Lamberto G. Bentivoglio

Percutaneous transluminal coronary angioplasty in 1985-1986 and 1977-1981. The National Heart, Lung, and Blood Institute Registry

In August 1985, the Percutaneous Transluminal Coronary Angioplasty Registry of the National Heart, Lung, and Blood Institute reopened at its previous sites to document changes in angioplasty strategy and outcome. The new registry entered 1802 consecutive patients who had not had a myocardial infarction in the 10 days before angioplasty. Patient selection, technical outcome, and short-term major complications were compared with those of the 1977 to 1981 registry cohort. The new-registry patients were older and had a significantly higher proportion of multivessel disease (53 vs. 25 percent, P less than 0.001), poor left ventricular function (19 vs. 8 percent, P less than 0.001), previous myocardial infarction (37 vs. 21 percent, P less than 0.001), and previous coronary bypass surgery (13 vs. 9 percent, P less than 0.01). The new-registry cohort also had more complex coronary lesions, and angioplasty attempts in these patients involved more multivessel procedures. Despite these differences, the in-hospital outcome in the new cohort was better. Angiographic success rates according to lesion increased from 67 to 88 percent (P less than 0.001), and overall success rates (measured as a reduction of at least 20 percent in all lesions attempted, without death, myocardial infarction, or coronary bypass surgery) increased from 61 to 78 percent (P less than 0.001). In-hospital mortality for the new cohort was 1 percent, and the nonfatal myocardial infarction rate was 4.3 percent. Both rates are similar to those for the old registry. The long-term efficacy of current angioplasty remains to be determined.

Incidence and consequences of periprocedural occlusion. The 1985-1986 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry.

Of 1,801 patients in the 1985-1986 Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry, 122 (6.8%) had periprocedural occlusion (4.9% in the catheterization laboratory, 1.9% outside the laboratory). Baseline patient factors independently associated with increased occlusion rates included triple-vessel disease, high risk status for surgery, and acute coronary insufficiency. Lesion characteristics showing significant positive association included severe stenosis before PTCA, diffuse or multiple discrete morphology, thrombus, and collateral flow from the lesion. Intimal tear and dissection were also very strongly associated with occlusion. Sixty patients (49%) had a transient occlusion that was reopened with PTCA, 43 (35%) were not redilated and managed with bypass surgery, and 19 (16%) were not redilated and managed medically. In-hospital mortality was 5% in each of these treatment groups, compared with 1% in occlusion-free patients. In-hospital infarction rates ranged from 27% in patients with transient occlusion to 56% in the patients managed with surgery, compared with 2% in patients without occlusion. During 2 years of follow-up, somewhat increased mortality continued in patients with occlusion, whereas follow-up infarction rates were comparable for all patients regardless of occlusion. Patients with an occlusion that was reopened or managed medically had increased rates of surgery during follow-up. Rates of repeat PTCA were comparable (about 23% by 2 years) in patients with transient occlusion and those without occlusion. Occlusion remains a serious complication of angioplasty and is associated most strongly with major events and surgical procedures that occur during the in-hospital period.

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)

Intracoronary thrombus in nontransmural myocardial infarction and in unstable angina pectoris

Although intracoronary thrombus formation plays a major role in acute transmural myocardial infarction (MI), its occurrence in unstable angina (UA) and nontransmural MI has not clearly been established. To determine whether intracoronary thrombus does occur in these syndromes, coronary arteriography was performed before, during, and after intracoronary nitroglycerin and streptokinase infusion in 17 patients. None of the 8 patients with nontransmural MI and 1 of the 9 patients with UA responded to intracoronary nitroglycerin. Seven of 8 patients with nontransmural MI and 4 of 9 patients with UA responded to streptokinase infusion with opening of an occluded vessel, an increase in stenotic diameter, dissolution of an intracoronary filling defect, or a combination of these. Serial opening and closing of ischemia-related vessels occurred spontaneously and in response to streptokinase in some patients in whom thrombolysis was demonstrated. Evidence of thrombolysis was not seen in any patient studied longer than 1 week from the onset of the rest pain syndrome. The finding of thrombolysis in several patients with nontransmural MI and UA suggests that intracoronary thrombus formation plays a pathogenetic role in some patients with these ischemic syndromes.

Long-term efficacy of percutaneous transluminal coronary angioplasty (PTCA): Report from the national heart, lung, and blood institute PTCA registry

The NHLBI PTCA Registry has collected data from 3,079 patients who underwent PTCA at 105 centers from September 1977 through September 1981 that document the initial risks and benefits of PTCA. A subgroup of 2,272 patients at 65 centers was chosen to examine the long-term effects of PTCA (97% follow-up). All patients were followed for 1 year, 191 for 3 years and 57 for 4 years. Initial success occurred in 1,397 (61%), and 72% remained improved at 1 year with no further procedures; during the first year of follow-up, 14% had repeat PTCA, 12% had CABG, 3% had MI and 1.6% died. After 1 year, 67% were asymptomatic; of these, 52% had no other procedure, 7% had a second PTCA and 8% had CABG. Follow-up at 2 to 4 years was similar except that there were few repeat PTCA or CABG procedures after 1 year. The annual mortality rate after PTCA in patients with 1-vessel diseases was less than 1% per year and with multivessel CAD, 3% per year. Thus, successful PTCA alone results in sustained improvement in 84% of patients; 59% were asymptomatic (12% had repeat PTCA). PTCA offers extended effective therapy in selected patients with CAD.

Idiopathic Dilatation of the Pulmonary Artery

Thirteen patients with idiopathic dilatation of the pulmonary artery are described and their clinical, roentgenologic, electrocardiographic, and hemodynamic features are elaborated. Absence or mildness of symptoms was the most significant finding in this series. A pulmonic systolic murmur was constantly present. The roentgenogram showed various degrees of dilatation of the pulmonary artery in the presence of normal heart size. The electrocardiogram was normal. The hemodynamic studies showed a mild systolic pressure gradient across the pulmonic valve in some cases in the presence of normal right ventricular pressure. A possible explanation of this finding is discussed. Idiopathic dilatation of the pulmonary artery is a benign lesion and does not affect cardiac function to any appreciable degree.

Percutaneous transluminal coronary angioplasty (PTCA) in patients with relative contraindications: results of the National Heart, Lung, and Blood Institute PTCA Registry.

The effects of relative contraindications on the immediate results of PTCA were investigated in 1,939 patients, and on long-term results in 998 patients with isolated stenosis of 1 coronary artery. Immediate results subjected to analysis were: success rate, major complications (coronary occlusion, MI and death) and emergency CABG. The analysis of long-term results included: status of angina pectoris, occurrence of MI, restenosis, repeat PTCA, CABG and death. Unstable angina and previous MI had no negative effects on immediate results, whereas a significantly lower success rate was noted in patients with angina for more than 1 year compared to patients with angina of shorter duration (p less than 0.05) and patients older than 60 years compared with younger patients (p less than 0.01). During follow-up, patients with unstable angina had higher CABG rate (p less than 0.01); the other relative clinical contraindications to PTCA did not exert adverse effects. Angiographically, there was a lower immediate success rate in patients with nonproximal stenosis (p less than 0.001) and in patients with calcium in the affected artery (p less than 0.01) and at the site of stenosis (p less than 0.001). Patients with tubular or diffuse stenoses had similar success rates but higher rates of complications, excluding death, than those with discrete stenoses (p less than 0.01). Patients with eccentric stenoses had a lower success rate and a higher rate of complications and emergency CABG than patients with concentric stenoses (p less than 0.001 for all 3 variables).(ABSTRACT TRUNCATED AT 250 WORDS)

Outcome of percutaneous transluminal coronary angioplasty in subsets of unstable angina pectoris: A report of the 1985–1986 National Heart, Lung, and Blood Institute and percutaneous transluminal coronary angioplasty registry☆

OBJECTIVES The purpose of this study was to characterize the outcome of coronary angioplasty according to the various presentations of unstable angina pectoris. BACKGROUND Although unstable angina is a mosaic of clinical manifestations, a comprehensive analysis of short- and long-term outcome of coronary angioplasty in subsets of unstable angina is not available. METHODS Data from 15 clinical centers for the 857 patients with unstable angina in the 1985-1986 National Heart, Lung, and Blood Institute percutaneous transluminal coronary angioplasty registry were analyzed. Five-year follow-up was available in > 96.5%. Patients were first classified as those with (679 [79%]) or without (178 [21%]) rest angina. Patients were also allocated to five mutually exclusive categories of decreasing unstable angina severity: postinfarction angina, acute coronary insufficiency, plain rest angina, accelerating angina and new onset angina. RESULTS The group with rest angina had more older patients (p < 0.01) and women (p < 0.001), and a greater proportion had a previous myocardial infarction (p < 0.001) and a left ventricular ejection fraction < or = 50% (p < 0.01) than did the group without rest angina. Angiographic characteristics were nearly the same, whereas procedural characteristics and outcome were the same for both categories. At 5-year follow-up, there was a higher crude mortality rate in patients with than without rest angina (p < 0.05). Resolution into five subsets yielded additional information. Women were more represented only in the acute coronary insufficiency and plain rest angina subsets (p < 0.001). Patients with angina after myocardial infarction had the second shortest history of angina (p < 0.001), the highest percent of smokers (p < 0.01) and, with those with acute coronary insufficiency, the highest incidence of congestive heart failure (p < 0.05) and an ejection fraction < or = 50% (p < 0.001). They had the highest percent of totally occluded arteries, coronary thrombus and collateral blood flow received but also the lowest rate of severe stenoses (p < 0.001 for all). Patients with new onset angina had the highest prevalence of single-vessel disease (p < 0.05), critical and complex stenoses (p < 0.001) and no coronary angioplasty-related deaths. The crude 5-year mortality rate was higher for both postinfarction and acute insufficiency groups (p < 0.05) than for the other subsets. After adjustments for risk factors, no significant differences in adverse event rates remained among the different unstable angina subgroups. CONCLUSIONS Analysis of the diverse clinical presentations of unstable angina supports underlying pathogenetic differences. Coronary angioplasty is safe and effective in all subsets of unstable angina. Long-term survival is good in general but is related to the baseline status of left ventricular function.

National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry as a standard for comparison of new devices. When should we use it, and what should we compare?

T he ongoing National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry is a continuation of the registry originally established for studying the safety and efficacy of PTCA when it first became available for nonsurgical coronary revascularization. The 1979-1981 registry consisted of the consecutive cases performed by the pioneers in the field. To study long-term efficacy, the registry was extended to include a minimum 5-year follow-up. During these 5 years, there were important improvements in dilatation equipment, which had a major impact on case selection and outcome. Documentation of this rapid technological improvement was accomplished by the same investigators who entered a new series of consecutive cases in the registry between August 1985 and May 1986. The multicenter nature of the data base, the excellence of the coop-

Frequency and importance of unprovoked coronary spasm in patients with angina pectoris undergoing percutaneous transluminal coronary angioplasty

Abstract Coronary spasm superimposed on fixed coronary artery stenosis was discovered in 14 of 74 candidates for percutaneous transluminal coronary angioplasty (PTCA). In 3 of the 14, spasm developed during PTCA and was presumably catheter-induced. Eleven of the 14, with unprovoked spasm, are the subject of this study. Three of the 11, in whom the fixed component of the mixed stenosis was subcritical were treated medically, with good results in 2 but with persistent angina pectoris and eventual myocardial infarct in 1. Nitroglycerin administered by the intracoronary route relieved spasm resistant to sublingual nitroglycerin in 1 of the 3. In 8 of the 11 with critical fixed stenosis, spasm was discovered either before PTCA (7 patients) or on follow-up (1 patient). Six of the 8 had successful PTCA, with no or mild symptoms on follow-up. Of the 2 failures, 1, uncomplicated, was followed by successful elective coronary artery bypass surgery while the other, complicated, led to successful emergency coronary artery bypass surgery, with disappearance of symptoms in both. The rate of success was similar in patients with documented unprovoked spasm (6 of 8) and patients without (39 of 63, 62%). It is concluded that (1) coronary spasm, if properly sought for, is probably not uncommon in single-vessel candidates for PTCA; (2) patients considered candidates for PTCA should have intracoronary nitroglycerin administered before PTCA; (3) in patients with critical, fixed coronary artery disease, associated spasm does not reduce the chances of successful PTCA; (4) coronary spasm may outlast the relief by PTCA of the fixed component of the mixed stenosis and requires long-term vasodilator therapy; and (5) the lack of adverse effects when PTCA is performed in patients with spasm superimposed on critical fixed single-vessel stenosis appears to justify its use for the time being.