Differential impact on survival of electrocardiographic Q-wave versus enzymatic myocardial infarction after percutaneous intervention: a device-specific analysis of 7147 patients.

BACKGROUND: The relative prognostic importance of ECG myocardial infarction (MI) after intervention compared with varying degrees of enzymatic elevation has not been characterized, and the device-specific implications of periprocedural MI are also unknown. METHODS AND RESULTS: Serial creatine phosphokinase (CPK)-MB levels were determined after elective percutaneous intervention of 12 098 lesions in 7147 consecutive patients at a tertiary referral center. Procedural, in-hospital, and follow-up data were collected by independent research nurses, and clinical and ECG events were adjudicated by a separate committee. Stents were implanted in 50.6% of lesions, atheroablation was performed in 54.8%, and PTCA alone was performed in 9.8%. The peak periprocedural CPK-MB level was >3x the upper limit of normal (ULN) in 17.9% of patients, and Q-wave MI developed in 0.6%. By multivariate analysis, the periprocedural development of new Q waves was the most powerful independent determinant of death (2-year mortality rate, 38.3%; hazard ratio, 9.9; P<0.0001). Non-Q-wave MI with CPK-MB >8x ULN was also a strong predictor of death (2-year mortality rate, 16.3%; hazard ratio, 2.2; P<0.0001); survival was unaffected by lesser degrees of CPK-MB elevation. Though CPK-MB elevation was more common after atheroablation and stenting than PTCA, the rates of Q-wave MI and survival were device-independent. CONCLUSIONS: Myonecrosis after percutaneous intervention is common in a high-risk referral population dominated by atheroablation and stent use. Large periprocedural infarctions (signified by new Q waves and CPK-MB >8xULN) are powerful determinants of death, whereas lesser degrees of CPK-MB release and specific device use do not adversely affect survival.

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.

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

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.

Normal flow (TIMI-3) before mechanical reperfusion therapy is an independent determinant of survival in acute myocardial infarction: analysis from the primary angioplasty in myocardial infarction trials.

BACKGROUND: Whereas survival after lytic therapy for myocardial infarction is strongly dependent on early administration, it is unknown whether the otherwise excellent outcomes in patients undergoing primary PTCA for acute myocardial infarction, in whom TIMI-3 flow rates of >90% may be achieved, can be further improved by early reperfusion. METHODS AND RESULTS: Among 2507 patients enrolled in 4 PAMI trials undergoing primary PTCA, spontaneous reperfusion (TIMI-3 flow) was present in 16% at initial angiography. Compared with patients without TIMI-3 flow, those with TIMI-3 flow before PTCA had greater left ventricular ejection fraction (57+/-10% versus 53+/-11%, P=0.003) and were less likely to present in heart failure (7.0% versus 11.6%, P=0.009). Patients with initial TIMI-3 flow had significantly lower in-hospital rates of mortality, new-onset heart failure, and hypotension and had a shorter hospital stay. Cumulative 6-month mortality was 0.5% in patients with initial TIMI-3 flow, 2.8% with TIMI-2 flow, and 4.4% with initial TIMI-0/1 flow (P=0.009). By multivariate analysis, TIMI-3 flow before PTCA was an independent determinant of survival (odds ratio 2.1, P=0.04), even when corrected for by postprocedural TIMI-3 flow. CONCLUSIONS: Patients undergoing primary PTCA in whom TIMI-3 flow is present before angioplasty present with greater clinical and angiographic evidence of myocardial salvage, are less likely to develop complications related to left ventricular failure, and have improved early and late survival. These data warrant prospective randomized trials of pharmacological strategies to promote early reperfusion before definitive mechanical intervention in acute myocardial infarction.

Cost-effectiveness of coronary stenting in acute myocardial infarction: results from the stent primary angioplasty in myocardial infarction (stent-PAMI) trial.

BACKGROUND: Although several randomized trials have demonstrated that coronary stenting improves angiographic and clinical outcomes for patients with acute myocardial infarction (AMI), the cost-effectiveness of this practice is unknown. The objective of the present study was to evaluate the long-term costs and cost-effectiveness (C/E) of coronary stenting compared with primary balloon angioplasty as treatment for AMI. Methods and Results- Between December 1996 and November 1997, 900 patients with AMI were randomized to undergo balloon angioplasty (PTCA, n=448) or coronary stenting (n=452). Detailed resource utilization and cost data were collected for each patient's initial hospitalization and for 1 year after randomization. Compared with conventional PTCA, stenting increased procedural costs by approximately $2000 per patient ($6538+/-1778 versus $4561+/-1598, P<0.001). During the 1-year follow-up period, stenting was associated with significant reductions in the need for repeat revascularization and rehospitalization. Although follow-up costs were significantly lower with stenting ($3613+/-7743 versus $4592+/-8198, P=0.03), overall 1-year costs remained approximately $1000/patient higher with stenting than with PTCA ($20 571+/-10 693 versus 19 595+/-10 990, P=0.02). The C/E ratio for stenting compared with PTCA was $10 550 per repeat revascularization avoided. In analyses that incorporated recent changes in stent technology and pricing, the 1-year cost differential fell to <$350/patient, and the C/E ratio improved to $3753 per repeat revascularization avoided. The cost-utility ratio for primary stenting was <$50 000 per quality-adjusted life year gained only if stenting did not increase 1-year mortality by >0.2% compared with PTCA. CONCLUSIONS: As performed in Stent-PAMI, primary stenting for AMI increased 1-year medical care costs compared with primary PTCA. The overall cost-effectiveness of primary stenting depends on the societal value attributed to avoidance of symptomatic restenosis, as well as on the relative mortality rates of primary PTCA and stenting.

Treatment of in-stent restenosis with excimer laser coronary angioplasty versus rotational atherectomy: comparative mechanisms and results.

BACKGROUND: Atheroablation yields improved clinical results for balloon angioplasty (percutaneous transluminal coronary angioplasty, PTCA) in the treatment of diffuse in-stent restenosis (ISR). METHODS AND RESULTS: We compared the mechanisms and clinical results of excimer laser coronary angioplasty (ELCA) versus rotational atherectomy (RA), both followed by adjunct PTCA; 119 patients (158 ISR lesions) were treated with ELCA+PTCA and 130 patients (161 ISR lesions) were treated with RA+PTCA. Quantitative coronary angiographic and planar intravascular ultrasound (IVUS) measurements were performed routinely. In addition, volumetric IVUS analysis to compare the mechanisms of lumen enlargement was performed in 28 patients with 30 lesions (16 ELCA+PTCA, 14 RA+PTCA). There were no significant between-group differences in preintervention or final postintervention quantitative coronary angiographic or planar IVUS measurements of luminal dimensions. Angiographic success and major in-hospital complications with the 2 techniques were also similar. Volumetric IVUS analysis showed significantly greater reduction in intimal hyperplasia volume after RA than after ELCA (43+/-14 versus 19+/-10 mm(3), P<0.001) because of a significantly higher ablation efficiency (90+/-10% versus 76+/-12%, P = 0.004). However, both interventional strategies had similar long-term clinical outcome; 1-year target lesion revascularization rate was 26% with ELCA+PTCA versus 28% with RA+PTCA (P = NS). CONCLUSIONS: Despite certain differences in the mechanisms of lumen enlargement, both ELCA+PTCA and RA+PTCA can be used to treat diffuse ISR with similar clinical results.

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.

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.

Implications of recurrent ischemia after reperfusion therapy in acute myocardial infarction: a comparison of thrombolytic therapy and primary angioplasty.

OBJECTIVES: The purpose of this study was to examine the incidence and implications of recurrent ischemia after different reperfusion strategies in acute myocardial infarction. BACKGROUND: The rates and effects of recurrent ischemia after reperfusion with thrombolytic therapy and with primary percutaneous transluminal coronary angioplasty have not been compared. METHODS: At 12 centers 395 patients presenting within 12 h of the onset of acute myocardial infarction were prospectively randomized to receive recombinant tissue-type plasminogen activator (rt-PA) or primary coronary angioplasty. Sixteen clinical variables were examined by using univariate and multiple logistic regression analysis to identify the predictors of recurrent ischemia. The relation of recurrent ischemic events to patient outcome was analyzed. RESULTS: Recurrent ischemia developed in 76 patients (19.2%) before hospital discharge, resulting in reinfarction in 18 patients (4.6%) and death in 5 (2.6%). Recurrent ischemia occurred in 56 patients (28.0%) after rt-PA but in only 20 patients (10.3%) after coronary angioplasty (p < 0.0001), directly contributing to a higher rate of death or reinfarction (7.5% vs. 3.1%, p = 0.05), catheterization and revascularization procedures and prolonged hospital stay after thrombolysis. By multivariate analysis, treatment with coronary angioplasty rather than rt-PA was the strongest predictor of freedom from recurrent ischemia. Although the incidence of recurrent ischemia after angioplasty and after rt-PA was similar within the 1st 2 days of admission (9.2% vs. 14.5%, p = 0.11), after hospital day 2 recurrent ischemia occurred in only 2 patients who received primary angioplasty compared with 27 patients who received rt-PA (1.1% vs. 13.5%, p < 0.0001). CONCLUSIONS: The development of recurrent ischemia adversely affects patient outcome, increasing morbidity, mortality and resource utilization. The much lower rate of recurrent ischemia after primary coronary angioplasty than after rt-PA results in improved survival without reinfarction and allows a shorter, less complicated hospital stay. Given the extremely low rate of recurrent ischemia after hospital day 2, safe early discharge on day 3 after primary coronary angioplasty should be feasible in selected patients with acute myocardial infarction.

Predictors of in-hospital and 6-month outcome after acute myocardial infarction in the reperfusion era: the Primary Angioplasty in Myocardial Infarction (PAMI) trail.

OBJECTIVES: This study examined the predictors of in-hospital and 6-month outcome after different reperfusion strategies in acute myocardial infarction. BACKGROUND: Thrombolytic therapy and primary angioplasty are both widely applied as reperfusion modalities in patients with myocardial infarction. Although it is accepted that restoration of early patency of the infarct-related artery can reduce mortality and salvage myocardium, the optimal reperfusion strategy remains controversial, and the predictors of outcome in the reperfusion era have been incompletely characterized. METHODS: At 12 centers, 395 patients presenting within 12 h of onset of acute transmural myocardial infarction were prospectively randomized to receive tissue-type plasminogen activator (t-PA) or undergo primary angioplasty without antecedent thrombolysis. Sixteen clinical variables were examined with univariate and multiple logistic regression analysis to identify the predictors of clinical outcome. RESULTS: By univariate analysis, in-hospital mortality was increased in the elderly, women, patients with diabetes and in patients treated with t-PA as opposed to angioplasty. Only advanced age and treatment by t-PA versus angioplasty independently correlated with increased in-hospital mortality (6.5% vs. 2.6%, respectively, p = 0.039 by multiple logistic regression analysis). Similarly, the only variables independently related to in-hospital death or nonfatal reinfarction were advanced age and treatment by t-PA versus angioplasty (12.0% vs. 5.1%, p = 0.02). The reduction in in-hospital death or reinfarction with angioplasty versus t-PA was particularly marked in patients > or = 65 years of age (8.6% vs. 20.0%, p = 0.048). Furthermore, primary management with angioplasty versus t-PA was the most powerful multivariate correlate of freedom from recurrent ischemic events (10.3% vs. 28.0%, p = 0.0001). The independent beneficial effect of angioplasty on freedom from death or reinfarction was maintained at 6-month follow-up (8.2% vs. 17.0%, p = 0.02). CONCLUSIONS: In the reperfusion era, the two most powerful determinants of freedom from death, reinfarction and recurrent ischemia after myocardial infarction are young age and treatment by primary angioplasty.

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.

Clinical and angiographic outcomes in patients with previous coronary artery bypass graft surgery treated with primary balloon angioplasty for acute myocardial infarction. Second Primary Angioplasty in Myocardial Infarction Trial (PAMI-2) Investigators.

OBJECTIVES: We sought to characterize the presenting characteristics of patients with previous coronary artery bypass graft surgery (CABG) and acute myocardial infarction (AMI) and to determine the angiographic success rate and clinical outcomes of a primary percutaneous transluminal coronary angioplasty (PTCA) strategy. BACKGROUND: Patients who have had previous CABG and AMI comprise a high risk group with decreased reperfusion success and increased mortality after thrombolytic therapy. Little is known about the efficacy of primary PTCA in AMI. METHODS: Early cardiac catheterization was performed in 1,100 patients within 12 h of onset of AMI at 34 centers in the prospective, controlled Second Primary Angioplasty in Myocardial Infarction trial (PAMI-2), followed by primary PTCA when appropriate. Data were collected by independent study monitors, end points were adjudicated and films were read at an independent core laboratory. RESULTS: Of 1,100 patients with AMI, 58 (5.3%) had undergone previous CABG. The infarct-related vessel in these patients was a bypass graft in 32 patients (55%) and a native coronary artery in 26 patients. Compared with patients without previous CABG, patients with previous CABG were older and more frequently had a previous myocardial infarction and triple-vessel disease. Coronary angioplasty was less likely to be performed when the infarct-related vessel was a bypass graft rather than a native coronary artery (71.9% vs. 89.8%, p = 0.001); Thrombolysis in Myocardial Infarction trial (TIMI) flow grade 3 was less frequently achieved (70.2% vs. 94.3%, p < 0.0001); and in-hospital mortality was increased (9.4% vs. 2.6%, p = 0.02). As a result, mortality at six months was 14.3% versus 4.1% in patients with versus without previous CABG (p = 0.001). By multivariate analysis, independent determinants of late mortality in the entire study group were advanced age, triple-vessel disease, Killip class and post-PTCA TIMI flow grade <3. CONCLUSIONS: Reperfusion success of a primary PTCA strategy in patients with previous CABG, although favorable with respect to historic control studies, is reduced as compared with that in patients without previous CABG. New approaches are required to treat patients with previous CABG and AMI, especially when the infarct-related vessel is a diseased saphenous vein graft.

Prospective, randomized, multicenter comparison of laser-facilitated balloon angioplasty versus stand-alone balloon angioplasty in patients with obstructive coronary artery disease. The Laser Angioplasty Versus Angioplasty (LAVA) Trial Investigators.

OBJECTIVES: The goal of this study was to examine the relative safety and efficacy of laser-facilitated percutaneous transluminal coronary angioplasty (PTCA) versus "stand-alone" PTCA. BACKGROUND: Plaque debulking with lasing before PTCA may result in improved lumen dimensions and decreased rates of periprocedural ischemic complications, thus improving short- and long-term outcomes after percutaneous intervention. The mid-infrared holmium:yttrium-aluminum-garnet (YAG) laser has been shown to be effective in a variety of plaque subtypes and may be particularly useful in high risk acute ischemic syndromes. METHODS: A total of 215 patients (mean [+/-SD] age 61 +/- 12 years) with 244 lesions were prospectively randomized at 14 clinical centers to laser versus stand-alone PTCA. After laser treatment, all patients underwent PTCA; 148 patients (69%) had unstable angina. RESULTS: The procedural success rate without major catheterization laboratory complications was similar in patients assigned to laser treatment or PTCA alone (96.6% vs. 96.9%, p = 0.88), as was the in-hospital clinical success rate (89.7% vs. 93.9%, p = 0.27). There was no difference in postprocedural diameter stenosis after laser treatment compared with PTCA (18.3% +/- 13.6% vs. 19.5% +/- 15.1%, p = 0.50). However, use of the laser, versus PTCA alone, did result in significantly more major and minor procedural complications (18.0% vs. 3.1%, p = 0.0004), myocardial infarctions (4.3% vs. 0%, p = 0.04) and total in-hospital major adverse events (103% vs. 4.1%, p = 0.08). At a mean follow-up time of 11.2 +/- 7.7 months, there were no differences in late or event-free survival in patients assigned to laser treatment versus PTCA alone. CONCLUSIONS: Compared with stand-alone PTCA, laser-facilitated PTCA results in a more complicated hospital course, without immediate or long-term benefits.

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.

Procedural outcome of angioplasty for total coronary artery occlusion: an analysis of 971 lesions in 905 patients.

This study analyzes the results of angioplasty in 905 consecutive patients with 971 total occlusions. The procedures were performed by five cardiologists from January 1980 to January 1989 at one institution. The overall success rate per lesion was 72%. Even the most experienced operator (524 occlusions attempted) has continued to improve on a learning curve, with 83% of his most recent 100 occlusions successfully dilated. Procedural death occurred in seven patients (0.8%), five patients (0.6%) sustained a myocardial infarction and seven patients (0.8%) required urgent coronary bypass surgery. Complications were significantly more likely to occur in the elderly, in women and in patients with triple vessel disease and depressed left ventricular function. Compared with angioplasty in 6,950 patients with nonoccluded stenoses, angioplasty of total occlusions had a lower success rate (72% versus 96%, p = 0.001), although the complication rate was also lower (1.9% versus 3.5%, p = 0.01). Multivariate analysis of 20 clinical and angiographic variables in 100 consecutive patients undergoing angioplasty of 104 total occlusions in 1988 identified only bridging collateral vessels (85% success rate if absent versus 18% if present, p less than 0.001) and a tapered occlusion morphology (88% success rate if present versus 59% if absent, p = 0.01) as independent correlates of procedural outcome. Other variables, including the estimated duration of occlusion, lesion length and location, and extent of disease were unrelated to technical success. With present techniques and sufficient operator experience, 70% to 80% of total occlusions can be successfully recanalized by coronary angioplasty with a complication rate of less than 2%.(ABSTRACT TRUNCATED AT 250 WORDS)

Direct coronary angioplasty in acute myocardial infarction: outcome in patients with single vessel disease.

Percutaneous transluminal coronary angioplasty was performed as primary therapy in 215 consecutive patients (aged 56 +/- 11 years, 75% male) with acute myocardial infarction and single vessel coronary artery disease. Wide patency of the infarct-related artery was restored in 212 patients (99%). Complications consisted of one urgent coronary bypass operation (0.5%); there were no procedural deaths. A recurrent ischemic event before discharge occurred in eight patients (4%). The in-hospital mortality rate was 1%; five of six patients presenting with cardiogenic shock were alive at discharge. In 126 patients in whom predischarge angiography was performed, the ejection fraction improved from 55 +/- 12% to 61 +/- 12% (p less than 0.005) and increased by greater than or equal to 5% units in 66 patients (52%). Regional wall motion improved in 60 patients (48%). By multivariate analysis, a depressed initial ejection fraction, a limited increase in serum creatine kinase, young age and sustained patency of the infarct-related artery were found to be independent predictors of improvement in left ventricular function. Follow-up data were available in 214 patients (99.5%) at a mean interval of 35 months. The actuarial 3 year cardiac survival rate was 92%. By multivariate analysis, only the baseline ejection fraction correlated with long-term cardiac survival. Nine patients (4%) sustained a late nonfatal myocardial infarction, and 11 patients (5%) underwent subsequent coronary bypass surgery. At late follow-up study, 149 (77%) of 194 patients alive were free of angina. In summary, in patients with acute myocardial infarction and single vessel disease, coronary angioplasty without prior thrombolytic therapy can be performed with a high success rate and few procedural complications. After direct angioplasty, regional wall motion and global ejection fraction improve in 50% of patients, especially in those with depressed initial left ventricular function. This approach results in an excellent early and late event-free survival.

Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices.

OBJECTIVES: We evaluated the vascular complications after hemostasis with arteriotomy closure devices (ACD) versus manual compression after percutaneous coronary interventions (PCI). BACKGROUND: Previous clinical studies have indicated that ACD can be used for achievement of hemostasis and early ambulation after PCI. This study investigated the safety of ACD in achieving hemostasis after PCI compared with manual compression in a large cohort of consecutive patients. METHODS: A total of 5,093 patients were followed after PCI was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with ACD (n = 516) or with manual compression (n = 5,892) as a hemostasis option after sheath removal. RESULTS: The use of ACD was associated with a more frequent occurrence of hematoma compared with manual compression (9.3 vs. 5.1%, p < 0.001). There was also a higher rate of significant hematocrit drop (>15%) with ACD versus manual compression (5.2% vs. 2.5%, p < 0.001). Similar rates of pseudoaneurysm and arteriovenous fistulae were noted with either hemostasis technique. Vascular surgical repair at the access site was required more often with ACD versus manual compression (2.5 vs. 1.5%, p = 0.03). CONCLUSIONS: In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

Are we making progress with percutaneous saphenous vein graft treatment? A comparison of 1990 to 1994 and 1995 to 1998 results.

OBJECTIVES: We sought to determine whether strategies to reduce procedural distal embolization and late repeat revascularization have resulted in more favorable outcomes after saphenous vein graft (SVG) angioplasty. BACKGROUND: Angioplasty of SVG lesions has been associated with frequent procedural and late cardiac events. Therefore, evolving strategies have been attempted to improve outcomes after SVG angioplasty. METHODS: We compared our earlier experience (1990 to 1994) of 1,055 patients with 1,412 SVG lesions with a recent group (1995 to 1998) of 964 patients with 1,315 lesions. RESULTS: Baseline characteristics were similar between the groups. However, there were significantly more unfavorable lesion characteristics (older, longer and significantly more degenerated SVGs) in the recent series. Between the two periods, there was decreased use ofatheroablative devices, whereas stent use increased. The procedural success rates (96.6% vs. 96.1%) were similar. However, one-year outcome (event-free survival) was significantly improved in the more recent experience (70.7% vs. 59.1%, p < 0.0001), especially late mortality (6.1% vs. 11.3%, p < 0.0001). Multivariate analysis showed stent use to be the only protective variable for both periods. CONCLUSIONS: This study shows that despite higher risk lesions, strategies to reduce distal embolization have maintained high procedural success. Late cardiac events, including mortality, have also been substantially reduced.

Quality of life after balloon angioplasty or stenting for acute myocardial infarction. One-year results from the Stent-PAMI trial.

OBJECTIVES: The goal of this study was to compare the impact of primary stenting or percutaneous transluminal coronary angioplasty (PTCA) on health-related quality of life (HRQOL) in patients undergoing direct angioplasty for acute myocardial infarction (AMI). BACKGROUND: Previous studies have demonstrated that coronary stenting reduces clinical and angiographic restenosis compared with PTCA. However, the impact of stenting on HRQOL from the patient's perspective remains unknown. METHODS: We administered the Seattle Angina Questionnaire and the Medical Outcomes Study Short-form Survey at 1, 6 and 12 months after initial treatment to all North American patients in the Stent-Primary Angioplasty for Myocardial Infarction trial (Stent-PAMI) (n = 509)-a randomized trial comparing primary stenting to conventional PTCA for patients with AMI. RESULTS: At one month, most HRQOL measures were similar for the two groups, but stent patients reported less bodily pain than PTCA patients (p = 0.03). At six-month follow-up, stenting resulted in significant improvements in several dimensions of HRQOL including reduced anginal frequency and bodily pain as well as improved disease perception (all p < or = 0.03) and a trend towards better anginal stability (p = 0.056). By 12-month follow-up, however, none of these differences remained statistically significant. These differences in HRQOL were largely explained by the greater need for ischemia-driven target-vessel repeat revascularization procedures in PTCA patients during the first six months (16.0% vs. 6.2%, p < 0.001). CONCLUSIONS: In patients undergoing revascularization for AMI, initial stent placement is associated with improvements in several dimensions of health status during the first six months of follow-up. In the absence of differences in mortality, these findings add to the overall argument in favor of initial stenting in patients treated with mechanical reperfusion for myocardial infarction.

The current practice of intra-aortic balloon counterpulsation: results from the Benchmark Registry.

OBJECTIVES: This study presents clinical data from the first large registry of aortic counterpulsation, a computerized database that incorporates prospectively gathered data on indications for intra-aortic balloon counterpulsation (IABP) use, patient demographics, concomitant medication and in-hospital outcomes and complications. BACKGROUND: The intra-aortic balloon pump (IABP) is widely used to provide circulatory support for patients experiencing hemodynamic instability due to myocardial infarction, cardiogenic shock, or in very high risk patients undergoing angioplasty or coronary artery bypass grafting. METHODS: Between June 1996 and August 2000, 203 hospitals worldwide (90% U.S., 10% non-U.S.) collected 16,909 patient case records (68.8% men, 31.2% women; mean age 65.9 +/- 11.7 years). RESULTS: The most frequent indications for use of IABP were as follows: to provide hemodynamic support during or after cardiac catheterization (20.6%), cardiogenic shock (18.8%), weaning from cardiopulmonary bypass (16.1%), preoperative use in high risk patients (13.0%) and refractory unstable angina (12.3%). Major IABP complications (major limb ischemia, severe bleeding, balloon leak, death directly due to IABP insertion or failure) occurred in 2.6% of cases; in-hospital mortality was 21.2% (11.6% with the balloon in place). Female gender, high age and peripheral vascular disease were independent predictors of a serious complication. CONCLUSIONS: This registry provides a useful tool for monitoring the evolving practice of IABP. In the modern-day practice of IABP, complication rates are generally low, although in-hospital mortality remains high. There is an increased risk of major complications in women, older patients and patients with peripheral vascular disease.