Impact of dual antiplatelet therapy duration on clinical outcome after coronary bifurcation stenting: results from the euro bifurcation club registry

BACKGROUND: Optimal duration of Dual Antiplatelet Therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. METHODS: We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of Major Adverse Cardiac and Cardiovascular Events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as BARC ≥ 3 were evaluated too. RESULTS: Patients were divided into 3 groups: Short DAPT (<6-months, n=375); Standard DAPT (≥6-months but ≤12-months, n=636); Prolonged DAPT (>12- months, n=1273). At 24 months follow-up MACCE-free survival was significantly lower in Short DAPT patients (Log-Rank: 45.23, p for trend <0.001). MACCE occurred less frequently in the Prolonged DAPT group (148 (11.6%)) as compared with both the Short (83 (22.1%) HR:0.48 (0.37-0.63), p<0.001) and Standard DAPT groups (137 (21.5%) HR:0.51 (0.41-0.65), p<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 (0.20-0.36) and HR: 0.44 (0.34-0.57)). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC ≥ 3 bleedings were 0.3% in the Standard DAPT, 1.6% in Short and 1.9% in Prolonged DAPT groups. CONCLUSIONS: In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.

Mid term outcomes after percutaneous interventions in coronary bifurcations

BACKGROUND: The optimal treatment of patients undergoing percutaneous coronary interventions (PCI) for lesions located at coronary bifurcations is still debated. METHODS: Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centers between January 2012 and December 2014 were collected. RESULTS: Follow-up at a median 18 months (IQR 11-28) was available for 4506 patients (89%). Major Adverse Cardiac Events (MACE) occurred in 395 patients (8.8%): cardiac death in 152 (3.4%), myocardial infarction, excluding periprocedural, in 156 (3.5%) and stent thrombosis in 110 cases (2.4%). At multivariable Cox regression, left ventricular ejection fraction ≤30% (P < 0.001), bail-out stenting (beyond a planned strategy of either single or double stenting) (P < 0.001), admission for an acute coronary syndrome (P < 0.001), age >66 years (P < 0.001), multivessel disease (P < 0.001) and diabetes (P < 0.001) were independently associated with MACE. Sensitivity analysis identified premature discontinuation of dual antiplatelet therapy (DAPT) (P < 0.001) and side branch (SB) lesion length ≥9 mm (P < 0.05) as additional independent predictors of MACE. CONCLUSIONS: Beyond traditional risk factors, multivessel disease, the length of the SB lesion, "bail-out" stenting and premature DAPT discontinuation are independent predictors of mid-term MACE after PCI of coronary bifurcations. This highlights the importance of a carefully planned PCI strategy and adequate therapy adherence to improve the clinical outcomes in these patients. (AU)

Procedural and early clinical outcomes of patients withde novo coronary bifurcation lesions treated with the novelNile PAX dedicated bifurcation polymer-free paclitaxelcoated stents: results from the prospective, multicentre,non-randomised BIPAX clinical trial

Aims: To demonstrate the acute and early outcomes of the novel Nile PAX dedicated polymer-free paclitaxelcoatedstents (Minvasys SAS, Gennevilliers, France) in the treatment of de novo coronary bifurcation lesions.Methods and results: The Nile PAX device incorporates a cobalt-chromium alloy with a side aperture inthe mid-stent designed to optimise scaffold at the bifurcation carina and side branch (SB) ostium, while maintainingSB access during procedure. From December 2008 to February 2010, 101 patients were prospectivelyenrolled in a non-randomised, multicentre study. Lesion criteria were: vessel size 2.5-3.5 mm in the parentvessel (PV) and 2.0-3.0 mm in the SB, and lesion length <14 mm in the PV, and <5 mm in the SB. Mean agewas 63 years, 29% had diabetes, LAD/Dg was involved in 80.4%, and 61.7% had significant involvement ofboth branches. The study stent was successfully attempted and implanted in 98%. SB received additionalstent in 26%; final kissing-balloon inflation was performed in 93%; and lesion (angiographic) success wasachieved in 98%. There was only one non-Q myocardial infarction during hospitalisation, and no additionalevents up to 30 days.Conclusions: Preliminary results of the prospective, non-randomised, multicentre BIPAX clinical trial demonstratedencouraging results with the novel Nile PAX bifurcation DES in the treatment of coronary bifurcationlesions, including high device and procedural success. Overall, there was only one major adverse cardiac eventduring hospitalisation, with no additional events up to 30 days follow-up. Long-term follow-up is warranted.