Optimum percutaneous transluminal coronary angioplasty compared with routine stent strategy trial (OPUS-1): a randomised trial.

BACKGROUND: Whether routine implantation of coronary stents is the best strategy to treat flow-limiting coronary stenoses is unclear. An alternative approach is to do balloon angioplasty and provisionally use stents only to treat suboptimum results. We did a multicentre trial to compare the outcomes of patients treated with these strategies. METHODS: We randomly assigned 479 patients undergoing single-vessel coronary angioplasty routine stent implantation or initial balloon angioplasty and provisional stenting. We followed up patients for 6 months to determine the composite rate of death, myocardial infarction, cardiac surgery, and target-vessel revascularisation. RESULTS: Stents were implanted in 227 (98.7%) of the patients assigned routine stenting. 93 (37%) patients assigned balloon angioplasty had at least one stent placed because of suboptimum angioplasty results. At 6 months the composite endpoint was significantly lower in the routine stent strategy (14 events, 6.1%) than with the strategy of balloon angioplasty with provisional stenting (37 events, 14.9%, p=0.003). The cost of the initial revascularisation procedure was higher than when a routine stent strategy was used (US$389 vs $339, p<0.001) but at 6 months, average per-patient hospital costs did not differ ($10,206 vs $10,490). Bootstrap replication of 6-month cost data showed continued economic benefit of the routine stent strategy. INTERPRETATION: Routine stent implantation leads to better acute and long-term clinical outcomes at a cost similar to that of initial balloon angioplasty with provisional stenting.

The transstenotic pressure gradient trend as a predictor of acute complications after percutaneous transluminal coronary angioplasty.

The transstenotic pressure gradient recorded during coronary angioplasty (PTCA) reflects the dynamic relationship that exists between coronary blood flow and the effective cross-sectional area of the arterial lumen. An apparent relationship between the dynamic behavior of the pressure gradient and subsequent acute vessel closure was observed in our catheterization laboratory. We therefore examined the usefulness of the pressure gradient trend in predicting acute complications after 463 attempted PTCA procedures. Two pressure gradient trend patterns were identified: (1) a rising trend pattern identified by an increasing pressure gradient in the interval after deflation of the angioplasty, and (2) a stable trend pattern identified by a constant or decreasing pressure gradient. The incidence of acute vessel closure (17% vs 4%, p = .0001), emergency CABG (5.6% versus 1%, p less than .05), and myocardial infarction (13% versus 2%, p less than .0001) after the PTCA procedure was significantly higher among patients with rising trend patterns when compared with patients with stable trend patterns. Multivariate analysis identified independent predictors for an acute closure event as rising trend pattern (p less than .001), post-PTCA gradient (p less than .05), and post-PTCA percent diameter stenosis (p less than .02). Independent predictors for emergency coronary artery bypass grafting and myocardial infarction were post-PTCA gradient (p less than .001) and a rising trend pattern (odds ratio = 2.91, p less than .001), respectively. The dynamic behavior of the gradient trend provides additional useful information about the results of dilatation.(ABSTRACT TRUNCATED AT 250 WORDS)

Coaxial laser energy delivery using a steerable catheter in canine coronary arteries.

Intracoronary delivery of argon laser energy was studied in eight anesthetized mongrel dogs. A No. 4.5 French single lumen catheter, with steerable guidewire and an optical fiber, was introduced through a Judkins-type femoral-coronary guiding catheter into three left anterior descending and eight left circumflex coronary arteries. A total of 65 laser energy exposures were made coaxially at 24 sites in the 11 arteries. At five sites, angiographically evident arterial perforation occurred with the first laser exposure, while at seven sites multiple laser exposures were made without angiographically evident perforation. All eight dogs remained hemodynamically stable, and were electively killed 5 +/- 1 hours following the procedure. Sections of myocardium from territories supplied by treated arteries demonstrated minimal or no pathology in 10 cases, while one territory had a small zone of early myocardial necrosis. This study suggests that standard coronary artery catheterization techniques can be used to introduce and position a steerable guidewire and an optical fiber in canine coronary arteries. Laser energy can repeatedly be delivered coaxially. Short-term deleterious effects may be reduced or eliminated, and exposure of blood elements to argon laser energy does not appear to create debris.

Effect of nifedipine on recurrent stenosis after percutaneous transluminal coronary angioplasty.

This double-blind, randomized study evaluated the effect of nifedipine on restenosis after coronary angioplasty. Two hundred forty-one patients with dilation of 271 coronary sites were randomized at the time of hospital discharge to receive nifedipine, 10 mg (123 patients), or placebo (118 patients) four times daily for 6 months. No patient was known to have coronary artery spasm. The mean duration of therapy was 4.4 +/- 2 (mean +/- SD) months for nifedipine and 4.3 +/- 2 months for placebo. A restudy angiogram was available in 100 patients (81%) in the nifedipine group and 98 patients (83%) in the placebo group. A recurrent coronary stenosis was noted in 28% of patients in the nifedipine group and in 29.5% of those in the placebo group (p = NS). The mean diameter stenosis was 36.4 +/- 23% for the nifedipine group and 36.7 +/- 23% for the placebo group (p = NS). By pill count, 78% of patients receiving nifedipine and 82% of those receiving placebo complied with the study drug regimen. Coronary stenosis recurred in 33% of patients in the placebo group and in 29% of patients in the nifedipine group who complied with the regimen and had angiograms (p = NS). In conclusion, the study did not demonstrate a significant beneficial effect of nifedipine on the incidence of recurrent stenosis after successful percutaneous transluminal coronary angioplasty.

Measurement of transstenotic pressure gradient during percutaneous transluminal coronary angioplasty.

Obstruction to blood flow is accompanied by a pressure gradient across the obstructed site. In certain clinical settings, magnitude of pressure gradient has been used to judge severity of obstruction, and gradient reduction to judge success of an interventional procedure. In percutaneous transluminal coronary angioplasty (PTCA) the relationships between transstenotic pressure gradient, diameter stenosis, and lesion length are imprecisely known. We therefore examined 4263 sets of measurements in patients who underwent PTCA on single, discrete coronary arterial lesions. Multivariate regression analysis demonstrated that pressure gradient was artifactually elevated by about 12 mm Hg at low values of diameter stenosis but increased by the 4th power of stenosis as expected from fluid dynamics models. Pressure gradient was dampened and relatively constant at values of diameter stenosis of 60% or higher, probably because of total or near-total occlusion of the artery. Lesion length was not found to influence pressure gradient. Reductions in diameter stenosis (delta D) and pressure gradient (delta G) were related nonlinearly, with delta D proportional to the square root of delta G, suggesting that a reduction in gradient is directly proportional to an increase in cross-sectional area of the stenosis. The predictive value of final post-PTCA pressure gradients was found: a final gradient of 15 mm Hg or less predicted a final post-PTCA diameter stenosis of 30% or less, with 75% sensitivity and 29% specificity (p less than .01). The results of this study suggest that (1) pressure gradient as currently measured during PTCA is related to diameter stenosis but not to lesion length (2) reductions in pressure gradient and diameter stenosis are nonlinearly related.(ABSTRACT TRUNCATED AT 250 WORDS)

Steerable fiberoptic catheter delivery of laser energy in atherosclerotic rabbits.

Imprecision in guiding and positioning is a recurring problem with fiberoptic delivery of laser energy (E) in small arteries. Manipulation can produce mechanical perforation of the vessel, and noncoaxial alignment can result in thermal perforation at relatively low laser energy levels. A No. 4.5 French single-lumen catheter was designed to accommodate both a steerable guidewire and an optical fiber. It was passed, under fluoroscopic control, into the abdominal aorta in 18 atherosclerotic rabbits. Argon laser energy was delivered coaxially at three sites in each of 14 rabbits (total = 42 sites); four rabbits were controls. Laser power levels (1 to 6 W) and exposure times (20 to 60 seconds) were varied. Energy level in joules (J) was calculated for each exposure. Saline flush at 25 ml/min was delivered through the catheter during laser exposures. Angiographic or microscopic evidence of vessel perforation was observed at 10 sites (E = 174 +/- 108 J). Another six sites exhibited microscopic laser effect only, without evidence of vessel perforation (E = 155 +/- 91 J). The remaining 26 sites exhibited no effects of laser energy (E = 117 +/- 92 J). No angiographically visible perforation occurred with E less than 120 J. This study suggests that a fiberoptic catheter with steerable guidewire allows safer intravascular manipulation of optical fibers, improves coaxial alignment in the arterial lumen, and may permit substantial laser energy delivery into atherosclerotic arteries.

Restenosis after successful coronary angioplasty in patients with single-vessel disease.

To determine risk factors for restenosis, we studied 998 patients who underwent elective coronary angioplasty (PTCA) to native coronary arteries between July 1980 and July 1984. Restenosis, defined as a luminal narrowing of greater than 50% at follow-up, was present in 302 patients (30.2%). Univariate analysis of 29 factors revealed seven factors related to restenosis: vessel dilated (circumflex coronary artery 18%, right coronary artery 27%, left anterior descending artery 34%; p less than .01), final gradient of 15 mm Hg or less compared with greater than 15 mm Hg (27% vs 38%, p less than .01), duration of angina greater than 2 months compared with angina of shorter duration (27% vs 35%, p = .01), post-PTCA stenosis of 30% or less compared with 31% to 50% (28% vs 36%, p less than .025), stable vs unstable angina (26% vs 34%, p less than .05), presence vs absence of intimal dissection (26% vs 32%, p = .07), and female gender vs male gender (25% vs 32%, p = .08). Multivariate analysis revealed five factors independently related to increased risk of restenosis in the following order of importance: PTCA in the left anterior descending artery, absence of intimal dissection immediately after PTCA, final gradient greater than 15 mm Hg, a large residual stenosis after PTCA, and unstable angina. Restenosis after PTCA is a multifactorial problem. The hemodynamic and angiographic result at the time of PTCA significantly influences long-term outcome, but additional measures aimed at reducing the rate of recurrence of atherosclerotic plaque are required.

In-hospital morbidity and mortality in patients undergoing elective coronary angioplasty.

We prospectively recorded all in-hospital complications of the first 3500 consecutive patients to undergo elective coronary angioplasty (PTCA) at Emory University Hospitals from July 14, 1980, to August 28, 1984, by three operators. PTCA was attempted in a total of 3933 lesions, with a primary success rate of 91%. Multiple-lesion PTCA was performed in 401 patients, and PTCA of saphenous vein grafts was attempted in 172. No complications were recorded in 3116 (89%) cases, isolated minor complications occurred in 241 (6.9%), and major complications (emergency surgery, myocardial infarction, death) were observed in 145 (4.1%). Emergency coronary artery bypass graft surgery (CABG) was performed in 96 patients (2.7%), with a myocardial infarction rate of 49% (47/96), a Q wave infarction rate of 23% (22/96), and an emergency surgery mortality rate of 2% (2/96). Hospital discharge occurred within 2 weeks of attempted PTCA in 91% (87/96) of patients undergoing emergency CABG. The overall myocardial infarction rate was 2.6% (94/3500). There were two nonsurgical deaths, giving a total mortality rate of 0.1% (4/3500). Univariate and multivariate analysis of 3099 patients undergoing single-lesion PTCA identified five preprocedure predictors of a major complication: multivessel coronary disease, lesion eccentricity, presence of calcium in the lesion, female gender, and lesion length. Unstable angina, duration of angina, lesion severity, previous CABG, and vein graft dilatation were not associated with an increased incidence of major complications. The strongest predictor of a major complication was the procedural appearance of an intimal dissection. Intimal dissection was evident in 894/3099 (29%) patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Primary angiographic success rates of percutaneous transluminal coronary angioplasty.

Three distinct periods in catheter design have been identified since the advent of percutaneous transluminal coronary angioplasty (PTCA) in 1977. In the first period PTCA was performed using a double-lumen balloon catheter that had a fixed, flexible guidewire at the tip. In the second period, an independent, steerable guidewire and the steerable catheter system were used. In the third period, low-profile catheters were introduced. A total of 2,969 patients who had single-vessel PTCA of a native coronary artery was separated into groups according to the period during which PTCA was performed. Introduction of the steerable catheter system was accompanied by improvement in primary success rate in PTCA attempts on the right coronary artery (78% vs 88%, p less than 0.005). Introduction of the low-profile catheter was accompanied by improved primary success in PTCA attempts on the left anterior descending coronary artery (LAD) (90% vs 94%, p less than 0.005). The percentage of PTCA attempts on the LAD decreased over the 3 periods (70% to 60% to 56%), while the percentage of attempts on the left circumflex artery increased (7% to 12% to 16%). Before steerable and low-profile catheters were used, there were significant differences in ability to reach and cross stenoses among the 3 major coronary arteries. These differences no longer exist. These results indicate that technical improvements and operator experience have made stenoses in all 3 major coronary arteries equally accessible to dilatation catheters and that primary success rates and reasons for failure in these arteries are now similar.

Distal coronary artery perfusion during percutaneous transluminal coronary angioplasty.

Perfusion of the coronary artery distal to an occluding angioplasty balloon was performed in 34 patients undergoing coronary angioplasty (PTCA). A randomized crossover study was employed using two exogenous substances as perfusates: lactated Ringer's solution (LR) and a fluorocarbon emulsion (FL), Fluosol-DA 20%. Both substances are electrolyte solutions, but the FL will dissolve more oxygen than the LR. During two attempted coronary artery occlusions of 90 seconds each, we perfused through the central lumen (guidewire channel) of the PTCA catheter at 60 ml/min. With FL perfusion the mean time to onset of angina after occlusion was delayed (41 +/- 21 vs 33 +/- 16 seconds, mean +/- SD; p less than 0.05), the mean duration of angina was shortened (77 +/- 58 vs 92 +/- 70 seconds, p less than 0.05), and the rise in the ST segment of the ECG was reduced (0.15 +/- 0.24 vs 0.2 +/- 0.23 mV, p less than 0.001) when compared to LR perfusion. Balloon occlusion time was able to be extended with FL perfusion (71 +/- 22 vs 59 +/- 22 seconds p less than 0.001). These results indicate that perfusion of the distal coronary artery is possible during PTCA and can reduce ischemia during a prolonged balloon occlusion time.

Influence of intimal dissection on restenosis after successful coronary angioplasty.

We studied 986 patients who underwent follow-up angiography after successful percutaneous transluminal coronary angioplasty (PTCA) to determine the influence of uncomplicated intimal dissection on restenosis rate. Angiographic evidence of intimal dissection after PTCA was present in 248 patients or 25%. After a mean follow-up time of 7 +/- 5 months (SD) the restenosis rate in patients without intimal dissection was 30% compared with 24% in patients with intimal dissection (p = .08). Patients with available transstenotic pressure gradients were divided according to the hemodynamic result into two subgroups: those with final gradients at the conclusion of PTCA of 15 mm Hg or less (n = 638) and those with gradients greater than 15 mm Hg (n = 244). Patients with intimal dissection had a significantly lower restenosis rate than patients without intimal dissection if the final gradient was 15 mm Hg or less (19% vs 28%; p less than .05). If the final gradient was greater than 15 mm Hg, the presence or absence of intimal dissection had no significant influence on restenosis rate, which was 35% and 39%, respectively (p = NS). We conclude that an uncomplicated intimal dissection after a successful coronary angioplasty has no adverse influence on angiographic restenosis. An excellent angiographic long-term outcome can be expected if the intimal dissection is associated with a favorable hemodynamic result.

Percutaneous transluminal coronary angioplasty (PTCA).

The role of PTCA in the management of coronary artery disease has continued to evolve during the past six years as experience has grown and technical advances have been made. As has been clearly demonstrated in its relatively short history, PTCA offers an effective means of immediate palliation in symptomatic coronary artery disease. The natural history of coronary artery disease is one of progression and the ideal therapy is one which can be used repeatedly through the years. Advances in diagnostic technique hopefully will enable physicians to intervene earlier in the course of the disease, prior to the compromise of ventricular function which often accompanies triple vessel disease. The main question, however, is still unanswered and that is whether PTCA is an alternative approach to coronary artery bypass graft surgery in patients with multivessel disease. Preliminary reports indicate safety and good results may be obtained when PTCA is performed in these patients. However, the true usefulness and exact role needs to be carefully determined in a randomized study comparing coronary artery bypass surgery and PTCA in patients with multivessel disease. Hopefully in the future, patients with coronary artery disease can be diagnosed early before their disease progresses to severe triple vessel disease, when it may be too late for PTCA.

Right ventricular and right atrial collapse in patients with cardiac tamponade--a combined echocardiographic and hemodynamic study.

To determine the hemodynamic derangement associated with right ventricular diastolic collapse and to assess the value of right ventricular and right atrial collapse in identifying cardiac tamponade, two-dimensional echocardiograms were recorded simultaneously with measurement of right atrial, pulmonary capillary wedge, intrapericardial, and systemic arterial pressures and cardiac output in 16 patients as they underwent pericardiocentesis. Twelve patients (group I) had evidence of right ventricular or right atrial collapse or both on their echocardiograms and hemodynamic evidence of cardiac tamponade before pericardiocentesis. All hemodynamic parameters improved after pericardiocentesis (p less than or equal to .05). Continuous monitoring during pericardiocentesis in three of these patients showed significant improvement in all parameters except heart rate (p less than or equal to .02) at the point of disappearance of right ventricular diastolic collapse, with further improvement in cardiac output as pericardiocentesis continued (p less than .01). Right atrial collapse persisted after right ventricular collapse disappeared but was no longer present when pericardiocentesis was completed. Three patients (group II) had no right ventricular or right atrial collapse, no hemodynamic evidence of cardiac tamponade, and no improvement in hemodynamic parameters after pericardiocentesis. A single patient (group III) was found to have elevated right heart pressures and right ventricular hypertrophy before pericardiocentesis. Although there was hemodynamic evidence of cardiac tamponade in this patient, there was no evidence of right ventricular or right atrial collapse. In this study, the sensitivity of right ventricular collapse as a marker for cardiac tamponade was 92%, its specificity 100%, its accuracy 94%, and its predictive value 100%.(ABSTRACT TRUNCATED AT 250 WORDS)

The hemodynamic derangement associated with right ventricular diastolic collapse in cardiac tamponade: an experimental echocardiographic study.

Clinical reports indicate that right ventricular diastolic collapse (RVDC) is associated with cardiac tamponade. To assess the hemodynamic abnormalities associated with RVDC, we studied six chronically instrumented conscious dogs (group A) with two-dimensional echocardiography during cardiac tamponade induced by continuous saline infusion into the pericardial space. We recorded cardiac output (electromagnetic flowmeter), heart rate, respiration, and aortic, intrapericardial, and right atrial pressures. In four additional animals (group B), we recorded right ventricular pressure and placed a hydraulic occluder around the pulmonary artery so that short-term reversible obstruction to right ventricular outflow could be produced. None of the dogs had RVDC when the pericardial space was empty, but all dogs showed RVDC during cardiac tamponade. The appearance of RVDC in group A was associated with a 21% reduction in cardiac output (p less than .01) and no change in mean aortic pressure. Short-term partial pulmonary artery obstruction led to increased right ventricular pressures and a striking reduction in RVDC in early tamponade, suggesting that RVDC is caused by pericardial pressure exceeding right ventricular pressure in early diastole. An additional animal had right ventricular hypertrophy caused by a severe "heart worm" infestation and did not show RVDC during cardiac tamponade. These observations suggest that in the absence of increased resistance to right ventricular outflow or right ventricular hypertrophy, RVDC occurs early in the course of cardiac tamponade and is associated with a hemodynamically important decrease in cardiac output.