Carotid artery stenting outcomes are equivalent to carotid endarterectomy outcomes for patients with post-carotid endarterectomy stenosis.

BACKGROUND: Carotid artery stenting (CAS) has been advocated as an alternative to redo surgery for patients with post-carotid endarterectomy (CEA) stenosis. This study compares early and late clinical outcomes for both groups. METHODS: This study analyzes 192 patients: 72 had reoperation (Group A) and 120 had CAS for post-CEA stenosis (Group B). Patients were followed prospectively and had duplex ultrasounds at 1 month, and every 6 to 12 months thereafter. The perioperative complications (perioperative stroke, myocardial infarction/death, cranial nerve injury) and 4-year end points were analyzed. A Kaplan-Meier lifetable analysis was used to estimate rates of freedom from stroke, stroke-free survival, ≥50% restenosis, and ≥80% restenosis. RESULTS: Demographic/clinical characteristics were comparable for both groups, except for diabetes mellitus and coronary artery disease, which were significantly higher in Group B. The indications for reoperations were transient ischemic attacks/stroke in 72% for Group A versus 57% for Group B (P=.0328). The mean follow-up was 33 months (range, 1-86 months) for Group A and 24 months (range, 1-78 months) for Group B (P=.0026). The proportion of early (<24 months) carotid restenosis prior to intervention was 51% in Group A versus 27% in Group B (P=.0013). The perioperative stroke rates were 3% and 1%, respectively (P=.5573). There were no myocardial infarctions or deaths in either group. The overall incidence of cranial nerve injury was 14% for Group A versus 0% for Group B (P<.0001). However, there was no statistical difference between the groups relating to permanent cranial nerve injury (1% versus 0%). The combined early and late stroke rates for Groups A and B were 3% and 2%, respectively (P=.6347). The stroke-free rates at 1, 2, 3, and 4 years for Groups A and B were 97%, 97%, 97%, and 97% and 98%, 98%, 98%, and 98%, respectively (P=.6490). The stroke-free survival rates were not significantly different. The rates of freedom from ≥50% restenosis at 1, 2, 3, and 4 years were 98%, 95%, 95%, and 95% for Group A versus 95%, 89%, 80%, and 72% for Group B (P=.0175). The freedom from ≥80% restenosis at 1, 2, 3, and 4 years for Groups A and B were 98%, 97%, 97%, and 97% versus 99%, 96%, 92%, and 87%, respectively (P=.2281). Four patients (one symptomatic) in Group B had reintervention for ≥80% restenosis. The rate of freedom from reintervention for Groups A and B were 100%, 100%, 100%, and 100% versus 94%, 89%, 83%, and 79%, respectively (P=.0634). CONCLUSIONS: CAS is as safe as redo CEA. Redo CEA has a higher incidence of transient cranial nerve injury; however, CAS has a higher incidence of ≥50% in-stent restenosis.

Randomized comparison of GR-II stent and Palmaz-Schatz stent for elective treatment of coronary stenoses.

BACKGROUND: This prospective multicenter randomized clinical trial was designed to evaluate the long-term angiographic and clinical outcomes of elective treatment with the GR-II stent compared with the Palmaz-Schatz (PS) stent in patients with coronary stenoses. METHODS AND RESULTS: Seven hundred fifty-five patients with myocardial ischemia and de novo native coronary stenoses in 3- to 4-mm vessels were randomly assigned to the PS (375 patients) or the GR-II stent (380 patients). The primary end point was 12-month target lesion revascularization (TLR)-free survival. Angiography was performed at baseline and at follow-up in the first 300 consecutive patients to assess the frequency of angiographic restenosis. Procedure success was 98.5% for the GR-II stent and 99.4% for the PS stent (P:=0.19). At 30 days, patients assigned to the GR-II stent had a higher stent thrombosis rate (3.9% versus 0.3% for PS stent, P:<0.001) and TLR rate (3.9% versus 0.5% for PS stent, P:<0.001). The GR-II group had a higher follow-up restenosis frequency (47.3% versus 20.6% for the PS group, P:<0.001) and a lower 12-month TLR-free survival rate (71.7% versus 83.9% for the PS group, P:<0. 001). Multivariate logistic regression analysis identified a smaller final stent minimal lumen diameter (odds ratio [OR] 2.49, 95% CI 1. 56 to 3.98; P:<0.001), diabetes mellitus (OR 2.14, 95% CI 1.42 to 3. 22; P:<0.001), and use of the GR-II stent (OR 1.78, 95% CI 1.20 to 2. 64; P:<0.01) as independent determinants of 12-month TLR. CONCLUSIONS: On the basis of these long-term follow-up data, we conclude that use of the GR-II stent should be limited to the acute treatment of abrupt or threatened closure after failed conventional balloon angioplasty procedures.

Outcome probabilities and life history after surgical mitral commissurotomy: implications for balloon commissurotomy.

From 1967 to 1988, 339 patients with mitral stenosis underwent surgical commissurotomy, 103 with a closed and 236 with an open technique. The 1 month and 1, 5, 10 and 20 year overall survival rate was 99.7%, 99%, 95%, 87% and 59%, respectively, and the technique (open versus closed) was not a risk factor. Technique was also not a risk factor for a second mitral commissurotomy, subsequent mitral valve replacement, thromboembolism or poor functional status. Risk factors were older age at commissurotomy, black race, higher pulmonary vascular resistance, mitral leaflet calcification, left ventricular enlargement and postcommissurotomy mitral incompetence. The closed technique was a risk factor for mitral incompetence immediately after commissurotomy, but important incompetence developed in only 2 of the 103 patients undergoing closed commissurotomy. Mitral valve replacement was not required within 10 years in 78% of patients and within 20 years in 47%. Despite some increased prevalence of postcommissurotomy mitral incompetence and particularly in view of the considerable long-term likelihood of mitral valve replacement, initial therapy for most patients with mitral stenosis should probably be surgical closed (or percutaneous balloon) mitral commissurotomy. The equations developed in the present study can be used to predict and compare outcome probability after percutaneous balloon commissurotomy with that after surgical commissurotomy and to compare these with outcome probability after mitral valve replacement.

Is traditionally defined complete revascularization needed for patients with multivessel disease treated by elective coronary angioplasty? Multivessel Angioplasty Prognosis Study (MAPS) Group.

OBJECTIVES: The purpose of this study was to determine the effect of incomplete revascularization by percutaneous transluminal coronary angioplasty in patients with multivessel disease on adverse long-term cardiac events (death, coronary artery bypass surgery or myocardial infarction) and to develop an optimal definition of adequate revascularization based on clinical outcome. BACKGROUND: The effect of incomplete coronary revascularization by coronary angioplasty on long-term adverse clinical events remains controversial. METHODS: Three hundred seventy well characterized patients were followed-up for 27 +/- 16 months after angioplasty. Mean patient age was 58 +/- 11 years; 72% were male; 70% had two-vessel disease (> or = 50% diameter stenosis by caliper measurement); and the mean left ventricular ejection fraction was 58 +/- 11% (range 20% to 85%). Angioplasty was successfully accomplished in 339 patients (91.6%), but complete revascularization by the standard definition (no residual > or = 50% stenosis in a coronary artery > or = 1.5 mm in diameter) was achieved in only 91 patients (25%). RESULTS: Three-year event-free survival (i.e., freedom from death, myocardial infarction, coronary artery bypass surgery) in the entire cohort was 76.5%. By the standard definition, complete revascularization was strongly and negatively associated (p = 0.003) with long-term cardiac events, even after correction for the effects of other independent correlates of events, using Cox proportional hazard regression analysis. Seventeen other definitions, evaluating the severity and extent of residual stenoses and whether they were associated with contractile myocardium, were tested to find that which best stratified late event-free survival and had an outcome with complete revascularization no worse than that associated with the standard definition. The best definition for the entire cohort, having more predictive value than the standard definition, allowed < 10% of estimated left ventricular mass to be served by vessels with mild stenoses (< 60%) without being considered "incomplete." CONCLUSIONS: Mild stenoses in coronary arteries > or = 1.5 mm in diameter serving modest amounts of myocardium do not appear to need to be revascularized to achieve good long-term outcome with coronary angioplasty. Hence, angioplasty in such lesions may not be justified except when they are documented to cause life-style-limiting angina, and the standard definition of complete revascularization by angioplasty appears to be suboptimal. The importance of optimally defined adequate revascularization should be considered in the interpretation of the results of randomized trials assessing the clinical efficacy of coronary angioplasty compared with that of other modalities of therapy.

Reduction of ischemia with a new flow-adjustable hemoperfusion pump during coronary angioplasty. The Coronary Hemoperfusion Ischemia Prevention Study (CHIPS) Investigators.

A new flow-adjustable pump for coronary hemoperfusion to prevent ischemia during routine coronary angioplasty was evaluated in a multicenter prospective study of 110 patients. The protocol included patients who had angina or ST segment elevation during a control balloon inflation of less than or equal to 3 min. Hemoperfusion was performed by means of a new large lumen angioplasty catheter utilizing the patient's renal vein or femoral artery blood. Vessels perfused were the left anterior descending coronary artery (n = 74), right coronary artery (n = 39), left circumflex artery (n = 9) and coronary vein grafts (n = 15). Mean (+/- SD) perfusion flow was 41 +/- 9 ml/min (range 17 to 70); mean perfusion time was 9.3 +/- 4 min (median 8.5, range 2 to 30). Chest pain score (0 to 4) decreased from 2.9 +/- 1 to 1.4 +/- 1 during hemoperfusion (p less than 0.001); ST segment elevation score (0 to 4) decreased from 2.6 +/- 1 to 0.7 +/- 1 (p less than 0.005) and inflation time increased from 1.3 +/- 0.9 to 7 +/- 4 min, (p less than 0.001). At least a 50% increase in tolerated inflation time was obtained in 104 patients (95%). Free plasma hemoglobin and creatine kinase levels did not increase significantly over baseline values. Angioplasty was successful in 107 patients (97%), with mean stenosis reduced from 87 +/- 11% to 20 +/- 17%; 3 patients had urgent bypass surgery, 2 (1.8%) had a myocardial infarction (1 Q wave, 1 non-Q wave) and 2 (1.8%) died later in the hospital of probable noncoronary causes.(ABSTRACT TRUNCATED AT 250 WORDS)

Nonsurgical closure of femoral pseudoaneurysms complicating cardiac catheterization and percutaneous transluminal coronary angioplasty.

OBJECTIVES: This study was performed to describe the initial experience and follow-up of ultrasound-guided compression of pseudoaneurysms in patients receiving systemic anticoagulant or antiplatelet therapy, or both, after recent cardiac catheterization or percutaneous transluminal coronary angioplasty. BACKGROUND: Femoral artery pseudoaneurysm formation after an interventional procedure is becoming more common as larger caliber catheters and prolonged anticoagulant and antiplatelet therapy are being used. Traditional treatment of this complication has been surgical repair. This study describes a new method of closing femoral pseudoaneurysms by using external compression guided by Doppler color flow imaging. METHODS: Fifteen patients, 3 undergoing cardiac catheterization and 12 undergoing coronary angioplasty, developed an expansile groin mass at the vascular access site diagnosed as a femoral artery pseudoaneurysm by Doppler ultrasound. Seven of the patients had undergone coronary stenting and were receiving postprocedural anticoagulant therapy. These patients underwent progressive graded mechanical (C-clamp) external compression guided by ultrasound. The mechanical compression was titrated to obliterate the vascular tracts to these aneurysms and maintain adequate flow in the femoral artery. RESULTS: After an average compression time of 30 min (range 10 to 120), these tracts remained closed. Follow-up ultrasound examination at 24 h or later confirmed continued closure in all. CONCLUSIONS: This study suggests that nonsurgical closure of femoral pseudoaneurysms is feasible. This technique may be valuable in managing vascular access-related complications after diagnostic and interventional procedures, even in patients requiring prolonged anticoagulant therapy.

Four-year follow-up of patients undergoing percutaneous balloon mitral commissurotomy. A report from the National Heart, Lung, and Blood Institute Balloon Valvuloplasty Registry.

OBJECTIVES: This study reports the long-term outcome of patients undergoing percutaneous balloon mitral commissurotomy who were enrolled in the National Heart, Lung, and Blood Institute (NHLBI) Balloon Valvuloplasty Registry. BACKGROUND: The NHLBI established the multicenter Balloon Valvuloplasty Registry in November 1987 to assess both short- and long-term safety and efficiency of percutaneous balloon mitral commissurotomy. METHODS: Between November 1987 and October 1989, 736 patients > or = 18 years old underwent percutaneous balloon mitral commissurotomy at 23 registry sites in North America. The maximal follow-up period was 5.2 years. RESULTS: The actuarial survival rate was 93 +/- 1% (mean +/- SD), 90 +/- 1.2%, 87 +/- 1.4% and 84 +/- 1.6% at 1, 2, 3 and 4 years, respectively. Eighty percent of the patients were alive and free of mitral surgery or repeat balloon mitral commissurotomy at 1 year. The event-free survival rate was 80 +/- 1.5% at 1 year, 71 +/- 1.7% at 2 years, 66 +/- 1.8% at 3 years and 60 +/- 2.0% at 4 years. Important univariable predictors of actuarial mortality at 4 years included age > 70 years (51% survival), New York Heart Association functional class IV (41% survival) and baseline echocardiographic score > 12 (24% survival). Multivariable predictors of mortality included functional class IV, higher echocardiographic score and higher postprocedural pulmonary artery systolic and left ventricular end-diastolic pressures (p < 0.01). CONCLUSIONS: Percutaneous balloon mitral commissurotomy has a favorable effect on the hemodynamic variables of mitral stenosis, and long-term follow-up data suggest that it is a viable alternative with respect to surgical commissurotomy in selected patients.

Prospective case-control comparison of percutaneous transluminal coronary revascularization in patients with multivessel disease treated in 1986-1987 versus 1991: improved in-hospital and 12-month results. Multivessel Angioplasty Prognosis Study (MAPS) Group.

OBJECTIVES: This study sought to ascertain whether early and 12-month clinical outcomes after percutaneous coronary revascularization have improved between 1986-1987 and 1991. BACKGROUND: Since the mid-1980s, when the results of percutaneous revascularization were considered to be somewhat static, justifying large-scale clinical trials of percutaneous transluminal coronary angioplasty versus other modes of therapy, balloon technology has improved, and several new percutaneous revascularization techniques have become available. The clinical results of the current integrated approach to revascularization compared with those for coronary angioplasty alone in the late 1980s are not known. METHODS: In this prospective case-control study, 200 consecutively treated patients with multivessel disease in 1991 were studied prospectively and compared with 400 consecutive patients from the same centers during 1986-1987. Patients from 1991 were matched with earlier patients on the basis of four previously described prognostic determinants (left ventricular ejection fraction, presence of unstable angina, diabetes and target lesion morphology score) and the treating institution and were assessed for treatment outcome (completeness of revascularization, procedural success and event-free survival [freedom from death, myocardial infarction and further revascularization]). RESULTS: The 1991 cohort of patients was older (mean [+/- SD] age 62 +/- 11 vs. 58 +/- 11 years, p < 0.001) and tended to have slightly worse left ventricular function (ejection fraction 56 +/- 10% vs. 58 +/- 11%, p = 0.009) than the 1986-1987 cohort. Overall lesion morphology risk scores were similar. New devices (other than coronary angioplasty) were used in 26% of patients. The 1991 patient cohort had more frequent total revascularization (35% vs. 21%, p = 0.003), fewer emergency bypass operations (1.0% vs. 5.5%, p = 0.006) and an improved overall procedural success rate (90% vs. 84%, p = 0.04). In addition, at 12 months the event-free survival rate was superior in the 1991 cohort (73.3% vs. 63.6%, p = 0.02), although there was no difference in infarct-free survival rate (94.6% vs. 93.2%, p = NS). CONCLUSIONS: Improved results with percutaneous revascularization in 1991 have important implications for patient care and interpretation of ongoing randomized trials enrolling patients in the late 1980s and intending to compare standard coronary angioplasty with other forms of therapy.

Quantitative coronary angiographic and intravascular ultrasound assessment of a new nonarticulated stent: report from the Advanced Cardiovascular Systems MultiLink stent pilot study.

OBJECTIVES: The purpose of this study was to evaluate the safety, feasibility, optimal deployment technique and 1-year clinical outcome for the Advanced Cardiovascular Systems (ACS) MultiLink stent. BACKGROUND: Optimal stent deployment assessed by quantitative coronary angiography and intravascular ultrasound (IVUS) is associated with improved clinical outcome. METHODS: Forty-nine consecutive patients with a discrete stenosis in a native coronary artery 3 to 4 mm in diameter were treated with the new, balloon-expandable ACS MultiLink stent. Stent expansion was assessed in all patients using quantitative coronary angiography and serial IVUS imaging after 8-, 12- and 16-atm inflations. Clinical follow-up was obtained at 30 days and 1 year. RESULTS: All 49 patients had successful placement of a MultiLink stent without death, emergency coronary artery bypass graft surgery or Q wave myocardial infarction. After placement of the MultiLink stent, the minimal lumen diameter increased from 1.24 to 2.98 mm (p < 0.001), and diameter stenosis decreased from 61% to 7% (p = 0.001). Minimal lumen cross-sectional area by IVUS increased progressively after 8, 12 and 16 atm (5.6 to 6.8 to 7.4 mm2, respectively, p < 0.001). However, only 64% of stents achieved a lumen/reference area ratio > or = 70%. No adverse clinical events occurred by 30 days, and by 1 year only one patient (2.0%) required revascularization of the stented artery. CONCLUSIONS: Treatment of stenoses in native coronary arteries with the MultiLink stent is associated with a high success rate and a low incidence of adverse events by 1 year, despite the fact that the majority of stents did not meet IVUS-defined criteria for "optimal stenting" derived from first-generation devices.

Bailout and corrective use of Gianturco-Roubin flex stents after percutaneous transluminal coronary angioplasty: operator reports and angiographic core laboratory verification from the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention Registry.

OBJECTIVES: We sought to determine the in-hospital clinical outcome and angiographic results of patients prospectively entered into the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention (NHLBI/NACI) Registry who received Gianturco-Roubin stents as an unplanned new device. BACKGROUND: Between August 1990 and March 1994, nine centers implanted Gianturco-Roubin flex stents as an unplanned new device in the initial treatment of 350 patients (389 lesions) who were prospectively enrolled in the NHLBI/NACI Registry. METHODS: Patients undergoing implantation of the Gianturco-Roubin flex stent were prospectively entered into the Gianturco-Roubin stent portion of the NHLBI/NACI Registry. Only subjects receiving the Gianturco-Roubin stent as a new device in an unplanned fashion are included. RESULTS: The mean age of the patient group was 61.8 years, and the majority of the patients were men. A history of percutaneous transluminal coronary angioplasty (PTCA) was present in 35.4% of the group, and 16.9% had previous coronary artery bypass graft surgery. Unstable angina was present in 67.7%. Double- or triple-vessel coronary artery disease was present in 55.4%, and the average ejection fraction was 58%. The presence of thrombus was noted in 7.3%, and 7.2% had moderate to severe tortuosity of the lesion. The angiographic success rate was 92%. Individual clinical sites reported that 66.3% of the stents were placed after suboptimal PTCA, 20.3% for abrupt closure and 13.4% for some other technical PTCA failure. Major in-hospital events occurred in 9.7% of patients, including death in 1.7%, Q wave myocardial infarction in 3.1% and emergency bypass surgery in 6%. Abrupt closure of a stented segment occurred in 3.1% of patients at a mean of 3.9 days. Cerebrovascular accident occurred in 0.3%, and transfusion was required in 10.6%. Vascular events with surgical repair occurred in 8.6% of patients. CONCLUSIONS: Despite these complications, the use of this device for the treatment of a failed or suboptimal PTCA result remains promising given the adverse outcome of abrupt closure with conventional (nonstent) treatment.

Value and limitations of color Doppler echocardiography in the evaluation of percutaneous balloon mitral valvuloplasty for isolated mitral stenosis.

The limitations of 2-dimensional and pulsed Doppler echocardiography in patients undergoing mitral valvuloplasty are well known. This study was undertaken to assess the value of color Doppler flow imaging in 36 symptomatic mitral stenosis patients who subsequently underwent successful balloon mitral valvuloplasty by comparing the results to those obtained at cardiac catheterization. Color Doppler-guided conventional Doppler assessment agreed well with cardiac catheterization results in classifying mitral stenosis as mild, moderately severe and severe, both before and after valvuloplasty. Color Doppler was also useful in identifying patients who had moderate to severe mitral regurgitation before and after valvuloplasty. Color Doppler flow mapping was more sensitive than oximetry in the detection of iatrogenic atrial septal defects, which were noted in 25 patients. The defects of those patients with smaller defects by color Doppler (diameter less than 0.7 cm) or echocardiographic shunt volume less than 0.7 liters/min tended to close, usually within 6 months, as opposed to those with larger defects or higher shunt volumes, which tended to persist. Echocardiographic shunt volumes revealed a fair correlation with oximetric results.

Comparison of primary angioplasty versus thrombolytic therapy for acute myocardial infarction. Alabama Registry of Myocardial Ischemia Investigators.

To determine the relative merits of primary percutaneous transluminal coronary angioplasty (PTCA) and intravenous thrombolytic therapy for acute myocardial infarction, 12 tertiary care hospitals entered patients who had > or = 30 minutes of chest pain and were admitted to a cardiac intensive care unit within 12 hours of symptom onset into a prospective registry. Of 1,170 such patients, 118 (10%) underwent primary PTCA and 230 (19%) received intravenous thrombolytic therapy within 6 hours of registry hospital admission (144 at the registry hospital and 86 prior to arrival at the registry hospital). Baseline demographic characteristics of PTCA and thrombolytic subgroups were remarkably similar. The interval from initial evaluation at the registry hospital to treatment was shorter with intravenous thrombolytic therapy than with primary PTCA (64 vs 104 minutes, p < 0.001), as was the interval from pain onset to treatment (184 vs 252 minutes, p < 0.001). Among the 230 thrombolytic patients, coronary arteriography and PTCA were performed within the first 24 hours in 44% and 18%, respectively, and during the entire hospitalization in 90% and 49%, respectively. During hospitalization, blood was transfused in 16% of the 230 thrombolytic patients versus 5.9% of the 118 PTCA patients (p < 0.001). Otherwise, adverse events during the initial hospitalization were similar in PTCA and thrombolytic groups. Survival at 1-year follow-up was 88% in the PTCA group and 91% in the thrombolytic group (p = NS), and survival free of reinfarction was 85% and 88%, respectively (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term (three years) effect of estrogen replacement therapy on major adverse cardiac events in postmenopausal women after intracoronary stenting.

This study examined whether estrogen replacement therapy (ERT) in postmenopausal women impacts intermediate and long-term outcome after successful coronary stenting. Our findings offer evidence that ERT significantly reduces target lesion revascularization after intracoronary stenting in postmenopausal patients who are on ERT before the intervention.

Acute angiographic and clinical results of long balloon percutaneous transluminal coronary angioplasty and adjuvant stenting for long narrowings.

Historically, long coronary artery stenoses undergoing percutaneous transluminal coronary angioplasty (PTCA) are reported to have reduced procedural and clinical success in comparison with shorter lesions. The efficacy of long balloons (30 or 40 mm) in long lesions was evaluated. Eighty-two patients had 84 PTCA procedures with a primary long balloon. In all, 86 lesions were available for analysis. Data were collected prospectively on standard PTCA procedure forms. Coronary angiograms were reviewed and measured with digital calipers. Hospital charts were examined for complications. PTCA was performed in the left anterior descending artery in 44 cases (51%), the right coronary artery in 29 (34%) and the circumflex artery in 13 (15%). With the use of a modified classification system, 47 lesions (55%) were class C, 24 (28%) were class B2 and 15 (17%) were class B1. Mean lesion length was 22 +/- 11 mm (range 10 to 72), and 38 lesions (44%) were > or = 20 mm. Twelve patients received an intracoronary stent. The long balloon alone produced angiographic success (< 50% residual stenosis) in 77 lesions (90%). Angiographic success was achieved ultimately in all stenoses, using a stent in 7 patients and a short balloon in 2. There were 2 deaths (2%) and 1 Q-wave myocardial infarction (1%). One patient needed coronary artery bypass surgery. Clinical success without death, Q-wave infarction or bypass surgery was achieved in 83 of 86 procedures (97%). In conclusion, the use of long PTCA balloons with adjuvant stenting produced excellent results in these long stenoses. Lesion length was not a precursor of poor angiographic or clinical outcome.

A cost analysis of coronary stenting without anticoagulation versus stenting with anticoagulation using warfarin.

A case-controlled study was performed comparing hospitalization costs and length of hospital stay in a group of patients managed with antiplatelet therapy only, versus a group treated with anticoagulation using warfarin after coronary artery stenting. The patients managed with antiplatelet therapy alone had significantly reduced total hospitalization costs and a significantly reduced average hospital stay than patients managed with anticoagulation.

Early results of percutaneous intervention for severe coexisting carotid and coronary artery disease.

Fifty-one patients with severe coexisting carotid and symptomatic coronary artery occlusive disease successfully underwent staged or simultaneous coronary angioplasty and carotid stenting. One pericardial effusion and 2 minor strokes with full recovery occurred in the hospital, but no major neurologic events, myocardial infarction, or death were observed and no repeat revascularization was required within the 30-day follow-up.

Elective carotid artery stenting in the presence of contralateral occlusion.

Significant carotid stenosis in the presence of an occluded contralateral artery has a poor prognosis with medical therapy alone. Carotid cross clamping during surgical endarterectomy results in critical flow reductions in patients with inadequate collateral flow, and represents a significant risk for procedural strokes. Carotid stenting is being evaluated as an alternative to endarterectomy. We describe the immediate and late outcome of a series of 26 patients treated with carotid stenting in the presence of contralateral carotid occlusion. The mean age of the patients in this group was 65 +/- 9 years, 23 (89%) were men and 10 (39%) were symptomatic from the vessel treated. The procedural success of carotid stenting in this group of patients was 96%. The mean diameter stenosis was reduced from 76 +/- 15% to 2.8 +/- 5%. There was 1 (3.8%) minor stroke in a patient who developed air embolism during baseline angiography. At late follow-up there was no neurologic event in any patient at a mean of 16 +/- 9.5 months after the procedure. Thus, carotid stenting of lesions with contralateral occlusion can be performed successfully with a low incidence of procedural neurologic complications and late stroke.

Results of elective stenting of branch-ostial lesions.

Coronary stenting using both Palmaz-Schatz and Gianturco-Roubin stents for branch ostial lesions was performed in 48 patients with high success and low complication rates. The 6-month event-free survival rates were high in these patients.

The use of the Gianturco-Roubin intracoronary stent: the New Approaches to Coronary Intervention (NACI) registry experience.

The objective of this study is to compare the in-hospital and follow-up outcome in patients receiving the Gianturco-Roubin stent (GRS) who were enrolled in the New Approaches to Coronary Intervention (NACI) registry. The GRS was approved by the US Food and Drug Administration (FDA) in August 1992 for the treatment of acute or threatened closure after a percutaneous intervention. The application of intracoronary stenting has broadened substantially in the last few years, but less is known about the use of this device for other indications. Since the NACI registry includes patients stented for other indications, a comparison of these groups with patients being stented for acute or threatened closure was undertaken. A GRS was deployed in 497 NACI registry patients. Of these, 466 patients received a GRS in 1 of 3 of the following ways: (1) 351 unplanned stenting after conventional angioplasty of the same lesion; (2) 54 after failed/suboptimal use of a new device in the same lesion; and (3) 61 in planned stenting procedures. This analysis focuses on these 3 patient subgroups and compares their in-hospital outcome and subsequent follow-up to 1 year. There were 520 stented segments in the 466 patients. The group with stenting after failed/suboptimal new-device use had a higher incidence of myocardial infarction (MI) and cardiogenic shock than either the patients with unplanned stenting after percutaneous transluminal coronary angioplasty (PTCA) or planned stenting (MI 22.2% vs 12.0% vs 0%, respectively, and cardiogenic shock 5.6% vs 0.9% vs 0%, respectively; p < 0.05). This group also had significantly lower procedural success (58.7% vs 75.3% vs 81.5%, respectively; p < 0.05). Although not statistically significant, the requirement for transfusion was higher in the unplanned and new-device stented groups than in the planned group (10.5% vs 16.7% vs 1.6%, respectively). Likewise, the incidence of Q-wave MI was higher in the new-device group (22.2% vs 12% vs 0%, respectively; p < 0.05). Despite a higher, in-hospital complication rate in the unplanned groups, follow-up from discharge to 1 year showed similar outcome. In particular, percutaneous reintervention of the stented segment occurred in: 13.0% in the unplanned after new device; 17.4% in the unplanned after PTCA; and 26.2% in the planned group. Although not statistically significant, the higher incidence of percutaneous target lesion revascularization in the planned group probably represents the greater incidence of restenotic lesions in this cohort. In this very heterogeneous group of patients, including those with failure of another new device, the use of the GRS is associated with acceptable in-hospital and follow-up complication rates, although complications were clearly greater when unplanned use of the stent was needed, particularly after failure of another new device. Although the experience is small, patients having the GRS placed in an elective fashion, i.e., the planned group, appear to experience lower in-hospital complication rates, although they have a higher rate of subsequent target lesion revascularization, in this group of predominantly restenotic lesions.

Comparison of aspirin alone versus aspirin plus ticlopidine after coronary artery stenting.

This prospective nonrandomized study was performed comparing aspirin alone (n = 46) versus aspirin and ticlopidine (p = 338) following native coronary artery stenting. There were significantly more stent thrombosis events in the aspirin-only group than in the aspirin and ticlopidine group (6.5% vs 0.9%, p = 0.02) and significantly more Q-wave myocardial infarctions and cardiac-related deaths in the aspirin-only group than in the aspirin and ticlopidine group (6.5% vs 0%, p = 0.002 and 4.4% vs 0.3% p = 0.02, respectively).