Randomized trial of contrast media utilization in high-risk PTCA: the COURT trial.

BACKGROUND: Previous in vitro and in vivo studies have suggested an association between thrombus-related events and type of contrast media. Low osmolar contrast agents appear to improve the safety of diagnostic and coronary artery interventional procedures. However, no data are available on PTCA outcomes with an isosmolar contrast agent. METHODS AND RESULTS: A multicenter prospective randomized double-blind trial was performed in 856 high-risk patients undergoing coronary artery intervention. The objective was to compare the isosmolar nonionic dimer iodixanol (n=405) with the low osmolar ionic agent ioxaglate (n=410). A composite variable of in-hospital major adverse clinical events (MACE) was the primary end point. A secondary objective was to evaluate major angiographic and procedural events during and after PTCA. The composite in-hospital primary end point was less frequent in those receiving iodixanol compared with those receiving ioxaglate (5.4% versus 9.5%, respectively; P=0.027). Core laboratory defined angiographic success was more frequent in patients receiving iodixanol (92.2% versus 85. 9% for ioxaglate, P=0.004). There was a trend toward lower total clinical events at 30 days in patients randomized to iodixanol (9.1% versus 13.2% for ioxaglate, P=0.07). Multivariate predictors of in-hospital MACE were use of ioxaglate (P=0.01) and treatment of a de novo lesion (P=0.03). CONCLUSIONS: In this contemporary prospective multicenter trial of PTCA in the setting of acute coronary syndromes, there was a low incidence of in-hospital clinical events for both treatment groups. The cohort receiving the nonionic dimer iodixanol experienced a 45% reduction in in-hospital MACE when compared with the cohort receiving ioxaglate.

Seven year survival of patients with normal or near normal coronary arteriograms: a CASS registry study.

The effect on 7 year survival of having a normal or near normal coronary arteriogram was examined using data from the CASS registry of 21,487 consecutive coronary arteriograms taken in 15 clinical sites. Of these, 4,051 arteriograms were normal or near normal, and the patients had normal left ventricular function as judged by absence of a history of congestive heart failure, no reported segmental wall motion abnormality and an ejection fraction of at least 50%; 3,136 arteriograms were entirely normal and the remaining 915 revealed mild disease with less than 50% stenosis in one or more segments. The 7 year survival rate was 96% for the patients with a normal arteriogram and 92% for those whose study revealed mild disease (p less than 0.0001). Nine risk variables recorded at entry were analyzed for predictive value for survival: age, sex, height, weight, history of smoking, presence of absence of mild disease, electrocardiographic response to exercise, family history of coronary heart disease and a history of hypertension. Of these, age, smoking history, presence or absence of disease and a history of hypertension had predictive value.

Combined percutaneous coronary atherectomy and coronary angioplasty: experience in 19 consecutive patients.

Among 82 patients undergoing coronary atherectomy, 19 (23%) underwent this procedure in combination with coronary angioplasty. The most frequently involved vessel was the left anterior descending coronary artery. In 11 patients (58%), attempted atherectomy preceded coronary angioplasty. In 6 of the 11, angioplasty was used after the atherectomy catheter could not be positioned across the lesion; 4 patients underwent "rescue" angioplasty after developing vessel occlusion related to atherectomy and 1 patient had an unsatisfactory result of atherectomy. The success rate of the combined intervention was 82% for these 11 patients. In eight patients (42%), atherectomy was performed after initial angioplasty. In four of the eight, atherectomy was a rescue procedure to manage vessel occlusion by thrombus or intimal dissection and was successful in three. In the other four, angioplasty was performed to establish an easier passage for the atherectomy catheter and was successful in three. Thus, the success rate of the combined intervention was 75% for these eight patients. The overall success rate for all 19 patients was 79%; there was one in-hospital death and one non-Q wave infarction, and one patient required immediate coronary artery surgery. Two other patients underwent coronary artery surgery before hospital discharge. Combined intervention with coronary angioplasty and atherectomy seems to be a relatively safe and effective approach in selected patients when either of these procedures alone is unsuccessful or is accompanied by acute coronary complications.

Changing experience with dual chamber (DDD) pacemakers.

Dual chamber (DDD) or "universal" pacemakers have had a significant impact on the advancement of artificial pacemakers by providing a more physiologic approach to cardiac pacing. However, with the early generation of DDD pacemakers (pacemakers that sense and pace in both the atrium and the ventricle), a significant number of patients experienced pacemaker-mediated tachycardia because intact ventriculoatrial conduction was sensed in the atrium and a reentrant tachycardia was induced. Newer generation DDD pacemakers have provided longer atrial refractory periods, which should correct this problem. In this study the first and second years of a 2 year experience with DDD pacemakers were compared to determine if the newer generation devices have allowed maintenance of pacing in the DDD mode as opposed to reprogramming to some alternate mode because of pacemaker-mediated tachycardia or other pacing problems. The results showed a significant decrease in pacemaker-mediated tachycardia during the second year and continuation of pacing in the DDD mode in a higher percent of patients. This improvement is attributed to improvement in the pulse generator as well as better patient selection.

Differential histopathology of primary atherosclerotic and restenotic lesions in coronary arteries and saphenous vein bypass grafts: analysis of tissue obtained from 73 patients by directional atherectomy.

Vascular tissue obtained using a directional percutaneous atherectomy device was examined microscopically. Tissue was obtained from coronary arteries without prior instrumentation (primary lesions, n = 31), aortocoronary saphenous vein bypass grafts with primary lesions (n = 8), coronary arteries with lesions developing after prior balloon angioplasty or mechanical atherectomy (restenotic lesions, n = 30) and vein bypass grafts with restenotic lesions (n = 4). Primary lesions were characterized by dense intimal fibrosis with necrotic debris (83% of intimal tissue) and foam cells typical of atherosclerosis. These lesions frequently contained cholesterol crystals (45% of coronary arteries, 50% of vein grafts) and calcium deposits (65% of coronary arteries, 38% of vein grafts). Restenotic lesions were characterized by an increased proportion of loose fibroproliferative tissue (45% of coronary artery intima, 35% of vein graft intima). Immunohistochemical stains confirmed this proliferative tissue to be primarily smooth muscle cells. Thrombus was rarely observed. Comparison of resected tissues indicated that dense fibrosis and necrosis are significantly more common in primary than in restenotic lesions (83% versus 56% of intimal tissue, p = 0.0005), whereas smooth muscle cell hyperplasia is more common in restenotic than in primary lesions (44% versus 17% of intimal tissue, p less than 0.0005). Partial-thickness resection of medial tissue or full-thickness resection of media with associated adventitial tissue occurred in 27 (56%) of 39 primary atheromatous lesions and 16 (47%) of 34 restenotic lesions; subintimal tissue obtained from primary lesions appeared identical to that obtained from restenotic lesions. These data indicate that the histopathologic characteristics of the neointimal layer of restenotic lesions differ from those of the intimal layer of primary atherosclerotic lesions.(ABSTRACT TRUNCATED AT 250 WORDS)

Systemic embolism in chronic left ventricular aneurysm: incidence and the role of anticoagulation.

The incidence and prevention of systemic embolism in patients with chronic left ventricular aneurysm have been controversial. This retrospective study investigated the incidence of clinically evident embolic events and the effect of oral anticoagulation in patients with unequivocal angiographically defined left ventricular aneurysm. Between 1971 and 1979, 76 patients met the ventriculographic criteria and received initial medical management. The median interval from myocardial infarction to ventriculography was 11 months (range 1 month to 16 years) and subsequent median follow-up time was 5 years. Twenty patients receiving anticoagulant therapy were followed up for a total of 40 patient-years and 69 patients not on anticoagulant therapy were followed up for a total of 288 patient-years; 13 patients were included in both subsets. Twenty-eight patients died during follow-up and the 3 and 5 year survival rates were 75 and 61%, respectively. Only one patient not receiving anticoagulant therapy had a clinical embolic event, resulting in an incidence of 0.35 per 100 patient-years. Therefore, in the absence of other predisposing conditions, the extremely low incidence of systemic emboli in these patients with chronic (first documented at least 1 month after myocardial infarction) left ventricular aneurysm does not justify the use of long-term oral anticoagulant therapy.

Balloon angioplasty of aortocoronary saphenous vein bypass grafts: a histopathologic study of six grafts from five patients, with emphasis on restenosis and embolic complications.

Among 103 patients undergoing percutaneous transluminal balloon angioplasty of obstructed aortocoronary saphenous vein bypass grafts at the Mayo Clinic, six grafts from 5 patients were available for histopathologic examination. The interval from graft insertion to angioplasty ranged from 5 to 105 months and that from angioplasty to graft excision ranged from 6 h to 24 months. Angioplasty produced intimal fissures in three grafts initially obstructed by intimal fibromuscular proliferation. Healing and restenosis resulted from filling of lacerations with fibrocellular tissue and apparently also from restitution of muscular tone. In two of three grafts initially narrowed by atherosclerosis, balloon angioplasty cause extensive plaque rupture and restenosis resulted from extrusion of plaque debris and secondary luminal thrombosis. In the third graft, angioplasty produced no distinct lesions and late restenosis was due to progressive atherosclerosis of the vein graft. Atheroembolization was observed in both patients with plaque rupture and was associated with reoperation in one and death in the other. In conclusion, the results derived from six saphenous vein bypass grafts subjected to balloon angioplasty indicate that restenosis may result from intimal fibrocellular proliferation, thrombosis, restitution of muscular tone and progressive atherosclerosis. Symptomatic atheroembolization may occur in grafts greater than 1 year old.

Initial experience with reuse of coronary angioplasty catheters in the United States.

OBJECTIVES: We sought to evaluate the performance of angioplasty catheters, restored under a strict manufacturing process, in patients with coronary artery disease. BACKGROUND: Most countries outside the United States routinely reuse disposable medical equipment, resulting in significant cost savings. Because of quality and legal concerns, reuse in the United States has been limited. We investigated the reuse of percutaneous transluminal coronary angioplasty (PTCA) balloon catheters, restored by a process strictly controlled for bioburden and sterility, in patients undergoing PTCA. METHODS: Used PTCA balloon catheters were shipped to a central facility and were decontaminated, cleaned and tested for endotoxin using the limulus amebocyte lystate (LAL) gel clot method. Physical testing and quality assurance were performed. The products were packaged and sterilized with ethylene oxide. Catheter performance was assessed in a pilot study powered to detect a 5% difference in the angiographic failure rates of new and reused balloons (beta 0.8). RESULTS: The study enrolled 107 patients. The indication for PTCA was stable angina pectoris in 69 patients, unstable angina in 22 and acute myocardial infarction in 16. Of the 107 patients enrolled, 106 had a successful laboratory outcome, and 1 required coronary artery bypass graft surgery after failed rescue stenting. There were 122 lesions attempted (American College of Cardiology/American Heart Association classification A, n = 32; B1, n = 43; > or = B2, n = 35; C, n = 12). Of the 110 lesions initially approached with restored PTCA catheters, 108 were crossed and dilated. Sixty-four required no further procedures. Stenting was performed in 37 patients (29 planned, 8 rescue). Thus, the angiographic failure rate was 7% (10 of 108, 95% confidence interval 2% to 12%), comparable to the 10% rate seen with new balloons in other studies. CONCLUSIONS: Restoration of disposable coronary angioplasty catheters using a highly controlled process appears to be safe and effective, with success rates similar to those of new products and no detectable sacrifice in performance. Cost analysis suggests that implementation of reuse technology for expensive disposable equipment may offer cost savings for U.S. hospitals, without sacrifice of quality.

Coronary morphology after percutaneous directional coronary atherectomy in humans: autopsy analysis of three patients.

The morphologic basis of angiographically successful percutaneous directional atherectomy and subsequent restenosis in human coronary arteries is unknown. The clinical and pathologic features of three patients who died after coronary atherectomy are described. Tissue fragments obtained with atherectomy demonstrated atheromatous and fibroproliferative intima, media and adventitia. At autopsy, treated vascular segments (from the left anterior descending artery in two patients and a vein graft in one patient) demonstrated discrete defects in the vascular wall. Defects extending into atheroma, media or adventitia corresponded with the presence of these tissues in the atherectomy specimens. Tissues were otherwise not disrupted in the manner associated with balloon angioplasty. Acute mural thrombus deposition was evident in the resection zone in one patient. Late findings included fibroproliferative intimal tissue extending from the resected areas into the vascular lumen. In one patient intimal hyperplasia was sufficient to narrow the vascular lumen by 82% and was implicated in subsequent myocardial ischemia and infarction. The study indicates that 1) the vascular injury associated with atherectomy is distinct from that associated with balloon angioplasty, 2) acute mural thrombus deposition may occur even with resection limited to the intima, and 3) intimal hyperplasia may develop in regions treated with atherectomy and may be associated with late myocardial ischemia and infarction.

Anomalous coronary arteries: location, degree of atherosclerosis and effect on survival--a report from the Coronary Artery Surgery Study.

Limited information is available about clinical presentation, degree of atherosclerosis and effect on overall survival in a large series of patients with coronary artery anomalies. From the National Heart, Lung, and Blood Institute Multicenter Coronary Artery Surgery Study (CASS), detailed coding of coronary angiograms was available in 24,959 patients. Of these patients, 73 (0.3%) had major coronary artery anomalies: 70 had one coronary anomaly and 3 had two coronary anomalies. The most common anomaly involved the circumflex coronary artery (60%). In 69% of these, the circumflex artery arose from a separate ostium in the right coronary sinus, and in 31% it originated as a branch of the right coronary artery. The most common anomalous course was anterior or posterior to the great vessels but not between the great vessels. The major exception to this finding was an anomalous right coronary artery; 7 of 15 such arteries coursed between the great vessels. Anomalous circumflex coronary arteries had a significantly greater degree of stenosis than that in nonanomalous arteries in age- and gender-matched control patients (p = 0.02). Despite this difference, at 7 years there was no significant difference in survival by location or degree of stenosis in the anomalous artery.

A randomized comparison of the nephrotoxicity of iopamidol and diatrizoate in high risk patients undergoing cardiac angiography.

Three hundred seven high risk patients with renal impairment (serum creatinine greater than or equal to 1.5 mg/dl) were randomized in a double-blind manner to either iopamidol (a nonionic, low osmolar radiocontrast agent) or diatrizoate (a conventional radiocontrast agent) at cardiac angiography with subsequent follow-up study of renal function. Baseline clinical and angiographic variables were similar in the iopamidol (n = 155) and diatrizoate (n = 152) groups. Change in renal function after angiography was less pronounced with iopamidol compared with diatrizoate as measured by mean ( +/- SD) increase in 24 h serum creatinine (0.11 +/- 0.2 versus 0.22 +/- 0.26 mg/dl, p less than 0.001), mean maximal increase in serum creatinine (0.2 +/- 0.44 versus 0.38 +/- 0.73 mg/dl, p less than 0.0001) and percent of patients with a maximal increase in serum creatinine greater than 0.5 mg/dl (8% versus 19%, p less than 0.01). Such differences could not be documented in diabetic patients using insulin. There was no significant difference between agents in the number of patients developing clinically severe acute renal dysfunction. It is concluded that iopamidol is less nephrotoxic than diatrizoate in high risk patients at cardiac angiography. However, the difference in nephrotoxicity is small, of no major clinical significance in the majority of high risk patients and could not be documented in insulin-using diabetic patients. Iopamidol may be the preferred agent in certain patients with advanced renal impairment, but further study is warranted.

Intracoronary thrombus: role in coronary occlusion complicating percutaneous transluminal coronary angioplasty.

Angiograms from 238 consecutive patients who underwent percutaneous transluminal coronary angioplasty at the Mayo Clinic were reviewed to determine the presence of intracoronary thrombus before dilation. Patients with previously occluded vessels and those receiving streptokinase therapy were excluded. Intracoronary thrombus before dilation was present in 15 patients (6%); complete occlusion occurred in 11 (73%) of these during or immediately after dilation. None of these patients had angiographic evidence of major intimal dissection. In contrast, among the 223 patients in whom no intracoronary thrombus was present before dilation, complete occlusion occurred in 18 (8%) and in 12 was associated with major intimal dissection. The difference between the complete occlusion rates for patients with and without prior intracoronary thrombus was highly significant (73 versus 8%, respectively, p less than 0.001). Therefore, the presence of intracoronary thrombus identifies a group of patients who are at increased risk of developing complete occlusion during or after attempted coronary artery dilation.

Restenosis after directional coronary atherectomy: differences between primary atheromatous and restenosis lesions and influence of subintimal tissue resection.

Rates of restenosis were evaluated in 70 patients (74 lesions) after successful directional coronary atherectomy. The extent of vascular tissue resection was correlated with restenosis rates for coronary (n = 59) and vein bypass graft (n = 15) lesions. After 6 months, the overall restenosis rate was 50% (37 of 74 lesions); it was 42% (15 of 36 lesions) when intima alone was resected, 50% (7 of 14 lesions) when media was resected and 63% (15 of 24 lesions) when adventitia was resected. Subintimal tissue resection increased the restenosis rate for vein grafts (43% with intimal resection versus 100% with subintimal resection, p = 0.01) but not for coronary arteries (50% versus 48%). There was no overall difference in restenosis rates after atherectomy between primary lesions and restenosis lesions that occurred after balloon angioplasty (46% versus 54%). Among postballoon angioplasty restenosis lesions, a higher rate of restenosis after atherectomy was found with subintimal than with intimal resection (78% versus 32%, p = 0.01). Tissues from patients undergoing a second atherectomy for restenosis after initial atherectomy (n = 8) demonstrated neointimal hyperplasia that appeared histologically identical to restenotic tissue developing after balloon angioplasty (n = 37). These data suggest that the cellular response to directional coronary atherectomy is characterized by neointimal proliferation similar to that which may develop after balloon angioplasty. The extent of fibrous hyperplasia appears to be related to the depth of tissue resection in vein graft lesions and coronary artery restenosis lesions that occur after balloon angioplasty but not in primary atheromatous coronary artery lesions.

Does intracoronary infusion of Fluosol-DA 20% prevent left ventricular diastolic dysfunction during coronary balloon angioplasty?

Distal intracoronary infusion of the perfluorochemical Fluosol-DA 20% has been shown to prevent systolic dysfunction during coronary artery balloon occlusion in coronary angioplasty. To assess its effect on global diastolic dysfunction, a randomized, single-blind, crossover protocol comparing intracoronary infusion of Fluosol or no infusion (control) was performed during 60 s balloon inflations in 10 patients (mean age 67 years) undergoing coronary angioplasty. Assessment of global systolic and diastolic function was obtained with high fidelity micromanometer measurements of left ventricular pressure. Eighteen pairs of balloon inflations (Fluosol versus control) were analyzed. Patients reported significantly less severe chest pain during inflations accompanied by Fluosol compared with control. However, during coronary balloon occlusion, no significant differences in the changes from baseline values were observed between Fluosol and control with regard to ventricular relaxation, including the time constant of early ventricular relaxation (tau) and maximal rate of fall in left ventricular pressure (maximal negative dP/dt). No differences between Fluosol and control were observed in terms of the increase in end-diastolic pressure or minimal diastolic pressure during balloon inflation. Mean systolic pressure decrease from baseline values was greater during control than during Fluosol inflations (-9.0 +/- 3.3 mm Hg, p = 0.013), but no significant difference was observed in the change in maximal rate of rise in left ventricular pressure (maximal positive dP/dt). These results suggest that Fluosol does not preserve global left ventricular diastolic function during coronary balloon occlusion, possibly because of its limited oxygen delivery capability relative to arterial blood.

Restenosis and the proportional neointimal response to coronary artery injury: results in a porcine model.

Restenosis is a reparative response to arterial injury occurring with percutaneous coronary revascularization. However, the quantitative characteristics of the relation between vessel injury and the magnitude of restenotic response remain unknown. This study was thus performed to determine the relation between severity of vessel wall injury and the thickness of resulting neointimal proliferation in a porcine model of coronary restenosis. Twenty-six porcine coronary artery segments in 24 pigs were subjected to deep arterial injury with use of overexpanded, percutaneously delivered tantalum wire coils. The vessels were studied microscopically 4 weeks after coil implantation to measure the relation between the extent of injury and the resulting neointimal thickness. For each wire site, a histopathologic score proportional to injury depth and the neointimal thicknesses at that site were determined. Mean injury scores were compared with both mean neointimal thickness and planimetry-derived area percent lumen stenosis. The severity of vessel injury strongly correlated with neointimal thickness and percent diameter stenosis (p less than 0.001). Neointimal proliferation resulting from a given wire was related to injury severity in adjacent wires, suggesting an interaction among effects at injured sites. If the results in this model apply to human coronary arteries, restenosis may depend on the degree of vessel injury sustained during angioplasty.

Effect of external beam irradiation on neointimal hyperplasia after experimental coronary artery injury.

Human coronary artery restenosis after percutaneous revascularization is a response to mechanical injury. Smooth muscle cell proliferation is a major component of restenosis, resulting in obstructive neointimal hyperplasia. Because ionizing radiation inhibits cellular proliferation, this study tested in a porcine coronary injury model the hypothesis that the hyperplastic response to coronary artery injury would be attenuated by X-irradiation. Deep arterial injury was produced in 37 porcine left anterior descending coronary artery segments with overexpanded, percutaneously delivered tantalum wire coils. Three groups of pigs were irradiated with 300-kV X-rays after coil injury: Group I (n = 10), 400 cGy at 1 day; Group II (n = 10), 400 cGy at 1 day and 400 cGy at 4 days and Group III (n = 9), 800 cGy at 1 day. Eight pigs in the control group underwent identical injury but received no radiation. Treatment efficacy was histologically assessed by measuring neointimal thickness and percent area stenosis. Mean neointimal thickness in all irradiated groups was significantly higher than in the control groups and thickness was proportional to X-ray dose. X-irradiation delivered at these doses and times did not inhibit proliferative neointima. Rather, it accentuated the neointimal response to acute arterial injury and may have potentiated that injury.

Angioplasty in total coronary artery occlusion.

Percutaneous transluminal coronary angioplasty was attempted without streptokinase in 24 patients with total coronary artery occlusion but without acute transmural myocardial infarction. The maximal duration of occlusion was estimated to be 1 week or less in 10 patients, more than 1 to 4 weeks in 6, more than 4 to 12 weeks in 3 and more than 12 weeks in 5. Dilation of the occluded artery was attempted in the left anterior descending coronary artery in 17 patients, in the right coronary artery in 4 and in the circumflex coronary artery in 3. Angioplasty was successful in 13 patients (54%): left anterior descending coronary artery in 59%, right coronary artery in 50% and circumflex coronary artery in 33%. In patients with successful dilation, there was a mean decrease in coronary artery stenosis from 100 to 23%. In the 19 patients whose occlusion was estimated to be of 12 weeks' duration or less, angioplasty was successful in 68%. In the five patients whose occlusion was estimated to be of more than 12 weeks' duration, dilation was not successful in any (p = 0.006). It is concluded that in selected patients with symptomatic coronary artery disease and recent coronary artery occlusion without associated acute myocardial infarction, percutaneous transluminal coronary angioplasty alone may be effective in restoring patency.

Long-term outcome after primary angioplasty: report from the primary angioplasty in myocardial infarction (PAMI-I) trial.

OBJECTIVES: This study sought to compare the two-year outcome after primary percutaneous coronary angioplasty or thrombolytic therapy for acute myocardial infarction. BACKGROUND: Primary angioplasty, that is, angioplasty without antecedent thrombolytic therapy, has been shown to be an effective reperfusion modality for patients suffering an acute myocardial infarction. This report reviews the two-year clinical outcome of patients randomized in the Primary Angioplasty in Myocardial Infarction trial. METHODS: At 12 clinical centers, 395 patients who presented within 12 h of the onset of myocardial infarction were randomized to undergo primary angioplasty (195 patients) or to receive tissue-type plasminogen activator (t-PA) (200 patients) followed by conservative care. Patients were followed by physician visits, phone call, letter and review of hospital records for any hospital admission at one month, six months, one year and two years. RESULTS: At two years, patients undergoing primary angioplasty had less recurrent ischemia (36.4% vs. 48% for t-PA, p = 0.026), lower reintervention rates (27.2% vs. 46.5% for t-PA, p < 0.0001) and reduced hospital readmission rates (58.5% vs. 69.0% for t-PA, p = 0.035). The combined end point of death or reinfarction was 14.9% for angioplasty versus 23% for t-PA, p = 0.034. Multivariate analysis found angioplasty to be independently predictive of a reduction in death, reinfarction or target vessel revascularization (p = 0.0001). CONCLUSIONS: The initial benefit of primary angioplasty performed by experienced operators is maintained over a two-year follow-up period with improved infarct-free survival and reduced rate of reintervention.

Comparison of complications during percutaneous transluminal coronary angioplasty from 1977 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry.

Because the effects of changing technology in percutaneous transluminal coronary angioplasty, increased operator experience and use of the procedure in patients with extensive disease are unknown in regard to complication patterns, the initial 1977-1981 cohort and the recent 1985-1986 cohort of the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry were analyzed with respect to complications. Compared with the initial cohort of 1,155 patients, the 1,801 new cohort patients were older and had an increased prevalence of multivessel coronary artery disease, depressed left ventricular function and prior infarction. Overall complication rates in the recent cohort were either unchanged or decreased from the rates in the initial cohort despite a higher risk patient population. The most significant decreases were in the incidence of coronary spasm (p less than 0.001) and the need for emergency coronary bypass surgery (p less than 0.01). Overall in-hospital mortality was low but was dependent on the extent of vessel disease--0.2% for single vessel disease, 0.9% for double vessel disease and 2.2% for triple vessel disease (p less than 0.001 for linear trend). Acute coronary complications of branch occlusion, dissection or abrupt closure were associated with increased rates of death, nonfatal infarction or need for emergency surgery. Factors showing a multivariate association with increased mortality included a history of congestive heart failure (p less than 0.001), age greater than or equal to 65 years (p less than 0.01), triple vessel or left main coronary artery disease (p less than 0.05), female gender (p less than 0.05) and new onset angina.(ABSTRACT TRUNCATED AT 250 WORDS)

Bailout and corrective use of Gianturco-Roubin flex stents after percutaneous transluminal coronary angioplasty: operator reports and angiographic core laboratory verification from the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention Registry.

OBJECTIVES: We sought to determine the in-hospital clinical outcome and angiographic results of patients prospectively entered into the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention (NHLBI/NACI) Registry who received Gianturco-Roubin stents as an unplanned new device. BACKGROUND: Between August 1990 and March 1994, nine centers implanted Gianturco-Roubin flex stents as an unplanned new device in the initial treatment of 350 patients (389 lesions) who were prospectively enrolled in the NHLBI/NACI Registry. METHODS: Patients undergoing implantation of the Gianturco-Roubin flex stent were prospectively entered into the Gianturco-Roubin stent portion of the NHLBI/NACI Registry. Only subjects receiving the Gianturco-Roubin stent as a new device in an unplanned fashion are included. RESULTS: The mean age of the patient group was 61.8 years, and the majority of the patients were men. A history of percutaneous transluminal coronary angioplasty (PTCA) was present in 35.4% of the group, and 16.9% had previous coronary artery bypass graft surgery. Unstable angina was present in 67.7%. Double- or triple-vessel coronary artery disease was present in 55.4%, and the average ejection fraction was 58%. The presence of thrombus was noted in 7.3%, and 7.2% had moderate to severe tortuosity of the lesion. The angiographic success rate was 92%. Individual clinical sites reported that 66.3% of the stents were placed after suboptimal PTCA, 20.3% for abrupt closure and 13.4% for some other technical PTCA failure. Major in-hospital events occurred in 9.7% of patients, including death in 1.7%, Q wave myocardial infarction in 3.1% and emergency bypass surgery in 6%. Abrupt closure of a stented segment occurred in 3.1% of patients at a mean of 3.9 days. Cerebrovascular accident occurred in 0.3%, and transfusion was required in 10.6%. Vascular events with surgical repair occurred in 8.6% of patients. CONCLUSIONS: Despite these complications, the use of this device for the treatment of a failed or suboptimal PTCA result remains promising given the adverse outcome of abrupt closure with conventional (nonstent) treatment.