on behalf of the ReoPro and Primary PTCA Organization and Randomized Trial (RAPPORT) Investigators* Background-The benefit of catheter-based reperfusion for acute myocardial infarction (MI) is limited by a 5% to 15% incidence of in-hospital major ischemic events, usually caused by infarct artery reocclusion, and a 20% to 40% need for repeat percutaneous or surgical revascularization. Platelets play a key role in the process of early infarct artery reocclusion, but inhibition of aggregation via the glycoprotein IIb/IIIa receptor has not been prospectively evaluated in the setting of acute MI. Methods and Results-Patients with acute MI of Ͻ12 hours' duration were randomized, on a double-blind basis, to placebo or abciximab if they were deemed candidates for primary PTCA. The primary efficacy end point was death, reinfarction, or any (urgent or elective) target vessel revascularization (TVR) at 6 months by intention-to-treat (ITT) analysis. Other key prespecified end points were early (7 and 30 days) death, reinfarction, or urgent TVR. The baseline clinical and angiographic variables of the 483 (242 placebo and 241 abciximab) patients were balanced. There was no difference in the incidence of the primary 6-month end point (ITT analysis) in the 2 groups (28.1% and 28.2%, Pϭ0.97, of the placebo and abciximab patients, respectively). However, abciximab significantly reduced the incidence of death, reinfarction, or urgent TVR at all time points assessed (9.9% versus 3.3%, Pϭ0.003, at 7 days; 11.2% versus 5.8%, Pϭ0.03, at 30 days; and 17.8% versus 11.6%, Pϭ0.05, at 6 months). Analysis by actual treatment with PTCA and study drug demonstrated a considerable effect of abciximab with respect to death or reinfarction: 4.7% versus 1.4%, Pϭ0.047, at 7 days; 5.8% versus 3.2%, Pϭ0.20, at 30 days; and 12.0% versus 6.9%, Pϭ0.07, at 6 months. The need for unplanned, "bail-out" stenting was reduced by 42% in the abciximab group (20.4% versus 11.9%, Pϭ0.008). Major bleeding occurred significantly more frequently in the abciximab group (16.6% versus 9.5%, Pϭ0.02), mostly at the arterial access site. There was no intracranial hemorrhage in either group. Conclusions-Aggressive platelet inhibition with abciximab during primary PTCA for acute MI yielded a substantial reduction in the acute (30-day) phase for death, reinfarction, and urgent target vessel revascularization. However, the bleeding rates were excessive, and the 6-month primary end point, which included elective revascularization, was not favorably affected. (Circulation. 1998;98:734-741.)
Inflammation markers and their serial changes predict death and shock in patients with STEMI undergoing primary angioplasty. Pexelizumab reduced C-reactive protein and IL-6, suggesting treatment benefits mediated through anti-inflammatory effects.
Background-Angioplasty has become an accepted treatment of patients with coronary artery disease and is now commonly used to treat patients with multivessel disease. The major disadvantage of angioplasty has been restenosis requiring repeat interventions with resultant loss of initial cost savings. Compared with the right and the circumflex coronary arteries, the left anterior descending artery (LAD) has been more adversely affected by restenosis. Recently, minimally invasive direct coronary artery bypass (MIDCAB) to the LAD through a small left anterior thoracotomy using the left internal mammary artery has been performed in some centers with excellent early results and with reduced costs compared with standard bypass surgery. Methods and Results-We retrospectively reviewed the first 31 consecutive patients treated in our institution with integrated coronary revascularization (ICR): MIDCAB to the LAD combined with PTCA of the other diseased vessels in patients with multivessel disease. Postoperative angiography in 84% of patients revealed a patent anastomosis and normal flow in the graft and bypassed vessel. Thirty-eight (97%) of 39 vessels were successfully treated percutaneously. At a mean follow-up of 7 months, all patients are currently asymptomatic. There have been 2 adverse clinical events, both related to angioplasty and not to MIDCAB. The average length of stay at the hospital after MIDCAB was 2.79Ϯ1.05 days. Conclusions-These preliminary results with ICR are encouraging and suggest that a randomized, prospective clinical trial comparing ICR with standard coronary artery bypass surgery for the revascularization of symptomatic patients with multivessel disease involving the LAD is warranted. (Circulation. 1998;98;1048-1050.)
BackgroundThe American Heart Association Mission: Lifeline STEMI (ST‐segment–elevation myocardial infarction) Systems Accelerator program, conducted in 16 regions across the United States to improve key care processes, resulted in more patients being treated within national guideline goals (time from first medical contact to device: <90 minutes for direct presenters to hospitals capable of performing percutaneous coronary intervention; <120 minutes for transfers). We examined whether the effort reduced reperfusion disparities in the proportions of female versus male and black versus white patients.Methods and ResultsIn total, 23 809 patients (29.3% female, 82.3% white, and 10.7% black) presented with acute STEMI between July 2012 and March 2014. Change in the proportion of patients treated within guideline goals was compared between sex and race subgroups for patients presenting directly to hospitals capable of performing percutaneous coronary intervention (n=18 267) and patients requiring transfer (n=5542). The intervention was associated with an increase in the proportion of men treated within guideline goals that presented directly (58.7–62.1%, P=0.01) or were transferred (43.3–50.7%, P<0.01). An increase was also seen among white patients who presented directly (57.7–59.9%, P=0.02) or were transferred (43.9–48.8%, P<0.01). There was no change in the proportion of female or black patients treated within guideline goals, including both those presenting directly and transferred.ConclusionThe STEMI Systems Accelerator project was associated with an increase in the proportion of patients meeting guideline reperfusion targets for male and white patients but not for female or black patients. Efforts to organize systems of STEMI care should implement additional processes targeting barriers to timely reperfusion among female and black patients.
Background-Vascular smooth muscle cell (VSMC) proliferation is a critical factor in the neointima formation that causes restenosis after coronary angioplasty (PTCA). Desferri-exochelin 772SM (D-EXO), a highly diffusible, lipophilic iron chelator secreted by Mycobacterium tuberculosis, inhibits proliferation of VSMCs in culture. We hypothesized that treatment with D-EXO would inhibit neointima formation in balloon-injured vessels in vivo. Methods and Results-We subjected 24 pigs to overstretch coronary artery injury with standard PTCA balloons and then administered intramural injections of either D-EXO (nϭ14) or vehicle (nϭ10) through an Infiltrator catheter. Treatments were randomized, and the investigators were blinded with regard to treatment group until data analysis was completed. One month later, we euthanized the pigs, excised the injured coronary segments, made multiple sections of each segment, and identified the site of maximal neointima formation. An injury score based on the degree of disruption of the internal or external elastic lamina or media was assigned. D-EXO reduced stenosis index (neointima area divided by the area within the internal elastic lamina), adjusted for injury score, by 47%. Neointima thickness was also reduced. Conclusions-D-EXO, injected intramurally, substantially inhibited formation of neointima in a porcine vascular injury model.
The objective of this study was to derive a method for quantifying the dynamic geometry of coronary arteries. Coronary artery geometry plays an important role in atherosclerosis. Coronary artery geometry also influences the performance of coronary interventions. Conversely, implantation of stents may alter coronary artery geometry. Clinical tools to define vessel shape have not been readily available. Using a Frenet-Serret curvature analysis applied to 3D reconstruction data derived from standard coronary angiograms, 21 coronary arteries were analyzed at end-diastole (ED) and end-systole (ES). Vessels were divided anatomically: type 1 consisted of vessels lying in the AV groove (left circumflex, right coronary) and type 2 consisted of vessels overlying actively contracting myocardium (left anterior descending, diagonal, obtuse marginal, right ventricular marginal, posterior descending, posterolateral). Vessel segments were analyzed by assessing the changes in curvature, torsion, and discrete flexion points (FPs), areas of systolic bending in the arterial contour. The curvature from ED to ES of type 1 vessels was unchanged (-0.02 +/- 0.03 cm(-1)), while the curvature change of type 2 vessels showed a 38% increase (0.33 +/- 0.04 cm(-1); P < 0.001). Type 1 vessels had fewer FPs per vessel than type 2 vessels (0.38 +/- 0.18 and 2.40 +/- 0.23 FP/vessel, respectively; P < 0.001). FPs were more common in distal segments and branch vessels. A method to quantify cyclic changes in coronary artery shape was applied to 3D data sets derived from standard coronary angiograms. Coronary arteries undergo a cyclic change in shape resulting in changes in overall curvature as well as formation of discrete flexion points. These changes in vessel shape are asymmetrically distributed in coronary arteries.
These data suggest that in the current era of published treatment guidelines, implementation of a critical pathway can further improve AMI quality indicators and clinical care.
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