Online First

2020 : Volume 1, Issue 1

Comparative Study between Biodegradable-Polymer-Stentsand Standard Drug Eluting Stents in Diabetic Patients Presented with Acute Coronary Syndrome (ACS)

Author(s) : Ehab Elhefny 1 , Layth Mimish 2 , Samy Nouh 1 and Ahmed Nada 2

1 Department of Cardiology , Al-Alzhar University , Egypt

2 Department of Cardiology , King Abdul-Aziz University , Saudi arabia

J Clin Cardiol Cardiovasc Res

Article Type : Research Article

Abstract

Background: It has been suggested that the persistence of polymeric coating of drug-eluting stents provokes delayed arterial healing and as well as a cascade of cellular and biochemical events that cause patho-physiological processes such as release of cytokines which trigger the proliferation of smooth muscle cells, block the endothelialization of the nearby tissue, and induce other side-effects such as late andvery late stent thrombosis.

Aim: The primary aim of our prospective study was tocompare between the uses of BDP-DES and DP-DES in diabetic patients presented with ACS, regarding stent thrombosis, ISR and MACE during 12 months clinical followup and follow up coronary angiography in 6-12 months postACS index admission as well.

Methods: Our study enrolled 100 diabetic patients presentedto the Emergency department at King Abdul-Aziz university hospital as a case of ACS who were candidate for coronary angiography with PTCA and stenting.

Patients were divided into 2 groups according to the deployed stent:

Group A (BP-DES: 50 cases)
Group B (DP-DES: 50 cases)


Inclusion criteria: All patients post-Acute Coronary Syndromewho have DM and underwent for coronary angiography with PTCA and stenting.


Exclusion criteria: 1-Non diabetic patients. 2- known IschemicHeart Disease (IHD) or previous coronary intervention (PCI). 3- Pregnancy. 4- Allergy or contraindication to Aspirinand Plavix.

Results: There was no statistically significant difference as regard typical/atypical anginal symptoms in both groups in the 12 months follow up after the procedure.

Also, there was no statistically significant difference between the incidence of ISR, stent diameter (p=0.791) and stent length (p=0.952) in both groups. The mean diameter and length ± SD in the BDP-DES group and the PP-DES group were (2.82 ± 0.39 and 2.88 ± 0.43), and (26.2 ± 11.9 and 30.1± 13.1) respectively.

ISR was 10% in biodegradable polymer DES group and 12% in durable polymer DES group and it wasn’t significant statistically (p=0.719).

There were no reported cases of stent thrombosis in both groups.

Conclusion: BDP-DES, when compared to DP-DES, in diabetic patients presenting with ACS, showed no statistically significant difference and the outcomes were comparable between both the groups.

Keywords

Acute coronary syndrome (ACS); Diabetes mellitus (DM);In-stent restenosis (ISR)

Abbreviations

Acute Coronary Syndrome (ACS); Biodegradable-polymerdrug eluting stents (BDP-DES); Durable polymer drug elutingstents (DP-DES); Diabetes Mellitus (DM); Ischemic heartdisease (IHD); in-stent restenosis (ISR); Major advancedcardiovascular events (MACE); Percutaneous coronaryintervention (PCI); Percutaneous trans luminal coronaryangioplasty (PTCA); non ST segment elevation myocardialinfarction (NSTE-MI); stent thrombosis (ST); ST segmentelevation (STEMI).

Introduction

The introduction of coronary stents was implemented sincemore than two decades; during this period the stent designshave been modified to improve patient safety [1]. Bare metalstents (BMS) were traced by first generation drug elutingstents [2] (DP-DES) with durable polymer (Paclitaxel andSirolimus) [3] then followed by second generation DP-DES(Everolimus and Zotarolimus) and nowadays biodegradablepolymer DES [4] (BDP-DES) are contemplated potentially toimprove patient outcomes [3].

Stent designing is considered the cornerstone of interventionalcardiology research with dynamic changes. BMS constructionused a simple expandable metal alloy frame work,while durable polymer DES use an anti-proliferative drugcoating on the metal platform, glued by a binding such polymerto hold and elute its drug over a certain time [5].

Coronary intervention practice over years confirmed thatdurable polymer DES (DP-DES) are superior to BMS indecreasing restenosis, however DP-DES require a longerduration of dual-antiplatelet therapy to avert the risk ofstent thrombosis [6].

The metal alloy and the persistence of the polymer are amongthe culprits for prolonged inflammation with subsequentvery late stent thrombosis and late restenosis (late catchupphenomena) hereafter the unremitting search for saferstents [7,8].

Material & Methods:

Patient’s selection:

Our study enrolled 100 diabetic patients presented to the Emergency department at King Abdul-Aziz university hospital as an Acute Coronary Syndrome who were candidate for coronary angiography with PTCA and stenting. Selected patients were divided equally into 2 specific groups according to the deployed stent: Group A (BDP-DES: 50 cases). Group B (DP-DES: 50 cases).

Inclusion criteria: All patients post-Acute Coronary Syndrome who:

1. Have Diabetes Mellites (DM):
2. Underwent for coronary angiography with PTCA and stenting.

Exclusion criteria:

1. Non diabetic patients.
2. Known IHD or previous PCI
3. Pregnancy
4. Allergy or contraindication to Aspirin and Plavix.

Methods: After giving informed consent and approval of the ethical committee, the selected patients were subjected to the following:

A. Thorough history taking and physical examination with particular stress on: Known IHD or previous PCI, last menstrual date in women in childbearing period, any history of allergy or bleeding, history of kidney disease.

B. Electrocardiogram within 10 minutes from arrival to emergency department beside continuous ECG monitoring in a coronary care unit (CCU). At discharge as well as at follow up visits and during any possible recurrence of ischemic symptoms.

C. Routine Laboratory Investigations: Done as a baseline and as needed during hospital admission and follow up period: Cardiac troponins I(TNI) at 0,6,12 hours intervals, random blood sugar (RBS) Accumulated hemoglobin (HBA1C), Complete blood count (CBC), Lipid profile, Renal and liver function test, Coagulation profile.

D. Echocardiogram: 2-dimensional trans-thoracic echocardiography using General Electric Vivid S7 echocardiography machine to identify any regional wall motion abnormalities (RWMA), estimation of ejection fraction, examining atrial and ventricular septae beside assessing valvular morphology and functions.

E. Coronary angiography pre-procedural preparation: Informed Consent beside explanation of the procedure and its complications in full details in addition to repeat procedure in six to nine months and in case of emergency. Lastly strict compliance to dual anti-platelet drugs for twelve months or more starting immediately after the procedure. All patients received loading doses of dual anti-platelet drugs.

F. Coronary angiography procedure: Vascular access: femoral or radial, introduction of 6 Fr catheters to engage both right and left coronary arteries. Immediately after finalizing diagnostic coronary angiography (Siemens Cathlab machine ARTIS ZEE Bi-plane ECO) and planning to proceed for intervention, all patients received a bolus of 100 IU/kg heparin, with a repeated bolus of 2000 IU heparin to maintain the activated clotting time (ACT) of ? 300s. PTCA/stenting to culprit artery/ies was/were done successfully to all patients.

G. Post PCI procedure management & Follow Up: All patients remained in CCU for 48-72 hours after the procedure according to clinical scenario, then shifted to general ward to complete in-hospital management course. All patients received high intensity statins, ACE-I and beta-blockers on discharge.

H. Out-patient department follow up in 1,3,6,12 months basis: included the following data: History taking as regards recurrence of the symptoms, Detailed cardiac examination, Compliance of medical treatment.
    
I. Follow up coronary angiography in 6-8 months: All patients underwent coronary angiography to identify instent restenosis in both groups in six to twelve months post index intervention, patients with angiographic ISR were managed through PTCA and stenting.

Statistical analysis:

Data were collected, checked and analyzed using Epi-Info version 6 and SPSS for Windows version 14.0 (SPSS, Chicago, IL, USA). Data were summarized using mean, standard deviation (SD), Chi-Square test and Independent t-test. The threshold of significance is fixed at 5% level (P-value), P value of >0.05 indicates non-significant results, P value < 0.05: Significant (S) and P value < 0.01: Highly significant (HS).

Results

Our prospective study was conducted upon 100 patients divided into 2 groups, group A (BDP-DES), and group B (DPDES) which was used during PCI procedures that were done in included study population.

Baseline patient characteristics:

I. Gender distribution: The BDP-DES group included 44 male patients (88%) and 6 female patients (12%). The DP-DES group included 47 male patients (94%) and 3 female patients (6%). Chi-square test (p=0.294).

II. Age distribution: The mean age in the BDP-DES group was 55.18 +/- 11.06 with the age range between 32-78-year-old. The mean age in the DP-DES group was 55.64 +/- 10.89 with the age range between 34-83-yearold. Independent t-test (p=0.836).

III. Risk factors of CAD:

  1. Diabetes mellitus: Both groups included diabetic patients as per inclusion criteria
  2. Hypertension: In the BDP-DES group there were 31 patients with history of hypertension (62%) and 19 patients with no history of hypertension (38%). In the DP-DES group there were 27 patients with history of hypertension (54%) and 23 patients with no history of hypertension (46%). Chi-square test (p=0.417).
  3. Smoking: In the BDP-DES group there were 31 smoker patients (62%) and 19 non-smoker patients (38%). In the DP-DES group there were 29 smoker patients (58%) and 21 non-smoker patients (42%). Chi-square test (p=0.683).
  4. Body Mass Index (BMI): The Mean+/-SD BMI in the BDPDES group was 30.1 +/- 3.53. The Mean+/-SD BMI in the DP-DES group was 29.9 +/- 3.77. Independent t-test (p=0.813).
  5. Dyslipidemia: In the BDP-DES group there were 23 patients with history of dyslipidemia (46%) and 27 patients with no history of dyslipidemia (54%). In the DP-DES group there were 24 patients with history of dyslipidemia (48%) and 26 patients with no history of dyslipidemia (52%). Chi-square test (p=0.841).
  6. Family history of coronary artery disease:

In the BDP-DES group there were 11 patients with positive family history of coronary artery disease (22%) and 39 patients with no family history (78%) whereas in the DP-DES group there were 17 patients with positive family history of coronary artery disease (34%) and 33 patients with no (66%). Chi-square test (p=0.181) (Figure 1-3).

There was no statistically significant difference as regard patient demographics in both groups (Table 1).
 

 

Patients with deployed biodegradable polymer drug-eluting stents BDP-DES

Patients with deployed durable polymer drug-eluting stents DP-DES

P-value

Sig.

 

 

No.=50

No.=50

 

 

Gender

Males

44 (88.0%)

47 (94.0%)

0.294

NS

Females

6 (12.0%)

3 (6%)

Age

Mean ± SD

55.18 ± 11.06

55.64 ± 10.89

0.836

NS

Range

32 – 78

34 – 83

HTN

Yes

31 (62.0%)

27 (54.0%)

0.417

NS

No

19 (38.0%)

23 (46.0%)

DM

Yes

100%

100%

NA

 

No

0%

0%

Smoking

Yes

31 (62.0%)

29 (58.0%)

0.683

NS

No

19 (38.0%)

21 (42.0%)

Dyslipidemia

Yes

23 (46.0%)

24 (48.0%)

0.841

NS

No

27 (54.0%)

26 (52.0%)

FH

Yes

11 (22.0%)

17 (34.0%)

0.181

NS

No

39 (78.0%)

33 (66.0%)

BMI

Mean ± SD

30.1 ± 3.53

29.9 ± 3.77

0.813

NS


Table 1: Baseline patient characteristics DM: Diabetes mellitus; FH: Family history; HTN: Hypertension; NS: Non significant; *: Chi-square test; •: Independent t-test.


Figure 1: 58 years old, male, anterior STEMI, coronary angiography (trans-radial approach), spider view, totally occluded LAD, ostial LCX tight lesion.


Figure 2: Coronary angiography (trans-radial approach), LAO Cranial view, post PCI to LM-LAD/LCX, DK Crush technique.


Figure 3: Follow up coronary angiography after 6 months, (trans-femoral approach), spider view, widely patent stents.

IIV. Types of ACS at presentation:

In the BDP-DES group there were 23 patients with STEMI (46%) and 18 patients with NSTEMI (36%) and 9 patients with UA (18%). In the DP-DES group there were 19 patients with STEMI (38%) and 24 patients with NSTEMI (48%) and 7 patients with UA (14%). There was no statistically significant difference between the percentage of types of ACS patients in both groups using Chisquare test (p=0.475).
In the BDP-DES group there were 23 patients with STEMI (46%) and 18 patients with NSTEMI (36%) and 9 patients with UA (18%). In the DP-DES group there were 19 patients with STEMI (38%) and 24 patients with NSTEMI (48%) and 7 patients with UA (14%). There was no statistically significant difference between the percentage of types of ACS patients in both groups using Chisquare test (p=0.475).

Stented vessel:

In the BDP-DES group there were 27 patients with the LAD being stented vessel (54%), 6 patients with the LCX (12%) and 17 patients with the RCA being the stented vessel (34%).
In the PP-DES group there were 20 patients with the LAD being the stented vessel (40%), 8 patients with the LCX (16%) and 22 patients with the RCA being the stented vessel
(44%). There was no statistically significant difference as regard stented vessel in both groups using Chi-square test (p=0.373) (Table 2).

Stented vessel

Patients with deployed permanent polymer drug-eluting stents

 

Patients with deployed polymer free drug-eluting stents

 

P-value

Sig.

 

No.

%

No.

%

 

 

LAD

27

54.00%

20

40.00%

0.373

NS

LCX

6

12.00%

8

16.00%

RCA

17

34.00%

22

44.00%


Table 2: Stented vessel distribution in the patients; LAD: Left anterior descending;
LCX: Left circumflex; NS: Non significant; RCA: Right coronary artery; S: Significant *: Chi-square test.

Stent parameters: The mean diameter in the BDP-DES group was 2.98 ± 0.39 with the diameter range between 2.5-4.0 mm. The mean diameter in the PP-DES group was 3.04 ± 0.41 with the diameter range between 2.5-4.0 mm. There was no statistically significant difference between the mean diameter in both groups using independent t-test (p=0.428). The mean length in the BDP-DES group was 27.7 ± 12.36 with the length of each stent ranges between 12-40 mm. The mean length in the DP-DES group was 28.1 ± 13.1 with the length of each stent ranges between 12-38 mm. There was no statistically significant difference between the mean length in both groups using independent t-test (p=0.862).

V. Left ventricular ejection fraction LVEF:

The mean LVEF in the BDP-DES group was 48.28 +/- 10.55. The mean LVEF in the DP-DES group was 47.6 +/- 9.69. There was no statistically significant difference between the
mean age in both groups using independent t-test (p=0.762) (Figure 4-7).

 

Patients with deployed permanent polymer drug-eluting stents

Patients with deployed polymer free drug-eluting stents

P-value

Sig.

No.=50

No.=50

0.428

NS

Diameter of the stent

Mean ± SD

2.98 ± 0.39

3.04 ± 0.41

Range

2.5 – 4.0

2.5 – 4.0

0.862

NS

Length of the stent

Mean ± SD

27.70 ± 12.36

28.10 ± 13.1

Range

12 – 40

12 – 38

0.762

NS

EF

Mean ± SD

48.28 +/- 10.55

47.6 +/- 9.69


Table 3: Stent parameters and ejection fraction distribution of the patients; EF: Ejection fraction; NS: Non significant *: Chi-square test; •: Independent t-test.



Figure 4: 62 years old, male, NSTEMI, coronary angiography (trans-femoral approach), spider view, LAD and LCX tight lesions.



Figure 5: Coronary angiography (trans-femoral approach), spider view, post PCI to LCX with DES.



Figure 6: Coronary angiography (trans-femoral approach), RAO Cranial view, post PCI to LAD and LCX with DESs.