Survival following coronary angioplasty versus coronary artery bypass surgery in anatomic subsets in which coronary artery bypass surgery improves survival compared with medical therapy. Results from the Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: We sought to compare survival after coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA) in high-risk anatomic subsets. BACKGROUND: Compared with medical therapy, CABG decreases mortality in patients with three-vessel disease and two-vessel disease involving the proximal left anterior descending artery (LAD), particularly if left ventricular (LV) dysfunction is present. How survival after PTCA and CABG compares in these high-risk anatomic subsets is unknown. METHODS: In the Bypass Angioplasty Revascularization Investigation (BARI), 1,829 patients with multivessel disease were randomized to an initial strategy of PTCA or CABG between 1988 and 1991. Stents and IIb/IIIa inhibitors were not utilized. Since patients in BARI with diabetes mellitus had greater survival with CABG, separate analyses of patients without diabetes were performed. RESULTS: Seven-year survival among patients with three-vessel disease undergoing PTCA and CABG (n = 754) was 79% versus 84% (p = 0.06), respectively, and 85% versus 87% (p = 0.36) when only non-diabetics (n = 592) were analyzed. In patients with three-vessel disease and reduced LV function (ejection fraction <50%), seven-year survival was 70% versus 74% (p = 0.6) in all PTCA and CABG patients (n = 176), and 82% versus 73% (p = 0.29) among non-diabetic patients (n = 124). Seven-year survival was 87% versus 84% (p = 0.9) in all PTCA and CABG patients (including diabetics) with two-vessel disease involving the proximal LAD (n = 352), and 78% versus 71% (p = 0.7) in patients with two-vessel disease involving the proximal LAD with reduced LV function (n = 72). CONCLUSION: In high-risk anatomic subsets in which survival is prolonged by CABG versus medical therapy, revascularization by PTCA and CABG yielded equivalent survival over seven years.

Predictors of bleeding complications after rescue coronary interventions.

The purpose of this study was to determine predictors of bleeding complications after current rescue coronary interventions including stenting and adjunctive platelet inhibitors. Previous studies of rescue angioplasty for thrombolytic failure have identified variable rates of bleeding complications with balloon angioplasty alone. Although coronary stents and glycoprotein 2b/3a inhibitors have been shown to improve outcome in a wide variety of coronary interventions, the impact of these therapies on bleeding complications after rescue coronary intervention has not been determined. From 1996 through 1998, we treated 108 consecutive patients with rescue coronary intervention (defined as attempted coronary intervention within 12 hours of thrombolysis for ongoing symptoms or electrocardiogram [ECG] changes) including conventional percutaneous transluminal coronary artery (PTCA), stenting (n = 45), and glycoprotein 2b/3a inhibitor use (n = 31). In-hospital clinical outcomes were obtained in all patients, and univariate and multivariate predictors of bleeding complications were identified. In hospital, moderate to severe bleeding complications occurred in 17.6% of the cohort, but the rate of severe bleeding complications (2.7%) and vascular repair (1.9%) were low. Independent predictors of bleeding complications were age > 60y, female gender, cardiogenic shock, and streptokinase use. Neither the delayed use of abciximab (on average 4 hours after thrombolytic therapy initiation) nor the use of rescue stenting were predictors of increased moderate to severe bleeding complications. Current rescue coronary intervention, including stents and platelet inhibitors, is associated with a low rate of severe bleeding complications. Moderate to severe bleeding complications were more common in selected subgroups of patients but not increased significantly by stenting or delayed abciximab use.

A simplified lesion classification for predicting success and complications of coronary angioplasty. Registry Committee of the Society for Cardiac Angiography and Intervention.

In 1988, the American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures presented a classification of coronary lesions utilizing 26 lesion features to predict the success and complications of balloon angioplasty. Using data from the Registry of the Society for Cardiac Angiography and Interventions (SCAI) we evaluated the ability of this classification to predict success and complications. Lesion success, death in hospital, emergency cardiac bypass surgery, and major adverse events were evaluated in 41,071 patients who underwent single-vessel angioplasty from January 1993 to June 1996. Logistic models using the ACC/AHA lesion classification, vessel patency, or both, were compared. A new classification based on the interaction of the ACC/AHA classification plus lesion patency was compared with the existing ACC/AHA classification. Vessel patency, added to the ACC/AHA classification, improved prediction of lesion success (p

Influence of pre-PTCA strategy and initial PTCA result in patients with multivessel disease: the Bypass Angioplasty Revascularization Investigation (BARI).

BACKGROUND: In PTCA patients with multivessel coronary artery disease, incomplete revascularization (IR) is the result of both pre-PTCA strategy and initial lesion outcome. The unique contribution of these components on long-term patient outcome is uncertain. METHODS AND RESULTS: From the Bypass Angioplasty Revascularization Investigation (BARI), 2047 patients who underwent first-time PTCA were evaluated. Before enrollment, all significant lesions were assessed by the PTCA operator for clinical importance and intention to dilate. Complete revascularization (CR) was defined as successful dilatation of all clinically relevant lesions. Planned CR was indicated in 65% of all patients. More lesions were intended for PTCA in these patients compared with those with planned IR (2.8 versus 2.1). Successful dilatation of all intended lesions occurred in 45% of patients with planned CR versus 56% with planned IR (P<0. 001). In multivariable analysis, planned IR (versus planned CR), initial lesions attempted (not all versus all intended lesions attempted), and initial lesion outcome (not all versus all attempted lesions successful) were unrelated to 5-year risk of cardiac death or death/myocardial infarction but were all independently related to risk of CABG. CONCLUSIONS: Overall, a pre-PTCA strategy of IR in BARI-like patients appears comparable to a strategy of CR except for a higher need for CABG. Whether the use of new devices may attenuate the elevated risk of CABG in patients with multivessel disease and planned IR remains to be determined.

Coronary arterial dimension-to-left ventricular mass ratio in idiopathic dilated cardiomyopathy.

This study demonstrated that, compared with normal controls, coronary artery dimensions are not increased appropriately for the increase in left ventricular mass in patients with nonischemic cardiomyopathy. The extent of coronary artery dimension to left ventricular mass mismatch did not correlate with the severity of heart failure.

Better outcome for women compared with men undergoing coronary revascularization: a report from the bypass angioplasty revascularization investigation (BARI)

BACKGROUND: Numerous studies have shown that women undergoing coronary revascularization procedures do so at a higher risk for an adverse outcome compared with men. However, the impact of advances in technology and improvements in techniques on in-hospital and long-term outcome after revascularization in women is unclear. METHODS AND RESULTS: We evaluated 1829 patients with symptomatic multivessel coronary disease randomized to CABG or PTCA in the Bypass Angioplasty Revascularization Investigation (BARI), of whom 27% were women. As expected, women were older (64.0 versus 60.5 years), with more congestive heart failure (14% versus 7%), hypertension (68% versus 42%), treated diabetes mellitus (31% versus 15%), and unstable angina (67% versus 61%) than men but had similar preservation of left ventricular function and extent of multivessel disease. Women assigned to surgery received the same number of total grafts but fewer internal mammary artery grafts (72% versus 85%, P<0. 01), and those assigned to angioplasty had more intended lesions (76% versus 71%, P<0.01) successfully dilated than men. At an average of 5.4 years' follow-up, crude mortality rates were similar in women (12.8%) and men (12.0%). The Cox regression model adjusting for baseline differences revealed that women had a significantly lower risk of death (relative risk, 0.60; 95% CI, 0.43 to 0.84; P=0. 003) but not a significantly lower risk of death plus myocardial infarction (relative risk, 0.84; 95% CI, 0.66 to 1.07; P=0.16) than men. CONCLUSIONS: Although the unadjusted mortality rate suggests that women and men undergoing CABG and PTCA have a similar 5-year mortality, women have higher risk profiles; consequently, contrary to previous reports, female sex is an independent predictor of improved 5-year survival after we control for multiple risk factors.

Modifiable risk factors for vascular access site complications in the IMPACT II Trial of angioplasty with versus without eptifibatide. Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis.

OBJECTIVES: This study was designed to identify potential predictors of vascular access site (VAS) complications in the large-scale Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) II trial, which studied angioplasty with versus without a new glycoprotein (GP) IIb/IIIa receptor inhibitor (eptifibatide). BACKGROUND: GP IIb/IIIa receptor inhibition during coronary interventions has been associated with excess VAS complications. If other predictors of VAS complications could be identified, they might be manipulated to reduce complications. METHODS: A total of 4,010 patients undergoing percutaneous transluminal coronary revascularization (PTCR) were randomized into one of three bolus/20- to 24-h infusion arms: placebo bolus/placebo infusion; 135-microg/kg body weight eptifibatide bolus/0.5-microg/kg per min eptifibatide infusion; or 135-microg/kg eptifibatide bolus/0.75-microg/kg per min eptifibatide infusion. Heparin during the procedure was weight adjusted and stopped 4 h before sheaths were removed. Logistic regression modeling was used to identify independent predictors of VAS complications. RESULTS: VAS complications were more common in patients treated with eptifibatide (9.9% vs. 5.9% placebo-treated patients, p < 0.001). Multivariate analysis identified eptifibatide therapy (p < 0.0001), advanced age (p = 0.0001), longer time to sheath removal (p = 0.0002), stent placement (with intense post-stent anticoagulation) (p = 0.0004), female gender (p = 0.0006), PTCR within 24 h of thrombolytic therapy (p = 0.002), larger heparin doses during PTCR (p = 0.009), major coronary dissection (p = 0.03) and placement of a venous sheath (p = 0.04) as independent predictors of VAS complications. CONCLUSIONS: VAS complications may be reduced by early sheath removal, by avoiding placement of venous sheaths and by limiting heparin dosing to avoid excessive activated clotting times. Early sheath removal during inhibition of platelet aggregation by eptifibatide is feasible.

Bypass Angioplasty Revascularization Investigation (BARI): baseline clinical and angiographic data.

This report presents baseline clinical and angiographic data from the Bypass Angioplasty Revascularization Investigation (BARI), a multicenter international trial assessing the relative efficacy of percutaneous transluminal coronary angioplasty (PTCA) versus coronary artery bypass graft surgery (CABG) in selected patients with multivessel coronary artery disease. PTCA is commonly performed in patients with multivessel coronary artery disease, yet its long-term efficacy in comparison to CABG is unknown. From August 1988 through August 1991, 1,829 qualifying patients with multivessel disease suitable for either procedure were randomized to PTCA or CABG; sample size estimates were based on anticipated 5-year mortality. Two registry populations were also defined for follow-up: (1) 2,013 patients eligible for randomization but not randomized; and (2) 422 patients considered by angiography as unsuitable for randomization. Patients randomized in BARI were at relatively high risk for subsequent cardiac events: 39% were > or = 65 years old, 55% had prior myocardial infarction, 69% presented with unstable angina or non-Q wave myocardial infarction, and 43% had 3-vessel coronary artery disease. Patients randomized to PTCA and CABG were equally matched in all the important baseline variables. The randomized and the eligible but not randomized groups were similar in most respects. However, the nonrandomized group had a higher proportion with college education; fewer with a history of myocardial infarction, heart failure, diabetes, and smoking; and a somewhat better average ejection fraction. At the 3-month follow-up, PTCA had been performed more commonly in the nonrandomized eligible patients, especially those with 2-vessel disease.(ABSTRACT TRUNCATED AT 250 WORDS)

Do fish oils prevent restenosis after coronary angioplasty?

BACKGROUND: The omega-3 polyunsaturated fatty acids derived from fish oils have been shown to modulate many factors believed to affect the pathogenesis of atherosclerosis. Because certain features of restenosis following angioplasty mimic some of the early changes of atherogenesis, some researchers have suggested that fish oil might prevent restenosis following angioplasty. We report the effects of omega-3 fatty acids on the rate of restenosis following percutaneous intraluminal coronary angioplasty (PTCA). METHODS AND RESULTS: From August 1989 through September 1992, 551 patients were randomized to start receiving a daily dietary supplement of ten 1.0-g capsules containing 80.6% ethyl esters of omega-3 fatty acids providing 4.1 g eicosapentaenoic acid (EPA) and 2.8 g docosahexaenoic acid (DHA) for 6 months or an equal amount of an ethyl ester of corn oil. Four hundred seventy subjects who were well matched for risk factors completed successful angioplasty of one or multiple lesions in native coronary vessels and constituted the study cohort, of whom 447 were evaluable at 6 months after PTCA. The criteria for restenosis were that the quantitative coronary angiography at 6 months show a > 30% increase in narrowing at the stenosis site or loss of at least half of the gain achieved at the time of PTCA and final restenosis with < 50% luminal diameter remaining. In 93% of the patients, the end point was determined by angiography and in all except 1% of these by quantitative coronary angiography. Compliance with the fish oil supplement was good as judged by incorporation of EPA and DHA in plasma and red blood cell phospholipids. The restenosis rate among analyzable patients was 46% for corn oil and 52% for fish oil (P = .37). The addition of 200 mg alpha-tocopherol for all subjects during the study had no effect on restenosis rates. CONCLUSIONS: This was the largest of such trials to date, and a supplement of 8 g/d of omega-3 fatty acids failed to prevent the usual high rate of restenosis after PTCA. No adverse effects were attributable to this large daily supplement of omega-3 fatty acids.

Blood flow velocity in the right coronary artery: assessment before and after angioplasty.

OBJECTIVES: This study attempted 1) to assess the utility of rest measurements of intracoronary blood flow velocity for the physiologic assessment of coronary stenoses before and after right coronary artery angioplasty, and 2) to compare the phasic flow pattern in the right coronary artery proper with the phasic flow pattern in its major branches to the left ventricle. BACKGROUND: Previous investigations have demonstrated that a reduction in distal blood flow velocity and a loss of distal diastolic predominant flow are characteristic of physiologically significant stenoses and that these indexes normalize after successful coronary artery dilation. However, these studies were predominantly performed in the left coronary artery. The utility of monitoring rest velocity variables during angioplasty of the right coronary artery has not been studied. METHODS: We studied 20 patients undergoing angioplasty of the right coronary artery with use of a Doppler angioplasty guide wire. RESULTS: Values were expressed as the mean value +/- 1 SD. The rest average peak velocity did not decrease distal to angiographically significant right coronary artery stenoses (23.3 +/- 9.4 cm/s proximal vs. 20.2 +/- 11.1 cm/s distal, p = 0.20). The proximal/distal velocity ratio was 1.4 +/- 0.9 before angioplasty and did not significantly decrease after angioplasty (p = 0.58). This study had a 99.4% power to detect a difference between proximal and distal average peak velocity. There was no relation between percent diameter stenosis and proximal/distal velocity ratios (r = 0.15, p = 0.55). Diastolic predominant flow was not observed in the proximal or distal right coronary artery. However, after angioplasty, diastolic predominant flow was observed in the posterolateral and posterior descending coronary arteries. CONCLUSIONS: Rest phasic Doppler flow velocity indexes are not useful for evaluating stenoses in the right coronary artery proper before or after angioplasty. In contrast to the right coronary artery proper, diastolic predominant flow is observed in the posterior descending and posterolateral coronary arteries. The utility of measuring hyperemic Doppler flow velocity indexes, such as distal coronary flow reserve, for assessing right coronary artery stenoses merits further investigation.

Use of sequential teboroxime imaging for the detection of coronary artery occlusion and reperfusion in ischemic and infarcted myocardium.

Nine Yorkshire pigs underwent coronary artery occlusion followed by 2 hours of reperfusion. In five pigs (group A) the occlusion time was 15 minutes and in four pigs (group B) the occlusion time was 1 hour. Teboroxime was administered and images were acquired at baseline, and following occlusion and reperfusion. Infarct size was determined by triphenyl tetrazolium staining. Normalized regional myocardial blood flow, as determined by radio-labeled microspheres, was 0.26 +/- 0.09 following occlusion and 0.83 +/- 0.07 following reperfusion (p < 0.01). Significant differences were found between the defect/normal scan ratios on the baseline and occlusion scans (1.0 +/- 0.03 vs 0.54 +/- 0.10; p < 0.01) and between the occlusion and reperfusion scans (0.54 +/- 0.10 vs 0.97 +/- 0.17; p < 0.01). This is the first study to demonstrate that rapid sequential teboroxime imaging can detect acute coronary occlusion and reperfusion to both ischemic and infarcted myocardium. Teboroxime may be an excellent tracer for the early evaluation of infarct artery patency in patients receiving thrombolytic therapy.

Sequential teboroxime imaging during and after balloon occlusion of a coronary artery.

OBJECTIVES: We sought to assess whether sequential teboroxime imaging can rapidly evaluate vessel patency and identify the coronary artery occluded in patients undergoing balloon occlusion of a coronary artery. BACKGROUND: Intravenous thrombolytic therapy results in successful reperfusion of the infarct-related artery in only 50% to 80% of cases. A noninvasive technique to serially evaluate coronary perfusion would identify patients who might benefit from other interventions such as emergency percutaneous transluminal coronary angioplasty, coronary artery bypass grafting or increased intensity of thrombolytic therapy. METHODS: Teboroxime scans were performed during balloon occlusion in 15 nonconsecutive patients undergoing angioplasty of a major coronary artery. Equivalent views were repeated after successful angioplasty. RESULTS: The mean time between balloon occlusion and reperfusion imaging was 1.6 +/- 0.6 h. The mean number of defects decreased significantly from 4.13 +/- 1.01 during balloon occlusion to 0.27 +/- 0.44 after reperfusion (p = 0.0006). There was a 30% decrease in the defect/normal zone count/pixel ratios during balloon occlusion and normalization of these ratios after reperfusion (p = 0.0006). The scans correctly identified all nine left anterior descending coronary artery occlusions and both right coronary artery occlusions. One of the four left circumflex coronary artery occlusions was incorrectly identified as a right coronary artery occlusion by scan criteria. Overall, the scans correctly identified the occluded artery 93% of the time (kappa = 0.88). The scan was 100% accurate for distinguishing occlusion of the left anterior descending coronary artery (n = 9) from occlusions of the left circumflex or right coronary artery (n = 6). CONCLUSIONS: We believe that this is the first clinical study to demonstrate that sequential planar imaging with teboroxime can 1) rapidly detect acute coronary artery occlusion and reperfusion, and 2) identify the occluded coronary artery. A trial comparing rapid sequential teboroxime imaging with coronary angiography in patients receiving thrombolytic therapy for acute myocardial infarction is warranted.

Accelerated coronary artery stenosis at a site proximal to coronary angioplasty.

Rapid progression of coronary stenosis has been described in patients undergoing percutaneous transluminal coronary angioplasty (PTCA), typically resulting in symptomatic angina 3 to 30 months postprocedure. We report a case of accelerated coronary stenosis in the instrumented vessel resulting in angina 3 days post-PTCA.

Coronary angioplasty performed within the thrombolysis in Myocardial Infarction II study.

BACKGROUND: Percutaneous transluminal coronary angioplasty (PTCA) of the infarct-related artery was performed within 42 days of recombinant tissue-type plasminogen activator (rt-PA) administration in 1,414 of the 3,534 patients who participated in the Thrombolysis In Myocardial Infarction (TIMI) II study. Primary angiographic success was obtained in 88.7%, with bypass surgery within 24 hours in 3.3% and death within 24 hours in 0.7% of patients. By 1 year, 25.1% of the 1,414 patients had sustained one or more adverse outcomes including death (3.6%), reinfarction (8.4%), or the need for further revascularization (20%). METHODS AND RESULTS: Despite these generally favorable results, multivariate testing identified several anatomic and clinical subgroups as having an increased risk ratio (RR) for adverse outcome: Unsuccessful PTCA was more common in patients undergoing protocol-assigned PTCA within 2 hours of rt-PA administration (RR, 2.7; p less than 0.001) and in patients over age 70 years (RR, 1.7; p = 0.034). The need for further revascularization within 1 year was increased in the 30.4% of patients with multivessel disease (RR, 2.5; p less than 0.001), patients with prior angina (RR, 1.4; p less than 0.006), or those undergoing ischemia-driven PTCA within 15 hours of rt-PA administration (RR, 1.7; p = 0.022). The risk of death or recurrent infarction within 1 year was increased by the presence of multivessel disease (RR, 1.6; p = 0.007) or prior angina (RR, 1.5; p = 0.014). CONCLUSIONS: These observations do not necessarily apply to patients undergoing primary PTCA (or PTCA after other thrombolytic agents); however, they do offer a unique yardstick against which to evaluate the results of PTCA in myocardial infarction.

Angiographically documented thrombotic coronary artery occlusion secondary to mild nonpenetrating thoracic trauma.

A 22-yr-old man was found to have a subtotally occluding thrombus in the proximal left anterior descending (LAD) coronary artery shortly after suffering mild blunt chest trauma. After 6 days of anticoagulant therapy, the LAD appeared angiographically normal.

Heparin pharmacokinetics and in vitro anticoagulant activity in patients receiving nonionic radiographic contrast media.

Nonionic radiographic contrast media are used frequently in diagnostic and interventional angiography. However, there is concern that they may possess thrombogenic properties, and some studies have suggested that patients receiving nonionic contrast media are difficult to systemically anticoagulate with intravenous heparin. To investigate the potential effects of nonionic contrast media on systemic anticoagulation during diagnostic cardiac catheterization, pharmacokinetics and in vitro anticoagulant activity following a 3,000 U intravenous heparin bolus were assessed in 12 patients assigned randomly to either an ionic or a nonionic contrast agent. Independent of contrast agent, all patients exhibited biphasic (nonlinear) heparin pharmacokinetics characterized by an initial rapid disappearance phase, followed by a second slower phase. Each patient achieved a therapeutic plasma heparin concentration (greater than or equal to 0.2 U/ml) within 10 min of receiving the bolus, and maintained this level throughout the procedure. Heparin anticoagulant activity, as estimated by a standard activated partial thromboplastin time (APTT) was not affected differently by nonionic as compared with ionic contrast media (p greater than 0.05). Each patient rapidly achieved a level of systemic anticoagulation commonly considered therapeutic (APTT greater than or equal to 1.5 times the control), and maintained this level throughout the procedure. In both groups, APTT correlated directly with plasma heparin concentration (r = 0.95; p less than 0.0001), and inversely with the total amount of contrast media used during the procedure (r = -0.25; p = 0.01). Plasma heparin concentration did not correlate with total contrast media (r = -0.16; p greater than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)