Percutaneous coronary revascularization in coronary artery disease: lessons from a single center experience.

OBJECTIVES: To determine the role of percutaneous coronary intervention (PCI) and its impact on mortality in coronary artery disease (CAD). BACKGROUND: It's unclear whether PCI provides benefit in patients with CAD outside of acute settings. We sought to determine the role of PCI and its effect on mortality in patients with similar entry criteria to prior RCTs and compare outcomes with medical treatment. METHODS: Using institutional diagnostic catheterization database of consecutive patients undergoing coronary angiography from 1/2004 to 1/2010, we examined records for patients with a positive stress test and >70% coronary stenosis or symptoms of angina and >80% coronary stenosis. We excluded those with acute coronary syndromes, low ejection fraction (EF), history of CABG, and CABG following index catheterization. We stratified patients by treatment and performed unadjusted and propensity matched analyses. The outcome was all-cause mortality obtained from the social security death index. RESULTS: We identified 3,375 patients using study inclusion criteria. Mean age was 65 ± 11 years and 69% (n = 2,332) were men. Mean EF was 55% ± 8%. In the unadjusted cohort, 1,265 patients received medical management and 2,110 received PCI. The unadjusted analysis revealed significantly better survival in PCI patients (P < 0.0001) (HR: 0.51; 95% confidence interval (CI), 0.41-0.63). Propensity matching was performed for 1,580 patients and analysis showed better survival among patients receiving PCI (0 = 0.04) (HR: 0.74; 95% CI, 0.55-0.98). PCI continued to show better survival after excluding patients with malignancy (P = 0.03) and unstable angina (P = 0.007). CONCLUSIONS: This single center registry analysis demonstrated better survival in stable CAD patients undergoing PCI compared to medical management alone. These data suggest there may be a benefit of PCI beyond symptom relief. Future randomized trials are needed to further understand the role of PCI in broader patient populations.

Subintimal guidewire tracking during successful percutaneous therapy for chronic coronary total occlusions: insights from an intravascular ultrasound analysis.

OBJECTIVES: We sought to determine the frequency of subintimal guidewire tracking during successful percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) and to better understand the procedural implications of this event. BACKGROUND: Successful PCI for chronic CTO is associated with improved outcomes in patients with ischemia. While subintimal guidewire tracking resulting in failure to cross is recognized as the major mode of failure for CTO PCI, the implications of subintimal guidewire tracking during successful CTO PCI are unknown. METHODS: Between March 2007 and October 2007, 26 consecutive patients, each with one de-novo CTO lesion successfully crossed with a guidewire were included in the analysis. Intravascular ultrasound (IVUS) was performed in each CTO vessel after guidewire crossing. Cases were classified as having definite subintimal wire tracking or no clear evidence of subintimal wire tracking based on analysis of IVUS images. RESULTS: Subintimal wire tracking occurred in 45% of cases. In cases where subintimal wire tracking was present, a previous attempt at CTO PCI was more common (42% vs. 7%, P ≤ 0.05). Subintimal wire tracking was also associated with significantly longer final mean stent length (71 vs. 50 mm), procedure time (122 vs. 69 min), fluoroscopy time (47 vs. 22 min), and contrast dose (300 vs. 199 mL, P ≤ 0.05 for all). There was one perforation in the subintimal group which was successfully treated with stent placement. CONCLUSIONS: Subintimal wire tracking occurs frequently during successful PCI for CTO and is associated with increased lesion and procedural complexity.

Initial experience with a dedicated coronary re-entry device for revascularization of chronic total occlusions.

OBJECTIVE: The aim of this registry was to evaluate a new device designed to facilitate antegrade guidewire re-entry into the true lumen of a chronic total coronary occlusion (CTO) from the adjacent subintimal space. BACKGROUND: Successful recanalization of CTOs results in clinical improvement in appropriately selected patients. CTO intervention is time- and resource-consuming, and a simplified approach enabling antegrade guidewire re-entry into the distal true lumen might improve success. METHODS: Patients with CTO and ischemia were entered into a prospective registry regardless of lesion characteristics. If wire manipulation resulted in subintimal wire entrapment, a new re-entry tool (a 2.5-mm flat subintimal balloon with two exit ports offset by 180°) was used as a platform to attempt guidewire penetration into the distal true lumen. The primary endpoint assessed was successful device-guided re-entry. Standard techniques were then utilized to open the CTO. RESULTS: In 40 consecutive CTO lesions attempted, 19 resulted in subintimal wire entrapment (mean occlusion length 44 mm). Sixteen of these 19 were successfully crossed with an antegrade guidewire into the distal true lumen using the new device (84%). One patient with unsuccessful re-entry was subsequently recanalized with a retrograde technique. All crossed lesions were stented (17/17), resulting in TIMI 3 flow without major complications. Two cases were unsuccessful. One patient had a grade I coronary perforation requiring no treatment. CONCLUSIONS: A new device to recanalize CTOs complicated by subintimal wire entrapment can be used successfully by experienced operators. Further study of this coronary re-entry device is ongoing.

Lessons learned from balloon aortic valvuloplasty experience from the pre-transcatheter aortic valve implantation era.

BACKGROUND: Balloon aortic valvuloplasty (BAV) has been used as a bridge to surgical aortic valve replacement (SAVR) in high-risk patients with severe symptomatic aortic stenosis (AS). Such patients are now being referred for transcatheter aortic valve implantation (TAVI). We sought to study the indications and outcomes of BAV in patients with severe AS in the pre-TAVI era. METHODS: We analyzed consecutive patients with severe AS undergoing BAV from 1990 to 2005. In these patients with no immediate surgical option, BAV was attempted to temporarily improve hemodynamics, with a goal to improve general health of the patient, and ultimately AVR. RESULTS: A total of 99 BAVs (eight repeats, one second repeat) were performed in 90 consecutive patients. Baseline ejection fraction was ≤25% in 36 (36%) patients. The 30-day mortality rate was 17% (n = 17). Of the 99 patients, 27 (30%) underwent AVR. Average follow-up of patients with and without AVR was 55 ± 57 months and 16 ± 23 months, respectively. The 6-month and 1-year survival rates in patients who underwent AVR were 81% and 78%, respectively, versus 57% and 44% in patients who did not undergo AVR (P = 0.024). CONCLUSION: BAV can be used successfully to clinically improve the health of some nonsurgical patients with severe symptomatic AS, and a proportion of these patients improve to a point where AVR can be performed. Bridging to TAVI will provide further options to high-risk patients who cannot be bridged to conventional AVR. The role of BAV in bridging to TAVI merits further study.

Safety and efficacy of overlapping sirolimus-eluting versus paclitaxel-eluting stents.

BACKGROUND: The short-term and long-term safety and efficacy of paclitaxel versus sirolimus-overlapping drug-eluting stents (DES) is unknown. We sought to examine the clinical consequences of overlapping sirolimus versus paclitaxel DES. METHODS: We reviewed catheterization reports from April 2003 to May 2005 for all patients who underwent percutaneous coronary revascularization with DES. All patients were followed-up for at least 1 year. Patients were included if they received only 2 single-type overlapping stent (eg, sirolimus-sirolimus) during the index procedure. The end points included early (inhospital and 30-day) and late composite of all-cause mortality, stent thrombosis, myocardial infarction, and target lesion revascularization. RESULTS: A total of 282 individuals met our study criteria. Of these, 188 had sirolimus and 94 had paclitaxel-overlapping DES. There were 78 events for a median follow-up of 24 months for the composite end point. No statistically significant differences between overlapping sirolimus and paclitaxel DES were seen for inhospital, 30-day (16% vs 23%, respectively; P = .13), and long-term (25% vs 33%, respectively; P = .16) composite end points. In addition, in Kaplan-Meier and Cox proportional hazard analysis, no significant differences for the composite end point were noted. CONCLUSIONS: In this analysis, there were no significant differences in safety or efficacy between the 2 types of overlapping DES. Trends toward more events with overlapping paclitaxel stents should be evaluated in an adequately powered randomized controlled trial.

Predictors of Successful Hybrid-Approach Chronic Total Coronary Artery Occlusion Stenting: An Improved Model With Novel Correlates.

OBJECTIVES: The aim of this study was to develop a hybrid approach-specific model to predict chronic total coronary artery occlusion (CTO) percutaneous coronary intervention success, useful for experienced but not ultra-high-volume operators. BACKGROUND: CTO percutaneous coronary intervention success rates vary widely and have improved with the "hybrid approach," but current predictive models for success have major limitations. METHODS: Data were obtained from consecutively attempted patients from 7 clinical sites (9 operators, mean annual CTO volume 61 ± 17 cases). Angiographic analysis of 21 lesion variables was performed centrally. Statistical modeling was performed on a randomly designated training group and tested in a separate validation cohort. The primary outcome of interest was technical success. RESULTS: A total of 436 patients (456 lesions) met entry criteria. Twenty-five percent of lesions had prior failed percutaneous coronary interventions at the site. The right coronary artery was the most common location (56.4%), and mean occlusion length was 24 ± 20 mm. The initial approach was most often antegrade wire escalation (70%), followed by retrograde (22%). Success was achieved in 79.4%. Failure was most closely correlated with presence of an ambiguous proximal cap, and in the presence of an ambiguous proximal cap, specifically defined collateral score (combination of Werner and tortuosity scores) and retrograde tortuosity. Without an ambiguous proximal cap, poor distal target, occlusion length >10 mm, ostial location, and 1 operator variable contributed. Prior failure, and Werner and tortuosity scores alone, were only weakly correlated with outcomes. The basic 7-item model predicted success, with C statistics of 0.753 in the training cohort and 0.738 in the validation cohort, the later superior (p < 0.05) to that of the J-CTO (Multicenter CTO Registry of Japan) (0.55) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (0.61) scores. CONCLUSIONS: Success can be reasonably well predicted, but that prediction requires modification and combination of angiographic variables. Differences in operator skill sets may make it challenging to create a powerful, generalizable, predictive tool.

Preprocedural statin use is associated with a reduced hazard of postprocedural myonecrosis in patients undergoing rotational atherectomy--a propensity-adjusted analysis.

Incidence of myonecrosis in patients undergoing rotational atherectomy was evaluated by preprocedural statin use. The incidence of any myonecrosis (24.1% vs 52.3%, P < .001) or significant myonecrosis (7.5% vs 21.8%, P < .001) was significantly lower among patients pretreated with statins. This difference remained significant after multivariable and propensity adjustment.

Death following creatine kinase-MB elevation after coronary intervention: identification of an early risk period: importance of creatine kinase-MB level, completeness of revascularization, ventricular function, and probable benefit of statin therapy.

BACKGROUND: Creatine kinase (CK)-MB elevation after percutaneous coronary intervention (PCI) has been associated with subsequent cardiac death. The patients at risk, the timing of risk, and potential treatment implications are uncertain. METHODS AND RESULTS: Eight thousand, four hundred nine consecutive non- acute myocardial infarction patients with successful PCI and no emergency surgery or Q-wave myocardial infarction were followed for 38+/-25 months; 1446 (17.2%) had post-PCI CK-MB above normal on routine ascertainment. Patients were prospectively stratified into those with CK-MB 1 to 5x or CK-MB >5x normal. No patient with CK-MB 1 to 5x normal died during the first week after PCI, and excess risk of early death for patients with CK-MB elevation occurred primarily in the first 3 to 4 months. The actuarial 4-month risk of death was 8.9%, 1.9%, and 1.2% for patients with CK-MB >5x, CK-MB 1 to 5x, and CK-MB < or =1x normal (P<0.001). Death within 4 months was independently correlated with the degree of CK-MB elevation, creatinine > or =2 mg%, post-PCI C-reactive protein, low ejection fraction, age, and congestive heart failure class (P<0.01 for all). In a matched subset analysis, incomplete revascularization (P<0.001), congestive heart failure class (P=0.005), and no statin treatment at hospital discharge (P=0.009) were associated with death. CONCLUSIONS: Patients with CK-MB elevation after PCI are at excess risk of death for 3 to 4 months, although prolonging hospitalization for CK-MB 1 to 5x is unlikely to modify risk. CK-MB >5x normal, incomplete revascularization, elevated C-reactive protein, heart failure, the elderly, and hospital discharge without on statin therapy increases risk. Several of these factors suggest that inflammation may play a part in the excess risk of death.

Emergency coronary artery bypass surgery in the contemporary percutaneous coronary intervention era.

BACKGROUND: Since the advent of percutaneous coronary interventions (PCIs), technological advances, adjunctive pharmacotherapy, and increasing operator experience have contributed to lowering the occurrence of major complications. However, emergency coronary artery bypass surgery (CABG) for failed PCI is still associated with important morbidity and mortality, even in the era of coronary stenting. We sought to determine the prevalence, indications, predictors, and complications of emergency CABG after PCI in the past decade. METHODS AND RESULTS: We reviewed 18 593 PCIs performed from 1992 through 2000. There was a need for emergency CABG in 113 (0.61%) cases. The major indications were extensive dissection (n=61, 54%), perforation/tamponade (n=23, 20%), and recurrent acute closure (n=23, 20%). Prevalence of emergency CABG decreased from 1.5% of PCIs in 1992 to 0.14% in 2000 (P<0.001). Independent predictors of the need for emergency CABG included the worst ACC/AHA scoring of the intervened lesion (P<0.001) and female sex (P= 0.028), whereas history of prior bypass surgery and use of stents resulted in a decreased need for emergency CABG (P<0.001 for both). In patients undergoing emergency CABG, there were 17 (15%) in-hospital deaths, 14 (12%) perioperative Q-wave myocardial infarctions, and 6 (5%) cerebrovascular accidents. CONCLUSIONS: The need for emergency CABG has considerably decreased over time. Risk factors include female sex and a higher ACC/AHA score of the intervened lesion. However, morbidity and mortality of emergency CABG remain high even in the new millennium.

Differential influence of diabetes mellitus on increased jeopardized myocardium after initial angioplasty or bypass surgery: bypass angioplasty revascularization investigation.

BACKGROUND: Data are absent that compare midterm angiographic outcome between patients with and without diabetes after initial percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass graft surgery (CABG). Importantly, diabetes mellitus may differentially influence long-term survival after PTCA or CABG. METHODS AND RESULTS: Patients with multivessel coronary disease who were previously enrolled in the Bypass Angiopathy Revascularization Investigation to compare initial PTCA versus CABG (n=1829) and who had a reduction in jeopardized myocardium after initial revascularization and at least 1 angiogram during 5-year follow-up were analyzed (n=897). This included 369 CABG-treated patients (16% with diabetes) and 528 PTCA-treated patients (18% with diabetes). The influence of diabetes on angiographic increase in percentage of jeopardized myocardium after initial revascularization with either PTCA or CABG was investigated. Among PTCA patients, the mean percentage increase in total jeopardized myocardium was significantly greater in those with diabetes than in those without at 1-year protocol-directed angiography (42% versus 24%, P=0.05) and on the first clinically performed (unscheduled) angiogram within 30 months (63% versus 50%, P=0.01) but not at 5-year protocol-directed angiography (34% versus 26%, P=0.33). This excess midterm risk associated with diabetes persisted after statistical adjustment. In contrast, among CABG patients, diabetes was not associated with percentage increase in jeopardized myocardium at any angiographic follow-up interval. CONCLUSIONS: Presence of diabetes differentially influences worsening of jeopardized myocardium after initial PTCA compared with CABG. This differential effect occurs irrespective of whether follow-up angiography is undertaken for clinical or nonclinical purposes.

Medical costs and quality of life 10 to 12 years after randomization to angioplasty or bypass surgery for multivessel coronary artery disease.

BACKGROUND: Coronary bypass surgery (CABG) and angioplasty (PTCA) have been compared in several randomized trials, but data about long-term economic and quality-of-life outcomes are limited. METHODS AND RESULTS: Cost and quality-of-life data were collected prospectively from 934 patients who were randomized in the Bypass Angioplasty Revascularization Investigation (BARI) and followed up for 10 to 12 years. CABG had 53% higher costs initially, but the gap closed to <5% during the first 2 years; after 12 years, the mean cumulative cost of CABG patients was 123,000 dollars versus 120,750 dollars for PTCA, yielding a cost-effectiveness ratio of 14,300 dollars/life-year added. CABG patients experienced significantly greater improvement in their physical functioning for the first 3 years but not in later follow-up. Recurrent angina substantially reduced all quality-of-life measures throughout follow-up. Cumulative costs were significantly higher among patients with diabetes, heart failure, and comorbid conditions and among women; costs also were increased by angina, by the number of revascularization procedures, and among patients who died. CONCLUSIONS: Early differences between CABG and PTCA in costs and quality of life were no longer significant at 10 to 12 years of follow-up. CABG was cost-effective as compared with PTCA for multivessel disease.

Leukocyte count predicts microembolic Doppler signals during carotid stenting: a link between inflammation and embolization.

BACKGROUND AND PURPOSE: Protected stenting has emerged as a safe and effective alternative to endarterectomy for the treatment of carotid stenosis in patients at high operative risk. Distal microembolization occurs invariably during carotid stenting. Little is known about the relationship between systemic inflammation and embolization during carotid stenting. METHODS: We examined 43 consecutive patients who underwent carotid stenting with simultaneous transcranial Doppler (TCD) monitoring of the ipsilateral middle cerebral artery. Embolization was quantified by measuring microembolic signals (MES) on TCD. Preprocedure leukocyte counts were related to MES. RESULTS: In unadjusted analyses, preprocedure leukocyte count was positively correlated with total procedural MES (r2= 0.16; P=0.008). After considering age, gender, comorbidities, concomitant medical therapies, and the use of emboli prevention devices, increasing leukocyte count (beta=35 for each 1000/microL increment; P=0.018) remained a significant and independent predictor of embolization (model-adjusted r2=0.365; P=0.0005). CONCLUSIONS: Increasing preprocedure leukocyte count independently predicted more frequent MES during carotid stenting. These data suggest that systemic inflammation may influence the degree of procedural embolization.

The impact of body mass index on short- and long-term outcomes inpatients undergoing coronary revascularization. Insights from the bypass angioplasty revascularization investigation (BARI).

OBJECTIVES: We sought to investigate the impact of body mass index (BMI) on short- and long-term outcomes after initial revascularization with percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft surgery (CABG). BACKGROUND: Equivocal results exist on the impact of BMI on the risk of in-hospital complications after PTCA or CABG, and no long-term mortality data exist from a large series of revascularized patients. METHODS: From the randomized series and observational registry of the Bypass Angioplasty Revascularization Investigation (BARI), 2,108 patients who had PTCA and 1,526 patients who had CABG were evaluated by taking their BMI at study entry. They were classified as follows: low (< 20 kg/m(2)), normal (20 to 24.9 kg/m(2)), overweight (25 to 29.9 kg/m(2)), class I obese (30 to 34.9 kg/m(2)) and class II/III obese (greater-than-or-equal 35 kg/m(2)). In-hospital complications and short- and long-term mortalities were compared between levels of BMI within each mode of initial revascularization. RESULTS: Among patients who had PTCA, each unit increase in BMI was associated with a 5.5% lower adjusted risk of a major in-hospital event (death, myocardial infarction, stroke, coma); among patients who had CABG, no difference in the in-hospital outcome was observed according to BMI. In contrast, BMI was not associated with five-year mortality in the PTCA group; among the CABG group, adjusted relative risks of five-year cardiac mortality according to levels of BMI were 0.0 (low), 1.0 (normal), 2.02 (overweight), 3.16 (class I obese) and 4.85 (class II/III obese) (linear p < 0.001). CONCLUSIONS: Body mass index appears to have a differential impact on short- and long-term outcomes after coronary revascularization. These results underscore the need for further research to identify factors responsible for the apparent short-term protective effect of a higher BMI in patients undergoing PTCA and to study the impact of weight reduction on the long-term survival of obese patients undergoing CABG.

A prospective, multicenter, randomized trial of percutaneous transmyocardial laser revascularization in patients with nonrecanalizable chronic total occlusions.

OBJECTIVES: We sought to evaluate the safety and efficacy of percutaneous transmyocardial revascularization (PTMR) in patients with refractory angina caused by one or more chronic total occlusions (CTOs) of a native coronary artery. BACKGROUND: Previous unblinded, randomized trials of PTMR in patients with end-stage coronary artery disease and refractory angina have demonstrated significant relief of angina and increased exercise duration. Whether such benefits would be realized in blinded patients with less extensive coronary artery disease is unknown. METHODS: A total of 141 consecutive patients with class III or IV angina caused by one or more chronically occluded native coronary arteries in which a percutaneous coronary intervention (PCI) had failed were prospectively randomized, at 17 medical centers, in the same procedure, to PTMR plus maximal medical therapy (MMT) (n = 71) or MMT only (n = 70). Blinding was achieved through heavy sedation, dark goggles and the concurrent performance of PCI in all patients. RESULTS: Baseline characteristics were similar between the two groups. A median number of 20 laser channels were created in patients randomized to PTMR. At six months, the anginal class improved by two or more classes in 49% of patients assigned to PTMR and in 37% of those assigned to MMT (p = 0.33). The median increase in exercise duration from baseline to six months was 64 s with PTMR versus 52 s with MMT (p = 0.73). There were no differences in the six-month rates of death (8.6% vs. 8.8%), myocardial infarction (4.3% vs. 2.9%) or any revascularization (4.3% vs. 5.9%) in the PTMR and MMT groups, respectively (p = NS for all). CONCLUSIONS: In patients with class III or IV angina caused by nonrecanalizable CTOs, the performance of PTMR does not result in a greater reduction in angina, improvement in exercise duration or survival free of adverse cardiac events, as compared with MMT only.

Native coronary disease progression exceeds failed revascularization as cause of angina after five years in the Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: Coronary angiograms obtained five years following revascularization were examined to assess the extent of compromise in myocardial perfusion due to failure of revascularization versus progression of native disease. BACKGROUND: The Bypass Angioplasty Revascularization Investigation (BARI) randomized revascularization candidates between bypass surgery and angioplasty. Entry and five-year angiograms from 407 of 519 (78%) patients at four centers were analyzed. METHODS: Analysis of the distribution of coronary vessels and stenoses provided a measure of myocardial jeopardy that correlates with presence of angina. The extent to which initial benefits of revascularization were undone by failed revascularization versus native disease progression was assessed. RESULTS: Myocardial jeopardy fell following initial revascularization, from 60% to 17% for percutaneous coronary intervention (PCI)-treated patients compared with 60% to 7% for coronary artery bypass graft (CABG) surgery patients (p < 0.001), rebounding at five years to 25% for PCI and 20% for surgery patients (p = 0.01). Correspondingly, angina prevalence was higher at five years in PCI-treated patients than in surgery-treated patients (28% vs. 18%; p = 0.03). However, myocardial jeopardy at five years, and not initial treatment (PCI vs. surgery), was independently associated with late angina. Increased myocardial jeopardy from entry to five-year angiogram occurred in 42% of PCI-treated patients and 51% of CABG-treated patients (p = 0.06). Among the increases in myocardial jeopardy, two-thirds occurred in previously untreated arteries. CONCLUSIONS: Native coronary disease progression occurred more often than failed revascularization in both PCI- and CABG-treated patients as a cause of jeopardized myocardium and angina recurrence. These results support intensive postrevascularization risk-factor modification.

Carotid artery stenting protected with an emboli containment system.

BACKGROUND AND PURPOSE: Fear of distal embolization and stroke has aroused concern regarding carotid stenting. Devices to protect the cerebral circulation may make carotid stenting safer. METHODS: A multidisciplinary study group tested a balloon occlusion-aspiration emboli entrapment device in conjunction with carotid stenting. The device consists of an elastomeric balloon on a steerable wire with a detachable adapter that inflates and deflates the distal temporary occlusion balloon. An aspiration catheter is used to remove trapped emboli after stenting and before occlusion balloon deflation. RESULTS: Seventy-five patients with severe internal carotid artery stenosis were treated with stents deployed with this cerebrovasculature protection system. All 75 patients (100%) had grossly visible particulate material aspirated, and all were treated successfully without major or minor stroke or death at 30 days. Preintervention stenosis was 81+/-10%, and residual stenosis was 5+/-7%. Nine patients (12%) had angiographic evidence of thrombus before intervention, but no patient had thrombus or vessel cutoff after the procedure. Four patients (5%) developed transient neurological symptoms during protection balloon occlusion, but symptoms resolved with balloon deflation. The 22 to 667 particles aspirated per patient ranged from 3.6 to 5262 microm in maximum diameter (mean, 203+/-256 microm). These particles included fibrous plaque debris, lipid or cholesterol vacuoles, and calcific plaque fragments. CONCLUSIONS: Protected carotid stenting was performed successfully and safely in this study early in the experience with cerebrovascular protection devices. Particulate emboli are frequent with stenting, and cerebral protection will likely be necessary to minimize stroke. Randomized trials comparing protected carotid stenting with endarterectomy are warranted.

Impact of female sex on outcome after percutaneous coronary intervention.

BACKGROUND: Prior reports have suggested that women have increased mortality compared to men following percutaneous coronary intervention (PCI). It remains unclear if this difference is secondary to sex or other confounding variables. METHODS: We sought to examine the characteristics and outcomes of 18039 consecutive women and men undergoing PCI at The Cleveland Clinic Foundation from 1992-2002. RESULTS: Procedural success rates were similar in both sexes, but the female cohort had a greater incidence of access site hematoma (5% vs. 2%, P < .0001) and blood product transfusion (12% vs. 4%, P < .0001) following PCI. The rate of myocardial infarction (MI) at 1 year was slightly higher among females (10% vs. 9%, P = .004), but revascularization rates were not significantly different between sexes. One-year mortality was also higher in the female cohort (7% vs. 5%, P < .0001). After adjustment in a multivariate model, the Cox proportional hazard ratio for mortality in females was 1.01 (95% CI 0.93-1.11, P = .78). The hazard ratio for the combined endpoint of death or MI was 1.05 (95% CI 0.97-1.13, P = .23). CONCLUSIONS: After adjustment for differences in comorbidities, the risk for long-term mortality is not significantly different between sexes following PCI. However, there is a greater incidence of post-procedural bleeding complications among women.

Effects of long-term prednisone (> or =5 mg) use on outcomes and complications of percutaneous coronary intervention.

To assess the potential risk of long-term steroid use in the setting of coronary angioplasty, 114 patients of 12,883 consecutively treated patients who were on long-term steroids were compared with those not taking steroids. Steroid use was not associated with increased risk of composite major ischemia events but was associated with a threefold risk (p = 0.01) of major vascular complications and a three- to fourfold risk (p = 0.026) of coronary perforation.