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255,788 result(s) for "coronary"
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Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI
In this trial involving 2492 patients, coronary revascularization guided by iFR, as compared with fractional flow reserve-guided revascularization, was within the prespecified margin for noninferiority with respect to major adverse cardiac events. For the past 20 years, physiological measurements obtained during invasive procedures have been used to guide coronary revascularization. Pioneering work supported the use of flow measurements to make safe decisions about revascularization, 1 , 2 but this approach was soon superseded by the use of fractional flow reserve (FFR), which measures pressure as a surrogate of flow to estimate the severity of stenosis. 3 – 5 FFR was successful largely because of its technical simplicity and because clinical trials showed that it was associated with improved clinical outcomes after percutaneous coronary intervention (PCI). 6 , 7 Consequently, FFR is now included in the appropriate-use criteria for . . .
Phenomapping-derived selection of fractional flow reserve or optical coherence tomography to personalise percutaneous coronary intervention
IntroductionAn evidence-based selection between fractional flow reserve (FFR) and optical coherence tomography (OCT) to drive percutaneous coronary intervention is still lacking.MethodsPatients enrolled in the Fractional Flow Reserve vs. Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses (FORZA) trial and in the OCT-Features Of moRphology, coMposItion anD instABility of culprit and not culprit coronary pLaquE in ACS patient (OCT-FORMIDABLE) registry were included. Target vessel revascularisation (TVR) and major adverse cardiac events (MACE), a composite endpoint of cardiac death, myocardial infarction (MI) and TVR were considered as coprimary endpoints. Phenomapping with clustering was performed: incidence of outcomes according to FFR and OCT was explored.Results405 patients were treated according to OCT and 405 to FFR. Three different clusters were identified. 48% of the patients were included in the first cluster, presenting mainly with stable angina and a relevant burden of risk factors (cardiovascular risk factors, CVRFs). 21% of the patients were included in the second cluster, presenting with ST segment elevation MI (STEMI) and with low rates of CVRFs. 31% of the patients, being admitted mostly for non-STEMI (NSTEMI) and with high rates of CVRFs, were included in the third cluster. FFR and OCT performed similarly in terms of MACE and TVR in the first cluster. In the second cluster, rates of MACE were lower in the OCT arm (3% vs 12%, p 0.04), mainly driven by TVR (2% vs 6%, p 0.18). In the third cluster, rates of TVR were significantly reduced in the OCT arm (6% vs 14%, p 0.037) with a neutral impact on MACE (12% vs 15%, p 0.71).ConclusionsCompared with a functional assessment, an OCT-based approach reduces revascularisation in patients with STEMI/NSTEMI, while FFR proved non-inferior for patients with stable angina.
OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions
In patients with coronary bifurcation lesions, optical coherence tomography–guided PCI was associated with a lower incidence of major adverse cardiac events at a median 2 years of follow-up than angiography-guided PCI.
Rationale and design of the prevail global trial program evaluating the prevail drug-coated balloon in patients with in-stent restenosis and de novo small vessel disease
•In-stent restenosis (ISR) and small vessel disease (SVD) remain difficult to treat.•Drug-coated balloons (DCB) are an alternative treatment option for ISR and SVD.•Prevail global is a clinical trial that will assess the prevail DCB in ISR and SVD. In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease. The safety and efficacy of the Prevail DCB will be assessed for (1) the treatment of ISR and (2) de novo lesions in small vessels. Prevail Global is a prospective, international, dual cohort clinical study enrolling (1) patients undergoing PCI for ISR in a randomized controlled trial (1:1) design comparing the Prevail DCB versus an FDA-approved DCB (AgentTM, Boston Scientific Corporation, Natick MA), and (2) patients with de novo small vessel disease undergoing PCI with the Prevail DCB as part of a single-arm study compared with a historical control. The primary endpoint is target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months post procedure. Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years. Enrollment is expected to start in early 2025. The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and de novo small vessel lesions. Prevail Global, NCT06535854, is registered at https://clinicaltrials.gov/study/NCT06535854.
Long-term outcomes of intravascular ultrasound-guided percutaneous coronary intervention versus coronary artery bypass grafting for multivessel coronary artery disease
BackgroundIntravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown to improve outcomes in complex coronary artery disease compared with angiography-guided PCI. However, long-term comparisons between IVUS-guided PCI and coronary artery bypass grafting (CABG) for multivessel disease (MVD) remain limited.MethodsThis post hoc analysis of the Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment Extended Follow-up study included 880 patients with MVD, excluding 15 patients who received medical therapy. Patients were categorised into IVUS-guided PCI (n=333), angiography-guided PCI (n=131) and CABG (n=401). The primary endpoint was the composite of death, myocardial infarction (MI) or target-vessel revascularisation over a median follow-up of 11.8 years.ResultsThe IVUS-guided PCI group showed no difference in the primary endpoint compared with CABG (adjusted HR 1.013; 95% CI 0.747 to 1.374; p=0.93). In contrast, angiography-guided PCI was associated with a higher risk of clinical events (adjusted HR 2.231; 95% CI 1.582 to 3.145; p<0.001). The safety endpoint (composite of death, MI and stroke) did not differ between IVUS-guided PCI and CABG (adjusted HR 0.845; 95% CI 0.605 to 1.181; p=0.324), while angiography-guided PCI was associated with a higher risk (adjusted HR 2.016; 95% CI 1.405 to 2.895; p<0.001). Both PCI groups had higher rates of repeat revascularisation compared with CABG.ConclusionsIVUS-guided PCI demonstrated comparable long-term outcomes to CABG in terms of mortality and safety endpoints, supporting its use in the treatment of MVD. These findings highlight the potential benefits of IVUS guidance in complex PCI procedures.Trial registration numbers NCT05125367 and NCT00997828.