The complications reported in the first 1500 patients enrolled in the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry are analyzed. Data were contributed from 73 centers between September 1977 and April 1981. PTCA was successful in 63% of attempts. Five hundred forty-three in-hospital complications occurred in 314 patients (21%). The most frequent complications were prolonged angina in 121, myocardial infarction (MI) in 72, and coronary occlusion in 70. One hundred thirty-eight patients (9.2%) had major complications (MI, emergency surgery or in-hospital death). One hundred two patients (6.8%) required emergency surgery, usually for coronary dissection or coronary occlusion. Sixteen patients (1.1%) died in-hospital; the mortality rate was 0.85% in patients with one-vessel disease and 1.9% in those with multivessel disease. The mortality rate was significantly higher in patients who had had bypass surgery (p less than 0.001). Nonfatal complications were significantly influenced by the presence of unstable angina (p less than 0.001) and initial lesion severity greater than 90% diameter stenosis (p less than 0.001). This report delineates and assesses the complications encountered with PTCA during its initial 3 1/2-year clinical experience. These results support the relative safety of PTCA as a method of nonsurgical myocardial revascularization in carefully selected patients.

Registry, 122 (6.8%) had periprocedural occlusion (4.9%o in the catheterization laboratory, 1.9%o 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 PITCA 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. (Circulaon 1990;82:739-750) T he occurrence of periprocedural occlusion either in or out of the catheterization laboratory has remained a serious complication of percutaneous transluminal coronary angioplasty

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.

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)

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