Regional differences in PCI practice and clinical outcomes among patients with diabetes mellitus enrolled in a contemporary world-wide registry
Authors: Roffi M 
Published: November 2020

Abstract

Background
Diabetes mellitus (DM) is a major risk factor for coronary artery disease (CAD) and PCI. Little is known about differences in PCI patterns and outcomes among DM patients across the globe.

Purpose
We aimed to determine differences in clinical outcomes and PCI practices among DM patients undergoing contemporary PCI across the continents.

Methods
e-Ultimaster is a prospective worldwide registry that enrolled 36; 671 patients and 1-year follow-up is currently available for 94,2% of the patients. All underwent PCI with a thin strut sirolimus-eluting stent with abluminal biodegradable polymer. This abstract focus on the DM population. Primary endpoint was target lesion failure (TLF) at 1-year (cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization). A Clinical Event Committee adjudicated all endpoint-related adverse events. Patients were divided according to four regions of enrolment: Europe (EU), Asia (A), Africa/Middle East (A/ME), and Mexico/South America (M/SA).

Results
The prevalence of DM in e-Ultimaster ranged from 24.3% in E to 47.5% in A/ME. Among 9709 DM patients, 60% were enrolled in EU, 21% in A, 11% in A/ME and 8% in M/SA. Mean age ranged from 61.7 year in A as well as A/ME to 67.5 years in EU. The highest proportion of insulin requiring DM was found in A/ME (32.4%). Presentation with acute coronary syndromes ranged from 49% in A/ME to 55.6% in M/SA. The rate of primary endpoint (TLF) at one year was 4.2%. Definite/probable stent thrombosis (ST) occurred in 0.7% of at 1-year. Independent predictors of TLF included age, insulin-requiring DM, renal failure, previous PCI, number of lesions identified, presence of ACC/AHA type C lesions, treatment of left main lesions, treatment of bifurcation lesions, and number of stents implanted. Independent predictors of definite/probable ST included male gender, renal failure, history of MI, ST-elevated MI at presentation and number of lesions identified. TLF occurred in 2.1% in A/ME, 3.1% in A, 4.4% in M/SA and 5.0% in E. Definite/probable ST was lowest in A (0.3%) and A/ME (0.4%) and highest in M/SA and EU (both 0.9%).
Penetration of radial access ranged from 86.0% in EU to 56.9% in A/ME. The use of intravascular imaging ranged from 3.9% in EU to 30.3% in A. Use of dual antiplatelet therapy (DAPT), left at the discretion of the operator, was lowest in EU (92.9% at 3 months; 63.8% at 1 year) and highest in A (94.5% at 3 months; 82.6% at 1 year).

Conclusions
The analysis on more than 9000 DM patients treated with the same contemporary stent within a world-wide registry with defined inclusion/exclusion criteria and adjudicated clinical events showed favourable clinical outcomes at one year and detected major differences in patient characteristics, PCI pattern, DAPT prescription and clinical outcomes across continents. Data on the entire e-Ultimaster DM population will be available for ESC.

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Terumo Europe