Biomedical subjects

M B Leon

Publications and source records attributed to M B Leon.

At least 73 records · Page 4Linked to original sources

PubMed2000

Electromagnetic guidance for catheter-based transendocardial injection: a platform for intramyocardial angiogenesis therapy. Results in normal and ischemic porcine models.

OBJECTIVES: To test the feasibility of myocardial angiogenic gene expression using a novel catheter-based transendocardial injection system. BACKGROUND: Angiogenesis has been induced by direct injection of growth factors into ischemic myocardium during open-heart surgery. Catheter-based transendocardial injection of angiogenic factors may provide equivalent benefit without need of surgery. METHODS: A new guidance system for intramyocardial therapy utilizes magnetic fields and catheter-tip sensors to locate a position in space and reconstruct three-dimensional left ventricular (LV) electromechanical maps without using fluoroscopy. A retractable 27G needle was coupled with the guidance system for LV transendocardial injection. In 12 pigs, the catheter was used to inject 0.1 ml of methylene-blue (MB) dye and 8 pigs had myocardial injections of adenoviral vector (1 x 10(10) particles per site) containing the LacZ transgene. Ten pigs underwent catheter-based transendocardial injection and six pigs were injected using transepicardial approach with the gene encoding adenovirus vascular endothelial growth factor-121 (Ad.VEGF121; 1 x 10(10) viral particles x 6 sites) and sacrificed at 24 h. Injection sites were identified with ultraviolet light by coinjection of fluorescent beads. RESULTS: Overall, 138 of 152 attempted injection MB tracks (91%) were found after sacrifice. Tissue staining was 7.1+/-2.1 mm in depth and 2.3+/-1.8 mm in width. No animal had pericardial effusion or tamponade. In Ad.LacZ injected animals, gross pathology showed positive staining in injected zones, and histology confirmed positive myocyte staining. Adenovirus vascular endothelial growth factor-121 injected sites showed high levels of VEGF121 production that was of similar magnitude whether injected using the transendocardial (880.4+/-412.2 pg VEGF121/mg protein) or transepicardial (838.3+/-270 pg VEGF121/mg protein) delivery approach (p = 0.62). CONCLUSIONS: Using this magnetic guidance catheter-based navigational system, transgenes can effectively be transfected into designated myocardial sites. Thus, if it is determined that direct intramyocardial injection of angiogenic factors enhances collateral function in patients, this less invasive catheter-based system offers a similar gene delivery efficiency and, thus, may have clear advantages compared with the surgically-based transepicardial injection approach.

Animals↗

PubMed2000

Percutaneous revascularization of the internal mammary artery graft: short- and long-term outcomes.

OBJECTIVES: We evaluated the short- and long-term clinical outcomes after percutaneous revascularization of the internal mammary artery (IMA) graft. BACKGROUND: Previous reports in a relatively small number of patients have indicated the safety of balloon angioplasty for the treatment of stenoses in the IMA graft. However, the use of alternative interventional techniques and their long-term results have not yet been evaluated. METHODS: We analyzed the in-hospital and one-year clinical outcomes of 174 consecutive patients who underwent percutaneous revascularization of 202 lesions located in the IMA graft, by either balloon angioplasty or stenting. RESULTS: Anastomotic lesions were evident in 128 cases (63%), and they were more commonly treated with balloon angioplasty (116/128, 91%), whereas lesions located at the ostium (n = 16, 8%) were more frequently treated with stents (11/16, 69%). Procedural success was 97% with excellent in-hospital outcome: 0.6% mortality rate, no Q-wave myocardial infarction (MI) and 0.6% rate of urgent bypass surgery. Cumulative one-year rates were: mortality 4.4%, MI 2.9% and target lesion revascularization (TLR) 7.4%. CONCLUSIONS: Revascularization of the IMA graft can be performed safely, with high procedural success and a low rate of in-hospital complications. Long-term follow-up showed very low TLR rate.

Adult↗

PubMed2000

Procedural results and late clinical outcomes after percutaneous interventions using long (> or = 25 mm) versus short (< 20 mm) stents.

OBJECTIVES: To evaluate clinical outcomes after the use of long coronary stents. BACKGROUND: The use of long slotted-tube stents has been recently approved in the U.S. to treat long lesions or dissections. Procedural success and long-term outcomes of long versus short stents have not been established. METHODS: We evaluated procedural success, major in-hospital complications, target lesion revascularization and long-term (one year) clinical outcomes in 1,226 consecutive patients (1,259 native coronary lesions) who underwent a single vessel intervention using a single long (> or =25 mm, 116 patients) or short (<20 mm, 1,110 patients) tubular-slotted stent. RESULTS: Patients treated with long stents had more diffuse (>10 mm length) lesions (63% vs. 28%, p = 0.001). The mean stent length was 28 +/- 5 mm versus 15 +/- 2 mm for long versus short stent groups (p = 0.001). Overall procedural success was similar in the long versus short stent groups (96% vs. 98%, p = 0.08). However, major in-hospital complications tended to occur more frequently in patients treated with longer stents (3.4% vs. 1.0%, p = 0.04). The rate of periprocedural non-Q-wave myocardial infarction (MI) (creatine kinase-MB > or =5 times normal) was notably higher after long stent implantation (23% vs. 11%, p = 0.001). Target lesion revascularization at one year was 14.5% vs. 13.8% (p = 0.69), and target vessel revascularization rate was 19.6% vs. 17.3% (p = 0.41) in the long versus short stent group, respectively. There was no difference in one year mortality (2.5% vs. 3.5%, p = 0.49) or Q-wave MI (2.7% vs. 1.2%, p = 0.48), and the overall cardiac event-free survival was similar for the two groups (81%). CONCLUSIONS: The use of single coronary long (> or =25 mm) versus short (<20 mm) stents is associated with: 1) somewhat increased major procedural complications, 2) significantly higher frequency of periprocedural non-Q-wave MIs, and 3) equivalent repeat revascularization risk and cardiac event-free survival out-of-hospital up to one year.

Blood Vessel Prosthesis Implantation↗

PubMed2000

Atherosclerotic plaque burden and CK-MB enzyme elevation after coronary interventions : intravascular ultrasound study of 2256 patients.

BACKGROUND: Elevation of serum creatine kinase MB fraction (CK-MB) after percutaneous coronary interventions has been associated with early and late mortality; however, the pathogenesis of CK-MB elevation is still unknown. We hypothesized that CK-MB elevation was related to atherosclerotic plaque burden as assessed by preintervention intravascular ultrasound (IVUS). METHODS AND RESULTS: We studied 2256 consecutive patients who underwent intervention of 2780 native coronary lesions and had complete high-quality preintervention IVUS imaging in the era before routine use of platelet glycoprotein IIb/IIIa inhibitors. Patients were divided into 3 groups: CK-MB within normal range (1675 patients; 2061 lesions); CK-MB elevation 1 to 5 times upper limit of normal (292 patients; 355 lesions); and CK-MB elevation > or = 5 times upper limit of normal (289 patients; 364 lesions). Qualitative angiographic lesion morphology and quantitative analysis were similar among the 3 groups. On preintervention IVUS, progressively more reference segment and lesion site plaque burden and lesion site calcium occurred in the groups with CK-MB elevation. Positive remodeling was more common in lesions with CK-MB elevation. As levels of CK-MB increased, cross-sectional narrowing (percentage plaque burden) increased, both at the reference site (mean cross-sectional narrowing values were 45.1%, <49.3%, and <52.2% for normal CK-MB, 1 to 5 times upper limit of normal, and > or =5 times upper limit of normal groups, respectively; P=0.03) and at the lesion site (81.9%, <85.4%, and <87.1%, respectively; P=0.04). Multivariate analysis indicated that de novo lesions, atheroablative technique, plaque burden at the lesion and reference segments, and final minimal lumen diameter were independent predictors of CK-MB elevation. CONCLUSIONS: CK-MB elevation correlates with a greater atherosclerotic plaque burden. CK-MB elevation after intervention may be a marker of diffuse atherosclerotic disease or a consequence of catheter-based intervention in more diseased arteries or both.

Aged↗

PubMed2000

Optimally deployed stents in the treatment of restenotic versus de novo lesions.

Results from earlier trials performed before the implementation of optimal stent deployment techniques suggest that stenting for restenotic lesions may be associated with a higher risk of restenosis when compared with de novo lesions. The aim of this study was to compare the short- and long-term outcome of optimal stent deployment in restenotic versus de novo lesions. In all, 1,865 consecutive patients with 2,707 de novo lesions and 489 patients with 633 restenotic lesions underwent intravascular ultrasound-guided optimal stent deployment. In-hospital outcome was similar for both groups, except for a higher incidence of non-Q-wave myocardial infarction in the de novo group (14.6% vs 8.6%, p = 0.001). At 12-month follow-up, there was no statistical significant difference in the incidence of death or myocardial infarction, but event-free survival was better in the de novo lesion group of patients (74.5% vs 63.7%, p = 0.001). There was a higher incidence of target lesion revascularization in the restenosis group (25.1% vs 13.0%, p = 0.001). By multivariate analysis, restenotic lesions, vein graft lesions, and diabetes mellitus were strong determinants of repeat revascularization, whereas larger preprocedural reference vessel minimal lumen diameter and larger final minimal lumen diameter were associated with a reduced chance of restenosis and increased event-free survival. This study shows that optimal stent deployment for restenotic and de novo lesions has favorable short- and long-term outcome. However, the incidence of target lesion revascularization was significantly greater in restenotic lesions. Saphenous vein graft lesions and diabetes mellitus were confirmed as other independent risk factors for clinical restenosis.

Aged↗

PubMed2000

Influence of patient age on acute and late clinical outcomes following Palmaz-Schatz coronary stent implantation.

Procedural success may be lower and complication rates higher after balloon angioplasty in older patients. Elective stent implantation improves procedural outcome in younger patients; however, few series have specifically analyzed the octogenarian population. Therefore, we studied 2,534 consecutive patients (3,965 native coronary artery stenoses) who were treated electively with Palmaz-Schatz stents and divided them into 3 groups: (1) < or = 70 years old (n = 1,805), (2) 71 to 80 years old (elderly, n = 607), and (3) > 80 years old (octogenarian, n = 122). Major in-hospital complications (death, myocardial infarction, and urgent bypass surgery) were significantly higher in the octogenarians than in the elderly and patients < or = 70 years of age (4.5% vs 2.0% and 1.5%; p = 0.001). At 1-year follow-up, cardiac events (death, nonfatal myocardial infarction, and need for any revascularization) did not differ among groups; however, there was a stepwise increase in late death in octogenarians (5%) compared with elderly patients (2%) and patients aged < or = 70 years (1%) (p = 0.001). Target lesion revascularization was similar among the groups (11% in octogenarian vs 14% in elderly and 15% in patients < or = 70 years, p = 0.791). By multivariate logistic regression analysis, age was an independent predictor of late mortality (odds ratio 1.05, p = 0.0001), but not a predictor of target lesion revascularization. Stent implantation in octogenarians is associated with (1) more acute complications, (2) a higher in-hospital mortality, (3) a higher late mortality, and (4) a target lesion revascularization similar to younger patients.

Age Factors↗

PubMed2000

Three-year clinical and angiographic follow-up after intracoronary radiation : results of a randomized clinical trial.

BACKGROUND: Although several early trials indicate treatment of restenosis with radiation therapy is safe and effective, the long-term impact of this new technology has been questioned. The objective of this report is to document angiographic and clinical outcome 3 years after treatment of restenotic stented coronary arteries with catheter-based (192)Ir. METHODS AND RESULTS: A double-blind, randomized trial compared (192)Ir with placebo sources in patients with previous restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to (192)Ir and 29 to placebo. At 3-year follow-up, target-lesion revascularization was significantly lower in the (192)Ir group (15. 4% versus 48.3%; P<0.01). The dichotomous restenosis rate at 3-year follow-up was also significantly lower in (192)Ir patients (33% versus 64%; P<0.05). In a subgroup of patients with 3-year angiographic follow-up not subjected to target-lesion revascularization by the 6-month angiogram, the mean minimal luminal diameter between 6 months and 3 years decreased from 2.49+/-0.81 to 2.12+/-0.73 mm in (192)Ir patients but was unchanged in placebo patients. CONCLUSIONS: The early clinical benefits observed after treatment of coronary restenosis with (192)Ir appear durable at late follow-up. Angiographic restenosis continues to be significantly reduced in (192)Ir-treated patients, but a small amount of late loss was observed between the 6-month and 3-year follow-up time points. No events occurred in the (192)Ir group to suggest major untoward effects of vascular radiotherapy. At 3-year follow-up, vascular radiotherapy continues to be a promising new treatment for restenosis.

Aged↗

PubMed2000

Delivery strategies to achieve therapeutic myocardial angiogenesis.

The use of recombinant genes or growth factors to enhance myocardial collateral blood vessel function may represent a new approach to the treatment of cardiovascular disease. Proof of concept has been demonstrated in animal models of myocardial ischemia, and clinical trials are underway. Currently, it is unknown which is the safest and most effective delivery strategy to induce clinically important therapeutic angiogenic responses in ischemic myocardium. Most strategies for transcatheter delivery of angiogenic factors have used an intracoronary route, which may have limitations because of imprecise localization of genes or proteins and systemic delivery to noncardiac tissue. The effect of direct intraoperative intramyocardial injection of angiogenic factors on collateral function has been reported in experimental models, and angiogenesis is being studied after direct intramyocardial injection of angiogenic peptides or plasmid vectors during open heart surgery in patients. Catheter-based transendocardial injection of angiogenic factors may provide equivalent benefit without the need for surgery. Intrapericardial delivery of angiogenic factors may offer a theoretical advantage of prolonged exposure of either coronary or myocardial tissue to the administered drug as result of a reservoir function of the pericardium. In this article, we review the different modes of administration for therapeutic myocardial angiogenesis therapy.

Animals↗

PubMed2000

Comparison of time course of target lesion revascularization following successful saphenous vein graft angioplasty versus successful native coronary angioplasty.

We studied 1,267 patients with 2,186 saphenous vein graft (SVG) lesions to determine the time course of target lesion revascularization (TLR) after successful SVG angioplasty. We found that the time course of TLR in SVG appears prolonged, with only 54% occurring within the first 6 months and continued TLR even after 1 year.

Aged↗

PubMed2000

Relation of coronary artery size to one-year clinical events after new device angioplasty of native coronary arteries (a New Approach to Coronary Intervention [NACI] Registry Report).

The influence of vessel size on clinical and angiographic outcomes after new device angioplasty has not been well documented. We reviewed clinical and angiographic outcomes of 2,044 patients undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Quantitative angiography was performed using standard methods. Patients were divided into 3 groups according to reference vessel diameter (RVD) (<2.75, 2.75 to 3.25, and >3.25 mm). Patients with the smallest vessels had a higher incidence of diabetes (26% vs. 16%, p<0.01), multivessel disease (50% vs. 45%, p<0.01), left anterior descending coronary artery disease (61% vs. 39% p<0.01), and in general, more severe baseline lesion characteristics than patients with larger (>3.25 mm) vessels. Absolute baseline and final minimal lumen diameter (MLD) was also smaller in patients with RVD <2.75 mm despite similar final percent diameter stenosis. Although in-hospital events were similar, patients who underwent interventions in vessels <2.75 mm had an increased incidence of death (p<0.01), surgical revascularization (p<0.05), and target lesion revascularization (TLR) (p<0.01) at 1 year. Multivariate analysis by vessel size showed a stepwise increase in the risk of TLR by 1 year in patients with the smaller RVD (p = 0.0001) and the combined end point of 1 year death/Q wave-myocardial infarction/TLR (p = 0.02). Thus, despite similar early clinical events among patients undergoing new device angioplasty, patients who underwent treatment of smaller vessels had a significantly increased risk of major adverse clinical events and particularly TLR by 1 year after new device angioplasty of native coronary arteries.

Angioplasty↗

PubMed2000

Late thrombosis following intracoronary brachytherapy.

Vascular brachytherapy has been the subject of an extensive ongoing investigation into the safety and efficacy of this technique for preventing restenosis. Preclinical studies have demonstrated reduction of the neointimal proliferation and the late vascular constriction with radiation therapy. However, radiation is also known to delay the healing process and may contribute to a new phenomenon of late thrombosis. We report on two cases of patients with in-stent restenosis who underwent intervention followed by intracoronary vascular radiation therapy (utilizing beta and gamma radiation) and presented with acute onset of unstable angina. Angiographic study demonstrated late thrombosis, which were treated successfully with the Angiojet thrombectomy device.

Aged↗

PubMed2000

Importance of lesion length on new device angioplasty of native coronary arteries. NACI Investigators. New Approaches to Coronary Interventions.

The influence of lesion length on early and late outcomes after new device angioplasty has not been well documented. We reviewed the clinical and angiographic outcomes of 2,980 patients (3,902 lesions) undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Patients were divided into three groups according to the longest lesion length (< 10, 10-20, and > 20 mm) treated. Patients with the longest lesions had more multivessel disease (56.9% vs. 49.0%, P<0.05), right coronary artery disease (52.7% vs. 32.0%, P<0.001), and total occlusions (19.1% vs. 2.5%, P<0.001) than patients with shorter lesions. Longest lesions had the smallest minimal lumen diameter (P<0.001) at baseline and at the end of the procedure. Although in-hospital events were similar, there were differences in clinical outcomes at 1 year due mainly to more target lesion revascularization in the longest lesion group (P<0.01). Multivariate analysis showed that each 1-mm increase in lesion length was associated with an increase relative risk of 1.014 (95% CI, 1.004-1.025) for target lesion revascularization at 1 year. We conclude that despite similar early clinical events, patients undergoing new device angioplasty of longer lesions have more target lesion revascularization at 1 year.

Aged↗

PubMed2000

Prognostic value of recurrent episodes of creatine kinase-MB elevation following repeated catheter-based coronary interventions.

Creatine kinase-MB (CK-MB) enzyme elevations were shown to affect cardiac prognosis following percutaneous coronary interventions (PCIs). This study examined whether recurrent episodes of CK-MB elevation following repeated PCIs may be associated with a cumulative adverse prognostic risk. We studied 767 consecutive patients (age, 64 +/- 11 years; 69% male) who underwent two consecutive PCI procedures on two separate hospitalizations (mean interval, 121 +/- 110 days). Patients were stratified into four groups according to number of episodes of any (> 4 ng/ml) postinterventional CK-MB rise (no elevation, previously elevated, currently elevated, or elevated at the time of both procedures; n = 403, 107, 153, and 104 patients, respectively). In-hospital clinical outcomes (death, Q-MI, and repeat revascularization) and up to 1-year follow-up events were obtained. Recurrent episodes of CK-MB elevation were associated with increased in-hospital mortality (3.8% vs. 0.9% vs. 0% vs. 0%, P = 0.0003), increased cumulative mortality (18.9% vs. 5.9% vs. 4.3% vs. 4.3%, P = 0.0003) and cumulative Q wave MI (8.0% vs. 4.9% vs. 1.0% vs. 0.8%, P = 0.005) at 1 year, and lower overall cardiac event-free survival at follow-up (66.8% vs. 80.5% vs. 88.8% vs. 88.8%, P = 0.0001 for patients with twice, current, previous, and no CK-MB elevation, respectively). By multivariate analysis, CK-MB elevated at the time of both procedures, was the strongest independent predictor for cumulative mortality (OR 3.4, 95% CI 1.6-7.1, P = 0.001) or any adverse cardiac events (OR 2.6, 95% CI 1.6-4.3, P = 0.0002). We conclude that cumulative episodes of periprocedural CK-MB elevation are associated with an incremental adverse prognostic risk including mortality and Q-wave MI. Thus, measures aimed at reducing subsequent CK-MB rise may be warranted in particular among patients with a prior history of PCI related CK-MB elevation.

Aged↗

PubMed2000

Lesion-to-lesion relationship of the restenosis process after placement of coronary stents.

The interrelation between multiple stented lesions within one patient in the restenosis process is only partially understood. From 492 patients with follow-up angiograms after coronary stent placement, 115 patients underwent multilesion procedures involving 233 lesions. In randomly chosen 39 patients with 79 lesions, additional intravascular ultrasound (IVUS) studies were performed to measure intimal hyperplasia cross-sectional area (CSA) and thickness. A general linear model with intraclass correlation was used to calculate the coefficient of correlation rho (rho = 1.0 indicates perfect correlation; rho = 0.0 indicates no correlation) of late loss, late loss index, intimal hyperplasia CSA, and intimal hyperplasia thickness. Multivariate analysis showed restenosis in the companion lesion (odds ratio 4.68, 95% confidence interval 1. 68-12.92, P = 0.003) and small minimal lumen diameter preintervention (odds ratio 0.28, 95% confidence interval 0.11-0.73, P = 0.009) to be predictors of restenosis. There was a weak correlation between multiple lesions within the same patient for late lumen loss rho = 0.28 (95% confidence interval 0.10-0.46, P < 0. 001) and late loss index. IVUS analysis demonstrated correlation of intimal hyperplasia CSA rho = 0.40 (95% confidence interval 0.06-0. 74, P = 0.009) and of intimal hyperplasia thickness. In conclusion, late loss and intimal hyperplasia demonstrate a correlation between multiple stented lesions within one patient. In addition to known lesion related factors, restenosis in a companion lesion is a predictor for restenosis. Cathet. Cardiovasc. Intervent. 51:266-272, 2000.

Aged↗

PubMed2000

A novel platinum-iridium, potentially gamma radioactive stent: evaluation in a porcine model.

In-stent restenosis (ISR) is a major problem within stented arteries. Surface treatment of stents with platinum and gold were found to have the maximum charge with least neointima formation (NF). This study was designed to evaluate platinum (maximum electrical charge) as a material to make stents to reduce NF. Iridium was added to make an alloy suitable for stent manufacture, with the potential to make the stent radioactive. We implanted the novel platinum-iridium (PI) stent in 10 porcine coronaries and compared to the Palmaz-Schatz (PS) stent implanted in 8 coronary arteries. Six weeks after implantation, angiography of the stented vessel was performed before sacrifice. The coronaries were perfusion-fixed and stained, and vessel parameters were analyzed by computer-aided histomorphometry. The thrombus formation and the inflammatory response was less in the PI stent (0.04 +/- 0.1 vs. 0.24 +/- 0.2, P = 0.005; and 1.1 +/- 0.5 vs. 2.4 +/- 0.3, P < 0.001). The NF from PI-stented arteries was smaller in size than the PS controls (1.9 +/- 0.6 mm(2) vs. 2.4 +/- 0.4 mm(2), P = 0.06). However, PI stents presented with higher recoil than the PS stent (16% vs. 5%, P < 0.001). Platinum-iridium is a highly biocompatible material with high performance, low inflammatory response with small NF. This stent does not lead to thrombus formation and has the potential (due to the presence of iridium) to be irradiated to form a gamma radioactive stent. Cathet. Cardiovasc. Intervent. 51:364-368, 2000.

Animals↗

PubMed2000

Percutaneous transmyocardial laser revascularization: overview of US clinical trials.

Data from four surgical trials of laser transmyocardial revascularization (TMR) show pain reductions of at least two classes occurred among 25-76% of patients, significantly greater than with optimal medical therapy. The safety and feasibility of percutaneous TMR (PTMR) was proved in multiple uncontrolled registry studies. With PTMR in two randomized trials enrolling about 550 patients, improvements were found among 45% and 66% of patients as compared with 13% for best medical therapy. Other encouraging observations included significant improvements in exercise time (85 and 100 seconds) as compared with minimal or negative results for medical therapy, consistent overall exercise time improvements for PTMR, and overall patient perceptions of anginal stability and global health. Peri-procedural mortality is low and ranged from 0% to 0.6%. Some skepticism remains about the procedures, arising from failure in most cases to show improvements with SPECT imaging and lack of conclusive insights into the mechanism of action. A randomized 'blinded' study is underway to establish a definitive therapeutic value for catheter-based TMR. Nonetheless, preliminary clinical data seem promising for catheter-based TMR for obtaining symptomatic improvement in patients with chronic refractory ischemic coronary syndromes.

Angina Pectoris↗

PubMed2000

Long-term clinical events following creatine kinase--myocardial band isoenzyme elevation after successful coronary stenting.

OBJECTIVE: We sought to evaluate the impact of intermediate creatine kinase-myocardial band isoenzyme (CK-MB) elevation on late clinical outcomes in patients undergoing successful stent implantation in native coronary arteries. BACKGROUND: Elevations of CK-MB after percutaneous coronary interventions are frequent. An association between high level of CK-MB elevation (>5 times normal) and late mortality after balloon and new device angioplasty has been reported previously. However, significant controversy remains on the long-term clinical importance of lower CK-MB elevations (one to five times normal) after percutaneous coronary revascularization. Moreover, the incidence and prognostic importance of cardiac enzyme elevation after coronary stenting have not been well established. METHODS: Prospectively collected data from 900 consecutive patients (1,213 lesions) undergoing successful stenting in native vessels were analyzed. Based on the CK-MB levels after coronary stenting, patients were classified into three groups: normal group 1 (n = 585), elevation of >1 to 5 times normal group 2 (n = 238) and elevation of >5 times normal group 3 (n = 77). RESULTS: Patients in group 3 had more in-hospital recurrent ischemia (p = 0.001) and pulmonary edema (p = 0.01) than patients in groups 1 and 2. Long-term clinical end points were similar between groups 1 and 2. However, patients in group 3 had an increased incidence of late mortality compared with patients in groups 2 and 1 (6.9%, 1.2% and 1.7%, respectively, p = 0.01). Multivariate analysis showed that patients with CK-MB >5 times normal after coronary stenting had an increased risk of major adverse clinical events (relative risk: 1.70, p < 0.05) and death (relative risk: 3.25, p < 0.05) that was not observed in patients with lower CK-MB rise. CONCLUSIONS: Patients with CK-MB elevation >5 times normal had higher late mortality and more unfavorable event-free survival than those patients with normal or lower CK-MB rise after coronary stenting. While intermediate CK-MB elevation (>1 to 5 times normal) is frequent after coronary stenting (26%), this was not associated with an increased risk of late mortality or major adverse clinical events.

Aged↗

PubMed2000

Comparison of debulking followed by stenting versus stenting alone for saphenous vein graft aortoostial lesions: immediate and one-year clinical outcomes.

OBJECTIVES: We compared in-hospital and one-year clinical outcomes in patients undergoing debulking followed by stent implantation versus stenting alone for saphenous vein graft (SVG) aortoostial lesions. BACKGROUND: Stent implantation in SVG aortoostial lesions may improve procedural and late clinical outcomes. However, the impact of debulking before stenting in this complex lesion subset is unknown. METHODS: We studied 320 consecutive patients (340 SVG aortoostial lesions) treated with Palmaz-Schatz stents. Debulking with excimer laser or atherectomy was performed in 133 patients (139 lesions) before stenting (group I), while 187 patients (201 lesions) underwent stent implantation without debulking (group II). Procedural success and late clinical outcomes were compared between the groups. RESULTS: Overall procedural success (97.6%) was similar between the groups. Procedural complications were also similar (2.2% for group I and 2.6% for group II). At one-year follow-up, target lesion revascularization (TLR) was 19.4% for group I and 18.2% for group II (p = 0.47). There was no difference in cumulative death or Q wave myocardial infarction between the groups. Overall cardiac event-free survival was similar (69% for group I and 68% for group II). By Cox regression analysis, the independent predictors of late cardiac events were final lumen cross-sectional area (CSA) by intravascular ultrasound (IVUS) (p = 0.001) and restenotic lesions (p = 0.01). Similarly, final IVUS lumen CSA (p = 0.0001) and restenotic lesions (p = 0.006) were found to predict TLR at one year. CONCLUSIONS: These results suggest that, in most patients with SVG aortoostial lesions, debulking before stent implantation may not be necessary.

Aged↗