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The FAST-MI Tunisia registry was set up by the Tunisian Society of Cardiology and Cardiovascular Surgery to assess the demographic and clinical characteristics, management and hospital outcome of patients with ST-elevation myocardial infarction (STEMI). Data for 459 consecutive patients (mean age 60.8 years; 88.5% male) with STEMI, treated in 16 public hospitals (representing 72.2% of public hospitals in Tunisia treating STEMI patients), were collected prospectively.The most common risk factors were smoking (63.6%), hypertension (39.7%), diabetes (32%) and dyslipidaemia (18.2%). Among the 459 patients, 61.8% received reperfusion therapy: 30% with primary percutaneous coronary intervention (PPCI) and 31.8% with intravenous fibrinolysis (IF) (28.6% with pre-hospital thrombolysis). The median time from symptom onset to thrombolysis was 185 min and to PPCI was 358 min. In-hospital mortality was 5.3%. Compared with those managed at regional hospitals, patients managed at interventional university hospitals (n = 357) were more likely to receive reperfusion therapy (52.9% vs. 34.1%; p<0.001), with less IF (28.6% vs. 43.1%; p = 0.002) but more PPCI (37.8% vs. 3.9%; p<0.0001). However, in-hospital mortality in the two types of hospitals was similar (5.3% vs. 5.1%; p = 0.866). Data from the FAST-MI Tunisia registry show that a pharmaco-invasive strategy of management for STEMI should be promoted in non-interventional regional hospitals.

We sought to systematically review the evidence supporting the role of drug coated balloons (DCBs) in the treatment of coronary bifurcation lesions. DCBs are emerging as an attractive alternative treatment strategy for treating coronary bifurcations due to simplifying the approach and reducing rates of stent related complications. We systematically reviewed the evidence for DCB use in coronary bifurcations and conducted a focused meta-analysis on late lumen loss in the side branch comparing DCB and plain old balloon angioplasty (POBA). This study was conducted in line with the PRISMA statement. All studies (including both RCTs and observational studies, excluding case reports) using DCB as part of a bifurcation strategy were included in this review. A literature search identified a total of ten studies for inclusion. A focused meta-analysis was undertaken for the use of DCB in side-branch compared with POBA. Mean late lumen loss was used with a random effects model due to heterogeneity. DCB was found to be superior to POBA for side branch treatment in bifurcations (p = 0.01). There are four studies that investigated the use of DCB for main branch treatment in a bifurcation, with evidence supporting its safety in main branches of bifurcation lesions, while prospective observational studies have demonstrated favourable target lesion revascularisation rates. Although there is a lack of robust RCTs comparing DCBs with current generation DES, DCBs appear safe in main branch bifurcation lesions with improved side branch late lumen loss when compared with DES or POBA.

AbstractObjectivesTo investigate whether a less intense antiplatelet regimen could be used for people receiving drug coated balloons.DesignMulticentre, randomised, open label, assessor blind, non-inferiority trial (REC-CAGEFREE II).Setting41 hospitals in China between 27 November 2021 and 21 January 2023.Participants1948 adults (18-80 years) with acute coronary syndrome who received treatment exclusively with paclitaxel-coated balloons according to the international drug coated balloon consensus.InterventionsParticipants were randomly assigned (1:1) to either the stepwise dual antiplatelet therapy (DAPT) de-escalation group (n=975) consisting of aspirin plus ticagrelor for one month, followed by five months of ticagrelor monotherapy, and then six months of aspirin monotherapy, or to the standard DAPT group (n=973) consisting of aspirin plus ticagrelor for 12 months.Main outcome measuresThe primary endpoint was net adverse clinical events (all cause death, stroke, myocardial infarction, revascularisation, and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding) at 12 months in the intention-to-treat population. Non-inferiority was established if the upper limit of the one sided 95% confidence interval (CI) for the absolute risk difference was smaller than 3.2%.ResultsThe mean age of participants was 59.2 years, 74.9% were men, 30.5% had diabetes, and 20.6% were at high bleeding risk. 60.9% of treated lesions were in small vessels, and 17.8% were in-stent restenosis. The mean drug coated balloon diameter was 2.72 mm (standard deviation 0.49). At 12 months, the primary endpoint occurred in 87 (8.9%) participants in the stepwise de-escalation group and 84 (8.6%) in the standard group (difference 0.36%; upper boundary of the one sided 95% CI 2.47%; Pnon-inferiority=0.013). In the stepwise de-escalation versus standard groups, BARC type 3 or 5 bleeding occurred in four versus 16 participants (0.4% v 1.6%, difference −1.19% (95% CI −2.07% to −0.31%), P=0.008), and all cause death, stroke, myocardial infarction, and revascularisation occurred in 84 versus 74 participants (8.6% v 7.6%, difference 1.05% (95% CI −1.37% to 3.47%), P=0.396). Treated as having hierarchical clinical importance by the win ratio method, more wins were noted with the stepwise de-escalation group (14.4% wins) compared with the standard group (10.1% wins) for the predefined hierarchical composite endpoint of all cause death, stroke, myocardial infarction, BARC type 3 bleeding, revascularisation, and BARC type 2 bleeding (win ratio 1.43 (95% CI 1.12 to 1.83), P=0.004). Results from the per-protocol and the intention-to-treat analysis were similar.ConclusionsAmong participants with acute coronary syndrome who could be treated by drug coated balloons exclusively, a stepwise DAPT de-escalation was non-inferior to 12 month DAPT for net adverse clinical events.Trial registrationClinicaltrials.gov NCT04971356

In-stent restenosis (ISR) accounts for 10% of percutaneous coronary intervention (PCI) in the United States. Paclitaxel-coated balloons (PCBs) have been evaluated as a therapy for coronary ISR in multiple randomized controlled trials (RCTs). We searched PubMed/MEDLINE, Cochrane Library, and ClinicalTrials.gov (from inception to April 1, 2024) for RCTs evaluating PCBs versus uncoated balloon angioplasty (BA) in patients with coronary ISR. The outcomes of interest were target lesion revascularization (TLR), major adverse cardiovascular events (MACEs), all-cause mortality, cardiovascular mortality, myocardial infarction (MI), and stent thrombosis. We pooled the estimates using an inverse variance random-effects model. The effect sizes were reported as risk ratio (RR) with 95% confidence interval (CI). A total of 6 RCTs with 1,343 patients were included. At a follow-up ranging from 6 to 12 months from randomization, the use of PCBs was associated with a statistically significant decrease in TLR (RR 0.28, 95% CI 0.11 to 0.68) and MACE (RR 0.35, 95% CI 0.20 to 0.64) compared with BA for coronary ISR. However, there was no significant difference in risk between PCBs and BA in terms of all-cause mortality (RR 0.56, 95% CI 0.14 to 2.31), cardiovascular mortality (RR 0.61, 95% CI 0.02 to 16.85), MI (RR 0.60, 95% CI 0.27 to 1.31), and stent thrombosis (RR 0.13, 95% CI 0.00 to 5.06). In conclusion, this meta-analysis suggests that PCBs compared with uncoated BA for the treatment of coronary ISR at intermediate-term follow-up of 1 year were associated with a significant decrease in TLR and MACE without any difference in mortality, MI, or stent thrombosis.

Background: Bleeding and transfusion after percutaneous coronary intervention (PCI) are known predictors of mortality. Transradial arterial access reduces bleeding and transfusion related to femoral access complications, although its association with mortality is unknown. Objective: To determine the association of arterial access site (radial or femoral) with transfusion and mortality in unselected PCIs. Design, setting and patients: By data linkage of three prospectively collated provincial registries, 38 872 procedures in 32 822 patients in British Columbia were analysed. The association between access site, transfusion and outcomes was assessed by logistic regression, propensity score matching and probit regression. Main outcome measures: 30-Day and 1-year mortality. Results: 1134 (3.5%) patients had at least one blood transfusion. Transfused patients had a significantly increased 30-day and 1-year mortality, adjusted odds ratio (95% CI) 4.01 (3.08 to 5.22) and 3.58 (2.94 to 4.36), respectively. By probit regression the absolute increase in risk of death at 1 year associated with receiving a transfusion was 6.78%. The number needed to treat was 14.74 (prevention of 15 transfusions required to “avoid” one death). Radial access halved the transfusion rate. After adjustment for all variables, radial access was associated with a significant reduction in 30-day and 1-year mortality, odds ratio = 0.71 (95% CI 0.61 to 0.82) and 0.83 (0.71 to 0.98), respectively (all p<0.001). Conclusions: In a registry of all comers to PCI, transradial access was associated with a halving of the transfusion rate and a reduction in 30-day and 1-year mortality.

Background With advancements in chronic total coronary occlusion (CTO) recanalization techniques and concepts, the success rate of recanalization has been steadily increasing. However, the current data are too limited to draw any reliable conclusions about the efficacy and safety of drug-coated balloons (DCBs) in CTO percutaneous coronary intervention (PCI). Herein, we conducted a meta-analysis to confirm the efficacy of DCB in CTO PCI. Methods We systematically searched PubMed, Web of Science and Embase from inception to July 25, 2023. The primary outcome was major advent cardiovascular events (MACE), including cardiac death, nonfatal myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). The follow-up angiographic endpoints were late lumen enlargement (LLE), reocclusion and restenosis. Results Five studies with a total of 511 patients were included in the meta-analysis. Across studies, patients were predominantly male (72.9-85.7%) and over fifty years old. The summary estimate rate of MACE was 13.0% (95% CI 10.1%-15.9%, I 2  = 0%, p  = 0.428). The summary estimate rates of cardiac death and MI were 2.2% (95% CI 0.7%-3.7%, I 2  = 0%, p  = 0.873) and 1.2% (95% CI -0.2-2.6%, I 2  = 13.7%, p  = 0.314), respectively. Finally, the pooled incidences of TLR and TVR were 10.1% (95% CI 5.7%-14.5%, I 2  = 51.7%, p  = 0.082) and 7.1% (95% CI 3.0%-11.2%, I 2  = 57.6%, p  = 0.070), respectively. Finally, the summary estimate rates of LLE, reocclusion and restenosis were 59.4% (95% CI 53.5–65.3%, I 2  = 0%, p  = 0.742), 3.3% (95% CI 1.1–5.4%, I 2  = 0%, p  = 0.865) and 17.5% (95% CI 12.9–22.0%, I 2  = 0%, p  = 0.623), respectively. Conclusion Accordingly, DCB has the potential to be used as a treatment for CTO in suitable patients.

Background Few studies investigated the implications of post-PCI QFR and post-PCI ΔQFR (absolute increase of QFR) in de novo lesions of small coronary disease after drug-coated balloon (DCB). Objectives We sought to investigate the prognostic implications of post-PCI QFR and post-PCI ΔQFR in patients who received DCB only. Methods Patients were divided according to the optimal cutoff value of the post-PCI QFR and the post-PCI ΔQFR. The primary outcome was major adverse cardiovascular events (MACE), including target vessel revascularization (TVR), cardiac death, and myocardial infarction (MI). Results The optimal cutoff values of QFR and ΔQFR for the MACE rate were 0.86 and 0.57, respectively. There were 175 patients (61.2%) with a high QFR (≥ 0.86) and 113 patients (39.5%) with a high ΔQFR (≥ 0.57) after PCI. The MACE rate was significantly higher in patients with a low QFR compared to a high QFR (5.7% vs. 27.0%, hazard ratio [HR]: 3.632, 95% confidence interval [CI]: 1.872 to 7.044, P  < 0.001). The MACE rate was higher in patients with a low ΔQFR increase compared to those with high ΔQFR (4.4% vs. 20.2%, HR: 4.700, 95%CI: 2.430 to 9.089, P  = 0.001). In multivariable model, a low post-PCI QFR and a low post-PCI ΔQFR was independent predictor of MACE (adjusted HR: 4.071, 95%CI: 2.037 to 8.135, P  = 0.001). Conclusions After DCB in de novo lesions of small coronary disease, both post-PCI QFR and ΔQFR showed similar prognostic implications in MACE.

Background Drug-coated balloons (DCB) have promising results in the management of large coronary artery lesions (CAD), still their role in treating small CAD is not well established. We aimed to provide a comprehensive appraisal of the efficacy and safety of DCBs in patients with small CAD. Methods We searched PubMed, Scopus, web of science, Ovid, and Cochrane Central from inception until 30 March, 2023. We included all relevant studies that compared DCB versus drug-eluting stents (DES) in small CAD patients undergoing PCI. We reported clinical outcomes as MACE, all-cause death, cardiac death, MI, TLR, TVR, and stent thrombosis, while angiographic outcomes were late lumen loss (LLL), mean lumen diameter (MLD), net luminal gain (NLG), and in-segment binary restenosis. Results Twenty studies comprising 18,469 patients were included in this meta-analysis. The incidence rate of MACE was 9.4% in the DCB group compared to 9.9% in the DES group, without a significant difference in the risk of MACE (OR = 0.97, 95% CI: 0.77 to 1.22, p  = 0.78). Moreover, DCB significantly decreased MLD and NLG compared to DES, with the following values, respectively (MD= -0.19, 95% CI: -0.32 to -0.06, p  < 0.001, and MD -0.21, 95% CI: -0.40 to -0.01, p  = 0.04). On the other hand, DCB was associated with higher odds in the risk of in-segment binary restenosis (OR 1.66, 95% CI: 1.03 to 2.68, p  = 0.04). Conclusion DCB is an alternative approach to DES in the management of small CAD and should be validated in daily clinical practice. Prospero registration CRD42023413068.

Background Various devices and techniques have been used for plaque modification in the treatment of severe coronary artery calcification. This prospective, multicenter, randomized, open-label study aims to evaluate the safety and efficacy of cutting balloon angioplasty using a novel bioabsorbable polymer-coated everolimus-eluting coronary stent for treating various degrees of calcified coronary lesions. Methods We outline the trial design aimed at assessing whether the cutting balloon (Wolverine™) is non-inferior to the non-compliant balloon in treating patients with calcified lesions, encompassing both de novo and in-stent restenosis (ISR) lesions. We aim to enroll 250 patients who have undergone bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™) implantation. The primary endpoint is the minimal stent cross-sectional area at the calcium site as determined by intravascular ultrasonography. The secondary endpoints include major adverse cardiac events and target lesion revascularization at 12 months, alongside procedural convenience and operator-centric parameters, such as the number of balloons used, procedure time, and total contrast medium volume used. Discussion In this study, we will evaluate the efficacy and safety of Wolverine™ and non-compliant balloon in patients with calcified coronary lesions and provide a rationale for which type of balloons will optimally modify calcium lesions. In addition, we will attempt to expand the indications of the cutting balloon for treating mild-to-severe calcified coronary lesions. As the scope of insurance coverage for cutting balloons remains limited in some countries, this study may provide evidence for extending insurance coverage to the treatment of de novo calcified and ISR lesions. Trial registration ClinicalTrials.gov NCT06177808. Registered on January 1, 2024.

Background Percutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain. Study design The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo , non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization. Discussion The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo , non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting. Trial registration Registered on clinicaltrial.gov (NCT04561739).