Percutaneous transluminal coronary angioplasty in acute myocardial infarction. A prospective controlled study

In the present study we compared the outcome of primary percutaneous coronary angioplasty (PTCA) (PTCA without prior or concomitant administration of thrombolytic drugs) in 82 consecutive patients with acute myocardial infarction (AMI) with the outcome of 82 AMI patients, who were treated with intravenous thrombolysis. The thrombolysis patients were prospectively matched to the angioplasty patients regarding age, sex, duration of symptoms and infarct localisation. The in-hospital mortality was 3.7% in the PTCA group versus 4.9% in the thrombolysis group. Thrombolysis-treated patients had increased use of diuretics and ACE-inhibitors as compared to PTCA-treated patients. The mean ejection fraction was 52 +/- 11% in the PTCA group versus 47 +/- 10% (p = 0.01) in the thrombolysis group. We conclude that initial Danish experience with primary PTCA is promising, and that this treatment may favourably affect the outcome of acute myocardial infarction.     

Randomized trial of direct coronary angioplasty versus intravenous streptokinase in acute myocardial infarction

OBJECTIVES: The objective of this study was to obtain preliminary data on the relative clinical utility of direct coronary angioplasty compared with that of intravenous thrombolytic therapy for patients with acute myocardial infarction. BACKGROUND: The relative merits of intravenous thrombolytic therapy and direct coronary angioplasty as treatment for acute myocardial infarction are incompletely understood, and randomized trials of these treatments have been extremely limited. METHODS: One hundred patients with ST segment elevation presenting to a single high volume interventional center within 6 h of the onset of chest pain were randomized to receive either streptokinase (1.2 million U intravenously over 1 h) or immediate catheterization and direct coronary angioplasty. Patients were excluded for age > or = 75 years, prior bypass surgery, Q wave infarction in the region of ischemia or excessive risk of bleeding. All patients were then treated with aspirin (325 mg orally/day) and heparin (1,000 U intravenously/h) for 48 h until catheterization was performed to determine the primary study end point, namely, infarct-related artery patency at 48 h. Secondary end points were in-hospital death, left ventricular ejection fraction at 48 h and time to treatment. RESULTS: There was no difference in the baseline characteristics of the two treatment groups. Overall patient age was 56 +/- 10 years, 83% of patients were male, 11% had prior infarction, 40% had anterior infarction and 97% were in Killip class I or II. Although time to treatment was delayed in the angioplasty group (238 +/- 112 vs. 179 +/- 98 min, p = 0.005), there was no difference in 48-h infarct-related artery patency or left ventricular ejection fraction (patency 74% vs. 80%; ejection fraction 59 +/- 13% vs. 57 +/- 13%; angioplasty vs. streptokinase, p = NS for both). There were no major bleeding events, and the mortality rate with angioplasty (6%) and streptokinase (2%) did not differ (p = NS). CONCLUSIONS: These results suggest that intravenous thrombolytic therapy might be preferred over coronary angioplasty for most patients because of the often shorter time to treatment.     

Cost comparison of immediate angioplasty versus thrombolysis followed by conservative therapy for acute myocardial infarction: a randomized prospective trial. Mayo Coronary Care Unit and Catheterization Laboratory Groups

OBJECTIVE: Immediate angioplasty and thrombolysis followed by conservative therapy are treatment strategies for acute myocardial infarction. The objective of this study was to compare the costs of these two strategies during a 12-month period. METHODS: Of 103 patients with acute myocardial infarction who sought medical assistance within 12 hours after onset of symptoms, 4 were excluded from analysis for various reasons, 51 received tissue plasminogen activator, and 48 underwent immediate angioplasty as the initial revascularization strategy. The main outcome determinants were direct monetary costs and indirect measures of costs, including duration of hospital stay and return to work. RESULTS: No significant difference in monetary costs between the two initial treatment strategies could be demonstrated. A trend was noted toward a briefer hospital stay and fewer late in-hospital procedures for patients treated initially with immediate angioplasty. Other measures of indirect costs were not statistically different. CONCLUSION: The hypothesis that thrombolysis followed by conservative therapy would be more cost-effective than immediate angioplasty in the treatment of patients with acute myocardial infarction could not be substantiated. The two strategies seem to have similar cost-effectiveness.     

Trabeculectomy with releasable sutures: a prospective, randomized pilot study

OBJECTIVE: To compare the short-term and long-term efficacy of using releasable sutures vs conventional interrupted sutures for scleral flap suturing in trabeculectomy. DESIGN: A prospective randomized study. SETTING: A university-affiliated referral eye hospital. PATIENTS: Thirty consecutive patients requiring trabeculectomy for uncontrolled primary glaucoma. INTERVENTION: Fifteen patients underwent trabeculectomy with permanent interrupted sutures; the same number underwent trabeculectomy with releasable sutures. MAIN OUTCOME MEASURES: Incidence of short-term shallowing of anterior chamber or hypotony and related complications, and long-term intraocular pressure control and bleb score. RESULTS: The mean percentage reduction in intraocular pressure on day 1 in the group with releasable sutures was 55.2%, while only a 0.8% reduction in anterior chamber depth was noted. This compared with figures of 59.3% and 10.1%, respectively, in the group without releasable sutures. Hypotony (intraocular pressure < or =6 mm Hg) was noted in 8 (53%) of cases without releasable sutures and 3 (20%) of cases with releasable sutures. Shallow anterior chamber (central anterior chamber depth, < or =1 mm) was noted in 5 (33%) of cases without releasable sutures and 1 (7%) of cases with releasable sutures. The mean +/- SD final bleb score was 5.4 +/- 0.3 in the group with releasable sutures compared with 4.2 +/- 0.6 in the group without releasable sutures (P<.001). The mean +/- SD final intraocular pressure at the end of 12 months was 16.9 +/- 1.2 mm Hg in the group without releasable sutures and 15.0 +/- 0.9 mm Hg in the group with releasable sutures (P<.001). Final intraocular pressure was controlled (intraocular pressure < or =21 mm Hg) in all patients in the group with releasable sutures, giving a success rate of 100%, and in 12 patients in the group without releasable sutures, giving a success rate of 80%. CONCLUSIONS: Use of releasable sutures is an effective way at no extra cost or instrumentation to maximize the long-term bleb score and lower intraocular pressure, and to minimize the short-term complications of trabeculectomy.     

Abciximab in primary coronary angioplasty for acute myocardial infarction improves short- and medium-term outcomes

OBJECTIVES: The purpose of this study was to compare the outcome of primary percutaneous transluminal coronary angioplasty for acute myocardial infarction (MI) when performed with or without the platelet glycoprotein IIb/IIIa antibody, abciximab. BACKGROUND: Abciximab improves the outcome of angioplasty but the effect of abciximab in primary angioplasty has not been investigated. METHODS: Data were collected from a computerized database. Follow-up was by telephone or review of outpatient or hospital readmission records. RESULTS: A total of 182 consecutive patients were included; 103 received abciximab and 79 did not. The procedural success rate was 95% in the two groups. At 30-day follow-up, the composite event rate of unstable angina, reinfarction, target vessel revascularization and death from all causes was 13.5% in the group of patients who did not receive abciximab, 4% (p < 0.05) in the abciximab group and 2.4% (p < 0.05) in the subgroup of patients (n = 87) who completed the 12-h abciximab infusion. At the end of follow-up (mean 7+/-4 months), the composite event rate was 32.4%, 17% (p < 0.05) and 13.1% (p < 0.01) in these three categories respectively. Abciximab bolus followed by a 12-h infusion was an independent predictor of event-free survival, in a Cox proportional hazards model (relative risk 0.49; 95% confidence interval 0.24 to 0.99; p < 0.05). CONCLUSIONS: Abciximab given at the time of primary angioplasty may improve the short- and medium-term outcome of patients with acute MI, especially when a 12-h infusion is completed.     

Piperacillin/tazobactam versus cefepime as initial empirical antimicrobial therapy in febrile neutropenic patients: a prospective randomized pilot study

The objective of the presented prospective, randomized study was to compare the efficacy of empirical antimicrobial monotherapy with piperacillin/tazobactam (PIP/TAZ) to cefepime (CEFP) for treatment of infections in neutropenic patients. From a total of 102 febrile episodes 100 were evaluable. The most frequent microorganisms were gram-negative, documented in 22% vs. 24% of the febrile episodes (gram-positives 18% vs. 16%, fungi 2% vs. 4%). The response rate was similar with 22/51 (43%) of episodes treated with PIP/TAZ vs. 19/49 (39%) with CEFP. Of the different infection types classified at the end of the febrile episodes, patients with fever of unknown origin (FUO) and primary bacteremias showed the best initial responses with 25/44 (57%) and 11/22 (50%). Lower initial response rates were found in pneumonias with totally 3/13 (23%) and other clinically documented infections with 2/21 (10%), without any difference between both groups. Gram positive infections showed a higher response with PIP/TAZ than with CEFP (4/9 vs. 0/8), gram negative responded less frequently (3/11 vs. 7/13). The median time until persistent defervescence was equal in both groups (2.5 vs. 2 days), likewise the response rates after the different steps of therapy modifications (change to imipenem or ceftazidim, or addition of gentamycin, vancomycin or amphotericin B). Totally, 96% of febrile episodes responded in both therapy arms. Overall, we found no significant differences in efficacy between the two therapeutic regimens. In conclusion, PIP/TAZ as well as CEFP might be a sufficient initial therapy for febrile neutropenia, but further randomized trials with larger patient numbers are necessary.     

Myocardial contrast echocardiography versus dobutamine echocardiography for predicting functional recovery after acute myocardial infarction treated with primary coronary angioplasty

OBJECTIVES: We sought to compare myocardial contrast echocardiography with low dose dobutamine echocardiography for predicting 1-month recovery of ventricular function in acute myocardial infarction treated with primary coronary angioplasty. BACKGROUND: The relation between myocardial perfusion and contractile reserve in patients with acute myocardial infarction, in whom anterograde flow is fully restored without significant residual stenosis, is still unclear. METHODS: Thirty patients with acute myocardial infarction treated successfully with primary coronary angioplasty underwent intracoronary contrast echocardiography before and after angioplasty and dobutamine echocardiography 3 days after the index infarction. One month later, two-dimensional echocardiography and coronary angiography were repeated in all patients and contrast echocardiography in 18 patients. RESULTS: After coronary recanalization, 26 patients showed myocardial reperfusion within the risk area, although 4 did not. At 1-month follow-up, all patients had a patient infarct-related artery without significant restenosis. Both left ventricular ejection fraction and wall motion score index within the risk area significantly improved in the patients with reperfusion ([mean +/- SD] 38 +/- 8% vs. 48 +/- 12%, p < 0.005; and 2.35 +/- 0.5 vs. 2 +/- 0.6, p < 0.001, respectively), but not in those with no reflow. Of the 72 nonperfused segments before angioplasty, 27 showed functional improvement at follow-up. Myocardial contrast echocardiography had a sensitivity and a negative predictive value similar to dobutamine echocardiography in predicting late functional recovery (96% vs. 89% and 89% vs. 93%, respectively), but a lower specificity (18% vs. 91%, p < 0.001), positive predictive value (41% vs. 86%, p < 0.001) and overall accuracy (47% vs. 90%, p < 0.001). CONCLUSIONS: Microvascular integrity is a prerequisite for myocardial viability after acute myocardial infarction. However, contrast enhancement shortly after recanalization does not necessarily imply a late functional improvement. Thus, contractile reserve elicited by low dose dobutamine is a more accurate predictor of regional functional recovery after reperfused acute myocardial infarction than microvascular integrity.     

Direct coronary angioplasty versus thrombolysis in the acute phase of myocardial infarction--inpatient outcome

Both thrombolysis and percutaneous transluminal coronary angioplasty (PTCA) are effective methods for the treatment of acute myocardial infarction (AMI). In our centre we perform primary PTCA during the available schedule of the hemodynamics laboratory. In this article we compare the predischarge evolution of patients submitted to each therapeutic procedure. From January 1996 to June 1997, 298 patients were admitted with the diagnosis of AMI. Eighty-four patients (28%) were thrombolysed (TB group) and 30 patients (10%) underwent primary PTCA (PTCA group). There were no significant differences among the two groups concerning demographic characteristics: age (61 +/- 13--TB and 59 +/- 12 years--PTCA); sex (male 81%--TB; 83%--PTCA), risk factors and previous cardiac history. The mean time since the onset of symptoms until arrival at the hospital was 156 +/- 156 minutes for TB and 202 +/- 210 minutes for PTCA (p < 0.02). The delay since admission until the beginning of treatment was 100 +/- 88 minutes for TB and 119 +/- 142 minutes for PTCA. The primary success rate of PTCA was 94% and there were no complications during the procedure. During the hospital stay, 12 patients developed post-infarction angina in the TB group and two patients in the PTCA group; in 15 patients of the TB group a revascularization procedure was performed (surgery in 5 and PTCA in 10 patients); one patient suffered reinfarction in the TB group. Two patients of the TB group (2.4%) had intracranial hemorrhage; the in-hospital mortality was 9.5% in the TB group and 3.3% in the PTCA (p < 0.001). The mean in-hospital stay was 11 +/- 5.6 in the TB group and 7.8 +/- 2.5 days in the PTCA group (p = 0.055). In our experience, primary PTCA in AMI appeared to be a safe procedure with lower occurrence of coronary events and hemorrhagic complication, with an earlier hospital discharge when compared to thrombolysis.     

One-year outcomes of diabetic versus nondiabetic patients with non-Q-wave acute myocardial infarction treated with percutaneous transluminal coronary angioplasty

Risk factors and outcomes associated with non-Q-wave myocardial infarction (MI) in diabetics and nondiabetics were analyzed for 376 consecutive patients, 77 with diabetes (20%) and 299 nondiabetics (80%), who had non-Q-wave MI and had percutaneous transluminal coronary angioplasty (PTCA) performed before discharge from hospital during the period from January 1992 to February 1996. Diabetics were slightly older (64 +/- 10 years vs 61 +/- 12 years, p <0.053), had more prior coronary artery bypass grafting (CABG) surgery (27% vs 12%, p <0.001), and hypertension (77% vs 49%, p <0.001). There was no significant difference in unstable angina, saphenous vein graft PTCA, single versus multiple vessel disease, or history of MI. PTCA success rates for diabetics versus nondiabetics were similar (96% vs 97%, p = NS). In-hospital complications such CABG, recurrent MI, repeat PTCA, stroke, and death were not statistically significant between the 2 groups. At 1-year follow-up, survival in diabetics (92%) was similar to nondiabetics (94%, p = NS), although event-free survival (PTCA, CABG, MI, death) was worse in diabetics (55% vs 67% for nondiabetics, p <0.05). Although diabetic patients with non-Q-wave MI represent a cohort with more risk factors for poor outcome, aggressive in-hospital revascularization with PTCA results in an excellent short-term outcome as well as 1-year survival similar to the nondiabetic patients. However, total events at 1-year follow-up are more common in the diabetic patients, suggesting that more aggressive screening and therapy in follow-up may be warranted, and that a diabetic with non-Q-wave MI will require increased utilization of cardiovascular resources in the first year after the event.     

Projected cost-effectiveness of primary angioplasty for acute myocardial infarction

OBJECTIVES: This study sought to evaluate the cost-effectiveness of primary angioplasty for acute myocardial infarction under varying assumptions about effectiveness, existing facilities and staffing and volume of services. BACKGROUND: Primary angioplasty for acute myocardial infarction has reduced mortality in some studies, but its actual effectiveness may vary, and most U.S. hospitals do not have cardiac catheterization laboratories. Projections of cost-effectiveness in various settings are needed for decisions about adoption. METHODS: We created a decision analytic model to compare three policies: primary angioplasty, intravenous thrombolysis and no intervention. Probabilities of health outcomes were taken from randomized trials (base case efficacy assumptions) and community-based studies (effectiveness assumptions). The base case analysis assumed that a hospital with an existing laboratory with night/weekend staffing coverage admitted 200 patients with a myocardial infarction annually. In alternative scenarios, a new laboratory was built, and its capacity for elective procedures was either 1) needed or 2) redundant with existing laboratories. RESULTS: Under base case efficacy assumptions, primary angioplasty resulted in cost savings compared with thrombolysis and had a cost of $12,000/quality-adjusted life-year (QALY) saved compared with no intervention. In sensitivity analyses, when there was an existing cardiac catheterization laboratory at a hospital with > or = 200 patients with a myocardial infarction annually, primary angioplasty had a cost of < $30,000/QALY saved under a wide range of assumptions. However, the cost/QALY saved increased sharply under effectiveness assumptions when the hospital had < 150 patients with a myocardial infarction annually or when a redundant laboratory was built. CONCLUSIONS: At hospitals with an existing cardiac catheterization laboratory, primary angioplasty for acute myocardial infarction would be cost-effective relative to other medical interventions under a wide range of assumptions. The procedure's relative cost-ineffectiveness at low volumes or redundant laboratories supports regionalization of cardiac services in urban areas. However, approaches to overcoming competitive barriers and close monitoring of outcomes and costs will be needed.     

Subconjunctival versus peribulbar anesthesia in trabeculectomy: a prospective, randomized study

BACKGROUND AND OBJECTIVE: To compare the use of subconjunctival and peribulbar anesthesia for trabeculectomy. PATIENTS AND METHODS: Sixty patients undergoing trabeculectomy were prospectively randomized to receive either peribulbar or subconjunctival anesthesia. Peribulbar anesthesia consisted of a 3-ml inferior and a 1-ml superior injection of a 1:1 mixture of 2% mepivacaine, 0.75% bupivacaine, and hyaluronidase. Subconjunctival anesthesia consisted of a 1- to 2-ml injection of the same mixture without hyaluronidase in the superotemporal quadrant. Intraoperative pain, presence of eye movements, and complications during surgery were evaluated. RESULTS: The frequency and intensity of pain was statistically similar between the two groups. All episodes of pain (20% in the subconjunctival group and 6.6% in the peribulbar group) were rated as mild. Eye movement was more common in the subconjunctival group than in the peribulbar group, but it was controlled by verbal command and did not interfere with the procedure. No clinically significant complications occurred during surgery. CONCLUSION: Subconjunctival anesthesia is an effective alternative to peribulbar anesthesia for trabeculectomy.     

Laparoscopic versus conventional appendectomy: a prospective randomized study

The discussion about laparoscopic appendectomy has increased since the introduction of this method. Randomized comparisons are still feasible, whereas this cannot be stated for other laparoscopic procedures (e.g., laparoscopic cholecystectomy). This randomized controlled trial included 170 patients. Open appendectomy was employed in 83 patients, and 87 were treated laparoscopically. The treatment groups were comparable regarding age, sex, Broca index, ASA classification, preliminary operations, and preoperative leucocytes. No statistically significant differences could be found with respect to surgical and general complications, operating time, consumption of analgesics and antibiotics, and return to work. The analysis revealed a statistically significant shorter hospital stay, a shorter time until return to normal physical activity, and a shorter duration of complaints for the laparoscopic group. We were unable to demonstrate any statistically significant advantage in using the open procedure.     

A comparison of thrombolytic therapy with primary coronary angioplasty for acute myocardial infarction. Myocardial Infarction Triage and Intervention Investigators

BACKGROUND: Several relatively small randomized trials have shown that primary angioplasty results in a better short-term outcome than thrombolytic therapy in patients with acute myocardial infarction. These results, however, have not been duplicated other than in investigational trials. METHODS: We compared mortality during hospitalization and long-term mortality, as well as the use of resources, among 1050 patients in a primary-angioplasty group and 2095 patients in a thrombolytic-therapy group. Patients were selected from the Myocardial Infarction Triage and Intervention Project Registry cohort of 12,331 consecutive patients admitted with acute myocardial infarction to 19 Seattle hospitals between 1988 and 1994. Because of the potential for selection bias, several subgroup analyses were performed that included patients eligible for thrombolysis, high-risk patients, and patients in the primary-angioplasty group who were treated at hospitals with high volumes of angioplasty. RESULTS: There was no significant difference in mortality during hospitalization or long-term follow-up between patients in the thrombolytic-therapy group and those in the primary-angioplasty group (mortality during hospitalization, 5.6 percent and 5.5 percent, respectively; P=0.93; adjusted hazard ratio for the risk of death within three years after primary angioplasty, 0.95; 95 percent confidence interval, 0.8 to 1.2). There was also no significant difference in mortality between high-risk subgroups of patients in the two treatment groups. The rates of procedures and costs were lower among patients in the thrombolytic-therapy group both at the time of hospital discharge and after three years of follow-up (30 percent fewer coronary angiograms, 15 percent fewer coronary angioplasties, and 13 percent lower costs after three years of follow-up). CONCLUSIONS: In a community setting, we observed no benefit in terms of either mortality or the use of resources with a strategy of primary angioplasty rather than thrombolytic therapy in a large cohort of patients with acute myocardial infarction.     

Serial changes of plasma plasminogen activator inhibitor activity in acute myocardial infarction: difference between thrombolytic therapy and direct coronary angioplasty

The fibrinolytic system is impaired in patients with acute myocardial infarction (AMI). The primary regulatory element of fibrinolytic activity is plasminogen activator inhibitor (PAI). There are no reports, however, on the serial changes of PAI activity after thrombolysis or coronary angioplasty in patients with AMI undergoing emergency coronary angiography. This study was designed to examine the difference in the change of fibrinolytic activity between patients with AMI who underwent thrombolytic therapy with recombinant tissue-plasminogen activator (rTPA) and those who underwent direct percutaneous coronary angioplasty (PTCA). We measured the serial changes of PAI activity and tissue plasminogen activator (TPA) antigen after rTPA therapy or direct PTCA. Twenty-two patients received emergency coronary angiography and were treated with rTPA intravenously. Twenty patients underwent direct PTCA. Plasma PAI activity levels were increased on admission and further increased within 24 hours in patients treated with rTPA and in those treated with direct PTCA. In the thrombolysis group, there were two peaks in plasma PAI activity levels (IU/ml) at 4 hours (27.0 +/- 2.9) and at 16 hours (25.6 +/- 2.5) after the initiation of rTPA infusion. However, in the direct PTCA group, there was one peak of PAI activity (IU/ml) at 16 hours (23.9 +/- 2.7) after the initiation of direct PTCA. In conclusion, the PAI activity has two peaks in the thrombolysis group and one peak in the direct PTCA group.     

Percutaneous transluminal coronary angioplasty versus medical therapy for stable angina pectoris: outcomes for patients with double-vessel versus single-vessel coronary artery disease in a Veterans Affairs Cooperative randomized trial. Veterans Affairs ACME InvestigatorS

OBJECTIVES: This study sought to assess outcomes of men with double-vessel coronary artery disease randomly assigned to treatment by percutaneous transluminal coronary angioplasty (PTCA) or medical therapy, compared with previously reported outcomes for men with single-vessel disease. BACKGROUND: We previously reported that PTCA provides better symptom relief and treadmill performance than medical therapy for men with stable angina pectoris due to single-vessel disease. Whether this advantage applies to patients with double-vessel disease is unknown. METHODS: Male patients (n = 328) with stable angina pectoris and ischemia on treadmill testing were randomly assigned to PTCA or medical therapy; 101 patients had double-vessel disease, and 227 had single-vessel disease. Symptoms, treadmill performance, quality of life score, coronary stenosis and myocardial perfusion were compared at baseline and at 6 months. Patients were followed up for up to 6 years and underwent additional treadmill testing 2 to 3 years after randomization. RESULTS: PTCA-treated and medically treated patients with double-vessel disease experienced comparable improvement in exercise duration (+1.2 vs. +1.3 min, respectively, p = 0.89), freedom from angina (53% and 36%, respectively, p = 0.09) and improvement of overall quality of life score (+1.3 vs. +4.4, respectively, p = 0.32) at 6 months compared with baseline. This contrasts with greater advantages favoring PTCA by these criteria in patients with single-vessel disease (p = 0.0001 to 0.02). Trends present at 6 months persisted at late follow-up. Patients undergoing double-vessel dilation had less complete initial revascularization (45% vs. 83%) and greater average stenosis of worst lesions at 6 months (74% vs. 56%). Likewise, patients with double-vessel disease showed less improved myocardial perfusion imaging (59% vs. 75%). CONCLUSIONS: PTCA is beneficial in male patients with double-vessel disease; however, we cannot demonstrate the same advantage over medical therapy seen in similar patients with single-vessel disease. Less complete revascularization and greater restenosis for patients having multiple dilations would account for these findings. Alternatively, a type 2 error might be operative. Technical advances since completion of this trial might improve these outcomes. These findings warrant further investigation in a larger trial.