Clin Res Cardiol 107, Suppl 1, April 2018

Magmaris vs. DESolve: a comparison study of acute mechanical performance using optical coherence tomography
N. F. Boeder1, O. Dörr1, R. Gaderer2, T. Bauer1, A. Elsässer3, S. Achenbach4, H. Möllmann5, C. W. Hamm1, H. Nef1
1Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 2Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Giessen und Marburg GmbH, Gießen; 3Klinik für Kardiologie, Klinikum Oldenburg AöR, Oldenburg; 4Med. Klinik 2 - Kardiologie, Angiologie, Universitätsklinikum Erlangen, Erlangen; 5Klinik für Innere Medizin I, St.-Johannes-Hospital Dortmund, Dortmund;

Background: The bioresorbable scaffold (BRS) is a novel approach for the treatment of coronary artery disease. Outcome after everolimus-eluting BRS implantation seen in registries and meta-analyses continue to show a higher rate of scaffold thrombosis than those reported with DES. The available BRS are poly-lactid acid based. Lately, a resorbable magnesium scaffold gained permission for clinical use (Biotronik Magmaris, Biotronik AG, Bülach, Switzerland).

 

Objectives: To evaluate the acute performance of resorbable magnesium scaffold using optical coherence tomography (OCT) in terms of appropriate scaffold deployment and to compare acute post-implantation behaviour with novolimus-eluting BRS.

 

Design: Consecutive patients undergoing PCI with OCT-guided scaffold implantation from January 2014 to July 2017 were reviewed. Using the very final pullback, the following indexes were calculated: mean and minimal area, residual area stenosis (RAS), incomplete strut apposition (ISA), tissue prolapse, eccentricity index, symmetry index, strut fracture and edge dissection. Longitudinal cross-sections were analysed at 1-mm intervals within the stented lesion. Statistical analysis was carried out using IBM SPSS Statistics (SPSS Statistics 23, IBM Deutschland GmbH, Ehningen, Germany).

 

Results: A total of 98 patients were included. While 79 patients were treated with an DESolve BRS, 19 patients received a Magmaris BRS. Significantly more female patients were enrolled in the Magmaris BRS group (68.4 vs. 36.7%, p=0.01). The patients did not differ significantly with respect to their age (62.0±8.1 vs. 61.7±8.9, p=0.81) and baseline characteristics. Clinical indication was stable angina in most of the cases (66.7 vs. 57.0%, p=0.36). Lesions were of de novo type in all cases. They were typically located in the RCA (47.4 vs. 41.8%, p=0.78). Average BRS diameter (3.1±0.2 vs. 3.1±0.4mm, p=0.91) and length (18.9±4.0 vs. 19.7±5.7mm, p=0.68) were similar in both groups. Post-dilatation was performed in 100% of the cases; pre-dilatation - on the other hand - in only 94.9% of DESolve patients versus 100% in Magmaris BRS group (p=0.33). Maximum post-dilatation balloon inflation pressure (15.4±3,9 vs. 16.6±3.5atm, p=0.29) was akin while similar balloons were used (diameter 3.5±0.3 vs 3.6±0.6mm, p=0.41). Though, in the Magmaris group pre-dilatation (16.5±2.3 vs. 13.7±3.1atm, p<0.001) and BRS deployment pressure were higher (15.1±1.9 vs. 13.4±2.4atm, p<0.001).

OCT analysis did not show a difference in mean scaffold area (7.9±1.5 vs. 7.7±2.3mm2, p=0.54) and lumen area (3.4±0.3 vs. 3.4±0.5mm2, p=0.30). Minimum scaffold diameter, however, varied significantly (2.9±0.2 vs. 2.7±0.4mm, p=0.01). Assessment of geometrical parameters revealed a mean eccentricity index of 0.89±0.20 vs. 0.70±0.10, p<0.001 and a symmetry index of 0.31±0.08 vs. 0.42±0.09, p<0.001. Mean residual area stenosis was 13.5 and 16.6% respectively. More patients in the DESolve group showed a RAS > 20% (p=0.01). OCT showed dissections predominantly in the DESolve group and strut fractures solely. The percentage of malapposed struts was 0.03 vs. 2.3%, p<0.001.

 

Conclusion: OCT showed a good acute mechanical performance of the resorbable magnesium scaffolds. Analysis even showed a favourable outcome with respect to geometrical parameters in comparision to the DESolve group. This might reflect the thorough lesion preparation. We need further outcome data to assess the relevance for daily clinical use.

http://www.abstractserver.de/dgk2018/jt/abstracts//P1746.htm