12-month Major Adverse Cardiac Events Research Articles

Coronary Stents in Patients with ST-Elevation Myocardial Infarction and Chronic Kidney Disease Undergoing Primary Percutaneous Coronary Intervention

Background and ObjectivesChronic kidney disease (CKD) is associated with poor outcomes after percutaneous coronary intervention (PCI). We sought to compare different coronary stents used during primary PCI in patients with ST-elevation myocardial infarction (STEMI) and CKD.Subjects and MethodsWe selected 2408 consecutive STEMI patients with CKD (estimated glomerular filtration rate <60 mL/min/1.73 m2) undergoing primary PCI and divided them into 5 groups based on the type of stent implanted: 1) bare metal stent (BMS), 2) paclitaxel-eluting stent (PES), 3) sirolimus-eluting stent (SES), 4) zotarolimus-eluting stent (ZES), or 5) everolimus-eluting stent (EES). The study endpoint was the number of major adverse cardiac events (MACE) at 12 months.ResultsThere was no significant difference in the incidence of 12-month myocardial infarction, target lesion revascularization, or target vessel revascularization between stent groups; however, the overall rate of repeat revascularization differed significantly between groups. All-cause death differed significantly among the groups. The incidence of 12-month MACE in BMS, PES, SES, ZES, and EES was 8.3%, 9.8%, 8.6%, 5.5%, and 2.6%, respectively (p<0.001). Kaplan-Meier analysis did not show a significant differences in 12-month MACE-free survival among the groups (log-rank p=0.076). This finding remained the same after adjusting for multiple confounders (p=0.147).ConclusionAny of the 5 stents can be used to treat STEMI patients with CKD undergoing primary PCI; all have similar risk of 12-month MACE. This result is hypothesis-generating and warrants further evaluation with a long-term randomized study.

Risk prediction with serial myeloperoxidase monitoring in patients with acute chest pain.

Although myeloperoxidase (MPO) monitoring is predictive for cardiovascular outcomes in suspected acute coronary syndromes, the value of serial testing is unknown. We investigated the relationship between serial MPO concentrations in 490 individuals with acute chest pain and incident major adverse cardiac events (MACE) during 6 months of follow-up. We measured MPO with the CardioMPO assay, and cardiac troponin I (cTnI), with the Abbott Architect assay. Plasma MPO concentrations during the first 16 h were higher in individuals who experienced MACE. Higher MPO quartiles predicted a greater likelihood of 6-month MACE at baseline [OR (95% CI), 2.4 (1.4-4.1), P = 0.001 for highest vs lowest quartile] and all subsequent time points, with strongest predictive ability found in 16-h postbaseline samples [9.9 (4.7-20.9), P < 0.001 for highest vs lowest quartile]. MPO was predictive for MACE among individuals whose cTnI remained within reference intervals (<0.028 μg/L). The lowest rate of missed cases was found when MPO was <640 pmol/L at baseline and all other time points. Serial MPO monitoring predicted MACE risk better than baseline MPO measurements alone (c statistic 0.813 vs 0.602; P = 0.002), including in individuals whose cTnI remained within reference intervals (c statistic 0.903; P = 0.009). Combined serial cTnI and MPO testing improved accuracy for predicting 6-month MACE, reduced the number of missed MACE events from cTnI testing alone, and improved risk classification in 26.1% of patients. MPO concentrations are predictive of outcome up to 16 h after presentation with chest pain and predict events missed by cTnI testing, supporting a potential role in rapid patient triage.

Abstract 9443: Long-Term Clinical Outcomes of Infarct-Related Artery versus Multivessel Revascularization in Acute ST-Segment Elevation Myocardial Infarction with Multivessel Disease: An Analysis from Korea Acute Myocardial Infarction Registry

Many STEMI patients have multivessel disease. Guidelines recommend multiple revascularization only in cardiogenic shock. We compared clinical outcomes of multivessel revascularization with infarct-related artery(IRA) revascularization in ST-segment myocardial infarction(STEMI) patients. The 1,283 STEMI patients with multivessel disease[975 in IRA group(group I), 308 in multivessel group(group II)] received primary PCI and were analyzed from a nationwide Korea Acute Myocardial Infarction Registry. Primary outcomes were in-hospital mortality and 12-month major adverse cardiac events(MACE, defined as death, myocardial infarction, and repeated revascularization). Secondary outcomes were in-hospital complications and components of the MACE. There were more hemodynamic unstable patients in group I. In-hospital mortality was higher in group I with marginal significance(6.6% vs. 3.6%, p = 0.051). 12-month MACE occurred in 84(14.6%) in group I, 20(11.5%) in group II(p = 0.294). Each components of MACE were occurred similarly in two groups but non-target vessel revascularization(6.4% vs. 1.7%, p = 0.012). Adjusting for confounding factors, multivessel revascularization did not reduce in-hospital mortality(OR 0.935, 95% CI 0.403-2.167, p=0.875). It was same for 12-month MACE(OR 0.953, 95% CI 0.406-2.233, p = 0.911) and secondary outcomes. But multivessel revascularization reduced non-target vessel revascularization(OR 0.279, 95% CI 0.085-0.922, p = 0.036). There was no significant difference of clinical outcomes except for low risk of non-target vessel revascularization in multivessel revascularization group. Therefore, results of our study support current guidelines.

Threshold Level of Low‐Density Lipoprotein Cholesterol for the Short‐Term Benefit of Statin Therapy in the Acute Phase of Myocardial Infarction

Little is known about the threshold level of low-density lipoprotein cholesterol (LDL-C) for statin therapy in acute myocardial infarction (AMI). The aim of this study was to investigate the short-term benefit of the statin in post-MI patients with low LDL-C levels. Between November 2005 and January 2008, 6866 statin-naive patients were selected from the Korea AMI registry. Major adverse cardiac event (MACE) was defined as a composite of death, recurrent MI, and revascularizations. The 6-month MACE and mortality showed a U-shaped curve, with the lowest rate at 114-122 mg/dL. Propensity scores for statin use were calculated for patients with LDL-C ≤ 113 mg/dL, and they were used to match the patients who received statin (statin user, n = 1031) with those who did not receive it (statin nonuser, n = 1031). The 6-month MACE was not significantly different between statin users and statin nonusers (9.4% vs 11.0%; hazard ratio [HR]: 0.847, 95% confidence interval [CI]: 0.646-1.111, P = 0.230), whereas the 6-month mortality was significantly lower in statin users (7.2% vs 9.7%; HR: 0.728, 95% CI: 0.539-0.984, P = 0.039). However, when the analyses were repeated in the patients with LDL-C ≤ 105 mg/dL, not only the 6-month MACE (9.5% vs 9.9%; HR: 0.945, 95% CI: 0.700-1.277, P = 0.713) but also the 6-month mortality (7.0% vs 8.7%; HR: 0.793, 95% CI: 0.566-1.111, P = 0.177) was not significantly different between statin users and statin nonusers (n = 876 in each group). The beneficial effects of statin therapy seem to vanish when LDL-C is below a certain level in AMI patients.

Impact of Iso-Osmolar Versus Low-Osmolar Contrast Agents on Contrast-Induced Nephropathy and Tissue Reperfusion in Unselected Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (From the Contrast Media and Nephrotoxicity Following Primary Angioplasty for Acute Myocardial Infarction [CONTRAST-AMI] Trial)

Conflicting data have been reported on the effects of low-osmolar and iso-osmolar contrast media on contrast-induced acute kidney injury (CI-AKI). In particular, no clinical trial has yet focused on the effect of contemporary contrast media on CI-AKI, epicardial flow, and microcirculatory function in patients with ST-segment elevation acute myocardial infarction who undergo primary percutaneous coronary intervention. The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty for Acute Myocardial Infarction (CONTRAST-AMI) trial is a prospective, randomized, single-blind, parallel-group, noninferiority study aiming to evaluate the effects of the low-osmolar contrast medium iopromide compared to the iso-osmolar agent iodixanol on CI-AKI and tissue-level perfusion in patients with ST-segment elevation acute myocardial infarction. Four hundred seventy-five consecutive, unselected patients who underwent primary percutaneous coronary intervention were randomized to iopromide (n = 239) or iodixanol (n = 236). All patients received high-dose N-acetylcysteine and hydration. The primary end point was the proportion of patients with serum creatinine (sCr) increases ≥25% from baseline to 72 hours. Secondary end points were Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade, increase in sCr ≥50%, increase in sCr ≥0.5 or ≥1 mg/dl, and 1-month major adverse cardiac events. The primary end point occurred in 10% of the iopromide group and in 13% of the iodixanol group (95% confidence interval -9% to 3%, p for noninferiority = 0.0002). A TIMI myocardial perfusion grade of 0 or 1 was present in 14% of patients in the 2 groups. No differences between the 2 groups were found in any of the secondary analyses of sCr increase. No significant difference in 1-month major adverse cardiac events was found (8% vs 6%, p = 0.37). In conclusion, in a population of unselected patients with ST-segment elevation acute myocardial infarction who underwent primary percutaneous coronary intervention, iopromide was not inferior to iodixanol in the occurrence of CI-AKI; no significant differences were found in terms of tissue-level reperfusion and major adverse cardiac events between the 2 contrast agents.

Clinical Benefit of Statin Pretreatment in Patients Undergoing Percutaneous Coronary Intervention

Background— Previous studies suggested that statin pretreatment reduces cardiac events in patients undergoing percutaneous coronary intervention. However, most data were observational, and single randomized trials included limited numbers of patients. Methods and Results— We performed a collaborative meta-analysis using individual patient data from 13 randomized studies in which 3341 patients received either high-dose statin (n=1692) or no statin/low-dose statin (n=1649) before percutaneous coronary intervention, with all patients receiving statin therapy after intervention. Occurrence of periprocedural myocardial infarction, defined as postintervention creatine kinase–MB increase ≥3 times the upper limit of normal, and 30-day major adverse cardiac events (death, myocardial infarction, target-vessel revascularization) was evaluated. Incidence of periprocedural myocardial infarction was 7.0% in the high-dose statin versus 11.9% in the control group, which corresponds to a 44% risk reduction in the active-treatment arm (odds ratio by fixed-effects model 0.56, 95% confidence interval, 0.44 to 0.71, P &lt;0.00001). The rate of major adverse cardiac events at 30 days was significantly lower in the high-dose statin group (7.4% versus 12.6%, a 44% risk reduction; P &lt;0.00001), and 1-month major adverse cardiac events, excluding periprocedural events, were also reduced (0.6% versus 1.4%; P =0.05). The benefit of high-dose statins was realized irrespective of clinical presentation ( P for interaction=0.43) and was maintained across various subgroups but appeared greater in the subgroup with elevated baseline C-reactive protein levels (n=734; 68% risk reduction for periprocedural myocardial infarction versus 31% in those 1861 patients with normal CRP; P for quantitative interaction=0.025). Conclusions— High-dose statin pretreatment leads to a significant reduction in periprocedural myocardial infarction and 30-day adverse events in patients undergoing percutaneous coronary intervention. This strategy should be considered in all patients with planned percutaneous coronary intervention.

Does Occlusion Duration Influence Procedural and Clinical Outcome of Patients Who Underwent Percutaneous Coronary Intervention for Chronic Total Occlusion?

Previous studies have reported that the indeterminable aging and long-duration occlusion are associated with procedural failure and adverse long-term outcome. We aimed to investigate the clinical impact of occlusion duration in a consecutive series of patients who underwent percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions. From October 2005 to June 2009, a total of 303 patients with 328 CTO lesions were consecutively treated achieving a success rate of 86.3%. The average of occlusion duration estimated in 62.5% of cases (known occlusion duration [KOD] patients, n = 188) was 29.8 ± 41.3 months. In the remaining 37.5% of cases, the occlusion duration was indeterminate (indetermination of occlusion duration [IOD] patients, n = 115). No influence of duration in procedural outcome was observed. Moreover, no differences of 1-year major adverse cardiac events (MACE) were observed between KOD and IOD patients. The multivariate COX regression analysis identified diabetes mellitus and multivessel coronary disease as independent predictors of 12-month MACE (HR 5.023; 95% CI 0.164-9.653; P = 0.025 and HR 0.801; 95% CI 0.109-0.909, P = 0.033). The analysis did not show any influence of IOD and long occlusion duration in the occurrence of MACE. Predictors of angiographic failure recognized with multivariate binary logistic were vessel diameter <2.5 mm (OR 5.3; 95% CI 1.19-8.91; P = 0.02), CTO length >20 mm (OR 6.3; 95% CI 1.22-9.54; P = 0.02), and severe calcification (OR 3.2; 95% CI 1.62-5.51; P = 0.03). IOD and long duration of CTO do not affect procedural and clinical outcome of patients who underwent CTO PCI. This marks the importance of considering PCI treatment, a reliable strategy in cases of IOD or long occlusion duration.

Standard versus high loading doses of clopidogrel in Asian ST-segment elevation myocardial infarction patients undergoing percutaneous coronary intervention: Insights from the Korea Acute Myocardial Infarction Registry

The optimal loading dose of clopidogrel in Asian patients with ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. We compared bleeding, vascular complications, and midterm outcomes of a 300-mg versus a 600-mg loading dose of clopidogrel in a large series of Korean patients with STEMI undergoing primary percutaneous coronary intervention (PCI). A total of 2,664 STEMI patients (age 61.96 ± 11.91 years, men 70.4%) who underwent primary PCI were enrolled in this study. The patients were divided into a standard loading dose group (300 mg; n = 1,447 patients) and a high loading dose group (600 mg; n = 1,217 patients). Bleeding and vascular complications, and in-hospital and clinical outcomes up to 12 months were compared between the 2 groups. In-hospital bleeding and vascular complications were similar between the 2 groups. There were no differences in bleeding and vascular complications and in 1- and 12-month clinical outcomes, including mortality, myocardial infarction, repeated PCI, and major adverse cardiac events, between the 2 groups. These findings were consistent even after the propensity score-matched analysis. The standard loading dose of clopidogrel may be as safe and similarly effective as the high loading dose in Asian STEMI patients undergoing primary PCI.

A Novel Risk Stratification Model for Patients with Non-ST Elevation Myocardial Infarction in the Korea Acute Myocardial Infarction Registry (KAMIR): Limitation of the TIMI Risk Scoring System

The Thrombolysis in Myocardial Infarction (TIMI) risk score (TRS) has proven value in predicting prognosis in unstable angina/non ST-elevation myocardial infarction (NSTEMI) as well as in ST-elevation myocardial infarction. The TRS system has little implication, however, in the extent of myocardial damage in high-risk patients with NSTEMI. A total of 1621 patients (63.6±12.2 years; 1043 males) with NSTEMI were enrolled in the Korea Acute Myocardial Infarction Registry (KAMIR). We analyzed the risk for major adverse cardiac events (MACE) during a 6-month follow-up period. The TRS system showed good correlation with MACE for patients in the low and intermediate groups but had poor correlation when the high-risk group was included (p=0.128). The MACE rate was 3.8% for TRS 1, 9.4% for TRS 2, 10.7% for TRS 3, and 12.3% for TRS 4 (HR=1.29, p=0.026). Among the biomarkers and clinical risk factors, elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) (HR=2.61, p=0.001) and Killip class above III showed good correlation with MACE (HR=0.302, p<0.001). Therefore, we revised an alternative clinical scoring system by including these two variables that reflect left ventricular dysfunction: age > 65 years, history of ischemic heart disease, Killip class above III, and elevated pro-BNP levels above the 75th percentile. This modified scoring system, when tested for validity, showed good predictive value for MACE (HR=1.64, p<0.001). Compared with the traditional TRS, the novel alternative scoring system based on age, history of ischemic heart disease, Killip class, and NT-proBNP showed a better predictive value for 6-month MACE in high-risk patients with NSTEMI.

Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting

It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD. We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively. MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.

Drug-eluting stents versus coronary artery bypass grafting for the treatment of coronary artery disease: A meta-analysis of randomized and nonrandomized studies

We performed the present systematic review and meta-analysis of randomized and nonrandomized comparative studies in an attempt to compare the safety and efficacy of drug-eluting stents with coronary artery bypass grafting for patients with coronary artery disease. Twenty-five eligible comparative studies (1 randomized and 24 nonrandomized) were assessed. Two reviewers independently appraised each study. Meta-analysis was performed by combining the results of reported incidence of morbidity, mortality, and repeat revascularization. The relative risk was used as a summary statistic. In these 25 studies 34,278 patients were compared, of whom 18,538 received drug-eluting stents and 15,740 underwent coronary artery bypass grafting. It must be acknowledged that this comparison represented a selected group of patients who received drug-eluting stents or underwent coronary artery bypass grafting. The accumulative incidences of all-cause mortality at 12 months (4.5% vs 4.0%, P = .92) and 24 months (6.2% vs 8.4%, P = .27) and 30-day myocardial infarction (1.4% vs 2.0%, P = .60) were similar, respectively, between the drug-eluting stent and coronary artery bypass grafting groups. Drug-eluting stents were associated with lower rates of all-cause mortality at 30 days (0.9% vs 2.3%, P < .001), stroke (0.4% vs 1.7%, P < .001), and 30-day major adverse cardiac and cerebrovascular events (3.6% vs 5.5%, P < .04). However, the coronary artery bypass grafting group had a lower incidence of postprocedural myocardial infarction (5.5% vs 4.7%, P = .03), repeat revascularization (22.2% vs 4.1%, P < .001), and 12-month major adverse cardiac and cerebrovascular events (16.7% vs 10.5%, P < .001). Subgroup analysis of patients with multivessel coronary artery disease showed similar results. Drug-eluting stents are associated with less periprocedural risks but a higher incidence of postprocedural myocardial infarction, repeat revascularization, and 12-month major adverse cardiac and cerebrovascular events compared with coronary artery bypass grafting.

Six-Year Clinical Follow-up After Treatment of Diffuse In-Stent Restenosis With Cutting Balloon Angioplasty Followed by Intracoronary Brachytherapy With Liquid Rhenium-188-Filled Balloon via Transradial Approach

Long-term follow-up studies revealed a significant decline in the benefits of intracoronary radiation for in-stent restenosis. A total of 25 study and 25 contemporaneous control patients with diffuse in-stent restenosis who underwent cutting balloon angioplasty (CBA) transradially, followed by subsequent intracoronary irradiation with a liquid β-emitter Rhenium-188 (¹⁸⁸Re)-filled balloon were enrolled in the study. The mean clinical follow-up durations were 64.9 ± 13.0 and 66.3 ± 13.8 months for the irradiated and control patients, respectively. Six-month angiographic restenosis was observed in 16% (4 of 25) of the patients in the irradiated group and 48% (12 of 25) of the patients in the control groups (P = 0.03). The 6-month major adverse cardiac events (MACE) rate was 12% and 44%, respectively (P = 0.025). The 3-year follow-up angiography was performed in 16 of 21 (76%) irradiated patients and in 4 of 13 (31%) control patients who had no significant restenosis at the 6-month angiographic follow-up. Restenosis occurred in 1 of 16 (7%) irradiated patients and 2 of 4 (50%) control patients. Late target lesion revascularization was performed in 1 irradiated and 2 control patients. The MACE rate within 6 years was significantly reduced in the irradiated group (20% vs. 56%, P = 0.019). Brachytherapy using ¹⁸⁸Re-filled balloon following CBA for diffuse in-stent restenotic native coronary arteries is effective in reducing target lesion restenosis and improving long-term outcomes.

Usefulness of Mean Platelet Volume as a Biomarker for Long-Term Outcomes After Percutaneous Coronary Intervention

Larger size platelets have enhanced reactivity. The mean platelet volume (MPV) is a marker of platelet activation and is usually measured as part of blood testing. The aim of the present study was to investigate the utility of the MPV as a biomarker in prognosticating the long-term outcomes after percutaneous coronary intervention (PCI). The baseline MPV values from consecutive patients undergoing PCI were screened. Of the 1,432 patients, the composite primary end point of mortality or myocardial infarction at 1 year occurred in 80 (5.6%). The patients in the highest tertile (MPV >9.1 fL) had an increased frequency of the primary end point compared to those in the mid (8.1 to 9.1 fL) and lowest (<8.1 fL) tertiles (9.0%, 4.5%, and 3.5%, respectively; p <0.01). Logistic regression analysis demonstrated diabetes (odds ratio 2.44, 95% confidence interval 1.48 to 4.00) and highest tertile of MPV (odds ratio 2.42, 95% confidence interval 1.47 to 3.99) as the best predictors of adverse outcomes. In patients with acute coronary syndrome, the preprocedural MPV and troponin levels demonstrated a comparable predictive relation to the primary end point (receiver operator characteristics curve analysis, area under the curve 0.64, p = 0.01; and 0.63, p = 0.01, respectively). In conclusion, an elevated MPV was a strong independent predictor of long-term outcomes after PCI. The preprocedural MPV had prognostic value similar to that of troponin in patients with acute coronary syndrome. These findings could be of importance in the clinical evaluation of patients before PCI and the design of future studies assessing antiplatelet therapies.

Gender differences in epicardial and tissue-level reperfusion in patients undergoing primary angioplasty for acute myocardial infarction

ObjectiveThe impact of gender on clinical course after ST-elevation myocardial infarction (STEMI) is not fully understood. We prospectively investigated whether there are gender-related differences in epicardial and myocardial tissue-level perfusion, both of which represent important prognotic determinants in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). MethodsA total of 594 consecutive non-selected STEMI patients undergoing PPCI were prospectively enrolled. Primary end-point of the study was post-procedural epicardial and myocardial perfusion. Secondary end-points were the 30-day and 6-month composite occurrence of major adverse cardiac events (MACE). ResultsWomen with STEMI had higher risk factor profiles than men. Although PPCI achieved equal rates of successful epicardial reperfusion, women tended to have impaired microvascular reperfusion as reflected by lower rates of normal TIMI myocardial perfusion grade (P=0.007) and complete ST-segment resolution (P=0.079). After adjustment for the risk profiles, multivariable analysis showed that gender itself was not an independent predictor of impaired microvascular reperfusion. Both female gender and impaired myocardial reperfusion were independent predictors of 30-day MACE, whereas gender lost its prognostic significance for 6-month MACE. Multivariable analysis restricted to female patients identified incomplete ST-segment resolution as the strongest determinant of 30-day MACE. ConclusionThe differences in microvascular reperfusion after PPCI between women and men are attributed to higher risk profiles in women. Both female gender and impaired myocardial reperfusion were independent predictors of 30-day outcomes after PPCI, emphasizing the importance of successful microvascular reperfusion in the women with STEMI.

Endovascular management of transplant renal artery stenosis with drug-eluting stents

Renal impairment (RI) is known to be an independent risk factor for the progression of cardiovascular disease. Its impact, however, on the outcomes in patients undergoing percutaneous coronary intervention (PCI) especially in the era of drug-eluting stents (DES) is not well known.We analysed data from patients undergoing PCI from April 1, 2004, to September 30, 2006, who were part of the Melbourne Interventional Group registry. RI was defined as an estimated glomerular filtration rate (eGFR), calculated using Cockcroft–Gault formula, of <60 ml/min. We compared outcomes at 30 days and 12 months in patients with and without RI.Four thousand one hundred ninety-five patients (3043 male) with an average age 65±12 years (mean±S.D.) underwent PCI. Twelve-month follow-up was available in 3963 (95%) patients, and these were included in the analysis. One thousand twelve patients (26%) had RI; of these, 608 (60%) presented with an acute coronary syndrome. Both 30-day major adverse cardiac events (MACE), 9.1% vs. 4.6% (P<.01), and all-cause mortality, 4.5% vs. 0.7% (P<.01), were significantly higher in those with RI compared to those without RI. Twelve-month mortality (8.8% vs. 1.7%, P<.01) and MACE (19.7% vs. 10.3%, P<.01) were also significantly higher in those with RI. In multiple regression analysis, RI was an independent predictor of 12-month MACE [OR 2.0 (CI 1.6–2.6), P<.01].RI is an independent predictor of 30-day and 12-month MACE and death after PCI in patients with stable and unstable coronary syndromes, even with widespread use of DES. eGFR should be used to help risk-stratify patients undergoing PCI.

Is There an Obesity Paradox After Percutaneous Coronary Intervention in the Contemporary Era?: An Analysis From a Multicenter Australian Registry

We sought to determine whether an obesity paradox exists in the contemporary era of percutaneous coronary intervention (PCI) and to explore potential clinical factors that might contribute. Previous studies have suggested that overweight and obese patients might have better outcomes after PCI than patients with a normal or low body mass index (BMI); however this "obesity paradox" remains poorly understood. We evaluated 4,762 patients undergoing PCI between April 1, 2004 and September 30, 2007, enrolled in the MIG (Melbourne Intervention Group) registry. Patients were classified as underweight, normal, overweight, class I obese, and class II to III obese, BMI <20, 20 to 25, 25.1 to 30, 30.1 to 35, and >35 kg/m(2), respectively. We compared in-hospital, 30-day, and 12-month outcomes. As BMI increased from <20 to >35 kg/m(2), there was a statistically significant, linear reduction in 12-month major adverse cardiac events (MACE) (21.4% to 11.9%, p = 0.008) and mortality (7.6% to 2.0%, p < 0.001). Obesity was, with multivariate analysis, an independent predictor of reduced 12-month MACE and showed a trend for reduced 12-month mortality. At 12 months, obese patients had higher use of aspirin, clopidogrel, beta-blockers, renin-angiotensin system blockers and statins. Compared with normal-weight individuals, overweight and obese patients had lower in-hospital and 12-month MACE and mortality rates after PCI. Moreover, obese patients had a higher rate of guideline-based medication use at 12 months, which might in part explain the obesity paradox seen after PCI.

Impact of gender differences on long-term outcomes after successful percutaneous coronary intervention in patients with acute myocardial infarction

Abstract Many observational and randomized studies have suggested that women have a higher short-term mortality after acute myocardial infarction (AMI) following primary percutaneous coronary intervention (PCI). However, little is known about the effect of gender differences on short- and long-term outcomes in the drug-eluting stent (DES) era. To evaluate the clinical outcomes of women who have undergone PCI with DES, we analyzed 3298 consecutive eligible patients using the Korea Acute Myocardial Infarction Registry (KAMIR). No differences in primary PCI success rates were found between women and men. On univariate analysis, women showed worse outcomes than men for one-month major adverse cardiac event (MACE) (odds ratio [OR], 2.30; 95% confidence interval [CI], 1.81–2.92) and 12-month MACE (OR, 1.64; 95% CI, 1.36–1.97). On multivariable analysis, older age (OR, 1.03; 95% CI, 1.02–1.05), dyslipidemia (OR, 2.28; 95% CI, 1.16–4.49), smoking (OR, 1.54; 95% CI, 1.07–2.21) and Killip class (OR, 3.63; 95% CI, 2.76–4.91), but not gender, were associated with one-month MACE in this national registry. In 12-month MACE, old age, ischemic heart disease history, diabetes, dyslipidemia, and Killip class were independent predictors of patients undergoing primary PCI with DES. Older age and additional comorbidities, but not gender, are likely to explain the deteriorating short- and long-term outcomes in the DES era.

Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial

To evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy undergoing percutaneous coronary intervention (PCI). Five hundred and three patients on >10 days clopidogrel therapy (41% with non-ST-segment elevation acute coronary syndrome, ACS) randomly received 600 mg clopidogrel loading 4-8 h before PCI (n = 252) or placebo (n = 251). Primary endpoint was 30-day incidence of major adverse cardiac events (MACE). In the overall population primary endpoint occurred in 6.7% of patients in the reload vs. 8.8% in the placebo arm [odds ratios (OR) 0.75, 95% confidence intervals (CI) 0.37-1.52; P = 0.50]. In stable angina patients, 1-month MACE were not significantly different (7.0 vs. 3.9%; OR 1.84, 0.60-5.88; P = 0.36), whereas ACS patients had significant clinical benefit with reloading (6.4 vs. 16.3%; OR 0.34, 95% CI 0.32-0.90, P = 0.033 at multivariable analysis; interaction test: P = 0.01). There was no excess bleeding in the reload arm (6% in both groups). ARMYDA-4 RELOAD reveals no overall benefit from reloading patients on chronic clopidogrel therapy prior to PCI; the benefit observed in ACS patients is a hypothesis-generating finding that needs to be confirmed by larger studies.

A Novel Paclitaxel-Eluting Stent With an Ultrathin Abluminal Biodegradable Polymer: 9-Month Outcomes With the JACTAX HD Stent

The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions. The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 microm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 microg each of polymer and paclitaxel per 16-mm stent). In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%). The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 +/- 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 +/- 11.2%. The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. ("JACTAX" Trial Drug Eluting Stent Trial; NCT00754728).

Transradial Approach Percutaneous Coronary Interventions in an Out-Patient Clinic Safety and Feasibility Trial of Same-Day Discharge Versus Hospital Admission

Same-day discharge transradial percutaneous coronary intervention (TRI) has been reported to be safe and feasible in Western countries. However, Asia has not produced any reports related to this matter. The present study explored the safety and feasibility of patients with indications for TR coronary angiography and ad hoc PCI with a same-day discharge protocol. Between October 1995 and December 2002, 660 adult patients were admitted to our hospital for ad hoc PCIs. Of these, 214 patients were discharged on the day of their PCI (group A), while the remaining 446 patients were referred for out-patient department (OPD) PCI with subsequent admission (group B). Periprocedural complications were not significantly different between the groups. There were no differences in 1-month major adverse cardiac events including death, myocardial infarction, and target vessel revascularization (1.4% versus 0.2% for groups A and B, respectively; P = 0.068). Three group A cases (1.4%) experienced peri- and post-PCI myocardial infarction and one group B case (0.2%) experienced a post-PCI myocardial infarction. No patient died or required emergency bypass surgery. In group A, 8 cases (3.7%) required cutting balloon angioplasty and 2 cases (0.9%) needed rotational atherectomy. TRI is safe and feasible on an outpatient basis. For select patients, even though PCI can carry the potential risk of subsequent cutting balloon angioplasty or rotational atherectomy, the procedure should still be considered.