Application of the MADS classification system in a “mega mammoth” stent trial: Feasibility and preliminary clinical implications
Objectives and Background: We attempted to test the feasibility of application of the MADS classification system in the largest stent trial to date and evaluate the preliminary clinical implications of this approach. Methods: In the randomized GLOBAL LEADERS trial, testing two different antiplatelet strategies in patients undergoing PCI with bivalirudin and biolimus-eluting stents, the e-CRF was dedicated to bifurcation treatment according to the MADS classification. Based on this e-CRF, the techniques used for bifurcations treatment in GLOBAL LEADERS were described and compared with two large, all-comer registries of bifurcations treatment (I-BIGIS and COBIS), used as historical controls. Results: Among 15,991 patients enrolled in the trial, 22,957 lesions treated at the index and staged procedure were available for analysis and 2,765 of these lesions were bifurcations. The e-CRF-based MADS classification was achieved in 2,759 of these lesions (99.8%). 80.3% of bifurcations were treated using a single stent, 18.8% using 2 stents and 1% using 3 stents. Overall, the “main across side first” approach (A) was used in 77.4% with the “side branch first” approach (S) being the second most frequently used technique (10.2%). A single stent was used in the majority of the “A” approach (88%). A reduction in the use of 2-stent techniques (from 33.9 to 18.8%) was observed between GLOBAL LEADERS and I-BIGIS. The “A” approach was the most frequently used technique in GLOBAL LEADERS, while in COBIS the “S” strategy was most frequently employed. Conclusions: Application of the MADS classification through an e-CRF was feasible in the largest stent trial today and provided useful information about the trends observed overtime in the treatment of bifurcation lesions.