Planned angiographic control versus clinical follow-up for patients with unprotected left main stem stenosis treated with second generation drug-eluting stents: A propensity score with matching analysis from the FAILS (failure in left main with second generation stents-Cardiogroup III Study).

BACKGROUND: The value of angiographic follow-up in unprotected left main (ULM) stenting remains undefined. METHODS: The FAILS-2 registry included consecutive patients presenting with a critical lesion of an ULM treated with second generation drug eluting stents in 6 centers from June 2007 to January 2015. Patients were stratified into two groups: those discharged with planned angiographic follow-up and those with clinical follow-up. MACE (Major Adverse Clinical Events, a composite end point of death, myocardial infarction, TLR, and ST) was the primary end point, while each component was a secondary endpoint Sensitivity analysis was performed for patients treated with a provisional or a two-stent strategy. A propensity score analysis was used to compare the outcomes in the two groups. RESULTS: After multivariate adjustment, 220 patients per group were selected. Planned angiographic follow up was performed after a median of 7 (6-10) months. After 16 (14-21) months, rates of MACE were similar between the two groups (24 vs. 21%, P = 0.29) with lower rates of all cause and cardiovascular death in the angiographic control group (6 vs. 14%, P = 0.01 and 3 vs. 6%, P = 0.04) but with higher rates of TLR (15 vs. 5%, P < 0.001). The same trend was seen irrespective of the stent strategy. CONCLUSION: planned angiographic control results in more TLR but may reduce mortality. These findings need to be confirmed by adequately powered randomized controlled trial.

Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: A propensity matched analysis.

AIMS: There is uncertainty on which stenting approach confers the best long-term outlook for unprotected left main (ULM) bifurcation disease. METHODS AND RESULTS: This is a non-randomized, retrospective study including all consecutive patients with 50% stenosis of the left main involving at least 1 of the arteries stemming from the left main treated with drug-eluting stents (DES) in 9 European centers between 2002 and 2004. Patients were divided into two groups: those treated with provisional stentings vs. those treated with two stent strategy. The outcomes of interest were 10-year rates of target lesion revascularization (TLR), major adverse cardiac events (MACE), and their components (cardiovascular death, myocardial infarction [MI], or repeat revascularization), along with stent thrombosis (ST). A total of 285 patients were included, 178 (62.5%) in the provisional stenting group and 87 (37.5%) in the two stent group. After 10 years, no differences in TLR were found at unadjusted analysis (19% vs 25%, p>0.05) nor after propensity score matching (25% vs 28%, p>0.05). Similar rates of MACE (60% vs 66%, p>0.05), death (34% vs 43%, p>0.05), MI (9% vs 14%, p>0.05) and ST were also disclosed at propensity-based analysis. CONCLUSION: Even after 10 year follow-up, patients treated with provisional stenting on left main showed comparable rates of target lesion revascularization compared to two stent strategy.

Long-Term (≥10 Years) Safety of Percutaneous Treatment of Unprotected Left Main Stenosis With Drug-Eluting Stents.

Percutaneous coronary intervention (PCI) of unprotected left main disease (ULM) with drug-eluting stents (DES) is hampered by lack of information on long-term (≥10 years) safety data. All patients treated with PCI on ULM in 9 international centers with at least 10 years follow-up were enrolled. Baseline and procedural features were recorded. Repeat PCI (re-PCI) on ULM at 10 years was the primary end point. Secondary end points included major adverse cardiac events and its components (cardiac and noncardiac death, myocardial infarction, re-PCI not on ULM, and stent thrombosis). Sensitivity analysis was performed according to the presence of isolated ULM disease: 284 patients were enrolled. A total of 70 patients (21%) performed a re-PCI on ULM, 39 in the first year, and 31 between 1 and 10 years (only 5 overall performed for acute coronary syndrome). Patients with re-PCI on ULM did not show differences in baseline and procedural features, or experience higher rates of cardiovascular death (12% vs 11%, p 0.65), myocardial infarction (11% vs 6%, p 0.56), or of re-PCI on non-ULM disease (31% vs 27%, p 0.76) compared with those without re-PCI on ULM. At Kaplan-Meier analysis, patients with PCI in other coronary vessels were at higher risk of major adverse cardiac events, driven by target vessel revascularization (20.4% vs 32.9%, p 0.009), as confirmed at multivariate analysis (stenosis other than LM; hazard ratio 2, 1.4 to 2.7, all CI 95%). In conclusion, despite of using first-generation stents, PCI on ULM is safe, with low rates of recurrent events due to index revascularization. Progression of atherosclerotic lesions on other coronary vessels represents the only independent predictive factor for prognosis.