An anti-CD11/CD18 monoclonal antibody in patients with acute myocardial infarction having percutaneous transluminal coronary angioplasty (the FESTIVAL study).

Maximal benefits of coronary reperfusion after acute myocardial infarction (AMI) with ST-segment elevation may be attenuated by neutrophil-mediated reperfusion injury. Inflammatory mediators released from potentially viable myocytes cause activation of neutrophils, which traverse the endothelium and enter the myocardium. This process involves interaction between the neutrophil-expressed CD11/CD18 and endothelial-expressed intercellular adhesion molecule-1 (ICAM-1). Preclinical studies have shown that monoclonal antibodies (MAb) to CD18 can limit infarct size and preserve left ventricular function. We sought to determine the initial clinical safety and tolerability of Hu23F2G (LeukArrest), a humanized MAb to CD11/CD18, in patients with AMI who underwent percutaneous transluminal coronary angioplasty (PTCA). Sixty patients with AMI were randomized to low- (0.3 mg/kg) or high-dose (1.0 mg/kg) Hu23F2G or to placebo immediately before PTCA. We found no clinically significant differences in vital signs, physical examination, laboratory evaluation, or need for subsequent cardiac interventions. In Hu23F2G treatment groups, serum concentration of Hu23F2G increased rapidly to 3,234 +/- 1,298 microg/L (low-dose group) and 15,558 +/- 4409 microg/L (high-dose group) between 5 and 60 minutes, then declined over 72 hours to near-baseline values. Myocardial single-photon emission computed tomographic imaging 120 to 260 hours after PTCA showed no statistically significant differences in final left ventricular defect size. Hu23F2G was well tolerated, with no increase in adverse events, including infections. Thus, Hu23F2G appears safe and well tolerated in patients undergoing PTCA for AMI.

No-touch technique for reducing aortic wall trauma during renal artery stenting.

Cholesterol embolism, a serious but infrequent complication of renal artery stenting, may be avoided by minimizing contact between the guide catheter and the atherosclerotic aorta. In this report, we illustrate the "no-touch" technique for stenting renal arteries. By placing a second 0.035-inch J-wire within the guide catheter during cannulation of the renal artery to prevent the tip of the guide from rubbing the aortic wall, we minimize the contact between the guide catheter and atherosclerotic plaques and reduce the potential for intimal disruption and cholesterol embolization.

Final results of the Balloon vs Optimal Atherectomy Trial (BOAT)

BACKGROUND: Previous directional coronary atherectomy (DCA) trials have shown no significant reduction in angiographic restenosis, more in-hospital complications, and higher 1-year mortality than conventional balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA]). DCA, however, has subsequently evolved toward a more "optimal" technique (larger devices, more extensive tissue removal, and routine postdilation to obtain diameter stenosis <20%). METHODS AND RESULTS: The Balloon vs Optimal Atherectomy Trial (BOAT) was conducted to evaluate whether optimal DCA provides short- and long-term benefits compared with balloon angioplasty. One thousand patients with single de novo, native vessel lesions were randomized to either DCA or PTCA at 37 participating centers. Lesion success was obtained in 99% versus 97% (P=.02) of patients to a final residual diameter stenosis of 15% versus 28% (P<.0001) for DCA and PTCA, respectively, the latter including stents in 9.3% of the patients. There was no increase in major complications (death, Q-wave myocardial infarction, or emergent coronary artery bypass graft surgery [2.8% versus 3.3%]), although creatine kinase-MB >3X normal was more common with DCA (16% versus 6%; P<.0001). Angiographic restudy (in 79.6% of eligible patients at 7.2+/-2.6 [median, 6.9] months) showed a significant reduction in the prespecified primary end point of angiographic restenosis by DCA (31.4% versus 39.8%; P=.016). Clinical follow-up to 1 year showed nonsignificant 13% to 17% reductions in the DCA arm of the study for mortality rate (0.6% versus 1.6%; P=.14), target-vessel revascularization (17.1% versus 19.7%; P=.33), target-site revascularization (15.3% versus 18.3%; P=.23), and target-vessel failure (death, Q-wave myocardial infarction, or target-vessel revascularization, 21.1% versus 24.8%; P=.17). CONCLUSIONS: Optimal DCA provides significantly higher short-term success, lower residual stenosis, and lower angiographic restenosis than conventional PTCA, despite failing to reach statistical significance for reducing late clinical events compared with PTCA with stent backup.

Randomized comparison of coronary thrombolysis achieved with double-bolus reteplase (recombinant plasminogen activator) and front-loaded, accelerated alteplase (recombinant tissue plasminogen activator) in patients with acute myocardial infarction. The RAPID II Investigators.

BACKGROUND: The therapeutic benefit of thrombolytic therapy has been shown to correlate directly with completeness (TIMI grade 3 flow) and speed of reperfusion of the infarct-related coronary artery. The purpose of the RAPID II study was to determine whether a double-bolus regimen of reteplase, a recently developed deletion mutant of wild-type tissue plasminogen activator, could improve 90-minute coronary artery patency rates achieved with the most successful standard regimen, an "accelerated" front-loaded infusion of alteplase. METHODS AND RESULTS: Three hundred twenty-four patients with acute myocardial infarction were randomized to receive (along with intravenous heparin and aspirin) either a 10 plus 10 megaunits double bolus of reteplase or front-loaded alteplase. The primary end point of "patency at 90 minutes, graded according to the TIMI classification" was centrally assessed in a blinded fashion. Infarctrelated coronary artery patency (TIMI grade 2 or 3) and complete patency (TIMI grade 3) at 90 minutes after the start of thrombolytic therapy were significantly higher in the reteplase-treated patients (TIMI grade 2 or 3: 83.4% versus 73.3% for front-loaded alteplase-treated patients, P = .03; TIMI grade 3: 59.9% versus 45.2%, P = .01). At 60 minutes, the incidence of both, patency and complete patency, was also significantly higher in reteplase-treated patients (reteplase versus alteplase, TIMI grade 2 or 3: 81.8% versus 66.1%, P = .01; TIMI grade 3: 51.2% versus 37.4%, P < .03). Reteplase-treated patients required fewer acute additional coronary interventions (13.6% versus 26.5%, P < .01), and 35-day mortality was 4.1% for reteplase and 8.4% for alteplase (P = NS). There were no significant differences between reteplase and alteplase in bleedings requiring a transfusion (12.4% versus 9.7%) or hemorrhagic stroke (1.2% versus 1.9%). CONCLUSIONS: Reteplase, when given as a double bolus of 10 plus 10 megaunits to patients with acute myocardial infarction, achieves significantly higher rates of early reperfusion of the infarct-related coronary artery and requires significantly fewer acute coronary interventions than front-loaded alteplase without an apparent increased risk of complications.

Use of coronary Palmaz-Schatz stent in the percutaneous treatment of vertebral artery stenoses.

A case of chronic vertebrobasilar insufficiency due to severe stenoses at the origins of both vertebral arteries was treated with percutaneous transluminal angioplasty and coronary Palmaz-Schatz stents. Use of stents led to a better angiographic result than angioplasty alone. The patient is improved 8 mo later.

Use of coronary Palmaz-Schatz stent in the percutaneous treatment of an intracranial carotid artery stenosis.

A 69-yr-old man had chronic transient ischemia attacks due to severe stenosis of the intracranial portion of the right carotid artery. After failure of both antiplatelet and anticoagulant therapy, treatment was successful with percutaneous transluminal angioplasty and a coronary Palmaz-Schatz stent. Use of the stent led to a better angiographic result than angioplasty alone. The patient is asymptomatic 4 mo later.

Comparison of fixed-wire and over-the-wire balloon dilatation systems for percutaneous transluminal coronary angioplasty.

There is controversy concerning the relative safety and efficacy of the 2 currently available percutaneous transluminal coronary angioplasty dilatation systems--fixed-wire (FW) and over-the-wire (OW). A randomized, prospective trial comparing the 2 systems was performed to examine this controversy. Of 1,513 patients undergoing percutaneous transluminal coronary angioplasty at 3 centers between June 1990 and October 1991, 602 (40%) fulfilled the eligibility criteria for the study. There were 643 lesions, of which 327 were randomized to FW and 316 to OW systems. There was no difference in the success rate between FW (92%) and OW (94%) systems. Inability to cross with a wire was infrequent with either system (FW: 1.8%; and OW: 1.6%). Inability to cross with a balloon when the wire crossed the lesion did not occur. An FW system was successful in 6 cases (1.9%) in which the OW system had been unsuccessful, whereas an OW system succeeded in 14 (4.3%) after the FW system had been unsuccessful (p = NS). Time to cross stenoses was 200 +/- 21 and 233 +/- 22 seconds, procedural time was 21 +/- 1.3 and 21 +/- 1.0 minutes, fluoroscopy time was 6.7 +/- 0.4 and 7.1 +/- 0.4 minutes, contrast used was 89.0 +/- 4.2 and 84.0 +/- 3.5 ml, and number of cine runs was 5.9 +/- 3.0 and 6.3 +/- 3.4 in the FW and OW systems, respectively. Complications were infrequent with either system (FW: 10.4%; and OW: 9.5%). Acute closure occurred in 1.8 and 2.2% of cases in the FW and OW systems, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Brachial approach directional coronary atherectomy of a left coronary artery saphenous vein bypass graft.

Directional coronary atherectomy (DCA) of a saphenous vein bypass graft to the left coronary artery was performed percutaneously from the brachial artery approach using a 7F endomyocardial biopsy sheath. Initial positioning was accomplished with a left bypass graft catheter inserted in the sheath. This technique permits use of smaller catheters than usual for DCA in patients in whom larger guides cannot be used.

Randomized placebo-controlled trial of amlodipine in vasospastic angina. Amlodipine Study 160 Group.

OBJECTIVES: This study was designed to assess the efficacy and safety of amlodipine, a long-acting calcium channel blocker, in patients with vasospastic angina. BACKGROUND: Previous studies have established the value of short-acting calcium channel blockers in the treatment of coronary spasm. METHODS: Fifty-two patients with well documented vasospastic angina were entered into the present study. After a single-blind placebo run-in period, patients were randomized (in a double-blind protocol) to receive either amlodipine (10 mg) or placebo every morning for 4 weeks. Twenty-four patients received amlodipine and 28 received placebo. All patients were given diaries in which to record both the frequency, severity, duration and circumstances of anginal episodes and their intake of sublingual nitroglycerin tablets. RESULTS: The rate of anginal episodes decreased significantly (p = 0.009) with amlodipine treatment compared with placebo and the intake of nitroglycerin tablets showed a similar trend. Peripheral edema was the only adverse event seen more frequently in amlodipine-treated patients. No patient was withdrawn from the double-blind phase of the study because of an adverse event. Patients who completed the double-blind phase as responders to amlodipine or as nonresponders to placebo were offered the option of receiving amlodipine in a long-term, open label extension phase. During the extension, the daily dose of amlodipine was adjusted to 5 or 15 mg if needed and the rate of both anginal episodes and nitroglycerin tablet consumption showed statistically significant decreases between baseline and final assessment. CONCLUSION: This study suggests that amlodipine given once daily is efficacious and safe in the treatment of vasospastic angina.

Initial treatment of patients with acute ischemic heart disease hospitalized in a community hospital.

During the 1980s, tremendous advances occurred in understanding the pathophysiology of ischemic heart disease. Numerous clinical trials were performed to help clinicians formulate treatment plans and diagnostic schemes to care for patients with coronary artery disease. To see how these studies affect the evaluation and treatment of patients with acute coronary syndromes today, we reviewed the hospital records of patients admitted to our community hospital during September 1990. We found that such patients generally have a good short-term prognosis. Most can be stabilized using modern medical means, and in-hospital mortality is low. Antithrombotic and antianginal therapies are used liberally. Thrombolytic therapy is administered commonly, even to elderly patients. Invasive and noninvasive diagnostic testing procedures are both used frequently, and most acute myocardial infarction and unstable angina patients undergo revascularization.

Coronary angioplasty in patients who were considered poor bypass surgery candidates.

In most patients who undergo coronary angioplasty (PTCA), coronary bypass surgery (CABG) is an alternative. Patients with severe symptoms secondary to coronary disease, amenable to PTCA, but who are poor CABG candidates are commonly seen. From April 1988 to December 1989 PTCA was performed in 751 patients. Patients with evolving infarction (47) were excluded. Of the remaining 704, 605 were considered candidates for CABG and they were compared to the 99 patients not felt to be candidates for CABG. The objective of this report was to compare these 2 patient groups. These salvage PTCA patients were older, had a higher incidence of heart failure, more prior CABG, higher left ventricular end-diastolic pressure and lower ejection fraction (all p less than 0.01). PTCA had a high success rate per lesion in both groups (96% CABG candidates vs. 95% salvage patients), but there were more patients whose culprit lesion could not be dilated in the salvage group (14% vs. 7%, p less than 0.02). Severe complications including Q wave infarction (2% vs. .3%) and in-hospital death (7% vs. 0.2%) were more common in salvage patients. As planned, emergency CABG was not performed on any salvage PTCA patient but on 2.6% of the other patients. Patients who may benefit from PTCA but were not felt to be operable made up 13% of our PTCA experience. PTCA can be performed in these patients but risks were increased.

Randomized comparison of over-the-wire and fixed-wire balloon devices for coronary angioplasty.

One hundred and fifteen consecutive patients undergoing coronary angioplasty (PTCA) were randomized to low profile over-the-wire (OTW, e.g., Mini, Sulp II) or fixed-wire (FW, e.g., Ace, Orion, Probe) PTCA balloon wire devices. Overall success, ability to begin and finish with the same balloon device, fluoroscopy time, physician time, and amount of contrast media used were prospectively assessed. Overall final success rate was excellent regardless of which type of system was used first (OTW 92%; FW 96%). In 6 patients no wire would cross, in another, the stenosis would not dilate despite high pressure ( greater than 18 atm). When an OTW device was used first, it was initially successful in 69% of patients and was changed with success to a second OTW balloon in 4 (cumulative 76%). An OTW balloon was changed to FW in 11 patients (success 9 patients, 82%). This was because of inability to cross with balloon of the OTW system after a steerable wire had crossed in 9 of the patients. When a FW device was used first, it was initially successful in 89%. A change to another FW device led to success in 4 additional patients (cumulative 96%). In no patient was a FW changed to an OTW device. Thus, a FW device was more likely to be successful (either 54 of 56 patients initially randomized to FW, or 63 of 67 total patient number in whom a FW device was used) than an OTW device (45 of 59 patients) p less than .05.(ABSTRACT TRUNCATED AT 250 WORDS)

Is short-stay coronary angioplasty safe?

Percutaneous transluminal coronary angioplasty (PTCA) is usually performed as an inpatient procedure and the patients are monitored for several days afterward. Over a 13-month period, in 91 of 373 PTCA procedures, the clinical condition of the patient did not necessitate inpatient status before PTCA. PTCA was done the day of admission and discharge planned the following. Overall hospital stay was planned as less than 24 hours. PTCA was done in one vessel in 62 patients, two vessels in 24, three vessels in 3, and four vessels in 2 patients. PTCA was initially successful (less than 50% residual stenosis) in 85 patients (93%). In one of these, acute occlusion occurred the next morning and urgent bypass surgery was done. PTCA failed in 6 patients who left the catheterization laboratory with unchanged coronary anatomy. Bypass surgery was performed that day in 2 patients, on another admission in 1 patient, and medical therapy continued in the other 3 patients. Of the 88 patients not receiving same admission bypass surgery, 84 (95%) were discharged in less than 24 h. Hospitalization was prolonged (1-5 days) in 4 patients. This was because of nonobstructive dissection treated with heparin for approximately 24 h in 2 patients; a catheterization site hematoma in 1 patient, and post-PTCA noncardiac chest pain in another. No patient had inhospital myocardial infarction or death. The only late complication was in a patient treated with heparin and monitored for 2 days; 3 weeks later angina returned and he died suddenly. These data suggest PTCA can safely be done in selected patients with both single and multivessel disease in a short stay inhospital setting.(ABSTRACT TRUNCATED AT 250 WORDS)

A comparison of heparinized low osmolality ionic and nonionic contrast media in 500 patients undergoing cardiac angiography.

Low osmolar contrast media (CM) cause less hemodynamic and electrical changes than conventional CM, and many cardiologist have switched to the newer agents. Recently, concerns about a possible increased frequency of thromboembolic complications with low osmolar CM have been raised. This study compared two low osmolar heparinized CM, one ionic (Hexabrix) and the other nonionic (Isovue), in 500 consecutive patients undergoing either diagnostic catheterization (417) or coronary angioplasty (83). Adverse effects were uncommon (37 patients), but were more frequent with Hexabrix (12%) than Isovue (3%); p less than 0.05. The most common adverse effects were nausea or vomiting. Death, related to abrupt occlusion of a severe left main stenosis occurred in one patient who received Hexabrix, and acute pulmonary edema occurred in one patient who received Isovue. No apparent thromboembolic complication occurred. In conclusion, both low osmolar CM were well tolerated, but Hexabrix caused more transient nausea or vomiting. Both CM were safe and the incidence of thromboembolic complications when prospectively looked for was very low.

The role of coronary angioplasty in the treatment of patients with acute myocardial infarction: one interventional cardiologist's opinion.

The role of percutaneous transluminal coronary angioplasty (PTCA) in patients with evolving or a recent acute myocardial infarction (AMI) continues to be defined. PTCA can be applied in most patients with AMI, but recent controlled trials have shown it will play a more supplemental role to intravenous thrombolysis than previously predicted. PTCA is useful in the immediate treatment of AMI patients with cardiogenic shock, those with contraindications to thrombolytic therapy, those with no clinical response to thrombolytic therapy, and perhaps in those in whom the AMI-related artery remain occluded. During the convalescent phase of AMI, PTCA is useful in patients with recurrent ischemia whether or not thrombolytic therapy was given initially. The percentage of patients with recurrent ischemia will vary depending on how vigorously it is searched for. For example, more patients will be identified if myocardial perfusion scanning is combined with predischarge stress testing than with stress testing alone, which in turn would identify more patients than with ischemia occurring only spontaneously. Whether all patients with "recurrent ischemia" should undergo further evaluation, whether or not ischemia is controlled with antianginal therapy, has not been definitively studied; but my response is in the affirmative.

Hemodynamic and angiographic effects of prostaglandin E1 in coronary artery disease.

The effects of prostaglandin E1 (PGE1) were assessed in 24 patients with coronary artery disease. Quantitative coronary angiography was performed in 15 patients. PGE1 was found to produce dilation of coronary stenoses (6 +/- 12% to intravenous PGE1, difference not significant, 19 +/- 22% to intracoronary PGE1, p less than 0.05), but usually no change in the diameter of angiographically normal segments. In these patients intracoronary nitroglycerin consistently dilated the normal segments not altered with PGE1 and often led to further dilation of the stenoses. In 9 other patients who were undergoing coronary angioplasty, hemodynamics and the time to ischemia induced by coronary occlusion were measured. In both patient groups PGE1 led to decreases in aortic, pulmonary artery and pulmonary arterial wedge pressures and an increase in heart rate (all p less than 0.05). Before coronary occlusion PGE1 produced coronary vasodilation manifested by preservation in coronary sinus flow (130 +/- 41 to 126 +/- 42 ml/min, difference not significant); as aortic pressure declined coronary resistance decreased (0.9 +/- 0.3 to 0.8 +/- 0.3 mm Hg/ml/min, p less than 0.05). During coronary occlusion residual flow to the affected region was usually similar to control occlusions (37 +/- 20 to 36 +/- 25 ml/min, difference not significant) and collateral resistance was decreased (3.2 +/- 2.9 to 2.9 +/- 2.6 mm Hg/ml/min, p less than 0.05). However, time to ischemia usually remained unchanged. PGE1 shows an interesting angiographic and hemodynamic profile in patients with coronary artery disease. Although no obvious clinical benefit was seen, PGE1 was safely administered both intravenously and directly into narrowed coronary arteries.