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Biomedical subjects

M B Leon

Publications and source records attributed to M B Leon.

At least 91 records · Page 5Linked to original sources

Late total occlusion after intracoronary brachytherapy for patients with in-stent restenosis.

OBJECTIVES: The study sought to determine the incidence and predictors of late total occlusion (LTO, >30 days) in-patients with in-stent restenosis who were treated with intracoronary radiation. BACKGROUND: Intracoronary radiation both with beta and gamma emitters has been shown to reduce recurrent in-stent restenosis. METHODS: We reviewed the records of 473 patients who presented with in-stent restenosis and who were enrolled in various radiation protocols, whether randomized to placebo versus radiation or entered into registries. There were 165 placebo and 308 radiated patients, including both gamma and beta emitters. Maximum dose to the vessel wall was 30 to 55 Gy. Following radiation, all patients received antiplatelet therapy with aspirin and either ticlopidine or clopidogrel for one month. All patients completed at least six months of angiographic follow-up. RESULTS: The LTO was documented in 28 patients (9.1%) from the irradiated group versus 2 placebo patients (1.2%), p < 0.0001. The LTO rates were similar across studies and emitters. In the irradiated group, LTO presented as acute myocardial infarction in 12 patients (43%), unstable angina in 14 (50%), and asymptotic in 2 (7%). Mean time to LTO was 5.4 +/- 3.2 months in the irradiated group versus 4.5 +/- 2.1 in placebo patients (p = NS). The overall rate of restenting for the entire study group at the time of radiation was 48.6%. Importantly, new stents were placed in 82% of the irradiated and in 100% of the placebo patients who presented with LTO. Multivariate analysis determined that new stenting was the main predictor of LTO. CONCLUSIONS: Intracoronary radiation for patients with in-stent restenosis is associated with a high rate of LTO. Restenting may contribute late thrombosis. Prolonged antiplatelet therapy (up to six months) should be considered for these patients.

Angioplasty, Balloon, Coronary↗

Influence of diabetes mellitus on early and late clinical outcomes in saphenous vein graft stenting.

OBJECTIVES: The purpose of this study was to compare early and late clinical outcomes in diabetic and nondiabetic patients after stent implantation in saphenous vein grafts (SVG). BACKGROUND: Patients with diabetes mellitus have less favorable acute and long-term outcomes after stent implantation in native coronary arteries. The impact of diabetes on SVG stenting, however, is not known. METHODS: We studied 908 consecutive patients (1,366 SVG lesions) treated with Palmaz-Schatz stents. In-hospital and late clinical outcomes (death, Q-wave myocardial infarction and repeat revascularization rates at one year) were compared between diabetic (n = 290) and nondiabetic (n = 618) patients. RESULTS: In-hospital mortality was significantly higher in diabetic as compared with nondiabetic patients (2.2% vs. 0.3%, p = 0.003). At one-year follow-up, target lesion revascularization (TLR) was 16.6% in diabetic and 12.3% in nondiabetic patients (p = 0.03). Overall cardiac event-free survival (freedom from death, Q-wave myocardial infarction and any coronary revascularization procedure) at one year was significantly lower in the diabetic (68%) compared with the nondiabetic patients (79%, p = 0.0003). By Cox regression analysis, diabetes mellitus was an independent predictor of both TLR (relative risk: 1.23; confidence interval: 0.96 to 1.58; p = 0.004) and late cardiac events (relative risk: 1.40; confidence interval: 1.05 to 1.86; p = 0.02). CONCLUSIONS: Patients with diabetes undergoing stent implantation in SVG have: 1) higher in-hospital and late mortality, 2) higher one-year TLR rates, and 3) significantly lower one-year cardiac event-free survival. Thus, diabetic patients have less favorable acute and late clinical outcomes after stent implantation in SVG lesions.

Aged↗

Effect of plaque debulking and stenting on short- and long-term outcomes after revascularization of chronic total occlusions.

OBJECTIVES: We evaluated the effect of plaque burden modification (debulking) on the short- and long-term clinical outcomes of patients with a totally occluded native coronary artery undergoing successful stent deployment. BACKGROUND: Although the primary success rate of crossing a chronic totally occluded coronary artery has improved with the development of new interventional devices and guidewires, the rate of acute reocclusion and restenosis remains high. METHODS: The in-hospital and late clinical outcomes of 150 patients who had undergone successful stenting of 176 chronic total occlusions were analyzed. After successful crossing of the lesion, 44 patients with 50 lesions underwent debulking by laser angioplasty, rotational or directional atherectomy followed by stenting, whereas 106 patients with 126 lesions underwent stent implantation without prior debulking. RESULTS: Baseline clinical and angiographic characteristics were similar for the two groups, except for a higher incidence of left anterior descending coronary artery location and longer lesions in the group of patients who underwent debulking prior to stenting. In-hospital mortality, myocardial infarction and repeat angioplasty rates were similar for the two groups. At a mean 14 +/- 8 months follow-up time, there were no deaths in either group, and target lesion revascularization rates were the same (16.3% in the debulking plus stent group vs. 14.4% in the stent alone group, p = NS). CONCLUSIONS: Treatment of chronic total native coronary artery occlusions with stent deployment with and without lesion modification (debulking) results in a favorable in-hospital outcome, with relatively low long-term target lesion revascularization rates.

Adult↗

Procedural results and intermediate clinical outcomes after multiple saphenous vein graft stenting.

OBJECTIVES: We evaluated the early and mid-term (18-month) clinical events in a consecutive series of patients undergoing a nonstaged multiple saphenous vein grafting (SVG) intervention with stents as compared with a single SVG stent procedure. BACKGROUND: Saphenous vein graft angioplasty has been limited by high rates of distal embolization, myocardial infarction, restenosis and late mortality. It is unknown whether stenting of multiple, different SVGs at the same setting is associated with higher risk. METHODS: We evaluated in-hospital and mid-term clinical outcomes (death, Q wave myocardial infarction [MI] and repeat revascularization rates up to 18 months) in 70 consecutive patients treated with coronary stents in 2 (93% of patients) or 3 SVGs, as compared with 649 patients undergoing stenting of a single SVG between January 1, 1994 and December 31, 1997. RESULTS: Overall procedural success was obtained in 97% of patients with 2 or 3 SVGs and 97% of patients with a single SVG (p = 0.94). Procedural complications were also similar (2.8% for multiple SVGs vs. 2.7% for a single SVG, p = 0.94). There was a higher prevalence of periprocedural non-Q wave MI (28% vs. 16%, p = 0.009) in the multiple SVG group. During follow-up (18 months), target lesion revascularization was 11% in multiple SVG and 15% in single SVG interventions (p = 0.19), and repeat revascularization (calculated per treated patient) was also similar for both groups (19% vs. 18%, p = 0.94). There was no difference in death (5.6% vs. 5.3%, p = 0.92) and Q wave MI rate (4.3% vs. 2.9%, p = 0.55) after the multiple SVG intervention. Overall cardiac event-free survival was similar for both groups (62% vs. 60%, p = 0.75). The study was powered to detect a clinically meaningful difference of 10% in mortality; smaller differences could not be evaluated on the basis of this sample size. CONCLUSIONS: Simultaneous stenting of multiple SVGs in carefully selected patients has similar in-hospital procedural success and major complications rates, as well as mid-term (18-month) clinical outcomes, as compared with single SVG stenting. Thus, multiple SVG interventions using stents may be a viable revascularization strategy for carefully selected patients and suitable lesions in multiple SVG disease.

Aged↗

Heparin infusion prior to stenting (HIPS) trial: final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia.

BACKGROUND: Local delivery of pharmacologic agents or genes at the site of angioplasty is a promising approach to reduce restenosis. However, there are unresolved questions concerning the safety and feasibility of local vascular delivery in clinical practice as well as the efficacy of delivered drug. To this end, the safety, feasibility, and efficacy of local delivery of heparin were evaluated in the Heparin Infusion Prior to Stenting (HIPS) trial. METHODS AND RESULTS: A total of 179 patients were enrolled in this multicenter, randomized, prospective, core laboratory-evaluated trial. Patients were randomly assigned to 5000 U heparin either administered to the coronary artery lumen or infused into the arterial wall immediately after angioplasty and before stent placement. End points included procedural events and clinical, angiographic, and intravascular ultrasound events at 6 months. Patient groups were evenly matched. There was no difference in the incidence of arterial injury, defined as an increase in arterial dissection, acute closure, or decrease in Thrombolysis In Myocardial Infarction grade blood flow in the group receiving local delivery. At follow-up there was no difference in the major adverse event rate between intraluminal (22.7%) and local groups (24.7%). There was no difference between intraluminal and local therapy in the angiographic in-stent restenosis rate (12.5%, 12.7%) or the in-stent volumetric analysis by intravascular ultrasound (IVUS) (37.19 +/- 20. 86 mm(3) vs 43.79 +/- 25.52 mm(3)). CONCLUSIONS: Local delivery of 5000 U heparin into the arterial wall before stent implantation is safe and feasible. There was not a favorable effect of locally delivered heparin on clinical, angiographic, or IVUS end points of restenosis. The use of IVUS to measure volume of intimal hyperplasia in a multicenter, core laboratory-controlled trial is feasible.

Blood Flow Velocity↗

Low-power laser irradiation increases cyclic GMP synthesis in penile smooth muscle cells in vitro.

OBJECTIVE: The objective of the present study was to determine the effect of low-power laser irradiation (LPLI) on cyclic guanosine monophosphate (cGMP) produced by human corpus cavernosum smooth muscle cells (HCC SMC) in vitro. BACKGROUND DATA: Numerous reports suggest that LPLI is capable of affecting cellular processes in the absence of significant thermal effect METHODS: HCC SMC cultures were irradiated with single-dose LPLI using a He-Ne continuous wave laser (632 nm) with different energy densities (0.52-2.1 J/cm2). Assessment of effect on cell viability was performed utilizing Alamar Blue assay. Effect of LPLI on cGMP production was studied by radioimmunoassay. RESULTS: We observed that: (1) LPLI of HCC SMC results in a statistically significant increase of cGMP synthesis in culture and is dose dependent (maximal effect was observed with LPLI irradiance of 1.57 J/cm2. (2) There were no changes in Normalized Viability Index (NVI) immediately after and 24 h following laser irradiation. CONCLUSION: Our studies demonstrate that LPLI irradiation stimulates elevation of cGMP in vitro.

Adult↗

Histopathologic analysis of in-stent neointimal regression in a porcine coronary model.

BACKGROUND: Animal and clinical studies have demonstrated late regression of in-stent neointima. This study was performed to identify the temporal changes in the in-stent neointimal constituents responsible for late regression. METHODS: NIR stents were implanted in porcine coronary arteries (size of stent (in mm) to size of artery (in mm) approximately equal to 1.1) and harvested at 2 months and 6 months (n = 6 stents/group). Histopathologic analyses included morphometric analysis, smooth muscle cell density, and extracellular matrix contents. RESULTS: Compared with the findings at 2 months, at 6 months there was a significant reduction in area stenosed (from 21 +/- 3% to 14 +/- 1%, P < 0.05) and neointimal thickness (from 0.2 +/- 0.03 mm to 0.03 +/- 0.02 mm, P < 0.05), despite similar injury scores (0.05 +/- 0.06 at 2 months and 0.36 +/- 0.29 at 6 months). This regression was accompanied mainly by a reduction in proteoglycan (from 24 +/- 19% to 5 +/- 8%, P = 0.05), with no change in smooth muscle cell density (71 +/- 7 compared with 76 +/- 23/high power field) or collagen content (25 +/- 19% compared with 25 +/- 19%). CONCLUSIONS: The study confirmed the regression of in-stent neointima, which was mainly attributable to a reduction in proteoglycan content, resembling the natural healing response.

Animals↗

Immediate effect of Biosense guided percutaneous direct myocardial revascularization with holmium:yttrium aluminium garnet laser on myocardial contractility assessed by transesophageal echocardiography.

OBJECTIVE: To evaluate immediate changes in left ventricular wall motion in patients treated using Biosense direct myocardial revascularization laser system. METHODS: Regional wall motion in 10 patients undergoing catheter-based direct myocardial revascularization using a holmium:yttrium aluminium garnet laser was assessed by transesophageal echocardiography before and immediately after the procedure. RESULTS: Mild deterioration in wall-motion score occurred rarely for only three of 160 (1.9%) segments and did not induce clinical heart failure. CONCLUSION: With the current catheter-based laser myocardial revascularization strategy, mild deterioration in wall motion of treated segments was rarely observed and did not effect overall left ventricular function or induce clinical congestive heart failure.

Aged↗

Preintervention lesion remodelling affects operative mechanisms of balloon optimised directional coronary atherectomy procedures: a volumetric study with three dimensional intravascular ultrasound.

AIMS: To classify atherosclerotic coronary lesions on the basis of adequate or inadequate compensatory vascular enlargement, and to examine changes in lumen, plaque, and vessel volumes during balloon optimised directional coronary atherectomy procedures in relation to the state of adaptive remodelling before the intervention. DESIGN: 29 lesion segments in 29 patients were examined with intravascular ultrasound before and after successful balloon optimised directional coronary atherectomy procedures, and a validated volumetric intravascular ultrasound analysis was performed off-line to assess the atherosclerotic lesion remodelling and changes in plaque and vessel volumes that occurred during the intervention. Based on the intravascular ultrasound data, lesions were classified according to whether there was inadequate (group I) or adequate (group II) compensatory enlargement. RESULTS: There was no significant difference in patient and lesion characteristics between groups I and II (n = 10 and 19), including lesion length and details of the intervention. Quantitative coronary angiographic data were similar for both groups. However, plaque and vessel volumes were significantly smaller in group I than in II. In group I, 9 (4)% (mean (SD)) of the plaque volume was ablated, while in group II 16 (11)% was ablated (p = 0.01). This difference was reflected in a lower lumen volume gain in group I than in group II (46 (18) mm(3) v 80 (49) mm(3) (p < 0.02)). CONCLUSIONS: Preintervention lesion remodelling has an impact on the operative mechanisms of balloon optimised directional coronary atherectomy procedures. Plaque ablation was found to be particularly low in lesions with inadequate compensatory vascular enlargement.

Adult↗

Postprocedural hypotension after carotid artery stent placement: predictors and short- and long-term clinical outcomes.

PURPOSE: To describe the predictors of persistent hypotension after carotid artery stent (CAS) placement and define the clinical outcome of patients with this hemodynamic disturbance. MATERIALS AND METHODS: One hundred forty CAS procedures were performed in 133 consecutive patients. Post-CAS hypotension-defined as a greater than 40 mm Hg decrease in arterial pressure without evidence of hypovolemia, with a systolic pressure lower than 90 mm Hg at the end of CAS and lasting at least 1 hour-was observed in 25 patients (group 1); 108 patients did not have hypotension (group 2). RESULTS: Post-CAS hypotension developed in 33.9% of cases after balloon-expandable stent placement versus in 13.6% of cases after self-expanding stent placement (P =.04). In-hospital minor ipsilateral strokes occurred in 16% of cases in group 1 versus in 3% of cases in group 2 (P =.03). There was one (0.9%) major stroke (transient) and three (2.6%) transient ischemic attacks, all of which occurred in group 2 (not significant vs group 1 for both conditions). At 10 months +/- 4 (SD) of follow-up, there was greater total mortality in group 1 than in group 2 (20% vs 4%, P =.02), whereas neurologic events did not differ significantly between the groups. CONCLUSION: Hypotension due to carotid sinus stimulation is frequent after CAS with balloon-expandable stents. This phenomenon correlates with increased in-hospital complications and long-term risk of death.

Aged↗

Safety, efficacy, and durability of carotid artery stenting for restenosis following carotid endarterectomy: a multicenter study.

PURPOSE: To present the results of a multicenter registry established to collect data on carotid stent procedures in patients with restenosis following carotid endarterectomy. METHODS: The procedural details, outcomes, and late follow-up results were collected from 14 centers in the United States. Thirty-day and late stroke and death rates were analyzed. RESULTS: Three hundred and thirty-eight patients (201 men; 71 +/- 8 years) underwent carotid stenting in 358 arteries. The average duration from carotid endarterectomy was 5.5 +/- 7.3 years. Sixty-one percent of the patients were asymptomatic. The overall 30-day stroke and death rate was 3.7%. The minor stroke rate was 1.7% (6/358), and the major nonfatal stroke rate was 0.8% (3/358). The fatal stroke rate was 0.3% (1/358), and the nonstroke-related death rate was 0.9% (3/338). There was 1 (0.3%) fatal and 1 (0.3%) nonfatal stroke during the follow-up period. The overall 3-year rate of freedom from all fatal and nonfatal strokes was 96% +/- 1% (+/- SE). CONCLUSIONS: Carotid artery stenting can be performed in patients with restenosis following carotid endarterectomy with 30-day complication rates comparable to those of most published studies on repeat carotid endarterectomy. Results of late follow-up suggest that this technique is durable and efficacious.

Aged↗

Photoactivation of vascular iNOS and elevation of cGMP in vivo: possible mechanism for photovasorelaxation and inhibition of restenosis in an atherosclerotic rabbit models.

Recently, intravascular low-power red laser light (LPRLL) therapy has been proposed for the prevention of postangioplasty restenosis due to the observed inhibition of experimental neointimal formation. The objective of this study was to determine the impact of endoluminal LPRLL on vascular levels of inducible nitric oxide synthase (iNOS) and cyclic guanosine monophosphate (cGMP) to help define the mechanism of this effect. Eight atherosclerotic male adult New Zealand White rabbits weighing 4-6 kg were used in these studies. The iliac arteries were treated in separate zones with: (1) balloon inflation only; (2) laser illumination only; and (3) balloon inflation + laser illumination. An uninjured zone of the iliac artery served as a control. Laser irradiation (630 nm) was delivered to the vessel wall via a Cold laser Illuminator (Cook, Inc., Bloomington, IN), with a 3 mm-diameter balloon. Experiments demonstrated that vascular cGMP levels obtained immediately following treatment in the balloon only group was the lowest (0.29 +/- 0.05 pmol/mg protein) and significantly lower compared with the uninjured controls (1.01 +/- 0.07 pmol/ mg protein) (P < 0.001). In the laser only treated group cGMP levels were significantly increased (2.87 +/- 0.12 pmol/mg protein) compared with the uninjured control (P < 0.001) and the balloon only group (P < 0.001). Vascular cGMP levels in the balloon + laser group (2.09 +/0.07 pmol/mg protein) was also increased compared to the balloon only (P < 0.001) and control (P < 0.001) groups. Qualitative analysis of Western blot demonstrated that laser illumination induces iNOS. In contrast balloon dilatation did not induce iNOS. Balloon + laser treatment, however, tended to restore the expression of iNOS. Our study demonstrated that intravascular low dose laser irradiation induces iNOS and elevates vascular cGMP in an in vivo atherosclerotic rabbit model.

Angioplasty, Balloon↗

Clinical outcomes following "rescue" administration of abciximab in patients undergoing percutaneous coronary angioplasty.

Pre-intervention administration of abciximab in patients at "high risk" for coronary angioplasty has been shown to reduce acute and long-term cardiac outcomes. The role of intra-procedural ("rescue") administration of abciximab has not been fully elucidated. We assessed the clinical outcomes associated with rescue administration of abciximab during complex percutaneous coronary interventions. We studied in-hospital and long-term (1-year) outcomes (death, myocardial infarction and target lesion revascularization) of 298 consecutive patients (78% male; age, 62 +/- 11 years; 83% with acute coronary syndrome) treated with abciximab for thrombus-containing lesions, sub-optimal angioplasty results, procedural dissections or other complications. Stents were used in 73% of procedures. Procedural success was 97.0% and overall major in-hospital complication rate was 3.0% (death, 1.3%; Q-wave myocardial infarction, 0.7%; and emergent bypass surgery, 1.0%). Most frequent angiographic complications included visible thrombus (17%), dissections (17%), threatened closure (7%), and distal embolization (7%). In-hospital non-Q wave myocardial infarction (defined as CK-MB 5 times normal) occurred in 31.0%. Out-of-hospital to one-year events included death (1.7%), Q-wave myocardial infarction (2.7%), and target lesion revascularization (15.1%); cardiac event-free survival was 82.9%. We conclude that rescue administration of abciximab is associated with relatively low in-hospital complications and favorable long-term outcome in patients with sub-optimal angioplasty results and/or procedure-related complications, although peri-procedural non-Q wave myocardial infarction rate is high. A clinical and cost-effective comparison between provisional and rescue administration of abciximab may be warranted.

Abciximab↗

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.

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.

Aged↗

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

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.

Aged↗

Acute and long-term results of an intravascular ultrasound-guided percutaneous transluminal coronary angioplasty/provisional stent implantation strategy.

Two hundred eighty-four consecutive patients with 438 native coronary artery stenoses were enrolled prospectively in a study of intravascular ultrasound (IVUS)-guided provisional percutaneous transluminal coronary angioplasty (PTCA): (1) IVUS-guided, aggressive lesion-site media-to-media balloon sizing, (2) IVUS assessment of residual lumen dimensions to identify optimal PTCA results (minimum lumen area > or =65% of the average of the proximal and distal reference lumen areas or > or =6.0 mm2 and no major dissection), and (3) liberal stent crossover. Overall, 206 stenoses in 134 patients were treated with PTCA alone. Reasons for crossover were flow-limiting or lumen compromising dissections in 28% of patients or a suboptimal IVUS minimum lumen area in 72% of patients. Sixty-three stenoses (27%) were treated with Gianturco-Roubin stents and 169 (73%) with Palmaz-Schatz stents. The clinical success rate and major in-hospital complication rates were similar in the optimal PTCA and stent crossover groups. At 1 year, 42 patients (15%) with 53 stenoses (12%) underwent revascularization: 8% of stenoses in the PTCA group and 16% in the stent crossover group. In approximately half of the patients treated using an IVUS guided aggressive PTCA strategy, stent implantation could be avoided without sacrificing an increase in acute complications or late clinical outcome. This provides an alternative strategy for interventionalists less inclined to use routine elective stenting.

Angioplasty, Balloon, Coronary↗

Cardiac troponin I levels and clinical outcomes in patients with acute coronary syndromes: the potential role of early percutaneous revascularization.

OBJECTIVES: To establish the role of early catheter-based coronary intervention among patients sustaining acute coronary syndromes (ACS) stratified according to admission plasma troponin I (Tn-I) levels. BACKGROUND: The impact of early revascularization strategy on the clinical outcomes in patients with ACS stratified by plasma Tn-I levels has not been established. METHODS: In-hospital complications and long-term outcomes were assessed in 1,321 consecutive patients with non-ST elevation ACS undergoing early (within 72 h) catheter-based coronary interventions. Patients were grouped according to admission Tn-I levels. Group I (n = 1,099) had no elevated plasma Tn-I (<0.15 ng/ml), Group II (n = 95) had Tn-I level between 0.15 to 0.45 ng/ml and Group III (n = 127) had Tn-I >0.45 ng/ml. In-hospital composite cardiac events (death, Q-wave MI, urgent in-hospital revascularization) and 8 months clinical outcomes (death, MI, repeat revascularization or any cardiac event) were compared between the three groups. RESULTS: The rate of in-hospital composite cardiac events was 6.1% among patients with Tn-I >0.45 ng/ml, 1.0% in patients with Tn-I between 0.15-0.45 ng/ml and 3.1% in patients without elevated admission Tn-I (p = 0.09 between groups). There was no difference in hospital mortality (p = 0.25). At eight months of follow-up, there was no difference in out-of-hospital death (3.5%, 3.8% and 1.8%, p = 0.17, respectively), MI (2.6%, 3.8% and 2.9%, p = 0.94) or target lesion revascularization (9.0%, 8.3% and 11.5%, p = 0.47), and cardiac event-free survival was also similar between groups (p = 0.66). By multivariate analysis, Tn-I >0.45 ng/ml was independently associated with in-hospital composite cardiac events [odds ratio (OR) = 2.4, p = 0.04] but not with out-of-hospital clinical events up to eight months. CONCLUSIONS: In patients with ACS, early (within 72 h) catheter-based coronary intervention may attenuate the adverse prognostic impact of admission Tn-I elevation during eight months of follow-up despite a trend towards increased in-hospital composite cardiac events.

Aged↗

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

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.

Angioplasty, Balloon, Coronary↗