Skip to main content
Top
Published in: BMC Cardiovascular Disorders 1/2018

Open Access 01-12-2018 | Research article

Three-years outcomes of diabetic patients treated with coronary bioresorbable scaffolds

Authors: Remzi Anadol, Katharina Schnitzler, Liv Lorenz, Melissa Weissner, Helen Ullrich, Alberto Polimeni, Thomas Münzel, Tommaso Gori

Published in: BMC Cardiovascular Disorders | Issue 1/2018

Login to get access

Abstract

Background

Diabetes is among the strongest predictors of outcome after coronary artery stenting and the incidence of negative outcomes is still high in this specific group. Data of long-term outcomes comparing diabetic patients with non-diabetic patients treated with bioresorbable scaffolds are still incomplete. This work evaluates the long-term outcomes after implantation of a coronary bioresorbable scaffold (BRS) in diabetic patients compared to non-diabetics.

Methods

Patients who received at least one Absorb BRS in the time of May 2012 to December 2014 were enrolled into this single-center registry. Quantitative coronary angiography (QCA) was performed.

Results

Six hundred fifty seven patients including 138 patients (21%, mean age 65 ± 11, 78% male) with diabetes were enrolled.
Patients in the diabetic group were significantly older, were more likely to suffer from hypertension and hyperlipidemia and had more often a prior stroke or TIA as well as a reduced renal function (all P < 0.05). The initial stenosis was less severe in the diabetic group (74.8% vs. 79.6%, P = 0.036), but the residual stenosis after BRS implantation exceeded that of the control group (16.7% vs. 13.8%, P = 0.006).
History of diabetes had no impact on the incidence of events within one year after BRS implantation. Beyond 1 year, diabetic patients had a higher incidence of cardiovascular death (6.9 vs. 1.4%, HR:5.37 [1.33–21.71], P = 0.001), scaffold restenosis (17.6 vs. 7.8%, HR:3.56 [1.40–9.05], P < 0.0001) and target lesion revascularization (P = 0.016). These results were confirmed in the propensity score analysis.
In both diabetics and non-diabetics, there was a strong association (HR:18.6 [4.7–73.3]) between the risk of restenosis and the technique used at implantation; in contrast, the impact of vessel size was more manifest in non-diabetics than in diabetic patients, and an increased risk of restenosis was demonstrated for both large and small vessels.

Conclusion

As for metal stents, beyond one year after implantation, diabetes was associated with an increased incidence of scaffold restenosis and related outcomes. This negative impact of diabetes was reset when an optimal implantation technique was used.
Appendix
Available only for authorised users
Literature
1.
go back to reference Ritsinger V, Saleh N, Lagerqvist B, Norhammar A. High event rate after a first percutaneous coronary intervention in patients with diabetes mellitus: results from the Swedish coronary angiography and angioplasty registry. Circulation Cardiovascular interventions. 2015;8(6):e002328.CrossRefPubMed Ritsinger V, Saleh N, Lagerqvist B, Norhammar A. High event rate after a first percutaneous coronary intervention in patients with diabetes mellitus: results from the Swedish coronary angiography and angioplasty registry. Circulation Cardiovascular interventions. 2015;8(6):e002328.CrossRefPubMed
2.
go back to reference Akin I, Bufe A, Eckardt L, Reinecke H, Senges J, Richardt G, et al. Comparison of outcomes in patients with insulin-dependent versus non-insulin dependent diabetes mellitus receiving drug-eluting stents (from the first phase of the prospective multicenter German DES.DE registry). Am J Cardiol. 2010;106(9):1201–7.CrossRefPubMed Akin I, Bufe A, Eckardt L, Reinecke H, Senges J, Richardt G, et al. Comparison of outcomes in patients with insulin-dependent versus non-insulin dependent diabetes mellitus receiving drug-eluting stents (from the first phase of the prospective multicenter German DES.DE registry). Am J Cardiol. 2010;106(9):1201–7.CrossRefPubMed
3.
go back to reference Windecker S, Kolh P, Alfonso F, Collet J-P, Cremer J, Falk V, et al. 2014 ESC/EACTS guidelines on myocardial revascularizationThe task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35(37):2541–619.CrossRefPubMed Windecker S, Kolh P, Alfonso F, Collet J-P, Cremer J, Falk V, et al. 2014 ESC/EACTS guidelines on myocardial revascularizationThe task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35(37):2541–619.CrossRefPubMed
4.
go back to reference Serruys PW, Garcia-Garcia HM, Onuma Y. From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J 2012;33(1):16-25b. Serruys PW, Garcia-Garcia HM, Onuma Y. From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J 2012;33(1):16-25b.
5.
go back to reference Kwon JS, Kim YS, Cho AS, Kim JS, Jeong SY, Hong MH, et al. Origin of restenosis after drug-eluting stent implantation in hyperglycemia is inflammatory cells and thrombus. J Atheroscler Thromb. 2011;18(7):604–15.CrossRefPubMed Kwon JS, Kim YS, Cho AS, Kim JS, Jeong SY, Hong MH, et al. Origin of restenosis after drug-eluting stent implantation in hyperglycemia is inflammatory cells and thrombus. J Atheroscler Thromb. 2011;18(7):604–15.CrossRefPubMed
6.
go back to reference Onuma Y, Sotomi Y, Shiomi H, Ozaki Y, Namiki A, Yasuda S, et al. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016;12(9):1090–101.CrossRefPubMed Onuma Y, Sotomi Y, Shiomi H, Ozaki Y, Namiki A, Yasuda S, et al. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016;12(9):1090–101.CrossRefPubMed
7.
go back to reference Ali ZA, Gao RF, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, et al. Three-year outcomes with the absorb Bioresorbable scaffold: individual-patient-data meta-analysis from the ABSORB randomized trials. Circulation. 2017. Ali ZA, Gao RF, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, et al. Three-year outcomes with the absorb Bioresorbable scaffold: individual-patient-data meta-analysis from the ABSORB randomized trials. Circulation. 2017.
8.
go back to reference Wykrzykowska JJ, Kraak RP, Hofma SH, van der Schaaf RJ, Arkenbout EK, IJ AJ, et al. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med. 2017;376(24):2319–28.CrossRefPubMed Wykrzykowska JJ, Kraak RP, Hofma SH, van der Schaaf RJ, Arkenbout EK, IJ AJ, et al. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med. 2017;376(24):2319–28.CrossRefPubMed
9.
go back to reference Ellis SG, Steffenino G, Kereiakes DJ, Stone GW, van Geuns RJ, Abizaid A, et al. Clinical, angiographic, and procedural correlates of acute, subacute, and late absorb scaffold thrombosis. JACC Cardiovasc Interv. 2017;10(18):1809–15.CrossRefPubMed Ellis SG, Steffenino G, Kereiakes DJ, Stone GW, van Geuns RJ, Abizaid A, et al. Clinical, angiographic, and procedural correlates of acute, subacute, and late absorb scaffold thrombosis. JACC Cardiovasc Interv. 2017;10(18):1809–15.CrossRefPubMed
10.
go back to reference Polimeni A, Weissner M, Schochlow K, Ullrich H, Indolfi C, Dijkstra J, et al. Incidence, clinical presentation, and predictors of clinical restenosis in coronary Bioresorbable scaffolds. JACC Cardiovasc Interv. 2017;10(18):1819–27.CrossRefPubMed Polimeni A, Weissner M, Schochlow K, Ullrich H, Indolfi C, Dijkstra J, et al. Incidence, clinical presentation, and predictors of clinical restenosis in coronary Bioresorbable scaffolds. JACC Cardiovasc Interv. 2017;10(18):1819–27.CrossRefPubMed
11.
go back to reference Wiebe J, Gilbert F, Dorr O, Liebetrau C, Wilkens E, Bauer T, et al. Implantation of everolimus-eluting bioresorbable scaffolds in a diabetic all-comers population. Catheter Cardiovasc Interv. 2015;86(6):975–81.CrossRefPubMed Wiebe J, Gilbert F, Dorr O, Liebetrau C, Wilkens E, Bauer T, et al. Implantation of everolimus-eluting bioresorbable scaffolds in a diabetic all-comers population. Catheter Cardiovasc Interv. 2015;86(6):975–81.CrossRefPubMed
12.
go back to reference Kereiakes DJ, Ellis SG, Kimura T, Abizaid A, Zhao W, Veldhof S, et al. Efficacy and safety of the absorb Everolimus-eluting Bioresorbable scaffold for treatment of patients with diabetes mellitus. JACC Cardiovasc Interv. 2017;10(1):42–9.CrossRefPubMed Kereiakes DJ, Ellis SG, Kimura T, Abizaid A, Zhao W, Veldhof S, et al. Efficacy and safety of the absorb Everolimus-eluting Bioresorbable scaffold for treatment of patients with diabetes mellitus. JACC Cardiovasc Interv. 2017;10(1):42–9.CrossRefPubMed
13.
go back to reference Capranzano P, Capodanno D, Brugaletta S, Latib A, Mehilli J, Nef H, et al. Clinical outcomes of patients with diabetes mellitus treated with absorb bioresorbable vascular scaffolds: a subanalysis of the European multicentre GHOST-EU registry. Catheter Cardiovasc Interv. 2018;91(3):444-53. Capranzano P, Capodanno D, Brugaletta S, Latib A, Mehilli J, Nef H, et al. Clinical outcomes of patients with diabetes mellitus treated with absorb bioresorbable vascular scaffolds: a subanalysis of the European multicentre GHOST-EU registry. Catheter Cardiovasc Interv. 2018;91(3):444-53.
14.
go back to reference Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, et al. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014;7(5):482–93.CrossRefPubMed Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, et al. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014;7(5):482–93.CrossRefPubMed
15.
go back to reference Markovic S, Kugler C, Rottbauer W, Wohrle J. Long-term clinical results of bioresorbable absorb scaffolds using the PSP-technique in patients with and without diabetes. J Interv Cardiol. 2017;30(4):325–30.CrossRefPubMed Markovic S, Kugler C, Rottbauer W, Wohrle J. Long-term clinical results of bioresorbable absorb scaffolds using the PSP-technique in patients with and without diabetes. J Interv Cardiol. 2017;30(4):325–30.CrossRefPubMed
16.
go back to reference Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol. 2016;67(8):921–31.CrossRefPubMed Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol. 2016;67(8):921–31.CrossRefPubMed
17.
go back to reference Gori T, Schulz E, Hink U, Kress M, Weiers N, Weissner M, et al. Clinical, angiographic, functional, and imaging outcomes 12 months after implantation of drug-eluting Bioresorbable vascular scaffolds in acute coronary syndromes. JACC Cardiovasc Interv. 2015;8(6):770–7.CrossRefPubMed Gori T, Schulz E, Hink U, Kress M, Weiers N, Weissner M, et al. Clinical, angiographic, functional, and imaging outcomes 12 months after implantation of drug-eluting Bioresorbable vascular scaffolds in acute coronary syndromes. JACC Cardiovasc Interv. 2015;8(6):770–7.CrossRefPubMed
18.
go back to reference Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344–51.CrossRefPubMed Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344–51.CrossRefPubMed
19.
go back to reference Anadol R, Gori T. The mechanisms of late scaffold thrombosis. Clin Hemorheol Microcirc. 2017. Anadol R, Gori T. The mechanisms of late scaffold thrombosis. Clin Hemorheol Microcirc. 2017.
20.
go back to reference Anadol R, Lorenz L, Weissner M, Ullrich H, Polimeni A, Munzel T, et al. Characteristics and outcome of patients with complex coronary lesions treated with bioresorbable scaffolds three years follow-up in a cohort of consecutive patients. EuroIntervention. 2017. Anadol R, Lorenz L, Weissner M, Ullrich H, Polimeni A, Munzel T, et al. Characteristics and outcome of patients with complex coronary lesions treated with bioresorbable scaffolds three years follow-up in a cohort of consecutive patients. EuroIntervention. 2017.
21.
go back to reference Kitahara H, Okada K, Kimura T, Yock PG, Lansky AJ, Popma JJ, et al. Impact of stent size selection on acute and long-term outcomes after drug-eluting stent implantation in De novo coronary lesions. Circ Cardiovasc Interv. 2017;10(10) Kitahara H, Okada K, Kimura T, Yock PG, Lansky AJ, Popma JJ, et al. Impact of stent size selection on acute and long-term outcomes after drug-eluting stent implantation in De novo coronary lesions. Circ Cardiovasc Interv. 2017;10(10)
22.
go back to reference Gori T, Weissner M, Gonner S, Wendling F, Ullrich H, Ellis S, et al. Characteristics, predictors, and mechanisms of thrombosis in coronary Bioresorbable scaffolds: differences between early and late events. JACC Cardiovasc Interv. 2017;10(23):2363–71.CrossRefPubMed Gori T, Weissner M, Gonner S, Wendling F, Ullrich H, Ellis S, et al. Characteristics, predictors, and mechanisms of thrombosis in coronary Bioresorbable scaffolds: differences between early and late events. JACC Cardiovasc Interv. 2017;10(23):2363–71.CrossRefPubMed
23.
go back to reference Chen HY, Hermiller J, Sinha AK, Sturek M, Zhu L, Kassab GS. Effects of stent sizing on endothelial and vessel wall stress: potential mechanisms for in-stent restenosis. J Appl Physiol. 2009;106(5):1686–91.CrossRefPubMedPubMedCentral Chen HY, Hermiller J, Sinha AK, Sturek M, Zhu L, Kassab GS. Effects of stent sizing on endothelial and vessel wall stress: potential mechanisms for in-stent restenosis. J Appl Physiol. 2009;106(5):1686–91.CrossRefPubMedPubMedCentral
24.
go back to reference Biscaglia S, Ugo F, Ielasi A, Secco GG, Durante A, D'Ascenzo F, et al. Bioresorbable scaffold vs. second generation drug eluting stent in long coronary lesions requiring overlap: a propensity-matched comparison (the UNDERDOGS study). Int J Cardiol. 2016;208:40–5.CrossRefPubMed Biscaglia S, Ugo F, Ielasi A, Secco GG, Durante A, D'Ascenzo F, et al. Bioresorbable scaffold vs. second generation drug eluting stent in long coronary lesions requiring overlap: a propensity-matched comparison (the UNDERDOGS study). Int J Cardiol. 2016;208:40–5.CrossRefPubMed
25.
go back to reference Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, et al. Differential clinical responses to everolimus-eluting and paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011;124(8):893–900.CrossRefPubMed Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, et al. Differential clinical responses to everolimus-eluting and paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011;124(8):893–900.CrossRefPubMed
Metadata
Title
Three-years outcomes of diabetic patients treated with coronary bioresorbable scaffolds
Authors
Remzi Anadol
Katharina Schnitzler
Liv Lorenz
Melissa Weissner
Helen Ullrich
Alberto Polimeni
Thomas Münzel
Tommaso Gori
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cardiovascular Disorders / Issue 1/2018
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-018-0811-7

Other articles of this Issue 1/2018

BMC Cardiovascular Disorders 1/2018 Go to the issue