Prevalence of aspirin and clopidogrel resistance among patients with and without drug-eluting stent thrombosis.

Drug-eluting stent (DES) thrombosis has a multifactorial etiology. Variable responsiveness to antiplatelet therapy likely contributes to its pathogenesis. We aimed to determine whether patients who had experienced DES thrombosis compared with a cohort of patients who had not would exhibit greater platelet reactivity and a greater prevalence of aspirin and clopidogrel resistance. The effect of aspirin and clopidogrel on platelet reactivity was determined after angiographically proven DES thrombosis in 26 patients and in 21 patients who had not experienced stent thrombosis (ST) > or =18 months after DES implantation. Aspirin effect was assessed using the VerifyNow Aspirin Assay, and the effect of clopidogrel was assessed using the VerifyNow P2Y12 Assay and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P). Aspirin resistance was present in 23% of patients with ST and 5% of controls (p = NS). Clopidogrel resistance was present in 40% of patients with ST and 14% of controls using the P2Y12 assay (p = 0.02) and 90% of patients with ST and 67% of controls using the VASP-P assay (p = NS). Mean aspirin reaction units were significantly greater among all patients with ST and those with early ST compared with controls (477 +/- 89 vs 429 +/- 58, p = 0.04; and 485 +/- 84 vs 429 +/- 58, p = 0.02, respectively). Mean P2Y12 reaction units were significantly greater among patients with early ST compared with controls (265 +/- 102 vs 184 +/- 76, p = 0.01). The results of the VASP-P assay did not correlate with the presence of ST. In conclusion, patients who experienced DES thrombosis demonstrated significantly greater rates of clopidogrel resistance as determined by P2Y12 reaction units, but not VASP-P, compared with patients without DES thrombosis. Aspirin reaction units were significantly greater in the DES thrombosis population. Point-of-care testing with the VerifyNow Aspirin and P2Y12 Assays has the potential to identify patients at increased risk of ST, particularly early ST, after DES deployment.

Head-to-head comparison of bivalirudin versus heparin without glycoprotein IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing primary angioplasty.

BACKGROUND: In patients receiving primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI), bivalirudin with provisional glycoprotein (GP) IIb/IIIa inhibitors has been demonstrated to be noninferior to heparin plus systematic GP IIb/IIIa inhibitors in preventing recurrent ischemic events with improved safety in terms of bleeding. However, no study has been performed comparing head-to-head bivalirudin with heparin without GP IIb/IIIa inhibitor infusion in STEMI patients. METHODS: We retrospectively studied 899 consecutive patients who presented with STEMI treated by primary angioplasty within 12 h after symptoms. Among them, 566 received bivalirudin and 333 received unfractionated heparin. Their in-hospital outcome in terms of efficacy and safety was assessed using rates of major adverse cardiac events (MACE) and major bleeding, respectively. Clinical, angiographic and procedural characteristics were well matched between the two groups. RESULTS: Patients in the heparin group more frequently required intra-aortic balloon pumping (6.6% vs. 3.6%, P=.037). Regarding the safety end point, the MACE rate, including death, ischemic stroke and urgent repeated revascularization, was low and similar in both groups (2.7% bivalirudin vs. 1.2% heparin, P=.15). The rate of major bleeding, including major hematoma, gastrointestinal bleeding and hematocrit drop >15% during hospitalization, was high and identical in the two groups (4.1% bivalirudin vs. 4.2% heparin, P=.92). CONCLUSION: This study suggests that bivalirudin and heparin present similar safety and efficacy profiles when used without GP IIb/IIIa inhibitor infusion during primary angioplasty.

Impact of thrombus aspiration use for the treatment of stent thrombosis on early patient outcomes.

BACKGROUND: Recent data suggest a clinical benefit with the systematic use of thrombus aspiration (TA) for the treatment of ST-elevation myocardial infarction (STEMI). Nevertheless, the impact of TA as a treatment strategy for stent thrombosis (ST) is unknown. This study aimed to analyze the impact of TA use for the treatment of ST on patient outcomes. METHODS: From 2003 to 2008, 91 consecutive patients who presented with a definite ST were included in this analysis. We compared procedural success rates and the incidence of the composite criteria death-recurrent MI-recurrent ST at 30 days in patients who were treated with TA (TA group, n = 36) versus those who were not (No-TA group, n = 55). RESULTS: Baseline characteristics were similar between the two groups except for the body mass index: 26.2 +/- 5.4 vs. 29.3 +/- 6.2 in the TA and No- TA groups, respectively (p = 0.028). ST presented more likely as STEMI in the TA group: 86.1% vs. 67.3% (p = 0.043). Except for TA use, there was no difference in the treatment therapeutics between groups, including for glycoprotein IIb/IIIa inhibitors. The rate of procedural success was higher in the TA group than in the No-TA group: 88.9% vs. 70.9% (p = 0.043). The incidence of the endpoint of death-recurrent MI-recurrent ST was significantly lower in the TA group: 22.2% vs. 47.2% (p = 0.026). By multivariate analysis, TA use was independently associated with a decrease in the composite criteria (HR = 0.45, p = 0.039). CONCLUSION: This study suggests that TA use for ST treatment permits an improvement in patient outcomes at 30 days with a significant decrease in the incidence of the composite criteria death-recurrent MI-recurrent ST. Further prospective studies are needed, however, to definitively address the benefit of TA use in this particular setting.

Prognostic value of the Syntax score in patients undergoing coronary artery bypass grafting for three-vessel coronary artery disease.

BACKGROUND: The Syntax score prognostic value has recently been highlighted in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary artery disease (CAD), however its prognostic value in patients undergoing coronary artery bypass grafting (CABG) for multivessel CAD is still unknown. The aim of this study was to evaluate the prognostic value of the Syntax score in patients undergoing CABG for 3-vessel CAD. METHODS: A cohort of 320 consecutive patients with multivessel (3-vessel) CAD who were subjected for CABG were included in this study and divided into tertiles according to the Syntax score (<24.5, 24.5-34, and >34). During the 1-year follow-up, cardiovascular events including death, myocardial infarction (MI), and stroke were systematically indexed. The primary end point was the composite criteria death/MI/stroke. RESULTS: The Syntax score ranged from 11-74 with a mean of 31.2 +/- 12.6 and a median of 28.5 [22-38]. Baseline clinical characteristics were similar among the tertiles. No statistical difference was found for the composite criteria death/MI/stroke: 9.4% versus 7.5% versus 10.4% in the groups with a Syntax score <24.5, 24.5-34, and >34, respectively (P = 0.754). CONCLUSION: Unlike for PCI, the Syntax score has a poor prognostic value for severe cardiovascular events in patients undergoing CABG for 3-vessel CAD. Other risk scores should be used to predict the outcome of this population.

Temporal relation between Clopidogrel cessation and stent thrombosis after drug-eluting stent implantation.

The risk of late thrombotic events and the need for prolonged dual antiplatelet therapy detract from the clinical advantage offered by drug-eluting stents (DESs). Short-term studies have shown premature clopidogrel cessation to be a strong predictor of stent thrombosis (ST) after DES implantation. Data pertaining to the utility of clopidogrel therapy and its optimal duration to prevent late ST remain limited. The study population consisted of 2,889 patients who underwent unrestricted intracoronary DES implantation from April 2003 to January 2007 for whom clopidogrel compliance data were available. Definite ST proved by angiography or autopsy within 12 months of the index procedure occurred in 61 patients. Comparisons of clinical and procedural characteristics in addition to outcomes (death and Q-wave myocardial infarction) were made between the ST and no-ST (2,828 patients) groups. Clopidogrel compliance was assessed at all follow-up time points. For patients in the ST group, clopidogrel compliance status for the remaining study period was defined as that at the time of ST. Logistic regression analysis was performed at 30 days, 6 months, and 12 months to identify independent predictors of cumulative ST. Patients with ST were more likely to have previous congestive heart failure and worse left ventricular ejection fraction. ST was associated with significantly higher mortality at 12 months (23.5% vs 3.2%, p <0.001). Clopidogrel compliance was 80.2% in the overall population and 73.8% in patients presenting with ST (82.6% in patients presenting with early ST and 43.8% in those with late ST). By logistic regression analysis, clopidogrel cessation was an independent predictor of cumulative ST at 30 days and 6 months but not at 12 months. In conclusion, high rates of clopidogrel compliance can be achieved in contemporary practice. Clopidogrel cessation by 12 months is no longer predictive of ST, thus suggesting the optimal duration of therapy for the prevention of ST to be 6 to 12 months.

Requirement for emergent coronary artery bypass surgery following percutaneous coronary intervention in the stent era.

Performance of percutaneous coronary intervention (PCI) at centers without cardiothoracic surgery is a contentious issue. Although this practice allows greater access to care, there are safety concerns. The aim was to assess the requirement for emergent coronary artery bypass grafting (CABG) after PCI and characterize patients at highest risk using independent predictors. The study population consisted of 21,957 unselected patients who underwent PCI from August 1994 (Food and Drug Administration stent approval) to January 2008 at a single medical center. Patients requiring emergent CABG (defined as within 24 hours of the index procedure) were identified. Logistic regression analysis was performed to assess for independent correlates of emergent CABG. Emergent CABG was required in 90 patients (cumulative incidence 0.41%). Indications for CABG included triple-vessel disease, dissection, acute closure, perforation, and failure to cross. These patients had significantly higher in-hospital cardiac death rates (7.8% vs 0.7%; p <0.01) and higher rates of Q-wave myocardial infarction, neurologic events, and renal insufficiency. Independent correlates of emergent CABG after PCI were acute ST-segment elevation myocardial infarction presentation, cardiogenic shock, triple-vessel disease, and type C lesion. Risk assessment based on these predictors identified 0.3% of the patient population to have a 9.3% cumulative incidence of emergent CABG. In conclusion, the need for emergent CABG after PCI in the stent era was low and was associated with poor in-hospital outcomes. Risk was nonuniform, with 0.3% of the study population, characterized by acute presentation and complex coronary disease, at heightened risk of emergent surgery.

Very late stent thrombosis after bare-metal stent implantation: case reports and review of the literature.

Stent thrombosis (ST) is a catastrophic complication that frequently presents as an acute myocardial infarction and/or death. The most recently accepted definition established by the Academic Research Consortium classifies ST as: early (occurring within 30 days), late (30 days to 1 year) or very late (after 1 year). Very late ST has been reported following drug-eluting stent implantation with rates up to 0.6% per year and has been attributed to delayed strut endothelialization. However, very late ST is unusual after bare-metal stent (BMS) implantation. We report two cases of patients presenting with ST-elevation myocardial infarction due to very late ST 6 and 8 years after BMS implantation.

Outcome differences with the use of drug-eluting stents for the treatment of in-stent restenosis of bare-metal stents versus drug-eluting stents.

Drug-eluting stent (DES) implantation is the standard treatment for patients with bare-metal stent (BMS) in-stent restenosis (ISR) and is associated with low rates of target-vessel revascularization. Outcomes in patients with DES ISR treated using repeated DES placement are less certain. A total of 119 patients who presented with BMS ISR and 119 patients with DES ISR matched for baseline characteristics were evaluated. Both groups of patients were treated using DESs and compared with regard to major adverse cardiac events, including death, myocardial infarction, and target-vessel revascularization, at 1 year. Baseline characteristics were similar between groups. Compared with patients with BMS ISR, those with DES ISR had similar 1-year rates of death (5.1% BMS ISR vs 3.5% DES ISR; p = 0.75) and myocardial infarction (2.6% BMS ISR vs 3.5% DES ISR; p = 0.72) when treated using DESs. However, at 1 year, patients with DES ISR experienced significantly higher rates of target-vessel revascularization (10.3% BMS ISR vs 22.2% DES ISR; p = 0.01), with a trend toward increased overall major adverse cardiac events, including death, myocardial infarction, and target-vessel revascularization (16.0% BMS ISR vs 25.2% DES ISR; p = 0.08). Stent thrombosis occurred with similar frequency in both groups (2.5% BMS ISR vs 0.8% DES ISR; p = 0.62). In conclusion, DES ISR continues to be a therapeutic challenge because patients with DES ISR treated using DESs experience higher rates of recurrence compared with patients with BMS ISR treated using DESs. The optimal treatment of patients with DES restenosis remains to be defined.

Prognostic significance of small troponin I rise after a successful elective percutaneous coronary intervention of a native artery.

Cardiac troponin I is a sensitive marker of myonecrosis. Data regarding the prognostic value of troponin I increase after percutaneous coronary intervention (PCI) are conflicting. A recent American College of Cardiology/American Heart Association statement defined a troponin I increase >3 times the 99th percentile as periprocedural myocardial infarction (MI). We sought to evaluate whether or not, in patients with a successful elective PCI judged on angiographic and clinical criteria, the postprocedural increase of troponin I could predict 1-year outcomes. A cohort of 3,200 consecutive patients with successful elective PCI was studied. End points included death/MI and major adverse cardiac events at 1 year. A troponin I increase >97.5th percentile was observed in 1,402 patients (43.8%, mean 0.32 ng/ml, range 0.01 to 4.94). A total of 751 patients (23.4%) had a troponin I increase >3 x 99th percentile. Troponin I status was associated with more complex coronary disease (19.6% vs 16.4%, p <0.005) and multivessel PCI (2.1 vs 1.6, p <0.001). At 1 year, there was no difference in death/MI (2.8% vs 3.5%, p = 0.3) or in major adverse cardiac events (9.6% vs 10.4%, p = 0.5) according to the level of troponin I increase. The lack of association between troponin I increase after PCI and outcome was found when troponin I increase was used as a continuous or a categorical variable. Logistic regression models failed to find any threshold from which troponin I increase could affect outcome. In conclusion, a small troponin I increase after a successful elective PCI was not infrequent and did not affect outcome in our study. The definition of periprocedural MI may be too strict. Measurement of troponin I after a successful PCI is questionable.

Racial disparities in outcomes following percutaneous coronary intervention with drug-eluting stents.

Previous research has documented that African-Americans compared with non-African-Americans have higher rates of adverse cardiac outcomes and are less likely to be referred for an invasive cardiac procedure. These differences persist even after controlling for co-morbidities and socioeconomic status. We sought to compare 1-year outcomes between African-American and non-African-American patients in a clinical registry of patients after percutaneous coronary intervention receiving drug-eluting stents. We compared 1,221 African-American patients with 4,335 non-African-American patients referred for percutaneous coronary intervention. Patients were followed for 1 year with regard to major adverse cardiac events, including death, Q-wave myocardial infarction, and target vessel revascularization. We performed multivariable Cox proportional hazards regression to adjust for confounding variables, including median household income by zip code, to assess the contribution of African-American race to 1-year outcomes. At 1 year, African-American patients had significantly higher rates of overall major adverse cardiac events (17.7% African-American vs 12.4% non-African-American, p <0.001) and each component of death (7.8% African-American vs 5.4% non-African-American, p = 0.001), Q-wave myocardial infarction (1.2% African-American vs 0.2% non-African-American, p <0.001), and target vessel revascularization (10.7% African-American vs 7.5% non-African-American, p <0.001). Stent thrombosis was also higher in the African-American population at 1 year (2.5% African-American vs 0.7% non-African-American, p <0.001). After multivariable analysis and adjustment for socioeconomic status, however, African-American race was not a significant predictor of major adverse cardiac events. In conclusion, in this referral population, traditional risk factors and socioeconomic status accounted for the disparity between African-American and non-African-American patients.

Five-year outcomes of moderate or ambiguous left main coronary artery disease and the intravascular ultrasound predictors of events.

The long-term outcome of a moderately diseased left main coronary artery (LMCA) remains unknown. One hundred and fourteen patients who underwent angiographic and intravascular ultrasound (IVUS) evaluation for moderate LMCA disease (< 50% diameter stenosis) without intervention were followed for 5 years. There were 11 patients who underwent coronary artery bypass graft surgery (CABG) within 30 days of IVUS analysis based on IVUS findings and 3 patients who died of noncardiac diseases during the follow-up period. These 14 patients were excluded from the cohort, and 100 patients comprised the study group. Six patients (6%) died (1 of cardiac causes and 5 of unknown causes) at a follow up of 31.5 +/- 17.0 months post-IVUS assessment. Two patients (2%) underwent CABG at a follow up of 19.0 +/- 7.1 months. There were no percutaneous LMCA interventions and no myocardial infarctions. Univariate predictors for events were age, mean plaque and media (P&M) area and plaque burden over the entire length of the LMCA lesion, and minimum luminal area (MLA), P&M area, plaque burden, and arc of calcium > 90 degrees at the MLA site. By multiple logistic regression analysis, plaque burden at the MLA (odds ratio = 1.34, 95% confidence interval 1.04-1.73; p = 0.025) was the only independent predictor of events. In conclusion, moderately diseased LMCAs had a 5- year event rate of 8%. The occurrence of future events in moderate diseased LMCAs is dependent on the amount of disease at the MLA site.

Impact of a 600-mg loading dose of clopidogrel on 30-day outcome in unselected patients undergoing percutaneous coronary intervention.

On the basis of biologic studies of platelet reactivity, the recent American College of Cardiology and American Heart Association guidelines recommend a 600-mg loading dose (LD) of clopidogrel in patients who undergo percutaneous coronary intervention (PCI). There is, however, a lack of studies addressing the clinical impact of such a clopidogrel LD. The aim of this study was to compare the clinical efficacy and safety of a 600-mg LD of clopidogrel with that of a 300-mg LD in an unselected cohort of patients who underwent PCI. A cohort of 4,105 unselected patients who underwent PCI were included in the study and divided according to the LD used: the high-LD group (600 mg) included 3,146 patients, and the low-LD group (300 mg) included 959. The primary end point was the rate of major adverse cardiovascular events (MACEs) at 1 month. Patients in the low-LD group more often had diabetes mellitus and histories of myocardial infarction (36.8% vs 31.9%, p = 0.01). Left ventricular ejection fractions were similar (0.49 +/- 0.14 vs 0.48 +/- 0.14, p = 0.25). Angiographic and procedural characteristics were identical between the 2 groups. Patients in the high-LD group had fewer MACEs after 1 month (2.9% vs 5.2%, p <0.001). In multivariate analysis, an LD of 600 mg was significantly associated with MACEs at 1-month follow-up, with an odds ratio of 0.62 (95% confidence interval 0.41 to 0.95, p = 0.03). In conclusion, a 600-mg LD was associated with a significant decrease in the rate of post-PCI MACEs at 1 month, without any in-hospital increase in bleeding complications. The results of this study therefore support the current guidelines of a 600-mg LD of clopidogrel in patients who undergo PCI.

Impact of optimal medical therapy and revascularization on outcome of patients with chronic kidney disease and on dialysis who presented with acute coronary syndrome.

Coronary artery disease is the main cause of death in patients with chronic kidney disease (CKD). The poor prognosis associated with acute coronary syndrome (ACS) in these patients has been related to therapeutic nihilism. This study included 2,357 patients with ACS who had percutaneous coronary intervention. According to their creatinine clearance and medical history, they were divided into 3 groups: dialysis (n = 73); CKD (n= 293); and control (n= 1,991). Rates of cardiovascular events were recorded during a 1-year follow-up period. Patients in all groups received similar contemporary therapy for ACS, including percutaneous coronary intervention and optimal medial therapy. On admission, patients with CKD and patients on dialysis more often presented with cardiogenic shock (p = 0.05 and 0.02, respectively). A graded increase in the rate of major adverse cardiovascular events at 1 year was observed with decreasing renal function (control 13%, CKD 22.9%, dialysis 45.2%, p <0.001 for all comparisons). In multivariate analysis, patients with CKD and on dialysis were significantly associated with 1-year major adverse cardiac events with adjusted hazard ratios of, respectively, 1.5 (95% confidence interval 1.1 to 2.1; p = 0.009) and 2.7 (95% confidence interval 1.7 to 4.1; p <0.001). In conclusion, despite optimal contemporary medical therapy and revascularization, the prognosis of patients with CKD and, in particular, of patients undergoing dialysis, remains poor.

Bleeding risk and outcomes of Bivalirudin versus Glycoprotein IIb/IIIa inhibitors with targeted low-dose unfractionated Heparin in patients having percutaneous coronary intervention for either stable or unstable angina pectoris.

For patients undergoing elective percutaneous coronary intervention (PCI), procedural anticoagulation with bivalirudin was previously shown to significantly reduce bleeding complications at the cost of a modest increase in ischemic events compared with unfractionated heparin (UFH) and glycoprotein IIb/IIIa inhibitors (GPIs). However, the excess bleeding in patients treated with UFH and GPIs may have been caused by excessively high UFH doses and increased activated clotting times. This study sought to determine the bleeding risk of targeted low-dose UFH with GPIs compared with bivalirudin in patients undergoing elective PCI. Of 1,205 patients undergoing elective PCI, 602 underwent PCI with adjunctive UFH and GPIs with the UFH dose targeted to an activated clotting time of approximately 250 seconds, and 603 patients matched for baseline characteristics underwent PCI with bivalirudin. Outcomes were analyzed for major bleeding (hematocrit decrease >15%, gastrointestinal bleed, or major hematoma) and 6-month major adverse cardiac events (death, myocardial infarction, and target-lesion revascularization). The maximum activated clotting time achieved was 261.7 +/- 61.6 seconds in the UFH/GPI group and 355.4 +/- 66.6 in the bivalirudin group (p <0.001). In-hospital major bleeding rates were similar between groups (1.8% UFH/GPI vs 1.7% bivalirudin; p = 0.83), as were transfusion requirements (1.2% UFH/GPI vs 0.5% bivalirudin; p = 0.61). The 6-month major adverse cardiac event rate was also similar between groups (9.5% UFH/GPI vs 9.0% bivalirudin; p = 0.81). In conclusion, there were no significant differences in major bleeding and 6-month major adverse cardiac events for patients undergoing elective PCI treated with targeted low-dose UFH and GPIs compared with those treated with bivalirudin.

Bivalirudin with provisional glycoprotein IIb/IIIa inhibitors in patients undergoing primary angioplasty in the setting of cardiogenic shock.

In patients undergoing percutaneous coronary intervention (PCI), clinical trials have demonstrated that the use of bivalirudin with provisional glycoprotein IIb/IIIa inhibitors is not inferior to heparin with systematic glycoprotein IIb/IIIa inhibitors on major adverse cardiac events and is associated with lower rates of bleeding in various clinical settings. Patients with cardiogenic shock (CS), however, have been excluded from all pivotal trials. A retrospective analysis of 86 consecutive patients undergoing PCI for acute myocardial infarction complicated by CS in our center from April 2003 to September 2007 was performed. In-hospital death, major adverse cardiac events, and bleeding rates were compared in 37 patients who received bivalirudin with or without glycoprotein IIb/IIIa inhibitors and 49 patients who were treated with heparin and glycoprotein IIb/IIIa inhibitors as anticoagulation management. Baseline demographic, clinical, and biological characteristics were similar in the 2 groups. The in-hospital death rate was significantly lower in the bivalirudin group (5.4 vs 32.7%, p = 0.002). There were no differences in the rate of major hematoma between the bivalirudin group and the heparin group (3 vs 2.6%, p = 0.46). In conclusion, bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitors appears to be a safe and effective anticoagualtion strategy in patients undergoing primary PCI for acute myocardial infarction complicated by CS.

Observations and outcomes of definite and probable drug-eluting stent thrombosis seen at a single hospital in a four-year period.

Stent thrombosis (ST) is a major safety concern after drug-eluting stent (DES) deployment, resulting in significant morbidity and mortality. The goal of this study was to examine the incidence, timing, clinical correlates, and outcomes after DES thrombosis in a real-world population. A retrospective analysis of 8,402 patients who underwent percutaneous coronary intervention and received a DES was performed. After DES implantation, 84 definite (DST) and 127 probable ST events occurred. The incidence of early DST was 0.8%, late DST was 0.4%, and very late DST was 0.4%. Multivariate analysis showed that a history of diabetes mellitus, myocardial infarction during admission, number of stents, and DES placement in a restenotic lesion were independently associated with DST. The incidence of early definite or probable ST (DPST) was 1.9%, late DPST was 1.4%, and very late DPST was 0.7%. Multivariate analysis showed that a history of diabetes, myocardial infarction during admission, cardiogenic shock, number of stents, and DES use in a restenotic lesion were independently associated with DPST. Both types of ST were associated with significantly higher rates of all-cause death, Q-wave myocardial infarction, and revascularization up to 24 months after DES implantation. In conclusion, ST after DES implantation in contemporary practice continues to occur from 30 days to 2 years at a rate > or =0.36%/year and is associated with high rates of morbidity and mortality. Diabetes mellitus, myocardial infarction, and DES use in a restenotic lesion were strongly associated with DST; therefore, careful consideration should apply when deploying a DES in these populations.

Two-year outcome of patients treated with sirolimus- versus paclitaxel-eluting stents in an unselected population with coronary artery disease (from the REWARDS Registry).

Multiple studies comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease have been performed. Despite these comparisons, it remains uncertain whether a differential in long-term efficacy and safety exists. Unselected patients treated exclusively with 1 drug-eluting stent type were enrolled in the Registry Experience at the Washington Hospital Center with Drug-Eluting Stents. There were 2,099 patients (3,766 lesions) treated with SES and 1,079 patients (1,850 lesions) treated with PES. Patients were followed at 30 days, 1 year, and 2 years for the clinical endpoints of death, myocardial infarction, target vessel revascularization, and definite and definite/probable stent thrombosis. Patients in the SES group had more dyslipidemia, history of congestive heart failure, and ostial lesions; patients treated with PES had more previous coronary artery bypass surgery, unstable angina, and type C lesions. At 2 years, unadjusted major adverse cardiac events (MACE) (22.6% vs 21.1%, p = 0.3) and target vessel revascularization (13.3% vs 11.2%, p = 0.1) were comparable. The incidence of definite stent thrombosis was higher in the SES group (1.8% vs 0.9%, p = 0.05) driven by early events. Similar results were seen after adjustment for baseline differences: MACE (hazard ratio 1.1, 95% confidence interval [CI] 0.9 to 1.3, p = 0.5), definite stent thrombosis (hazard ratio 2.3, 95% CI 1.0 to 5.2, p = 0.05), and target vessel revascularization (hazard ratio 1.1, 95% CI 0.9 to 1.4, p = 0.4). The incidence and rate of late stent thrombosis (>30 days) were similar (0.7% vs 0.5%, p = 0.4 and 0.24%/year, both groups, respectively). In conclusion, no major differential in long-term safety or efficacy was detected between SES and PES; both stent types were efficacious in reducing revascularization but were limited by a small continual increase in late stent thrombosis.

The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents.

AIMS: To assess the impact on clinical outcomes of intravascular ultrasound (IVUS) guidance during drug-eluting stent (DES) implantation. IVUS guidance during percutaneous coronary intervention (PCI) has been demonstrated to be useful in optimizing stent deployment. However, it is not proved that routine use of IVUS guidance with DES implantation can prevent stent thrombosis or restenosis. METHODS AND RESULTS: The clinical outcomes of 884 patients undergoing IVUS-guided intracoronary DES implantation from April 2003 to May 2006 were compared with the outcomes of a propensity-score matched population undergoing DES implantation with angiographic guidance alone. The primary endpoint of the study was definite stent thrombosis at 12 months. The secondary endpoint was major adverse cardiac events (MACE). After propensity-score matching, the two groups were well matched for clinical and angiographic characteristics. Patients undergoing IVUS-guided DES implantation underwent less direct stenting, more post-dilation, and had greater cutting balloon and rotational atherectomy use. At 30 days and at 12 months, a higher rate of definite stent thrombosis was seen in the No IVUS group (0.5 vs. 1.4%; P = 0.046) and (0.7 vs. 2.0%; P = 0.014), respectively. There were no major differences in late stent thrombosis and MACE (14.5 vs. 16.2%; P = 0.33) at 12 month follow-up between the groups. Rates of death and Q-wave myocardial infarction were similar, and there was no significant difference between groups in target vessel revascularization. However, a trend was seen in favour of the IVUS group in target lesion revascularization (5.1 vs. 7.2%; P = 0.07). IVUS guidance was an independent predictor of freedom from cumulative stent thrombosis at 12 months (adjusted HR 0.5, CI 0.1-0.8; P = 0.02). CONCLUSION: IVUS guidance during DES implantation has the potential to influence treatment strategy and reduce both DES thrombosis and the need for repeat revascularization.

Incidence, predictors, and outcomes of post-percutaneous coronary intervention nephropathy in patients with diabetes mellitus and normal baseline serum creatinine levels.

Diabetes mellitus is an independent predictor of nephropathy after percutaneous coronary intervention (PCI). The outcomes of patients with diabetes with normal baseline serum creatinine who undergo PCI remain underevaluated. The aim of the present study was to assess the incidence, outcomes, and correlates of post-PCI nephropathy in this subset. The study cohort consisted of 570 patients with diabetes with normal serum creatinine (< or =1.3 mg/dl) who underwent PCI from August 2004 to December 2006. Patients aged >75 years and those presenting with either acute myocardial infarctions or cardiogenic shock were excluded. Post-PCI nephropathy was defined as a > or =25% increase in baseline creatinine. The study end points were post-PCI nephropathy and major adverse cardiac events at 6 months. Logistic regression was performed to identify independent predictors. Post-PCI nephropathy occurred in 70 patients (incidence 12.3%). These patients were more likely to be women (55.7% vs 35.5%, p = 0.001) and to have histories of congestive heart failure (24.2% vs 14.7%, p = 0.048). Entry-site complications (hematoma, pseudoaneurysm) and the need for blood transfusion (16.7% vs 1.7%, p <0.001) were more common in this group. In-hospital mortality (8.6% vs 0.2%, p <0.001) and length of stay (4.51 +/- 5.2 vs 2.23 +/- 2.9 days, p <0.001) were significantly higher in the group with post-PCI nephropathy. No study patient required dialysis. At 6 months, major adverse cardiac events were markedly higher in patients with post-PCI nephropathy (21.4% vs 6.0%, p <0.001), driven by death and revascularization. Independent predictors of post-PCI nephropathy were lower body mass index and blood transfusion. Post-PCI nephropathy independently predicted major adverse cardiac events (hazard ratio 4.3, 95% confidence interval 2.1 to 8.6, p <0.001). In conclusion, post-PCI nephropathy occurred in 12.3% of patients with diabetes with normal baseline serum creatinine and carried a significant detrimental impact on prognosis. The requirement for blood transfusions was the strongest correlate identified.