A comparative analysis of primary stenting and optimal balloon coronary angioplasty in acute myocardial infarction. Six month results from the STENT PAMI trial

OBJECTIVE: To compare the outcome of balloon PTCA with final coronary stenosis diameter (SD) <=30%, with elective coronary stenting. METHODS: We performed a comparative analysis of the 6 month outcomes in patients treated with primary stenting and those who obtained an optimal balloon PTCA result treated during the first 12 hours of AMI onset included in the STENT PAMI randomized trial. RESULTS: The results were analysed into 3 groups: primary stenting (441 patients, SD=22±6%), optimal PTCA (245 patients), and nonoptimal PTCA (182 patients, SD= 37±5%). At the end of the 6 months primary stent group presented with the lowest restenosis(23 vs. 31 vs. 45%, p=0.001, respectively). Ischemia-driven target vessel revascularization rate (TVR) (7 vs. 15.5 vs. 19%, p=0.001, respectively). CONCLUSION: At the 6 month follow-up, primary stenting offered the lowest restenosis and ischemia-driven TVR rates. Compared to optimal balloon PTCA. Nonoptimal primary balloon PTCA pts (SD=31-50%), had the worst late angiographic outcomes and should be treated more actively with coronary stent implantation.

Clinical outcome following combination of cutting balloon angioplasty and coronary β-radiation for in-stent restenosis : a report from the RENO registry

RESUME : Actuellement la brachythérapie endovasculaire reste le seul traitement efficace pour la resténose intrastent. Malgré ceci, la limitation majeure de cette technique est la resténose aux extrémités du stent (effet de bord) due à une couverture incomplète par la source radioactive (geographical miss). Le ballon coupant et qui ne glisse pas pourrait limiter le barotraumatisme engendré par la dilatation et qui avec la diminution de la radiation aux extrémités de la source radioactive, est à la base du geographical miss. Cette étude prospective a pour but d'examiner l'efficacité du traitement de la resténose intrastent par la combinaison d'angioplastie avec cutting ballon et β - irradiation. Le registre « Radiation in Europe NOvoste » (RENO) inclut tous les patients traités par β - irradiation coronaire avec le système Beta-CathTM System (Novoste Corporation, Brussels, Belgium) n'ayant pas été inclus dans une autre étude randomisée. Un premier sous-groupe de ces patients (groupe 1, n=166), représente les patients traités par cutting ballon et β - irradiation intra coronaire. Ce groupe a été défini d'une manière prospective et les résultats cliniques à 6 mois ont été comparés par rapport aux autres patients qui ont reçu un traitement par dilatation coronaire conventionnelle et β - irradiation (groupe 2, n=712). A 6 mois de suivi, on a retrouvé une différence significative entre les 2 groupes par rapport à la nécessité d'une nouvelle revascularisation du vaisseau préalablement traité (10,2% de récidive dans le groupe 1 contre 16,6 % dans le groupe 2 , p=0,04). Le nombre d'événements cardiaques majeurs (mortalité, infarctus du myocarde et revascularisation) a également été diminué de manière significative (10,8% contre 19,2% ; />=0,01). Cette observation a été confirmée par une analyse multivariée qui indique un risque diminué pour les événements cardiaques majeurs à 6 mois, (rapport de côtes : 0,49 ; intervalle de confiance 0,27-0,88 ; p=0,02). Comparé à l'angioplastie coronarienne avec ballon conventionnel, l'utilisation de cutting ballon avant la β - irradiation dans le traitement de la resténose intrastent démontre une meilleure évolution clinique à 6 mois. ABSTRACT: At present, vascular brachytherapy is the only efficient therapy for in-stent restenosis. Nevertheless edge restenosis often relat¬ed to geographical miss has been identified as a major limitation of the technique. The non-slippery cutting balloon has the potential to limit vascular barotraumas which, together with low-dose irradiation at both ends of the radioactive source, are the prerequisite for geographical miss. This prospective study aimed to examine the efficacy of combining cut¬ting balloon angioplasty and brachytherapy for in-stent restenosis. The Radiation in Europe NOvoste (RENO) registry prospectively tracked all patients who had been treated by coronary β-radiation with the Beta-CathTM System (Novoste Corporation. Brussels, Belgium) but were not included in a randomized radiation trial, A subgroup of patients with in-stent restenosis treated by cutting balloon angioplasty and coronary β-radiation (group 1, n = 166) was prospectively defined, and clinical outcomes of patients at 6 months were compared with those of patients treated by conventional angioplasty and coronary β -radiation (group 2, n = 712). At 6-month follow-up, there was a significant difference between groups 1 and 2 in- target vessel revascularization (10.2% versus 16.6% respectively; p = 0.04) and in the incidence of major adverse clinical events (MACE) including, death, myocardial infarction, and revascularization (10.8% versus 19.2%; p= 0.01). This observation was confirmed by a multivariate analysis indicating a. lower risk for MACE at 6 months (odds ratio: 0.49; confidence intervals: 0.27-0.88; p = 0.02). Compared to conventional angioplasty, cutting balloon angio¬plasty prior to coronary beta-radiation with the Beta-CathTM System seems to improve the 6-month clinical outcome in patients with in-stent restenosis.

Local delivery of the KCa3.1 blocker, TRAM-34, prevents acute angioplasty-induced coronary smooth muscle phenotypic modulation and limits stenosis

Objective-We previously demonstrated that upregulation of intermediate-conductance Ca2+ -activated K+ channels (KCa 3.1) is necessary for mitogen-induced phenotypic modulation in isolated porcine coronary smooth muscle cells (SMCs). The objective of the present study was to determine the role of KCa3.1 in the regulation of coronary SMC phenotypic modulation in vivo using a swine model of postangioplasty restenosis. Methods and Results-Balloon angioplasty was performed on coronary arteries of swine using either noncoated or balloons coated with the specific KCa3.1 blocker TRAM-34. Expression of KCa3.1, c-jun, c-fos, repressor element-1 silencing transcription factor (REST), smooth muscle myosin heavy chain (SMMHC), and myocardin was measured using qRT-PCR in isolated medial cells 2 hours and 2 days postangioplasty. KCa3.1, c-jun, and c-fos mRNA levels were increased 2 hours postangioplasty, whereas REST expression decreased. SMMHC expression was unchanged at 2 hours, but decreased 2 days postangioplasty. Use of TRAM-34 coated balloons prevented KCa3.1 upregulation and REST downregulation at 2 hours, SMMHC and myocardin downregulation at 2 days, and attenuated subsequent restenosis 14 and 28 days postangioplasty. Immunohistochemical analysis demonstrated corresponding changes at the protein level. Conclusion-Blockade of KCa3.1 by delivery of TRAM-34 via balloon catheter prevented smooth muscle phenotypic modulation and limited subsequent restenosis. © 2008 American Heart Association, Inc.

Does Ad Hoc Coronary Intervention Reduce Radiation Exposure? – Analysis of 568 Patients

Background:Advantages and disadvantages of ad hoc percutaneous coronary intervention have been described. However little is known about the radiation exposure of that procedure as compared with the staged intervention.Objective:To compare the radiation dose of the ad hoc percutaneous coronary intervention with that of the staged procedureMethods:The dose-area product and total Kerma were measured, and the doses of the diagnostic and therapeutic procedures were added. In addition, total fluoroscopic time and number of acquisitions were evaluated.Results:A total of 568 consecutive patients were treated with ad hoc percutaneous coronary intervention (n = 320) or staged percutaneous coronary intervention (n = 248). On admission, the ad hoc group had less hypertension (74.1% vs 81.9%; p = 0.035), dyslipidemia (57.8% vs. 67.7%; p = 0.02) and three-vessel disease (38.8% vs. 50.4%; p = 0.015). The ad hoc group was exposed to significantly lower radiation doses, even after baseline characteristic adjustment between both groups. The ad hoc group was exposed to a total dose-area product of 119.7 ± 70.7 Gycm2, while the staged group, to 139.2 ± 75.3 Gycm2 (p < 0.001).Conclusion:Ad hoc percutaneous coronary intervention reduced radiation exposure as compared with diagnostic and therapeutic procedures performed at two separate times.

Potential Utility of the SYNTAX Score 2 in Patients Undergoing Left Main Angioplasty

Abstract Background: The revascularization strategy of the left main disease is determinant for clinical outcomes. Objective: We sought to 1) validate and compare the performance of the SYNTAX Score 1 and 2 for predicting major cardiovascular events at 4 years in patients who underwent unprotected left main angioplasty and 2) evaluate the long-term outcome according to the SYNTAX score 2-recommended revascularization strategy. Methods: We retrospectively studied 132 patients from a single-centre registry who underwent unprotected left main angioplasty between March 1999 and December 2010. Discrimination and calibration of both models were assessed by ROC curve analysis, calibration curves and the Hosmer-Lemeshow test. Results: Total event rate was 26.5% at 4 years.The AUC for the SYNTAX Score 1 and SYNTAX Score 2 for percutaneous coronary intervention, was 0.61 (95% CI: 0.49-0.73) and 0.67 (95% CI: 0.57-0.78), respectively. Despite a good overall adjustment for both models, the SYNTAX Score 2 tended to underpredict risk. In the 47 patients (36%) who should have undergone surgery according to the SYNTAX Score 2, event rate was numerically higher (30% vs. 25%; p=0.54), and for those with a higher difference between the two SYNTAX Score 2 scores (Percutaneous coronary intervention vs. Coronary artery by-pass graft risk estimation greater than 5.7%), event rate was almost double (40% vs. 22%; p=0.2). Conclusion: The SYNTAX Score 2 may allow a better and individualized risk stratification of patients who need revascularization of an unprotected left main coronary artery. Prospective studies are needed for further validation.

Primary percutaneous coronary intervention for unprotected left main disease in patients with acute ST-segment elevation myocardial infarction the AMIS (Acute Myocardial Infarction in Switzerland) plus registry experience.

OBJECTIVES: This study sought to assess outcomes in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) for unprotected left main (LM) disease. BACKGROUND: Limited data are available on outcomes in patients with ST-segment elevation myocardial infarction undergoing LM PCI. METHODS: Of 9,075 patients with ST-segment elevation myocardial infarction enrolled in the AMIS (Acute Myocardial Infarction in Switzerland) Plus registry between 2005 and June 30, 2010, 6,666 underwent primary PCI. Of them, 348 (5.2%; mean age: 63.5 ± 12.6 years) underwent LM PCI, either isolated (n = 208) or concomitant to PCI for other vessel segments (n = 140). They were compared with 6,318 patients (94.8%; mean age: 61.9 ± 12.5 years) undergoing PCI of non-LM vessel segments only. RESULTS: The LM patients had higher rates of cardiogenic shock (12.2% vs. 3.5%; p < 0.001), cardiac arrest (10.6% vs. 6.3%; p < 0.01), in-hospital mortality (10.9% vs. 3.8%; p < 0.001), and major adverse cardiac and cerebrovascular events (12.4% vs. 5.0%; p < 0.001) than non-LM PCI. Rates of mortality and major adverse cardiac and cerebrovascular events were highest for concurrent LM and non-LM PCI (17.9% and 18.6%, respectively), intermediate for isolated LM PCI (6.3% and 8.3%, respectively), and lowest for non-LM PCI (3.8% and 5.0%, respectively). Rates of mortality and major adverse cardiac and cerebrovascular events for LM PCI were higher than for non-LM multivessel PCI (10.9% vs. 4.9%, p < 0.001, and 12.4% vs. 6.4%, p < 0.001, respectively). LM disease independently predicted in-hospital death (odds ratio: 2.36; 95% confidence interval: 1.34 to 4.17; p = 0.003). CONCLUSIONS: Emergent LM PCI in the context of acute myocardial infarction, even including 12% cardiogenic shock, appears to have a remarkably high (89%) in-hospital survival. Concurrent LM and non-LM PCI has worse outcomes than isolated LM PCI.

The SYNTAX score predicts early mortality risk in the elderly with acute coronary syndrome having primary PCI.

BACKGROUND: The SYNTAX score (SXscore), an angiographic score reflecting coronary lesion complexity, predicts clinical outcomes in patients with left main or multivessel disease, and in patients with ST-segment elevation myocardial infarction undergoing primary PCI. The clinical SXscore (CSS) integrates the SXscore and clinical variables (age, ejection fraction, serum creatinine) into a single score. We analyzed these scores in elderly patients with acute coronary syndrome (ACS) undergoing primary PCI. The purpose of this analysis was not to decide which patients should undergo PCI, but to predict clinical outcomes in this population. METHODS: The SXscore was determined in a consecutive series of 114 elderly patients (mean age, 79.6 ± 4.1 years) undergoing primary PCI for ACS. Outcomes were stratified according to SXscore tertiles: SXLOW ≤15 (n = 39), 15< SXMID <23 (n = 40), and SXHIGH ≥23 (n = 35). The primary endpoint was all-cause mortality at 30 days. Secondary endpoints were nonfatal major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and 1-year outcomes in patients discharged alive. RESULTS: Mortality at 30 days was higher in the SXHIGH group compared with the aggregate SXLOW+MID group (37.1% vs 5.1%; P<.0001), and in the CSSHIGH group compared with the aggregate CSSLOW+MID group (25.5% vs 1.4%; P=.0001). MACCE rates at 30 days were similar among SXscore tertiles. The CSS predicted 1-year MACCE rates (12.1% for CSSHIGH vs 3.1% for CSSLOW+MID; P=.03). CONCLUSIONS: The SXscore predicts 30-day mortality in elderly patients with ACS undergoing primary PCI. In patients discharged alive, the CSS predicts risk of MACCE at 1 year.

Circadian variations of ischemic burden among patients with myocardial infarction undergoing primary percutaneous coronary intervention.

BACKGROUND: Several parameters of cardiovascular physiology and pathophysiology exhibit circadian rhythms. Recently, a relation between infarct size and the time of day at which it occurs has been suggested in experimental models of myocardial infarction. The aim of this study is to investigate whether circadian rhythms could cause differences in ischemic burden in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).¦METHODS: In 353 consecutive patients with STEMI treated by PPCI, time of symptom onset, peak creatine kinase (CK), and follow-up at 30 days were obtained. We divided 24 hours into 4 time groups based on time of symptom onset (00:00-05:59, 06:00-11:59, 12:00-17:59, and 18:00-23:59).¦RESULTS: There was no difference between the groups regarding baseline patients and management's characteristics. At multivariable analysis, there was a statistically significant difference between peak CK levels among patients with symptom onset between 00:00 and 05:59 when compared with peak CK levels of patients with symptom onset in any other time group (mean increase 38.4%, P < .05). Thirty-day mortality for STEMI patients with symptom onset occurring between 00:00 and 05:59 was significantly higher than any other time group (P < .05).¦CONCLUSION: This study demonstrates an independent correlation between the infarct size of STEMI patients treated by PPCI and the time of the day at which symptoms occurred. These results suggest that time of the day should be a critical issue to look at when assessing prognosis of patients with myocardial infarction.

Previous Percutaneous Coronary Intervention as Risk Factor for Coronary Artery Bypass Grafting

Background: Percutaneous coronary intervention (PCI) has increased as the initial revascularization strategy in chronic coronary artery disease. Consequently, more patients undergoing coronary artery bypass grafting (CABG) have history of coronary stent. Objective: Evaluate the impact of previous PCI on in-hospital mortality after CABG in patients with multivessel coronary artery disease. Methods: Between May/2007 and June/2009, 1099 consecutive patients underwent CABG on cardiopulmonary bypass. Patients with no PCI (n=938, 85.3%) were compared with patients with previous PCI (n=161, 14.6%). Logistic regression models and propensity score matching analysis were used to assess the risk-adjusted impact of previous PCI on in-hospital mortality. Results: Both groups were similar, except for the fact that patients with previous PCI were more likely to have unstable angina (16.1% x 9.9%, p=0.019). In-hospital mortality after CABG was higher in patients with previous PCI (9.3% x 5.1%, p=0.034) and it was comparable with EuroSCORE and 2000 Bernstein-Parsonnet risk score. Using multivariate logistic regression analysis, previous PCI emerged as an independent predictor of postoperative in-hospital mortality (odds ratio 1.94, 95% CI 1.02-3.68, p=0.044) as strong as diabetes (odds ratio 1.86, 95% CI 1.07-3.24, p=0.028). After computed propensity score matching based on preoperative risk factors, in-hospital mortality remained higher among patients with previous PCI (odds ratio 3.46, 95% CI 1.10-10.93, p=0.034). Conclusions: Previous PCI in patients with multivessel coronary artery disease is an independent risk factor for in-hospital mortality after CABG. This fact must be considered when PCI is indicated as initial alternative in patients with more severe coronary artery disease. (Arq Bras Cardiol 2012;99(1):586-595)

Percutaneous transluminal coronary angioplasty and coronary events in a biethnic Texas community, 1985--1990

The relationship between change in myocardial infarction (MI) mortality rate (ICD codes 410, 411) and change in use of percutaneous transluminal coronary angioplasty (PTCA), adjusted for change in hospitalization rates for MI, and for change in use of aortocoronary bypass surgery (ACBS) from 1985 through 1990 at private hospitals was examined in the biethnic community of Nueces County, Texas, site of the Corpus Christi Heart Project, a major coronary heart disease (CHD) surveillance program. Age-adjusted rates (per 100,000 persons) were calculated for each of these CHD events for the population aged 25 through 74 years and for each of the four major sex-ethnic groups: Mexican-American and Non-Hispanic White women and men. Over this six year period, there were 541 MI deaths, 2358 MI hospitalizations, 816 PTCA hospitalizations, and 920 ACBS hospitalizations among Mexican-American and Non-Hispanic White Nueces County residents. Acute MI mortality decreased from 24.7 in the first quarter of 1985 to 12.1 in the fourth quarter of 1990, a 51.2% decrease. All three hospitalization rates increased: The MI hospitalization rates increased from 44.1 to 61.3, a 38.9% increase, PTCA use increased from 7.1 to 23.2, a 228.0% increase, and ACBS use increased from 18.8 to 29.5, a 56.6% increase. In linear regression analyses, the change in MI mortality rate was negatively associated with the change in PTCA use (beta = $-$.266 $\pm$.103, p = 0.017) but was not associated with the changes in MI hospitalization rate and in ACBS use. The results of this ecologic research support the idea that the increasing use of PTCA, but not ACBS, has been associated with decreases in MI mortality. The contrast in associations between these two revascularization procedures and MI mortality highlights the need for research aimed at clarifying the proper roles of these procedures in the treatment of patients with CHD. The association between change in PTCA use and change in MI mortality supports the idea that some changes in medical treatment may be partially responsible for trends in CHD mortality. Differences in the use of therapies such as PTCA may be related to differences between geographical sites in CHD rates and trends. ^

Relation of cardiac troponin I measurements at 24 and 48 hours to magnetic resonance-determined infarct size in patients with ST-elevation myocardial infarction.

Levels of circulating cardiac troponin I (cTnI) or T are correlated to extent of myocardial destruction after an acute myocardial infarction. Few studies analyzing this relation have employed a second-generation cTnI assay or cardiac magnetic resonance (CMR) as the imaging end point. In this post hoc study of the Efficacy of FX06 in the Prevention of Mycoardial Reperfusion Injury (F.I.R.E.) trial, we aimed at determining the correlation between single-point cTnI measurements and CMR-estimated infarct size at 5 to 7 days and 4 months after a first-time ST-elevation myocardial infarction (STEMI) and investigating whether cTnI might provide independent prognostic information regarding infarct size at 4 months even taking into account early infarct size. Two hundred twenty-seven patients with a first-time STEMI were included in F.I.R.E. All patients received primary percutaneous coronary intervention within 6 hours from onset of symptoms. cTnI was measured at 24 and 48 hours after admission. CMR was conducted within 1 week of the index event (5 to 7 days) and at 4 months. Pearson correlations (r) for infarct size and cTnI at 24 hours were r = 0.66 (5 days) and r = 0.63 (4 months) and those for cTnI at 48 hours were r = 0.67 (5 days) and r = 0.65 (4 months). In a multiple regression analysis for predicting infarct size at 4 months (n = 141), cTnI and infarct location retained an independent prognostic role even taking into account early infarct size. In conclusion, a single-point cTnI measurement taken early after a first-time STEMI is a useful marker for infarct size and might also supplement early CMR evaluation in prediction of infarct size at 4 months.

Significant decrease in in-hospital mortality and major adverse cardiac events in Swiss STEMI patients between 2000 and December 2007.

To evaluate the in-hospital outcome of STEMI (ST elevation myocardial infarction) patients admitted to Swiss hospitals between 2000 and December 2007, and to identify the predictors of in-hospital mortality and major cardiac events. Data from the Swiss national registry AMIS Plus (Acute Myocardial Infarction and Unstable Angina in Switzerland) were used. All patients admitted between January 2000 and December 2007 with STEMI or a new LBBB (left bundle branch block) were included in the registry. We studied 12 026 STEMI patients admitted to 68 hospitals. The mean age was 64 +/- 13 years and 73% of the patients were male. Incidence of in-hospital death was 7.6% in 2000 and 6% in 2007. Reinfarction fell from 3.7% in 2000 to 0.9% in 2007. Thrombolysis decreased from 40.2% in 2000 to 2% in 2007. Clinical predictors of mortality were: age >65 years, Killips class III or IV, diabetes, Q wave myocardial infarction (at presentation). Patients undergoing percutaneous coronary intervention (PCI) had lower mortality and reinfarction rates (3.9% versus 11.2% and 1.1% versus 3.1% respectively, p <0.001) over time, although their numbers increased from 43% in 2000 to 85% in 2007. Patients admitted to hospitals with PCI facilities had lower mortality than patients hospitalised in hospitals without it, but the demographic characteristics differ widely between the two groups. Both in-hospital mortality and reinfarction decreased significantly over the time, parallel to an increased number of PCI. PCI was also the strongest predictor of survival. In-hospital mortality and reinfarction rate have decreased significantly in Swiss STEMI patients in the last seven years, parallel to a significant increase in the number of percutaneous coronary interventions in addition to medical therapy. Outcome is not related to the site of admission but to PCI access.