Background Small randomized trials have demonstrated that radial access reduces access site complications compared to a femoral approach. The objective of this meta-analysis was to determine if ...radial access reduces major bleeding and as a result can reduce death and ischemic events compared to femoral access. Methods MEDLINE, EMBASE, and CENTRAL were searched from 1980 to April 2008. Relevant conference abstracts from 2005 to April 2008 were searched. Randomized trials comparing radial versus femoral access coronary angiography or intervention that reported major bleeding, death, myocardial infarction, and procedural or fluoroscopy time were included. A fixed-effects model was used with a random effects for sensitivity analysis. Results Radial access reduced major bleeding by 73% compared to femoral access (0.05% vs 2.3%, OR 0.27 95% CI 0.16, 0.45, P < .001). There was a trend for reductions in the composite of death, myocardial infarction, or stroke (2.5% vs 3.8%, OR 0.71 95% CI 0.49-1.01, P = .058) as well as death (1.2% vs 1.8% OR 0.74 95% CI 0.42-1.30, P = .29). There was a trend for higher rate of inability to the cross lesion with wire, balloon, or stent during percutaneous coronary intervention with radial access (4.7% vs 3.4% OR 1.29 95% CI 0.87, 1.94, P = .21). Radial access reduced hospital stay by 0.4 days (95% CI 0.2-0.5, P = .0001). Conclusions Radial access reduced major bleeding and there was a corresponding trend for reduction in ischemic events compared to femoral access. Large randomized trials are needed to confirm the benefit of radial access on death and ischemic events.
Background Despite lower risks of access site–related complications with transradial approach (TRA), its clinical benefit for percutaneous coronary intervention (PCI) is uncertain. We conducted a ...systematic review and meta-analysis of clinical studies comparing TRA and transfemoral approach (TFA) for PCI. Methods Randomized trials and observational studies (1993-2011) comparing TRA with TFA for PCI with reports of ischemic and bleeding outcomes were included. Crude and adjusted (for age and sex) odds ratios (OR) were estimated by a hierarchical Bayesian random-effects model with prespecified stratification for observational and randomized designs. The primary outcomes were rates of death, combined incidence of death or myocardial infarction, bleeding, and transfusions, early (≤30 days) and late after PCI. Results We collected data from 76 studies (15 randomized, 61 observational) involving a total of 761,919 patients. Compared with TFA, TRA was associated with a 78% reduction in bleeding (OR 0.22, 95% credible interval CrI 0.16-0.29) and 80% in transfusions (OR 0.20, 95% CrI 0.11-0.32). These findings were consistent in both randomized and observational studies. Early after PCI, there was a 44% reduction of mortality with TRA (OR 0.56, 95% CrI 0.45-0.67), although the effect was mainly due to observational studies (OR 0.52, 95% CrI 0.40-0.63, adjusted OR 0.49 95% CrI 0.37-0.60), with an OR of 0.80 (95% CrI 0.49-1.23) in randomized trials. Conclusion Our results combining observational and randomized studies show that PCI performed by TRA is associated with substantially less risks of bleeding and transfusions compared with TFA. Benefit on the incidence of death or combined death or myocardial infarction is found in observational studies but remains inconclusive in randomized trials.
Summary Background Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to ...assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention. Methods The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , NCT01014273. Findings Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio HR 0·92, 95% CI 0·72–1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28–0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38–0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2%) of 3507 patients in the radial group compared with 114 (3·2%) of 3514 in the femoral group (HR 0·98, 95% CI 0·76–1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7%) of 3507 patients in the radial group compared with 33 (0·9%) of 3514 patients in the femoral group (HR 0·73, 95% CI 0·43–1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, 95% CI 0·28–0·57; p<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95% CI 0·13–0·71; p=0·006). Interpretation Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach. Funding Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research.
Thrombus aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have ...questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of thrombus aspiration during PCI in patients with ST-segment-elevation myocardial infarction.
Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days.
The 3 eligible randomized trials (TAPAS Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction, TASTE Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia, and TOTAL Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to thrombus aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to thrombus aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high thrombus burden (TIMI Thrombolysis in Myocardial Infarction thrombus grade ≥3), thrombus aspiration was associated with fewer cardiovascular deaths (170 2.5% versus 205 3.1%; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 0.9% versus 34 0.5%; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively.
Routine thrombus aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved thrombus aspiration technologies in this high-risk subgroup.
URLs: http://www.ClinicalTrials.gov http://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.
Objectives The purpose of this study was to determine the consistency of the effects of radial artery access in patients with ST-segment elevation myocardial infarction (STEMI) and in those with ...non–ST-segment elevation acute coronary syndrome (NSTEACS). Background The safety associated with radial access may translate into mortality benefit in higher-risk patients, such as those with STEMI. Methods We compared efficacy and bleeding outcomes in patients randomized to radial versus femoral access in RIVAL (RadIal Vs femorAL access for coronary intervention trial) (N = 7,021) separately in those with STEMI (n = 1,958) and NSTEACS (n = 5,063). Interaction tests between access site and acute coronary syndrome type were performed. Results Baseline characteristics were well matched between radial and femoral groups. There were significant interactions for the primary outcome of death/myocardial infarction/stroke/non–coronary artery bypass graft–related major bleeding (p = 0.025), the secondary outcome of death/myocardial infarction/stroke (p = 0.011) and mortality (p = 0.001). In STEMI patients, radial access reduced the primary outcome compared with femoral access (3.1% vs. 5.2%; hazard ratio HR: 0.60; p = 0.026). For NSTEACS, the rates were 3.8% and 3.5%, respectively (p = 0.49). In STEMI patients, death/myocardial infarction/stroke were also reduced with radial access (2.7% vs. 4.6%; HR 0.59; p = 0.031), as was all-cause mortality (1.3% vs. 3.2%; HR: 0.39; p = 0.006), with no difference in NSTEACS patients. Operator radial experience was greater in STEMI versus NSTEACS patients (400 vs. 326 cases/year, p < 0.0001). In primary PCI, mortality was reduced with radial access (1.4% vs. 3.1%; HR: 0.46; p = 0.041). Conclusions In patients with STEMI, radial artery access reduced the primary outcome and mortality. No such benefit was observed in patients with NSTEACS. The radial approach may be preferred in STEMI patients when the operator has considerable radial experience. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy RIVAL; NCT01014273 )
The aim of this study was to provide a quantitative appraisal of the effects on clinical outcomes of radial access for coronary interventions in patients with coronary artery disease (CAD).
...Randomized trials investigating radial versus femoral access for percutaneous coronary interventions have provided conflicting evidence. No comprehensive quantitative appraisal of the risks and benefits of each approach is available across the whole spectrum of patients with stable or unstable CAD.
The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for randomized trials comparing radial versus femoral access for coronary interventions. Data were pooled by meta-analysis using a fixed-effects or a random-effects model, as appropriate. Pre-specified subgroup analyses according to clinical presentation, in terms of stable CAD, non-ST-segment elevation acute coronary syndromes, or ST-segment elevation myocardial infarction were performed.
Twenty-four studies enrolling 22,843 participants were included. Compared with femoral access, radial access was associated with a significantly lower risk for all-cause mortality (odds ratio OR: 0.71; 95% confidence interval CI: 0.59 to 0.87; p = 0.001, number needed to treat to benefit NNTB = 160), major adverse cardiovascular events (OR: 0.84; 95% CI: 0.75 to 0.94; p = 0.002; NNTB = 99), major bleeding (OR: 0.53; 95% CI: 0.42 to 0.65; p < 0.001; NNTB = 103), and major vascular complications (OR: 0.23; 95% CI: 0.16 to 0.35; p < 0.001; NNTB = 117). The rates of myocardial infarction or stroke were similar in the 2 groups. Effects of radial access were consistent across the whole spectrum of patients with CAD for all appraised endpoints.
Compared with femoral access, radial access reduces mortality and MACE and improves safety, with reductions in major bleeding and vascular complications across the whole spectrum of patients with CAD.
Summary Background Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest ...randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. Methods The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov , number NCT01149044. Findings Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10 064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio HR 1·00 95% CI 0·87–1·15, p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 95% CI 0·76–1·14, p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 95% CI 1·10–2·51, p=0·015). Interpretation Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI. Funding Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.
Abstract
Aims
Recent randomized trials demonstrated a benefit of low-dose colchicine added to guideline-based treatment in patients with recent myocardial infarction or chronic coronary disease. We ...performed a systematic review and meta-analysis to obtain best estimates of the effects of colchicine on major adverse cardiovascular events (MACE).
Methods and results
We searched the literature for randomized clinical trials of long-term colchicine in patients with atherosclerosis published up to 1 September 2020. The primary efficacy endpoint was MACE, the composite of myocardial infarction, stroke, or cardiovascular death. We combined the results of five trials that included 11 816 patients. The primary endpoint occurred in 578 patients. Colchicine reduced the risk for the primary endpoint by 25% relative risk (RR) 0.75, 95% confidence interval (CI) 0.61–0.92; P = 0.005, myocardial infarction by 22% (RR 0.78, 95% CI 0.64–0.94; P = 0.010), stroke by 46% (RR 0.54, 95% CI 0.34–0.86; P = 0.009), and coronary revascularization by 23% (RR 0.77, 95% CI 0.66–0.90; P < 0.001). We observed no difference in all-cause death (RR 1.08, 95% CI 0.71–1.62; P = 0.73), with a lower incidence of cardiovascular death (RR 0.82, 95% CI 0.55–1.23; P = 0.34) counterbalanced by a higher incidence of non-cardiovascular death (RR 1.38, 95% CI 0.99–1.92; P = 0.060).
Conclusion
Our meta-analysis indicates that low-dose colchicine reduced the risk of MACE as well as that of myocardial infarction, stroke, and the need for coronary revascularization in a broad spectrum of patients with coronary disease. There was no difference in all-cause mortality and fewer cardiovascular deaths were counterbalanced by more non-cardiovascular deaths.
Graphical Abstract
Colchicine in coronary disease
PDF
