Coronary calcification in patients presenting with acute coronary syndromes: insights from the MATRIX trial.

AIMS: The role of coronary calcification on clinical outcomes among different revascularization strategies in patients presenting with acute coronary syndromes (ACSs) has been rarely investigated. The aim of this investigation is to evaluate the role of coronary calcification, detected by coronary angiography, in the whole spectrum of patients presenting with acute ACS. METHODS AND RESULTS: The present study was a post hoc analysis of the MATRIX programme. The primary endpoint was major adverse cardiovascular events (MACE), defined as the composite of all-cause mortality, myocardial infarction (MI), or stroke up to 365 days. Among the 8404 patients randomized in the MATRIX trial, data about coronary calcification were available in 7446 (88.6%) and therefore were included in this post hoc analysis. Overall, 875 patients (11.7%) presented with severe coronary calcification, while 6571 patients (88.3%) did not present severe coronary calcification on coronary angiography. Fewer patients with severe coronary calcification underwent percutaneous coronary intervention whereas coronary artery bypass grafting or medical therapy-only was more frequent compared with patients without severe calcification. At 1-year follow-up, MACE occurred in 237 (27.1%) patients with severe calcified coronary lesions and 985 (15%) patients without severe coronary calcified lesions [hazard ratio (HR) 1.91; 95% confidence interval (CI) 1.66-2.20, P < 0.001]. All-cause mortality was 8.6% in patients presenting with and 3.7% in those without severe coronary calcification (HR 2.38, 1.84-3.09, P < 0.001). Patients with severe coronary calcification incurred higher rate of MI (20.1% vs. 11.5%, HR 1.81; 95% CI 1.53-2.1, P < 0.001) and similar rate of stroke (0.8% vs. 0.6%, HR 1.35; 95% CI 0.61-3.02, P = 0.46). CONCLUSION: Patients with ACS and severe coronary calcification, as compared to those without, are associated with worse clinical outcomes irrespective of the management strategy.

Determinants of radiation dose during right transradial access: Insights from the RAD-MATRIX study.

BACKGROUND: The RAD-MATRIX trial reported a large operator radiation exposure variability in right radial percutaneous coronary procedures. The reasons of these differences are not well understood. Our aim was to appraise the determinants of operator radiation exposure during coronary right transradial procedures. METHODS: Patient arrangement during transradial intervention was investigated across operators involved in the RAD-MATRIX trial. Operator radiation exposure was analyzed according to the position of the patient right arm (close or far from the body) and in relation to the size of the upper leaded glass. RESULTS: Among the 14 operators who agreed to participate, there was a greater than 10-fold difference in radiation dose at thorax level (from 21.5 to 267 µSv) that persisted after normalization by dose-area product (from 0.35 to 3.5 µSv/Gy*cm2). Among the operators who positioned the instrumented right arm far from the body (110.4 µSv, interquartile range 71.5-146.5 µSv), thorax dose was greater than that in those who placed the instrumented arm close to the right leg (46.1 µSv, 31.3-56.8 µSv, P = .02). This difference persisted after normalization by dose-area product (P = .028). The use of a smaller full glass shield was also associated with a higher radiation exposure compared with a larger composite shield (147.5 and 60 µSv, respectively, P = .016). CONCLUSIONS: In the context of the biggest radiation study conducted in patients undergoing transradial catheterization, the instrumented right arm arrangement close to the leg and greater upper leaded shield dimensions were associated with a lower operator radiation exposure. Our findings emphasize the importance of implementing simple preventive measures to mitigate the extra risks of radiation exposure with right radial as compared with femoral access.

Radiation Exposure and Vascular Access in Acute Coronary Syndromes: The RAD-Matrix Trial.

BACKGROUND: It remains unclear whether radial access increases the risk of operator or patient radiation exposure compared to transfemoral access when performed by expert operators. OBJECTIVES: This study sought to determine whether radial access increases radiation exposure. METHODS: A total of 8,404 patients, with or without ST-segment elevation acute coronary syndrome, were randomly assigned to radial or femoral access for coronary angiography and percutaneous intervention, and collected fluoroscopy time and dose-area product (DAP). RAD-MATRIX is a radiation sub-study of the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) trial. We anticipated that 13 or more operators, each wearing a thorax (primary endpoint), wrist, and head (secondary endpoints) lithium fluoride thermoluminescent dosimeter, and randomizing at least 13 patients per access site, were needed to establish noninferiority of radial versus femoral access. RESULTS: Among 18 operators, performing 777 procedures in 767 patients, the noninferiority primary endpoint was not achieved (p value for noninferiority = 0.843). Operator equivalent dose at the thorax (77 µSv) was significantly higher with radial than femoral access (41 µSv; p = 0.02). After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ for right radial (84 µSv) compared to left radial access (52 µSv; p = 0.15). In the overall MATRIX population, fluoroscopy time and DAP were higher with radial compared to femoral access: 10 min versus 9 min (p < 0.0001) and 65 Gy·cm2 versus 59 Gy·cm2 (p = 0.0001), respectively. CONCLUSIONS: Compared to femoral access, radial access is associated with greater operator and patient radiation exposure when performed by expert operators in current practice. Radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radioprotective measures. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX; NCT101433627).

Management strategies in patients affected by chronic total occlusions: results from the Italian Registry of Chronic Total Occlusions.

BACKGROUND: Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate. OBJECTIVES: The aim of the Italian Registry of Chronic Total Occlusions (IRCTO) was to provide data on prevalence, characteristics, and outcome of CTO patients according to the management strategy. METHODS: The IRCTO is a prospective real world multicentre registry enrolling patients showing at least one CTO. Clinical and angiographic data were collected independently from the therapeutic strategy [optimal medical therapy (MT), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)]; a comparative 1-year clinical follow-up was performed. RESULTS: A total of 1777 patients were enrolled for an overall CTO prevalence of 13.3%. The adopted therapeutic strategies were as follows: MT in 826 patients (46.5%), PCI in 776 patients (43.7%), and CABG in the remaining 175 patients (9.8%). At 1-year follow-up, patients undergoing PCI showed lower rate of major adverse cardiac and cerebrovascular events (MACCE) (2.6% vs. 8.2% and vs. 6.9%; P < 0.001 and P < 0.01) and cardiac death (1.4% vs. 4.7% and vs. 6.3%; P < 0.001 and P < 0.001) in comparison with those treated with MT and CABG, respectively. After propensity score-matching analysis, patients treated with PCI showed lower incidence of cardiac death (1.5 vs. 4.4%; P < 0.001), acute myocardial infarction (1.1 vs. 2.9%; P = 0.03), and re-hospitalization (2.3 vs. 4.4% P = 0.04) in comparison with those managed by MT. CONCLUSIONS: Our data showed how CTO PCI might significantly improve the survival and decrease MACCE occurrence at 1 year follow-up in comparison with MT and/or CABG.

Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial.

BACKGROUND: It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. METHODS: We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. FINDINGS: We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). INTERPRETATION: In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. FUNDING: The Medicines Company and Terumo.

Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX).

BACKGROUND: Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. METHODS: The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. CONCLUSIONS: The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes.

Time course changes of cystatin C and inflammatory and biochemical markers in non-ST-elevation acute coronary syndromes.

BACKGROUND: Serum cystatin C (Cys-C), a good marker of renal function, predicts prognosis in non-ST-elevation acute coronary syndromes (NSTE-ACS). However, no data are available on the time course of Cys-C values after discharge. In this study, Cys-C was measured during admission (ACS sample) and 6 weeks after discharge, and was correlated with troponin (c-TNT), high-sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6) and the N-terminal portion of the pro-brain natriuretic peptide (proBNP) peptide (NT-proBNP) in a highly selected homogeneous group of NSTE-ACS patients. METHODS: In this prospective, multicentre study, patients with a first NSTE-ACS, single-vessel disease and successful percutaneous coronary interventions (PCIs) had their sera collected, aliquoted and stored at the enrolling site and then shipped for analysis to the clinical chemistry core laboratory. RESULTS: Cys-C values slightly, but significantly, increased from the ACS samples to the 6-week samples. In contrast, hsCRP, NT-proBNP and IL-6 values significantly decreased from the ACS to the 6-week sample. Patients with elevated c-TNT levels had higher hsCRP, NT-proBNP and IL-6 values than patients with normal c-TNT levels in the ACS sample, whereas Cys-C levels were similar in patients with and without elevated c-TNT. Cys-C was highly correlated with estimated glomerular filtration rate in both the ACS and 6-week samples. CONCLUSIONS: In contrast to inflammatory and biochemical stress markers, Cys-C is not affected by the occurrence of myocardial necrosis or by acute left-ventricular impairment, being a reliable marker of renal function during NSTE-ACS.

Coronary rotational atherectomy in current practice: acute and mid-term results in high- and low-volume centers.

We conducted a prospective observational study to evaluate the indications, technique, in-hospital and 9-month results of consecutive patients treated with rotational atherectomy (RA) in 12 centers during 1 year, as well as their relationship with volume of RA activity. The study included 345 lesions in 289 patients treated (4.4% +/- 2.6% of procedures at the participating centers). The lesions were mostly calcified (63%) and type B2 or C (74%). Procedural success was obtained in 94% of patients, with a major adverse cardiac event (MACE) rate of 4.5%. At 9 months, MACE occurred in 17.3%. Multivariate analysis identified multivessel disease and slow flow as negative predictors of procedural success, whereas balloon pressure

Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial.

BACKGROUND: Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. METHODS AND RESULTS: We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30-day and 6-month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE-covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30-day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6-month follow-up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6-month non-Q-wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153). CONCLUSIONS: The study did not demonstrate a difference in restenosis rate and 6-month clinical outcome between the PTFE-covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE-covered stent.

Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE).

OBJECTIVES: We sought to investigate the success rate and the acute and 12-month clinical outcome of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in the contemporary era. BACKGROUND: The technique of PCI involving CTO has improved over time. However, limited data on acute and follow-up results in patients treated with PCI on CTO in recent years are available. METHODS: Four hundred nineteen consecutive patients scheduled for PCI of CTO of > or =30 days of duration were enrolled in 29 centers; 390 CTOs were confirmed in 376 patients in an independent core laboratory. The end points were technical and procedural success, in-hospital and 12-month major adverse cardiac events (MACE) occurrence, and 12-month symptomatic status. RESULTS: Technical and procedural success was obtained in 77.2% and 73.3% of lesions, respectively. In-hospital major adverse cardiac events occurred in 5.1% of patients. Multivariate analysis identified CTO length >15 mm or not measurable, moderate to severe calcifications, duration > or =180 days, and multivessel disease as significant predictors of PCI failure. At 12 months, patients with a successful procedure experienced a lower incidence of cardiac deaths or myocardial infarction (1.05% vs. 7.23%, p = 0.005), a reduced need for coronary artery bypass surgery (2.45% vs. 15.7%, p < 0.0001), and were more frequently free of angina (88.7% vs. 75.0%, p = 0.008) compared with patients who had an unsuccessful procedure. CONCLUSIONS: Successful PCI was achieved in a high percentage of CTOs with a low incidence of complications. At one-year follow-up, patients with successful PCI of a CTO had a significantly better clinical outcome than those whose PCI was unsuccessful.