Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis.

AIM: To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). METHODS AND RESULTS: In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69-1.52, and HR: 1.24, 95% CI: 0.79-1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71-1.15, and HR: 0.91, 95% CI: 0.69-1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT. CONCLUSION: In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity. CLINICAL TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.

Impact of peripheral artery disease on prognosis after percutaneous coronary intervention: Outcomes from the multicenter prospective e-ULTIMASTER registry.

BACKGROUND AND AIMS: Patients with peripheral artery disease (PAD) represent a high risk group, and have an increased risk of cardiovascular events and worse cardiovascular outcomes. Our aim was to study the impact of PAD among patients undergoing percutaneous coronary intervention (PCI) with a newer-generation thin-strut DES. METHODS: In this analysis of the e-ULTIMASTER registry, patients with and without known PAD undergoing PCI were compared. A propensity-score was used to adjust for differences between the groups. The primary outcome was target lesion failure (TLF): a composite of cardiac death, target-vessel related myocardial infarction, and/or clinically driven target lesion revascularization at 1-year follow-up. RESULTS: Of 33,880 patients included in the analysis, PAD was present in 2255 (6.7%). Patients with PAD were older (69.0 ± 10.0 vs. 63.8 ± 11.3 years) with a higher burden of comorbidities. Patients with PAD were less likely to present with STEMI (9.6% vs. 21%), and more likely to undergo complex PCI (left main 5.5% vs. 3.0% ostial lesions 10.4% vs. 7.0%, bifurcations 14.5% vs. 12.3% and calcification 26.8% vs. 17.8%). PAD was found to be independently associated with 41% increased risk for TLF. The risk for all cause death and for cardiac death was 75% and 103% higher, respectably. No difference was found in the rates of stent thrombosis, clinically driven target lesion revascularization, or myocardial infarction (MI). CONCLUSIONS: Patients with PAD are at higher risk for (cardiac) death post PCI, but not target vessel or lesion repeat revascularizations. The PAD cohort represents a population with a higher risk clinical profile. Further research combining medical and device therapies is needed to further improve the outcomes in this high-risk population.

Complete revascularization optimizes patient outcomes in multivessel coronary artery disease: Data from the e-Ultimaster registry.

OBJECTIVES: The aim of this analysis was to assess the effect of the coronary revascularization strategy during index admission on clinical outcomes among patients undergoing percutaneous coronary intervention (PCI) with multivessel coronary artery disease (MVD). BACKGROUND: The value of complete revascularization (CR) over incomplete revascularization (IR) in MVD patients is not fully established. METHODS: Patients with MVD defined as ≥2 major epicardial vessels with ≥50% stenosis were selected from the observational all-comer e-Ultimaster registry. Patients were treated with a sirolimus-eluting thin-strut coronary stent. Completeness of revascularization was physician assessed at the index procedure or an eventually staged procedure during the index hospitalization. Outcomes measures at 1 year were target lesion failure (TLF) (composite of cardiac death, target vessel-related myocardial infarction [MI], and clinically driven target lesion revascularization [TLR]), and patient-oriented composite endpoint (POCE) (all-cause mortality, MI, or revascularization). The inverse probability of treatment weights (IPTW) methodology was used to perform a matched analysis. RESULTS: The registry recruited 37,198 patients of whom 15,441 (41.5%) had MVD. CR on hospital discharge was achieved in 7413 (48.0%) patients and IR in 8028 (52.0%) patients. Mean age was 64.6 ± 11.1 versus 65.7 ± 11.0 years (p < 0.01), male gender 77.9% and 77.3% (p = 0.41) and diabetes 31.3% versus 33.4% (p = 0.01) for CR and IR, respectively. Chronic stable angina patients more commonly underwent CR (47.6% vs. 36.8%, p < 0.01). After propensity weighted analysis, 90.5% of CR patients were angina-free at 1 year compared with 87.5% of IR patients (p < 0.01). TLF (3.3% vs. 4.4%; p < 0.01), POCE (6.8% vs. 10.8%; p < .01), and all-cause mortality (2.3% vs. 3.1%; p < .01) were all lower in CR patients. CONCLUSIONS: A physician-directed use of a CR strategy utilizing sirolimus-eluting thin-strut stent results in optimized clinical outcomes and less angina in an all-comer population. Our findings suggest that a CR should be aimed for.