Gerald Dorros

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.

Four-Year Follow-up of Palmaz-Schatz Stent Revascularization as Treatment for Atherosclerotic Renal Artery Stenosis

BACKGROUND Stent revascularization is perceived as superior to balloon angioplasty and surgical revascularization, but the paucity of stent publications precludes even historical comparison with surgical data. METHODS AND RESULTS Palmaz-Schatz stent revascularization of renal artery stenosis was successfully performed on 163 consecutive patients for poorly controlled hypertension or preservation of renal function. Of these, 145 were eligible for > or =6-month clinical follow-up of the effect of the procedure on renal function, blood pressure control, number of antihypertensive medications, and survival. At 4 years, systolic and diastolic blood pressures significantly decreased (from 166+/-26 to 148+/-22 mm Hg and from 86+/-14 to 80+/-11 mm Hg, respectively; P<0.05), and blood pressure control was more facile in approximately half of the patients. Creatinine decreased or remained stable in approximately two thirds of the patients. The cumulative probability of survival was 74+/-4% at 3 years, with few deaths related to end-stage renal disease. Survival was good in patients with normal (92+/-4%) baseline renal function, fair (74+/-7%) in those with mildly impaired renal function, and poor (52+/-7%) in patients with elevated baseline creatinine levels (> or =2.0 mg/dL). The combination of impaired renal function and bilateral disease adversely affected survival. CONCLUSIONS Renal artery stent revascularization in the presence of normal or mildly impaired renal function had a beneficial effect on blood pressure control and a nondeleterious effect on renal function. Survival was adversely affected by renal dysfunction despite adequate revascularization. Early diagnosis and adequate revascularization before the onset of renal dysfunction could beneficially affect blood pressure control, preserve or prevent deterioration of renal function, and improve patient survival.

Percutaneous Coronary Intervention in the Current Era Compared With 1985–1986 The National Heart, Lung, and Blood Institute Registries

Background—Although refinements have occurred in coronary angioplasty over the past decade, little is known about whether these changes have affected outcomes. Methods and Results—Baseline features and in-hospital and 1-year outcomes of 1559 consecutive patients in the 1997–1998 Dynamic Registry who were having first coronary intervention were compared with 2431 patients in the 1985–1986 National Heart, Lung, and Blood Institute Registry. Compared with patients in the 1985–1986 Registry, Dynamic Registry patients were older (mean age, 62 versus 58 years;P <0.001) and more often female (32.1% versus 25.5%;P <0.001). In the Dynamic Registry, procedures were more often performed for acute myocardial infarction (22.9% versus 9.9%;P <0.001) and treated lesions were more severe (84.5% versus 82.5% diameter reduction;P <0.001), thrombotic (22.1% versus 11.3%;P <0.001) or calcified (29.5% versus 10.8%;P <0.001). Stents were used in 70.5% of Dynamic Registry patients, whereas 1985–1986 patients received balloon angioplasty alone. Procedural success was higher in the Dynamic Registry (92.0% versus 81.8%;P <0.001) and the rate of in-hospital death, myocardial infarction, and emergency coronary bypass surgery combined was lower (4.9% versus 7.9%;P =0.001) than in the 1985–1986 Registry. The 1-year rate for CABG was lower in the Dynamic Registry (6.9% versus 12.6%;P <0.001). Conclusions—Although Dynamic Registry patients had more unstable and complex coronary disease than those in the 1985–1986 Registry, their rate of procedural success was higher whereas rates of complications and subsequent CABG were lower. Results of percutaneous coronary intervention have improved substantially over the past decade.

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)

Multicenter Trial of the Wallstent in the Iliac and Femoral Arteries

PURPOSE To report the results of the FDA phase II, multicenter trial of the Wallstent in the iliac and femoral arteries. PATIENTS AND METHODS Two hundred twenty-five patients entered the trial. Stents were placed in the iliac system in 140 patients and in the femoral system in 90 (five patients required both iliac and femoral stents). Clinical patency was measured over 2 years by means of life-table analysis with use of clinical and hemodynamic data and the Rutherford scale. Angiographic patency was measured at 6 months. RESULTS In the iliac system the primary clinical patency was 81% at 1 year and was 71% at 2 years. The secondary clinical patency was 91% and 86%, respectively. The 6-month angiographic patency was 93%. In the femoral system the primary clinical patency was 61% at 1 year and 49% at 2 years. The secondary patency was 84% and 72%, respectively. The 6-month angiographic patency was 80%. CONCLUSIONS The results are similar to those with the Palmaz stent in the iliac system and with angioplasty alone in the iliac and femoral systems.

Guidelines for Peripheral Percutaneous Transluminal Angioplasty of the Abdominal Aorta and Lower Extremity Vessels

A Statement for Health Professionals From a Special Writing Group of the Councils on Cardiovascular Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and Epidemiology and Prevention, the American Heart Association

One-year follow-up results of the 1985-1986 National Heart, Lung, and Blood Institute's Percutaneous Transluminal Coronary Angioplasty Registry.

In 1,801 patients in the 1985-1986 Percutaneous Transluminal Coronary Angioplasty Registry, overall 1-year mortality was 3.2%, the 1-year myocardial infarction rate was 7.2%, and the 1-year coronary artery bypass surgery rate was 13.2%. In the 78% of the cohort with all lesions successfully dilated and without major procedural complications (successful patients), the corresponding rates were 1.9%, 2.6%, and 6.4%. Nearly 20% of all deaths, 40% of all infarctions, and 25% of all bypass operations occurred in the small subset of patients (6.8%) who sustained periprocedural occlusion. Event rates were higher in patients with multivessel disease than in those with one-vessel disease. At 1 year, angina-free status was reported by approximately three fourths of all surviving patients, regardless of initial success. However, compared with successful patients, unsuccessful patients underwent intervening bypass surgery (42% vs. 6%) to achieve asymptomatic status more frequently. Comparison of the 1-year event rates in the 1985-1986 registry with those in the 1977-1981 registry indicated reductions in all major untoward events. These reductions became apparent after controlling for the more extensive disease of the 1985-1986 registry patients. In contrast, use of repeat angioplasty has increased by 50%. We conclude that the improved initial results reported in the 1985-1986 registry cohort were maintained at 1-year follow-up.

Follow-up of primary Palmaz-Schatz stent placement for atherosclerotic renal artery stenosis

A Palmaz-Schatz stent was successfully placed in 92 stenotic renal arteries (76 patients) for (1) hypertension in 62 (82%), and/or (2) chronic renal failure (serum creatinine > or = 1.5 mg/dl) and preservation of renal function in 39 (51%). Patients were followed to assess clinical and angiographic 6-month outcome. Angiography, performed in 45 of 62 eligible patients (73%) and in 56 of 74 treated arteries (76%), showed restenosis occurring in 14 renal arteries (25%). Serum creatinine improved or remained stable in 78% of patients. In patients with chronic renal failure, improvement or stability was observed in 55%. Blood pressure recordings significantly decreased for the entire cohort (systolic: 168 +/- 25 to 156 +/- 22 mm Hg, p < 0.0001; diastolic: 87 +/- 11 to 81 +/- 11 mm Hg, p < 0.005), and for hypertensive patients with normal creatinine (systolic: 179 +/- 20 to 155 +/- 23 mm Hg, p < 0.0001; diastolic: 92 +/- 9 to 83 +/- 12 mm Hg, p < 0.002). These follow-up data of a prospective, nonrandomized, observational study showed that stent recanalization of atherosclerotic renal artery stenoses was beneficial with regard to renal function and blood pressure response, and had a restenosis incidence of 25%.

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.

Multicenter Palmaz stent renal artery stenosis revascularization registry report: Four-year follow-up of 1,058 successful patients

Palmaz‐Schatz stent revascularization of renal artery stenosis was successfully performed on 1,058 patients who were entered into a voluntary, multicenter registry. The revascularization procedures were performed because of poorly controlled hypertension, preservation of renal function, and congestive heart failure. All 1,058 patients were eligible for ≥ 6‐month clinical follow‐up, which focused on subsequent renal function, blood pressure, number of antihypertensive medications, and survival. At 4‐year follow‐up, systolic and diastolic blood pressures had significantly decreased (168 ± 27 mm Hg to 147 ± 21 mm Hg, and 84 ± 15 to 78 ± 12 mm Hg; P < 0.05) and the blood pressure appeared to be more facilely controlled as indicated by the concomitant decrease in number of antihypertensive medications (2.4 ± 1.1 to 2.0 ± 1.0; P < 0.05). Serum creatinine had also significantly decreased (1.7 ± 1.1 to 1.3 ± 0.8 mg/dl; P < 0.05). The cumulative probability of survival was 74% ± 3% at 4 years. Survival was good for patients with normal (85% ± 3%) baseline renal function, fair (78% ± 5%) with mildly impaired renal function, and poor (49% ± 5%) with severely impaired renal function (baseline creatinine ≥ 2.0 mg/dl). The combination of impaired renal function and bilateral disease adversely effected survival (unilateral 55% ± 6% vs. bilateral 36% ± 11%; P < 0.05). Renal artery stent revascularization, in the presence of normal or mildly impaired renal function, had a beneficial effect on blood pressure control and on renal function (through stabilization or improvement). Survival was adversely effected by renal dysfunction despite adequate revascularization. Perhaps early diagnosis of renal artery stenosis and adequate revascularization prior to the onset of renal dysfunction could beneficially impact blood pressure control, preserve or prevent deterioration of renal function, and improve patient survival. Cathet Cardiovasc Intervent 2002;55:182–188.