Summary 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.
Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate.
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.
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.
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.
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.
To the Editor, Microcatheters are essential tools to facilitate guidewire manipulation and exchange, thus enhancing the guidewire penetration force.1 The ReCross over-the-wire dual-lumen ...microcatheter (DLM) (IMDS, The Netherlands) is the latest evolution among DLM microcatheters. However, no data are available in the medical literature yet. From September 2020 through November 2020 a total of 8 patients undergoing percutaneous coronary intervention (PCI) of chronic total coronary occlusions (CTO) with the ReCross at 5 Italian high-volume PCI-capable centers were retrospectively identified. This study complied with the Declaration of Helsinki, and written informed consent was obtained from all participants. Case 1. A proximal right coronary artery CTO underwent antegrade approach using the ReCross microcatheter (IMDS, The Netherlands) as a first choice due to the presence of a bifurcation at distal cap level (figure 1). The antegrade wire escalation technique was used with an Ultimate Bros 3 guidewire (Asahi Intecc, Japan) followed by a Gaia Second guidewire (Asahi Intecc, Japan) that was able to cross the CTO body and reach the side branch (right ventricular branch) distal true lumen (figure 1B). The ReCross was advanced over the Gaia Second guidewire through the lesion close to the bifurcation; afterwards, another Gaia Second guidewire was advanced through the...
Background:The effect of abciximab on survival in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) undergoing primary percutaneous coronary intervention ...(PCI) is not clear.Methods and Results:We evaluated outcome in 410 consecutive patients with STEMI and CS who underwent PCI treated without (n=123) or with (n=287) abciximab. The endpoint was survival at 1-year follow-up. The predictors of death at 1 year were also investigated. The groups with and without abciximab had similar survival at 1-year follow-up. Propensity score-adjusted Cox proportional hazards model identified age (adjusted hazard ratio HR, 1.02; 95% confidence interval 95% CI: 1.01–1.03, P=0.001), oro-tracheal intubation (HR, 1.49; 95% CI: 1.12–1.96, P=0.05), post-PCI TIMI flow grade 0–1 (HR, 2.08; 95% CI: 1.52–2.83, P=0.0001) but not abciximab use (HR, 1.08; 95% CI: 0.70–1.60, P=0.60) as independent predictors of death at 1-year follow-up. Cox adjusted 1-year survival rates were 42.8% and 51.6%, (P=0.56) in patients treated without vs. with abciximab, respectively.Conclusions:Patients with STEMI complicated by CS undergoing PCI treated with or without abciximab have similar 1-year survival rates; age, final TIMI 0–1 and oro-tracheal intubation are predictors of death. (Circ J 2015; 79: 1568–1574)
We reported a case of a fit and active 48 years’ old woman presented with acute coronary syndrome due to a spontaneous coronary dissection (SCAD) treated with bioresorbable scaffolds (BVS) ...implantation guided by intravascular ultrasounds (IVUS) with immediate and long-term good results.
Data on the long-term prognosis of percutaneous coronary intervention (PCI) in young patients are limited. The aim of the present study was to report the immediate and long-term clinical outcomes in ...a consecutive series of young patients with premature coronary artery disease who underwent PCI with stent implantation. During the study period (2005 to 2010), 214 consecutive patients aged ≤40 years who had undergone PCI with a bare metal stent or drug-eluting stent implantation were retrospectively selected and analyzed. Primary end point of this study was the incidence of major adverse cardiac and cerebrovascular events at short- and long-term follow-up. Mean age was 36.3 ± 3.5 years and 88.3% of patients were men. Three-quarters were active smokers and all patients had ≥1 conventional cardiovascular risk factor. The total number of implanted stents was 272 (154 bare metal stent and 118 drug-eluting stent). During the hospital stay, no patient died, and the incidence of major adverse cardiac and cerebrovascular events was 2.3%. No additional events had occurred at 30 days of follow-up. At a median follow-up of 757 days (interquartile range 365 to 1,818), the overall death rate was 0.9%, and a new revascularization procedure was needed in 12.6% of patients. The major adverse cardiac and cerebrovascular event-free survival rate at the median follow-up point and 1,818 days was 89.6% and 84.2%, respectively. Active smoking and left ventricular ejection fraction <50% were independent predictors of major adverse cardiac and cerebrovascular events. In conclusion, PCI in young patients lead to excellent results in short- and long-term follow-up and should be considered as the treatment of choice. Traditional risk factors are important prognostic determinants of adverse events and might help identify higher risk patients within this cohort.
BackgroundThe role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left ...main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.Methods and analysisPULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.Trial registration numberNCT04144881
Abstract Intravascular ultrasound has been used for >20 years to guide percutaneous coronary intervention in different subsets of coronary lesions. During the last decade, the interest in ...percutaneous coronary intervention for chronic total occlusion (CTO) has increased dramatically, leading to high success rates. Failure of guidewire crossing is the most common reason for failed CTO attempts. Certain angiographic features, such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel, increase procedural difficulty. A better understanding of the behavior of the guidewire within the CTO segment may represent a key issue to achieve successful outcome. In this respect, intravascular ultrasound imaging might have potential roles in the recanalization of CTOs. In this paper, we focused on the usefulness and the applications of intravascular ultrasound imaging in percutaneous CTO recanalization, underlying its impact on clinical outcome.
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.
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.
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).
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.).
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