximab. We evaluated the effects of the three drug regimens on tissue-level perfusion using the corrected Thrombolysis In Myocardial Infarction (TIMI) frame count, the TIMI myocardial perfusion grade (TMPG), and intracoronary myocardial contrast echocardiography (MCE) before and immediately after PCI and after cardiac troponin I (cTnI). RESULTS: The TMPG 0/1 perfusion was significantly less frequent with upstream tirofiban compared with HDB tirofiban and abciximab both before (28.1% vs. 66.7% vs. 71%, respectively; p = 0.0009) and after PCI (6.2% vs. 20% vs. 35.5%, respectively; p = 0.015). Upstream tirofiban was also associated with a significantly higher MCE score index (0.88 +/- 0.18 vs. 0.77 +/- 0.32 vs. 0.71 +/- 0.30, respectively; p < 0.05). Post-procedural cTnI elevation was significantly less frequent among patients in the upstream tirofiban group compared with the HDB tirofiban and abciximab groups (9.4% vs. 30% vs. 38.7%, respectively; p = 0.018). The cTnI levels after PCI were significantly lower with upstream tirofiban compared with HDB tirofiban (3.8 +/- 4.1 vs. 7.2 +/- 12; p = 0.015) and abciximab (3.8 +/- 4.1 vs. 9 +/- 13.8; p = 0.0002) CONCLUSIONS: Among high-risk non-ST-segment-elevation ACS patients treated with an early invasive strategy, upstream tirofiban is associated with improved tissue-level perfusion and attenuated myocardial damage.     

Effect of two-day atorvastatin pretreatment on long-term outcome of patients with stable angina pectoris undergoing elective percutaneous coronary intervention

Several randomized studies and meta-analyses have suggested that pretreatment with statins may decrease periprocedural myocardial infarction (MI) in patients undergoing percutaneous coronary intervention (PCI). The purpose of this randomized study was to investigate the effect of a 2-day atorvastatin therapy before PCI on long-term clinical outcome. Two hundred statin-naive patients with stable angina pectoris referred for PCI were enrolled and randomized (ratio 1:1) to 2-day pretreatment with atorvastatin 80 mg/day and subsequent PCI (atorvastatin group), or immediate PCI (control group). The registry group comprised 182 consecutive patients on long-term statin therapy referred for immediate PCI during the same period as randomized patients. We compared the first occurrence of MI or death during long-term follow-up. There were no significant differences in most clinical characteristics and early results among the 3 groups. Median follow-up was 45 months (1 to 59). Incidences of death/MI were 11.4%, 12.9%, and 13.8% in the atorvastatin, control, and registry groups, respectively. In the same groups, age-adjusted estimated 4-year freedom from death/MI was 0.78 versus 0.75 versus 0.80, respectively (p=0.882, log-rank test). In multivariate analysis, only age of patients (odds ratio 1.04, 95% confidence interval 1.02 to 1.07, p<0.001) was identified as a significant predictor of death or MI during follow-up. In conclusion, these results suggest that 2-day therapy with high-dose atorvastatin before PCI did not influence occurrence of periprocedural MI or long-term clinical outcomes.     

Comparison of one-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients with unprotected left main coronary artery disease and acute coronary syndromes (from the CUSTOMIZE Registry)

Uncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p <0.001), driven by a higher rate of target lesion revascularization (8.1% vs 1.7%, p = 0.001). This finding was consistent after statistical adjustment for MACEs (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 5.9, p = 0.01) and target lesion revascularization (adjusted HR 8.0, 95% CI 2.2 to 28.7, p = 0.001). No statistically significant differences between PCI and CABG were noted for death (adjusted HR 1.1, 95% CI 0.4 to 3.0, p = 0.81) and myocardial infarction (adjusted HR 4.8, 95% CI 0.3 to 68.6, p = 0.25). No interaction between clinical presentation (ST-segment elevation myocardial infarction or unstable angina/non-ST-segment elevation myocardial infarction) and treatment (PCI or CABG) was observed (p for interaction = 0.68). In conclusion, in patients with left main coronary artery disease and ACS, PCI is associated with similar safety compared to CABG but higher risk of MACEs driven by increased risk of repeat revascularization.     

Comparison of 600 versus 300-mg Clopidogrel loading dose in patients with ST-segment elevation myocardial infarction undergoing primary coronary angioplasty

The aim of the present study was to compare 600- and 300-mg clopidogrel loading doses in patients with ST-segment elevation myocardial infarctions who underwent primary percutaneous coronary intervention (PCI). Two hundred fifty-five consecutive patients presenting with ST-segment elevation myocardial infarctions who underwent primary PCI were enrolled. Patients were divided into 2 groups on the basis of the loading dose of clopidogrel received before the procedure (600 vs 300 mg). Procedural angiographic end points and 1-year major adverse cardiac events were compared between the 2 groups. Major adverse cardiac events were defined as death, nonfatal myocardial infarction, and target vessel revascularization. There were no significant differences in baseline clinical and angiographic features between the 2 groups: 157 (62%) in the clopidogrel 600 mg group and 98 (38%) in the 300 mg group. Patients receiving 600-mg loading dose of clopidogrel showed a significantly lower incidence of post-PCI myocardial blush grade 0 or 1 (odds ratio 0.64, 95% confidence interval 0.43 to 0.96, p = 0.03) and significantly less common no-reflow phenomenon (odds ratio 0.38, 95% confidence interval 0.15 to 0.98, p = 0.04) compared to those in the 300-mg group. Propensity-adjusted Cox analysis showed significantly higher survival free of major adverse cardiac events in patients receiving 600-mg loading dose of clopidogrel compared to those receiving the lower dose (hazard ratio 0.57, 95% confidence interval 0.33 to 0.98, p = 0.04). In conclusion, a 600-mg loading dose of clopidogrel is associated with improvements in procedural angiographic end points and 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction who undergo primary PCI compared to a 300-mg dose.     

Prognostic significance of elevated troponin I after percutaneous coronary intervention

OBJECTIVES: We sought to assess the incidence and clinical significance of elevated cardiac troponin I (cTnI) after percutaneous coronary intervention (PCI). BACKGROUND: Elevated creatine kinase-MB (CK-MB) is prognostically important after PCI, but the prognostic significance of elevated cTnI after PCI is uncertain. METHODS: In a prospective substudy of the Sibrafiban Versus Aspirin to Yield Maximum Protection From Ischemic Heart Events Post-acute Coronary Syndromes (SYMPHONY) trials, which randomized patients with acute coronary syndromes (ACS) to receive aspirin or sibrafiban, we measured cTnI (positive, > or =1.5 ng/ml) and CK-MB (positive, > or =7 ng/ml) in 481 patients with PCI. Samples were collected immediately before and at 0, 8 and 16 h after PCI and analyzed by a core laboratory. The primary end point was the Kaplan-Meier estimate of death, myocardial infarction or severe, recurrent ischemia at 90 days. RESULTS: Overall, 230 patients (48%) had elevated cTnI after PCI. Such patients underwent PCI sooner and were more likely to have coronary stenting. Elevated cTnI was associated with nonsignificantly higher risks of the primary end point (11.5% vs. 8.7%; p = 0.15) and of death (1.8% vs. 0.4%; p = 0.4) and a significantly higher risk of death or infarction (10.6% vs. 4.2%; p = 0.005). This pattern was more pronounced for patients who became positive only after PCI: primary end point, 20.7% vs. 10.1% for patients who remained negative after PCI (p = 0.05); death, 5.2% vs. 0% (p = 0.02); death or infarction, 18.1% vs. 4.1% (p = 0.007). CONCLUSIONS: Elevated cTnI, often observed after PCI in patients with ACS, is associated with worse 90-day clinical outcomes. This marker, therefore, is a useful prognostic indicator in such patients.     

A randomized trial to evaluate the relative protection against post-percutaneous coronary intervention microvascular dysfunction, ischemia, and inflammation among antiplatelet and antithrombotic agents: the PROTECT-TIMI-30 trial.

OBJECTIVES: The goal of this study was to evaluate glycoprotein IIb/IIIa inhibition with eptifibatide when administered with indirect thrombin inhibition as compared with monotherapy with direct thrombin inhibition with bivalirudin among patients with non-ST-segment elevation acute coronary syndromes (ACS). BACKGROUND: The optimal combination of antiplatelet and antithrombin regimens that maximizes efficacy and minimizes bleeding among patients with non-ST-segment elevation ACS undergoing percutaneous coronary intervention (PCI) is unclear. METHODS: A total of 857 patients with non-ST-segment elevation ACS were assigned randomly to eptifibatide + reduced dose unfractionated heparin (n = 298), eptifibatide + reduced-dose enoxaparin (n = 275), or bivalirudin monotherapy (n = 284). RESULTS: Among angiographically evaluable patients (n = 754), the primary end point of post-PCI coronary flow reserve was significantly greater with bivalirudin (1.43 vs. 1.33 for pooled eptifibatide arms, p = 0.036). Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade more often was normal with eptifibatide treatment compared with bivalirudin (57.9% vs. 50.9%, p = 0.048). The duration of ischemia on continuous Holter monitoring after PCI was significantly longer among patients treated with bivalirudin (169 vs. 36 min, p = 0.013). There was no excess of TIMI major bleeding among patients treated with eptifibatide compared with bivalirudin (0.7%, n = 4 vs. 0%, p = NS), but TIMI minor bleeding was increased (2.5% vs. 0.4%, p = 0.027) as was transfusion (4.4% to 0.4%, p < 0.001). CONCLUSIONS: Among moderate- to high-risk patients with ACS undergoing PCI, coronary flow reserve was greater with bivalirudin than eptifibatide. Eptifibatide improved myocardial perfusion and reduced the duration of post-PCI ischemia but was associated with higher minor bleeding and transfusion rates. Ischemic events and biomarkers for myonecrosis, inflammation, and thrombin generation did not differ between agents.     

Comparison of benefit and safety between different loading dose of clopidogrel on elderly patients undergoing primary percutaneous cronary intervention for ST-segment elevation myocardial infarction

Background Despite the proven benefit of 600-mg loading dose of clopidogrel in patients with acute ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous cronary intervention (PCI), there is still concern about its benefit and safety on elderly population. Methods Data of 172 consecutive elderly patients (≥75 years) with STEMI who underwent primary PCI at Guangdong Provincial Cardiovascular Institute from January 2008 to December 2011 were retrospectively collected. Patients were divided into 600-mg loading clopidogrel group and 300-mg clopidogrel group accoring to the loading dose of clopidogrel before primary percunaeous coronary intervention(PCI). Enzymatic myocardial infarction size estimated by peak creatine kinase-myocardial band (CK-MB) and patency of the infarct-related artery (IRA) were compared. Thirty-day major adverse cardiac events (MACEs), which consist of death, nonfatal myocardial infarction (MI), nonfatal stroke, target vessel revascularization (TVR) or stent thrombosis (ST) were compared to assess the efficacy of different loading dose. Bleeding information was compared as well to assess the safety of different pretreatment stragety before primary PCI. Results 96 patients were adminstered with 600-mg loading clopidogrel before primary PCI while 76 were administered with 300-mg. Patency of the IRA was significantly higher in patients administered with 600-mg loading clopidogrel therapy as compared with those who received 300-mg loading clopidogrel (94.8% vs. 85.5%, P = 0.038). 600-mg loading dose of clopidogrel was associated with lower incidence of 30-day MACEs compared with 300-mg loading dose of clopidogrel (8.3% vs. 19.7%, P = 0.029) while did not increase the risk of TIMI major (3.1% vs. 3.9%, P = 0.770) and minor bleeding (10.4% vs. 6.6%, P = 0.376). Conclusion 600-mg loading clopidogrel improves final patency of the IRA and clinical outcome as compared with 300-mg loading clopidogrel without increasing bleeding hazard.     

Effect of clopidogrel pretreatment on ischemic complications of percutaneous coronary intervention among bivalirudin-treated patients (from the EVENT registry)

Although clopidogrel pretreatment benefits patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes, these benefits are less well established among patients undergoing elective PCI--in particular, when they are treated with the direct thrombin inhibitor, bivalirudin. We used data from the multicenter Evaluation of Drug Eluting stents and ischemic Events registry to assess the association between clopidogrel pretreatment and PCI-related complications among patients undergoing elective PCI with bivalirudin as the antithrombotic regimen. The primary end point was the composite of in-hospital death or myocardial infarction. From January 2005 and December 2007, 4,681 patients underwent elective PCI at 55 United States centers, and 1,913 (41%) received bivalirudin as the planned anticoagulant. Clopidogrel pretreatment was used in 923 patients (48%). The incidence of in-hospital death or myocardial infarction was similar among patients who did and did not receive clopidogrel pretreatment (5.5% vs 5.8%, p = 0.83). This result was unchanged in propensity-adjusted analyses (adjusted odds ratio for pretreatment 0.91, 95% confidence interval 0.60 to 1.39, p = 0.66). Also, no differences were seen in the in-hospital bleeding events (1.0% vs 1.0%, p = 0.94) or 1-year ischemic complications between the 2 treatment groups (7.5% vs 8.3%, p = 0.26). In conclusion, among unselected patients undergoing elective PCI with bivalirudin as the planned anticoagulant, clopidogrel pretreatment was common but was not associated with a reduced risk of ischemic complications.     

One-year clinical outcomes with abciximab vs. placebo in patients with non-ST-segment elevation acute coronary syndromes undergoing percutaneous coronary intervention after pre-treatment with clopidogrel: results of the ISAR-REACT 2 randomized trial.

AIMS: The aim of this study is to investigate whether the benefit of abciximab in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACSs) undergoing percutaneous coronary intervention (PCI) after pre-treatment with 600 mg clopidogrel is sustained at 1 year. METHODS AND RESULTS: We performed 1-year follow-up of 2022 high-risk patients with NSTE-ACS undergoing urgent PCI, who were randomized to abciximab or placebo after pre-treatment with 600 mg clopidogrel in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 2 trial. The combined incidence of death, myocardial infarction, or target vessel revascularization at 1 year was the primary outcome analysis. At 1 year, the primary outcome was reached in 23.3% of patients allocated to abciximab vs. 28.0% of patients allocated to placebo [relative risk (RR) 0.80, 95% confidence interval (CI) 0.67-0.95, P = 0.012]. The combined incidence of death or myocardial infarction was 11.6% in patients allocated to abciximab vs. 15.3% in patients allocated to placebo (RR 0.74, 95% CI 0.59-0.94, P = 0.015). CONCLUSION: In high-risk patients with NSTE-ACS undergoing a PCI after pre-treatment with 600 mg clopidogrel, adverse events occurred less frequently with abciximab and the early benefit was maintained at 1 year after administration.     

New method of intracoronary adenosine injection to prevent microvascular reperfusion injury in patients with acute myocardial infarction undergoing percutaneous coronary intervention

The aim of our study was to examine the role of a new, simple protocol of intracoronary adenosine administration performed during primary angioplasty on the immediate angiographic results and clinical course. A prospective, single-center, randomized, placebo-controlled trial of 70 consecutive patients (64 ± 14 years, 54 men) with acute myocardial infarction with ST-segment elevation undergoing primary percutaneous coronary intervention (PCI) was conducted. Patients were randomized to 2 groups. Group 1 (n = 35) received intracoronary adenosine (1 to 2 mg) with a hand injection through the guiding catheter 2 times: immediately after crossing the lesion of the infarct-related artery with guidewire and then after the first balloon inflation. Group 2 (n = 35) received placebo. The baseline clinical and angiographic characteristics of the 2 groups were similar. Percutaneous coronary intervention resulted in Thrombolysis In Myocardial Infarction grade 3 flow after PCI in 32 patients (91.4%) in the adenosine group and 27 patients (77.1%) in the placebo group (p = 0.059). Myocardial blush grade 3 was observed at the end of PCI in 23 patients (65.7%) in the adenosine group and 13 (37.1%) in the placebo group (p < 0.05). Resolution of ST-segment elevation (> 50%) was more frequently observed in the adenosine than in the placebo group: 27 (77%) versus 15 (43%), respectively (p < 0.01). In conclusion, intracoronary adenosine administration improved the angiographic and electrocardiographic results in patients with acute myocardial infarction with ST-segment elevation undergoing PCI. Adenosine administration seemed to be associated with a more favorable clinical course.     

Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes: analysis from the TAXUS-IV trial

OBJECTIVES: We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). BACKGROUND: Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown. METHODS: In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome. RESULTS: Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04). CONCLUSIONS: The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.     

替罗非班在急性冠脉综合征患者介入治疗中的早期及即刻应用比较

目的比较高危急性冠脉综合症患者介入治疗早期和即刻使用替罗非班的疗效及安全性。方法选取行经皮冠状动脉介入(percutaneous coronary interventions,PCI)治疗的高危急性冠脉综合征患者201例,按电脑随机数字法随机分为早期使用替罗非班组(冠脉造影术前4～6h给药)和即刻应用替罗非班组(冠状动脉导丝通过病变时给药)。我们通过量化分析血清心肌肌钙蛋白I浓度和肌酸激酶同工酶浓度,同时评价抑制血小板聚集功能及心肌梗死溶栓实验(thrombolysis in myocardial infarction,TIMI)分级。随访PCI治疗后24h、90d、180d的主要心血管事件,同时记录出血并发症及替罗非班组给药期间出现的血小板减少。结果早期应用组与即刻应用组相比,PCI治疗后48h的心肌肌钙蛋白I浓度峰值明显降低[0.33(0.06～1.11)ng/mL vs.0.60(0.08～1.50)ng/mL,P0.05],肌钙蛋白I升高速度明显减慢(65%vs.85%,P0.05)。而两组患者PCI治疗后48h的肌酸激酶同工酶浓度峰值及升高速度比较,差异无统计学意义[16(14～35)ng/L vs.17(12～39)ng/L,P0.05;37%vs.42%,P0.05]。两组心电图改变及抑制血小板聚集功能比较,差异无统计学意义(P0.05)。早期应用组和即刻应用组的90d和180d主要心血管事件发生率比较,差异无统计学意义[1%vs.7%,P=0.33;6%vs.13%,P=0.09)。两组患者出血并发症及血小板减少症的发生率比较,差异无统计学意义(10%vs.8%,P0.05)。结论高危的非ST段抬高急性冠脉综合征患者早期应用替罗非班可减轻心肌损害而不会增加并发症。     

Triple antiplatelet therapy during percutaneous coronary intervention is associated with improved outcomes including one-year survival: results from the Do Tirofiban and ReoProGive Similar Efficacy Outcome Trial (TARGET)

OBJECTIVE: We sought to examine if clopidogrel treatment initiated before coronary stenting improved clinical outcomes among patients receiving aspirin and a glycoprotein (GP) IIb/IIIa inhibitor. BACKGROUND: Antiplatelet therapy plays a pivotal role in contemporary percutaneous coronary interventions (PCI). METHODS: Outcomes among 4,809 patients randomized to tirofiban or abciximab during PCI with stent placement were compared according to whether they received 300 mg of clopidogrel before PCI (93.1%) versus immediately after the procedure. RESULTS: The 30-day primary composite end point (death, myocardial infarction [MI], or urgent target vessel revascularization [TVR]) was lower among clopidogrel-pretreated patients (6.6% vs. 10.4%, p = 0.009), mainly because of reduction of MI (6.0% vs. 9.5%, p = 0.012). The benefit of clopidogrel pretreatment was sustained at six months (death, MI, any TVR: 14.6% vs. 19.8%, HR = 0.71, p = 0.010), and this was due mainly to lowering of death and MI (7.8% vs. 13.0%, p = 0.001). At one year, clopidogrel pretreatment was associated with a lower mortality rate (1.7% vs. 3.6%, p = 0.011). Because clopidogrel pretreatment was not randomized, multivariable and propensity analyses were performed. After adjusting for baseline heterogeneity, clopidogrel pretreatment was an independent predictor for death or MI at 30 days (HR = 0.63, p = 0.012) and at six months (HR = 0.61, p = 0.003), and survival at one year (HR = 0.53, p = 0.044). No excess in 30-day bleeding events was noted with clopidogrel pretreatment. CONCLUSIONS: Among patients undergoing coronary stent placement with aspirin and a GP IIb/IIIa inhibitor, clopidogrel pretreatment is associated with a reduction of death and MI irrespective of the type of GP IIb/IIIa inhibitor used.     

The relative safety and efficacy of abciximab and eptifibatide in patients undergoing primary percutaneous coronary intervention: insights from a large regional registry of contemporary percutaneous coronary intervention.

OBJECTIVES: This study sought to assess whether the use of eptifibatide instead of abciximab is associated with a difference in outcomes of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Pooled data from randomized controlled trials suggest that the use of abciximab may be associated with a survival advantage in patients undergoing primary PCI for acute STEMI. However, a large proportion of patients in the community are treated with eptifibatide, an agent that shares some but not all pharmacological properties with abciximab. METHODS: We evaluated the outcomes of 3,541 patients who underwent primary PCI for STEMI from October 2002 to July 2006 in a large regional consortium and who were treated with abciximab (n = 729) or with eptifibatide (n = 2,812). RESULTS: There was no difference in the incidence of in-hospital death (4.1% with abciximab vs. 3.5% with eptifibatide, p = 0.39), recurrent myocardial infarction (0.8% vs. 1.2%, p = 0.42), or stroke/transient ischemic attack (0.7% vs. 0.6%, p = 0.80). There was no difference in the need for blood transfusion (12.4% vs. 11.7%, p = 0.61), whereas there was a greater incidence of gastrointestinal bleeding with abciximab (4.8% vs. 2.8%, p = 0.01). In parsimonious risk-adjusted models, no significant difference between abciximab and eptifibatide was observed with respect to any of the outcomes measures. CONCLUSIONS: Currently, eptifibatide is used as the adjunct antiplatelet agent in the majority of patients undergoing primary PCI. There is no apparent difference in early outcomes of patients treated with eptifibatide compared with patients treated with abciximab.