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Effects of Coronary Artery Revascularization with a Polymer-Free Biolimus A9-Coated BioFreedom Stent Versus Bypass Surgery before Noncardiac Surgery.

ABSTRACT: The present study aimed to evaluate the efficacy and safety of polymer-free drug-coated BioFreedom stent implantation in comparison to coronary artery bypass graft (CABG) before major noncardiac surgery.In a multicenter registry, 55 patients required revascularization before major noncardiac surgery that should not be delayed >6 months. Of them, 27 underwent BioFreedom stent implantation and 28 underwent CABG. Primary outcomes included rate of noncardiac surgery, time from revascularization to noncardiac surgery, and occurrence of composite outcomes (all-cause death, myocardial infarction, stent thrombosis, stroke, repeat revascularization, or major bleeding).The rate of major noncardiac surgery was significantly higher in the BioFreedom group (92.6%) than in the CABG group (64.3%; p=0.027). Time from revascularization to noncardiac surgery was significantly shorter in the BioFreedom group (38.0 days) than in the CABG group (73.0 days; p=0.042). During the hospitalization for revascularization period, the occurrence of primary outcomes did not differ between the groups. However, the BioFreedom group showed a shorter hospitalization period and lower total treatment cost than the CABG group. During the hospital stay for noncardiac surgery, the occurrence of composite outcome was not significantly different between groups (4% vs. 0%; p>0.999): stroke occurred in only 1 case, and there were no cases of death or stent thrombosis in the BioFreedom group.This study demonstrated that BioFreedom stenting as a revascularization strategy before major noncardiac surgery might be feasible and safe in selected patients with less severe coronary artery diseases.

SUBMITTER: Kim K

PROVIDER: S-EPMC5949289 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Effects of Coronary Artery Revascularization with a Polymer-Free Biolimus A9-Coated BioFreedom Stent Versus Bypass Surgery before Noncardiac Surgery.

Kim Kyu K Kim Choongki C Kim Byeong Keuk BK Jang Ji Yong JY Her Ae Young AY Kim Seunghwan S Hong Sung Jin SJ Ahn Chul Min CM Kim Jung Sun JS Ko Young Guk YG Choi Donghoon D Hong Myeong Ki MK Jang Yangsoo Y

Yonsei medical journal 20180601 4

<h4>Purpose</h4>The present study aimed to evaluate the efficacy and safety of polymer-free drug-coated BioFreedom stent implantation in comparison to coronary artery bypass graft (CABG) before major noncardiac surgery.<h4>Materials and methods</h4>In a multicenter registry, 55 patients required revascularization before major noncardiac surgery that should not be delayed >6 months. Of them, 27 underwent BioFreedom stent implantation and 28 underwent CABG. Primary outcomes included rate of noncar ...[more]

PMID: 29749130

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Project description:IntroductionProlonged dual anti-platelet therapy (DAPT) may cause excess bleeding in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT. Data were gathered on the early experience implanting this stent in drug-eluting stent eligible patients deemed to be at high risk of bleeding.Background and methodsThe demographics, procedural data and clinical outcomes were gathered prospectively for 249 patients treated with a BA9-DCS stent at 2 UK centres, and compared to a cohort of patients treated in the same period with drug-eluting stents (PCI-DES).ResultsOperator-defined BA9-DCS indications included warfarin therapy, age, and anaemia. Patients receiving a BA9-DCS were older (71.6±11.8 vs. 64.8±11.6yrs, p<0.001), more often female (38.2 vs. 26.8%, P<0.001), and more likely to have comorbidity including chronic kidney disease or poor LV function than PCI-DES patients. The baseline Mehran bleed risk score was also significantly higher in the BA9-DCS group (19.4±8.7 vs. 13.1±5.8, p<0.001). Of the BA9-DCS cohort, 95.5% of patients demonstrated disease fitting NICE criteria for DES placement. The number of lesions treated (1.81±1.1 vs. 1.58±0.92, p = 0.003), total lesion length (32.1±21.7 vs. 26.1±17.6mm, p<0.001), number of stents used (1.93±1.11 vs. 1.65±1.4, p = 0.007) and total stent length (37.5±20.8 vs. 32.4±20.3, p<0.01) were greater for BA9-DCS patients. DAPT was prescribed for 3.3±3.9 months for BA9-DCS patients and 11.3±2.4 months for PCI-DES patients (p<0.001). At follow up of 392±124 days despite the abbreviated DAPT course stent related event were infrequent with ischemia-driven restenosis PCI (2.8 vs. 3.4%, p = 0.838), and stent thrombosis (1.6 vs. 2.1%, p = 0.265) rates similar between the BA9-DCS ad PCI-DES groups. After propensity scoring all clinical end-points were similar between both cohorts.ConclusionsThis early experience using polymer-free BA9 drug-coated stents in drug-eluting stent type patients at risk of bleeding are encouraging. Further studies are warranted.

Project description:BackgroundWhile thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84-88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES).MethodsIn total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions.ResultsMACE at 2 years occurred in 6.65% CoCr-BP-BES versus 13.23% SS-BP-BES groups (unadjusted HR 0.48 [0.31-0.73]; P=0.0005). Following propensity analysis, 2-year adjusted MACE rates were 7.4% versus 13.3% (HR 0.53 [0.35-0.79]; P=0.004). Definite or probable stent thrombosis, adjudicated using identical criteria in both studies, occurred less frequently with CoCr-BP-BES (1.12% vs. 3.22%; adjusted HR 0.32 [0.11-0.9]; P=0.034). In day-3 landmark analysis, the difference in 2-year MACE was no longer significant but there was a lower patient-orientated composite endpoint (11.7% vs. 18.4%; HR 0.6 [0.43-0.83]; P=0.006) and a trend to lower target vessel failure (5.8% vs. 9.1%; HR 0.63 [0.4-1.00]; P=0.078).ConclusionAt 2-year follow-up, propensity-adjusted analysis showed the thin strut (84-88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114-120um) Biomatrix Flex SS-BP-BES.

Project description:Current guidelines for delaying surgery after coronary stent placement are based on stent type. However, the indication for the stent may be an important risk factor for postoperative major adverse cardiac events (MACE).To determine whether the clinical indication for a coronary stent is associated with postoperative MACE.Retrospective cohort study in patients at US Veterans Affairs hospitals who had a coronary stent placed between January 1, 2000, and December 31, 2010, and underwent noncardiac surgery within the following 24 months. The association between the indication for stent and postoperative MACE rates was examined using logistic regression to control for patient and procedure factors.Three subgroups of stent indication were examined: (1) myocardial infarction (MI); (2) unstable angina; and (3) revascularization not associated with acute coronary syndrome (non-ACS).Composite 30-day postoperative MACE rates including all-cause mortality, MI, or revascularization.Among 26?661 patients (median [IQR] age, 68 [61.0-76.0] years; 98.4% male; 88.1% white) who underwent 41?815 surgical procedures within 24 months following coronary stent placement, the stent indication was MI in 32.8% of the procedures, unstable angina in 33.8%, and non-ACS in 33.4%. Postoperative MACE rates were significantly higher in the MI group (7.5%) compared with the unstable angina (2.7%) and non-ACS (2.6%) groups (P?<?.001). When surgery was performed within 3 months of percutaneous coronary intervention, adjusted odds of MACE were significantly higher in the MI group compared with the non-ACS group (odds ratio [OR]?=?5.25; 95% CI, 4.08-6.75). This risk decreased over time, although it remained significantly higher at 12 to 24 months from percutaneous coronary intervention (OR?=?1.95; 95% CI, 1.58-2.40). The adjusted odds of MACE for the unstable angina group were similar to those for the non-ACS group when surgery was performed within 3 months (OR?=?1.11; 95% CI, 0.80-1.53) or between 12 and 24 months (OR?=?1.08; 95% CI, 0.86-1.37) from stent placement. Stent type was not significantly associated with MACE regardless of indication.Surgery in patients with a coronary stent placed for MI was associated with increased postoperative MACE rates compared with other stent indications. The risk declined over time from PCI, and delaying surgery up to 6 months in this cohort of patients with stents may be important regardless of stent type.

Dataset Information

Effects of Coronary Artery Revascularization with a Polymer-Free Biolimus A9-Coated BioFreedom Stent Versus Bypass Surgery before Noncardiac Surgery.

Publications

Effects of Coronary Artery Revascularization with a Polymer-Free Biolimus A9-Coated BioFreedom Stent Versus Bypass Surgery before Noncardiac Surgery.

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