Objectives This study sought to compare radial and femoral approaches in patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing primary percutaneous coronary ...intervention (PCI) by high-volume operators experienced in both access sites. Background The exact clinical benefit of the radial compared to the femoral approach remains controversial. Methods STEMI-RADIAL (ST Elevation Myocardial Infarction treated by RADIAL or femoral approach) was a randomized, multicenter trial. A total of 707 patients referred for STEMI <12 h of symptom onset were randomized in 4 high-volume radial centers. The primary endpoint was the cumulative incidence of major bleeding and vascular access site complications at 30 days. The rate of net adverse clinical events (NACE) was defined as a composite of death, myocardial infarction, stroke, and major bleeding/vascular complications. Access site crossover, contrast volume, duration of intensive care stay, and death at 6 months were secondary endpoints. Results The primary endpoint occurred in 1.4% of the radial group (n = 348) and 7.2% of the femoral group (n = 359; p = 0.0001). The NACE rate was 4.6% versus 11.0% (p = 0.0028), respectively. Crossover from radial to femoral approach was 3.7%. Intensive care stay (2.5 ± 1.7 days vs. 3.0 ± 2.9 days, p = 0.0038) as well as contrast utilization (170 ± 71 ml vs. 182 ± 60 ml, p = 0.01) were significantly reduced in the radial group. Mortality in the radial and femoral groups was 2.3% versus 3.1% (p = 0.64) at 30 days and 2.3% versus 3.6% (p = 0.31) at 6 months, respectively. Conclusions In patients with STEMI undergoing primary PCI by operators experienced in both access sites, the radial approach was associated with significantly lower incidence of major bleeding and access site complications and superior net clinical benefit. These findings support the use of the radial approach in primary PCI as first choice after proper training. (Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention PCI STEMI-RADIAL; NCT01136187 )
Abstract
Aims
The COLchicine Cardiovascular Outcomes Trial (COLCOT) demonstrated the benefits of targeting inflammation after myocardial infarction (MI). We aimed to determine whether ...time-to-treatment initiation (TTI) influences the beneficial impact of colchicine.
Methods and results
In COLCOT, patients were randomly assigned to receive colchicine or placebo within 30 days post-MI. Time-to-treatment initiation was defined as the length of time between the index MI and the initiation of study medication. The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. The relationship between endpoints and various TTI (<3, 4–7 and >8 days) was examined using multivariable Cox regression models. Amongst the 4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata. After a median follow-up of 22.7 months, there was a significant reduction in the incidence of the primary endpoint for patients in whom colchicine was initiated < Day 3 compared with placebo hazard ratios (HR) = 0.52, 95% confidence intervals (CI) 0.32–0.84, in contrast to patients in whom colchicine was initiated between Days 4 and 7 (HR = 0.96, 95% CI 0.53–1.75) or > Day 8 (HR = 0.82, 95% CI 0.61–1.11). The beneficial effects of early initiation of colchicine were also demonstrated for urgent hospitalization for angina requiring revascularization (HR = 0.35), all coronary revascularization (HR = 0.63), and the composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke (HR = 0.55, all P < 0.05).
Conclusion
Patients benefit from early, in-hospital initiation of colchicine after MI.
Trial Registration
COLCOT ClinicalTrials.gov number, NCT02551094.
Graphical Abstract
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.
Inflammation appears to play a role in atherosclerosis, raising the possibility that treatments that reduce inflammation could prevent cardiovascular events. In a randomized, placebo-controlled trial ...involving 4745 patients with recent myocardial infarction, low-dose colchicine (0.5 mg once daily) prevented ischemic cardiovascular events.
The study sought to evaluate whether prophylactic ipsilateral ulnar artery compression during radial artery hemostasis could reduce the risk of radial artery occlusion (RAO).
RAO after transradial ...access (TRA) is a structural complication of TRA. It limits future ipsilateral TRA and may cause transient pain. Maintaining radial artery flow during hemostasis reduces the incidence of acute RAO. Ipsilateral ulnar compression increases radial artery flow and could impact the incidence of RAO.
Three thousand patients undergoing diagnostic cardiac catheterization using TRA were randomized to receive either standard patent hemostasis protocol (Group I) or prophylactic ipsilateral ulnar compression in addition to patent hemostasis (Group II). Using plethysmography, radial artery patency was evaluated at the time of removal of the compression device as well as 24 h and 30 days after the procedure. The primary study endpoint was 30-day RAO.
The primary endpoint, 30-day RAO, was significantly reduced in patients with patent hemostasis and prophylactic ulnar compression compared with standard patent hemostasis (0.9% vs. 3.0%; p = 0.0001). Baseline patient and procedural characteristics were similar between the 2 groups. RAO was significantly reduced by prophylactic ulnar compression at all time intervals (p < 0.0001).
Prophylactic ipsilateral ulnar compression during radial artery hemostasis is an effective, simple, and inexpensive technique that lowers the risk of RAO after TRA.
Summary Background Transradial access for cardiac catheterisation results in lower bleeding and vascular complications than the traditional transfemoral access route. However, the increased radiation ...exposure potentially associated with transradial access is a possible drawback of this method. Whether transradial access is associated with a clinically significant increase in radiation exposure that outweighs its benefits is unclear. Our aim was therefore to compare radiation exposure between transradial access and transfemoral access for diagnostic coronary angiograms and percutaneous coronary interventions (PCI). Methods We did a systematic review and meta-analysis of the scientific literature by searching the PubMed, Embase, and Cochrane Library databases with relevant terms, and cross-referencing relevant articles for randomised controlled trials (RCTs) that compared radiation parameters in relation to access site, published from Jan 1, 1989, to June 3, 2014. Three investigators independently sorted the potentially relevant studies, and two others extracted data. We focused on the primary radiation outcomes of fluoroscopy time and kerma-area product, and used meta-regression to assess the changes over time. Secondary outcomes were operator radiation exposure and procedural time. We used both fixed-effects and random-effects models with inverse variance weighting for the main analyses, and we did confirmatory analyses for observational studies. Findings Of 1252 records identified, we obtained data from 24 published RCTs for 19 328 patients. Our primary analyses showed that transradial access was associated with a small but significant increase in fluoroscopy time for diagnostic coronary angiograms (weighted mean difference WMD, fixed effect: 1·04 min, 95% CI 0·84–1·24; p<0·0001) and PCI (1·15 min, 95% CI 0·96–1·33; p<0·0001), compared with transfemoral access. Transradial access was also associated with higher kerma-area product for diagnostic coronary angiograms (WMD, fixed effect: 1·72 Gy·cm2 , 95% CI −0·10 to 3·55; p=0·06), and significantly higher kerma-area product for PCI (0·55 Gy·cm2 , 95% CI 0·08–1·02; p=0·02). Mean operator radiation doses for PCI with basic protection were 107 μSv (SD 110) with transradial access and 74 μSv (68) with transfemoral access; with supplementary protection, the doses decreased to 21 μSv (17) with transradial access and 46 μSv (9) with transfemoral. Meta-regression analysis showed that the overall difference in fluoroscopy time between the two procedures has decreased significantly by 75% over the past 20 years from 2 min in 1996 to about 30 s in 2014 (p<0·0001). In observational studies, differences and effect sizes remained consistent with RCTs. Interpretation Transradial access was associated with a small but significant increase in radiation exposure in both diagnostic and interventional procedures compared with transfemoral access. Since differences in radiation exposure narrow over time, the clinical significance of this small increase is uncertain and is unlikely to outweigh the clinical benefits of transradial access. Funding None.
Abstract Background Fractional flow reserve (FFR) prior to percutaneous coronary intervention (PCI) is useful to guide treatment. Whether post-PCI FFR assessment might have clinical impact is ...controversial. The aim of this study is to evaluate the range of post-PCI FFR values and analyze the relationship between post-PCI FFR and clinical outcomes. Methods We systematically searched the MEDLINE, EMBASE and Cochrane Library databases with cross-referencing of articles reporting post-PCI FFR and correlating post-PCI FFR values and clinical outcomes. The outcomes of interest were the immediate post-PCI FFR values and the correlations between post-PCI FFR and the incidence of repeat intervention and major adverse cardiac events (MACE). Results From 1995 to 2015, a total of 105 studies (n = 7470) were included with 46 studies reporting post-PCI FFR and 59 studies evaluating relationship between post-PCI and clinical outcomes up to 30 months after PCI. Overall, post-PCI FFR values demonstrated a normal distribution with a mean value of 0.90 ± 0.04. There was a positive correlation between the percentage of stent use and post-PCI FFR ( P < .0001). Meta-regression analysis indicated that higher post-PCI FFR values were associated with reduced rates of repeat intervention ( P < .0001) and MACE ( P = .0013). A post-PCI FFR ≥ 0.90 was associated with significant lower risk of repeat-PCI (OR: 0.43, 95% CI: 0.34–0.56, P < .0001) and MACE (OR: 0.71, 95% CI: 0.59–0.85, P = .0003). Conclusions FFR measurement after PCI was associated with prognostic significance. Further investigation is required to assess the role of post-PCI FFR and validate cut-off values in contemporary clinical practice.
Renal dysfunction is associated with worse outcomes after primary percutaneous coronary intervention (PCI). However, whether glomerular filtration rate (GFR) estimated with various equations can ...equally predict outcomes after ST-Elevation Myocardial Infarction (STEMI) is still debated.
We compared the clinical impact of 3 different creatinine-based equations (Cockcroft and Gault (CG), CKD-epidemiology (CKD-EPI) and Full Age Spectrum (FAS)) to predict 1-year mortality in STEMI patients.
Among 1755 consecutive STEMI patients who had undergone primary PCI included between 2006 and 2011, median estimated GFR was 79 (61;96) with the CG, 81 (65;95) with CKD-EPI and 75 (60;91) mL/min/1.73 m2 with FAS equation. Reduced GFR values were independently associated with 1-year mortality risk with the 3 equations. Receiver operating curves (ROC) of CG and FAS equations were significantly superior to the CKD-EPI equation, p = 0.03 and p = 0.01, respectively. Better prediction with FAS and CG equations was confirmed by net reclassification index.
Our results suggest that in STEMI patients who have undergone primary PCI, 1-year mortality is better predicted by CG or FAS equations compared to CKD-EPI.
ABSTRACT—There is currently substantial confusion between the conceptual definition of the metabolic syndrome and the clinical screening parameters and cut-off values proposed by various ...organizations (NCEP-ATP III, IDF, WHO, etc) to identify individuals with the metabolic syndrome. Although it is clear that in vivo insulin resistance is a key abnormality associated with an atherogenic, prothrombotic, and inflammatory profile which has been named by some the “metabolic syndrome” or by others “syndrome X” or “insulin resistance syndrome”, it is more and more recognized that the most prevalent form of this constellation of metabolic abnormalities linked to insulin resistance is found in patients with abdominal obesity, especially with an excess of intra-abdominal or visceral adipose tissue. We have previously proposed that visceral obesity may represent a clinical intermediate phenotype reflecting the relative inability of subcutaneous adipose tissue to act as a protective metabolic sink for the clearance and storage of the extra energy derived from dietary triglycerides, leading to ectopic fat deposition in visceral adipose depots, skeletal muscle, liver, heart, etc. Thus, visceral obesity may partly be a marker of a dysmetabolic state and partly a cause of the metabolic syndrome. Although waist circumference is a better marker of abdominal fat accumulation than the body mass index, an elevated waistline alone is not sufficient to diagnose visceral obesity and we have proposed that an elevated fasting triglyceride concentration could represent, when waist circumference is increased, a simple clinical marker of excess visceral/ectopic fat. Finally, a clinical diagnosis of visceral obesity, insulin resistance, or of the metabolic syndrome is not sufficient to assess global risk of cardiovascular disease. To achieve this goal, physicians should first pay attention to the classical risk factors while also considering the additional risk resulting from the presence of abdominal obesity and the metabolic syndrome, such global risk being defined as cardiometabolic risk.
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