BACKGROUNDIn patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.METHODSWe conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).RESULTSThere were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).CONCLUSIONSAs an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov].).

Background The bleeding risk associated with platelet glycoprotein IIb/IIIa inhibition in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) after full-dose thrombolysis for acute myocardial infarction (AMI) is unclear. We examined the risk and predictors of bleeding complications in patients with AMI who received abciximab during rescue or urgent PTCA after full-dose thrombolytic therapy. Methods A multicenter retrospective cohort of 147 consecutive patients who underwent PTCA within 48 hours after full-dose thrombolysis for AMI was studied. Bleeding events (major, minor, nuisance) from the onset of AMI to discharge were compared between those who received abciximab (n = 57) and those who did not (n = 90). Results Baseline clinical characteristics were similar between the two groups. Despite lower doses of procedural heparin, the incidence of non–coronary artery bypass graft–related major and minor bleeding was higher in the abciximab group than in controls (63% vs 39%, P =.004). Although the risk of major bleeding was 4-fold with abciximab (12% vs 3%, P =.04), only one intracranial and one fatal bleeding event occurred. Multivariable regression identified abciximab therapy as the most powerful independent predictor of combined major and minor bleeding, with a hazard risk ratio of 1.9 (P =.04). Conclusions In the setting of rescue or urgent PTCA within 48 hours after full-dose thrombolytic therapy after AMI, major and particularly minor bleeding were frequently encountered. The adjunctive use of abciximab increased these bleeding risks by approximately 2-fold. (Am Heart J 2001;141:218-25.)

Background The Total Occlusion Study of Canada (TOSCA) is a multicenter, randomized trial evaluating the effect of stenting with ≥1 heparin-coated stent on long-term patency after percutaneous coronary intervention by balloon angioplasty of occluded coronary arteries. The purpose of the current study was to compare the effect of stenting and balloon angioplasty on global left ventricular ejection fraction (LVEF) and regional wall motion and to examine what clinical and angiographic factors may have an effect on left ventricular function in this setting. Methods and Results Analysis at the core angiographic laboratory of paired baseline and follow-up left ventricular angiograms, as well as target vessel patency, was possible in 244 of 410 cases. An improvement in LVEF was observed in the entire group (59.4% ± 11% to 61.0% ± 11%, P =.003). The LVEF change was +1.84 ± 7.54 in the stent group (P =.009) and 1.28 ± 8.16 in the percutaneous transluminal coronary angioplasty group (P =.085). There was no significant intergroup difference. Patients with duration of occlusion ≤6 weeks had an improvement in LVEF (+2.98 ± 8.68, P =.0006), whereas those with an occlusion duration of >6 weeks had no improvement (+0.48 ± 7.01, P not significant). Multivariate analysis revealed baseline LVEF <60%, duration of occlusion ≤6 weeks, and Canadian Cardiology Society angina class I or II to be independent predictors of improvement in LVEF. Conclusions The restoration of coronary patency of nonacute occluded coronary arteries is associated with a small but significant improvement in regional and global left ventricular function, especially in patients with recent occlusions and depressed left ventricular function. In spite of significant effect on long-term patency, stenting of nonacute coronary occlusions does not result in significantly better left ventricular function compared with balloon angioplasty in this setting. (Am Heart J 2001;142:301-8.)

OBJECTIVES To test the hypothesis that endovascular stents used with dilation of coarctation of the aorta (CoA) improve late outcomes. Balloon dilation for CoA has been limited by concerns over the risk for acute dissection, late restenosis, or aneurysm formation. DESIGN All patients seen with CoA between November 1994 and September 1997 underwent attempted stent implantation. Follow up was obtained for all patients and a subgroup (n = 18) had repeat catheterisation at a mean (SD) of 1.3 (0.5) years to assess residual gradient and stent-CoA morphology. RESULTS Stents were placed in 27 patients (15 male and 12 female patients, mean age 30.1 (13.1) years), of whom seven had prior surgical coarctectomy and one had a prior balloon dilation. Hypertension was present in 26 patients (mean pressure 164 (26)/86 (13) mm Hg), of whom 16 were on antihypertension drugs. CoA gradients were 46 (20) mm Hg (range 18–106 mm Hg) at baseline and 3 (5) mm Hg after the procedure. One patient had a stroke following the procedure; another patient had incomplete dilation and underwent a second procedure. At 1.8 (1) years after the procedure the mean pressure was 130 (14)/74 (11) mm Hg with seven patients on antihypertension treatment. The clinical gradient was 4 (8) mm Hg (range 0–32 mm Hg). At follow up angiography, the mean gradient was 4(6) mm Hg, and two patients had a gradient over 10 mm Hg. Aneurysms formed in three patients at the dilation site; one patient was referred for surgery. CONCLUSION In this age group stent management for CoA appears to be an effective technique and results in sustained reduction in CoA gradients at early term follow up, but aortic aneurysm was detected in 17% of patients who had repeat angiography.

OBJECTIVE:To study the impact of intracoronary stents on clinical restenosis in the 'real world'.DESIGN:Retrospective comparison of the rates of clinical restenosis between two cohorts exposed to different strategies for percutaneous transcatheter intervention. The endpoint was the first of death, myocardial infarction, coronary artery bypass grafting, repeat percutaneous transluminal coronary angioplasty (PTCA) or repeat coronary angiography within nine months.SETTING:Tertiary care cardiac referral centre serving a large, metropolitan population.PATIENTS:Patients undergoing angiographic revascularization from January 1 to February 28, 1996 (the 'restricted' group [R], n=147) were compared with a before and after cohort (the 'usual' group [U], n=232, divided into those who underwent revascularization between November 1 and November 30, 1995, and those who underwent revascularization between April 1 and May 31, 1996).INTERVENTIONS:The R group was revascularized during a period of economic constraint, which imposed a shortage on stent availability. The U cohort underwent revascularization before and after the shortage (an 'unrestricted' environment for stent usage).MAIN RESULTS:There was no difference in clinical restenosis rates between the R (34.7%) and U (37.9%) groups (P=0.524, OR R/U=0.915, 95% CI 0.694 to 1.206). Also, the rate of clinical restenosis was the same among patients who underwent PTCA without stent insertion (34.8%) and those who received a stent (39.4%) (P=0.368, OR=1.13, 95% CI 0.87 to 1.44).CONCLUSIONS:At the authors' institution, a restricted stenting policy did not result in a higher clinical restenosis rate than that of usual practice.

Coronary artery lesions can develop in Kawaski disease as a major complication, and result in aneurysm formation and stenosis, Reported is the evolution of important coronary artery stenosis in a pediatric patient managed with an endovascular stent. (C) 1999 Wiley-Liss, Inc.

This report describes a case of successful percutaneous coronary transluminal angioplasty (PTCA) of a coronary artery bifurcating lesion using multiple intracoronary stents in an inverted 'Y' configuration. Balloon angioplasty of bifurcation coronary stenoses has a lower procedural success rate, higher restenosis rate and potential for side branch occlusion compared with nonbifurcation lesions. Numerous techniques, including two ('kissing') angioplasty balloons, have been used to overcome these problems. The authors believe that the technique described in this report, inserting stents into both branches simultaneously followed by a third proximal stent in a 'Y' configuration, allows successful dilatation of the bifurcation lesion while preserving flow into both branches and should be considered for similar complex anatomical subsets.

The USCI patent ductus occluder has been shown to be an effective nonsurgical technique for closure of the persistently patent ductus in a primarily pediatric population. Its clinical impact in the adult has been reported only within small subgroups of larger pediatric studies or for a small population. This study was conducted to determine the feasibility, success rate, and complications of device closure for the persistently patent ductus arteriosus (PDA) in the adult. The population consisted of 55 patients (4 men and 51 women; mean age 38.8 ± 15.0 years) with follow-up of 2.2 ± 2.1 years. All patients underwent echocardiography obtained as part of their follow-up assessment. The device was successfully placed in 54 patients, with 75% clinical and echocardiographic closure at the first follow-up assessment (2.4 ± 2.6 months). One patient with initial clinical and echocardiographic evidence of closure was subsequently found to have an open ductus. Spontaneous closure (2 patients) or second implant (6 patients) resulted in 86% closure at the most recent assessment. Thus, the percutaneous PDA double-umbrella occluder device is a feasible and effective technique for closing persistent PDA in the adult and will result in occlusion of the shunt in most patients without the need for thoracotomy.

A 34-year-old woman showed the development of significant main pulmonary artery obstruction along the supravalvar suture line 18 months following a Ross procedure. The patient underwent unsuccessful balloon angioplasty, followed by successful stent implantation. The angiographic narrowing disappeared postprocedure, and the excellent hemodynamic result maintained at 4 month follow-up.