Impact of diabetes mellitus on long-term outcomes in the drug-eluting stent era.

BACKGROUND: Diabetes mellitus is associated with an increased risk of restenosis, stent thrombosis, and death after percutaneous coronary interventions. Little is known about the late outcome of patients with diabetes mellitus who receive drug-eluting stents (DES). METHODS: This study includes a prospective database of 2557 consecutive patients with coronary artery disease who underwent DES implantation in native coronary arteries in 2 German hospitals. The primary end points of the study were mortality and clinical restenosis (target lesion revascularization). Secondary end points were binary angiographic restenosis, stent thrombosis, and the composite of death or myocardial infarction. RESULTS: Within a median follow-up period of 2.3 years, stent thrombosis occurred in 14 patients with diabetes versus 17 patients without diabetes: 3-year Kaplan-Meier estimates of stent thrombosis were 2.2% versus 1.0%, with a relative risk of 2.17 (95% CI 1.09-4.33, P = .027). Binary angiographic restenosis was observed in 87 patients with diabetes and 208 patients without diabetes (15.2% vs 13.5%, P = .32). Target lesion revascularization was needed in 93 patients with diabetes and 219 patients without diabetes (12.8% vs 12.0%, P = .56). There were 93 deaths among diabetic patients versus 118 deaths among nondiabetic patients: 3-year Kaplan-Meier estimates of mortality were 17.3% versus 7.8%, with a relative risk of 2.10 (95% CI 1.61-2.74, P < .001). After adjustment in the multivariable analyses, diabetes remained an independent predictor of 3-year mortality with a hazard ratio of 1.63 (95% CI 1.23-2.17, P < .001), but not of angiographic (P = .92) or clinical restenosis (P = .97). CONCLUSION: Although DES attenuate diabetes-associated excess risk of restenosis, risk of death and thrombotic complications remains higher in patients with diabetes than in nondiabetic patients in the DES era.

Relationship between residual blood flow in the infarct-related artery and scintigraphic infarct size, myocardial salvage, and functional recovery in patients with acute myocardial infarction.

UNLABELLED: In patients with acute myocardial infarction (AMI) before primary coronary stenting with adjunct glycoprotein IIb/IIIa receptor blockade, whether residual blood flow in the infarct-related artery (IRA) affects infarct size or myocardial salvage is not known. METHODS: This study included 118 patients with ST-segment elevation AMI who received coronary stenting plus abciximab. SPECT studies were performed before and 7-14 d after stenting. RESULTS: Patients were divided into a group with initial Thrombolysis in Myocardial Infarction (TIMI) flow grade < or = 1 (77 patients) and a group with initial TIMI flow grade > 1 (41 patients). The initial median perfusion defect and (in brackets) the 25th and 75th percentiles were 29.1% [21.0%; 52.0%] of the left ventricle in patients with TIMI flow grade < or = 1, versus 16.5% [8.0%; 33.1%] of the left ventricle in patients with TIMI flow grade > 1 (P < 0.001). Baseline left ventricular ejection fraction (54.0% [45.0; 63.0] vs. 57.0% [40.0; 62.0], P = 0.623) or extension of hypokinetic region (28.0 [14.0; 41.0] hypokinetic chords vs. 24.0 [13.0; 39.0] hypokinetic chords, P = 0.643) did not differ significantly between the group with TIMI flow grade < or = 1 and the group with TIMI flow grade > 1. Final infarct size was 11.0% [6.1%; 23.5%] of the left ventricle in the group with TIMI flow grade < = 1, versus 6.0% [2.0%; 12.8%] of the left ventricle in the group with TIMI flow > 1 (P = 0.008). Salvage index was 0.58 [0.38; 0.76] in the group with TIMI flow grade < or = 1, versus 0.61 [0.36; 0.74] in the group with TIMI flow grade > 1 (P = 0.952). At the day 14 angiography, patients with TIMI flow grade > 1 had better left ventricular ejection fraction (61.0% [54.0%; 68.0%] vs. 56.5% [42.9%; 65.0%]; P = 0.03) and a smaller hypokinetic region (7 chords [0; 22.0] vs. 16 chords [2.5; 30.0]; P = 0.024) than did patients with TIMI flow grade < or = 1. CONCLUSION: Preserved blood flow in the IRA in patients with AMI is associated with a smaller area at risk, a smaller infarct, and better recovery of regional and global left ventricular function. The proportion of initial area at risk salvaged by coronary stenting does not seem to depend on residual blood flow in the IRA.

Mechanical reperfusion in patients with acute myocardial infarction presenting more than 12 hours from symptom onset: a randomized controlled trial.

CONTEXT: No specifically designed studies have addressed the role of primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction (STEMI) presenting more than 12 hours after symptom onset. Current guidelines do not recommend reperfusion treatment in these patients. OBJECTIVE: To assess whether an immediate invasive treatment strategy is associated with a reduction of infarct size in patients with acute STEMI, presenting between 12 and 48 hours after symptom onset, vs a conventional conservative strategy. DESIGN, SETTING, AND PATIENTS: International, multicenter, open-label, randomized controlled trial conducted from May 23, 2001, to December 15, 2004, of 365 patients aged 18 to 80 years without persistent symptoms admitted with the diagnosis of acute STEMI between 12 and 48 hours after symptom onset. INTERVENTIONS: Random assignment to either an invasive strategy (n=182) based predominantly on coronary stenting with abciximab or a conventional conservative treatment strategy (n=183). MAIN OUTCOME MEASURES: The primary end point was final left ventricular infarct size according to single-photon emission computed tomography study with technetium Tc 99m sestamibi performed between 5 and 10 days after randomization in 347 patients (95.1%). Secondary end points included composite of death, recurrent MI, or stroke at 30 days. RESULTS: The final left ventricular infarct size was significantly smaller in patients assigned to the invasive group (median, 8.0%; interquartile range [IQR], 2.0%-15.8%) vs those assigned to the conservative group (median, 13.0%; IQR, 3.0%-27.0%; P<.001). The mean difference in final left ventricular infarct size between the invasive and conservative groups was -6.8% (95% confidence interval [CI], -10.2% to -3.5%). The secondary end points of death, recurrent MI, or stroke at 30 days occurred in 8 patients in the invasive group (4.4%) and 12 patients in the conservative group (6.6%) (relative risk, 0.67; 95% CI, 0.27-1.62; P = .37). CONCLUSION: An invasive strategy based on coronary stenting with adjunctive use of abciximab reduces infarct size in patients with acute STEMI without persistent symptoms presenting 12 to 48 hours after symptom onset.

Gender and myocardial salvage after reperfusion treatment in acute myocardial infarction.

OBJECTIVES: The aim of this study was to investigate whether there are gender-associated differences in the amount of myocardial salvage after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). BACKGROUND: Despite having a more adverse cardiovascular risk profile, women with AMI have similar or even better outcomes after primary PCI compared with men. The reasons for these findings are unclear. METHODS: In this study we included 202 women and 561 men with AMI who underwent primary PCI in the setting of three randomized trials. The primary end point of the study was myocardial salvage index (proportion of initial perfusion defect salvaged by reperfusion therapy), obtained by paired scintigraphic studies performed 7 to 10 days apart. RESULTS: The amount of myocardium at risk or initial perfusion defect (median [25th, 75th percentiles]) did not differ significantly between women and men (22.0% [12.0, 40.0] vs. 24.0% [14.0, 39.0] of the left ventricle [LV], p = 0.26). Final infarct size, measured in the follow-up scintigraphy, was significantly smaller in women than in men (6.0% [0.71, 18.7] vs. 10.0% [3.9, 21.8] of the LV, p = 0.001). Myocardial salvage index was 0.64 (0.35, 0.95) in women versus 0.50 (0.26, 0.77) in men (p < 0.001). After adjustment for baseline characteristics, female gender was an independent predictor of greater myocardial salvage after PCI (p = 0.002). CONCLUSIONS: The efficacy of primary PCI in patients with AMI appears to be gender-dependent. Myocardial salvage achieved by primary PCI is greater in women than in men.

Pacemaker auto-interference by thoracic impedance measurement for the rate response function.

This report describes two cases of pacemaker auto-interference caused by thoracic impedance measurements for the rate response function of a dual chamber pacemaker. Mechanisms of this phenomenon and reprogramming strategies are discussed.

Early administration of reteplase plus abciximab vs abciximab alone in patients with acute myocardial infarction referred for percutaneous coronary intervention: a randomized controlled trial.

CONTEXT: The optimal pharmacological strategy for bridging the delay between admission and performance of percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (MI) is not known. OBJECTIVE: To assess whether early administration of reteplase plus abciximab produces better results compared with abciximab alone in patients with acute MI referred for PCI. DESIGN, SETTING, AND PATIENTS: Open-label, randomized controlled study conducted from May 3, 2001, through June 2, 2003, of 253 patients who were admitted to 13 community hospitals without catheterization facilities (n = 186) and to 5 hospitals with catheterization facilities (n = 67), with the diagnosis of an ST-segment elevation acute MI within 12 hours from onset of symptoms. INTERVENTIONS: Patients received intravenously either the combination of a half-dose reteplase (two 5-U boluses, 30 minutes apart) with a standard dose of abciximab (0.25 mg/kg bolus, 0.125 microg/kg per minute infusion [maximum 10 microg/min for 12 hours]) or the standard dose of abciximab alone; all patients were then transferred for PCI. MAIN OUTCOME MEASURE: Final infarct size according to a single-photon emission computed tomography study with technetium Tc 99m sestamibi performed between 5 and 10 days after randomization in 228 patients (90.1% of entire sample). RESULTS: Of the 253 patients enrolled, 125 were assigned to reteplase plus abciximab and 128 to abciximab alone. The median (interquartile range) of the final infarct size of the left ventricle was 13.0% (3.0%-28.0%) in the reteplase plus abciximab group and 11.5% (3.0%-26.3%) in the abciximab-alone group (P =.81). The mean difference in final infarct size of left ventricle between the reteplase plus abciximab group and the abciximab group was 1.3% (95% confidence interval [CI], -3.1% to 5.7%). Within 6 months after randomization, the composite secondary end point of death, recurrent MI, or stroke occurred in 8 patients (6.4%) in the reteplase plus abciximab group and 6 patients (4.7%) in the abciximab group (relative risk, 1.4; 95% CI, 0.5-3.9; log-rank P =.56). Major bleeding complications were observed in 7 patients (5.6%) in the reteplase plus abciximab group and 2 patients (1.6%) in the abciximab group (P =.16). CONCLUSION: Early administration of reteplase plus abciximab does not lead to a reduction of infarct size compared with abciximab alone in patients with acute MI referred for PCI.