One-Year Follow-Up Results From the Observational, Multicenter, Prospective, and Controlled Registry: The WALTZ All-Comers Study.

The aim of this study was to evaluate 1-year follow-up results in an all "comers" population treated with a new cobalt chromium bare-metal stent (BMS) design. Since August 2016 to March 2017, 201 (9.7% of screening population) consecutive patients undergoing coronary stent implantation in 11 centers in Argentina were prospectively included in our registry. The inclusion criteria were multiple-vessel disease and/or unprotected left main disease, acute coronary syndromes (ACS) with at least one severe (⩾70%) stenosis in any of major epicardial vessel. In-stent restenosis, protected left main stenosis, or impossibility to receive dual-antiplatelet therapy was an exclusion criterion. Major adverse cardiac events (MACE) were the primary endpoint and included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR); also, all components of the primary endpoint were separately analyzed. Completeness of revascularization was analyzed as post hoc data using residual SYNTAX or ERACI risk scores. Demographic characteristics showed that 6.5% of patients were very elderly, 22.5% have diabetes, 47% have multiple-vessel disease, 67% have ACS, and 32% have ST elevation MI. At a mean of 376 ± 18.1 days of follow-up, MACE was observed in 10.4% of patients: death + MI + cardiovascular accident (CVA) in 3% (6 of 201) and cardiac death + MI + CVA in 1.5% (3 of 201). Residual ERACI score ⩽5 was associated with 98% of event-free survival (P < .04). In conclusion, this prospective, multicenter, and observational all-comers registry with this novel BMS design showed a low incidence of adverse events at 1 year mainly due to coronary restenosis.

Second vs. First generation drug eluting stents in multiple vessel disease and left main stenosis: Two-year follow-up of the observational, prospective, controlled, and multicenter ERACI IV registry.

OBJECTIVE: To compare second generation drug eluting stents (2DES) with first generation (1DES) for the treatment of patients (pts) with multiple coronary vessel disease (MVD). BACKGROUND: Although 2DES improved safety and efficacy compared to 1DES, MVD remains a challenge for percutaneous coronary interventions. METHODS: ERACI IV was a prospective, observational, and controlled study in pts with MVD including left main and treated with 2DES (Firebird 2, Microport). We included 225 pts in 15 sites from Argentina. Primary endpoint was the incidence of major adverse cardiovascular events (MACCE) defined as death, myocardial infarction (MI), cerebrovascular accident (CVA) and unplanned revascularization; and to compare with 225 pts from ERACI III study (1DES). PCI strategy was planned to treat lesions ≥70% in vessels ≥ 2.00 mm, introducing a modified Syntax score (SS) where severe lesions in vessels < 2.0 mm and intermediate lesions were not scored. RESULTS: Baseline characteristics showed that compared to ERACI III, ERACI IV pts had higher number of diabetics (P = 0.02), previous revascularization (P = 0.007), unstable angina IIb/IIIc (P < 0.001) and three vessels/left main disease (P = 0.003). Modified SS was 22.2 ± 11. At 2 years of follow-up ERACI IV group had significantly lower incidence of death+ MI + CVA, (P = 0.01) and MACCE (P = 0.001). MACCE rate was similar in diabetics, (5.8%) and nondiabetics (7.0%). After performing a matched propensity score, MACCE remain significantly lower in ERACI IV (P = 0.005). CONCLUSION: This registry showed that 2DES in MVD has a remarkable low incidence of MACCE in unadjusted and adjusted analysis. © 2016 Wiley Periodicals, Inc.

Second vs. first-generation drug-eluting stents in complex lesions subsets: 3 years' follow-up of ERACI IV study.

BACKGROUND: Although percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES-1) did not show a benefit in terms of death rate and myocardial infarction (MI) compared to bypass surgery (coronary artery bypass graft [CABG]), DES platforms have seen a remarkable improvement in the last few years, and a significant increase in their safety and efficacy was observed in randomized controlled trials and observational studies in comparison with DES-1 in patients with coronary artery disease (CAD). One-year results from the ERACI IV registry using a second-generation DES (DES-2) demonstrated significantly greater efficacy and safety in patients with multiple vessel CAD, including diabetics, compared to DES-1. Long-term results are yet unknown. METHODS: The ERACI IV registry was a multicenter, prospective and controlled open-label study conducted in 9 sites in Argentina during 2013 and 2014, which evaluated a DES-2 for the treatment of patients with multiple vessel CAD including unprotected left main disease (ULMD) and diabetes. The primary endpoint was to compare the composite of death of any cause, MI and cerebrovascular accident (CVA) as hard endpoints with ERACI III DES-1 arm. Secondary endpoints included each component of the primary endpoint and target vessel revascularization (TVR) as major adverse cardiovascular events (MACCE) and stent thrombosis. We include a modified Syntax Score (SS) taking in account functional revascularization, treating lesions ≥70% in vessels ≥ 2.00 mm, whereas severe lesions in vessels < 2.0 mm and intermediate lesions were not rated. RESULTS: Baseline characteristics were similar between groups, with higher numbers of diabetics and 3-vessel/ULMD (P=0.02 and P=0.003, respectively) in ERACI IV. At 34.7 months' follow-up, the incidence of the composite of death/MI/CVA between ERACI IV and ERACI III (4.9% vs. 13.7%, P<0.001); unplanned new revascularization (5.3% vs. 14.2%, P<0.001) and MACCE (9.3% vs. 22.7%, P<0.001), were significantly lower in ERACI IV DES-2. MACCE rate was similar in diabetics, (5.8%) and nondiabetics (7.0%). After performing a matched propensity score, MACCE remain significantly lower in ERACI IV (P = 0.005). Incidence of stent thrombosis was lower although not significantly between groups, (0.9% vs. 3.1% in ERACI IV and III, respectively; P=0.13). CONCLUSIONS: The use of DES-2 in patients with complex lesions subsets together with a functional PCI strategy were associated with a remarkable low incidence of adverse events at 3 years' follow-up and the benefit was also seen in in diabetic population. Late outcome of this study strongly validated our lesion PCI scoring and assessment.