ABC | Volume 112, Nº1, January 2019

Original Article Quintella et al FFR-versus angiography-guided PCI in multivessel disease Arq Bras Cardiol. 2019; 112(1):40-47 Objectives To assess the occurrence of MACE and CE of FFR, compared with angiographic criteria for patients with multivessel diseases undergoing PCI. Methods Prospective, randomized, clinical study on PCI in 70 patients with multivessel disease attending Pedro Ernesto University Hospital of the Federal University of Rio de Janeiro and Aloysio Castro Institute of Cardiology between April 2011 and May 2016. Patients were randomized using computer-generated random numbers (R software, 2.11) to: 1. FFRmeasurements of significant lesions and PCI with stent implantation for lesions with FFR < 0.75 (FFR group); 2. PCI with stent implantation for stenosis > 60% by visual assessment with angiography (ANGIO group). Each computer-generated number corresponded to one group. The numbers were put into opaque, sealed envelopes, which were sequentially opened for each patient recruited for the study by an independent person who was unaware of the allocation. Sample size was calculated using Epi-Info software, version 3.4, considering a power (1- β ) of 80% and 95% confidence interval. An estimated 17% difference in the costs between the two groups was used for calculation of the sample size required to reach statistically significant difference. The sample size calculated was 200 (100 for each group); however, due to financial constraints, the number of patients included was 70. Population Patients aged 21 years or older with stablemultivessel disease or at day 7 after acute coronary syndrome (ACS), with at least one moderate stenosis (>60%) without severe left ventricular dysfunction, and with NIT for ischemia, were divided into two groups (Table 1). In group 1 (FFR, n = 34), PCI was performed for FFR < 0.75, whereas in group 2 (ANGIO, n = 35), patients underwent PCI with stent implantation in all significant lesions. One patient was lost to follow-up, and a total of 69 patients were studied. Dual antiplatelet therapy (DAPT) was used for at least 6 months. Patients were assessed at 30 days, six months and one year of follow-up (Table 2). At six months, NIT and coronary angiography were performed in symptomatic or ischemic patients; FFR measurements were performed again in the first group, and restenosis was treated according to the course of disease. Cost-effectiveness We used the CE model proposed in the Brazilian study by Polanczyk et al. 10 CE outcome measure was “one-year restenosis-free survival”. Effectiveness analysis Estimates were obtained from the literature, 10 and the cost of procedure index calculated under the perspective of the Brazilian Unified Health System (SUS). We analyzed the mean costs of each intervention, considering SUS’s reimbursement to the hospitals. For each intervention, we calculated expected costs and the clinical outcomes described above. Statistical analysis Data were described as frequency, mean and standard deviations, andmedian and interquartile ranges. TheKruskal-Wallis test was used for outcome comparisons between the groups, and the Pearson’s chi-square test or Fisher’s exact test was used for comparisons of dichotomous variables. Logistic regression was used to analyze the association between independent variables andoutcomes. Kaplan-Meier survival curveswere constructed and compared by log-rank test. Survival was analyzed by bivariate and multivariate Cox regression analysis. SATAT 14 (SATA Inc) software was used for analysis. The level of significancewas set at p≤0.05%. All tests were two-tailed. Results Patients’ characteristics are described in Table 1. Most patients had a stable disease, or those with ACS patients were asymptomatic for 7 days. MACEs were reported by 12 patients (17.3%) – 6 patients (17.1%) in FFR group and 6 patients (17.1%) in ANGIO group. Three deaths occurred, 2 (2.8%) in the FFR group and 1 (1.4%) in the ANGIO group (AMI, without DAPT discontinuation). Nine (13.0%) had angina, 4 (5.7%) in FFR group and 5 (7.2%) in the ANGIO group (Figure 1). In the 4 patients of the FFR group, based on FFR measurements, 2 patients did not require a second PCI and continued in medical treatment. In the other 2 patients, intra‑stent restenosis was confirmed, and these patients were treated with pharmacological stents (PS), with satisfactory results. In group 2, one symptomatic patient with mild apical ischemia (according to scintigraphy), continued on medical treatment despite restenosis of marginal branch, but without restenosis of right coronary artery (Table 3). Event-free survival curve in the study population and by groups during the 18-month period of follow-up is depicted in Figure 2. Angiographic results In the analysis by group, no difference was observed in the number of lesions evaluated (vessels that require treatment) between the groups. There was a balanced distribution of lesions between anterior descending artery, circumflex artery and right coronary artery. Lesions by study group No difference was found in the number of stents per patient, with a mean of 1.0 ± 0.2 stents per lesion in the ANGIO group, and 0.4 ± 0.5 in the FFR group (p = 0.0001) (Kruskal-Wallis), i.e. a 50% reduction. The number of lesions treated in ANGIO group was 65% greater than in FFR group. On the other hand, 45% of lesions analyzed in FFR were treated. In ANGIO group, stent implantation per patient was more than twice the number observed in FFR group (1.1 vs. 2.2 stents /patient). Characteristics of the lesions were assessed by angiographic quantification. In group 1, FFR were measured before and after procedure (Table 4). 41