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percutaneous coronary intervention

Bleeding versus thromboembolic protection in atrial fibrillation and coronary stent procedures.

18 Apr, 17 | by flee

Five to 8% of people undergoing percutaneous coronary intervention (PCI) also have atrial fibrillation (AF).  The optimal antiplatelet / anticoagulant regimen in these individuals remains unclear as stroke and stent thrombosis prevention need to be balanced against the risks of major bleeding.  The PIONEER AF-PCI trial (Open-Label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with Atrial Fibrillation who Undergo Percutaneous Coronary Intervention) randomized 2124 patients with AF who had undergone PCI to 1 of 3 arms: 15mg rivaroxaban + a P2Y12 inhibitor alone for 12 months, 2.5mg of twice daily rivaroxaban + a P2Y12 inhibitor and aspirin (DAPT) for 1, 6 or 12 months or warfarin + DAPT for 1, 6 or 12 months.  The predominant P2Y12 inhibitor was clopidogrel (approx. 90%). The primary endpoint was clinically significant bleeding while efficacy – both myocardial infarction and stroke were secondary end-points.  Both rivaroxaban arms demonstrated significant reductions in major bleeding relative to the warfarin arm (16.8% vs. 18.0% vs. 26.7%; P<0.001).  Furthermore, overall rates of stroke and myocardial infarction were similarly low across all sub-groups.

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Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis

18 Apr, 17 | by flee

The use of percutaneous coronary intervention (PCI) for unprotected left main coronary artery stenosis is increasing but it remains unclear whether this approach is non-inferior to coronary artery bypass grafting (CABG). Both the Nordic-Baltic-British left main revascularization study (NOBLE, n=1201) and Evaluation of an everolimus eluting stent versus coronary artery bypass surgery for effectiveness of left main revascularization study (EXCEL, n=1905) randomized patients with severe left main coronary artery stenosis to PCI or CABG to address this question. Though similar, there are important differences in these studies’ design and results.  Primary outcomes were defined as all cause death, stroke and non-procedural myocardial infarction (MI) in both trials with the addition of repeat revascularization in NOBLE and post-procedural MI in EXCEL. Other study differences include intended duration of follow up, non-inferiority margins, allowable coronary complexity, and stent type. The prevalence of distal left main stenosis was quite high (~80%) in both trials.  In EXCEL, PCI was non-inferior to CABG with respect to the primary composite endpoint at 3 years (15.4% for PCI, 14.7% for CABG, confidence interval (CI) 0.79 to 1.26 while, NOBLE found that PCI was inferior to CABG for the 5-year estimated primary event rate (29% for PCI, 19% for CABG, CI 1.11 to 1.96). Adding repeat revascularization to the primary end-point in EXCEL did not change the finding of non-inferiority between PCI and CABG. All-cause mortality did not differ by treatment in either trial.

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COURAGE at 15 years

2 Feb, 16 | by flee

Although PCI improves morbidity and mortality in the context of an acute coronary syndrome, the benefit of PCI in the setting of stable ischemic heart disease appears limited to symptom relief.  This was best demonstrated by the COURAGE trial that randomized 2287 patients with stable angina to either intensive medical therapy alone or medical therapy with PCI.  The study found symptom reduction was greater in the first 6 to 24 months following PCI, but PCI did not impact cardiovascular events or all cause survival.  A prior follow-up study of COURAGE patients suggested mortality at 5 years may have been trending toward benefit with PCI.  In the current study, 15 years of survival data was gathered on 1211 patients (53% of the original cohort) with nearly all of these patients coming from the U.S. Veterans Affairs system.  In this cohort, a total of 561 deaths had occurred in follow-up with 284 deaths (25%) in the PCI group and 277 (24%) in the medical-therapy group (HR, 1.03; 95% CI, 0.83 to 1.21; P=0.76); demonstrating no long-term survival advantage with PCI for stable ischemic heart disease. Data on cause of death and any additional therapies such as PCI or CABG outside of the initial 5yr trial period were unavailable.

 

Conclusions: In 15-year follow-up of approximately half of the original COURAGE trial cohort, there was no difference in mortality between those randomized to PCI and medical therapy.  Ongoing studies will inform whether PCI can improve outcomes beyond symptom burden when targeted to patients with significant demonstrable ischemia.

 

Summarized by Hussain Contractor and Steven M. Bradley

 

Sedlis SP, Hartigan PM, Teo KK, Maron DJ, Spertus JA, Mancini GB, Kostuk W, Chaitman BR, Berman D, Lorin JD, Dada M, Weintraub WS and Boden WE. Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease. N Engl J Med. 2015 Nov 12;373(20):1937-46.

Highlighted articles from non-cardiological journals relevant to cardiology.

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