Effect of alpha-tocopherol on restenosis after angioplasty in a model of experimental atherosclerosis.

The ability of alpha-tocopherol to reduce restenosis after angioplasty was tested in a rabbit model in which angioplasty was performed on established atherosclerotic lesions. Lesions induced by 4 wk of cholesterol feeding after focal desiccation of femoral arteries were balloon dilated. 3 wk after angioplasty, angiographically determined minimum luminal diameters were less in the untreated group (0.80 +/- 0.51 mm) than in the group treated with oral alpha-tocopherol beginning 19 d before angioplasty (1.38 +/- 0.29 mm; P < 0.01). The cross-sectional area of the intima-media was greater in the untreated group (1.18 +/- 0.48 mm2) than in the alpha-tocopherol group (0.62 +/- 0.25 mm2, P < 0.0001). These differences were not due to vasoconstriction or altered plasma cholesterol. Alpha-tocopherol thus reduced restenosis after angioplasty in this model. In rabbit vascular smooth muscle cells, oxidized low density lipoprotein stimulated DNA synthesis. Alpha-tocopherol treatment inhibited DNA synthesis stimulated by oxidized low density lipoprotein, but not by serum. The findings are consistent with the hypothesis that oxidized lipids can stimulate hyperplasia and that antioxidants may limit hyperplasia by inhibiting either the oxidation or the proliferative effects of oxidants on cells.

Relation between lesion characteristics and risk with percutaneous intervention in the stent and glycoprotein IIb/IIIa era: An analysis of results from 10,907 lesions and proposal for new classification scheme.

BACKGROUND: The currently used American College of Cardiology/American Heart Association lesion classification scheme dates from an era when balloon angioplasty was the only percutaneous treatment available and major complications occurred in approximately 7% of patients. Major advances in treatment options would suggest that this scheme may be outmoded, but the schemes that have been suggested to update lesion classification have not been widely accepted. METHODS AND RESULTS: Four thousand one hundred eighty-one consecutive patients (6,676 lesions) formed a training set and 2,146 patients (4,231 lesions) formed a validation set treated from 1995 to 1997 at a single center used by 3 hospital groups. Twenty-seven pretreatment candidate variables were analyzed with the use of stepwise proportional logistic regression, and 9 (nonchronic total occlusion with TIMI flow 0, degenerated vein graft, vein graft age >10 years, lesion length >/= 10 mm, severe calcium, lesion irregularity, large filling defect, angulated >/= 45 degrees plus calcium, and eccentricity) were independently correlated (P<0.05) with ranked adverse outcome (death, Q-wave or creatine kinase >/= 3x normal myocardial infarction, or emergency coronary artery bypass grafting>>creatine kinase 2 to 3x myocardial infarction>>possibly related to non-Q-wave myocardial infarction>>no complication). A scheme based on these findings and the old American College of Cardiology/American Heart Association scheme were found to have c-statistics in the validation set of 0.672 and 0.620 (P = 0.010 vs old scheme), respectively. CONCLUSIONS: Appreciation of these contemporary risk factors for complications of coronary intervention may assist in patient selection and in risk adjustment for comparison of outcomes between providers.

beta-blockers before percutaneous coronary intervention do not attenuate postprocedural creatine kinase isoenzyme rise.

BACKGROUND: beta-blocker (BB) use reduces infarct size in spontaneously occurring nonreperfused infarcts but probably does not change infarct size in patients treated with reperfusion therapy. A recent observational study suggested that BB use concurrent with percutaneous coronary intervention (PCI) decreased the risk of creatine kinase (CK)-MB elevation. The cogency of such a conclusion is dependent on the ability to risk-adjust for the multiple differences in patients treated with and without BBs. METHODS AND RESULTS: Using propensity score and multivariate regression analyses, 6200 consecutive patients were analyzed to assess the relationship between BB use before PCI and per protocol-measured CK and CK-MB rise. There were several highly significant (P<0.001) differences between patients with and without BB treatment (eg, age, prior infarction, unstable angina). Maximum CK and CK-MB levels were higher in patients taking BBs (CK median, 95 U [interquartile range: 61, 175]; CK-MB, 3 U [2, 5]) than in patients not taking BBs (CK, 91 U [60, 157]; CK-MB, 3 U [2, 4]) (P=0.011 and P=0.021 for CK and CK-MB, respectively). After adjustment for significant differences in baseline characteristics there was no difference in either maximum CK rise (P=0.21) or maximum CK-MB rise (P=0.99). CONCLUSIONS: The results of this large observation study do not support the contention that BB use before PCI decreases myocardial injury.

Long-term clinical outcomes after unprotected left main trunk percutaneous revascularization in 279 patients.

BACKGROUND: Percutaneous coronary revascularization (PCI) has been increasingly applied to unprotected left main trunk (LMT) lesions, with varied long-term success. This study attempts to define the predictors of outcome in this population. METHODS AND RESULTS: Two hundred seventy-nine consecutive patients who had LMT PCI at 1 of 25 sites between 1993 and 1998 were studied. Forty-six percent of these patients were deemed inoperable or at high surgical risk. Thirty-eight patients (13.7%) died in hospital, and the rest were followed up for a mean of 19 months. The 1-year incidence was 24.2% for all-cause mortality, 20.2% for cardiac mortality, 9.8% for myocardial infarction, and 9.4% for CABG. Independent correlates of all-cause mortality were left ventricular ejection fraction /=2.0 mg/dL, and severe lesion calcification. For the 32% of patients <65 years old with left ventricular ejection fraction >30% and without shock, the prevalence of these adverse risk factors was low. No periprocedural deaths were observed in this low-risk subset, and the 1-year mortality was only 3.4%. CONCLUSIONS: Patients undergoing unprotected LMT PCI have frequent serious comorbidities and consequently have high event rates. PCI may be an alternative to CABG for a select proportion of elective patients and may also be appropriate for highly symptomatic inoperable patients. Meticulous follow-up of hospital survivors is required because of the rather high mortality during the first few months after treatment.

Transluminal atherectomy for occlusive peripheral vascular disease.

The failure of balloon angioplasty to provide a durable result has led to the development of other methods of catheter-associated interventional therapy. In this study, 112 patients with superficial femoral artery stenosis or occlusion were treated with percutaneous atherectomy. Patients were considered to have a simple lesion if the occluded or stenotic arterial segment was less than 5 cm, and a complex lesion if the length of the occluded segment was greater than 5 cm. All atherectomies were performed in the superficial femoral and popliteal arteries; urokinase thrombolysis was used in conjunction with atherectomy in 16 patients. Atherectomy was considered successful if there was less than 20% residual stenosis determined by arteriography. Initial atherectomy results (30 day patency) were 100% successful in the group with a simple lesion and 93% successful in the group with a complex lesion. At a mean follow-up period of 12 months (range 5 to 24), there was a continued patency rate of 93% and 86%, respectively, in the simple and complex groups. In the patients who had restenosis, all pathologic specimens obtained during the second procedure demonstrated myointimal hyperplasia and organized thrombus. Eight major complications (7.1%) occurred, including one fatal myocardial infarction. The complication rate was 3.5% in the simple group and 8.3% in the complex group. With the exception of the myocardial infarction, all complications were associated with catheter entry site hematomas. Femoropopliteal atherectomy has a high rate of success and low morbidity and mortality for both simple and complex lesions and is a viable and competitive alternative therapy for patients with severe peripheral vascular disease.(ABSTRACT TRUNCATED AT 250 WORDS)

Percutaneous transluminal angioplasty of saphenous vein graft stenosis: long-term follow-up.

Percutaneous transluminal angioplasty was used to treat 101 patients with saphenous vein bypass graft stenosis at a mean of 50.1 months (range 2 to 196) after coronary artery bypass surgery. The patients presented between March 1981 and April 1987. A total of 107 saphenous vein grafts were dilated at 117 sites. The primary success rate was 91.8%. The incidence of cardiac complications was 7.1%. There were no cardiac complications in 53 patients with grafts implanted less than 36 months before angioplasty (Group 1). The 48 patients with grafts implanted for greater than 36 months (Group 2) had a 12.5% incidence rate of myocardial infarction, a 4% incidence rate of emergent bypass surgery and a 4% incidence rate of death for an overall cardiac complication rate of 14.9% (p less than 0.01). Follow-up was obtained at a mean of 16.8 +/- 13.9 months (range 1 to 54) in 87 patients (97% of successful cases). Repeat coronary angiography was performed in 49 patients and revealed restenosis in 30 patients (61.2%), with no difference in recurrence rates for proximal, mid or distal graft sites. Clinical recurrence (defined as recurrence of symptoms, myocardial infarction, repeat angioplasty, surgery or death) was 33.1% for Group 1 patients and 64.1% for Group 2 patients (p less than 0.01). The complication and recurrence rates of saphenous vein graft angiography are significantly higher when performed for late (greater than 36 months) vein graft failure. All therapeutic options should be carefully examined before proceeding with angioplasty for saphenous vein graft stenosis in this type of patient.

Subselective measurement of coronary blood flow velocity using a steerable Doppler catheter.

The accuracy of coronary arteriography to predict obstruction to coronary blood flow has recently been questioned. Assessment of coronary hemodynamic variables and vasodilator reserve may provide more reliable information regarding the significance of coronary stenosis. To provide a clinically safe and reliable method of measuring coronary blood flow velocity and coronary flow reserve, a 3F steerable Doppler catheter capable of subselective placement in the coronary circulation was developed and validated in an animal model. Coronary blood flow velocity measured with the catheter correlated with simultaneous measurements by a previously validated external cuff type Doppler probe (r = 0.97), coronary sinus flow collections (r = 0.78) and femoral artery flow collections (r = 0.96). The extravascular Doppler cuff measurements of rest flow velocity and vasodilator reserve were not significantly different with or without the catheter in the artery, indicating that the Doppler catheter caused no obstruction to blood flow. The Doppler catheter has recorded stable and reproducible signals without complications in 28 patients, including 62 separate arterial cannulations. Thus: 1) the 3F Doppler coronary catheter is nonobstructing, steerable and safe; 2) there is an excellent correlation of blood flow velocity with volume collections; and 3) the catheter provides a reliable method of determining coronary blood flow velocity and coronary vasodilator reserve.

Protection against ischemia during prolonged balloon inflation by distal coronary perfusion with use of an autoperfusion catheter or Fluosol.

OBJECTIVES: The purpose of this report was to study the protective effects of passive and active distal coronary perfusion during prolonged balloon inflation. BACKGROUND: Prolonged balloon inflation has been proposed to improve immediate and long-term results of percutaneous transluminal coronary angioplasty, but it requires protection against myocardial ischemia. METHODS: A 30-min balloon occlusion of the left anterior descending artery was performed in three groups of closed chest anesthetized dogs: 1) control (no distal coronary perfusion, n = 13), 2) passive distal coronary perfusion (autoperfusion catheter, n = 10), and 3) active distal coronary perfusion (infusion of the perfluorochemical Fluosol at 30 ml/min, n = 11). RESULTS: At 10 min of balloon inflation, echocardiographic wall motion indexes (scored from 1 [normal] to 5 [dyskinesia]) in the autoperfusion catheter and Fluosol groups (2.4 +/- 1.2 and 2.0 +/- 0.9, respectively) were significantly better than in the control group (3.6 +/- 0.4, p = 0.001), but at 25 min this improvement in wall motion had attenuated and became statistically insignificant when compared with values in the control group. Left ventricular end-diastolic pressure at peak inflation in the Fluosol group (19.5 +/- 5.5 mm Hg) was higher than in the control (7.6 +/- 3.6) and autoperfusion catheter (5.3 +/- 1.4, p < or = 0.01) groups. Pathologic evidence of infarction by tetrazolium staining was seen in three control dogs and in none of the other groups (p = 0.07). Ventricular tachycardia and fibrillation were less frequent in the autoperfusion catheter group (p = 0.02). Three deaths were observed in the control dogs, two in the Fluosol group and none in the dogs with an autoperfusion catheter (p = NS). CONCLUSIONS: Passive (the autoperfusion balloon catheter) and active (Fluosol) distal coronary perfusion methods are comparable and better than no perfusion in protecting the myocardium against ischemia produced by prolonged coronary balloon inflation in an experimental canine model. This protection is transient, attenuating after 10 to 25 min, and partial because there was no significant difference in the incidence of myocardial infarction and death among groups, although the latter observations may be related to small sample size.

Directional coronary atherectomy in unstable angina.

OBJECTIVES: To determine whether excision of complex, ulcerated plaque improves the risk of patients with unstable angina to the level of those with stable angina, the results of directional coronary atherectomy were compared in patients with these two syndromes. BACKGROUND: The procedural results of angioplasty in the setting of unstable angina are not as favorable as those observed for chronic stable angina, presumably because thrombus-associated plaque augments the risk of abrupt closure. METHODS: Two hundred eighty-seven consecutive patients who had undergone directional atherectomy for a single new stenosis were studied. Seventy-seven patients had stable angina (Group I); 110 patients had progressively worsening angina in the absence of rest or postinfarction angina (Group II); and 100 patients had rest or postinfarction angina, or both (Group III). RESULTS: Major ischemic complications (death, Q wave infarction, emergency bypass surgery) occurred more frequently in Group III (1.3% [Group I] vs. 0.9% [Group II] vs. 7% [Group III], p = 0.036). This difference was largely due to a higher incidence of emergency surgery in Group III (1.3% [Group I] vs. 0% [Group II] vs. 5% [Group III], p = 0.05). Clinical follow-up was obtained in 97% of successful procedures for a mean follow-up period of 22 months (range 9 to 52) and revealed a higher incidence of hospital admission for angina (p = 0.05) and a trend toward more bypass surgery (p = 0.09) and myocardial infarction (p = 0.16) in Group III. There was no difference in repeat percutaneous interventions among the three groups (range 19% to 24%, p = 0.75). CONCLUSIONS: These results show that the definition of unstable angina is important in determining the immediate outcome of directional atherectomy. In the absence of rest or postinfarction angina, the immediate results are not significantly different from those obtained in stable angina. Our results also suggest that both the immediate and short-term outcome in unstable angina are not greatly influenced by atherectomy but more so by the pathophysiology of unstable angina, which increases the complications of percutaneous interventions.

Percutaneous transluminal coronary angioplasty of one major coronary artery when the contralateral vessel is occluded.

OBJECTIVES: In 193 patients we evaluated the safety and efficacy of angioplasty of a critical stenosis of the right coronary artery (52 patients) or the left anterior descending coronary artery (141 patients), with the contralateral coronary artery occluded and the circumflex artery being without significant stenosis. BACKGROUND: Attempted angioplasty of either the left anterior descending or the dominant right coronary artery when the contralateral vessel is occluded may trigger overwhelming left ventricular dysfunction or hemodynamic collapse, or both. METHODS: Immediate and late outcome (33 +/- 18 months) in the study group were compared with outcome in 214 patients who had angioplasty in both the left anterior descending and right coronary arteries and in 194 patients who had coronary artery surgery and were matched for number and location of significant lesions, ejection fraction, age, gender and study period. RESULTS: Left ventricular function was normal (38%) or mildly (34%), moderately (22%) or severely (6%) compromised. There were 11 (5.7%) emergency and 5 (2.6%) elective coronary artery operations, 3 (1.6%) myocardial infarctions and 1 in-hospital death in the study group. After discharge there were 25 (13.1%) elective coronary operations, 7 (3.7%) myocardial infarctions and 9 (4.7%) deaths in the study group. The incidence of death and myocardial infarction was similar in all groups, with 80% power to detect a 7% difference in adverse events. The study group had more elective surgery before and after discharge than did the surgical control group (p = 0.02). CONCLUSIONS: Dilating one major vessel when the contralateral vessel is occluded appears to be as safe as coronary surgery or two-vessel angioplasty. Incomplete revascularization in study group patients did not impair survival or increase myocardial infarction compared with the angioplasty and surgical control groups.

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

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

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

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

Angioplasty of the proximal left anterior descending coronary artery: initial success and long-term follow-up.

From 1984 to 1987, 537 consecutive patients (mean age 58 years; range 34 to 79) underwent angioplasty for proximal left anterior descending coronary artery disease. The procedure was clinically successful in 516 (96.1%). Procedural complications included myocardial infarction (2.2%; Q wave 0.9%, non-Q wave 1.3%), in-hospital bypass surgery (3%) and death (0.4%). Follow-up was obtained in 534 patients (99.8%) for a mean duration of 44 months (range 8 to 75). Follow-up cardiac catheterization, performed in 391 patients (76%), demonstrated a 39.6% angiographic restenosis rate. Ninety-eight (19%) of the patients with a clinically successful result required additional revascularization for recurrent left anterior descending artery disease by angioplasty (12.8%) or coronary artery bypass grafting (4.7%), or both (1.5%). During follow-up there was a 2.5% incidence rate of myocardial infarction (anterior myocardial infarction 1.6%), and 27 patients (5.2%) died, 14 (2.7%) of cardiac causes. The actuarial 5-year cardiac survival rate was 97%, freedom from cardiac death and myocardial infarction was 94% and freedom from cardiac death, myocardial infarction, coronary artery bypass surgery and repeat left anterior descending artery angioplasty was 77%. At last follow-up 76% of patients were free of angina and 88% reported sustained functional improvement. Angioplasty is an effective treatment for proximal left anterior descending coronary artery disease that has a high success rate, low incidence of procedural complications and provides excellent long-term cardiac survival, freedom from cardiac events and sustained functional improvement.

Repeat coronary angioplasty as treatment for restenosis.

Repeat coronary angioplasty has become the standard approach to a first restenosis. However, the long-term outcome of such a strategy is not well defined. In the present study, 465 patients (mean age 58 years [range 27 to 79], 53% with multivessel disease) underwent a second angioplasty procedure at the same site. The procedure was successful in 96.8% with a 1.5% rate of in-hospital bypass surgery, a 0.9% incidence rate of myocardial infarction and no procedural deaths. Four hundred sixty-three patients (99.6%) were followed up for a mean of 40.5 months. Forty-nine patients (10.6%) underwent a third angioplasty procedure at the same site, 55 (11.8%) had coronary bypass surgery and 33 (7.1%) underwent angioplasty at a different site. During follow-up, 12 patients (2.6%) sustained a myocardial infarction and 21 (4.5%) died including 13 (2.8%) with cardiac death. Of the 442 surviving patients, 88% experienced sustained functional improvement and 78% were free of angina. The actuarial 5-year cardiac survival rate was 96% and the rate of freedom from cardiac death and myocardial infarction was 92%. For the subgroup of 49 patients who had a third angioplasty procedure at the same site, the success rate was 93.9% with a 2% incidence rate of myocardial infarction. There were no in-hospital deaths or coronary artery bypass operations. The mean follow-up interval for this subgroup was 30.5 months with a 22.4% cross-over rate to coronary bypass surgery, a 4.1% incidence rate of myocardial infarction and a 2% cardiac mortality rate. At last follow-up, 89% of patients had sustained functional improvement and 76% were free of angina. The combined angiographic and clinical restenosis rate was 48%. Repeat angioplasty as treatment for restenosis is an effective approach associated with a high success rate, low incidence of procedural complications, and sustained functional improvement in combination with an acceptable rate of bypass surgery. However, there is a trend toward diminished angioplasty efficacy after a second restenosis. Thus, decisions for further revascularization should be made after careful review of available options.

Percutaneous revascularization of ostial saphenous vein graft stenoses.

OBJECTIVES: This study sought to evaluate the short-term results and long-term outcome of percutaneous revascularization of ostial saphenous vein graft stenoses in a large patient series. BACKGROUND: Previous studies have demonstrated that the results of balloon angioplasty for native coronary ostial stenoses are significantly worse than those for nonostial lesions. However, it is controversial whether interventions in patients with ostial saphenous vein grafts carry a similar prognosis. METHODS: We identified 68 consecutive patients with ostial (group I) and 72 consecutive patients with proximal, nonostial (group II) saphenous vein graft stenoses who underwent percutaneous angioplasty or directional atherectomy for a single new stenosis at the Cleveland Clinic between 1986 and 1992. RESULTS: Success was achieved in 61 patients (89.7%) in group I and 64 (88.9%) in group II (p = 0.88). There were no differences in major procedural complications (death, Q wave infarction and bypass surgery) between the two groups. At a mean (+/- SD) follow-up of 23 +/- 17 months, 36 patients (64%) in group I had one or more adverse events (death, infarction, repeat coronary revascularization or cardiac-related hospital admission) compared with 34 patients (58%) in group II (p = 0.87). Twenty-eight patients (50%) were angina free in group I compared with 33 (56%) in group II (p = 0.65). During the follow-up period in group I, 7 patients died (13%), 10 had a myocardial infarction (18%), 11 had repeat bypass surgery (20%), 8 had repeat percutaneous interventions (14%), and 30 had one or more cardiac-related hospital admissions (54%). The incidence of these events was similar in group II except for a slightly higher incidence of myocardial infarction: 6 patients died (10%), 3 had a myocardial infarction (5%), 12 had repeat bypass surgery (20%), 12 had repeat percutaneous interventions (20%), and 26 had one or more cardiac-related hospital admissions (44%). CONCLUSIONS: Unlike ostial native coronary disease, the clinical, procedural and follow-up profile of ostial saphenous vein graft revascularization is not significantly worse than proximal nonostial disease. This finding may be related to the overall suboptimal results of percutaneous revascularization in saphenous vein grafts compared with native coronary arteries or to the unfavorable intrinsic properties of ostial native coronary arteries compared with ostial vein grafts.

High speed rotational atherectomy: outcome in calcified and noncalcified coronary artery lesions.

OBJECTIVES: This study sought to determine the success and complication rates of high speed rotational coronary atherectomy in calcified and noncalcified lesions. BACKGROUND: Percutaneous transluminal coronary angioplasty and directional coronary atherectomy of calcified lesions are associated with reduced procedural success and increased complications. Rotational atherectomy using the Rotablator catheter abrades noncompliant plaque and may improve outcome in calcified lesions. METHODS: Data from the completed Multicenter Rotablator Registry of 2,161 rotational atherectomy procedures in single lesions were analyzed to determine the relative efficacy of rotational atherectomy for 1,078 calcified and 1,083 noncalcified lesions. The power of the study was 0.86 to detect a significant difference in outcome, if the true success rates in the noncalcified and calcified lesions were 96% and 93%, respectively. RESULTS: Patients with calcified lesions were older (mean [+/- SD] age 66.2 +/- 10.3 vs. 60.5 +/- 11.0 years, p = 0.0001) than those with noncalcified lesions. Calcified lesions were more frequently new (75% vs. 64%, p = 0.0001), angulated (27% vs. 22%, p = 0.02), eccentric (75% vs. 64%, p = 0.0001) and long (32% vs. 27%, > 10 mm in length, p = 0.01). They were also more often complex (57% vs. 46%, p = 0.001) and located in the left anterior descending coronary artery (51% vs. 44%, p = 0.001). Adjunctive coronary angioplasty was used in 82.9% of calcified and 66.9% of noncalcified lesions. Procedural success, defined as < 50% residual stenosis without major complications, was achieved in 94.3% of calcified and 95.2% of noncalcified lesions (p = 0.32). Major complication rates were 4.1% in calcified and 3.1% in noncalcified lesions (p = 0.24). Non-Q wave myocardial infarction was documented in 10.0% of calcified and 7.7% of noncalcified lesions (p = 0.054). Mean postprocedural residual stenosis was 21.6 +/- 13.9% in calcified and 23.3 +/- 15% in noncalcified lesions (p = 0.39). CONCLUSIONS: In this review of data from a large multicenter registry, the success rate of rotational atherectomy was not reduced by calcification despite the more frequent complex nature of the calcified lesions. The Rotablator catheter is likely to be the device of choice for percutaneous intervention in calcified lesions, but definitive conclusions await the results of randomized trials.

The importance of proteinuria as a determinant of mortality following percutaneous coronary revascularization in diabetics.

OBJECTIVES: The aims of this study were to compare mortality and clinical events following percutaneous coronary intervention (PCI) between nondiabetics and diabetics with and without proteinuria. BACKGROUND: Diabetics have increased rates of late myocardial infarction, repeat revascularization and mortality when compared with nondiabetics following PCI. Proteinuria is a marker for diabetic nephropathy and potentially a surrogate marker for advanced atherosclerosis. It is unknown if proteinuria is a predictor of outcome in diabetics following PCI. METHODS: We performed an observational study of 2,784 patients who underwent PCI at the Cleveland Clinic between January 1993 and December 1995. There were 2,247 nondiabetics and 537 diabetics with urinalysis and follow-up data available (proteinuria n = 217, nonproteinuria n = 320). The diabetic proteinuria group was further prospectively stratified into low concentration (n = 182) and high concentration (n = 35). The end points were all-cause mortality and the composite end point of death, nonfatal myocardial infarction (MI) and need for revascularization. RESULTS: The mean follow-up time was 20.2 months. The two-year mortality rate was 7.3% and 13.5% for nondiabetics and diabetics, respectively (p < 0.001). The two-year mortality rate was 9.1% and 20.3% for the nonproteinuria and proteinuria groups, respectively (p < 0.001). There was a graded increase in mortality comparing the diabetic group. The two-year mortality rate was 9.1%, 16.2% and 43.1% for the nonproteinuria, low concentration and high concentration groups, respectively (p < 0.001). The difference in survival between the nondiabetic and nonproteinuric diabetics was not significant (p = 0.8). CONCLUSIONS: The presence of proteinuria is the key determinant of risk following PCI for diabetics. Diabetics without evidence of proteinuria have similar survival compared with nondiabetics.

The dilemma of diagnosing coronary calcification: angiography versus intravascular ultrasound.

OBJECTIVES: We sought to determine whether careful examination of angiograms in conjunction with other clinical information could reliably detect, quantitate and localize target lesion calcification before a coronary intervention. BACKGROUND: The presence, extent and location of calcium in coronary artery lesions are important determinants of outcome after coronary intervention. Intravascular ultrasound is proposed as a superior technique for identifying patients with coronary artery calcification. However, the precise role of this costly and invasive method has not yet been established. METHODS: Target lesion calcification was assessed in 183 patients (155 men; mean [+/-SD] age 58 +/- 10 years) by angiography and intravascular ultrasound before a planned percutaneous coronary intervention. RESULTS: Ultrasound detected calcium in 138 patients (>90 degrees in 56, 91 degrees to 180 degrees in 52, 181 degrees to 270 degrees in 22 and > 270 degrees in 8), whereas angiography showed calcification in 63 (1+ in 32, 2+ in 27 and 3+ in 4). The two techniques agreed in 92 patients and disagreed in 91. Sensitivity and specificity of angiography were 40% and 82%, respectively. The arc of calcium by ultrasound was greater in patients with angiographically visible calcification (175 degrees +/- 85 degrees vs. 108 degrees +/- 71 degrees, p=0.0001). The depth of calcification by ultrasound was superficial in 61 patients (44%), deep in 68 (49%) and mixed in 8 (7%). The sensitivity of angiography in identifying superficial calcium was 35%. Of 120 patients without angiographically visible calcium at the target lesion site, 83 showed calcium by ultrasound. The only predictor of ultrasound calcium in these 120 patients was angiographic calcification elsewhere in the coronary tree (p=0.0001). The probability of any calcium and superficial >90 degrees calcium were 60% and 12%, respectively, in the 90 patients without angiographic calcifications anywhere in the coronary tree. CONCLUSIONS: Despite poor sensitivity, angiography may help identify patients requiring intravascular ultrasound. When it is angiographically visible, the arc of calcium is likely to be large and superficial. Angiographic calcification at a remote site is a predictor of angiographically undetected target lesion calcium. Patients without angiographic calcification in the coronary tree may not need routine ultrasound examination, as the likelihood of >90 degrees superficial calcium is low.

Atrial natriuretic factor in patients with right ventricular infarction.

To determine the possible role of atrial natriuretic factor in right ventricular infarction, serial measurements of this hormone were performed in 21 patients with acute inferior myocardial infarction. All patients underwent enzymatic, electrocardiographic, echocardiographic and coronary arteriographic studies. Ten patients also had right heart hemodynamic measurements. Eight patients had evidence of an associated right ventricular infarction (Group I) and 13 patients did not (Group II). Enzymatically estimated infarct size, presence of left heart failure and arrhythmias were similar in both groups. Mean arterial pressure in Group I (72.1 +/- 4.4 mm Hg) was significantly lower (p = 0.02) than in Group II (89.5 +/- 4.6 mm Hg). Seven (88%) of the eight patients in Group I had elevated right atrial pressures and a higher incidence than Group II of prolonged hypotension (75%) and right ventricular dysfunction (75%) clinically and by echocardiography. Plasma atrial natriuretic factor levels (mean values +/- SEM in pg/ml) for days 1, 2, 3 and 7 after infarction were, respectively: 152 +/- 30, 165 +/- 48, 199 +/- 27 and 189 +/- 31 for Group I versus 55 +/- 9, 55 +/- 11, 61 +/- 13 and 77 +/- 20 for Group II. The difference between groups was significant for days 1 (p less than 0.05), 3 and 7 (p less than 0.01) and not significant for day 2 (p = 0.07). These findings show that atrial natriuretic factor elevation is part of the neurohumoral response to right ventricular infarction and are consistent with the hypothesis that atrial natriuretic factor may play a pathophysiologic role in the right ventricular infarct syndrome.

Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device.

OBJECTIVES: This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath. BACKGROUND: Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure, rapid methods of obtaining hemostasis at the time of sheath removal. METHODS: We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group I); 217 patients were assigned to the manual pressure control group (group II). RESULTS: There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 +/- 15.2 vs. 15.3 +/- 11.7 min [mean +/- SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group. CONCLUSIONS: This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.