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Interventional cardiology

Long-term data on fractional flow reserve guided PCI

8 Dec, 15 | by flee

The Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) trial was a landmark study of the use of fractional flow reserve (FFR) to guide coronary revascularization through the identification of ischemia-inducing stenosis at the time of coronary angiography. The previously published 1- and 2-year results of the FAME trial demonstrated fewer major adverse cardiac events in the FFR arm as compared to patients undergoing revascularization guided by angiographic assessment alone.  In the current study, the authors present the 5-year follow-up data from the FAME trial.  The original trial enrolled 1005 patients across 20 centers from 2006 to 2007, with 496 randomized to angiography-guided revascularization and 506 to FFR-guided revascularization.  Of these patients, 429 in the angiography-guided arm and 436 in the FFR-guided arm were included in the 5-year follow-up (86% overall).  At 5 years, there was no difference between treatment arms for major adverse cardiac events (31% angiography vs. 28% FFR, relative risk 0.91 [95% CI 0.75-1.10]), or individual outcomes of all cause mortality, myocardial infarction, or coronary revascularization. Similarly, cardiac mortality was not significantly different between treatment arms (16% angiography vs. 13% FFR, p= 0.21).  A sensitivity analysis in which death was assumed for lost-to-follow-up patients demonstrated similar findings.

 

Conclusions: At 5-years follow up, FFR-guided revascularization demonstrated similar outcomes when compared with revascularization guided by angiography alone.  These findings provide reassurance that the early benefits of FFR targeted revascularization are not overwhelmed by late events.

 

Summarized by Javier A. Valle and Steven M. Bradley

 

van Nunen LX, Zimmermann FM, Tonino PAL, Barbato E, Baumbach A, Engstrøm T, et al. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet 2015; 386: 1853–60.

Absorbable stents non-inferior….but is that enough?

25 Nov, 15 | by flee

A coronary artery stent that scaffolds the vessel immediately after angioplasty but disappears over time has been proposed as means to avoid complications of late stent thrombosis and restore physiological vasomotion.  Bioabsorbable platforms (termed scaffolds) are designed to slowly dissolve over 2 to 3 years, leaving little or no residue in the vessel.  However, conventional stent technology sets a very high bar with low rates of late complications, many years of operator experience, and large numbers of prior trials.  In the ABSORB III trial a total of 2008 patients with stable or unstable angina were randomized in a 2:1 fashion to revascularization with either the ABSORB bioabsorbable scaffold or a conventional drug-eluting stent (in this case the everolimus-eluting XIENCE platform).  The study was designed as a non-inferiority trial with a primary end-point of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization.  At 1 year of follow-up, the study demonstrated no significant difference in the primary end-point (7.8% vs. 6.1%, P=0.007 for noninferiority and P=0.16 for superiority) and no significant difference between the two groups in the individual components of the end-point.  However, it the point-estimates for adverse events were higher among patients receiving the bioabsorbable scaffold.

Conclusions

In this large study comparing first generation bioabsorbable coronary scaffolds against conventional third generation metallic drug-eluting stents, the bioabsorbable scaffolds demonstrated non-inferiority within the pre-specified margin of 4.5% in terms of both efficacy and safety.  However, the point estimates for bioabsorbable scaffolds in this trial raise concern about the true benefits, and even potential for harm, of this new technology.  Longer term data in larger studies is needed prior to wholesale adoption of absorbable coronary scaffolds in clinical practice.

Summarized by Hussain Contractor and Steven M. Bradley

Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Oct 12. [Epub ahead of print]

Similar Outcomes with Bivalirudin and Unfractionated Heparin During PCI for Acute Coronary Syndromes

4 Nov, 15 | by flee

Approximately two-thirds of all PCI are performed for acute coronary syndromes.  In this setting, the optimal balance of anticoagulation to avoid thrombosis against the risk of major bleeding is a pivotal area of procedural management.  Multiple clinical trials have compared bivalirudin and heparin (+/- IIb/IIIa inhibitor), but the optimal strategy remains debated.  In particular, changes in clinical practice, namely increasing use of radial access and decreasing use of IIb/IIIa inhibitors, may influence the optimal antithrombotic treatment strategy.  In the MATRIX trial, 7213 patients with an acute coronary syndrome (55% with ST-elevation) were randomly allocated to receive either bivalirudin or heparin at 70-100u/kg peri-procedurally with an additional randomization step at procedural completion to either stop bivalirudin or continue the infusion for 4 to 6 hours.  Approximately 25% of the heparin group also received a IIb/IIIa inhibitor at the treating physician’s discretion.  There was no significant difference in rates of major adverse cardiovascular events between the bivalirudin and heparin groups (10.3% vs. 10.9%; RR, 0.94; 95% CI, 0.81 to 1.09; P=0.44), nor was there any difference in safety outcomes between the two arms (P=0.12).  In addition, prolonging bivalirudin infusion made no difference to clinical outcomes with no change in rates of stent thrombosis or other adverse clinical events (P=0.34).

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Informed Decision Making for Percutaneous Coronary Intervention for Stable Coronary Disease

10 Sep, 15 | by flee

Prior studies suggest patients are often misinformed about the anticipated benefits of PCI for stable coronary disease.  However, there is little data on patient-provider discussions that may explain discrepancies in patient understanding about the limited benefits of PCI in this setting.   Rothberg and colleagues performed a cross-sectional analysis of 59 conversations between providers and patients about PCI.  The conversations included 23 cardiologists (all male, 6 interventionalists, median 19 years experience) representing all regions of the United States from 2008 to 2012.  Conversations were analyzed for discussion of 7 elements central to shared-decision making: more…

Antiplatelet therapy in long-term risk reduction after myocardial infarction

22 May, 15 | by Alistair Lindsay

The activated platelet is central to development of ischemic cardiovascular events. Guidelines recommend treatment with a P2Y12 receptor antagonist for 1-year after myocardial infarction (MI) to reduce the risk of recurrent events.  The PEGASUS trial sought to determine the impact of using the P2Y12 antagonist ticagrelor as part of long-term therapy after MI.  In this trial, a total of 21,162 clinically stable patients with a MI in the prior 1 to 3 years (median 18 months) were randomized in a 1:1:1 fashion to either placebo, ticagrelor 90mg twice daily, or ticagrelor 60mg twice daily.  All patients remained on aspirin and standard secondary prevention as tolerated.  Follow up was for a median of 33 months with the primary outcome being a composite of cardiovascular death, myocardial infarction, or stroke and the primary safety end-point of bleeding.  more…

Precision Medicine to Reduce Bleeding with PCI   

5 May, 15 | by Alistair Lindsay

 

Periprocedural bleeding remains one of the most common adverse events after percutaneous coronary intervention (PCI) and is associated with increased mortality.  Although strategies to minimize PCI bleeding have been identified, these strategies are infrequently applied to patients at highest bleeding risk.  Using a pre-post study design, Spertus et al. evaluated the impact of assessing individual patient bleeding risk from validated models and providing this bleeding risk estimate in personalized informed consent documents for PCI.  The intent of the intervention was to increase the procedural team’s awareness of patients at low, moderate, and risk for PCI related bleeding and thereby influence the use of bleeding avoidance strategies (i.e. bivalirudin, radial access, and vascular closure devices) and reduce periprocedural bleeding events.  more…

Second-generation stents fail to BEST CABG

16 Apr, 15 | by Alistair Lindsay

The technology of drug eluting stents for percutaneous coronary intervention (PCI) has improved over time with resultant improvements in patient outcomes.  Although prior studies have demonstrated the benefit of surgical coronary artery bypass grafting (CABG) over transcatheter PCI among patients with multivessel coronary artery disease (CAD), these studies did not incorporate newer generation drug-eluting stents.  The multicenter BEST trial randomized 880 patients with multivessel CAD to PCI with an everolimus-eluting stent or to CABG. The primary end point for this non-inferiority study was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years.  The results of the study non-significantly favored CABG at 2 years of follow-up with the primary end-point occurring in 7.9% of the CABG group and 11% of the PCI group.  more…

Aspiration thrombectomy fails to demonstrate benefit in primary PCI  

16 Apr, 15 | by Alistair Lindsay

Although primary percutaneous coronary intervention (PPCI) restores epicardial coronary flow in the majority of patients with ST-segment myocardial infarction, this approach can lead to microvascular obstruction resulting from distal embolization of thrombus.  Manual thrombectomy (i.e. aspiration thrombectomy) prior to PPCI has been proposed as a method to reduce thrombus burden and resultant distal embolization with PPCI.  Although results from early studies of aspiration thrombectomy suggested improvements in patient outcomes, subsequent trials have failed to demonstrate a clinical benefit of aspiration thrombectomy prior to PPCI.  more…

Coronary sinus reduction for intractable angina

2 Mar, 15 | by Alistair Lindsay

An increasing number of patients have angina that is refractory to maximal medical therapy and unable to be addressed with revascularization procedures. Prior small studies have suggested the promise of generating a pressure gradient upstream of the myocardial venous drainage system to relieve angina.  This can be accomplished through the percutaneous implantation of a device that reduces the orifice for coronary sinus blood flow.  The Coronary Sinus Reducer for Treatment of Refractory Angina (COSIRA) trial randomized 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina, evidence of myocardial ischemia, and no remaining revascularization options to percutaneous implantation of a coronary sinus reducing device or a sham procedure in a double blind fashion. more…

The DENERHTN Randomized Controlled Trial: Renal Denervation for Resistant Hypertension Revisited

17 Feb, 15 | by Alistair Lindsay

Despite large reductions in blood pressure seen in early studies of renal denervation, the SYMPLICITY HTN-3 randomized trial failed to show a reduction in systolic blood pressure with renal denervation when compared to medical therapy alone. As a result, interest in renal denervation as a treatment for resistant hypertension has waned.  In the DENERHTN trial, Azizi and colleagues assessed the incremental benefit of adding renal denervation to standardized stepped-care antihypertensive treatment (SSAHT) for patients with resistant hypertension in an open-label, randomized-controlled trial with blinded endpoint evaluation. After four weeks of a standardized anti-hypertensive regimen to confirm resistant hypertension, patients were randomized to renal denervation in addition to SSAHT versus SSAHT alone. more…

Highlighted articles from non-cardiological journals relevant to cardiology.

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