SYNTAX Score and Long-Term Outcomes: The BARI-2D Trial.

BACKGROUND: The extent of coronary disease affects clinical outcomes and may predict the effectiveness of coronary revascularization with either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score quantifies the extent of coronary disease. OBJECTIVES: This study sought to determine whether SYNTAX scores predicted outcomes and the effectiveness of coronary revascularization compared with medical therapy in the BARI-2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial. METHODS: Baseline SYNTAX scores were retrospectively calculated for BARI-2D patients without prior revascularization (N = 1,550) by angiographic laboratory investigators masked to patient characteristics and outcomes. The primary outcome was major cardiovascular events (a composite of death, myocardial infarction, and stroke) over 5 years. RESULTS: A mid/high SYNTAX score (≥23) was associated with a higher risk of major cardiovascular events (hazard ratio: 1.36, confidence interval: 1.07 to 1.75, p = 0.01). Patients in the CABG stratum had significantly higher SYNTAX scores: 36% had mid/high SYNTAX scores compared with 13% in the PCI stratum (p < 0.001). Among patients with low SYNTAX scores (≤22), major cardiovascular events did not differ significantly between revascularization and medical therapy, either in the CABG stratum (26.1% vs. 29.9%, p = 0.41) or in the PCI stratum (17.8% vs. 19.2%, p = 0.84). Among patients with mid/high SYNTAX scores, however, major cardiovascular events were lower after revascularization than with medical therapy in the CABG stratum (15.3% vs. 30.3%, p = 0.02), but not in the PCI stratum (35.6% vs. 26.5%, p = 0.12). CONCLUSIONS: Among patients with diabetes and stable ischemic heart disease, higher SYNTAX scores predict higher rates of major cardiovascular events and were associated with more favorable outcomes of revascularization compared with medical therapy among patients suitable for CABG. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes; NCT00006305).

Sex Differences in Outcomes Following Percutaneous Coronary Intervention According to Age.

BACKGROUND: Women <50 years of age with coronary artery disease may represent a group at higher risk for recurrent ischemic events after percutaneous coronary intervention (PCI); however, no long-term, multicenter outcomes assessment exists in this population. METHODS AND RESULTS: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated the association of sex and age on cardiovascular-related outcomes in 10,963 patients (3797 women, 394 <50 years) undergoing PCI and followed for 5 years. Death, myocardial infarction, coronary artery bypass graft surgery, and repeat PCI were primary outcomes comprising major adverse cardiovascular events. Although procedural success rates were similar by sex, the cumulative rate of major adverse cardiovascular events at 1 year was higher in young women (27.8 versus 19.9%; P=0.003), driven largely by higher rates of repeat revascularizations for target vessel or target lesion failure (coronary artery bypass graft surgery: 8.9% versus 3.9%, P<0.001, adjusted hazard ratio 2.4, 95% confidence interval 1.5-4.0; PCI: 19.0% versus 13.0%, P=0.005, adjusted hazard ratio 1.6, 95% confidence interval 1.2-2.2). At 5 years, young women remained at higher risk for repeat procedures (coronary artery bypass graft surgery: 10.7% versus 6.8%, P=0.04, adjusted hazard ratio 1.71, 95% confidence interval 1.01-2.88; repeat PCI [target vessel]: 19.7% versus 11.8%, P=0.002, adjusted hazard ratio 1.8, 95% confidence interval 1.24-2.82). Compared with older women, younger women remained at increased risk of major adverse cardiovascular events, whereas all outcome rates were similar in older women and men. CONCLUSIONS: Young women, despite having less severe angiographic coronary artery disease, have an increased risk of target vessel and target lesion failure. The causes of this difference deserve further investigation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00005677.

Benefit of long-term dual anti-platelet therapy in patients treated with drug-eluting stents: from the NHLBI dynamic registry.

The optimal duration of dual-antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important, unanswered question. This study was designed to evaluate the association of varying durations of DAPT on clinical outcomes after DES implantation for the treatment of coronary artery disease. Using the National Heart, Lung, and Blood Institute Dynamic Registry, patients enrolled in the last 2 waves after index percutaneous coronary intervention with DES and who were event free at the time of landmark analysis were included. Landmark analysis was performed 12 and 24 months after percutaneous coronary intervention, and patients were stratified according to continued use of DAPT or not. Subjects were evaluated for rates of death, myocardial infarction, and stent thrombosis at 4 years from their index procedures. The numbers of evaluable patients were 2,157 and 1,918 for the 12- and 24-month landmarks, respectively. In both landmark analyses, there was a significantly lower 4-year rate of death or myocardial infarction in the group that continued DAPT compared to the group that did not (12 months: 10.5% vs 14.5%, p = 0.01; 24 months: 5.7% vs 8.6%, p = 0.02). Beneficial differences in the group that continued on DAPT were preserved after multivariate and propensity adjustment. There were no significant differences in definite stent thrombosis in either landmark analysis. In conclusion, at 12 and 24 months after DES implantation, continued use of DAPT was associated with lower 4-year risk for death and myocardial infarction.

Outcomes of drug-eluting stents for protected left main coronary artery disease (from the Multicenter, United States DEScover registry).

Percutaneous coronary intervention (PCI) for protected left main coronary artery (PLM) disease is complex because of patient and lesion factors; however, limited data exist on the outcomes of drug-eluting stent (DES) use for this indication. DEScover is a prospective observational study that enrolled consecutive patients with PCI in 2005. In-hospital and 1-year statuses were analyzed for 6,172 patients treated with DES according to LM and coronary artery bypass grafting (CABG) statuses (PLM, n = 93; previous CABG native vessel non-LM, n = 722; no previous CABG, n = 5,357). Cumulative event rates were calculated by the Kaplan-Meier method. Cox proportional hazards regression was used for multivariable analysis of adverse events. Baseline clinical, angiographic, and procedural variables differed significantly among groups, with patients with previous CABG, PLM, and non-LM having higher risk characteristics. In patients with previous CABG, after adjustment with CABG non-LM as a reference group, there were no significant differences in 1-year risk of any adverse event except a trend toward a greater risk of myocardial infarction (MI) in patients with PLM (adjusted hazard ratio 2.4, confidence interval 0.95 to 6.2, p = 0.06). However, patients after CABG (PLM and non-LM) compared to patients without previous CABG had a similar adjusted risk of death, MI, and stent thrombosis; an increased risk of target lesion revascularization (adjusted hazard ratio 1.79, confidence interval 1.2 to 2.6, p = 0.003), target vessel revascularization and death/MI/target vessel revascularization; and a lower risk of CABG (adjusted hazard ratio 0.25, confidence interval 0.09 to 0.67, p = 0.006). In conclusion, status after CABG rather than PLM location increases the risk of repeat revascularization with PCI in DES-treated patients.

Percutaneous coronary intervention of moderate to severe calcified coronary lesions: insights from the National Heart, Lung, and Blood Institute Dynamic Registry.

OBJECTIVES: To evaluate the efficacy and safety of drug eluting stents (DES) when compared with bare metal stents (BMS) in patients with moderate to severe calcified coronary lesions. BACKGROUND: Calcified coronary lesions present unique technical challenges during percutaneous coronary intervention (PCI) and it is not known if DES are as safe and as effective in the presence of calcium, as randomized trials typically exclude this common patient subset. METHODS: We evaluated patients with PCI of a single calcified lesion enrolled across five recruitment waves in the National Heart, Lung, and Blood Institute Dynamic Registry between 1997 and 2006. Patients were divided into two groups based on the stent type- BMS and DES. The primary efficacy outcome was the need for repeat revascularization at 1 year and the primary safety outcome was a composite of death and myocardial infarction at 1 year. RESULTS: Among the 1,537 patients included in the analysis, 884 (57%) underwent PCI with BMS and 653 (43%) with DES. DES use was associated with a significant reduction in the risk of repeat revascularization (10.0% vs. 15.3%; P = 0.003) with no significant higher risk of primary safety outcome (9.3% vs. 10.5%; P = 0.45) when compared to the BMS group. In a propensity score adjusted analysis, DES use was associated with a significantly lower risk in repeat revascularization (HR = 0.57; 95% CI 0.40-0.82; P = 0.002) and no significant difference in the risk of death and myocardial infarction (HR = 0.78; 95% CI 0.53-1.15; P = 0.20) compared to BMS group. CONCLUSION: In this large multicenter registry of patients with a moderate to severe calcified coronary lesion, use of DES compared to BMS was associated with significant reduction in the risk of repeat revascularization without any increase in death and myocardial infarction.

Comparison of drug-eluting and bare metal stents for saphenous vein graft lesions (from the National Heart, Lung, and Blood Institute Dynamic Registry).

The effectiveness and safety of drug-eluting stents (DES) compared with bare-metal stents (BMS) in saphenous vein graft (SVG) disease remains unclear. In particular, there is a paucity of data on long-term outcomes. In this study, 395 patients enrolled in the National Heart, Lung, and Blood Institute Dynamic Registry who underwent stenting of SVG lesions with BMS (n = 192) from 1999 to 2006 or DES (n = 203) from 2004 to 2006 were analyzed. Patients were followed prospectively for the occurrence of cardiovascular events and death at 3 years. Patients treated with DES were more likely to have diabetes mellitus and other co-morbidities and previous percutaneous coronary intervention. Treated lesions in DES patients were more complex than those in BMS patients. At 3 years of follow-up, the adjusted risk for target vessel revascularization (hazard ratio 1.03, 95% confidence interval 0.65 to 1.62, p = 0.91) and death or myocardial infarction (hazard ratio 0.72, 95% confidence interval 0.49 to 1.04, p = 0.08) was similar in patients treated with DES and those treated with BMS. The combined outcome of death, myocardial infarction, or target vessel revascularization excluding periprocedural myocardial infarction was also similar (adjusted hazard ratio 0.82, 95% confidence interval 0.62 to 1.09, p = 0.16). In conclusion, this multicenter nonrandomized study of unselected patients showed no benefit of DES in SVG lesions, including no reduction in target vessel revascularization, compared with BMS at 3 years. An adequately powered randomized controlled trial is needed to determine the optimal stent type for SVG percutaneous coronary intervention.

Paclitaxel-eluting versus sirolimus-eluting stents in diabetes mellitus: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

BACKGROUND: Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. METHODS AND RESULTS: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES (n=677) and PES (n=328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P=0.20), death and myocardial infarction (14.9% versus 13.6%, P=0.55), repeat revascularization (14.8% versus 17.8%, P=0.36), and stent thrombosis (1.3% versus 1.3%, P=0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. CONCLUSIONS: PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.

A comparison of bare-metal and drug-eluting stents for off-label indications.

BACKGROUND: Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown. METHODS: We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm. RESULTS: Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents. CONCLUSIONS: Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.

Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

OBJECTIVES: This study sought to evaluate the safety and efficacy of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with insulin- and noninsulin-treated diabetes. BACKGROUND: Diabetes is a powerful predictor of adverse events after percutaneous coronary interventions (PCI), and insulin-treated diabetic patients have worse outcomes. The DES are efficacious among patients with diabetes; however, their safety and efficacy, compared with BMS, among insulin-treated versus noninsulin-treated diabetic patients is not well established. METHODS: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 1-year outcomes of insulin-treated (n = 817) and noninsulin-treated (n = 1,749) patients with diabetes who underwent PCI with DES versus BMS. RESULTS: The use of DES, compared with BMS, was associated with a lower risk for repeat revascularization for both noninsulin-treated patients (adjusted hazard ratio [HR] = 0.59, 95% confidence interval [CI] 0.45 to 0.76) and insulin-treated subjects (adjusted HR = 0.63, 95% CI 0.44 to 0.90). With respect to safety in the overall diabetic population, DES use was associated with a reduction of death or myocardial infarction (adjusted HR = 0.75, 95% CI 0.58 to 0.96). However, this benefit was confined to the population of noninsulin-treated patients (adjusted HR = 0.57, 95% CI 0.41 to 0.81). Among insulin-treated patients, there was no difference in death or myocardial infarction risk between DES- and BMS-treated patients (adjusted HR = 0.95, 95% CI 0.65 to 1.39). CONCLUSIONS: Drug-eluting stents are associated with lower risk for repeat revascularization compared with BMS in treating coronary artery disease among patients with either insulin- or noninsulin-treated diabetes. In addition, DES use is not associated with any significant increased safety risk compared with BMS. These findings suggest that DES should be the preferred strategy for diabetic patients.

Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry.

OBJECTIVES: We investigated the effectiveness and safety of drug-eluting stents (DES) as used in routine clinical practice. BACKGROUND: Randomized trials have shown that DES prevent target vessel revascularization in selected patients, but whether this translates into superior outcomes, compared with bare-metal stents (BMS), for the full spectrum of patients treated with DES in North America is unknown. METHODS: Patients in the National Heart, Lung, and Blood Institute Dynamic Registry enrolled in 2004 who received at least 1 DES (n = 1,460) were compared with 1,763 patients enrolled in the recruitment period immediately preceding the approval of DES (2001 to 2002) who received at least 1 BMS. RESULTS: Patients receiving DES more often had diabetes mellitus and less often presented with an acute myocardial infarction (MI). At 1 year, cumulative death and MI was 7.6% in DES- and 8.7% in BMS-treated patients (adjusted hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.68 to 1.15; p = 0.34). The 1-year rate of target vessel revascularization was 5.0% in DES and 9.2% in BMS patients (p < 0.001), and the risk of any repeat revascularization by percutaneous coronary intervention or coronary bypass was lower in DES patients (adjusted HR 0.38, 95% CI 0.25 to 0.60; p < 0.001). Patients with both simple and complex lesion characteristics benefited from DES with lower risk of repeat target vessel revascularization by percutaneous coronary intervention compared with BMS (any complex lesion: adjusted HR 0.57, 95% CI 0.39 to 0.83; absence of any complex lesion: adjusted HR 0.44, 95% CI 0.28 to 0.71). The 1-year incidence of stent thrombosis was 1.0% in DES patients. CONCLUSIONS: The generalized use of DES resulted in better outcomes than BMS, with fewer clinically driven revascularization procedures and similar rates of death and MI at 1 year.

Comparison of outcome in patients with ST-elevation versus non-ST-elevation acute myocardial infarction treated with percutaneous coronary intervention (from the National Heart, Lung, and Blood Institute Dynamic Registry).

Patients with ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) are increasingly being treated with percutaneous coronary intervention (PCI) and we sought to determine risk of adverse outcomes by type of MI. Patients enrolled in the National Heart, Lung, and Blood Institute Dynamic Registry from 1999 to 2004 who presented with an acute MI as an indication for PCI were studied. Baseline data and in-hospital and 1-year outcomes were compared based on ST-segment elevation (STEMI, n = 903; NSTEMI, n = 583) at presentation. Patients with STEMI were younger, had fewer co-morbidities, and had less extensive coronary artery disease than did patients with NSTEMI. Angiographic success and periprocedural complications were similar by MI type. In-hospital coronary artery bypass grafting, stroke, bleeding and recurrent MI were similar but mortality was higher in patients with STEMI (4.0% vs 1.4%, p = 0.004). Cardiogenic shock was associated with the greatest risk of in-hospital death (odds ratio 26.7, 95% confidence interval 11.4 to 62.3, p = 0.0001), but STEMI was also independently predictive of mortality. At 1 year, there was no influence of MI type on outcome. Age, cardiogenic shock, renal disease, peripheral vascular disease, and cancer were predictive of death and MI. Multivessel disease and a larger number of >50% lesions were associated with the need for repeat revascularization. In conclusion, STEMI was associated with a higher likelihood of in-hospital death than was NSTEMI, but long-term outcomes after PCI were independent of MI type. At 1 year, associated co-morbidities were strongly associated with death and MI, whereas only angiographic characteristics predicted the need for repeat revascularization.

Gender-based outcomes in percutaneous coronary intervention with drug-eluting stents (from the National Heart, Lung, and Blood Institute Dynamic Registry).

Gender-based outcomes have not been evaluated in unselected patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). We investigated whether gender influences the relative safety and efficacy of DESs compared with bare metal stents (BMSs) in routine clinical practice. Using the National Heart, Lung, and Blood Institute Dynamic Registry, in-hospital and 1-year outcomes were stratified by gender in patients who received > or =1 DES (486 women, 974 men) or BMS (631 women, 1,132 men). There were significant baseline differences by gender, including older age and a higher prevalence of co-morbidities in women and more previous coronary artery disease in men. There were no gender-related differences in in-hospital myocardial infarction, coronary artery bypass grafting, and death in those treated with BMSs or DESs. Antiplatelet use and stent thrombosis (1.3% of women vs 1.2% of men, p = 0.85) were similar at 1 year with DESs. At 1 year, patients with DESs had a lower rate of repeat PCI (14.1% in women vs 9.5%, p = 0.02; 12.0% in men vs 8.8%, p = 0.02). Adjusted 1-year outcomes in patients with BMSs and DESs, including death and myocardial infarction, were independent of gender. Use of DESs was the only factor, other than age, that conferred a lower risk for the need for repeat PCI in women (relative risk 0.61, 95% confidence interval 0.41 to 0.89, p = 0.01) and men (relative risk 0.68, 95% confidence interval 0.51 to 0.91, p = 0.001). In conclusion, the widespread use of DESs is safe and has decreased clinically driven revascularization compared with BMSs equally in women and men.

Marked improvements in outcomes of contemporary percutaneous coronary intervention in patients with diabetes mellitus.

We sought to determine if advances in percutaneous coronary intervention (PCI) are associated with better outcomes among patients with diabetes mellitus (DM). Patients with DM enrolled in the National Heart, Lung, and Blood Institute (NHLBI) early PTCA Registry (1985-1986) were compared to those in the subsequent contemporary Dynamic Registry (1999-2002) for in-hospital and one-year cardiovascular outcomes. The study population included 945 adults with DM, 325 from the PTCA Registry and 620 from the Dynamic Registry. Multivariable Cox regression models were built to estimate the risk of clinical events. Dynamic Registry patients were older, had more noncardiac comorbidities, and a lower mean ejection fraction (50.5% vs 57.8%, P < or = 0.001) compared to the PTCA Registry patients. The incidence of in-hospital mortality (1.9% vs 4.3%, P < or = 0.05), myocardial infarction (MI) (1.0% vs 7.4%, P

Recent trends in the percutaneous treatment of chronic total coronary occlusions.

Percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) has a lower success rate than PCI for non-CTO lesions. We sought to determine trends in the treatment of CTOs within the current interventional era. Using 4 sequential recruitment waves of the National Heart, Lung, and Blood Institute Dynamic Registry, we assessed the relative prevalence and success rates in treating CTO (n=371) versus non-CTO (n=4,802) lesions over a 7-year period (1997 to 2004). Characteristics of attempted lesions and factors associated with PCI outcome were evaluated. CTO lesion attempts decreased by 41% over time, from 9.6% (1997 to 1998) to 5.7% (2004, p<0.0001 for trend). More contemporary CTO lesions were longer (22.4 vs 17.0 mm, p=0.006 for trend), had thrombus less often (21.3% vs 35.4%, p=0.03 for trend), and were more often treated with stents (69.8% vs 45.4% p=0.02). The rate of successful intervention for CTO lesions decreased nonsignificantly during this time, from 79.7% to 71.4% (p=0.18). Using multivariable analysis, female gender (adjusted odds ratio 0.42, 95% confidence interval 0.20 to 0.88, p=0.02), and thrombus (adjusted odds ratio 0.31, 95% confidence interval 0.15 to 0.61, p=0.0008) were associated with higher success rates, whereas the presence of severe noncardiac disease (adjusted odds ratio 1.91, 95% confidence interval 1.05 to 3.45, p=0.03) was associated with a higher risk for PCI failure. Recruitment wave and patient age were not independently related to lesion success. In conclusion, during the PCI period of 1997 to 2004, CTO lesions were attempted less frequently and success rates did not increase, indicating a need for new operator techniques or device technologies to treat this important lesion subset by a percutaneous approach.

Ethnic differences in the presentation, treatment strategy, and outcomes of percutaneous coronary intervention (a report from the National Heart, Lung, and Blood Institute Dynamic Registry).

Information about the impact of race/ethnicity on adverse outcomes after percutaneous coronary intervention (PCI) in the modern era is limited. Using consecutive patients from the National Heart, Lung, and Blood Institute Dynamic Registry, this study investigated differences in clinical presentation, treatment strategy, and acute and long-term outcomes in 3,669 white, 446 black, 301 Hispanic, and 201 Asian patients who underwent PCI. All comparisons were made to whites. Blacks were more likely than whites to be younger, women, and to present with a higher prevalence of cardiovascular risk factors (hypertension, diabetes, and smoking). Hispanics tended to be younger, hypertensive, diabetic, and to be undergoing their first cardiovascular procedure. Asians were, on average, younger, men, and presented more often with hypertension and diabetes than whites. Although the rate of stent implantation was significantly lower in blacks compared with whites (63% vs 74%, p <0.001), angiographic and procedural success rates were high (> or =95%) and did not differ by race/ethnicity. In-hospital mortality (0.2% vs 1.7%, p <0.05) and death/myocardial infarction (MI)/coronary artery bypass grafting (CABG) (3.1% vs 5.5%, p <0.05) were lower in blacks. All other in-hospital complications were similar to whites. At 1 year, there were no statistical differences in cumulative adverse event rates by ethnicity; however by 2 years there was a modestly higher mortality rate (adjusted RR 1.87; 95% confidence interval 1.15 to 3.04) and adverse event rate (death/MI, death/MI/CABG) among black patients. Thus, although differences in patient demographics, clinical presentation, angiographic characteristics and treatment strategies did not impact the incidence of acute and 1-year adverse outcomes of non-whites, there appears to be a significant reduction in event-free survival among blacks by 2 years.

Comparison of in-hospital and one-year outcomes in patients with and without diabetes mellitus undergoing percutaneous catheter intervention (from the National Heart, Lung, and Blood Institute Dynamic Registry).

Extrapolation of improvements in percutaneous coronary intervention (PCI) and outcomes to patients with diabetes has not been systematically examined in clinical practice. Two waves of consecutive patients (n = 4,629) who underwent PCI from July 1997 to June 1999 enrolled in the National Heart, Lung, and Blood Institute Dynamic Registry comprise the study population. There were 1,058 patients with treated diabetes and 3,571 patients without clinically evident diabetes. As a group, patients with diabetes tended to have more clinical, angiographic, and procedural risk factors. Although crude in-hospital mortality rates were higher in patients with diabetes (diabetics 2.3%, nondiabetics 1.3%; p = 0.02), the adjusted risk of in-hospital death (odds ratio 1.46, 95% confidence interval [CI] 0.80 to 2.66) was not significantly different. At 1 year, patients with diabetes had a significantly higher adjusted risk of mortality (risk ratio [RR] 1.80, 95% CI 1.35 to 2.41) and need for repeat revascularization (RR 1.40, 95% CI 1.13 to 1.74). There was a significant interaction between stent use and diabetic status with the need for repeat revascularization (adjusted RR in nondiabetics 0.73, 95% CI 0.61 to 0.88; adjusted RR in patients with diabetes 1.20, 95% CI 0.88 to 1.65). Beta blockers at the time of hospital discharge were significantly associated with reduced mortality rates at 1 year in both groups.