Impact of bivalirudin use on outcomes in nonagenarians undergoing percutaneous coronary intervention.

BACKGROUND: With an aging population, nonagenarians constitute an increasing percentage of patients with coronary artery disease. The aim of this study was to determine the predictors and outcome of nonagenarians undergoing percutaneous coronary intervention (PCI) for symptomatic coronary artery disease. METHODS: From 2002 to 2007, a cohort of 171 consecutive nonagenarians underwent PCI and stent implantation in our center. Patients given bivalirudin (n = 79) during the procedure were compared to those given heparin (n = 92). In-hospital and 6-month rates of major adverse cardiovascular events (MACE) including death, myocardial infarction (MI), and target lesion revascularization were indexed. In-hospital bleedings were also indexed. RESULTS: The mean age was 92.5 +/- 2.5 years. The population was 52% female. Nearly 30% of patients had diabetes mellitus and >25% had renal failure. The mean left ventricular ejection fraction was 45%+/- 14%. The clinical presentation was an acute MI in 59% of the cases. The in-hospital rates of death and bleedings were 4.1% and 17.5%, respectively. Clinical presentations as MI or cardiogenic shock were associated with high rates of in-hospital death: 19.3% and 30%, respectively. Bivalirudin use was associated with a 41.5% decrease in in-hospital bleedings. The 6-month incidence of MACE was 13.6% and was driven by death. Predictors of 6-month outcomes were clinical presentations as MI or cardiogenic shock, renal failure, and total stent length. CONCLUSION: Nonagenarians represent a particular population with a high percentage of females and a high incidence of comorbidities. In this study, we highlighted that nonagenarians have logically a worse prognosis than is reported in younger patients, with especially high rates of in-hospital bleedings. Bivalirudin use was associated with an important decrease in in-hospital bleedings; thus, it should be systematically considered in such patients to improve early outcome.

Comparison of outcomes of drug-eluting stents versus bare-metal stents in nonostial proximal left anterior descending coronary arteries.

Drug-eluting stents (DES) have reduced the rate of in-stent restenosis compared with bare-metal stents, but are associated with an increased risk of late stent thrombosis. The proximal left anterior descending artery (LAD) is a large vessel and is considered to be at increased risk of both restenosis and stent thrombosis. The risk-benefit ratio of each type of stent therefore is of great clinical interest in this location. The aim was to compare 1-year outcomes of DESs and bare-metal stents in nonostial proximal LADs. Historic cohorts of patients who underwent percutaneous coronary intervention of nonostial proximal LAD lesions were compared. A total of 137 patients in the bare-metal stent group and 350 patients in the DES group were compared. The primary and secondary end points were target-lesion revascularization (TLR) rate and major adverse cardiac event rate, including death, myocardial infarction and TLR at 1-year follow-up. Patients in both groups had similar baseline characteristics. Intravascular ultrasound guidance was used in most percutaneous coronary intervention (bare-metal stents vs DESs 72.4% vs 74.5%; p = 0.6). Stent diameter was large in both groups (3.2 +/- 0.5 vs 3.2 +/- 0.3 mm; p = 0.6). Patients in the DES group had longer stents implanted (15 +/- 7 vs 17 +/- 7 mm; p <0.01). Major adverse cardiac event and TLR rates were not different (bare-metal stents vs DESs 16.4% vs 14.7%; p = 0.7 and 4.5% vs 5.2%; p = 0.8). In multivariate analysis, the TLR rate was independent of type of stent used. In conclusion, DESs carry no clinical benefit over bare-metal stents for nonostial proximal LAD lesions. Bare-metal stents therefore could be a cost-effective alternative in this location.

The predictive value of computed tomography calcium scores: a comparison with quantitative volumetric intravascular ultrasound.

OBJECTIVE: To evaluate the relationship between coronary artery calcium scoring (CACS) and intravascular ultrasound (IVUS) calcification and disease severity. METHODS: Forty-five angina patients who underwent CACS 18+/-23 days before IVUS were studied. The CACS was recorded for each lesion matched to a specific IVUS lesion. Cross-sectional area measurements of the external elastic membrane, lumen area, plaque and media, and plaque burden were performed. The arc and length of calcification were measured. RESULTS: There were 106 calcified lesions detected by IVUS. Eighty-five of those lesions (80%) were detected by CACS, but 21 calcified lesions (20%) were missed. Fourteen (50%) out of 28 of the lesions with an IVUS-calcium arc below the 25th percentile (51.4 degrees ) were detected by CACS vs. 91% of lesions with an IVUS-calcium arc >51.4 degrees (P<.05). Similarly, 21 (58%) of 36 lesions 3 mm (P<.05). We divided IVUS-calcified lesions into CACS 10. Mean plaque burden, calcified length, and arc of calcium increased significantly, while minimum lumen area decreased with increasing CACS. There was the same tendency in culprit and nonculprit calcified lesions, respectively. Multivariate analysis showed a calcified length (regression coefficient=8.718, 95% CI 4.668-12.77, P<.001) and an arc of calcium (regression coefficient=2.789, 95% CI 1.419-4.119, P<.001) were significant predictors for CACS. CONCLUSIONS: This study suggests that a CACS could evaluate coronary calcium burden noninvasively through the accurate estimation of calcium-arc and length.

Impact of "nuisance" bleeding on clopidogrel compliance in patients undergoing intracoronary drug-eluting stent implantation.

Premature cessation of clopidogrel is a strong risk factor for drug-eluting stent thrombosis in patients undergoing percutaneous coronary intervention. The impact that superficial or "nuisance" bleeding may have on clopidogrel compliance has not been described. The study population consisted of 2,360 unselected patients undergoing successful drug-eluting stent implantation. Nuisance bleeding, defined as easy bruising, bleeding from small cuts, petechia, and ecchymosis, was assessed during routine clinical follow-up. Internal and alarming bleeding was recorded. Cessation of clopidogrel as a consequence of such bleeding was then assessed. Study population characteristics were 66.1% men, mean age 64.5 +/- 11.8 years, diabetes mellitus in 31.1%, smoking in 18.5%, systemic hypertension in 81.8%, dyslipidemia in 87.9%, history of coronary artery disease in 49.1%, chronic renal insufficiency in 8.7%, and acute myocardial infarction in 10.8%. A total of 837 patients reported bleeding events (incidence 32.4%) of which 85.7% were nuisance, 13.6% were internal, and 0.7% were alarming. Rate of clopidogrel discontinuation as a result of bleeding in the nuisance bleeding group was 11.1%. In conclusion, superficial or nuisance bleeding is common in patients taking dual antiplatelet therapy after percutaneous coronary intervention. Overall, 11.1% of patients with nuisance bleeding discontinued clopidogrel. Greater education and follow-up in this patient subset may lead to improved compliance with clopidogrel therapy.

Can direct stenting in selected saphenous vein graft lesions be considered an alternative to percutaneous intervention with a distal protection device?

BACKGROUND: Distal embolization during percutaneous coronary intervention (PCI) of saphenous vein graft (SVG) lesions is associated with a high rate of myonecrosis. Although direct stenting (DS) is feasible with less catheter manipulations, its ability to prevent distal embolization in SVG lesions compared with distal protection devices (DPD) is unknown. METHODS: The study included 188 SVG lesions subjected to PCI, 101 patients with 101 lesions treated with DPD, and 87 patients with 87 lesions by DS without DPD. Major adverse cardiovascular events (MACE) in-hospital and at 30 days were compared. RESULTS: Baseline characteristics were comparable, except for higher frequencies of unstable angina (53% vs. 67%, P = 0.045) and prior myocardial infarction (38% vs. 53%, P = 0.07) in the DS group. There was no difference in lesion type aside from more restenotic lesions in the DS group (7% vs. 16%, P = 0.047). Drug-eluting stent deployment was similar. Stent length in the DPD group (22.8 +/- 7.2 mm) was significantly longer than that in the DS group (17.6 +/- 8.0 mm, P < 0.001). Although maximum creatine kinase (CK)-MB value in the DPD group (2.5 +/- 5.8 ng/ml) was significantly larger than in the DS group (1.3 +/- 1.5 ng/ml, P = 0.039), the frequency of CK-MB rise >2 times the upper limit of normal did not differ (11% vs. 6%, P = 0.2). There were no differences in MACE rates in-hospital and at 30 days. By multivariate analysis, neither DPD nor DS was a significant predictor for maximum CK-MB value. CONCLUSION: DS should be considered an alternative treatment to PCI with DPD for selected SVG lesions.

Optical coherence tomography and intravascular ultrasound imaging of bioabsorbable magnesium stent degradation in porcine coronary arteries.

BACKGROUND: Absorbable metallic stents (AMS) composed of magnesium alloy were designed to complete degradation within 90-120 days. Among the potential advantages of these stents, when compared to conventional stents, are the elimination of late stent thrombosis, chronic inflammation, and artifacts during noninvasive imaging. METHODS: Magnesium-based AMS were deployed in juvenile domestic pig coronary arteries. Angiography, optical coherence tomography (OCT), and intravascular ultrasound (IVUS) were performed before and after implant and then at 28 days and 3 months following stenting. The animals were sacrificed at 28 days or 3 months following stent implantation. Stented vessels were harvested and analyzed by histomorphometry. RESULTS: Over time, OCT, IVUS, and histologic images revealed a progressive degradation of the stents. Mean stent strut width in the OCT images after implantation was 0.24+/-0.032 mm, then decreased to 0.12+/-0.007 mm (P<.0001) at 28 days and to 0.151+/-0.032 mm at 3 months (P<.0001 vs. implant, P=.078 vs. 28 days). CONCLUSION: Magnesium-based AMS degrade over a 3-month time period in a porcine model. Its structure is not apparent by angiography but is well-visualized by OCT and IVUS. OCT allowed quantitative assessment of stent degradation.

Comparison of intravascular ultrasound to contrast-enhanced 64-slice computed tomography to assess the significance of angiographically ambiguous coronary narrowings.

The efficacy of contrast-enhanced multislice computed tomography (MSCT) for assessment of ambiguous lesions is unknown. We compared both quantitative coronary angiography (QCA) and MSCT to the gold standard for a significant stenosis-minimum luminal area (MLA) by intravascular ultrasound (IVUS)-in 51 patients (64 +/- 10 years old, 19 men) with 69 angiographically ambiguous, nonleft main lesions. The MSCT was performed 17 +/- 18 days before IVUS analysis. Overall diameter stenosis by QCAwas 51.0 +/- 9.8%; 39 of 51 patients (76%) eventually underwent revascularization (38 by percutaneous coronary intervention and 1 by coronary artery bypass graft). By univariate analysis, minimum luminal diameter, MLA, lumen visibility by MSCT, and minimum luminal diameter by QCA were significant predictors of MLA by IVUS

Drug-eluting stents versus bare metal stents for narrowing in saphenous vein grafts.

Conflicting data exist regarding an advantage of drug-eluting stents (DES) over bare metal stents (BMS) in catheter-based treatment of saphenous vein graft (SVG) stenoses. This study was undertaken to compare the efficacy of these modalities in that lesion subset. The DES group consisted of 138 cases with 183 lesions (sirolimus-eluting stents, n = 117; paclitaxel-eluting stents, n = 66) and the BMS group consisted of 344 cases with 478 lesions that were followed to 1 year. We examined a composite end point that comprised death, Q-wave myocardial infarction, and target lesion revascularization. More BMS were deployed per patient (p <0.001) and the diameters of BMS deployed was significantly greater (p <0.001). Peak postprocedure values of creatine kinase-MB (p = 0.003) and troponin I (p = 0.05) were higher in BMS. At 1 year there was no significant superiority of DES over BMS with regard to hard end points (death and Q-wave myocardial infarction). In conclusion, this study indicates that both DES and BMS for SVG disease provide acceptably safe and efficacious results, but unlike the case in native coronary arteries, DES use does not reduce the frequency of the need for repeat revascularization.

Adjunct thrombus aspiration reduces mortality in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction with high-risk angiographic characteristics.

Routine aspiration thrombectomy (AT) in percutaneous coronary intervention for patients with ST-segment elevation myocardial infarction (STEMI) has not proved effective in randomized trials. However, in patients undergoing primary percutaneous coronary intervention with severely reduced flow or visible thrombus, AT remains an intuitively attractive option. The use of adjunctive AT in a high-risk cohort of 158 consecutive patients with STEMI and Thrombolysis In Myocardial Infarction (TIMI) 0 to 1 flow or visible thrombus on baseline angiography was examined. Of these, 80 patients underwent AT as an adjunct to primary percutaneous coronary intervention, and 78 underwent percutaneous coronary intervention without AT (non-AT). TIMI 3 flow rates, residual thrombus after percutaneous coronary intervention, and major adverse cardiac events (mortality and nonfatal Q-wave myocardial infarction) at 30 days, 6 months, and 1 year were compared. Baseline characteristics were similar between groups. The AT group more frequently achieved TIMI 3 flow after the intervention (91.3% AT vs 67.9% non-AT; p <0.001) and had less residual thrombus (7.5% AT vs 19.2% non-AT; p = 0.03). AT was associated with reduced major adverse cardiac events at 6 months (6.8% AT vs 24.0% non-AT; p = 0.004) and 1 year (16.6% AT vs 29.2% non-AT; p = 0.009), and decreased mortality rates in the AT group at 6 months (5.4% AT vs 21.3% non-AT; p = 0.004) and 1 year (7.7% AT vs 26.2% non-AT; p = 0.005). In conclusion, for patients with STEMI and TIMI 0 or 1 flow or visible thrombus on baseline angiography, AT was associated with increased TIMI 3 flow rates, decreased residual thrombus, and decreased clinical events, including mortality.

Drug-eluting stents are associated with similar cardiovascular outcomes when compared to bare metal stents in the setting of acute myocardial infarction.

BACKGROUND: Recent randomized trials have demonstrated conflicting results regarding the use of drug-eluting stents (DESs) as compared to bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI). We compared outcomes among patients presenting with acute ST-elevation myocardial infarction (STEMI) who received DES with those who received BMS. METHODS: In-hospital, 30-day, 6-month, and 1-year outcomes of a cohort of 122 patients who underwent primary or facilitated PCI and received a BMS were compared to 122 propensity-matched patients who received a DES. Seventy-two patients received sirolimus-eluting stents, and 50 received paclitaxel-eluting stents. RESULTS: Baseline demographics were similar among groups. One-, 6-, and 12-month outcomes, including reinfarction, death, stent thrombosis, and target vessel revascularization (TVR), were similar among groups. At 1 year, all-cause mortality was 13.3% in the BMS group and 9.2% in the DES group [P=not significant (ns)], recurrent MI was 5.3% in the BMS group vs. 4.4% in the DES group (P=ns), and TVR was 7% in the BMS group vs. 8.7% in the DES group (P=ns). CONCLUSIONS: Our data do not support the general use of DES in the setting of STEMI given similar cardiovascular outcomes among patients receiving BMS or DES, the need for long-term dual antiplatelet therapy with DES, and the possible repercussions of very late stent thrombosis.

Drug-eluting stent safety.

Drug-eluting stents (DESs) held the promise of mitigating, if not abolishing, in-stent restenosis. This led to early adoption and high penetration of DES use in percutaneous coronary intervention (PCI). Outcomes have not demonstrated an improvement in the hard end points of death and myocardial infarction with these devices, but repeat procedures for in-stent restenosis have decreased. The problem of stent thrombosis, a major obstacle that arose early in coronary stent development, has raised new contemporary concerns about the safety of DESs. The risk for stent thrombosis after bare metal stent placement appears to diminish with time, while very late stent thrombosis (>1 year after index PCI) occurs in small but measurable numbers after DES placement at a rate that continues to increase. Late-acquired incomplete stent apposition and abnormal endothelial function have also been reported. Restenosis, although significantly lessened, does occur after DES PCI. This report reviews DES safety issues that have been described.

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel meeting on patent foramen ovale closure devices.

Patent foramen ovales (PFOs) are common congenital cardiac defects that are more prevalent among patients experiencing cryptogenic stroke than among those with strokes of known origin. Medical treatment for these processes is often considered inadequate, and mechanical closure of the PFO is an attractive, albeit controversial, alternative. Although it is plausible that percutaneous PFO closure will reduce the rate of recurrent stroke in these patients, randomized trials examining the efficacy of devices in this setting have not been completed. In 2007, the Food and Drug Administration convened a meeting of the Circulatory System Devices Panel to discuss the necessity of randomized trials, as well as obstacles to trial enrollment and completion.

Treatment of drug-eluting stent restenosis with the same versus different drug-eluting stent.

OBJECTIVE: The authors aimed to compare the clinical outcomes with repeat drug-eluting stent (DES) implantation utilizing the same type versus an alternate DES type for in-stent restenosis (ISR) of DES. BACKGROUND: : DES are proven as an effective treatment for bare metal ISR. METHODS: A cohort of 116 patients previously treated with a sirolimus-eluting stent (SES) or a paclitaxel-eluting stent (PES) who presented with angiographic ISR were treated with repeat DES. Of these, 62 (53.4%) were treated with different DES and 54 (46.6%) were treated with the same DES. This cohort was followed for clinical events at 30 days, 6 months, and 1 year. RESULTS: Baseline characteristics were similar except for more diabetes among patients receiving the different type of DES. Of the 116, overall 16.4% of the DES were implanted for previous ISR and 2.6% had previously received brachytherapy. At 6 months, the overall target vessel revascularization (TVR) rate was 12.2% for the entire cohort. The TVR-major adverse cardiac event (MACE) rate for the patients treated with different DES was 14.5% and 16.7% for the same DES (P = 0.750). Overall TVR rate at 1 year was 28.8%. The TVR-MACE was 32.6% for different DES and 35.0% for the same DES (P = 0.814). CONCLUSIONS: Reimplantation of DES for the treatment of DES ISR (same or different) is safe but associated with a high rate of recurrences at 1 year regardless of the initial DES type. Other treatment modalities for ISR of DES should be considered to further improve the overall TVR-MACE.

Comparison of effectiveness of bare metal stents versus drug-eluting stents in large (> or =3.5 mm) coronary arteries.

Drug-eluting stents (DESs) are superior to bare metal stents (BMSs) in decreasing restenosis rates across a wide range of patient and lesion subsets. However, widespread utilization of DESs raises concerns with regard to risks of prolonged dual antiplatelet therapy, the potential for late adverse events such as late thrombosis, and cost. Vessel diameter and lesion length have been previously identified as predictors for restenosis for DESs and BMSs. This study compared the clinical outcomes of DESs versus BMSs in large coronary arteries (> or =3.5 mm). A cohort of 233 patients who underwent single-vessel angioplasty with DES implantation in large vessels was compared with 233 propensity-matched patients who received BMSs in vessels with similar reference vessel diameters. Clinical outcomes at 30 days, 6 months, and 1 year were compared between groups. Baseline clinical and procedural characteristics were similar. Target lesion revascularization and target vessel revascularization rates and the incidence of major adverse cardiac events were low and comparable between the 2 groups at all follow-up intervals. At 1 year, the primary outcome occurred in 8.5% of patients with DESs and 7.7% of patients with BMSs (p = 0.80). There were no episodes of subacute stent thrombosis or late thrombosis in either group. In conclusion, implantation of DESs in large coronary arteries confers no additional benefit compared with BMSs, and the 2 approaches are associated with equally favorable clinical outcomes at 1 year.