Sex differences in long-term outcomes of coronary patients treated with drug-eluting stents at a tertiary medical center.

BACKGROUND: Limited data exist on contemporary sex-related differences in long-term outcomes of coronary patients receiving drug-eluting stents. In this study we evaluate differences for males (M) and females (F) in 2-year target lesion failure (TLF) in an unselected consecutive series of patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) at a tertiary medical center. METHODS: Data on 348 consecutive patients (M 221, F 127) stented with EES and PES were retrospectively analyzed. The primary end point of the study was to compare sex-related outcomes in TLF, defined as the combined end point of cardiac death, nonfatal myocardial infarction, and target lesion revascularization (TLR). Secondary end points included TLR, target vessel failure, target vessel revascularization, acute stent thrombosis as defined by the Academic Research Consortium, and cardiac death. The cineangiograms of the first consecutive 162 patients (M 105, F 57) were independently reviewed by a cardiologist blinded to clinical outcome, and SYNTAX scoring was performed. Follow-up was achieved using medical records and/or phone calls and was censored at 2 years. Descriptive analysis was performed on all variables. Univariate analysis compared the M and F cohorts. Multivariate analysis using Cox regression was performed to determine independent predictors of TLF with time, including sex as an independent variable in the model. RESULTS: M had more prior percutaneous coronary interventions and restenotic lesions and a higher prevalence of smoking. They also had longer length of disease and received more stents than F. F were older and had a higher prevalence of prior stroke. Angiographic complexity was not statistically different between the two groups, as judged by SYNTAX scoring (M 20.8±13.8, F 19.7±13.9, P=0.650). At 2-year follow-up, TLF was 27.4% and 24.8% (P=0.614) with no statistical difference between TLR (23.3% versus [vs] 21.6%), cardiac death (2.8% vs 3.2%), and definite and probable stent thrombosis (2.3% vs 0.0%) in M and F, respectively. Cox regression analysis using backward elimination showed that the number of stents per patient was the only independent predictor of TLF with time (hazard ratio 1.201, 95% confidence interval 1.126-1.280, P=0.001). CONCLUSION: In this cohort of patients receiving EES and PES, M and F did not have statistically different outcomes at 2-year follow-up, consistent with recent reports in the current era of percutaneous coronary interventions.

Treatment of left main coronary trifurcation lesions with the paclitaxel drug-eluting stent: mid-term outcomes from a tertiary medical center.

BACKGROUND: Left main trifurcating coronary artery disease (LMTCAD) is a complex and challenging anatomy to treat percutaneously. We report on the immediate- and mid-term outcomes of 52 consecutive patients with LMTCAD treated with the Taxus(R) paclitaxel- eluting stent (PES) (Boston Scientific Corp., Natick, Mass.) in our center over a period of 2 years. METHODS: All patients (n = 52) who underwent LMTCAD at our center in 2006-2007 and treated with the PES form the basis of this report. Demographic, clinical, procedural and in-hospital outcome variables were reviewed. Angiograms were analyzed by an operator blinded to the patients' history. Mid-term follow up was achieved from medical records and/or phone calls. The primary endpoint of the study was either cardiac death, nonfatal myocardial infarction or target lesion revascularization (TLR) on follow up. Follow up was achieved in 47/51 patients (92.2%) at a mean of 292.8 +/- 104.6 days. Patients were classified as Type A (30.8%) disease involving the LM and origin of branches, or Type B (69.2%) disease involving the origin of the trifurcation branches only, but not the LM artery. All patients were treated with kissing balloon after stenting. Descriptive analysis was performed on all variables with mean +/- standard deviation for continuous variables and percentages describing dichotomous variables. Univariate and logistic regression analyses were performed to determine the predictors of the primary endpoint. RESULTS: The mean patient age was 67.6 +/- 12.7 years. The LM artery was unprotected in 88.5% of cases. On follow up, the primary endpoint was met in 34% of patients. TLR occurred in 31.9% of patients, and target vessel revascularization (TVR) in 40.4%. One patient had cardiac death (2.1%) 5 months after the index procedure, possibly related to acute stent thrombosis. By univariate analysis, Type A lesions (vs. Type B; p = 0.02) and the placement of a greater number of stents (p = 0.044) correlated with a higher event rate. Logistic regression analysis showed that Type A lesions are the only predictors of the combined endpoint (p = 0.011). CONCLUSION: LM trifurcation stenting carries an overall high rate of adverse events, mostly driven by a high TLR rate. Type A lesions and the number of stents placed predicted a higher combined endpoint of death, nonfatal MI and TLR. By logistic regression analysis, Type A lesions are the only independent predictors of the primary outcome.

Evidence-based treatment of unprotected left main disease: a critical review of the literature.

Bypass surgery is currently the standard therapy for unprotected left main (UPLM) disease because it has been shown in randomized, long-term follow-up trials to reduce mortality compared with medical treatment. Early data in treating UPLM disease with bare metal stents has shown a high rate of restenosis and major adverse events. With the advent of drug-eluting stents (DES), stenting for treatment of UPLM disease has recently gained more acceptance among interventional cardiologists. DES have been shown to be superior to bare metal stents in reducing restenosis after treatment of UPLM disease. Also, observational and small randomized studies have shown promising short-term outcomes with the use of DES compared with bypass surgery. Furthermore, ostial left main (LM) stenting with DES appears to have superior outcome when compared with stenting of the distal LM at the bifurcation. These studies, however, are small, with significant selection biases and with limited follow-up. Large randomized trials are currently being performed to compare LM stenting with DES versus bypass surgery. UPLM stenting at this time needs to be reserved for high-risk surgical patients until more conclusive data about its safety and effectiveness become available from large randomized trials.

Interatrial septal defect closure for cerebrovascular accidents: exploring the role of various anticoagulants.

BACKGROUND: The role of different anticoagulants in reducing in-hospital complications in patients undergoing closure of interatrial septal defects (IASD) is unknown. In this study, we review our own experience with IASD closure data to determine if in-hospital complications and ambulation time are influenced by the use of various anticoagulants. METHODS: Fifty-five consecutive patients with a history of unexplainable stroke or transient ischemic attacks (TIA), with the exception of the presence of an IASD, were included in this study. Multiple variables were collected including age, gender, history of smoking, hypertension, diabetes, hypercholesterolemia, ejection fraction, anticoagulants used pre- and postprocedure, anticoagulants used during the closure procedure, shunt grade across the IASD pre- and postprocedure, defect size, and right-sided filling pressures. Descriptive analysis was performed on all variables including complications frequency and ambulation time, and compared between bivalirudin and indirect thrombin inhibitors. RESULTS: Of 55 consecutive patients included in this study, 22 patients received bivalirudin and 33 patients received unfractionated heparin (UFH) (n = 26) or enoxaparin (n = 7). The bivalirudin patients were older (60.1 vs 50.8 years; p = 0.028), with a higher incidence of interatrial septal aneurysm (75% vs. 40.7%; p = 0.037). In-hospital complications included 1 (5%) patient with a minor bleed (groin hematoma) in the bivalirudin group, and 3 patients with minor bleed (1 GI bleed, 1 groin hematoma, and 1 transient ischemia on electrocardiogram) in the non-bivalirudin group (9.1%). No patient had a major bleed that required a transfusion or prolonged hospital stay. Ambulation time was not significantly different between the two groups (7.7 +/- 5.9 hours for bivalirudin and 6.9 +/- 5.1 hours for other anticoagulants; p = NS). CONCLUSION: We conclude that bivalirudin is safe during IASD closure, with a statistically nonsignificant trend toward fewer minor complications than UFH and enoxaparin. No major bleeding occurred in either group. This could be due to the fact that IASD closure is performed via venous access that generally carries a low bleeding complication rate and allows safe early ambulation, irrespective of the anticoagulant utilized and despite the use of 10 and 11 Fr sheaths. Given that major differences do not appear to exist in this exploratory study between the anticoagulants studied, patent foramen ovale closure is currently being performed in our laboratory with UFH.

Interatrial septal defect closure for prevention of cerebrovascular accidents: impact on recurrence and frequency of migraine headaches.

BACKGROUND: Recent data suggest that percutaneous closure of interatrial septal defect (IASD) is associated with a reduction in the intensity, frequency and duration of migraine headaches. In this study we review our own data to determine if we can reproduce the relationship between IASD closure in patients with a history of a central nervous system event (stroke or a transient ischemic attack [TIA]) and migraine headaches (HA). METHODS: Fifty-eight consecutive patients with a history of unexplainable stroke or TIA with the exception of the presence of an IASD were included in this retrospective study. Multiple variables were collected including age, gender, history of smoking, hypertension, diabetes, hypercholesterolemia, ejection fraction, anticoagulant use pre- and postprocedure, shunt grade across the IASD pre- and postprocedure, defect size and right-sided filling pressures. All patients with a history of migraine HA answered the Migraine Disability Assessment Test (MIDAS), a standardized migraine questionnaire. Descriptive analysis was performed on all variables and compared among migraine and nonmigraine HA patients. Pre and post closure intensity and frequency of migraine HA were compared. RESULTS: Of 58 patients, 14 (24.14%) had migraine HAs prior to percutaneous closure. There were no significant differences among the migraine and nonmigraine HA groups except that the migraine HA sufferers were younger (p = 0.016). One patient with migraine HA died on follow up from complications of cardiomyopathy. Only 5 (38.5%) of 13 patients reported still having migraine HA post closure of IASD. The frequency (41.6 +/- 36.4 vs. 9.3 +/- 24.8; p = 0.005) and intensity (8.0 +/- 1.9 vs. 2.1 +/- 3.2; p = 0.001) of the migraine HAs were markedly reduced post closure at 759 +/- 545.6 days (range 89 to 1,433 days). There was no relationship between the shunt grade and the frequency or intensity of migraine HA. CONCLUSION: We conclude that IASD closure in patients with history of migraine HA and stroke or TIA have a marked improvement in the frequency and intensity of their HA. Migraine HA resolved in 61.54% patients post closure. Larger randomized studies are needed to confirm these findings, which could have significant implications for sufferers of migraine HA.

Long-term outcomes in treating left main trifurcation coronary artery disease with the Paclitaxel-eluting stent.

BACKGROUND: Left main trifurcation coronary artery disease stenting is a challenging and complex percutaneous procedure that has been infrequently reported. We present our own experience with left main trifurcation stenting using the Taxus paclitaxel-eluting stent (Boston Scientific). METHODS: Twenty consecutive left main trifurcation stenting procedures were performed in 2005 at our institution. The primary endpoint of the study was the combined endpoints of death, acute stent thrombosis and target lesion revascularization (TLR). Conditional logistic regression analysis was performed to determine the predictors of the primary endpoint using a number of variable combinations. RESULTS: The mean patient age was 71.7 +/- 8.9 years. The procedure was urgent in 10%, and the left main artery was unprotected in 95% of cases. Follow up was achieved in 17/20 (85%) patients, either from medical records or by phone calls. The follow-up median duration was 272 days (range 30 to 534 days). The primary endpoint was met in 5/17 (29.4%) patients. One of 19 patients (5.3%) had a sudden cardiac death 1 month after the procedure, 2/20 patients (10%) experienced an acute in-hospital stent thrombosis, and 2/17 (11.8%) patients underwent TLR. Conditional logistic regression analysis could not identify a relationship between the stenting method and the primary endpoint. The 2 patients who experienced in-hospital thrombosis were the only patients who received a clopidogrel load (600 mg) post-procedure after arrival to the floor, and were not on a glycoprotein IIb/IIIa inhibitor. All others received their clopidogrel either during the procedure (n = 7) or were on it chronically (n = 11). One patient with acute stent thrombosis did not have a kissing balloon performed post-stent deployment. CONCLUSION: Left main trifurcation stenting carries an overall high rate of adverse events and may need to be reserved for patients who are at high risk or who refuse bypass surgery. Overall TLR is low, but stent thrombosis remains a concern. Although we suspect that thrombosis could be related to failure to perform kissing balloon post-stent deployment and/or not receiving a clopidogrel load until after the procedure, the small number of patients in this study prevents us from making definite statistical conclusions about this observation.