Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial.

BACKGROUND: The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. METHODS: MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70-100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50-70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. FINDINGS: Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80-1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78-0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83-1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81-1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84-1·16; p=0·90). INTERPRETATION: In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. FUNDING: Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes.

BACKGROUND: Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS: We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS: The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). CONCLUSIONS: In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).

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.

Validation of a Contemporary Acute Kidney Injury Risk Score in Patients With Acute Coronary Syndrome.

BACKGROUND: A simple, contemporary risk score for the prediction of contrast-associated acute kidney injury (CA-AKI) after percutaneous coronary intervention (PCI) was recently updated, although its external validation is lacking. OBJECTIVES: The aim of this study was to validate the updated CA-AKI risk score in a large cohort of acute coronary syndrome patients from the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of angioX) trial. METHODS: The risk score identifies 4 risk categories for CA-AKI. The primary endpoint was to appraise the receiver-operating characteristics of an 8-component and a 12-component CA-AKI model. Independent predictors of Kidney Disease Improving Global Outcomes-based acute kidney injury and the impact of CA-AKI on 1-year mortality and bleeding were also investigated. RESULTS: The MATRIX trial included 8,201 patients with complete creatinine values and no end-stage renal disease. CA-AKI occurred in 5.5% of the patients, with a stepwise increase of CA-AKI rates from the lowest to the highest of the 4 risk categories. The receiver-operating characteristic area under the curve was 0.67 (95% CI: 0.64-0.70) with model 1 and 0.71 (95% CI: 0.68-0.74) with model 2. CA-AKI risk was systematically overestimated with both models (Hosmer-Lemeshow goodness-of-fit test: P < 0.05). The 1-year risks of all-cause mortality and bleeding were higher in CA-AKI patients (HR: 7.03 [95% CI: 5.47-9.05] and HR: 3.20 [95% CI: 2.56-3.99]; respectively). There was a gradual risk increase for mortality and bleeding as a function of the CA-AKI risk category for both models. CONCLUSIONS: The updated CA-AKI risk score identifies patients at incremental risks of acute kidney injury, bleeding, and mortality. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627).

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.

Indicators of poor prognosis of acute pericarditis.

BACKGROUND: The clinical search for indicators of poor prognosis of acute pericarditis may be useful for clinical triage of patients at high risk of specific causal conditions or complications. The aim of the present article is to assess the relationship between clinical features at presentation and specific causes or complications. METHODS AND RESULTS: A total of 453 patients aged 17 to 90 years (mean age 52+/-18 years, 245 men) with acute pericarditis (post-myocardial infarction pericarditis was excluded) were prospectively evaluated from January 1996 to August 2004. A specific cause was found in 76 of 453 patients (16.8%): autoimmune in 33 patients (7.3%), neoplastic in 23 patients (5.1%), tuberculous in 17 patients (3.8%), and purulent in 3 patients (0.7%). In multivariable analysis, women (hazard ratio [HR] 1.67, 95% confidence interval [CI] 1.03 to 2.70; P=0.036) and patients with fever >38 degrees C (HR 3.56, 95% CI 1.82 to 6.95; P<0.001), subacute course (HR 3.97, 95% CI 1.66 to 9.50; P=0.002), large effusion or tamponade (HR 2.15, 95% CI 1.09 to 4.23; P=0.026), and failure of aspirin or of nonsteroidal anti-inflammatory drugs (HR 2.50, 95% CI 1.28 to 4.91; P=0.008) were at increased risk of specific causal conditions. After a mean follow-up of 31 months, complications were detected in 95 patients (21.0%): recurrences in 83 patients (18.3%), tamponade in 14 patients (3.1%), and constriction in 7 patients (1.5%). In multivariable analysis, women (HR 1.65, 95% CI 1.08 to 2.52; P=0.020) and patients with large effusion or tamponade (HR 2.51, 95% CI 1.37 to 4.61; P=0.003) and failure of aspirin or of nonsteroidal anti-inflammatory drugs (HR 5.50, 95% CI 3.56 to 8.51; P<0.001) were at increased risk of complications. CONCLUSIONS: Specific clinical features (fever >38 degrees C, subacute course, large effusion or tamponade, and aspirin or NSAID failure) may be useful to identify higher risk of specific causal conditions and complications.

Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes.

BACKGROUND: Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs). OBJECTIVES: This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator. The 30-day coprimary outcomes were major adverse cardiovascular events (MACEs) (a composite of death, myocardial infarction, or stroke), and net adverse clinical events (NACEs) (a composite of MACEs or major bleeding). RESULTS: Among 3,603 patients assigned to receive UFH, 781 (21.7%) underwent planned treatment with GPI before coronary intervention. Bailout use of GPIs was similar between the bivalirudin and UFH groups (4.5% and 5.4%) (p = 0.11). At 30 days, the 2 coprimary endpoints of MACEs and NACEs, as well as individual endpoints of mortality, myocardial infarction, stent thrombosis or stroke did not differ among the 3 groups after adjustment. Compared with the UFH and UFH+GPI groups, bivalirudin reduced bleeding, mainly the most severe bleeds, including fatal and nonaccess site-related events, as well as transfusion rates and the need for surgical access site repair. These findings were not influenced by the administered intraprocedural dose of UFH and were confirmed at multiple sensitivity analyses, including the randomly allocated access site. CONCLUSIONS: In patients with ACS, the rates of MACEs and NACEs were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX [MATRIX]; NCT01433627).

[Does reluctance to perform mouth-to-mouth ventilation exist among emergency healthcare providers as first responders?]. / Esiste la riluttanza a praticare la rianimazione con ventilazione bocca a bocca senza mezzi di barriera tra gli operatori sanitari intervenuti come first responders?

BACKGROUND: Only 30% of survivors from out-of-hospital cardiac arrest receive basic life support (BLS) before the arrival of emergency personnel. This is also due to reluctance to perform BLS, especially mouth-to-mouth ventilation without barrier devices in victims who are unknown to the rescuer (either layperson or healthcare provider). METHODS: To evaluate the incidence of reluctance to perform mouth-to-mouth ventilation without barrier devices and its consequences in a simulated BLS scenario proposed by a questionnaire to healthcare providers of critical area in a public general hospital. RESULTS: Answers were collected from 128 of 165 (77.5%) interviewed healthcare providers. Physicians were 46 of 128 (35.9%), professional nurses were 78 of 128 (60.9%) and 4 of 128 (3.2%) were other health workers devoted to patient assistance. Seventy-five of 128 (58.6 %) were reluctant to perform mouth-to-mouth ventilation without barrier devices; 68 of 75 (90.6%) would perform BLS only by chest compression. Compared with non-reluctant providers, they would have been available to perform assisted ventilation by non-validated alternative methods (54.2 vs 18.8% respectively, p < 0.001). Seven of 75 (9.6%, no physician among them) would perform no BLS at all. The most significant predictors of reluctance were age < 40 years (p = 0.07) and previous attendance of BLS-BLSD courses (p = 0.07). CONCLUSIONS: Reluctance to perform mouth-to-mouth ventilation without barrier devices is frequent and may reduce the number of potential BLS providers. Because of the concern about disease transmission between victim and rescuer, rescuers with a duty to respond such as healthcare providers should follow precautions including the use of barrier device also outside their workplace. When barrier devices are unavailable first responders should consider chest compression alone instead of not performing any BLS maneuvers. BLS training should help give a greater emphasis on this topics.

[Initial experience in the management of myocardial infarction with primary angioplasty: results of the activity in two hospitals of the Turin area without on-site cardiac surgery]. / Iniziale esperienza organizzativa nel trattamento con angioplastica primaria dell'infarto miocardico acuto in due ospedali torinesi territoriali non dotati di cardiochirurgia: primi tre anni di attività.

BACKGROUND: Reperfusion therapy of ST-elevation myocardial infarction (STEMI) with primary coronary angioplasty (PTCA) is becoming an accepted therapeutical strategy because of a lower incidence of reinfarction, of hemorrhagic stroke and for a greater reduction of the infarct size in comparison to thrombolytic therapy. In this study we evaluated the feasibility and the effectiveness of such a strategy in two hospitals without on-site heart surgery but with a high volume of admission for acute coronary syndrome and a high caseload of elective interventional procedures. METHODS: Since January 2001 we started a program of primary PTCA for all STEMI patients presenting within 12 hours of symptom onset. An interventional team (physician, nurse and technician) were on call in a 24/7/365 fashion. Aspirin, heparin and abciximab were administered in the emergency room to all patients. Immediately after the procedure patients were given clopidogrel. RESULTS: Up to December 2003, 464 patients (mean age 63 +/- 12 years, 19.8% female) underwent primary PTCA. The symptom-emergency room interval was 3 +/- 3.9 hours, while the door-to-balloon time was 52.5 +/- 39.4 min. A TIMI 0-1 flow in the infarct-related artery was present in 55.8% of patients. Seventy patients (15.1%) presented with shock. In 430 patients (92.7%) a TIMI 3 flow was restored followed by a reduction in ST-segment elevation > 50% in 356 patients (76.7%). Total in-hospital mortality was 4.9% (23 out of 464 patients). The mortality of patients with shock was 31.4% (22 out of 70 patients). Two patients (0.4%) underwent emergency bypass. Four patients (0.8%) were electively referred to surgery prior to discharge in order to complete revascularization, which could not be obtained with further PTCA. The rate of major hemorrhagic complications was 0.8%. CONCLUSIONS: Primary PTCA for STEMI is a reperfusion strategy feasible and effective even in hospitals without on-site heart surgery, provided that a high volume of routine and emergency interventional procedures is maintained and when such a strategy is timely performed according to international guidelines.

Scientific foundation and possible implications for practice of the Minimizing Adverse Haemorrhagic Events by Transradial Access Site andSystemic Implementation of AngioX (MATRIX) trial.

Early invasive management and the use of combined antithrombotic therapies have decreased the risk of recurrent ischaemia in patients with acute coronary syndrome (ACS) but have also increased the bleeding risk. Transradial intervention (TRI) and bivalirudin infusion compared to transfemoral intervention (TFI) or unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI) decrease bleeding complications in patients with ACS. To what extent, a bleeding preventive strategy incorporating at least one of these two treatment options translates into improved outcomes is a matter of debate. The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX study is a large-scale, multicenter, prospective, open-label trial, conducted at approximately 100 sites in Europe aiming to primarily assess whether TRI and bivalirudin infusion, as compared to TFI and UFH plus provisional GPI, decrease the 30-day incidence of death, myocardial infarction or stroke across the whole spectrum of ACS patients.

Investigation on Colchicine for Acute Pericarditis: a multicenter randomized placebo-controlled trial evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of pericarditis; study design amd rationale.

BACKGROUND: Colchicine is safe and effective in the treatment and prevention of recurrent pericarditis after failure of conventional treatment. The recent guidelines of the European Society of Cardiology suggest that colchicine might be useful even in the treatment of the first episode. However, the use of the drug is not based on any strong evidence obtained from clinical trials, and no randomized placebo-controlled trial is available to guide the management of acute pericarditis. STUDY DESIGN: The Investigation on Colchicine for Acute Pericarditis (ICAP) trial will enroll 240 patients in a prospective, randomized, double-blind, multicenter investigation of colchicine compared to placebo in patients with acute pericarditis. The primary efficacy end point is the recurrence rate at 18 months. The secondary end points are symptom persistence at 72 h, remission rate at 1 week, number of recurrences, time to first recurrence, disease-related hospitalization, cardiac tamponade, and constrictive pericarditis. IMPLICATIONS: The ICAP trial will be the first randomized placebo-controlled trial in this area. This trial will provide important evidence regarding the possible benefit of the early use of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences, the most troublesome and commonest complication of pericarditis.

CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale.

BACKGROUND: Colchicine appears to be safe and effective in the treatment and prevention of recurrent pericarditis after failure of conventional therapies in case reports and non-randomized observational studies without control groups. On this basis, colchicine has been proposed as a therapeutic choice in the 2004 guidelines of the European Society of Cardiology. However, the exact number of responders is unknown, and no randomized placebo-controlled trial is available to guide the management of recurrent pericarditis. Moreover, some authors recommend the use of the drug at the first recurrence, whereas others propose to consider the drug only after failure of conventional therapies for the second or subsequent recurrence. STUDY DESIGN: The CORP trial will enroll 120 patients in a prospective, randomized, double-blind, multicentre investigation of colchicine compared with placebo in patients with a first episode of recurrent pericarditis. In the CORP-2 trial, 240 patients will be enrolled in a prospective, randomized, double-blind, multicentre investigation of colchicine compared with placebo in patients with two or more recurrences. In both trials, the primary efficacy end-point is the recurrence rate at 18 months, the secondary end-points are symptom persistence at 72 h, remission rate at 1 week, number of recurrences, time to recurrence, disease-related hospitalization, cardiac tamponade and constrictive pericarditis. IMPLICATIONS: The CORP and CORP-2 trials will be the first randomized placebo-controlled trials in this area. These trials will provide important evidence regarding the possible benefit of the early use of colchicine for the treatment and prevention of recurrent pericarditis.

Successful angioplasty and stenting of bilateral internal mammary artery grafts from the left radial approach. Case report and review of the literature.

We describe a case of successful percutaneous transluminal coronary angioplasty and stenting from the left radial approach in a patient with effort angina due to two tight stenoses at the distal anastomosis site of the internal mammary artery grafts. The left radial approach has several advantages compared with the conventional femoral approach: a lower rate of vascular complications and an easier vascular access to the left internal mammary artery graft. The distance from the access site to the origin of the artery is shorter and involves less angulation than the femoral approach. The radial approach is not only safe but it enables faster patient mobilisation and seems also useful in reducing management costs with a hospital stay that can be reduced to 6 h in low-risk cases.

Rationale and design of the COPPS trial: a randomised, placebo-controlled, multicentre study on the use of colchicine for the primary prevention of postpericardiotomy syndrome.

RATIONALE: Colchicine seems to be well tolerated and effective in the treatment and prevention of pericarditis. A preliminary clinical trial has shown that colchicine may be considered not only for the treatment of postpericardiotomy syndrome (PPS), but also for its primary prevention. STUDY DESIGN: The COPPS study is a multicentre, double-blind, randomised trial. On the third postoperative day, 360 patients, 180 in each treatment arm, will be randomised to receive placebo or colchicine (1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients > or =70 kg, and halved doses for patients <70 kg or intolerant to the highest dose). The primary efficacy endpoint is the incidence of PPS at 12 months. Secondary endpoints are disease-related hospitalisation, cardiac tamponade, constrictive pericarditis, and relapses at 18 months. Additional analysis will include the time to PPS. IMPLICATIONS: The COPPS trial will evaluate the use of colchicine for the primary prevention of PPS. This study will also provide important information on the frequency, clinical presentation, and prognosis of this syndrome in clinical practice.