Nine-month clinical outcomes in patients with

Original articles Herz https://doi.org/10.1007/s00059-017-4675-x Received: 14 November 2017 Revised: 14 December 2017 Accepted: 15 December 2017 © Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2018

F. Krackhardt1 · M. Waliszewski2 · J. Rischner3 · C. Piot4 · M. Pansieri5 · F. L. RuizPoveda6 · M. Boxberger2 · M. Noutsias7 · X. F. Ríos8 · B. Kherad1 1

Department of Cardiology, Charité – Universitätsmedizin Berlin, Campus Virchow, Berlin, Germany Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany 3 Hôpital Albert Schweitzer Colmar, Colmar, France 4 Clinique du Millénaire Montpellier, Montpellier, France 5 Centre Hospitalier d’Avigon, Avignon, France 6 Hospital General Universitario de Ciudad Real, Ciudad Real, Spain 7 Midgerman Heart Center, Department of Internal Medicine III, Division of Cardiology, Angiology and Intensive Medical Care, University Hospital Halle, Martin-Luther-University Halle, Halle, Germany 8 Complexo Hospitalario Universitario de A Coruña, Coruña, Spain 2

Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimuseluting stents and 6-month vs. 12-month dual-antiplatelet therapy (DAPT) Diabetes mellitus (DM) is known to be associated with worse clinical outcomes in patients with coronary artery disease (CAD) [1, 2]. Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is becoming increasingly more popular, especially among CAD patients with diabetes [3]. Although the revascularization rate has significantly decreased in patients with diabetes treated by DES [4], stent thrombosis (ST) is still a major concern in these patients [5] especially in those with premature discontinuation of dual antiplatelet therapy (DAPT) [6]. However, prolonged treatment with DAPT is associated with an increased risk of bleeding complications and morbidity [7]. Initially, patients with diabetes were believed to have a higher risk of bleeding under DAPT following PCI; however, recently a number of registry data and subgroup analyses showed that patients Contributions. All authors were involved in the data analysis plan and interpretation, drafting the article, critical revision, and the final approval.

with DM experienced a lower or equal risk of bleeding on DAPT compared with patients without DM [8, 9]. In patients undergoing PCI, clinical decision-making has to consider the balance between bleeding risk and thrombotic risk as well as the patient’s need to undergo noncardiac surgery following PCI. Defining the optimal duration of DAPT after DES implantation is the objective of several randomized controlled trials (RCTs) and meta-analyses [7, 10]. Recently, second-generation DES have been reported to be associated with a lower risk of ST compared with first-generation DES [11], suggesting the possibility of shorter DAPT requirements. Furthermore, a recent metaanalysis of more than 15,000 patients primarily treated with second-generation DES showed that an abbreviatedduration DAPT (≤6 months) was associated with a significant reduction in major bleeding complications with no evidence of significant risk increases in

death, myocardial infarction (MI), or ST [12]. Drug-coated balloons [13] and new coating technologies including bioabsorbable polymers and non-polymer coatings also offer further potential to maintain optimal ischemia outcomes while avoiding bleeding associated with prolonged DAPT. In this study, a polymer-free sirolimus-coated, ultrathin strut drug-eluting stent (PF-SES) allowing for accelerated vessel healing was used. This technology has the theoretical advantage of offering a shortened duration of DAPT without compromising target lesion revascularization (TLR) and major adverse cardiac event (MACE) rates. The ISAR-Test 5 trial demonstrated that this coating technology revealed similar safety and efficacy [4] to zotarolimus-eluting stents (ZES). The objective of this subgroup analysis of the all-comer ISAR 2000 registry was to assess the safety and efficacy of a short DAPT (≤6 months) versus a longer DAPT (>6 months) in DM patients treated with Herz

Original articles the PF-SES for de novo and restenotic lesions in native coronary arteries and coronary bypass grafts.

Methods Endpoints and definitions The international ISAR 2000 all-comers registry (ClinicalTrials.gov Identifier NCT02629575) prospectively enrolled patients in Europe and Asia. The study protocol was approved by all relevant ethics committees prior to patient recruitment. The primary endpoint was the 9-month TLR rate whereas secondary endpoints were the 9-month MACE rate, the in-hospital MACE rate, and the corresponding rates of MI, TLR (coronary artery bypass grafting and re-percutaneous coronary intervention [PCI]). Cardiac death was only defined in-hospital whereas the all-cause death rate was used to define MACE at 9 months (MI, TLR, in-hospital cardiac death, all deaths post discharge). The Academic Research Consortium (ARC) criteria [14] were used to define acute/subacute ST. Renal insufficiency was defined with a glomerular filtration rate (GFR) of 6 months DAPT

p

Number of patients

165

340

–

Number of lesions

189

376

–

Number of DES used

250

430

–

Age (years)

69.8 ± 9.2

67.4 ± 9.7

0.007

Male gender

123 (74.5%)

235 (69.1%)

0.208

Hypertension

146 (88.5%)

296 (87.1%)

0.649

Renal insufficiency

24 (14.5%)

35 (10.3%)

0.163

Dialysis dependence

4 (2.4%)

19 (5.6%)

0.110

Europe

155 (93.9%)

214 (59.1%)

0.001), the total length of the DES used was longer in the S-DAPT group (23.7 ± 13.0 mm vs. 21.9 ± 9.1 mm, p = 0.048), and the degree of stenosis after DES implantation was significantly lower in the S-DAPT group (0.3 ± 1.6% vs. 2.4 ± 7.5%, p < 0.001) (. Table 3).

Outcome results In-hospital events In-hospital clinical MACE was low in both groups and there were no significant differences between the two groups (. Table 4).

9-Month events Table 2

Lesion characteristics and procedural data ≤6 months DAPT

>6 months DAPT

p

189

376

–

LAD

69 (36.5%)

168 (44.7%)

0.059

Cx

44 (23.3%)

99 (26.3%)

RCA

74 (39.2%)

107 (28.5%)

Graft

2 (1.1%)

2 (0.5%)

Number of lesions Target vessel

Bleeding complications

Multivessel disease 0.004

One-vessel disease

157 (83.1%)

342 (91.0%)

Two-vessel disease

32 (16.9%)

31 (8.2%)

Three-vessel disease

0 (0.0%)

3 (0.8%)

Chronic total occlusion

16 (8.5%)

16 (4.3%)

0.041

Diffuse vessel disease

93 (49.2%)

169 (44.9%)

0.338

Calcification

82 (43.4%)

136 (36.2%)

0.096

Ostial lesion

20 (10.6%)

32 (8.5%)

0.422

Bifurcations

19 (10.1%)

67 (17.8%)

0.015

In-stent restenosis

13 (6.9%)

11 (2.9%)

0.028

Severe tortuosity

23 (12.2%)

66 (17.6%)

0.096

Saphenous vein graft

1 (0.5%)

2 (0.5%)

0.997

AHA/ACC type B2/C lesion

103 (54.5%)

210 (55.9%)

0.760

Reference diameter (mm)

2.86 ± 0.52

2.84 ± 0.50

0.593

Lesion length

20.8 ± 9.8

18.5 ± 9.0

0.021

Degree of stenosis (%)

82.7 ± 10.6

83.9 ± 10.1

0.177

Data expressed as mean ± SD DAPT dual antiplatelet therapy, LAD left anterior descending, Cx circumflex, RCA right coronary artery

rates of in-stent restenosis (6.9% vs. 2.9%, p = 0.08), and significantly longer lesions (20.8 ± 9.8 mm vs. 18.5 ± 9.0 mm, p = 0.021) (. Table 2).

Herz

The accumulated 9-month MACE rate was in both groups low and there was no significant difference between both groups in the overall MACE rate (4.6% vs. 3.1%, p = 0.441) or the 9-month accumulated ST rate (0.8% vs. 0.3%, p = 0.51) (. Table 4).

Procedural characteristics Procedural characteristics showed a numberofdifferences betweenthe twogroups. Predilation was performed significantly more often in the S-DAPT group (52.4% vs. 23.9%, p < 0.001), more DES were

The accumulated rate of bleeding complications was 5.3% in the S-DAPT group and 3.4% in the L-DAPT group. There were no significant differences in minor bleeding (bruises, nose bleedings, small bleeding, hematoma at puncture site) (2.3% vs. 0.9%, p = 0.565) and major bleeding events (upper and lower GI tract bleedings, intracranial bleedings; 0% vs. 0.3%) between the two groups (. Table 4).

Discussion Our subgroup analysis of DM patients undergoing elective PCI with PF-SES has two main findings. First, no statistically significant difference in ischemic and thrombotic events was observed between