Pivotal, randomized U.S. study of the Symbiottrade mark covered stent system in patients with saphenous vein graft disease: eight-month angiographic and clinical results from the Symbiot III trial.

OBJECTIVES: The purpose of this study was to evaluate the clinical and angiographic outcomes of the Symbiot ePTFE covered stent versus bare metal stents (BMS) for the treatment of saphenous vein graft (SVG) disease. BACKGROUND: The Symbiot stent was developed to reduce periprocedural complications, by potentially preventing distal embolization, and to serve as a possible barrier to cell migration, thus reducing restenosis. METHODS: Symbiot III is a prospective, randomized trial of 400 patients at 45 US sites, with 201 patients in the Symbiot group and 199 in the BMS group. Randomization was stratified based on the intended use of embolic protection devices and glycoprotein IIb/IIIa inhibitors. The primary endpoint was percent diameter stenosis (%DS) as measured by quantitative coronary angiography at 8 months. Secondary endpoints included MACE (cardiac death, MI, TVR). RESULTS: The groups were well matched for all baseline clinical and lesion characteristics. At 8 months, %DS was comparable between groups (30.9% Symbiot, 31.9% BMS, P = 0.80). Although the rates of binary restenosis in the stented segment were similar (29.1% Symbiot, 21.9% BMS, P = 0.17), more patients in the Symbiot group had binary restenosis at the proximal edge (9.0% Symbiot, 1.8% BMS, P = 0.0211). There was no difference in the incidence of MACE between groups (30.6% Symbiot, 26.6% BMS, P = 0.43). CONCLUSIONS: This study failed to show an advantage for the Symbiot stent in the treatment of degenerated SVGs. This PTFE covered stent does not appear to act as a barrier to prevent restenosis.

Multivessel percutaneous coronary intervention in patients with multivessel disease and acute myocardial infarction.

BACKGROUND: The optimal percutaneous interventional strategy for dealing with significant non-culprit lesions in patients with multivessel disease (MVD) with acute myocardial infarction (AMI) at presentation remains controversial. METHODS: A total of 820 patients treated with primary angioplasty for AMI between 1998 and 2002 were classified in groups of patients with single vessel disease (SVD) or MVD (> or =70% stenosis of > or =2 coronary arteries). Patients with MVD were subdivided in 3 groups on the basis of the revascularization strategy: 1) patients undergoing percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) only; 2) patients undergoing PCI of both the IRA and non-IRA(s) during the initial procedure; and 3) patients undergoing PCI of the IRA followed by staged, in-hospital PCI of the non-IRA(s). Procedural, 30-day, and 1-year outcomes are reported. RESULTS: At 1 year, compared with patients with SVD, patients with MVD had a higher incidence of re-infarction (5.9% vs 1.6%, P =.003), revascularization (18% vs 9.6%, P <.001), mortality (12% vs 3.2%, P <.001), and major adverse cardiac events (MACEs; 31% vs 13%, P <.001). In patients with MVD, compared with PCI restricted to the IRA only, multivessel PCI was associated with higher rates of re-infarction (13.0% vs 2.8%, P <.001), revascularization (25% vs 15%, P =.007), and MACEs (40% vs 28%, P =.006). Multivessel PCI was an independent predictor of MACEs at 1 year (odds ratio = 1.67, P =.01). CONCLUSIONS: These data suggest that in patients with MVD, PCI should be directed at the IRA only, with decisions about PCI of non-culprit lesions guided by objective evidence of residual ischemia at late follow-up. Further studies are needed to confirm these findings.

Improving in-hospital mortality in the setting of an increasing risk profile among patients undergoing catheter-based reperfusion for an acute myocardial infarction without cardiogenic shock.

UNLABELLED: Prompt myocardial reperfusion is the therapeutic goal for patients presenting with acute myocardial infarction (AMI). However, there remains a paucity of clinical data from single centers solely dedicated to a catheter-based reperfusion strategy. Therefore, we sought to identify significant predictors of in-hospital mortality, to determine the changing profile of patient demographics and to identify the mortality trend over time. METHODS: Consecutive patients who underwent percutaneous coronary intervention (PCI) for an AMI between January of 1982 and December of 1999 were included in this multivariable analysis (excluding cardiogenic shock). AMI was defined as an evolving myocardial infarction within the preceding 24 hours. The primary endpoint for this analysis was in-hospital mortality. RESULTS: There were 2,745 patients identified in this study, of which 8.3% (n = 228) were non-survivors. The significant multivariable predictors of in-hospital mortality included creatinine > 1.5 mg/dl [relative risk (RR), 5.7; 95% confidence interval (CI) 4.0 8.1], ejection fraction < 40% (RR, 6.6; 95% CI, 4.3 10.0), multivessel disease (RR, 2.8; 95% CI, 1.9 4.2), female (RR, 2.3; 95% CI, 1.6 3.1) and age > 70 years (RR, 1.6; 95% CI, 1.1 2.2). The incidence of patients with these high-risk characteristics increased in recent years; thus, the unadjusted slope of the mortality trend over 20 years was not significant. However, following adjustment for the temporal shift in high-risk variables, there was a significant reduction in the adjusted in-hospital mortality rate (RR, 0.89; 95% CI 0.8 0.98; p = 0.017). Despite the changing risk profile, the short-term mortality continues to improve for patients undergoing AMI PCI.

Diabetes mellitus is associated with a shift in the temporal risk profile of inhospital death after percutaneous coronary intervention: an analysis of 25,223 patients over 20 years.

BACKGROUND: Numerous studies have demonstrated that patients with diabetes have higher rates of restenosis, late myocardial infarction, and late death after percutaneous coronary interventions (PCI). However, it remains unclear whether patients with diabetes mellitus also have an increased hazard for early death after either elective or urgent PCI. METHODS: Patients undergoing PCI at the Mid American Heart Institute between 1980 and 1999 were identified. The main end point was inhospital death. Patients were stratified both by diabetes status and whether they underwent elective or urgent PCI. RESULTS: There were 17,341 nondiabetic patients and 4308 patients with diabetes who underwent elective PCI. There were 2946 nondiabetic patients and 628 patients with diabetes who underwent urgent PCI. Multivariate analysis demonstrated that diabetes was associated with increased inhospital mortality rate after any PCI (odds ratio 1.4, 95% CI 1.1-1.8, P =.003). The unadjusted inhospital mortality rates for the nondiabetic patients and patients with diabetes were 0.8% and 1.4%, respectively (P <.001), after elective PCI. The mortality rate was 6.9% for the nondiabetic patients and 12.7% for the patients with diabetes (P <.001) after urgent PCI. The inhospital mortality rates among diabetic patients appear to be decreasing over time among the elective cohort (elective PCI diabetes-time interaction, P =.007) but not in the urgent cohort (urgent PCI-diabetes-time interaction, P =.68). CONCLUSIONS: There has been an improvement in the inhospital survival rate among patients with diabetes in the elective PCI cohort. This improved hospital survival has yet to be realized among patients with diabetes undergoing urgent PCI.