Percutaneous Transluminal Coronary Angioplasty Registry Research Articles

Evolution of Percutaneous Coronary Intervention in Patients with Diabetes

OBJECTIVETo evaluate the association of successive percutaneous coronary intervention (PCI) modalities with balloon angioplasty (BA), bare-metal stent (BMS), drug-eluting stents (DES), and pharmacotherapy over the last 3 decades with outcomes among patients with diabetes in routine clinical practice.RESEARCH DESIGN AND METHODSWe examined outcomes in 1,846 patients with diabetes undergoing de novo PCI in the multicenter, National Heart, Lung, and Blood Institute–sponsored 1985–1986 Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry and 1997–2006 Dynamic Registry. Multivariable Cox regression models were used to estimate the adjusted risk of events (death/myocardial infarction [MI], repeat revascularization) over 1 year.RESULTSCumulative event rates for postdischarge (31–365 days) death/MI were 8% by BA, 7% by BMS, and 7% by DES use (P = 0.76) and for repeat revascularization were 19, 13, and 9% (P < 0.001), respectively. Multivariable analysis showed a significantly lower risk of repeat revascularization with DES use when compared with the use of BA (hazard ratio [HR] 0.41 [95% CI 0.29–0.58]) and BMS (HR 0.55 [95% CI 0.39–0.76]). After further adjustment for discharge medications, the lower risk for death/MI was not statistically significant for DES when compared with BA.CONCLUSIONSIn patients with diabetes undergoing PCI, the use of DES is associated with a reduced need for repeat revascularization when compared with BA or BMS use. The associated death/MI benefit observed with the DES versus the BA group may well be due to greater use of pharmacotherapy.

Twenty-Year Evolution of Percutaneous Coronary Intervention and Its Impact on Clinical Outcomes

Background— Percutaneous coronary intervention (PCI) has undergone rapid progress, both in technology and adjunct therapy. However, documentation of long-term temporal trends in relation to contemporary practice is lacking. Methods and Results— We analyzed PCI use and outcomes in 8976 consecutive patients in the multicenter, National Heart, Lung, and Blood Institute–sponsored 1985–1986 percutaneous transluminal coronary angioplasty (PTCA) and 1997–2006 Dynamic Registries waves (wave 1: 1997–1998, bare-metal stents; wave 2: 1999, uniform use of stents; wave 3: 2001–2002, brachytherapy; waves 4 and 5: 2004–2006, drug-eluting stents). Patients undergoing PCI in the recent waves were older and more often reported comorbidities than those in the balloon era. PCI was more often performed for acute coronary syndromes and, in spite of the greater disease burden, was more often selective. Procedural success was achieved and maintained more often in the stent era. Significant reductions were observed in in-hospital rates (%) of myocardial infarction (PTCA Registry: 4.9; wave 1, 2.7; wave 2, 2.8; wave 3, 1.9; wave 4, 2.6; wave 5, 2; P trend &lt;0.001) and emergency coronary artery bypass surgery (PTCA Registry: 3.7; wave 1, 0.4; wave 2, 0.4; wave 3, 0.3; wave 4, 0.4; wave 5, 0; P trend &lt;0.001). Compared with the PTCA Registry, risk for repeat revascularization (31 to 365 days after index PCI) was significantly lower in the dynamic waves (adjusted hazard ratio: wave 1, 0.72; wave 2, 0.51; wave 3, 0.51; wave 4, 0.30; wave 5, 0.36; P &lt;0.05 for all). Conclusions— Percutaneous interventions, in the last 2 decades, have evolved to include more urgent, comorbid cases, despite achieving high success rates with significantly reduced need for repeat revascularization.

Outcome of Percutaneous Coronary Intervention in Unstable Angina Pectoris Versus Stable Angina Pectoris in Two Different Time Periods

Percutaneous coronary intervention (PCI) for unstable angina pectoris (UAP) has traditionally been associated with a higher risk of ischemic complications than that for stable angina pectoris (SAP). However, PCI procedures have evolved, so this study was designed to determine whether PCI for UAP is still associated with less favorable outcomes. In-hospital and 1-year outcomes in Dynamic Registry patients who presented for PCI with UAP (n = 2,994) or SAP (n = 1,457) between 1997 and 2002 were compared. One-year results were also compared with consecutive patients who underwent angioplasty (n = 2,431) from the 1985 to 1986 Percutaneous Transluminal Coronary Angioplasty Registry. Although Dynamic Registry patients with UAP were older and more likely to smoke (p < 0.05), have diabetes mellitus (p = 0.03), or a previous myocardial infarction (p < 0.001), procedural success was higher than in patients with SAP. By 1 year, there was greater risk of death (4.4% vs 2.6%, p < 0.01), death/myocardial infarction (9.9% vs 6.6%, p < 0.001), and death, myocardial infarction, and coronary artery bypass grafting (15.1% vs 11.6%, p < 0.01) in patients with UAP. In patients with UAP, there was no significant difference in adjusted 1-year death and death/myocardial infarction rates when comparing the waves of the Dynamic Registry with those of the Percutaneous Transluminal Coronary Angioplasty Registry, although death/myocardial infarction rates among Dynamic Registry patients were lower. However, in patients with SAP, the adjusted rate for death/myocardial infarction was lower in wave 3, and for death, myocardial infarction, and revascularization, there was a significant decrease in event rates with each successive recruitment period (p < 0.05 for all comparisons). In conclusion, in contradistinction to patients with SAP, death and death/myocardial infarction rates in patients who have undergone PCI for UAP have not significantly decreased over the past 16 years and patients with UAP remain at a greater risk of ischemic events at 1 year compared with patients with SAP.

The impact of ejection fraction on outcomes after percutaneous coronary intervention in patients with congestive heart failure: An analysis of the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry and Dynamic Registry

Patients with congestive heart failure (CHF) have higher rates of adverse outcomes after percutaneous coronary intervention (PCI). A comprehensive analysis of outcomes in patients with CHF in the current era has not been done. We studied the outcomes of patients with CHF who underwent PCI in the National Heart, Lung, and Blood Institute-sponsored Percutaneous Transluminal Coronary Angioplasty (PTCA) and Dynamic registries. We evaluated demographic and angiographic characteristics and the clinical outcomes of patients with CHF in the Dynamic Registry and the PTCA Registry, excluding patients with acute myocardial infarction. In the Dynamic Registry, patients with CHF (n = 503) were compared with patients without CHF (n = 4194), and patients with CHF with a preserved ejection fraction (EF) (n = 134) were compared with patients with CHF who have a reduced EF (n = 199). The patients with CHF in the 1997 through 2001 Dynamic Registry (n = 236) were then similarly compared with patients with CHF in the earlier PTCA Registry (n = 117). In the Dynamic Registry, compared with patients without CHF, patients with CHF had a higher-risk clinical and angiographic profile, and a higher mortality rate both inhospital (2.6% vs 0.4%, P < or = .001) and at 1 year (13.1% vs 3.0%, P < .001). Patients with reduced EF had higher inhospital mortality rates and a trend toward higher mortality at 1 year. The patients with CHF in the Dynamic Registry compared with those in the PTCA Registry had a higher risk profile yet had significantly higher procedural success rates and improved clinical outcomes. Although CHF remains a strong predictor of adverse outcomes after PCI, significant improvement seen in the past decade is likely related to improved procedural techniques and improved medical therapy.

Target vessel revascularization following percutaneous coronary intervention. A 10-year report from the Danish Percutaneous Transluminal Coronary Angioplasty Registry

ObjectiveTo present the rate of target vessel revascularization (TVR) in a consecutive and unselected national population over 10 years.DesignFrom 1989 to 1998 all percutaneous coronary interventions (PCIs) performed in Denmark were recorded in the Danish PTCA Registry.ResultsFrom 1989 to 1998 the annual rate of PCI rose from 46 to 753 per million inhabitants. From 1995 to 1998 TVR with PCI or coronary artery bypass grafting (CABG) within 9 months from the index PCI decreased significantly (p<0.001) from 21.2% in 1995 (CABG 8.6% vs PCI 12.6%) to 11.7% in 1998 (CABG 4.3% vs PCI 7.4%). Independent predictors for TVR were: coronary stenting (OR 0.60; 95% CI 0.52–0.69, p<0.001), primary success rate (OR 0.69; 95% CI 0.53–0.89, p<0.005), pre-PCI stenosis severity (OR 1.01; 95% CI 1.00–1.01, p=0.03), left anterior descending coronary artery (OR 2.35; 95% CI 1.73–3.19, p<0.001), right coronary artery (OR 1.61; 95% CI 1.17–2.20, p=0.003), sapheneous vein graft (OR 2.03; 95% CI 1.13–3.63, p=0.017) and age (OR 0.99; 95% CI 0.98–1.00, p=0.002).ConclusionCoronary stenting, primary success rate, pre-PCI stenosis severity, age and treated vessel were independent predictors for TVR.

1138-64 Major reduction in adverse outcomes of patients with congestive heart failure undergoing percutaneous coronary intervention: A comparison of the National Heart, Lung, and Blood Institute 1985–1986 percutaneous transluminal coronary angioplasty registry and the current dynamic registry

1138-64 Major reduction in adverse outcomes of patients with congestive heart failure undergoing percutaneous coronary intervention: A comparison of the National Heart, Lung, and Blood Institute 1985–1986 percutaneous transluminal coronary angioplasty registry and the current dynamic registry

3718 Global management of acute myocardial infarction first hours from the field to the hospital, Torino network project: telematics, pathways and primary percutaneous transluminal coronary angioplasty registry

3718 Global management of acute myocardial infarction first hours from the field to the hospital, Torino network project: telematics, pathways and primary percutaneous transluminal coronary angioplasty registry

State of the art in coronary intervention

Issues related to restenosis have been known since the beginning of coronary intervention, and by now, restenosis has been characterized in terms of its time course, pathophysiology, clinical presentation, and some of its histology. In 1984, the initial National Heart, Lung, and Blood Institute’s percutaneous transluminal coronary angioplasty registry reported a restenosis rate of 33.6% and identified male gender, new unstable angina, diabetes mellitus, and treatment of bypass graft stenoses as risk factors. Today restenosis still occurs in 33% of patients, is still associated with recurrent angina, and occurs usually within several months after a successful intervention. These current conclusions are very interesting because we now treat a clearly different patient population. Clinical trials have documented that restenosis results in adverse clinical consequences. In recent large clinical trials involving patients with class B or C lesions, pharmacologic intervention with such agents as tranilast was still associated with a 33% restenosis rate and had no significant effect on major adverse cardiac events. More recently, drug-coated stents have been introduced and are undergoing testing in large clinical trials to definitively establish the long-term efficacy and safety suggested in their early promising experience. Thus, whether the solution for restenosis is at hand or whether we will continue to see patients who undergo successful intervention and develop restenosis only months later in the same position as the initial lesion remains an open issue.

Improved outcomes for women undergoing contemporary percutaneous coronary intervention: A report from the national heart, lung, and blood institute dynamic registry

ObjectivesThe goal of this study was to determine whether women undergoing contemporary percutaneous coronary intervention (PCI) remain at increased risk in comparison with men and whether the outcomes in women have improved. BackgroundPrevious studies have shown that women treated with coronary angioplasty have a higher incidence of procedural morbidity and mortality than men. MethodsGender differences in wave 1 of the National Heart, Lung and Blood Institute (NHLBI) Dynamic registry were evaluated. Baseline characteristics and outcomes in women in the Dynamic registry were compared with those in women in the 1985–1986 and 1993–1994 NHLBI Percutaneous Transluminal Coronary Angioplasty (PTCA) registries. ResultsWomen were older with a higher prevalence of diabetes mellitus, hypertension, congestive heart failure, unstable angina and single vessel disease in comparison with men. Although procedural success and in-hospital death (2.2% vs. 1.3%), myocardial infarction (MI) (2.3% vs. 3.0%) and coronary artery bypass graft surgery (CABG) (1.3% vs. 1.4%) were similar in women and men, respectively, one-year mortality (6.5% vs. 4.3%, p = 0.02) and combined end point of death/MI/CABG (18.3% vs. 14.4%, p = 0.03) were higher in women than in men. After controlling for other factors, gender was not a significant predictor of death or death plus MI at one year. Despite a higher risk profile in women in the Dynamic registry in comparison with women in the 1985–1986 NHLBI PTCA registry, in-hospital death/MI/CABG was lower (6.0% vs. 11.6%, p < 0.001). ConclusionsDespite persistent high-risk characteristics in women, gender differences in outcomes in patients undergoing contemporary PCI have decreased, and outcomes in women have improved.

Application of the New York State PTCA mortality model in patients undergoing stent implantation

Objectives. We sought to compare outcomes of patients treated in the National Heart, Lung, and Blood Institute (NHLBI) Percutaneous Transluminal Coronary Angioplasty (PTCA) and New Approaches to Coronary Intervention (NACI) registries.Background. Coronary angioplasty has numerous shortcomings. New devices for performing coronary interventions have been introduced in an effort to improve clinical outcomes.Methods. Under the sponsorship of the NHLBI, a registry of consecutive patients treated with PTCA during 1985 to 1986 was established. In 1990, the NHLBI funded a second registry, the NACI. The two registries used the same data coordinating center to collect detailed baseline and follow-up information.Results. Patients enrolled in the NACI registry were older, had undergone more previous bypass surgery procedures and had more stenoses located in bypass grafts than patients in the NHLBI PTCA registry. Procedural success was achieved in 72.1% and 82.6% of patients in the PTCA and NACI registries, respectively; however, in-hospital and 1-year mortality rates were 1.0% versus 1.8% and 3.1% versus 5.9% for the PTCA versus NACI registries, respectively. After risk adjustment, there was no difference in 1-year mortality. Rates of target lesion revascularization (TLR) were 21.5% for the PTCA registry and 24.2% for the NACI registry. NACI registry patients had a higher risk for TLR and the composite end point of death, myocardial infarction or revascularization (relative risk 1.28 and 1.23, respectively). However, the NACI registry patients who received stents tended to have a lower adjusted TLR rate.Conclusions. This comparative study found no overall superiority of these newer devices in terms of patient survival or freedom from TLR after adjustment for baseline risk profiles. Although technologic improvements (especially improved stenting) continue, these observations highlight the importance of careful assessment of clinical results in the broad population of patients in whom interventions are used.

Emergency coronary artery bypass surgery after failed percutaneous transluminal coronary angioplasty.

Coronary complications caused by percutaneous transluminal coronary angioplasty (PTCA) may necessitate emergency coronary artery bypass grafting (CABG). In 1994-1998, 132 patients (1.5% of the patients registered in the Danish PTCA registry) underwent CABG within 24 h because of angioplasty complications. We reviewed the files of 86 patients who had emergency operations within 6 h and found that 35% suffered from 1-vessel disease. Fifty-eight percent were taken directly to the operating room from the cardiovascular laboratory, and 13% were given preoperative cardiovascular resuscitation. The vessels most frequently injured were the right coronary artery and the left anterior descending branch (LAD). The patients received a mean of 2.4 coronary bypasses each. Forty-three percent of the patients with lesions of the left main coronary artery and/or the LAD received a vein graft to the LAD. A perioperative Q-wave myocardial infarction developed in 51% of the patients. The in-hospital mortality rate was 12%. These results are inferior to those obtained after elective surgery. Local cardiothoracic backup is vital when PTCA is performed in an unselected patient group.

Percutaneous transluminal coronary angioplasty

This paper is the first report from the Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry of the National Heart, Lung, and Blood Institute (NHLBI). The era of interventional cardiology was born with the performance of the first successful balloon angioplasty by Andreas Gruentzig on

Incidence and predictors of target vessel revascularization following percutaneous transluminal coronary angioplasty: a report from the national heart, lung, and blood institute percutaneous transluminal coronary angioplasty registry

We sought to determine the rate of target vessel revascularization (TVR) after percutaneous transluminal coronary angioplasty (PTCA) and to determine factors that predispose to its occurrence. The 10-year outcome of 2,262 patients in the National Heart, Lung, and Blood Institute PTCA Registry was analyzed to determine the incidence and characterize predictors of TVR. TVR was performed in 30.4% of patients. Male gender (relative risk [RR] 1.26; p <0.05), diabetes (RR 1.57; p <0.001), multiple discrete lesions (RR 1.38, p <0.01), diffuse lesions (RR 1.27; p <0.05), and calcium at the lesion site (RR 1.25; p <0.05) were predictors for TVR. TVR was performed early (≤1 year) in 18.3% and late (>1 year) in 12.2%. Age ≥65 years (RR 1.24; p <0.05), congestive heart failure (RR 1.70; p <0.05), acute coronary insufficiency (RR 1.28; p <0.05), and left anterior descending lesion location (RR 1.34, p <0.01) were significant predictors of early versus late TVR by multivariate analysis. Coronary artery bypass grafting (CABG) rather than PTCA was the TVR procedure in 21% of patients undergoing early TVR and 58% of those undergoing late TVR. Significant independent predictors of CABG as the TVR procedure were multivessel disease (RR 1.97; p <0.001), presence of collateral vessels (RR 1.81; p <0.05), diffuse (RR 1.89; p <0.01), or occluded (RR 1.82; p <0.05) target lesions, and a greater residual stenosis after the initial PTCA (RR 1.19; p <0.001). Age ≥65 years (RR 0.65; p <0.05) conferred a lower risk for CABG.

Chest pain after coronary interventional procedures. Incidence and pathophysiology.

Chest pain following successful percutaneous coronary interventions is a common problem. Although the development of chest pain after coronary interventions may be of benign character, it is disturbing to patients, relatives and hospital staff. Such pain may be indicative of acute coronary artery closure, coronary artery spasm or myocardial infarction, but may also simply reflect local coronary artery trauma. The distinction between these causes of chest pain is crucial in selecting optimal care. Management of these patients may involve repeat coronary angiography and additional intervention. Commonly, repeat coronary angiography following percutaneous transluminal coronary angioplasty (PTCA) in patients with chest pain demonstrates widely patent lesion sites suggesting that the pain was due to coronary artery spasm, coronary arterial wall stretching or was of non-cardiac origin. As reported by the National Heart, Lung and Blood Institute PTCA Registry, 4.6% of patients after angioplasty have coronary occlusions, 4.8% suffer a myocardial infarction, and 4.2% have coronary spasm. The frequency of chest pain after new device coronary interventions (atherectomy and stenting) seems to be even higher. However, only the minority of patients with post-procedural chest pain have indeed an ischemic event. Therefore, the vast majority of patients have recurrent chest pain without any signs of ischemia. There is some evidence that non-ischemic chest pain after coronary interventions is more common after stent implantation as compared to PTCA (41% vs. 12%). This may be due to the continuous stretching of the arterial wall by the stent as the elastic recoil occurring after PTCA is minimized. In conclusion, chest pain after coronary interventional procedures may potentially be hazardous when due to myocardial ischemia. However, especially after coronary stent placement, cardiologists must consider "stretch pain" due to the overdilation and stretching of the artery caused by the stent in the differential diagnosis. Clinically, it is, therefore, important to recognize that in addition to ischemia-related chest pain other types of chest pain do exist with cardiac origin.

Long-term analysis of conventional coronary balloon angioplasty and an initial "stent-like" result. The NHLBI PTCA Registry.

We examined the influence of an initial "stent-like" result on long-term outcome in patients in the 1985-86 NHLBI PTCA Registry. Stent use in selected patients is associated with improved angiographic and short-term clinical outcome; however, due to potential for in-stent restenosis and high costs of stents, there is interest in a strategy of more optimal dilatation to achieve a "stent-like" result without a stent. The long-term outcome of patients with a "stent-like" percutaneous transluminal coronary angioplasty (PTCA) remains unknown. Ten-year outcome was compared between 225 successfully treated patients with and 1,764 successfully treated patients without an initial "stent-like" result ( > or = 1 lesion dilated to < or = 10% stenosis). The sample had 75% and 80% power, respectively, to detect an absolute difference of 8% in the 10-year rate of death and myocardial infarction (MI) between the two groups. Ten-year rates of death and MI were similar between the stent-like and non-stent-like groups (22.3% vs. 22.2%, 17.6% vs. 17.9%), however, there was less target lesion revascularization in the stent-like group (30.2% vs. 36.8%). In subgroup analysis of patients with multivessel disease, those with a stent-like result had less follow-up bypass surgery (25.2% vs. 32.7%), yet more repeat PTCA (53.8% vs. 42.7%). These findings were unaffected by adjustment for differences in baseline characteristics between the two patient groups. Achievement of an initial stent-like result via balloon angioplasty alone may not appreciably reduce the long-term risk of death or MI, nor confer equivalent clinical benefit as achieving a stent-like result with a stent.

Documentation of decline in morbidity in women undergoing coronary angioplasty (a report from the 1993–1994 NHLBI Percutaneous Transluminal Coronary Angioplasty Registry)

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.

PTCA registry of German community hospitals. Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK) Study Group.

Percutaneous transluminal coronary angioplasty (PTCA) is widely used, but no quality control has been systematically performed as yet. A registry of all PTCA procedures has been established since October 1992 for the majority of the German community hospitals performing PTCA, representing about one third of all PTCA activity in Germany. Baseline demographic data, indication for PTCA, primary success and in-hospital clinical events were recorded. Each centre was visited at regular intervals to assure completeness and reliability of the data. Of 52453 procedures performed from October 1992 to December 1994 the catheter laboratory and discharge forms were 99.7% and 98.1% complete, respectively. In 85.9% a single lesion was dilated per procedure, but 48.7% of the patients had multivessel disease. The success rate was 66.5% in complete occlusions (residual stenosis < 70%) and 91.2% in non-occluded vessels (residual stenosis < 50%). Abrupt vessel closure occurred in 3.4%, of which 77.5% could be recanalized by repeat intervention. In procedures not done for acute myocardial infarction, the in-hospital mortality was 0.52%, the procedure-related mortality 0.37%. In 3.02% of all patients a severe complication occurred (procedure-related death, myocardial infarction or emergency bypass surgery). Complete recording of all PTCA procedures is feasible even on a nationwide basis. This is a pre-requisite for continuous quality control. The reporting of the procedures by itself very probably, has an impact on the quality which is, however, not measurable quantitatively.

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.Eligible but nonrandomized patients (the registry) in Emory Angioplasty versus Surgery Trial (EAST) were similar in most respects to those in the randomized trial and the treatment chosen favored surgery for 3-vessel disease. Overall survival of these registry patients was similar for angioplasty and surgery treated patients and was superior to those in the randomized cohort even after adjusting for measured baseline variables.

Multiple coronary thromboemboli complicating valvular heart disease and atrial fibrillation

T, and the Coinvestigators of the National Heart, Lung, and Blood Institute's Percutaneous Transluminal Coronary Angioplasty Registry. One-year follow-up results of the 1985-86 National Heart, Lung, and Blood Institute's Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1989;80:421-8. 6. Thomas MR, Wainwright RJ. Use of an intracoronary stent to control intrapericardial bleeding during artery rupture complicating coronary angioplasty. Cathet Cardiovasc Diaga 1993;30:169-72.

Has Improvement in PTCA Intervention Affected Long-term Prognosis?

The NHLBI Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry followed 1345 consecutive patients with first PTCA between 1977 and 1981 (registry 1) and 2136 consecutive patients with PTCA between 1985 and 1986 (registry 2). Changes in patient selection and in immediate and 1-year outcome are presented. This report extends to 5 years the comparison of the effects of early and more recent management with PTCA. Sixteen participating centers entered consecutive patients who had angioplasty for the first time between 1977 and 1981 and between 1985 and 1986. Patients with recent myocardial infarction (MI) were excluded. Vessel disease was defined according to the Coronary Artery Surgery Study. Successful dilatation required > or = 20% reduction in luminal narrowing and < 50% lumen diameter stenosis after intervention. Routine annual follow-up was conducted by telephone interview. The product-limit method was used to estimate freedom from untoward events, Cox regression analysis to model relative risk and adjusted relative risk of events between the two registries, and logistic regression when the exact time of outcome (such as recurrence of symptoms) was not known. Long-term event rates were computed by vessel disease for all patients and for the cohort of patients with initially successful PTCA. After adjustment for extent of disease, diabetes, prior bypass surgery (CABG), hypertension, age, and sex, the 5-year risk of death was similar in the two registry cohorts. However, rates of MI, CABG, and a combined outcome measure of death, MI, and/or CABG were significantly lower in the registry 2 cohort both for all patients and for patients who were initially treated successfully. Use of repeated PTCA was higher, and freedom from symptoms without adverse events was significantly better in the latter cohort. Compared with registry 1, the management of the registry 2 cohort resulted in lower 5-year morbid event rates and reduced CABG operations. Mortality rates remained similar. When symptomatic status was considered in combination with events, a significantly better outcome was seen overall and in the initially successful cohort. In registry 2, repeated PTCA was used with much greater frequency early after the initial procedure.