Mortality and morbidity following a major bleed in a registry population with acute ST elevation myocardial infarction.

Major bleeding has been associated with an increased risk of ischemic events and death in patients with acute coronary syndromes. We examined the relationship between bleeding and outcome in 1,389 consecutive patients with ST-elevation myocardial infarction (STEMI) presenting to a tertiary center between May 1, 2003 and July 10, 2007. We recorded bleeding, length of stay and death during the first 30 days after hospitalization. Major bleeding occurred in 10.9% (152/1389, 95% confidence interval [CI] 9.3-12.6%). In hospital mortality was significantly higher in patients with major bleeding compared to those without major bleeding (19.7 vs. 8.2%, odds ratio [OR] 2.8, 95% CI 1.8-4.3) and was evident in the subgroups of patients with a low TIMI STEMI risk score (7.9 vs. 1.8%, OR 4.6, 95% CI 1.2-17.0) and medium risk score (11.7 vs. 6.3%, OR 2.0, 95% CI 0.6-6.2) but not those with a high TIMI STEMI risk score (28.8 vs. 26.1%, OR 1.2, 95% CI 0.7-2.0) (P for interaction = 0.024). Our data indicate that serious bleeding is common in patients with STEMI treated with thrombolysis or PCI and is a powerful predictor of death, particularly in patients with a low TIMI risk score. Therapies that maintain efficacy while reducing bleeding and that reduce the risk of death in patients who develop bleeding are needed.

Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials.

BACKGROUND: Small randomized trials have demonstrated that radial access reduces access site complications compared to a femoral approach. The objective of this meta-analysis was to determine if radial access reduces major bleeding and as a result can reduce death and ischemic events compared to femoral access. METHODS: MEDLINE, EMBASE, and CENTRAL were searched from 1980 to April 2008. Relevant conference abstracts from 2005 to April 2008 were searched. Randomized trials comparing radial versus femoral access coronary angiography or intervention that reported major bleeding, death, myocardial infarction, and procedural or fluoroscopy time were included. A fixed-effects model was used with a random effects for sensitivity analysis. RESULTS: Radial access reduced major bleeding by 73% compared to femoral access (0.05% vs 2.3%, OR 0.27 [95% CI 0.16, 0.45], P < .001). There was a trend for reductions in the composite of death, myocardial infarction, or stroke (2.5% vs 3.8%, OR 0.71 [95% CI 0.49-1.01], P = .058) as well as death (1.2% vs 1.8% OR 0.74 [95% CI 0.42-1.30], P = .29). There was a trend for higher rate of inability to the cross lesion with wire, balloon, or stent during percutaneous coronary intervention with radial access (4.7% vs 3.4% OR 1.29 [95% CI 0.87, 1.94], P = .21). Radial access reduced hospital stay by 0.4 days (95% CI 0.2-0.5, P = .0001). CONCLUSIONS: Radial access reduced major bleeding and there was a corresponding trend for reduction in ischemic events compared to femoral access. Large randomized trials are needed to confirm the benefit of radial access on death and ischemic events.

Computed tomographic coronary angiographic assessment of high-risk coronary anatomy in patients with suspected coronary artery disease and intermediate pretest probability.

BACKGROUND: It is unclear if computed tomographic coronary angiography (CTA), an evolving technique for the evaluation of coronary artery disease (CAD), can identify patients with high-risk coronary anatomy. METHODS: Among patients referred for invasive angiography at Hamilton Health Sciences (Hamilton, Ontario, Canada), those with an intermediate pretest probability (25%-60% likelihood of a significant stenosis) were prospectively identified using a multivariate risk score and were studied on a 64-detector Toshiba Aquilion scanner (Toshiba Medical Systems, Tokyo, Japan) before invasive angiography. Patients with high-risk anatomy (left main, 3-vessel CAD, or 2-vessel CAD involving the proximal left anterior descending artery) or at least 1 significant stenosis were identified on CTA and invasive angiography, and the results of these modalities were compared on a per patient basis. RESULTS: Eighty patients were enrolled in the study (mean age 56 +/- 9 years, male-female ratio 43:37). Nondiagnostic scan results were obtained in 5 patients (6%). By CTA, 13 patients had high-risk anatomy and 31 patients had at least 1 significant stenosis. For the per patient detection of high-risk anatomy, CTA had 100% sensitivity (95% CI 69%-100%), 95% specificity (95% CI 86%-95%), a positive likelihood ratio of 18.0 (95% CI 6.4-50.3), and a negative likelihood ratio of 0.05 (95% CI 0-0.072). Revascularization was performed in 100% of patients with high-risk anatomy on CTA, 83% with at least 1 significant stenosis on CTA, and 0% without a significant stenosis on CTA. CONCLUSION: In appropriately selected patients, CTA is a highly sensitive and specific technique for the detection of high-risk anatomy and maybe a valuable method for noninvasive risk stratification.

Sirolimus-eluting stents in the canine cerebral vasculature: a prospective, randomized, blinded assessment of safety and vessel response.

OBJECT: Use of the sirolimus-eluting stent has led to a reduction of in-stent stenosis following treatment of coronary atherosclerosis, whereas treatment of intracranial atherosclerosis with bare-metal stents results in excessive restenosis rates of approximately 40%. Neurotoxicity effects and vessel injury are unknown in the cerebral vasculature. To assess the safety profile and vascular effects of sirolimus-coated stents, the authors conducted a prospective comparative study in which drug-eluting and bare-metal stents were implanted in the canine basilar artery (BA). METHODS: Sixteen mongrel dogs were randomized (eight animals per group) to receive either bare-metal 1.5 x 8-mm (six-cell) stents or sirolimus-eluting stents of the same dimensions. Interventionists, histopathologists, and histopathology technicians who participated in the study were blinded to the stent characteristics. Stents were implanted in the canine BA. Serial peripheral blood samples were obtained during the 1st week after implantation to determine the time-dependent serum concentration of sirolimus. Follow-up angiographic studies were performed 30 days after stent implantation to assess the effects of stent placement on the BA and brainstem perforating vessels. Explantation of the stent and BA was performed immediately after angiography by using a pressurized formalin fixation procedure. Histological and computer-assisted morphometric analyses of specimens obtained in each animal were performed. Sirolimus could not be detected in peripheral blood samples obtained later than 24 hours posttreatment. On follow-up angiography, all perforating vessels observed on initial angiograms remained patent, and no evidence of parent vessel damage or pseudoaneurysm formation was observed. Explanted vessels and brainstem sections did not demonstrate evidence of histological neurotoxicity, such as gliosis or infarction. No significant differences were found in the time to endothelialization of bare-metal and sirolimus-coated stents. Smooth-muscle cell (SMC) proliferation, the putative agent for restenosis, was lower in animals receiving sirolimus-coated stents (p = 0.003). Additionally, intimal fibrin density was increased in the dogs treated with sirolimus-coated stents (p < 0.0001). Histological evidence of an inflammatory response demonstrated a trend toward a reduced response in the sirolimus group (mean 0.58) compared with the bare-metal group (mean 0.83, p = 0.33). CONCLUSIONS: No neurotoxic effects were observed in the intracranial vessel walls or brainstem tissue in which sirolimus-coated stents were implanted. Compared with bare-metal stents, the sirolimus-coated devices did not impair endothelialization and, furthermore, tended to reduce the proliferation of SMCs. These findings indicate that sirolimus-coated devices may inhibit in-stent stenosis. Further studies with longer-term follow up are required to assess the restenosis rates of sirolimus-coated stents implanted in the intracranial vasculature.