Successful treatment of a coronary cameral fistula secondary to elective sirolimus-eluting stent implantation

Coronary cameral fistulae, communications between the coronary tree and the chambers of the heart, are a rare complication of percutaneous coronary intervention. The functional significance and management of these fistulae remain uncertain. We report such a case in a patient undergoing elective sirolimus-eluting stent implantation and provide a review of the literature.3 page(s

Vascular brachytherapy for patients with drug-eluting stent restenosis

BACKGROUND: The rate of drug-eluting stent (DES) in-stent restenosis (ISR) exceeds 10% in complex subsets of patients and lesions. The optimal management of DES ISR remains undetermined. Vascular brachytherapy (VBT) is proven to be effective for the treatment of bare metal stent ISR but its outcome for DES ISR has not been established. METHODS: Ninety-nine consecutive patients who presented with ISR following DES implantation in 122 lesions were subjected to conventional percutaneous coronary intervention with adjunct VBT using either beta radiation (Beta Rail in 74 patients [82.2%] and the Galileo system in 13 patients [14.4%]) or gamma radiation (Checkmate system in 3 patients [3.3%]). Patients were followed clinically for major adverse cardiac events (MACE) during 1-year follow-up. RESULTS: A high proportion of patients in this cohort presented with complex ISR; 31.1% had recurrences of ISR to the same site, 55% had diffuse or proliferate pattern of restenosis, and 23 lesions (18.9%) were located in a saphenous vein graft. Procedural success and uneventful in-hospital course were documented in all patients post VBT. At 12 months' follow-up, the target lesion revascularization (TLR) rate was 11% and the overall MACE rate was 26%. Patients with multiple episodes of ISR to the same site had a TLR of 16% and MACE rate of 35.5%. CONCLUSIONS: VBT for the treatment of DES ISR was found to be effective and safe and should be considered for the treatment of DES ISR, in particular in complex patients with multiple recurrences.7 page(s

Angiographic and procedural correlates of stent thrombosis after intracoronary implantation of drug-eluting stents

BACKGROUND: Stent thrombosis (ST) following the implantation of drug-eluting stents (DES) remains the major limitation of this new technology. The identification of modifiable correlates of ST may help reduce this catastrophic event. METHODS: This was a retrospective, single-center, lesion-based study. A cohort of 45 consecutive lesions (35 patients) initially treated with successful DES implantation from May 2003 to February 2005 that re-presented with ST within 12 months was identified. This cohort was compared to a control group of 1,620 unselected lesions (1,187 patients) that were successfully treated with DES implantation and which remained free of ST. Comparison of angiographic and procedural features was made between the ST and no-ST groups, and logistic regression analysis was then performed to identify independent correlates of ST. For the purposes of the study only definite ST events (angiographically or autopsy proven) were considered. RESULTS: Independent angiographic predictors of cumulative ST at 12 months were left anterior descending (LAD) artery (OR: 1.91, CI: 1.01-3.59, P = 0.045), bifurcation (OR: 2.43, CI: 1.06-5.56, P = 0.035), and in-stent restenotic (OR: 2.64, CI: 1.12-6.25, P = 0.027) lesions. Procedural predictors were number of stents per lesion (OR: 2.30, CI: 1.29-4.11, P = 0.005) and intravascular ultrasound (IVUS) guidance (OR: 0.45, CI: 0.24-0.84, P = 0.013). Correlates of subacute events were LAD artery, proximal segment, and lack of IVUS guidance. Correlates of late ST were bifurcation and in-stent restenotic lesions. CONCLUSIONS: Angiographic and procedural correlates of subacute and late ST after DES implantation differ. Lack of IVUS guidance was the only modifiable predictor identified. Treatment of bifurcation and restenotic lesions was predictive of late events.7 page(s

Measuring aspirin resistance, clopidogrel responsiveness, and postprocedural markers of myonecrosis in patients undergoing percutaneous coronary intervention

Aspirin and clopidogrel are proven to prevent thromboembolic events during percutaneous coronary intervention (PCI). Enzyme release of creatine kinase-MB (CK-MB) enzyme during PCI has been associated with an increased risk of future adverse cardiac events. This study examined the correlation between measurements of aspirin resistance and the level of inhibition of the thienopyridine-specific P2Y12 platelet receptor and CK-MB release after PCI. We prospectively studied 330 patients with elective PCI treated with drug-eluting stents. Patients were pretreated with aspirin and clopidogrel. Patients with positive CK-MB or acute coronary syndrome and those on glycoprotein IIb/IIIa inhibitors were excluded. Serum assays of aspirin resistance (Ultegra Rapid Platelet Function Assay-ASA, Accumetrics) and clopidogrel resistance (Rapid Platelet Function Assay P2Y12, Accumetrics) were performed before PCI. Serum troponinI and CK-MB levels were measured at 8, 16, and 24 hours after PCI. Aspirin resistance unit (ARU) measurement > or =550 was detected in 12 patients (3.7%). Mean platelet reactivity unit (PRU; measurement of inhibition of P2Y12 activity) was 192.2 +/- 95.4 (lower PRU, more inhibition of P2Y12 receptor). There was no correlation between level of ARU or PRU and troponin I or CK-MB release after PCI at any time point. Only multivessel coronary disease was found to be a predictor of any increase in CK-MB in a multivariate analysis (odds ratio 2.2, 95% confidence interval 1.4 to 3.3, p = 0.0003). A positive correlation was found between levels of ARU and PRU. Target vessel revascularization/major adverse cardiac event rate at 6 months was 8.2% with no correlation between ARU or PRU and release of cardiac enzymes or occurrence of adverse cardiac events. In conclusion, this study does not support routine measurements of aspirin and clopidogrel resistance in stable patients undergoing PCI.5 page(s

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 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.5 page(s

Outcomes after sirolimus- and paclitaxel-eluting stent implantation in patients with insulin-treated diabetes mellitus

Insulin-treated diabetic patients undergoing drug-eluting stent implantation are prone to high rates of adverse cardiac events. The efficacy of the sirolimus- (SES) and paclitaxel-eluting stent (PES) in this population was analyzed. Registry data for 434 consecutive patients with insulin-treated diabetes who underwent SES or PES implantation were analyzed. The end point, major adverse cardiac events (MACEs) at 1 year, was high for patients with SESs and PESs (20.6% vs 20.2%; p=0.91). Cox regression and propensity analysis were used to compare outcomes. The adjusted hazard ratio (HR) for MACEs according to stent type (Cox model) was 1.0 (95% confidence interval [CI] 0.64 to 1.76, p=0.82). The propensity score-adjusted (C statistic=0.66) HR was 0.95 (95% CI 0.56 to 1.61, p=0.84). Stent thrombosis rates were relatively high at 2.0% for SESs and 1.5% for PESs (p=0.49). The propensity score-adjusted HR for stent thrombosis was 2.7 (95% CI 0.31 to 23.6, p=0.37). In conclusion, SESs and PESs are similarly efficacious in insulin-treated diabetic patients. The high MACE and stent thrombosis rates are of concern. Additional studies in this group of patients are required to determine the optimal mode of revascularization and minimize the overall stent thrombosis rate.6 page(s

Comparison of safety, efficacy, and outcome of successful versus unsuccessful percutaneous coronary intervention in "true" chronic total occlusions

Despite improving techniques for opening chronic total occlusions (CTOs), the benefit of successful recanalization of the artery remains unclear. The aims of this study were to investigate the safety and efficacy of percutaneous coronary intervention for "true" CTO, defined by Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 and duration > or =3 months, and to compare the outcome of successful versus failed procedures. A cohort of 172 consecutive patients with de novo CTOs of native vessels confirmed by angiographic review in which percutaneous coronary interventions were attempted was studied. End points included angiographic success, in-hospital complications, and long-term major adverse cardiac events. Technical success was obtained in 73.8% of CTO lesions (127 of 172). No deaths or nonfatal Q-wave myocardial infarctions occurred in the hospital. Repeat percutaneous coronary interventions in the hospital were required in 1.6% of patients (2 of 127) in whom the CTOs were initially opened. Perforation during the initial failed attempts occurred in 6.7% of patients (3 of 45). One patient required operative repair. After an average follow-up period of 2 years, patients with successful procedures experienced similar incidences of cardiac death and nonfatal Q-wave myocardial infarctions as did patients with failed procedures (5.3% and 4.9%, respectively, p = 0.3). Patients with successfully opened arteries required target vessel revascularization more frequently, but this did not reach statistical significance (18.8% vs 0%, p = 0.06). In conclusion, attempts to open CTOs with the devices available at the time of this registry were accompanied by a significant risk for perforation. Furthermore, successful recanalization did not translate into a reduction in 2-year mortality or nonfatal Q-wave myocardial infarctions compared with patients with failed procedures.7 page(s

Does creatine kinase-MB (CK-MB) isoenzyme elevation following percutaneous coronary intervention with drug-eluting stents impact late clinical outcome?

BACKGROUND: The incidence of postprocedural creatine kinase (CK)-MB elevation to >3x the upper limit of normal after percutaneous coronary intervention (PCI) has been reported at rates of up to 18% in the bare metal stent era and is correlated with higher adverse cardiovascular outcomes. This study examined the incidence and prognostic significance of CK-MB elevations after drug-eluting stent (DES) implantation. METHODS: The records of 2,537 patients who underwent DES implantation and completed > or =6 months' follow-up were evaluated. Patients with acute myocardial infarction and those who presented in cardiogenic shock and had elevated cardiac enzymes at baseline were excluded from the analysis. Of these, 179 patients (7.1%) had > or =3x postprocedural CK-MB and 2,358 patients had or =3x elevation had a higher number of diseased vessels (2.15 +/- 0.86 vs. 1.81 +/- 0.87; P or =3x elevation following PCI with DES continues to be a marker for the complexity of coronary disease and lack of clinical success; and correlates with higher rates of subacute thrombosis as well as late adverse events at 6-months and 1-year postprocedure.6 page(s

Correlates of clinical restenosis following intracoronary implantation of drug-eluting stents

Despite significant decreases in restenosis and repeated intervention achieved using drug-eluting stents (DESs), the benefit has not been homogenous across all patient and lesion subsets. Identification of correlates of DES restenosis may allow a differing management approach and lead to improved patient outcomes. The study population consisted of 3,535 consecutive patients (5,046 lesions) who underwent successful sirolimus- or paclitaxel-eluting stent implantation for >or=1 native coronary artery or bypass graft lesion from April 2003 to September 2006. From this cohort, 197 patients (237 lesions) were identified to have in-stent restenosis (ISR) requiring revascularization within 12 months of stent implantation. This group was compared with the remainder of the patient population. Logistic regression analysis was performed to identify independent predictors of DES ISR. Independent correlates of DES ISR using multivariate analysis included both clinical and procedural factors. Clinical predictors were age, hypertension, and unstable angina. Procedural predictors were left anterior descending artery intervention, number of stents implanted, stented length/lesion, and lack of intravascular ultrasound guidance. Implantation of >or=3 stents was associated with a significantly higher restenosis risk (9.7% vs 5.1%; p=0.0003). A 10-mm increase in stented length was associated with an adjusted odds ratio of 1.18 (95% confidence interval 1.03 to 1.35). Diabetes, stent diameter, and stent type were found not to be predictive of DES ISR. In conclusion, correlates of DES ISR included both clinical and procedural factors. Limiting the number of stents and stented length, in addition to intravascular ultrasound guidance, may minimize DES ISR.5 page(s

Comparison between sirolimus- and paclitaxel-eluting stents in complex patient and lesions subsets

BACKGROUND: Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) both significantly reduce the need for repeat intervention compared to bare metal stents. Studies comparing the clinical outcomes of these stents in noncomplex subsets of patients and lesions demonstrate a similar safety and efficacy profile. The data for more complex subsets of patients and lesions remains conflicting. This study aimed to compare SES with PES in a selected population with a broad range of complex features. METHODS AND RESULTS: The patient population consisted of 1,591 consecutive patients with complex features undergoing drug-eluting stent (DES) implantation. In the SES group there were 1,095 patients (1,653 lesions) and in the PES group 496 patients (802 lesions). In-hospital, 30-day, and 12-month clinical outcomes were compared between groups. No discernable difference in major adverse cardiac events (MACE) between SES and PES was detected at intermediate and longer-term follow-up (SES 22.4% vs. PES 20.5% at 12 months; P=0.407). A trend toward increased angiographically documented stent thrombosis was observed in the SES group at both 3 and 12 months (SES 2.2% vs. PES 0.8% at 12 months; P=0.051). When adopting the more inclusive definition of probable stent thrombosis, this trend was no longer seen. After adjusting for baseline differences between the two groups, there still remained no difference in MACE between SES and PES (HR 1.051 [CI 0.826-1.339] P=0.685). The trend toward increased angiographically documented stent thrombosis in the SES group remained after adjustment for baseline differences (HR 2.836 [CI 0.968-8.311] P=0.057). CONCLUSIONS: In a selected population with complex disease the rate of MACE was comparable between SES and PES, with higher overall rates of thrombosis and MACE compared to a noncomplex population. Thus, the focus should be directed to prevent late complications in this complex subset regardless of stent type selection.6 page(s