Objectives This study sought to develop a practical risk score to predict the risk of stent thrombosis (ST) after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). ...Background ST is a rare, yet feared complication after PCI with stent implantation. A risk score for ST after PCI in ACS can be a helpful tool to personalize risk assessment. Methods This study represents a patient-level pooled analysis of 6,139 patients undergoing PCI with stent implantation for ACS in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trials who were randomized to treatment with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor. The cohort was randomly divided into a risk score development cohort (n = 4,093) and a validation cohort (n = 2,046). Cox regression methods were used to identify clinical, angiographic, and procedural characteristics associated with Academic Research Consortium–defined definite/probable ST at 1 year. Each covariate in this model was assigned an integer score based on the regression coefficients. Results Variables included in the risk score were type of ACS (ST-segment elevation myocardial infarction, non-ST-segment elevation ACS with ST deviation, or non–ST-segment elevation ACS without ST changes), current smoking, insulin-dependent diabetes mellitus, prior PCI, baseline platelet count, absence of early (pre-PCI) anticoagulant therapy, aneurysmal/ulcerated lesion, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0/1, final TIMI flow grade <3, and number of treated vessels. Risk scores 1 to 6 were considered low risk, 7 to 9 intermediate risk, and 10 or greater high risk for ST. Rates of ST at 1 year in low-, intermediate-, and high-risk categories were 1.36%, 3.06%, and 9.18%, respectively, in the development cohort (p for trend <0.001), and 1.65%, 2.77%, and 6.45% in the validation cohort (p for trend = 0.006). The C-statistic for this risk score was over 0.65 in both cohorts. Conclusions The individual risk of ST can be predicted using a simple risk score based on clinical, angiographic, and procedural variables. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction HORIZONS-AMI; NCT00433966 ) (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes ACUITY; NCT00093158 )
The treatment of calcified coronary lesions by percutaneous coronary intervention has been shown to be associated with poor outcomes and an increased rate of complications. However, the impact of ...coronary calcification in patients undergoing coronary artery bypass grafting (CABG) is unknown. A total of 755 patients presenting with acute coronary syndrome in the Acute Catheterization and Urgent Intervention Triage Strategy trial underwent CABG. Patients were divided into 3 groups according to the presence and extent of coronary calcifications (lesion level: severe, moderate, none to mild) as assessed by an independent angiographic core laboratory. Major ischemic and bleeding outcomes were assessed at 30 days and 1 year. Severe calcification was found in 103 patients (13.6%), moderate calcification in 249 patients (33.0%), and none-to-mild calcification in 403 patients (53.4%). The presence of severe calcification compared with moderate or none to mild was associated with a significantly higher unadjusted rate of death (11.8% vs 3.7% vs 4.5%, p = 0.006), death or myocardial infarction (MI; 31.1% vs 19.7% vs 16.4%, p = 0.006), and major adverse cardiac event (MACE; 32.0% vs 22.6% vs 20.8%, p = 0.059) at 1 year. By multivariate analysis, severe calcification (vs nonsevere calcification) was identified as an independent predictor of 1-year MACE (hazard ratio 1.49, 95% confidence interval 1.01 to 2.21, p = 0.04) and death or MI (hazard ratio 1.77, 95% confidence interval 1.18 to 2.66, p = 0.006). In conclusion, the presence of severe coronary calcification was associated with worse outcomes after CABG, including an increased risk of death. The presence of severe coronary calcification was identified as an independent predictor of MACE and death or MI 1 year after CABG.
The present study sought to determine the extent to which adverse angiographic events encountered during percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI) are ...associated with adverse clinical outcomes. Patients with STEMI represent a cohort at particularly high risk of intraprocedural thrombotic events (IPTEs). The overall frequency and implications of IPTEs occurring in patients with STEMI have not been systematically quantified in previous studies. A total of 3,163 patients undergoing primary percutaneous coronary intervention with stent implantation for STEMI in the Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial underwent detailed frame-by-frame core laboratory angiographic analysis to assess IPTEs. The clinical outcomes at 30 days were compared between the patients with and without IPTEs. IPTEs, defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, and distal embolization at any point during the procedure, occurred in 386 patients (12.2%). The independent predictors of IPTE were thrombus at baseline, lesion length, and randomization to bivalirudin; the patients with IPTEs were also more likely to receive bailout glycoprotein IIb/IIIa inhibitors and unplanned thrombectomy. Compared with patients without IPTEs, the patients with IPTEs had higher 30-day rates of composite major adverse cardiovascular events (death, myocardial infarction, ischemic target vessel revascularization, and stroke; 7.8% vs 4.2%, p = 0.002), major bleeding not related to coronary artery bypass grafting (11.8% vs 6.5%, p <0.001), and all-cause death (4.2% vs 1.8%, p = 0.002). On multivariate analysis, IPTEs were independently associated with 30-day major adverse cardiovascular events, major bleeding, and death. In conclusion, the development of IPTEs in patients undergoing primary percutaneous coronary intervention for STEMI was associated with subsequent adverse outcomes, including major adverse cardiovascular events, major bleeding, and death. Additional studies of strategies to decrease the occurrence of IPTEs are warranted.
Determinates of infarct size in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) have been incompletely characterized, in part because of the ...limited sample size of previous studies. Databases therefore were pooled from 4 contemporary trials of primary or rescue PCI (EMERALD, COOL-MI, AMIHOT, and ICE-IT), in which the primary end point was infarct size assessed using technetium-99m sestamibi single-photon emission computed tomographic imaging, measured at the same core laboratory. Of 1,355 patients, infarct size was determined using technetium-99m sestamibi imaging in 1,199 patients (88.5%), at a mean time of 23 ± 15 days. Median infarct size of the study population was 10% (interquartile range 0% to 23%; mean 14.9 ± 16.1%). Using multiple linear regression analysis of 18 variables, left anterior descending infarct artery, baseline Thrombolysis In Myocardial Infarction grade 0/1 flow, male gender, and prolonged door-to-balloon time were powerful independent predictors of infarct size (all p <0.0001). Other independent correlates of infarct size were final Thrombolysis In Myocardial Infarction grade <3 flow (p = 0.0001), previous AMI (p = 0.005), symptom-onset-to-door time (p = 0.021), and rescue angioplasty (p = 0.026). In conclusion, anterior infarction, time to reperfusion, epicardial infarct artery patency before and after reperfusion, male gender, previous AMI, and failed thrombolytic therapy were important predictors of infarct size after angioplasty in patients with AMI assessed using technetium-99m sestamibi imaging and should be considered when planning future trials of investigational drugs or devices designed to enhance myocardial recovery.
Objectives We compared intravascular ultrasound findings of drug-eluting stent (DES)–treated lesions that developed thrombosis versus in-stent restenosis (ISR). Background Stent underexpansion is a ...predictor of both DES thrombosis and ISR. However, all underexpanded DES may not be equal. Methods Intravascular ultrasound findings from 20 definite DES thrombosis patients (representing all definite thromboses from 1,407 consecutive DES patients undergoing intravascular ultrasound imaging) were compared with 50 risk-factor-balanced ISR patients with no evidence of stent thrombosis and 50 risk-factor-balanced “no-event” patients with neither thrombosis nor ISR. Results Minimum stent area (3.9 ± 1.0 mm2 vs. 5.0 ± 1.7 mm2 , p = 0.008), mean stent area (5.3 ± 1.0 mm2 vs. 7.2 ± 2.0 mm2 , p = 0.001), and both focal (55.4 ± 13.2% vs. 74.9 ± 19.9%, p < 0.001) and diffuse stent expansion (77.4 ± 19.3% vs. 109.5 ± 23.1%, p < 0.001) were significantly smaller in the stent thrombosis group versus ISR and in both groups versus the “no-event” group. Minimum stent area <4.0 mm2 (65% vs. 32%, p = 0.01) or <5.0 mm2 (85% vs. 52%, p = 0.01) was more common in the stent thrombosis versus the ISR group and in both groups vs. “no-event” patients; and the relative length of the stent area <5 mm2 was greatest in the stent thrombosis group (36.6 ± 37.7%), intermediate in the ISR group (22.8 ± 35.6%), and least in the “no-event” group (10.9 ± 26.4%), p = 0.04. In the stent thrombosis group, the minimum stent area site occurred in the proximal stent segment in 50% versus 24% in the ISR group (p = 0.03). There were no differences in edge dissection, stent fracture, or stent-vessel-wall malapposition among the groups. Conclusions The DES-treated lesions that develop thrombosis or restenosis are often underexpanded, but underexpansion associated with thrombosis is more severe, diffuse, and proximal in location.
Objectives Our aim was to study the impact of delay from symptom onset to first coronary device on infarct size and clinical outcomes at 30 days and 1 year in patients with ST-segment elevation ...myocardial infarction (STEMI) treated with primary percutaneous coronary intervention. Background Longer delay from symptom onset to reperfusion has been linked to increased mortality and worse clinical outcome. The mechanisms underpinning this association are not entirely clear. Methods The INFUSE-AMI trial (INFUSE-Anterior Myocardial Infarction) randomized patients with anterior STEMI undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation within 5 h of symptom onset to intralesion (IL) bolus abciximab versus no abciximab and to thrombus aspiration versus no aspiration. The primary endpoint was contrast magnetic resonance infarct size (IS) (percentage of left ventricular mass) at 30 days. Time to reperfusion was classified as <3 versus ≥3 h. Results There were 280 patients (62%) with <3-h delay and 170 patients (38%) with ≥3-h delay. Patients with longer delay were significantly older, more often women, and diabetic. Earlier reperfusion was not associated with higher rates of final Thrombolysis In Myocardial Infarction flow grade 3 or myocardial blush grade 2/3, but was an independent predictor of smaller IS (p = 0.02 by multivariable linear regression). Mortality at 1 year was reduced in patients with shorter delay to reperfusion (4.0% vs. 9.2%, p = 0.02). Conclusions In patients with large anterior myocardial infarction undergoing relatively early reperfusion, longer delays to reperfusion were associated with larger IS and 1-year mortality, but not with reduced reperfusion success. (The INFUSE - Anterior Myocardial Infarction AMI Study; NCT00976521 )
The clinical features and prognosis of patients with ST-segment elevation myocardial infarction (STEMI) and no significant coronary artery disease (CAD) have not been well studied. We examined the ...outcomes of patients with STEMI in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial according to the presence or absence of significant CAD. “No-CAD” was defined by the absence of any lesion with a diameter stenosis of ≥30% on quantitative coronary angiography of the baseline coronary angiogram. Of 3,602 patients, 127 (3.5%) had no-CAD. Of these, 86 (67.7%) had angiographically normal coronary arteries, and 41 (32.3%) had mild disease (diameter stenosis <30%). Eight patients had previously been treated with coronary artery bypass grafting. Compared to patients with CAD, patients with no-CAD were younger, had a lower body mass index, were more frequently black, had a lower prevalence of smoking and previous angina, and had a greater left ventricular ejection fraction. Cardiac enzymes were elevated in fewer patients with no-CAD than in those with CAD (63.2% vs 98.7%, p <0.001). At 3 years of follow-up, the patients with no-CAD versus CAD had lower rates of major adverse cardiovascular events (7.7% vs 22.2%, p = 0.002), net adverse clinical events (major adverse cardiovascular events or major bleeding not related to coronary artery bypass grafting, 12.5% vs 26.9%, p = 0.005), and postprocedure coronary revascularization (0% vs 19.5%, p <0.001). The differences in the rates of death or reinfarction, stroke, and major bleeding were not statistically significant. In conclusion, 3.5% of patients with STEMI had no significant CAD. The 3-year prognosis for these patients was favorable compared to that of patients with STEMI and with obstructive CAD.
Gender-Specific Outcomes After Sirolimus-Eluting Stent Implantation Emilia Solinas, Eugenia Nikolsky, Alexandra J. Lansky, Ajay J. Kirtane, Marie-Claude Morice, Jeffrey J. Popma, Joachim Schofer, ...Erick Schampaert, Tereza Pucelikova, Jiro Aoki, Martin Fahy, George D. Dangas, Jeffrey W. Moses, Donald E. Cutlip, Martin B. Leon, Roxana Mehran In this analysis of pooled data from the RAVEL (Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization), SIRIUS (SIRolImUS-coated Bx velocity balloon expandable stent in the treatment of patients with de novo coronary artery lesions), E-SIRIUS (Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries), and C-SIRIUS (Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries) trials, sirolimus-eluting stent (SES) versus bare metal-stent (BMS) implantation was associated with significant reductions in rates of in-segment binary restenosis both in women (6.3% vs. 43.8%) and in men (6.4% vs. 35.6%), as well as reductions in adverse clinical outcomes in both genders. By multivariable analysis, female gender was not an independent predictor of restenosis and clinical outcomes in SES- or BMS-treated patients.
Objectives The goal of this study was to characterize the extent and composition of coronary atherosclerosis in patients with diabetes mellitus or the metabolic syndrome (Met Syn) presenting with ...acute coronary syndromes (ACS). Background Diabetes and Met Syn patients have increased rates of major adverse cardiac events (MACE), yet a systematic description of nonculprit lesions for these high-risk groups is incomplete. Methods In the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study, ACS patients underwent 3-vessel quantitative coronary angiography, grayscale, and radiofrequency intravascular ultrasound after successful percutaneous coronary intervention (PCI). Subsequent MACE (cardiac death or arrest, myocardial infarction, or rehospitalization for unstable or progressive angina) were adjudicated to the originally treated culprit versus untreated nonculprit lesions in 3 patient groups: 1) diabetes; 2) Met Syn; and 3) neither. Median length of follow-up was 3.4 years. Results Of 673 patients, 119 (17.7%) had diabetes and 239 (35.5%) had Met Syn. The cumulative 3-year MACE rate was 29.4% in patients with diabetes, 21.3% with Met Syn, and 17.4% with neither (p = 0.03). MACE adjudicated to untreated nonculprit lesions occurred in 18.7%, 11.7%, and 9.7% of patients, respectively (p = 0.06). Nonculprit lesions in diabetes and Met Syn patients were longer and had greater plaque burden, smaller lumen areas, with greater necrotic core and calcium content. Diabetes and Met Syn patients with future MACE had greater necrotic core and calcification compared with the normal cardiometabolic group. Conclusions In this PCI ACS population, patients with diabetes and Met Syn had higher 3-year MACE rates. Lesion length, plaque burden, necrotic core, and calcium content were significantly greater among nonculprit lesions of patients with diabetes and Met Syn, but only necrotic core and calcium were significantly greater in the nonculprit lesions of patients with a future MACE in this exploratory analysis.
We assessed the ethnic differences in coronary atherosclerosis lesion morphology between white and Asian patients. Our hypothesis was that left main coronary artery (LMCA) disease was more focal and ...less complex in Asian than in Western white patients. We studied 99 Asian patients (Japan and South Korea) and 99 matched control United States white patients with a stable clinical presentation and >30% LMCA angiographic diameter stenosis by visual estimation. The matching parameters included age, gender, and diabetes mellitus. The vessel and lumen areas and calcium arc were analyzed every 0.5 mm and normalized for analysis length. Overall, 75.1% of the patients were men and 34.1% had diabetes. The patient age was 68.0 ± 10 years, with no differences between the Asian and white patients. The Asian patients had a lower prevalence of hyperlipidemia than the white patients (41.4% vs 81.8%; p <0.0001) and were smaller in size, and the white patients were more obese (body mass index 23.7 ± 2.6 vs 27.6 ± 4.1 kg/m2 , p <0.0001). The Asian patients had a smaller lumen area (5.2 ± 1.8 vs 6.2 ± 14 mm2 ; p <0.0001), larger vessel area (20.0 ± 4.9 vs 18.4 ± 4.4 mm2 ; p <0.0001), and larger plaque burden (72 ± 10 vs 64 ± 12%: p <0.0001) at the minimum lumen site and over the entire LMCA length. The white patients had more calcification, whether assessed by the maximum arc (82° ± 74° vs 49° ± 45°; p <0.0001) or total length (3.6 ± 3.2 vs 2.1 ± 2.1 mm; p <0.0001). In conclusion, after matching well-known risk factors, there appeared to be ethnic differences in coronary atherosclerosis morphology between Asian and white patients, at least as it affected LMCA morphology.
PDF
