Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.

AIMS: This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016). CONCLUSIONS: Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

Cobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I).

BACKGROUND: The CoStar stent is a novel cobalt chromium stent designed specifically for drug delivery. The COSTAR I trial represents the first-in-man study of the CoStar Paclitaxel-Eluting Coronary Stent System evaluating three dose release formulations of paclitaxel in a bioresorbable polymer matrix in the treatment of de novo coronary lesions. METHODS: The COSTAR I Trial was a prospective, multi-center registry enrolling 87 patients in four Indian centers for treatment of up to two de novo lesions = 25 mm in length in a reference vessel 2.5-3.5 mm in diameter. Three dose release formulations were studied: 30 microg eluted over 10 days bidirectionally (Group 1, n =10), 10 microg eluted over 30 days abluminally (Group 2, n=40) and 3 microg eluted over 30 days abluminally (Group 3, n = 37). RESULTS: Demographics and lesion characteristics were similar between the groups and treatment in all three groups included small caliber vessels (RVD 2.45 +/- 0.30 - 2.57 +/- 0.36 mm). The primary endpoint of in-stent late loss at four months was lowest in Group 2 (0.43 +/- 0.43 mm) compared to Group 1 and Group 3 (0.51 +/- 7 mn; 0.74 mm and 1.07 +/- 0.65 mm respectively). In-segment late loss followed similar trends, being lowest in Group 2 (0.24 +/- 0.39 mm) compared to Groups 1 and 3 (0.52 +/- 0.66 mm and 0.76 +/- 0.57 mm respectively). Group 2 demonstrated better angiographic out-comes at 12 months with in-stent late loss of 0.55 +/- 0.38 mm when compared to Groups 1 and 3 (0.90 +/- 0.76 mm and 0.74 +/- 0.55 mm respectively). Cumulative binary restenosis rates at twelve months were 1.9%, 35.7% and 39.1% in Groups 2, 1 and 3 respectively. Clinical outcomes trended similarly with cumulative MACE rates at twelve months being lowest at 7.5% in Group 2 as compared to 20% in Group 1 and 21.6% in Group 3 respectively. CONCLUSIONS: In this first-in-man feasibility trial, angiographic and clinical results seen with the extended release formulation at a higher dose (10 microg/30 days) demonstrate the feasibility of the CoStar stent platform in the treatment of native coronary lesions. It also demonstrates the importance of drug dose and release kinetics.