Application of the MADS classification system in a “mega mammoth” stent trial: Feasibility and preliminary clinical implications

Abstract

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, 22,921 lesions treated at the index and staged procedure were available for analysis and 2,757 of these lesions were bifurcations and 7 were trifurcation lesions. The e‐CRF‐based MADS classification was achieved in 2,757 of these lesions (100%). 80.3% of bifurcations were treated using a single stent, 18.9% using 2 stents and 0.7% 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 (87.9%). A reduction in the use of 2‐stent techniques (from 33.9 to 18.9%) 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.

European Bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions

“…In 2008, the EBC organized a dedicated international task force led by Yves Louvard (with Ran Kornowski's significant contribution) that conceived a classification based on the position of the first stent and was called “MADS” (main vessel or across side branch or double lumen in proximal main vessel or side branch) 10 . The efficacy of this classification for reporting technique during procedures has recently been confirmed by the large (more than 15,000 patients) GLOBAL LEADERS trial 19 . During the past decade some techniques have been abandoned or proven not effective, others have been refined.…”

Clinical relevance of ticagrelor monotherapy following 1‐month dual antiplatelet therapy after bifurcation percutaneous coronary intervention: Insight from GLOBAL LEADERS trial

“…The MADS classification classifies different stenting techniques according to which segment is initially stented; main proximal first (M), main across side first (A), distal first (D), and side branch first (S), and how many stents are used. In the GLOBAL LEADERS trial, the dedicated electronic case record form (e-CRF) based MADS classification was achieved in all sitereported bifurcation lesions, which represents a unique opportunity to analyze complete case study stratified for presence of bifurcation within the large contemporary PCI trial (9).…”