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The Take Home: EuroPCR
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The annual EuroPCR meeting featuring news, education and networking for interventional cardiologists was held May 17-20, 2016, in Paris. Cardiology Today’s Intervention asked attendees Robert Byrne, MB, BCh, PhD, with Klinik an der Technischen Universitat Munchen, Germany, and Spencer B. King III, MD, with Emory Saint Joseph’s Hospital and Emory University School of Medicine, Atlanta, to discuss their highlights from the meeting.
ROBERT BYRNE, MB, BCh, PhD
BIOSOLVE-II
Presentation of 12-month data from the BIOSOLVE-II trial, simultaneously published in European Heart Journal, was one of the highlights for me. This was a first-in-human, single-arm study investigating clinical and angiographic outcomes of 123 patients with up to two de novo lesions with reference diameter of 2.2 mm to 3.7 mm who were treated with a magnesium-backbone fully bioresorbable scaffold (Dreams 2G, Biotronik). Late lumen loss at 12 months was encouraging. Paired data of 42 patients: in-segment late lumen loss 0.2 mm vs. 0.25 mm, P = .117; difference, 0.05 mm (95% CI, 0.01 to 0.12); in-scaffold late lumen loss, 0.37 mm vs. 0.39 mm; P = .446; difference, 0.03 mm (95% CI, 0.04 to 0.1). Rates of clinical adverse events also were low, with a 3.4% rate of target lesion failure and no cases of definite or probable scaffold thrombosis.
At least in part based on the results presented, this device is likely to receive CE-mark approval for use in Europe. This will add to the treatment options that we have available for our patients. However, further data in larger patient cohorts and comparative efficacy testing against current-generation DES are required before we can fully assess the role that this device will have in our routine practice.
EWOLUTION REGISTRY
Martin W. Bergmann, MD, presented 3-month outcome data of patients with atrial fibrillation treated with a catheter-based left atrial appendage (LAA) closure device (Watchman, Boston Scientific) enrolled in the 1,025-patient EWOLUTION registry. The device studied is one of two devices in widespread use in Europe. In contradistinction to the randomized clinical trial data (eg, PROTECT-AF, PREVAIL), which studied patients eligible for either oral anticoagulation or LAA occlusion, this registry focused mainly on patients with contraindication to oral anticoagulation. These are the patients most of us treat day-to-day with these devices. As expected, patients were high risk for both bleeding and embolic events. Results were encouraging, with a very high overall implant success rate of 98.5%. Rates of serious complications related to the device were low, with relevant pericardial effusion or tamponade occurring in 0.7% of patients and device embolization in 0.4%. Most patients were treated with a course of dual antiplatelet therapy after implantation, providing more evidence that this approach — rather than anticoagulation after implantation — is a reasonable approach with this device.
Photo provided by EuroPCR, europcr.com; printed with permission
The availability of postmarketing surveillance data from new devices is an important part of the scientific and regulatory process for medical device evaluation. The results of this registry provide further support for the use of LAA occlusion in patients with AF at risk for stroke.
SPENCER B. KING III, MD
IVUS-XPL
IVUS-XPL had a 2x2 factorial design in which 1,400 patients receiving an everolimus-eluting stent (EES; Xience, Abbott Vascular) were randomly assigned to receive 6-month DAPT or 12-month DAPT, as well as implantation guidance with IVUS or angiography. In the imaging findings presented at the American Heart Association Scientific Sessions in 2015, IVUS-guided EES implantation was associated with better outcomes than angiography-guided implantation. In the DAPT findings presented here, the primary endpoint of cardiac death, MI, stroke or TIMI major bleeding at 1 year occurred in 2.2% of those assigned 6-month DAPT vs. 2.1% of those assigned 12-month DAPT (HR = 1.07; P = .854). Both groups had a definite or probable stent thrombosis rate of 0.3% (HR = 1; P = .99), and the primary endpoint did not differ in the cohorts of patients with ACS or with diabetes.
This group was at somewhat increased risk for stent thrombosis because they had longer lesions and were implanted with longer stents. Twelve months of DAPT has been the recommendation for these patients. This trial showed that in patients receiving the most modern type of DES, using DAPT for 6 months was noninferior to DAPT for 12 months. These results provide more ammunition to support the idea that with new-generation DES, 6-month DAPT seems to be enough, even with longer lesions, and the guidelines have changed in that direction. What we need to know more about is what happens after 12 months, and whether there is any risk for very late stent thrombosis.
WIN-TAVI
Data from WIN-TAVI, the first all-female transcatheter aortic valve replacement registry, were also presented at EuroPCR 2016. The primary endpoint of 30-day VARC-2 safety, defined as mortality, stroke, major vascular complications, life-threatening bleeding, acute kidney injury, coronary artery obstruction or repeat procedure for valve dysfunction, occurred in 14.2% of patients. The rate of stroke was 1.3%; all-cause mortality, 3.4%; life-threatening bleeding, 4.4%; major vascular complications, 7.7%; acute kidney injury, 1.3%; coronary artery obstruction, 0.7%; and BARC 3 or 5 bleeding, 12%.
Age, prior stroke, low ejection fraction, TAVR device generation (older vs. newer) and history of pregnancy were independent predictors of the composite outcome. All of these risk factors are similar to what has been seen in men except, of course, for pregnancy. History of pregnancy as a risk factor was a truly unexpected observation. It needs to be confirmed with longer-term follow-up and to be substantiated in other cohorts. This registry gives us a baseline for women who require TAVR.
BRAVO-3 MRI
In this substudy of the BRAVO-3 trial, 69 patients underwent brain MRI after TAVR was performed to determine the frequency and size of cerebral emboli after TAVR, and whether assignment to bivalirudin (Angiomax, The Medicines Company) or unfractionated heparin made a difference. While 61.5% of patients had cerebral emboli, anticoagulation assignment did not make a difference (P = .55).
There is a lot of interest in cerebral embolization, how it affects clinical events and how to prevent it. This study showed that while type of anticoagulation has no influence, the condition is prevalent in nearly two-thirds of patients. It suggests we are not going to solve the problem with anticoagulation, and points to the importance of research on distal embolization protection with devices, none of which were used in this study, and other technologies.
Disclosures: Byrne reports receiving lecture fees from B. Braun Melsungen, Biotronik and Boston Scientific and institutional research grants from Boston Scientific and HeartFlow. King reports no relevant financial disclosures.