High-risk patients have been excluded from most thrombolytic trials because of concern over hemorrhagic complications or lack of efficacy. However, based on several recent studies suggesting that patients with relative thrombolytic contraindications may also benefit from reperfusion, recommendations have been made to broadly expand the eligibility criteria for thrombolytic therapy, despite higher absolute complication rates. Primary percutaneous transluminal coronary angioplasty (PTCA) may be an attractive alternative for patients presenting at appropriately equipped hospitals who would otherwise remain at high risk after thrombolytic therapy. In the Primary Angioplasty in Myocardial Infarction (PAMI) trial, 395 patients with acute myocardial infarction were randomized to tissue plasminogen activator (t-PA) or primary PTCA. Conditions were present in 151 patients (38%) which formerly would have contraindicated thrombolytic therapy (age > 70 yr, symptom duration > 4 hr, or prior bypass surgery). In-hospital mortality was 4.3-fold higher in patients with former thrombolytic contraindications compared to lytic-eligible patients (8.6% vs. 2.0%, P = .002). Lytic-eligible patients treated with t-PA and PTCA had similar in-hospital mortality (1.7% vs. 2.4%, P = NS). In contrast, both in-hospital (2.9% vs. 13.2%, P = .025) and 6-mo mortality (2.9% vs. 15.7%, P = .009) were significantly reduced in patients with former thrombolytic contraindications treated by primary PTCA compared to t-PA. By logistic regression analysis, treatment by PTCA rather than t-PA was the strongest predictor of survival in patients with former thrombolytic contraindications. We conclude that patients with conditions formerly contraindicating thrombolytic therapy constitute a high-risk group with significant morbidity and mortality after lytic reperfusion. Our data suggest that patients with former contraindications to thrombolytic therapy may benefit by preferential management with primary PTCA without antecedent thrombolysis.

Direct percutaneous transluminal coronary angioplasty (PTCA) has emerged as effective reperfusion therapy for acute myocardial infarction; however, few data exist on its use in octogenarians. Thrombolytic therapy in this age group has reduced early mortality from approximately 30% to 20%, but is associated with an increased risk of stroke and major hemorrhage. We analyzed the acute and long-term results of direct PTCA performed on patients aged > or = 80 years at our institution between 1980 and 1993. The study group consisted of 55 patients (mean patient age 83.3 +/- 2.3 years). Infarcts were anterior in 27 patients (49%). Cardiogenic shock was present in 6 patients (11%). The mean time to reperfusion was 4.3 +/- 2.8 hours. Direct PTCA was successful in 53 patients (96%). There were no emergent bypass operations. In-hospital death occurred in 9 patients (16%), including 4 of 6 (67%) presenting in cardiogenic shock and 5 of 49 (10%) who were hemodynamically stable on presentation. Repeat PTCA for recurrent ischemia was performed in 6 patients (11%). There were no strokes during hospitalization. Bleeding complications requiring blood transfusion were present in 4 patients (7%). Thirty-day mortality was 16% and 1-year actuarial survival was 67%. Direct PTCA in patients aged > or = 80 years can be performed safely with a high procedural success rate. The clinical outcome with PTCA in this high risk subset of patients compares favorably with that reported previously for both thrombolytic and medical therapy.

In the Primary Angioplasty in Myocardial Infarction trial, 395 patients with acute myocardial infarction (AMI) were prospectively randomized to tissue plasminogen activator (tPA) or primary percutaneous transluminal coronary angioplasty (PICA). In 138 patients with anterior wall AMI, in-hospital mortality was significantly reduced by treatment with PICA compared with tPA (1.4% vs 11.9%, p = 0.01). PICA also resulted in lower rates of death or reinfarction (1.4% vs 18.0%, p = 0.0009), recurrent myocardial ischemia (11.3% vs 28.4%, p = 0.01), and stroke (0.0% vs 6.0%, p = 0.037) in anterior wall AMI. The independent beneficial effect of treatment with primary PICA rather than tPA in anterior wall AMI was confirmed by multivariate analysis and interaction testing. The in-hospital mortality of 257 patients with nonanterior wall AMI was similar after PTCA and tPA (3.2% vs 3.8%, p = 0.82). Compared with tPA, however, primary PTCA resulted in a markedly lower rate of recurrent myocardial ischemia (9.7% vs 27.8%, p = 0.0002), fewer unscheduled catheterization and revascularization procedures, and a shorter hospital stay (7.0 vs 8.6 days, p = 0.01) in nonanterior wall AMI. Thus, compared with tPA, primary PTCA in patients with anterior wall AMI results in significantly improved survival, with lower rates of stroke, reinfarction, and recurrent myocardial ischemia. In nonanterior wall AMI, treatment with PTCA and tPA results in similar early mortality, although PTCA-treated patients have a more stable hospital course characterized by reduced recurrent ischemia, fewer subsequent invasive procedures, and earlier discharge.

In summary, combination lovastatin and probucol effectively reduced lipid levels but did not prevent restenosis or clinical events during the first 6 months.

Objectives. We attempted to determine the relative risks and benefits of percutaneous transluminal coronary angioplasty (PTCA) and repeat coronary artery bypass grafting (re-CABG) in patients with previous coronary bypass surgery (CABG).Background. Due to an expanding population of patients with surgically treated coronary artery disease and the natural progression of atherosclerosis, an increasing number of patients with previous CABG require repeat revascularization procedures. Although there are randomized comparative data for CABG versus medical therapy and, more recently, versus PTCA, these studies have excluded patients with previous CABG.Methods. We retrospectively analyzed data from 632 patients with previous CABG who required either elective re-CABG (n = 164) or PTCA (n = 468) at a single center during 1987 through 1988. The PTCA and re-CABG groups were similar with respect to gender (83% vs. 85% male), age > 70 years (21% vs. 23%), mean left ventricular ejection fraction (46% vs. 48%), presence of class III or IV angina (70% vs. 63%) and three-vessel coronary artery disease (77% vs. 74%).Results. Complete revascularization was achieved in 38% of patients with PTCA and 92% of those with re-CABG (p < 0.0001). The in-hospital complication rates were significantly lower in the PTCA group: death (0.3% vs. 7.3%, p < 0.0001) and Q wave myocardial infarction (MI) (0.9% vs. 6.1%, p < 0.0001). Actuarial survival was equivalent at 1 year (PTCA 95% vs. re-CABG 91%) and 6 years (PTCA 74% vs. re-CABG 73%) of follow-up (p = 0.32). Both procedures resulted in equivalent event-free survival (freedom from death or Q wave MI) and relief of angina; however, the need for repeat percutaneous or surgical revascularization, or both, by 6 years was significantly higher in the PTCA group (PTCA 64% vs. re-CABG 8%, p < 0.0001). Multivariate analysis identified age > 70 years, left ventricular ejection fraction < 40%, unstable angina, number of diseased vessels and diabetes mellitus as independent correlates of mortality for the entire group.Conclusions. In this nonrandomized series of patients with previous CABG requiring revascularization, an initial stategy of either PTCA or re-CABG resulted in equivalent overall survival, event-free survival and relief of angina. PTCA offers lower procedural morbidity and mortality risks, although it is associated with less complete revascularization and a greater need for subsequent revascularization procedures.

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.

At 12 centers, 395 patients, including 288 men (73%) and 107 women (27%) with acute myocardial infarction (AMI), were prospectively randomized to treatment with tissue plasminogen activator (t-PA) or primary percutaneous transluminal coronary angioplasty (PICA). Compared with men, women were older (65.7 vs 57.7 years, p < 0.0001), more often had diabetes mellitus (19% vs 10%, p = 0.03), systemic hypertension (54% vs 39%, p = 0.005), prior congestive heart failure (5% vs 0%, p = 0.002), and presented later after symptom onset (229 vs 174 minutes, p = 0.0004). The in-hospital mortality in women was 3.3-fold higher than men (9.3% vs 2.8%, p = 0.005). After adjustment for comorbid baseline characteristics, however, only advanced age independently correlated with mortality. Among t-PA-treated patients, mortality was significantly higher in women than in men (14.0% vs 3.5%, p = 0.006). Intracranial hemorrhage after t-PA was also more common in women than in men (5.3% vs 0.7%, p = 0.037). In contrast, women and men had similar, in-hospital mortality after primary PICA (4.0% vs 2.1%, respectively, p = 0.46). No intracranial bleeding occurred in PTCA-treated patients. A univariate trend was present for reduced in-hospital mortality in women treated with PTCA rather than t-PA (4.0% vs 14.0%, p = 0.07). By multiple logistic regression analysis of 15 clinical variables, treatment with PTCA rather than t-PA, as well as younger age, were independently predictive of in-hospital survival in women. In men, in-hospital mortality was similar with both t-PA and PTCA (3.5% vs 2.1%, respectively, p = 0.46); only advanced age independently correlated with mortality in men. Compared with men, women with AMI are at increased risk for early mortality and life-threatening hemorrhagic complications after thrombolytic therapy. Primary PTCA reduces the risk of intracranial bleeding and results in improved survival in women, such that the prognosis of men and women is equally favorable.

Objectives. We report the comprehensive results of the first consecutive 3,000 patients treated in an excimer laser coronary angioplasty registry.Background. Excimer laser coronary angioplasty involves the use of a pulsed, 308-nm ultraviolet laser transmitted by optical fibers to reduce coronary stenoses. Preliminary reports have described safety and efficacy profiles in small numbers of patients.Methods, Patients were enrolled in a prospective, nonrandomized manner. The catheters used were 1.3, 1.6, 2.0, 2.2 and 2.4 mm in diameter, at energy densities up to 70 mJ/mm(2). Procedures were performed by standard angioplasty technique with conventional guide catheters.Results. Seventy-five percent of patients were male, 68% were in Canadian Cardiovascular Society functional class III or IV and the cohort included 3,592 lesions, Procedural success (final stenosis less than or equal to 50% without in-hospital Q wave myocardial infarction, coronary artery bypass surgery or death) was 90% and did not differ between the first 2,000 and the last 1,000 patients treated. There was no significant difference in successor complication rates with respect to lesion length, nor were there differences between selected complex and simple lesions. Complications included in-hospital bypass surgery (3.8%), Q wave myocardial infarction (2.1%) and death (0.5%). Coronary artery perforation occurred in 1.2% of patients (1% of lesions) but significantly decreased to 0.4% in the last 1,000 patients (0.3% of lesions). Angiographic dissection occurred in 13% of lesions, transient occlusion in 3.4% and sustained occlusion in 3.1%. Comprehensive lesion morphologic data collected in the latter portion of the study showed the procedure predominantly limited to American College of Cardiology-American Heart Association type B2 and C lesions, with no significant difference in short-term outcome between groups.Conclusions. Excimer laser angioplasty can be safely and effectively applied, even in a variety of complex lesions not well suited for percutaneous transluminal coronary angioplasty. These types may include aorto-ostial, long lesions, total occlusions crossable with a wire, diffuse disease and vein grafts. Most recent data show a trend for the selection of predominantly complex lesions and a reduction in the incidence of perforation. This procedure may broaden the therapeutic window for the interventional treatment of selected complex coronary artery disease.

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 ≥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.

Objectives. This study was designed to evaluate the safety and short- and long-term results of coronary angioplasty of totally occluded bypass grafts in patients with clinical conditions other than acute myocardial infarction.Background. Total occlusion of bypass grafts after coronary artery surgery often causes recurrent ischemia. The safety and results of percutaneous transluminal coronary angioplasty in occluded bypass grafts are controversial.Methods. All patients with dilation of a totally occluded bypass graft attempted between 1981 and 1991 were retrospectively identified from a data base. Patients treated in the setting of an acute myocardial infarction were excluded. Eighty-three patients met these criteria and constitute the study group. Hospital records, office charts and procedural reports were reviewed in all patients to supplement details available in the data base.Results. The time from bypass surgery to attempted coronary angioplasty ranged from 1 to 226 months (mean time 88 months). The mean (+/-SD) duration of graft occlusion was 31 +/- 46 days (range 1 to 180). In 27 attempts the bypass graft was the only site dilated, and in 56 attempts (68%) one to six other sites (n = 101) were dilated. Angiographic success (less than or equal to 40% residual lumen stenosis) was achieved in 61 grafts (73%) and 98 of the additional sites (97%) (p < 0.001). Major complications included one procedural death and two Q wave infarctions. Follow up for a mean of 32 months demonstrated a 1- and 3-year actuarial survival rate of 94% and 80%, respectively. At 3 years, only 34% of patients were free of repeat angioplasty or surgery.Conclusions. Angioplasty of totally occluded bypass grafts can be successful in the majority of selected patients, although major complications can occur. Strategies for sustained patency are needed to improve the long-term results.

OBJECTIVES:This study compared the relative risks and benefits of coronary angioplasty and coronary artery bypass graft surgery in patients > 70 years old. BACKGROUND:Few objective, comparative data exist to guide the clinician in the decision to use bypass surgery or angioplasty in elderly patients. METHODS:The study was a case-control, retrospective analysis of 195 consecutive patients who underwent bypass surgery in 1987 and 1988 and were compared with a concurrent cohort of 195 coronary angioplasty-treated patients. The groups were matched for left ventricular function, age and gender mix. RESULTS:The in-hospital morbidity and mortality rates were significantly lower in the coronary angioplasty-treated patients. Mean postprocedural hospital stay was 4.8 and 14.3 days for angioplasty and surgical group patients, respectively (p < 0.001). In-hospital death occurred in 2% of angioplasty-treated patients compared with 9% of surgically treated patients (p = 0.007). Serious in-hospital stroke occurred in no patient in the angioplasty group and in 5% of patients in the surgical group (p < 0.0001). Q wave infarction occurred in 1% of angioplasty-treated patients and 6% of bypass-treated patients (p = 0.01). The 5-year actuarial survival rate was similar in the two groups: 63% in the angioplasty group, 65% in the bypass group (p = NS). However, surgical group patients experienced less recurrent angina, required fewer repeat revascularization procedures and had fewer Q wave infarctions during follow-up compared with angioplasty group patients. CONCLUSIONS:When performed in patients > 70 years old, angioplasty and coronary bypass surgery result in similar long-term survival rates but otherwise distinctly different clinical courses.

Balloon angioplasty (PTCA) of left main (LM) stenoses is limited by frequent clinical restenosis. Directional coronary atherectomy (DCA) may be an effective alternative to PTCA due to its ability to achieve a greater postprocedural luminal diameter when treating bulky, eccentric plaques and aorto-ostial lesions. We analyzed the acute and long-term results following 24 DCA procedures in 22 patients with "protected" LM lesions. Acute success (residual stenosis < or = 40%, no major ischemic complications) was 88% overall, 100% in 13 planned procedures, and 73% in 11 adjunctive DCA procedures that followed suboptimal PTCA. Mean LM stenosis was reduced from 86% to 13% (P < 0.01). There were no procedural complications directly attributed to DCA. At a mean of 24 +/- 3 months, the clinical restenosis rate was 16%, survival was 100%, and event-free survival (freedom from death, MI, or repeat lesion-related interventions) was 89%. We conclude that DCA in protected LM lesions (1) can achieved excellent angiographic results with low procedural complication rates, (2) may succeed where PTCA yields suboptimal results, and (3) may provide late clinical outcomes superior to those of balloon angioplasty.

Objectives. The purpose of this study was to compare the mechanisms, predictors and outcome of patients with failed direct coronary angioplasty of the infarct-related artery with those in patients with successful direct angioplasty.Background. Direct coronary angioplasty of the infarct-related artery, without antecedent thrombolytic therapy, is an effective treatment for patients with acute myocardial infarction. Concern has been expressed over high mortality rates in patients with failed direct infarct angioplasty.Methods. All patients treated by angioplasty were prospectively entered into a computer data base. The characteristics and outcome of all patients with failed direct angioplasty were reviewed and compared with those of patients with successful direct angioplasty.Results. Direct angioplasty was successful in 705 (94%) of 750 patients and unsuccessful in 45 (6%). Patients in the failure group were more likely to be in cardiogenic shock (22% vs. 7%, p < 0.003), to have had a previous myocardial infarction (44% vs. 28%, p < 0.03) and to have three-vessel coronary artery disease (44% vs. 23%, p < 0.003). Age, gender, ejection fraction, previous bypass surgery and diabetes mellitus were similar in both groups. Only the presence of multivessel coronary artery disease (p < 0.004) and cardiogenic shock (p < 0.025) were independent predictors of failed direct angioplasty. In-hospital death (31% vs. 4.8%, p < 0.0001) and the need for emergency coronary artery bypass surgery (27% vs. 0.5%, p < 0.0001) were more frequent in patients with unsuccessful than in patients with successful direct angioplasty. Patients with failed direct angioplasty and in-hospital death usually had multiple high risk characteristics, including cardiogenic shock (50%), previous myocardial infarction (43%) and multivessel coronary artery disease (93%).Conclusions. Direct coronary angioplasty is an effective method for establishing reperfusion in acute myocardial infarction. Procedural failure is infrequent, usually occurring in patients with high risk baseline characteristics.