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

Gruberg, L; Hong, M K; Mintz, G S; Mehran, R; Waksman, R; Dangas, G; Kent, K M; Pichard, A D; Satler, L F; Lansky, A J; Kornowski, R; Stone, G W; Leon, M B
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
PMID: 11078302
ISSN: 0002-9149
CID: 147440

In-hospital and long-term results of stent deployment compared with balloon angioplasty for treatment of narrowing at the saphenous vein graft distal anastomosis site

Gruberg, L; Hong, M K; Mehran, R; Mintz, G S; Kornowski, R; Lansky, A J; Kent, K M; Pichard, A D; Satler, L F; Dangas, G; Wu, H; Stone, G W; Leon, M B
Disease at the distal anastomosis site of saphenous vein grafts (SVGs) has been successfully treated with balloon angioplasty, with a lower restenosis rate than at sites of the aortoostial or proximal portion of the SVG. The role of stents for these lesions has not been well defined. To compare the in-hospital and long-term outcome of patients who underwent treatment at this site by either balloon angioplasty or tubular stent implantation, we studied 182 consecutive patients who underwent balloon angioplasty and 77 patients who underwent stenting between January 1994 and August 1997. Baseline clinical characteristics for both groups were similar. Angiographically, SVG stenoses treated with stents were older, longer in lesion length, and more restenotic. The in-hospital outcome was similar for both groups, with 98% procedural success rates and 1% major ischemic complications. Long-term follow-up was obtained for 93% of the patients, for an average of 17 +/- 14 months. The mortality rates were similar for patients who underwent balloon angioplasty and stenting (11.6% vs 13%, p = NS). The Q-wave myocardial infarction rates were also similar (1% vs 0%, p = NS). There was a trend toward a higher rate of target lesion revascularization in the balloon angioplasty group (25% vs 14%, p = 0.058). We conclude that percutaneous revascularization of the SVG distal anastomosis site by either balloon angioplasty or stenting can be performed with a high rate of procedural success and favorable in-hospital and long-term outcomes. Stent deployment may further improve the long-term outcome of these patients by reducing the need for repeat revascularization
PMID: 10606108
ISSN: 0002-9149
CID: 147455

Creatine kinase-MB enzyme elevation following successful saphenous vein graft intervention is associated with late mortality

Hong, M K; Mehran, R; Dangas, G; Mintz, G S; Lansky, A J; Pichard, A D; Kent, K M; Satler, L F; Stone, G W; Leon, M B
BACKGROUND: Although the risk for development of creatine kinase (CK-MB) elevation after saphenous vein graft (SVG) intervention is high, its prognostic significance remains unknown. This study evaluated the impact of periprocedural CK-MB elevation on late clinical events following successful SVG angioplasty. METHODS AND RESULTS: We studied 1056 consecutive patients with successful (defined by angiographic success and absence of major complications) intervention of 1693 SVG lesions. These patients were grouped as normal CK-MB (n=556), minor CK-MB rise (CK-MB 1 to 5 times normal, n=339), and major CK-MB rise (CK-MB >5 times normal, n=161). There were no differences in major clinical events at 30-day follow-up among the 3 groups. However, 1-year mortality was 4.8%, 6.5%, and 11. 7%, respectively, P<0.05 (ANOVA). Even within a population without any intraprocedure or in-hospital complications (n=727, 69% of the overall cohort), 1-year mortality remained significantly higher with CK-MB elevation: 2.4%, 5.5%, and 10.7%, respectively, P<0.05 (ANOVA). Multivariate analysis revealed major CK-MB elevation as the strongest independent predictor of late mortality (odds ratio 3.3, with 95% CI 1.7 to 6.2), followed by diabetes mellitus (odds ratio 2. 6, with 95% CI 1.5 to 4.5). CONCLUSIONS: Major CK-MB elevation occurs after 15% of otherwise successful SVG interventions and is associated with increased late mortality
PMID: 10595951
ISSN: 1524-4539
CID: 147456

Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome

Mehran, R; Dangas, G; Abizaid, A S; Mintz, G S; Lansky, A J; Satler, L F; Pichard, A D; Kent, K M; Stone, G W; Leon, M B
BACKGROUND: The angiographic presentation of in-stent restenosis (ISR) may convey prognostic information on subsequent target vessel revascularizations (TLR). METHODS AND RESULTS: We developed an angiographic classification of ISR according to the geographic distribution of intimal hyperplasia in reference to the implanted stent. Pattern I includes focal (< or =10 mm in length) lesions, pattern II is ISR>10 mm within the stent, pattern III includes ISR>10 mm extending outside the stent, and pattern IV is totally occluded ISR. We classified a total of 288 ISR lesions in 245 patients and verified the angiographic accuracy of the classification by intravascular ultrasound. Pattern I was found in 42% of patients, pattern II in 21%, pattern III in 30%, and pattern IV in 7%. Previously recurrent ISR was more frequent with increasing grades of classification (9%, 20%, 34%, and 50% for classes I to IV, respectively; P=0.0001), as was diabetes (28%, 32%, 39%, and 48% in classes I to IV, respectively; P<0.01). Angioplasty and stenting were used predominantly in classes I and II, whereas classes III and IV were treated with atheroablation. Final diameter stenosis ranged between 21% and 28% (P=NS among ISR patterns). TLR increased with increasing ISR class; it was 19%, 35%, 50%, and 83% in classes I to IV, respectively (P<0.001). Multivariate analysis showed that diabetes (odds ratio, 2.8), previously recurrent ISR (odds ratio, 2. 7), and ISR class (odds ratio, 1.7) were independent predictors of TLR. CONCLUSIONS: The introduced angiographic classification is prognostically important, and it may be used for appropriate and early patient triage for clinical and investigational purposes
PMID: 10545431
ISSN: 1524-4539
CID: 147458

Preintervention arterial remodeling as an independent predictor of target-lesion revascularization after nonstent coronary intervention: an analysis of 777 lesions with intravascular ultrasound imaging

Dangas, G; Mintz, G S; Mehran, R; Lansky, A J; Kornowski, R; Pichard, A D; Satler, L F; Kent, K M; Stone, G W; Leon, M B
BACKGROUND: Pathological and intravascular ultrasound (IVUS) studies have documented arterial remodeling during atherogenesis. However, the impact of this remodeling process on the long-term outcome after percutaneous intervention is unknown. METHODS AND RESULTS: We used preintervention IVUS to define positive and negative/intermediate remodeling in a total of 777 lesions in 715 patients treated with nonstent techniques. Positive remodeling (lesion external elastic membrane area greater than average reference) was present in 313 lesions; intermediate/negative remodeling (lesion external elastic membrane area less than or equal to reference) was present in the other 464. Baseline clinical and angiographic characteristics were similar, except for a slightly higher percentage of insulin-dependent diabetic patients (10.2% versus 6.1%; P=0.054) in the negative/intermediate-remodeling group. Angiographic success and in-hospital and short-term complications were comparable in the 2 groups. There was no significant correlation between remodeling (as a continuous variable) and final lumen area (r=0.06) or final lesion plaque burden (r=0.17). At 18+/-13 months of clinical follow-up, both groups had similar rates of death and Q-wave myocardial infarction: 3.4% and 2.5% for the negative/intermediate-remodeling group versus 2.7% and 2.7% for the positive-remodeling group. However, the target-lesion revascularization (TLR) rate was 20.2% for the negative/intermediate-remodeling group versus 31.2% for the positive-remodeling group (P=0.007), and remodeling, as a continuous variable, was strongly correlated with probability of TLR (P=0.0001). By multivariable logistic regression analysis, diabetes (OR=2.3), left anterior descending artery location (OR=1.8), and remodeling (OR=5.9) were independent predictors of TLR. CONCLUSIONS: Positive lesion-site remodeling is associated with a higher long-term TLR after a nonstent interventional procedure. Thus, long-term clinical outcome appears to be determined in part by preintervention lesion characteristics
PMID: 10377078
ISSN: 1524-4539
CID: 147459