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.

Coronary heart disease in Filipino and Filipino-American patients: prevalence of risk factors and outcomes of treatment.

BACKGROUND: Very little has been published on Filipino (F) or Filipino-American (FA) health. Nothing has been written about coronary risk factors and their relationship to outcomes of percutaneous coronary intervention or cardiac surgical treatment in this group. The purpose of this study was to analyze prospectively collected data at a center treating coronary artery disease in a large series of Filipino patients. METHODS: From January 1, 1992 to December 1, 1996, 527 consecutive FA patients and 3,176 Caucasians (C) were identified from an ongoing cardiac database. In-hospital and late outcomes post discharge were evaluated and results between the FA and C groups were compared. RESULTS: The FA population had a higher incidence of hypertension (79% vs. 61%, p < 0.0001) and diabetes (34.7% vs. 24.1%, p < 0.001) compared to C patients. Hypercholesterolemia was similar in both groups. Obesity (FA 12.2% vs. C 18.3%, p < 0.0001) and current smoking (FA 15.8% vs. C 21.5%, p < 0.001) were more common in the C patients. Age at presentation did not differ between groups. Morbidity and mortality were higher in the FA patients following intervention in the catheterization lab (4.2% vs. 1.3%, p < 0.01). Logistic regression showed that FA ethnicity was an independent predictor of death after catheterization laboratory intervention (p < 0.01), along with emergency procedure, depressed ejection fraction, history of myocardial infarction (MI) and age greater than 65. For coronary bypass surgery, mortality and rate of MI was similar in both groups. Late follow-up post discharge (mean 17 months, range 12Eth 68) was obtained on 90% and 89% of eligible FA and C patients, respectively. Occurrence of late death and MI did not differ between the groups. However, need for any reintervention (catheterization laboratory or surgical) was significantly higher in the FA patients (21.2% vs. 14. 9%, p < 0.001). Cox proportional hazard regression modeling showed that FA ethnicity was an independent predictor of need for late reintervention (p < 0.01), along with type of initial treatment, history of diabetes, presence of triple vessel disease, initial presentation with acute MI and age greater than 65. CONCLUSION: Filipino-Americans have a higher prevalence of hypertension and diabetes, and a lower prevalence of smoking and obesity compared to Caucasians. FA ethnicity is an independent predictor of higher mortality after catheterization laboratory intervention and increased need for late reintervention. However, the rate of late MI and death in FA was similar to C patients. These results suggest that FA patients, especially those presenting with diabetes for CAD treatment, need to be followed closely after percutaneous intervention or cardiac surgery procedures.

Documentation of decline in morbidity in women undergoing coronary angioplasty (a report from the 1993-94 NHLBI Percutaneous Transluminal Coronary Angioplasty Registry). National Heart, Lung, and Blood Institute.

To determine whether there has been an improvement in the relatively unfavorable outcome of percutaneous transluminal coronary angioplasty (PTCA) in women, the 1993 to 1994 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry collected data from 12 clinical centers that participated in the earlier registries. We compared 274 consecutive women in 1993 to 1994 with 545 consecutive women in 1985 to 1986 undergoing PTCA. Women in the 1993 to 1994 registry were older (64.3 vs 61.0 years, p <0.001) with more diabetes mellitus (34.3% vs 19.9%, p <0.001), congestive heart failure (13.7% vs 8.6%, p <0.05), and comorbid disease (19.5% vs 9.3%, p <0.001). Left ventricular function and multivessel coronary artery disease were similar between groups. Angiographic success (90.9% vs 85.1%, p <0.05) and clinical success (89.4% vs 79.4%, p <0.001) were higher in women undergoing PTCA in 1993 to 1994 than in 1985 to 1986. Whereas there was no difference in in-hospital mortality (1.5% vs 2.6%), the incidence of nonfatal myocardial infarction (1.8% vs 4.6%, p <0.05), emergency coronary artery bypass graft surgery (1.8% vs 4.6%, p <0.05), and the combined end points of death, myocardial infarction, and emergency coronary artery bypass grafting (4.4% vs 9.7%, p <0.01) were lower in women in 1993 to 1994 than in women in 1985 to 1986, respectively. Multivariate analysis revealed an odds ratio of 0.36 (95% confidence interval 0.18 to 0.72) for major complications and of 2.34 (95% confidence interval, 1.49 to 3.69) for clinical success in the 1993 to 1994 versus 1985 to 1986 registry. Therefore, despite a higher risk profile, women undergoing PTCA in 1993 to 1994 have a higher clinical success and lower major complication rate than women treated with PTCA in 1985 to 1986.

Dyslipoproteinemias in atherosclerosis, thrombosis and restenosis after coronary angioplasty.

Lipids play a vital role in normal metabolic function in mammals. However, dyslipoproteinemias have been implicated in the pathophysiologic process of atherogenesis, thrombogenesis and restenosis after interventional procedures. Lipoproteins provide important chemical linkages among these three complex phenomena. Lipoproteins participate in atherogenesis and play a major role in plaque fissuring, the pathophysiologic common denominator of acute ischemic syndromes. Thrombogenesis is majoraly affected by the action of lipids on platelets, coagulation and fibrinolysis. LDL tend to destabilize platelet membrane activity, macrophages, endothelial and smooth muscle cell function; HDL tend to reverse these abnormalities. The metabolism of arachidonic acid, a metabolite of the essential polyunsaturated lipoprotein, linoleic acid, is integral to platelet and endothelial cell membrane formation, via the cyclooxygenase-prostanoid pathway. Arachidonic acid also is metabolized by the lipoxygenase-leukotreine pathway in neutrophils and monocytes. The relationship of dyslipoproteinemias (increased LDL and Lp(a); decreased HDL) to restenosis after angioplasty has been reported, though there is not universal agreement about causality. Lipid lowering regimens and other pharmacotherapy have had favorable effect slowing the rate of atherogenesis, decreasing the frequency of cardiac events (perhaps by "stabilizing" vulnerable plaques) and causing regression in some atheromata. The salutary effect of lipid-lowering agents upon the incidence of restenosis after angioplasty is problematic. Some investigators have found a statistically significant correlation, while others have not; but studies have not been standardized. In conclusion, the study of lipid metabolism across a wide range of physiochemical activities and the interaction of these phenomena describe complex, genetically determined linkages which instruct (and often humble) investigators in their study of lipids in health and disease.

Comparative study of the angiographic morphology of coronary artery lesions treated with PTCA, directional coronary atherectomy, or high-speed rotational ablation.

To evaluate trends in morphology-based intervention selection, series of 110 consecutive procedures of each of three devices, percutaneous transluminal balloon coronary angioplasty (PTCA), directional coronary atherectomy (DCA), or high-speed rotational ablation (HSRA), were reviewed. PTCA was used mainly in discrete, concentric, smooth, ACC/AHA type A and B1 lesions. PTCA was used less frequently on a bend, branching points or in calcified lesions. Using PTCA as a reference, DCA was used more often for the treatment of discrete, proximal, eccentric, and noncalcified lesions, often complicated with thrombus and located on straight segments. HSRA was used more frequently in diffuse, calcified multiple complicated and B2+C type lesions with frequent side branches and bend points. These results suggest that directional atherectomy and rotational ablation may be helpful in expanding the capacity of the operator to approach prognostically unfavorable lesions.

Adjunctive thrombolytic therapy during angioplasty for ischemic rest angina. Results of the TAUSA Trial. TAUSA Investigators. Thrombolysis and Angioplasty in Unstable Angina trial.

BACKGROUND: Acute closure is increased after angioplasty in unstable angina, and adjunctive intracoronary thrombolytic therapy has been used successfully to increase angiographic success. The role of prophylactic thrombolytic therapy during angioplasty in unstable angina is unknown. METHODS AND RESULTS: Four hundred sixty-nine patients with ischemic rest pain with or without a recent (< 1 month) infarction were randomized in double-blind fashion to intracoronary urokinase or placebo. Randomization was carried out in two sequential phases. In phase I, 257 patients were randomized to 250,000 U of urokinase or placebo given in divided doses at the time of angioplasty. In phase II, 212 patients were randomized to 500,000 U of urokinase or placebo in divided doses. All patients were pretreated with aspirin, and activated clotting times were followed to maintain them at > 300 seconds during angioplasty. Angiographic end points of thrombus after angioplasty were insignificantly decreased by urokinase (30 [13.8%] versus 41 [18.0%] with placebo; P = NS). Acute closure, on the other hand, was increased with urokinase (23 [10.2%] versus 10 [4.3%] with placebo; P < .02). The difference in acute closure between urokinase and placebo was more striking at the higher dose of urokinase (P < .04) than in phase I at the lower urokinase dose (P = NS). Adverse in-hospital clinical end points (ischemia, infarction, or emergency coronary artery bypass surgery) were also increased with urokinase versus placebo (30 [12.9%] versus 15 [6.3%], respectively; P < .02). Angiographic and clinical end points were worse with urokinase in unstable angina without recent infarction than with angioplasty after a recent infarction. CONCLUSIONS: Adjunctive urokinase given prophylactically during angioplasty for ischemic rest angina as administered in this trial is associated with adverse angiographic and clinical events. These detrimental effects may be related to hemorrhagic dissection, lack of intimal sealing, or procoagulant or platelet-activating effects of urokinase.

Triple vessel revascularization: coronary angioplasty versus coronary artery bypass surgery: initial results and five-year follow-up. Comparative costs and loss of working days and wages.

OBJECTIVES: The purpose of this study was to compare early and late outcomes in patients undergoing PTCA or CABG for triple vessel disease. BACKGROUND: Although early results of PTCA/CABG randomized trials have recently become available, at present little data exists on long-term medical and socioeconomic effects of these treatment modalities in patients with triple vessel revascularization. METHODS: During 1986-87, 76 patients undergoing triple vessel PTCA and 85 patients having triple vessel CABG were selected from a consecutive series of patients having multivessel revascularization. Initial results and 5 year outcome, hospital stay and charges and out-of-work time were assessed from prospectively collected data. RESULTS: Clinical and morphological factors were similar in the PTCA and CABG groups. Hospital success and complications were also similar, except for higher mortality in the CABG cohort (0 vs. 3.5%). Five year follow-up showed no differences in survival, nonfatal infarction and angina-free status; however, there was a difference in need for repeat revascularization (PTCA 55.4% vs. CABG 6.3%, p less than 0.001). Repeat PTCA accounted for 49% of the revascularization in the PTCA cohort. Crossovers were similar (PTCA[CABG 6.8%; CABG[PTCA 6.3%, pNS). Predictors of late death in the entire population were female gender (p less than 0.0001), diabetes (p<0.05) and depressed LVEF (p less than 0.05). The choice of revascularization procedure (PTCA vs. CABG) was not an independent predictor of late death or MI. Analysis of initial hospital charges showed a 2:1 advantage in favor of PTCA but this advantage was lost in late followup due to the need for repeat revascularization in the PTCA group. However, the PTCA cohort lost fewer working days than CABG patients (3017 vs 5874 days) and therefore, lost less wages ($7,022 vs. $14,685). CONCLUSIONS: The study shows that for selected triple vessel disease patients, PTCA and CABG results are comparable after 5 years, though repeat revascularization (mainly due to restenosis) was necessary in the PTCA group to maintain these favorable results. After 5 years, hospital charges are similar in the 2 groups, though out-of-work time and lost wages were 2:1 in favor of PTCA.

Coronary stenting with a new ultra-short balloon expandable device: early and late animal results.

The early and late effects of a new balloon-expandable coronary stent (Boneau II) were studied in 16 adult mongrel dogs. Thirty-three balloon-expandable stents were deployed using standard transfemoral coronary angioplasty technique. Single stents were placed in eight dogs and multiple (two to four) stents were placed in eight dogs. Intravenous heparin (3,000 units) was administered at the beginning of the procedure. Aspirin, dipyridamole, dextran, and warfarin were not administered before or after the procedure. All stent deployments were successful. Angiographic or pathologic examinations were performed within 24 hr of deployment on two of the dogs, at 2 weeks on two of the dogs, at 2 months on three of the dogs, at 6 months on six of the dogs, and at 1 year on three of the dogs. All successfully deployed stents were noted to be widely patent. There was no evidence of side-branch vessel occlusion. There was no evidence of acute or late vessel thrombosis. Histologic examination at 2 months showed a mean intimal thickness of 153 microns. The stainless steel Boneau II coronary stent is relatively short and easily deployed. This balloon-expandable coronary stent was successfully deployed in normal canine arteries without the use of anticoagulation or antiplatelet therapy before or after the procedure. The Boneau II intracoronary stent has a very low thrombogenic potential in dogs.

Late outcome of multivessel coronary artery disease after angioplasty or bypass surgery.

Background. Results from randomized trials to determine optimal treatment for patients with multivessel coronary disease are not yet available. Thus, the early and late outcomes of 191 PTCA and 221 CABG patients done in 1985-86 were evaluated. Methods and Results. CABG patients selected had more coronary risk factors and more severe coronary artery disease compared to PTCA patients. Comparison of the initial outcome showed that clinical success without major cardiovascular events was similar (93.7% for PTCA vs. 90.0% for CABG; p=n.s.). Five year followup was obtained in 99.0% of PTCA patients and 94.4% of CABG patients. In the PTCA group, 89.8% were alive, 4.8% had sustained an MI, and repeat revascularization was required in 46.8%. In the CABG group, 87.1% were alive, 3.2% had had a MI, and 3.5% required repeat revascularization. Statistical comparison demonstrated no difference between the groups in survival or late cardiac events, but rate of repeat revascularization was significantly higher for PTCA patients (p less than 0.0001). Incompleteness of revascularization (p<0.01) was independently associated with an increased need for repeat revascularization in the PTCA group. In the CABG group, depressed left ventricular function (p less than 0.001) and female sex (p<0.01) were associated with lower survival rates. An analysis of cost per patient showed that the strategies were comparable. Conclusions. PTCA and CABG in multivessel disease patients have similar early results and comparable rates of survival and late cardiac events. Significantly more repeat revascularization is required in PTCA patients to maintain these results.(ABSTRACT TRUNCATED AT 250 WORDS)

The evolution of a clinical database to evaluate the treatment of coronary artery disease.

BACKGROUND: The field of invasive cardiology has evolved rapidly since the initial use of catheters for treatment of coronary artery disease in the late 1970's. The pace of this change coupled with the complexity of the clinical setting and proliferation of devices and drugs used for therapy have made it extremely difficult to construct and maintain a viable clinical database. METHODS: Using a standard hardware and software system with the direct clinical input from a multidisciplinary team of physicians, nurses and biostatisticians, a clinical database was developed that is capable of tracking complex in-hospital and longterm follow-up data in patients undergoing treatment of coronary artery disease. RESULTS: The database has provided the basis for in-depth analysis of angioplasty results in patients with vessels and lesions of varying morphology, showing greater than 90% success in most complex lesion morphology using contemporary balloon technology and/or new devices. Longterm analysis (14 years) of patients after angioplasty has demonstrated that 76% survived without major cardiac events. Other analyses of various clinical and morphologic subsets have shown favorable results with angioplasty. The databases for angioplasty and coronary bypass surgery have been combined, showing comparable survival and freedom from cardiac events in multivessel disease patients treated with these procedures. CONCLUSIONS: The development of a dynamic and clinically relevant database that has evolved has contributed valuable information to the understanding and effective management of patients with coronary artery disease.(ABSTRACT TRUNCATED AT 250 WORDS)

Digital supine bicycle stress echocardiography: a new technique for evaluating coronary artery disease.

OBJECTIVES: The objective of this study was to determine the accuracy of digital supine bicycle stress echocardiography, a new technique for evaluating coronary artery disease during peak exercise. BACKGROUND: Prior stress echocardiographic techniques have not utilized peak exercise imaging to determine the extent and location of coronary artery disease. METHODS: Two-hundred twenty-two patients were studied: 180 underwent both supine bicycle stress echocardiography and coronary arteriography; 42 had a < 5% likelihood of disease. Forty-three patients had normal coronary arteries, 55 had single-vessel, 42 had double-vessel and 40 had triple-vessel coronary artery disease. RESULTS: Supine bicycle stress echocardiography was 93% sensitive, 86% specific and 92% accurate for identifying patients with coronary artery disease irrespective of prior myocardial infarction or achievement of > or = 85% maximal predicted heart rate. The "normalcy" rate in the low probability group was 100%. Supine bicycle stress echocardiography was 87% sensitive, 89% specific and 88% accurate for specific vessel identification. The sensitivity was greatest for the left anterior descending compared with the right coronary artery and the left circumflex coronary artery (95% vs. 81% vs. 78%, p < 0.01) and for vessels in patients with double- and triple-vessel compared with single-vessel disease (90% vs. 89% vs. 78%, p < 0.05). The procedure was significantly more sensitive for detection of vessels with 90% to 100% compared with 50% to 70% diameter stenosis (91% vs. 81%, p < 0.05) and was 88% correct in the prediction of multivessel disease. CONCLUSIONS: Supine bicycle stress echocardiography is a highly accurate tool for evaluating coronary artery disease, identifying both the patient with coronary artery disease and the location and extent of disease.

Supine bicycle stress echocardiography versus tomographic thallium-201 exercise imaging for the detection of coronary artery disease.

To compare the accuracy of supine bicycle stress echocardiography (SBSE), a new technique for evaluating coronary disease during peak exercise, with tomographic thallium-201 exercise imaging (SPECT), 71 patients were evaluated by SBSE, SPECT, and coronary arteriography. Twenty patients had normal coronary vessels; 22 had single-vessel, 14 had double-vessel, and 15 had triple-vessel disease. There were no differences in sensitivity (90% vs 92%), specificity (80% vs 65%), and accuracy (87% vs 85%) between SBSE and SPECT for the group of 71 patients. The results were similar in patients with and without prior myocardial infarction and with single-, double-, or triple-vessel disease. There were no differences between SBSE and SPECT for disease detection for the group of 213 individual vessels in sensitivity (88% vs 80%), specificity (87% vs 84%), and accuracy (88% vs 82%), but SBSE was more sensitive for the left anterior descending artery (97% vs 82%, p < 0.005) and for arteries involved in triple-vessel disease (93% vs 69%, p < 0.01) and more specific for the right coronary artery (88% vs 66%, p < 0.01). Supine bicycle exercise was associated with significantly lower maximal heart rates than treadmill exercise but with significantly higher systolic and diastolic blood pressures. There were no differences in heart rate x systolic blood pressure. We conclude that SBSE and SPECT are equally reliable for coronary disease detection in patients and for evaluation of disease in specific arteries with the exception of SBSE's higher sensitivity for the left anterior descending artery and arteries involved in triple-vessel disease and higher specificity for the right coronary artery.

Usefulness of supine bicycle stress echocardiography for detection of restenosis after percutaneous transluminal coronary angioplasty.

The role of supine bicycle stress echocardiography (SBSE) for detecting restenosis after percutaneous transluminal coronary angioplasty (PTCA) was evaluated in 80 patients: 41 (51%) with single and 39 (49%) with multivessel PTCA (total 129 dilated vessels). Total revascularization was performed in 54 (68%) and partial revascularization in 26 (32%) patients. Restenosis was angiographically demonstrated in 60 patients (75%) and in 72 vessels (56%) 6.1 +/- 2.9 months after PTCA. The results for detecting restenosis were: (1) SBSE versus exercise electrocardiographic sensitivity, 87 versus 55% (p < 0.001); (2) specificity, 95 versus 79%; and (3) accuracy, 89 versus 61% (p < 0.001). SBSE was 83% sensitive, 95% specific and 88% accurate for restenosis detection in specific vessels with comparable results for single versus multivessel PTCA and total versus partial revascularization. Sensitivity, specificity and accuracy were: 91, 93 and 91% for the left anterior descending coronary artery; 77, 94 and 85% for the right coronary artery; and 76, 96 and 88% for the left circumflex coronary artery. Ninety-four percent of the nondilated diseased vessels were correctly identified. It is concluded that SBSE is an excellent tool for identifying restenosis after PTCA.