Relation of Sex and Race to Outcomes in Patients Undergoing Percutaneous Intervention With Drug-Eluting Stents.

Cardiovascular disease is the leading cause of death in men and women, black and white. However, there exists limited outcomes data for women and blacks after percutaneous coronary intervention (PCI). The aim of this study was to evaluate the 1-year major cardiovascular events in patients who underwent PCI based on gender and race. We retrospectively analyzed data that were prospectively collected over 13 years at a large tertiary hospital in the United States. There were 12,050 patients who underwent PCI for both stable disease and acute coronary syndrome from 2003 to 2016. Of those, 1,952 were black men, 6,013 white men, 1,619 black women, and 2,466 white women. Major cardiovascular events at 1 year were assessed, and proportional Cox hazard model analyses were performed to assess outcome adjusted for confounding factors (i.e., age, body mass index, presentation with acute myocardial infarction, diabetes, smoking, history of coronary artery disease, family history of coronary artery disease, hyperlipidemia, hypertension, previous cardiovascular intervention, and chronic kidney disease). At 1 year, white men had significantly lower major cardiovascular events driven by lower rate of death compared with the other groups. Adjusted for confounders, major cardiovascular events were 1.3 to 1.5 times more likely to occur in black men and women and white women than in white men. There was a significant race by gender interaction (p <0.001).

Coronary perfusion pressure and left ventricular hemodynamics as predictors of cardiovascular collapse following percutaneous coronary intervention.

BACKGROUND/PURPOSE: Appropriate patient selection for mechanical circulatory support following percutaneous coronary intervention (PCI) remains a challenge. This study aims to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. METHODS/MATERIALS: We retrospectively analyzed all patients who underwent PCI for acute coronary syndrome (ACS) from 2003 to 2016. Coronary perfusion pressure was calculated for each patient and defined as the difference in mean arterial pressure and left ventricular end diastolic pressure (LVEDP). Logistic regression analysis was performed to determine predictor of composite outcome of in-hospital mortality, myocardial infarction (MI), congestive heart failure (CHF), and cardiogenic shock. RESULTS: Nine hundred twenty-two patients were analyzed. Two-hundred twenty-eight (25%) presented with ST-elevation MI (STEMI) while 694 (75%) underwent PCI for unstable angina or non-Q-wave MI. The mean LVEDP was significantly higher in the STEMI patients (24 ±â€¯9 vs. 19 ±â€¯8 mm Hg, p < 0.05) and perfusion pressure significantly lower (68 ±â€¯24 vs. 74 ±â€¯18 mm Hg, p < 0.05). Eighty-seven (9.4%) reached the composite endpoint, and there was no difference between the STEMI and Not-STEMI groups. Neither LVEDP nor coronary perfusion pressure was a predictor of the composite outcome following multivariable logistic regression analysis for either STEMI or Not-STEMI patients. Increasing age, chronic renal insufficiency (CRI), CHF, and low left ventricular ejection fraction were predictors of the composite outcome for Not-STEMI patients, whereas only history of cerebrovascular accident and CRI were predictors for STEMI patients. CONCLUSIONS: In hemodynamically stable patients presenting with ACS, LVEDP and coronary perfusion pressure are not predictive of in-hospital cardiovascular collapse. SUMMARY: The authors retrospectively analyzed 922 patients from a single center who underwent percutaneous coronary intervention (PCI) for acute coronary syndromes to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. They found that neither coronary perfusion pressure nor left ventricular end diastolic pressure was predictive of in-hospital cardiovascular collapse.

In-Stent Restenosis of Drug-Eluting Stents Compared With a Matched Group of Patients With De Novo Coronary Artery Stenosis.

Drug-eluting stents (DES) significantly reduced the incidence of in-stent restenosis (ISR). However, ISR still exists in the contemporary DES era. Previously deemed to be a benign process, ISR leads to complex presentation and intervention. This study aimed to compare the presentation and outcome of DES-ISR versus de novo lesions. We performed a retrospective analysis of 11,666 patients receiving percutaneous coronary intervention from 2003 to 2017 and divided them into 2 groups by de novo stenosis and ISR. They were matched based on common cardiovascular risk factors at a 4:1 ratio, respectively. After matching, a total of 1,888 patients with 3,126 de novo lesions and 472 patients with 508 ISR lesions were analyzed. Patients with ISR presented more often with unstable angina (61% vs 45%, p <0.001) and less often with myocardial infarction (6% vs 14%, p <0.001). One-year composite major adverse cardiovascular event, defined as death, Q-wave myocardial infarction, and target vessel revascularization, was 10% in the de novo group and 17% in the ISR group (hazard ratio 1.98, 95% confidential interval 1.58 to 2.46, p <0.001). After adjusting for myocardial infarction presentation, hazard ratio of major adverse cardiovascular events was still higher for the ISR group at 1 year (2.03, 95% confidential interval 1.62 to 2.55, p <0.001). ISR of DES remains a therapeutic challenge and leads to complex presentation and worse outcomes compared with matched de novo patients. These data show that DES-ISR demands better appreciation and prevention with more precise stent technique and should motivate the continued development of fully bioresorbable scaffolds.

Comparison of transradial and transfemoral access in patients undergoing percutaneous coronary intervention for complex coronary lesions.

OBJECTIVE: Comparison of transradial versus transfemoral access for complex percutaneous coronary intervention (PCI) with regard to both complications and long-term outcomes. BACKGROUND: Radial access has been shown to confer superior results in patients undergoing PCI, especially in patients with acute coronary syndromes. However, radial access has limitations of sheath and device size, which may increase procedure time and result in inferior outcomes. METHODS: Patients undergoing PCI for complex lesions, defined as type C according the ACC/AHA classification system, were included in this study. Propensity matching was performed to adjust for differences in baseline characteristics. Transradial patients were then compared to transfemoral patients in regard to procedural, in-hospital, and 6-month outcomes. RESULTS: Among 2142 patients with 2591 lesions treated, 1876 had femoral access and 267 had radial access. Radial access patients were more likely to be male (75% vs. 66%, P = 0.003) and less likely to present with acute myocardial infarction (27% vs. 42%, P < 0.001). Procedural characteristics demonstrated lower use of heparin in the femoral group (17% vs. 73%, P < 0.001) with similarly low use of glycoprotein inhibitors (5.6% vs. 3.4%, P = 0.14). Patients in the femoral group had higher rates of transfusions (3.7% vs. 0%, P = 0.004) and vascular complications (1.7% vs. 0%, P = 0.03). Following propensity matching, there was no difference in mid-term outcomes between radial and femoral groups. CONCLUSIONS: In patients with complex coronary lesions undergoing PCI, the radial approach demonstrates similar mid-term outcomes as the femoral approach with a potentially lower rate of complications. © 2016 Wiley Periodicals, Inc.

Frequency of Angina Pectoris After Percutaneous Coronary Intervention and the Effect of Metallic Stent Type.

Although metallic coronary stents significantly reduce angina pectoris compared with optimal medical therapy, angina after percutaneous coronary intervention (PCI) remains frequent. We, therefore, sought to compare the incidence of any angina during the 1 year after PCI among the spectrum of commercially available metallic stents. Metallic stent type was classified as bare metal stent, Cypher, Taxus Express, Xience V, Promus Element, and Resolute. The primary end point was patient-reported angina within 1 year of PCI. Multivariable logistic regression was performed to assess the independent association of stent type with any angina at 1 year. Overall, 8,804 patients were queried in regard to angina symptoms; 32.3% experienced angina at some point in the first year after PCI. Major adverse cardiovascular events, a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, increased with angina severity: 6.8% for patients without angina, 10.0% for patients with class 1 or 2 angina, and 19.7% for patients with class 3 or 4 angina (p <0.001 for trend). After multivariable adjustment, there was no significant association between stent type and angina at 1 year after PCI. Baseline Canadian Cardiovascular Society class 3 or 4 angina, history of coronary artery bypass grafting, and history of PCI were associated with a higher likelihood of angina at 1 year; increasing age, male gender, presentation with acute coronary syndrome, and higher stented length were associated with less angina. In conclusion, metallic stent type is not associated with the occurrence of angina at up to 1 year after PCI.

The influence of lipid-containing plaque composition assessed by near-infrared spectroscopy on coronary lesion remodelling.

AIMS: Vessel remodelling is commonly observed in coronary atherosclerosis, but factors influencing remodelling, such as plaque lipid content, remain poorly described. METHODS AND RESULTS: Remodelling index (RI) was calculated as the ratio of lesion to proximal and distal references external membrane area and was categorized as follows: positive (PR; RI > 1.05), intermediate (IR; RI 0.95-1.05), and negative remodelling (NR; RI < 0.95). RI was studied by near-infrared spectroscopy (NIRS) as a function of lipid content metrics, including the maximal 4 mm lipid core burden index of the segment (maxLCBI4 mm) and intravascular ultrasound (IVUS) lesion plaque burden (PB). The authors further stratified the analysis according to obstructive (≥50%) and non-obstructive (<50%) lesions using quantitative coronary angiography. Receiver-operating characteristic curves were performed to describe the maxLCBI4 mm level associated with PR. From May 2012 to November 2014, 100 de novo lesions from 67 patients underwent simultaneous NIRS-IVUS. PR was found in 28% of the lesions. There was a positive linear correlation between RI and maxLCBI4 mm (ρ = 0.58; P < 0.001). Although PR lesions had a larger PB than NR or IR (P < 0.001), the correlation of RI with maxLCBI4 mm was stronger compared with plaque volume (ρ = 0.18; P = 0.07) and with per cent PB (ρ = 0.41; P < 0.001). This relationship remained significant for obstructive (ρ = 0.72; P < 0.001) and non-obstructive lesions (ρ = 0.48; P < 0.001). By receiver-operating characteristic curve analysis, values of maxLCBI4 mm ≥ 439 were predictive for PR (area under the curve = 0.79, 95% confidence interval: 0.69-0.89). CONCLUSION: In vivo coronary lesion remodelling is positively correlated with lipid plaque content assessed by NIRS rather than simply PB. Thus, the use of NIRS can potentially aid in further stratifying vulnerable lesions.

The influence of advancing age on implantation of drug-eluting stents.

BACKGROUND: The influence of age upon the use of drug-eluting stents (DES) in patients aged ≥ 65 years is uncertain. The aim of this study is to investigate the impact of age increase in patients aged ≥ 65 years in the use of DES in patients undergoing percutaneous coronary intervention (PCI). METHOD: The study cohort comprised 8,598 patients ≥ 65 years of age who underwent stent implantation from April 2003 to March 2014. We defined the first DES era as the period April 2003 to July 2008 and the second DES era as the period July 2008 to March 2014. Multivariable logistic regression was performed for both eras to assess the impact of age increase and analyze independent factors associated with DES implantation. RESULTS: In the first DES era cohort, the two groups of patients differed in their risk factor profile with lower rates of male sex, diabetes, smokers, and hypercholesterolemia in those aged ≥ 75 years. There were more Caucasian and less African-Americans in this age group. Furthermore, patients aged ≥ 75 years had lower left ventricular ejection fraction (LVEF) and baseline haematocrit concentration were more likely to present with an acute myocardial infarction (MI) than stable or unstable angina and had higher rates of a previous history for congestive heart failure (CHF), chronic renal insufficiency (CRI), and peripheral vascular disease (PVD). These differences were broadly similar for patients in the second DES era except for similarities in LVEF, presentation with unstable angina, and PVD, as well as a lower rate for previous PCI. DES use was reduced with increasing age in both the first (OR=0.78; 95% CI=0.69-0.89) and second DES era (OR=0.53; 95% CI=0.47-0.58). In both eras, DES use was less likely in current smokers, patients presenting with acute MI and cardiogenic shock, and those with a previous history of CHF. CONCLUSION: In patients aged ≥ 65 years, the use of DES decreased with increasing age. This observation was apparent in both the first and second DES era. © 2015 Wiley Periodicals, Inc.

Comparison of clinical outcomes in patients presenting with an acute coronary syndrome due to stent thrombosis or saphenous vein graft occlusion and undergoing percutaneous coronary intervention.

OBJECTIVE: To compare the clinical outcomes of patients undergoing percutaneous intervention for stent thrombosis (ST) or saphenous vein graft (SVG) occlusion. BACKGROUND: Patients presenting with ST or SVG occlusion are at increased risk of adverse outcomes. There is limited literature comparing the outcome of such patients. METHODS: A cohort of 415 consecutive patients presenting to the MedStar Washington Hospital Center undergoing percutaneous coronary intervention (PCI) for an acute coronary syndrome secondary to ST (n=136) or SVG occlusion (n=279) was studied. The SVG group was subdivided into patients who underwent PCI in the occluded SVG (SVG-PCI: n=75) or in the subtended native coronary artery (NC-PCI: n=204). The analyzed clinical parameters were in-hospital complications as well as 30-day and 1-year major adverse cardiac events (MACE). MACE was defined as all-cause mortality, Q-wave myocardial infarction, or target vessel revascularization. RESULTS: The rates of death, major bleeding, and length of hospital stay were significantly different between the ST and NC-PCI groups. The SVG-PCI group had a shorter hospital stay. The 30-day MACE rate was significantly different in the ST and NC-PCI groups (18.9% vs. 7.5%; risk ratio=0.40, 95% CI=0.20-0.81, p=0.03) but not in the ST and SVG-PCI groups (18.9% vs. 15.1%; p=0.55, risk ratio=0.80, 95% CI=0.38-1.68). There were no differences in the 1-year MACE rate. CONCLUSIONS: As compared to patients undergoing NC-PCI, patients with ST have greater rates of in-hospital mortality and major bleeding as well as 30-day MACE rate. The 1-year MACE rate is similar in patients with ST and SVG occlusion who undergo PCI.

The effect of complete percutaneous revascularisation with and without intravascular ultrasound guidance in the drugeluting stent era.

AIMS: Our aim was to compare the outcomes of complete revascularisation (CR) and incomplete revascularisation (IR) in multivessel coronary artery disease (CAD), with and without intravascular ultrasound (IVUS) guidance, in the drug-eluting stent (DES) era. METHODS AND RESULTS: Overall, 2,132 consecutive patients with multivessel CAD, defined as at least two epicardial vessels with >70% stenosis, had at least one DES implant. Chronic total occlusions were not analysed. Successful treatment of epicardial vessels and significant branches was termed CR; otherwise, treatment was defined as IR. CR and IR were further categorised according to the use of IVUS. The primary outcome was death or Q-wave myocardial infarction (QWMI). Secondary outcomes included the rates of non-QWMI and repeat revascularisation, the latter assessed as either target vessel revascularisation (TVR) or target lesion revascularisation (TLR) at one year. CR was associated with lower rates of death/QWMI (HR 0.66 [0.4-0.9]; p=0.048) and non-QWMI at one year (1.1% vs. 2.6%; p=0.017). Completeness of revascularisation was not independently associated with repeat intervention, but rates of both TVR (89% vs. 93%; p<0.001) and TLR (91% vs. 95%; p<0.001) were higher with CR than IR. IVUS decreased the rates of TLR irrespective of completeness of revascularisation (p-interaction=0.75). CONCLUSIONS: CR in selected patients gives better outcomes than IR in multivessel CAD at one year. IVUS guidance can further improve results by reducing rates of repeat intervention irrespective of completeness of revascularisation.

Comparison of Rotational Atherectomy, Plain Old Balloon Angioplasty, and Cutting-Balloon Angioplasty Prior to Drug-Eluting Stent Implantation for the Treatment of Heavily Calcified Coronary Lesions.

BACKGROUND: The optimal technique for lesion preparation in heavily calcified coronary lesions (HCCL) prior to drug-eluting stent (DES) implantation has not been described. The aim of this study was to compare the clinical outcomes of lesion preparation with rotational atherectomy (ROTA), plain old balloon angioplasty (POBA), or cutting-balloon angioplasty (CBA) in patients with HCCL who were treated with DES. METHODS: The study cohort comprised 737 consecutive patients (874 lesions) who underwent RA (n = 264), POBA (n = 220), or CBA (n = 253) for HCCL at our institution and were treated with DES. Patients with mild or moderate calcified lesions, restenotic lesions, treatment with bare-metal stent (BMS), or history of prior coronary artery bypass graft (CABG) were excluded. The analyzed clinical parameters were the 1-month, 6-month, and 12-month rates of death (all-cause and cardiac), Q-wave myocardial infarction (MI), target-lesion revascularization (TLR), definite stent thrombosis (ST), and major adverse cardiac event (MACE), defined as the composite of death, Q-wave MI, or TLR. RESULTS: The patients were well matched for their baseline characteristics except for age (RA = 71.9 ± 10.4 years; POBA = 68.0 ± 10.8 years; CBA = 68.7 ± 11.8 years; P<.001) and hypertension (RA = 90.9%; POBA = 80.9%; CBA = 84.2%; P=.01), which were different among the three cohorts. The three cohorts had similar clinical outcomes at both short-term and long-term follow-up. The 12-month results were all-cause death (RA = 9.8%; POBA = 8.2%; CBA = 4.5%; P=.18), cardiac death (RA = 3.1%; POBA = 2.5%; CBA = 1.3%; P=.61), Q-wave MI (RA = 0%; POBA = 0%; CBA = 0.7%; P>.99), TLR (RA = 5.2%; POBA = 3.5%; CBA = 3.9%; P=.76), ST (RA = 0%; POBA = 0%; CBA = 0.6%; P=.63) and MACE (RA = 14.6%; POBA = 12.3%; CBA = 8.3%; P=.20). The 1-year MACE-free survival rates were also similar among the three cohorts (log-rank P=.20). CONCLUSION: A strategy of lesion preparation with RA, POBA, or CBA in HCCL may be associated with similar clinical outcomes in patients undergoing percutaneous intervention with DES. The RA group had a trend toward greater MACE, death, and TLR.

Safety and efficacy of everolimus-eluting stents for bare-metal in-stent restenosis.

OBJECTIVE: The aim of this study was to compare the safety and efficacy of the everolimus-eluting stents (EES) with the paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) for the treatment of bare-metal in-stent restenosis. BACKGROUND: The optimal treatment for bare-metal in-stent restenosis remains controversial. METHODS: The study cohort comprised 322 consecutive patients (543 lesions) who presented with bare-metal in-stent restenosis to our institution and underwent coronary artery stent implantation with EES (114 patients; 181 lesions), PES (65 patients; 116 lesions) and SES (143 patients; 246 lesions). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, MI, or TLR at 1-year. RESULTS: The three groups were well matched for the conventional risk factors except for age and chronic kidney disease. The 1-year analyzed clinical parameters were similar in the three groups: death (EES=3.5%, PES=4.6%, SES=4.2%; p=0.94), MI (EES=3.5%, PES=6.3%, SES=2.1%; p=0.31), TLR (EES=9.8%, PES=9.5%, SES=5.7%; p=0.42), TVR (EES=14.3%, PES=11.1%, SES=11.3%; p=0.74), definite ST (EES=0.9%, PES=3.1%, SES=3.5%; p=0.38) and MACE (EES=14.0%, PES=15.4%, SES=10.5%; p=0.54). Male gender (hazard ratio=0.47; 95% confidence interval=0.25-0.88) and number of treated lesions (hazard ratio=1.47; 95% confidence interval=1.06-2.05) were found to be independent predictors of MACE. CONCLUSION: The results of the present study indicate that EES may provide similar safety and efficacy as first generation DES for the treatment of patients presenting with bare-metal in-stent restenosis.

Clinical outcomes of first- and second-generation drug-eluting stents in patients undergoing rotational atherectomy for heavily calcified coronary lesions.

BACKGROUND: There is paucity of data regarding the clinical outcome of second generation drug- eluting stents (DES) post rotational atherectomy (RA) for heavily calcified coronary lesions (HCCL). METHODOLOGY: The study cohort comprised 99 (116 lesions) consecutive patients who underwent RA for HCCL at our institution and received either a first generation DES (40 patients, 53 lesions) or a second generation DES (59 patients, 63 lesions). The analyzed clinical parameters were the 12-month rates of death (all cause and cardiac), Q-wave MI, target lesion revascularization (TLR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, Q-wave MI, or TLR. RESULTS: The two groups were well matched for their baseline characteristics except for a lower left ventricular ejection fraction in the second generation DES group (46.0±23.0% vs. 55.0±9.0%; p=0.02). The group receiving second generation DES had more type C lesions (81.0% vs. 58.8%; p=0.01), shorter stent length (19.9±6.1 mm vs. 22.7±7.3 mm; p=0.04) and was more likely to undergo stent postdilatation (52.4% vs. 23.1%; p=0.001). The 1-year analyzed clinical parameters were similar in the two groups: all cause death (8.5% vs. 10.3%; p=1.0), cardiac death (8.5% vs. 2.5%; p=0.40), Q-wave MI (0% vs. 0%), TLR (3.6% vs. 2.7%; p=1.0), ST (0% vs. 0%), and MACE (11.9% vs. 12.8%; p=1.0). The 1-year MACE-free survival rate was also similar in the two cohorts. CONCLUSION: The use of second generation DES, following RA for HCCL, is associated with similar short and long-term clinical outcomes to first generation DES.

Safety and efficacy of limus-eluting stents and balloon angioplasty for sirolimus-eluting in-stent restenosis.

OBJECTIVES: The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR). BACKGROUND: The optimal treatment for drug-eluting in-stent restenosis remains controversial. METHODS: The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year. RESULTS: The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES=14%, SES=18%, POBA=20%; p=0.65), death (EES=2.3%, SES=6.2%, POBA=6.1%; p=0.61), MI (EES=4.8%, SES=2.1%, POBA=2.5%; p=0.69), TLR (EES=11.9%, SES=12.1%, POBA=24%; p=0.78), and TVR (EES=11.9%, SES=24.8%, POBA=22.2%; p=0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p=0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE. CONCLUSIONS: In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome.

Safety and long-term outcomes after percutaneous coronary intervention in patients with human immunodeficiency virus.

OBJECTIVE: This study aims to report the long-term outcomes after percutaneous coronary intervention (PCI) in human immunodeficiency virus (HIV+) patients. BACKGROUND: Sparse data exists regarding the risk of patients with HIV who undergo PCI. METHODS: Using a case-control design, we compared baseline characteristics, procedure-related outcomes, in-hospital, and 2-year clinical outcomes of 112 consecutive HIV+ patients versus 112 HIV- controls matched for age, gender, and diabetes mellitus who underwent PCI from April 2003 to September 2011. RESULTS: Baseline characteristics were generally comparable, save for more African Americans and history of chronic renal insufficiency in the HIV+ vs. HIV- group (62.5% vs. 21.4%, P < 0.001) and (27.7% vs. 9.9%, P < 0.001). There was no correlation between CD4 nadir count and extent and diffuseness of coronary artery disease. The occurrence of major adverse cardiac events at 2 years was similar in both groups. Multivariable analysis for independent correlates of major adverse cardiac events at 2 years detected patients with a history of chronic renal insufficiency (OR: 2.44, 95% confidence interval: 1.02-5.83; P = 0.04) and acute myocardial infarction (OR: 2.92, 95% confidence interval: 1.39-6.15; P = 0.005) as correlates for outcome. Post-hoc analysis showed that drug-eluting stent (DES) use in the HIV+ group was beneficial. CONCLUSION: PCI in HIV+ patients is safe, with high procedural success rates, and produces similar outcomes to those seen in HIV- patients at 2 years. HIV+ patients should be treated with DES if possible.

Clinical presentation and outcomes of coronary in-stent restenosis across 3-stent generations.

BACKGROUND: Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients undergoing target lesion revascularization is well characterized and negatively affects on outcomes, whereas the presentation and outcomes of first- and second-generation drug-eluting stents (DESs) remains under-reported. METHODS AND RESULTS: The study included 909 patients (1077 ISR lesions) distributed as follows: bare metal stent (n=388), first-generation DES (n=425), and second-generation DES (n=96), categorized into acute coronary syndrome (ACS) or non-ACS presentation mode at the time of first target lesion revascularization. ACS was further classified as myocardial infarction (MI) and unstable angina. For bare metal stent, first-generation DES and second-generation DES, ACS was the clinical presentation in 67.8%, 71.0%, and 66.7% of patients, respectively (P=0.470), whereas MI occurred in 10.6%, 10.1%, and 5.2% of patients, respectively (P=0.273). The correlates for MI as ISR presentation were current smokers (odds ratio, 3.02; 95% confidence interval [CI], 1.78-5.13; P<0.001), and chronic renal failure (odds ratio, 2.73; 95% CI, 1.60-4.70; P<0.001), with a protective trend for the second-generation DES ISR (odds ratio, 0.35; 95% CI, 0.12-1.03; P=0.060). ACS presentations had an independent effect on major adverse cardiac events (death, MI, and re-target lesion revascularization) at 6 months (MI versus non-ACS: adjusted hazard ratio, 4.06; 95% CI, 1.84-8.94; P<0.001; unstable angina versus non-ACS: adjusted hazard ratio, 1.98; 95% CI, 1.01-3.87; P=0.046). CONCLUSIONS: ISR clinical presentation is similar irrespective of stent type. MI as ISR presentation seems to be associated with patient and not device-related factors. ACS as ISR presentation has an independent effect on major adverse cardiac events, suggesting that ISR remains a hazard and should be minimized.

Bivalirudin versus heparin for percutaneous coronary intervention: an updated meta-analysis of randomized controlled trials.

AIMS: Given controversy over anticoagulation regimens for percutaneous coronary intervention (PCI), we performed an updated meta-analysis of randomized controlled trials (RCTs) to compare bivalirudin versus heparin. METHODS AND RESULTS: Medline/Pubmed and Cochrane CENTRAL were searched for all RCTs comparing bivalirudin with provisional glycoprotein IIb/IIIa inhibitor (GPI) use versus heparin with provisional or routine GPI use for PCI. Pooled estimates of 30day outcomes, presented as risk ratios (RR) [95% confidence intervals], were generated with random-effect models. Our analysis included 14 studies with 30,446 patients that were randomized to bivalirudin with provisional GPI use (n=14,869) versus heparin with provisional (n=6451) or routine GPI use (n=9126). There was no significant difference between anticoagulation with bivalirudin compared with heparin for death (RR 0.95 [0.78-1.14]) or myocardial infarction (RR 1.10 [0.97-1.25]). Early stent thrombosis was significantly greater with bivalirudin compared with heparin (RR 1.61 [1.18-2.20], p=0.003), especially in patients undergoing primary PCI (2.15 [1.15-4.03], p=0.02). However, bivalirudin reduced the risk of major bleeding (RR 0.59 [0.51-0.70], p<0.0001) and TIMI major bleeding (RR 0.59 [0.48-0.72], p<0.0001) compared with heparin. Meta-regression analysis demonstrated that bleeding risk with use of heparin significantly increases with increasing GPI use (p=0.02). CONCLUSION: Meta-analysis of 14 RCTs with 30,446 patients demonstrated that bivalirudin is associated with higher risk of stent thrombosis but lower risk of major bleeding compared with heparin.

Safety and efficacy of everolimus-eluting stents compared with first-generation drug-eluting stents in patients undergoing primary percutaneous coronary intervention.

OBJECTIVE: To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation drug-eluting stents (DES) in patients with acute myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI). BACKGROUND: EES have been associated with improved clinical outcomes compared to paclitaxel-eluting stents (PES) and with similar outcomes compared to sirolimus-eluting stents (SES). METHODS: A total of 520 patients who presented with ST-elevation myocardial infarction (STEMI) from 2003 to 2013, who underwent primary PCI with DES, were retrospectively analyzed. Of these, 247 received SES, 136 PES, and 137 EES. Patients were followed up to 2 years for major adverse cardiac events (MACE). Univariate and multivariate models detected correlates to outcome. RESULTS: EES implantation, compared with PES and SES, resulted in comparable rates of MACE (8.8% vs. 16.2%, p=0.06 and 8.8% vs. 12.6%, respectively, p=0.26), stent thrombosis, MI, and target lesion revascularization. Patients who received EES had lower rates of all-cause mortality (3.7% vs. 12.6% vs. 9.4%, p=0.03) at 1-year follow up. However, in the univariate and multivariate analyses, stent type was not independently associated with the primary outcome or with all-cause mortality. Diabetes mellitus and number of stents implanted were independently associated with the primary outcome. CONCLUSION: While EES seem to be associated with better outcome when compared to PES, the main correlates of STEMI patients are the presence of diabetes and number of stents implanted, and not the type of stent used for intervention.

Transfer distance effect on reperfusion: timeline of ST-elevation patients transferred for primary percutaneous coronary intervention.

OBJECTIVES: This study aims to establish if transfer distance impacts the outcome of ST-elevation myocardial infarction (STEMI) patients transferred to a percutaneous coronary intervention (PCI). BACKGROUND: Regional emergency care systems were designed to decrease delays in reperfusion of patients but the effect of transfer distance on outcome is less established. METHODS: We compare the characteristics and outcomes of STEMI patients transferred from a distance >25 miles (GT25) to those transferred from distances ≤25 miles (LT25) by utilizing data from a regional STEMI care network in the greater Washington DC area. RESULTS: Within the transferred patients (n=1065), 609 patients (57%) were transferred from GT25 (median distance 36 miles), while 456 (43%) were transferred from LT25 (median distance 13 miles). Most of the baseline characteristics between the groups were similar. Door-to-balloon (DTB) was defined as the time elapsed from the presentation to the center without PCI capability to flow restoration in the culprit artery. No differences were noted in the median DTB (GT25: 158min [122-213] vs. 149 [118-219]; p=0.5) or in in-hospital mortality (8% vs. 7.2%; p=0.617). By implementing the regional STEMI care network, a constant decrease in DTB was noted throughout its years of operation. CONCLUSIONS: For STEMI patients presenting to a non-PCI capable center, a network care system for PCI mitigates the distance factor on DTB time. This is turn translates into comparable outcomes.

The impact of diabetes mellitus on long-term clinical outcomes after percutaneous coronary saphenous vein graft interventions in the drug-eluting stent era.

OBJECTIVES: We aimed to compare early and late clinical outcomes in diabetic and nondiabetic patients who underwent saphenous vein graft (SVG) percutaneous coronary interventions (PCI) with the use of drug-eluting stents (DES). BACKGROUND: Patients with diabetes mellitus are shown to have less favorable outcomes after SVG intervention with the use of bare metal stents. In the DES era, the impact of diabetes mellitus on restenosis and clinical outcomes post-SVG intervention is not clearly defined. METHODS: From our institutional PCI registry database, we retrospectively analyzed 477 consecutive patients with prior coronary artery bypass graft surgery undergoing SVG PCI with the implantation of DES stratified by the presence or absence of diabetes mellitus. The primary end-point was 1-year major adverse cardiac event (MACE) rate, defined as death, Q wave myocardial infarction, and target lesion revascularization. RESULTS: Baseline clinical characteristics, including mean graft age (120 ± 77 vs. 131 ± 86 months, P = 0.14), were similar between groups, save for a higher prevalence of systemic hypertension and chronic renal insufficiency, and higher body mass index in the diabetic group. Among the 604 SVG lesions treated with DES, the angiographic and procedural characteristics were well matched between groups except for the higher rate of distal protection device use (32% vs. 29%, P = 0.007) in the diabetic group. The rates of 1-year MACE (21% vs. 15%, P = 0.12) and all-cause mortality (7.6% vs. 6.7%, P = 0.86) were similar between groups. After adjustment for the relevant clinical co-variables, diabetic status was not associated with the composite end-point. CONCLUSION: In conclusion, DES, when used for the treatment of vein graft lesions, equate the short- and long-term outcomes between diabetic and nondiabetic patients, suggesting that DES should be considered the default stent in diabetic populations undergoing PCI for the treatment of SVG lesions.