A randomized, double-blind, placebo-controlled trial of abciximab for prevention of in-stent restenosis in diabetic patients after coronary stenting: results of the ASIAD (Abciximab in Stenting Inhibits restenosis Among Diabetics) Trial.

OBJECTIVES: Coronary stenting is associated with a high incidence of restenosis in patients with diabetes mellitus. Recent data suggest that diabetic patients treated with abciximab have a lower rate of target vessel revascularization (TVR). We sought to investigate whether abciximab can reduce in-stent restenosis after coronary stenting in diabetic patients. METHODS: In this prospective double-blind trial, we randomly assigned 254 patients with type 2 diabetes mellitus undergoing nonurgent coronary stenting to receive abciximab with an initial heparin bolus of 50 U/kg (n = 128) or placebo with an initial heparin bolus of 70 U/kg (n = 126). All patients received aspirin and clopidogrel before the procedure. The primary endpoint was angiographic restenosis by quantitative coronary angiography at 6 months. The secondary endpoint was death, myocardial infarction (MI), or target lesion revascularization (TLR) at 6 months. RESULTS: The clinical, angiographic, and procedural characteristics were matched between the 2 groups. Angiographic follow-up was completed in 226 patients (90%). Angiographic restenosis occurred in 29.1% of the abciximab group, and 24% of the placebo group (p = 0.30). The rates of the secondary endpoint were similar between the 2 groups (23.4% in the abciximab group versus 22.2% in the placebo group; p = 0.88). TLR was performed on 36 (18.4%) lesions in 29 (23.4%) patients of the abciximab group, and 26 (13.6%) lesions in 23 (18.3%) patients of the placebo groups, respectively (p = 0.21 and 0.35, respectively). CONCLUSIONS: Abciximab does not reduce angiographic restenosis or TLR in type 2 diabetic patients undergoing nonurgent coronary stenting.

Automatic mode switching of implantable pacemakers: II. Clinical performance of current algorithms and their programming.

While the hemodynamic and clinical significance of automatic mode switching (AMS) in patients with pacemakers has been demonstrated, the clinical behavior of AMS algorithms differ widely according to the manufacturers and pacemaker models. In general, a "rate-cutoff" detection method of atrial tachyarrhythmias provides a rapid AMS onset and resynchronization to sinus rhythm at the termination of atrial tachyarrhythmias, but may cause intermittent oscillations between the atrial tracking and AMS mode. This can be minimized with a "counter" of total number of high rate events before the AMS occurs. The use of a "running average" algorithm results in more stable rate control during AMS by reducing the incidence of oscillations, but at the expense of delayed AMS onset and resynchronization to sinus rhythm. Algorithms may be combined to fine tune the AMS response and to avoid rapid fluctuation in pacing rate. Appropriate programming of atrial sensitivity, and the avoidance of ventriculoatrial cross-talk are essential for optimal AMS performance.

Automatic mode switching of implantable pacemakers: I. Principles of instrumentation, clinical, and hemodynamic considerations.

Automatic mode switching (AMS) is now a programmable function in most contemporary dual chamber pacemakers. Atrial tachyarrhythmias are detected when the sensed atrial rate exceeds a "rate-cutoff," "running average," "sensor-based physiological" rate, or using "complex" detection algorithms. AMS algorithms differ in their atrial tachyarrhythmia detection method, sensitivity, and specificity and, thus, respond differently to atrial tachyarrhythmia in terms of speed to the AMS onset, rate stability of the response, and speed to resynchronize to sinus rhythm. AMS is hemodynamically beneficial, and most patients with atrial tachyarrhythmias are symptomatically better with an AMS algorithm in their pacemakers. New diagnostic capabilities of pacemaker especially stored electrograms not only allow programming of the AMS function, but enable quantification of atrial fibrillation burden that facilitate clinical management of patients with implantable devices who have concomitant atrial tachyarrhythmia.

Comparison of perindopril versus captopril for treatment of acute myocardial infarction.

Angiotensin-converting enzyme (ACE) inhibitors reduce mortality in patients with acute myocardial infarction (AMI), but these benefits might be limited by acute hemodynamic changes and difficulties in titrating to recommended doses. The objective of this study was to compare the hemodynamic changes and tolerability of perindopril with captopril after AMI. We randomized 212 patients to receive either captopril (n = 102) or perindopril (n = 110) within 72 hours of AMI. Captopril was given as an initial dose of 6.25 mg, and then 50 mg/day on day 1 and 100 mg/day thereafter. The corresponding doses of perindopril were 2, 4, and 8 mg/day. Acute hemodynamic changes, the percentage of patients who reached target doses, and in-hospital and 6-month cardiovascular events were monitored. Baseline clinical characteristics of the 2 groups were identical, but patients randomized to perindopril were in a higher Killip class (1.4 +/- 0.6 vs 1.2 +/- 0.5, p = 0.05). During the first 6 hours, treatment with perindopril resulted in higher minimal systolic (97 +/- 15 vs 91 +/- 14 mm Hg, p <0.01) and diastolic blood pressure (BP) (57 +/- 11 vs 54 +/- 10 mm Hg, p <0.02), later occurrence of minimal BP (3.6 +/- 0.2 vs 2.7 +/- 0.1 hour, p <0.001), and a lower incidence of persistent hypotension with systolic BP < 90 mm Hg for > or =1 hour (5% vs 16%; p < 0.01) compared with captopril. At initial administration, target doses of perindopril and captopril were attained in 97% and 82% of the patients, respectively (p < 0.01). After 6 months, there were no differences between patients treated with perindopril and captopril in mortality rates (6% vs 13%, p = 0.16) and need for revascularization (20% vs 21%, p = 0.9). Thus, in patients during AMI, perindopril treatment showed better short-term tolerance than treatment with captopril, with significantly less acute hemodynamic changes and fewer withdrawals.