Nicholas Lembo

A Randomized Trial Comparing Coronary Angioplasty with Coronary Bypass Surgery

Background The clinical benefit of percutaneous transluminal coronary angioplasty (PTCA) as compared with coronary-artery bypass grafting (CABG) for patients with multivessel coronary artery disease has not been established. To determine the outcomes of these treatments in patients referred for the first time for coronary revascularization, we conducted a three-year prospective, randomized trial comparing the two procedures. Methods Revascularization was performed by accepted methods. Follow-up clinical information was collected every six months, and coronary arteriography and thallium stress scanning were performed at one and three years. The primary end point was a composite of death, Q-wave myocardial infarction, and a large ischemic defect identified on thallium scanning at three years. Secondary end points included clinical and angiographic status and the need for additional revascularization procedures. Data were analyzed according to the intention-to-treat principle. Results Of the 5118 patients sc...

Eight-year mortality in the Emory Angioplasty versus Surgery Trial (EAST)

OBJECTIVES To evaluate the long-term outcome of patients randomized to coronary bypass surgery or coronary angioplasty. BACKGROUND The Emory Angioplasty versus Surgery Trial (EAST) is a single center randomized comparison of a strategy of initial coronary angioplasty (n = 198) or coronary bypass surgery (n = 194) for patients with multivessel coronary artery disease. The primary end point (death, myocardial infarction or a large ischemic defect at 3 years) was not different, and repeat revascularization was significantly greater in the angioplasty group. Subsequently, the National Heart, Lung and Blood Institute supported a five-year extension of the trial. METHODS After the three year anniversary visit, annual questionnaires, telephone contact and examination of medical records were accomplished until death or the eight year anniversary in 100% of the patients surviving at 3 years. RESULTS Survival at 8 years is 79.3% in the angioplasty group and 82.7% in the surgical group (p = 0.40). Patients with proximal left anterior descending stenosis and those with diabetes tended to have better late survival with surgical intervention although not reaching statistical significance. After the first 3 years, repeat interventions remained relatively equal for both treatment groups. CONCLUSIONS Long-term survival is not significantly different between angioplasty and surgery, and late (three to eight year) revascularization procedures were infrequent. Patients without treated diabetes had similar survival in both groups.

Effect of pretreatment with aspirin versus aspirin plus dipyridamole on frequency and type of acute complications of percutaneous transluminal coronary angioplasty

It is unknown whether the addition of dipyridamole to aspirin as pretreatment for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) decreases acute complications. In this study 232 patients were prospectively randomized to receive either aspirin 325 mg orally 3 times daily (group 1, n = 115) or aspirin 325 mg orally 3 times daily plus dipyridamole 75 mg orally 3 times daily (group 2, n = 117) before elective PTCA. All clinical, angiographic and PTCA-related variables were similar between groups. Angiographic success rate was 93% in both groups. Clinical success was achieved in 107 patients (92%) in group 1 and in 101 patients (88%) in group 2 (difference not significant). Q-wave myocardial infarction occurred in 2 patients (1.7%) in group 1 and 5 patients (4.3%) in group 2 (difference not significant). Emergency coronary artery bypass grafting was required in 3 patients (2.6%) in group 1 and 7 patients (6.1%) in group 2 (difference not significant). There was 1 in-hospital death (in group 2). In this study, the addition of dipyridamole to aspirin as pretreatment of patients undergoing PTCA did not significantly reduce acute complications compared to aspirin alone.

Bedside Diagnosis of Systolic Murmurs

The diagnostic accuracy of bedside maneuvers in the evaluation of patients with systolic murmurs has not been assessed objectively. Therefore, we evaluated 50 patients with documented systolic murmurs and compared all standard bedside techniques. Murmurs originating within the right-sided chambers of the heart were best differentiated from all other murmurs by augmentation of their intensity with inspiration (100 percent sensitivity, 88 percent specificity) and diminution of their intensity with expiration (100 percent sensitivity, 88 percent specificity). The murmur of hypertrophic cardiomyopathy was distinguished from all other murmurs by an increase in intensity with the Valsalva maneuver (65 percent sensitivity, 96 percent specificity) and during squatting-to-standing action (95 percent sensitivity, 84 percent specificity), and by a decrease in intensity during standing-to-squatting action (95 percent sensitivity, 85 percent specificity), passive leg elevation (85 percent sensitivity, 91 percent specificity), and handgrip (85 percent sensitivity, 75 percent specificity). The murmurs of mitral regurgitation and ventricular septal defect had parallel responses to all maneuvers, but could be differentiated from other systolic murmurs by augmentation of their intensity with handgrip (68 percent sensitivity, 92 percent specificity) and during transient arterial occlusion (78 percent sensitivity, 100 percent specificity), and by a decrease in their intensity during the inhalation of amyl nitrite (80 percent sensitivity, 90 percent specificity). No single maneuver identified the murmur of aortic stenosis, but the diagnosis could be made by exclusion. Although no single maneuver is 100 percent accurate in diagnosing the cause of a systolic murmur, its origin can be determined accurately at the bedside by observation of the response to a combination of maneuvers.

Angioplasty or Surgery for Multivessel Coronary Artery Disease: Comparison of Eligible Registry and Randomized Patients in the EAST Trial and Influence of Treatment Selection on Outcomes

The Emory Angioplasty versus Surgery Trial (EAST) showed that multivessel patients eligible for both percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass surgery (CABG) had equivalent 3-year outcomes regarding survival, myocardial infarction, and major myocardial ischemia. Patients eligible for the trial who were not randomized because of physician or patient refusal were followed in a registry. This study compares the outcomes of the randomized and registry patients. Of the 842 eligible patients, 450 did not enter the trial. Their baseline features closely resembled those of the randomized patients and follow up was performed using the same methods. In the registry there was a bias toward selecting CABG in patients with 3-vessel disease (84%) and PTCA in patients with 2-vessel disease (54%). Three-year survival for the registry patients was 96.4%, which was better than the randomized patients, 93.4% (p = 0.044). Angina relief in the registry was equal for CABG and PTCA patients and was better for the PTCA registry (12.4%) than PTCA randomized patients (19.6%) (p = 0.079). Thus, the registry confirms that EAST is representative of all eligible patients and does not represent a low-risk subgroup. Since baseline differences were small, improved survival in the registry may be due to treatment selection. Physician judgment, even in patients judged appropriate for clinical trials, remains a potentially important predictor of outcomes.

Usefulness of Serum Lipoprotein (a) as a Predictor of Restenosis After Percutaneous Transluminal Coronary Angioplasty

Serum lipoprotein (a) (Lp[a]) has been associated with coronary artery atherosclerosis. Its association with restenosis after percutaneous transluminal coronary angioplasty (PTCA) has not been previously studied. Serum levels of Lp(a), in addition to other lipoproteins, and their components using standard assays, were determined in subjects undergoing cardiac catheterization within 10 months after PTCA. Clinical (e.g., sex, diabetes, angina class) and angiographic (e.g., PTCA percent diameter reduction) factors were not different between the group without (diameter reduction less than 50%; group A) and the group with (diameter reduction greater than or equal to 50%; Group B) restenosis. Total cholesterol, triglycerides, high- and low-density lipoprotein cholesterol, apolipoprotein A-I, apolipoprotein B and Lp(a) were compared. Univariate predictors of restenosis were serum triglycerides (2.50 +/- 1.07 mmol/liter for group A vs 1.72 +/- 0.79 +/- mmol/litre for group B, p = 0.008), and Lp(a) (median: 7.0 mg/dl [range 0 to 44] for group A vs 19 mg/dl [range 1 to 120] for group B; p = 0.006). Stepwise logistic regression revealed the only significant independent predictor of restenosis to be serum Lp(a) (p = 0.018). Each quintile of Lp(a) was associated with a progressively higher risk of restenosis, with the highest quintile (40 to 120 mg/dl) having an odds ratio of 11 (95% confidence interval 9 to 13) compared with the lowest quintile (0 to 3.9 mg/dl) (p = 0.033). A serum Lp(a) of greater than 19 mg/dl was associated with an odds ratio of 5.9 (95% confidence interval 4.6 to 7.2) (restenosis rates of 58% in the group with 0 to 19 mg/dl and 89% in the group with 19 to 120 mg/dl; p = 0.006).(ABSTRACT TRUNCATED AT 250 WORDS)

Retrograde Coronary Chronic Total Occlusion Revascularization: Procedural and In-Hospital Outcomes From a Multicenter Registry in the United States

OBJECTIVES This study sought to examine the contemporary outcomes of retrograde chronic total occlusion (CTO) interventions among 3 experienced U.S. centers. BACKGROUND The retrograde approach, pioneered and developed in Japan, has revolutionized the treatment of coronary CTO, yet limited information exists on procedural efficacy, safety, and reproducibility of outcomes in other settings. METHODS Between 2006 and 2011, 462 consecutive retrograde CTO interventions were performed at 3 U.S. institutions. Patient characteristics, procedural outcomes, and in-hospital clinical events were ascertained. RESULTS Mean patient age was 65 ± 9.7 years, 84% were men, and 50% had prior coronary artery bypass surgery. The CTO target vessel was the right coronary artery (66%), circumflex (18%), left anterior descending artery (15.5%), and left main artery or bypass graft (0.5%). The retrograde approach was used as the primary method in 46% of cases and after failed antegrade recanalization in 54%. Retrograde collateral vessels were septal (68%), epicardial (24%), and bypass grafts (8%). Technical and procedural success was 81.4% (n = 376) and 79.4% (n = 367), respectively. The mean contrast volume and fluoroscopy time were 345 ± 177 ml and 61 ± 40 min, respectively. A major complication occurred in 12 patients (2.6%). In multivariable analysis, years since initiation of retrograde CTO percutaneous coronary intervention (PCI) at each center, female sex, and ejection fraction ≥40% were associated with higher technical success. CONCLUSIONS Among selected U.S. programs, retrograde CTO PCI is often performed in patients with prior coronary bypass graft surgery and is associated with favorably high success and low complication rates.

Procedural Outcomes of Revascularization of Chronic Total Occlusion of Native Coronary Arteries (from a Multicenter United States Registry)

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is a rapidly evolving area of interventional cardiology. We sought to examine the immediate procedural and in-hospital clinical outcomes of native coronary artery CTO PCI from a multicenter United States (US) registry. We retrospectively examined the procedural outcomes of 1,361 consecutive native coronary artery CTO PCIs performed at 3 US institutions from January 2006 to November 2011. Mean age was 65 ± 11 years, 85% of patients were men, 40% had diabetes, 37% had previous coronary artery bypass graft surgery, and 42% had previous PCI. The CTO target vessel was the right coronary artery (55%), circumflex (23%), left anterior descending artery (21%), and left main or bypass graft (1%). The retrograde approach was used in 34% of all procedures. The technical and procedural success rates were 85.5% and 84.2%, respectively. The mean procedural time, fluoroscopy time, and contrast utilization were 113 ± 61 minutes, 42 ± 29 minutes, and 294 ± 158 ml, respectively. In multivariate analysis, female gender, no previous coronary artery bypass surgery, and years since initiation of CTO PCI at each center were independent predictors of procedural success. Major complications occurred in 24 patients (1.8%). In conclusion, among selected US-based institutions with experienced operators, native coronary artery CTO PCI can be performed with high success and low major complication rates.

Application and outcomes of a hybrid approach to chronic total occlusion percutaneous coronary intervention in a contemporary multicenter US registry

BACKGROUND A hybrid approach to chronic total occlusion (CTO) percutaneous coronary intervention (PCI) prioritizing and combining all available crossing techniques was developed to optimize procedural efficacy, efficiency, and safety, but there is limited published data on its outcomes. METHODS We examined the procedural techniques and outcomes of 1036 consecutive CTO PCIs performed using a hybrid approach between 2012 and 2015 at 11 US centers. RESULTS Mean age was 65 ± 10 years and 86% of the patients were men, with a high prevalence of diabetes mellitus (43%) and prior coronary artery bypass graft surgery (34%). Most target CTOs were located in the right coronary artery (59%), followed by the left anterior descending artery (23%) and the circumflex (19%). Dual injection was used in 71%. Technical success was achieved in 91% and a major procedural complication occurred in 1.7% of cases. The final successful crossing technique was antegrade wire escalation in 46%, antegrade dissection/re-entry in 26%, and retrograde in 28%. The initial crossing strategy was successful in 58% of the lesions, whereas 39% required an additional approach. Overall, antegrade wire escalation was used in 71%, antegrade dissection/re-entry in 36%, and the retrograde approach in 42% of procedures. Median contrast volume, fluoroscopy time, and air kerma radiation dose were 260 (200-360) ml, 44 (27-72) min, and 3.4 (2.0-5.4) Gray, respectively. CONCLUSION Application of a hybrid approach to CTO crossing resulted in high success and low complication rates across a varied group of operators and hospital practice structures, supporting its expanding use in CTO PCI.

Angiographic predictors of a rise in serum creatine kinase (distal embolization) after balloon angioplasty of saphenous vein coronary artery bypass grafts

Distal coronary embolization is thought to be increased in the balloon angioplasty of coronary by-pass vein grafts. One hundred fifty-five procedures of balloon angioplasty involving single vein graft dilatation were successfully performed. Distal coronary embolization was defined as an elevation of creatine phosphokinase greater than twice the preangioplasty value and positive MB fraction. Twenty procedures were found to have embolism by this definition. Forty preangioplasty angiograms were randomly selected from the remaining procedures and analyzed as a control group. Eight angiographic features were evaluated as possible risk factors for distal coronary embolization, i.e., diffusely diseased vein graft, presence of thrombus, ulcerated lesion surface, marked eccentricity, large plaque volume, lesion angulation, abrupt proximal face and ectasia. A diffusely diseased vein graft (p = 0.002), presence of thrombus (p = 0.006), irregular or ulcerated lesion surface (p = 0.007), large plaque volume (p = 0.02) and marked eccentricity (p = 0.03) were found to be important predictors by univariate analysis. A diffusely diseased vein graft and a large plaque volume were found to be important independent predictors by multivariate analysis. The presence of thrombus and an irregular or ulcerated lesion surface frequently coexist with a diffusely diseased vein graft. It is concluded that a diffusely diseased vein graft and a large plaque volume are important independent predictors of distal embolization, and thrombus and an ulcerated lesion surface are also important.