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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 3  |  Issue : 1  |  Page : 25-31

Outcomes of supraflex sirolimus eluting coronary stents


1 Department of Cardiology, Apusnova Multisuperspeciality Hospital, Meerut, Uttar Pradesh, India
2 Department of Cardiology, Super Speciality Hospital GMC, Srinagar, Jammu and Kasmir, India
3 Batra Hospital and Medical Research Centre, New Delhi, India

Date of Submission15-Oct-2021
Date of Decision17-Dec-2021
Date of Acceptance19-Dec-2021
Date of Web Publication24-Mar-2022

Correspondence Address:
Dr. Sheikh Mohammad Tahir
Super Speciality Hospital GMC, Srinagar, Jammu and Kasmir
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jascp.jascp_25_21

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  Abstract 


Background: The introduction of Sirolimus Eluting Coronary Stents (SES) was a major breakthrough in interventional cardiology. The large, randomized, clinical trials using SES have shown a remarkable reduction in angiographic restenosis and target vessel revascularization (TVR) compared with bare-metal stents as well as other drug-eluting stents (DESs). However, there is only limited data on the outcome of Indian patients treated by DES of Indian origin. The purpose of the study was to evaluate the outcomes of the supraflex sirolimus-eluting coronary stents for the treatment of coronary artery disease and to determine major adverse cardiovascular and cerebrovascular events (MACCE). Materials and Methods: This was a single-centre, observational, nonrandomized study that enrolled unselected real-world patients at a tertiary care center who had undergone implantation with supraflex sirolimus-eluting stents. The primary end-point of the study was MACCE, which is a conglomeration of cardiac death, target lesion revascularization (TLR), TVR, cerebrovascular accident (CVA), and heart failure at 1-year follow-up. Results: A total of 100 patients were intervened successfully with sirolimus-eluting stents. Out of total patients, diabetes and hypertension were observed in 38% and 35% of patients. According to ACC/AHA classification, there were 68% Type B lesions and 32% Type C lesions. At 1-year follow-up, MACE was found to be 11%, which is a composite of 4% TLR, 3% TVR, 1% CVA, and 5% heart failure. Diabetes (P = 0.02), hypertension (P = 0.01), kidney dysfunction (P = 0.002), and LV function (P = 0.01) strongly correlate with outcome (MACCE). Conclusion: There was an acceptable rate of adverse events after implantation of the supraflex sirolimus-eluting stents, although it was slightly higher compared to other studies. Diabetes, hypertension, kidney dysfunction, and LV function strongly correlate with outcome (MACCE).

Keywords: Acute coronary syndrome, drug-eluting stents, percutaneous coronary intervention, percutaneous coronary intervention outcomes


How to cite this article:
Singh VV, Tahir SM, Sharma S. Outcomes of supraflex sirolimus eluting coronary stents. J Appl Sci Clin Pract 2022;3:25-31

How to cite this URL:
Singh VV, Tahir SM, Sharma S. Outcomes of supraflex sirolimus eluting coronary stents. J Appl Sci Clin Pract [serial online] 2022 [cited 2022 May 17];3:25-31. Available from: http://www.jascp.com/text.asp?2022/3/1/25/340880




  Introduction Top


The treatment of coronary artery disease (CAD) has been dramatically revolutionized since the introduction of percutaneous coronary intervention (PCI) by Andreas Gruentzig in 1977.[1],[2] Balloon angioplasty and subsequently, coronary stenting has significantly influenced the management of stable and unstable CAD.[3]

Initial results with percutaneous balloon angioplasty only, although encouraging, raised concern regarding periprocedural complications, such as plaque rupture and coronary dissection, which are often clinically translated into acute myocardial infarction (MI), especially in the days following the procedure. Emergency coronary artery bypass grafting (CABG) due to acute vessel closure as a result of dissection was not uncommon. In addition, at follow-up, the benefits derived from revascularization were further counterbalanced by the high incidence of restenosis, which could reach 40%.[4] The advent of stents in the early 1990s significantly reduced these side effects and contributed to the widespread use of PCI. Nowadays, in the USA, more than a million patients are treated with PCI every year, often for nonacute CAD.[5]

The beneficial angiographic and clinical effects of stents were documented by several trials that demonstrated a significant reduction of restenosis and target-vessel revascularization (TVR) in patients allocated to bare-metal stent (BMS) implantation compared with those with percutaneous transluminal coronary angioplasty.[6] BMSs reduced restenosis rates from 30% to 40% in the balloon angioplasty era to 20%–25% by providing a mechanical scaffold to maintain radial support, minimizing elastic recoil.[6],[7] The advantage of coronary stents in reducing the occurrence of restenosis after PCI is essentially due to the ability to eliminate the elastic recoil and negative vessel remodelling that occurs after balloon dilation.[8]

However, with the widespread use of BMS, two notable complications emerged: In-stent restenosis and stent thrombosis. Although stent thrombosis was significantly reduced with the use of dual antiplatelet therapy after stent implantation, in-stent restenosis still remains a challenge.[9] In-stent restenosis is a simpler reaction to the coronary intervention, resulting from an excessive proliferative neointimal response. In the pathophysiology of in-stent restenosis, there are four clears but overlapping components: Platelet deposition, leukocyte recruitment, smooth muscle cell migration, and proliferation and matrix deposition. While the risk of developing in-stent restenosis is linked to a variety of clinical and procedural factors (particularly diabetes, long lesions, small vessels, and procedural failure), all BMS, regardless of the thickness of the struts, provoke a considerable proliferative response.[8]

First-generation drug-eluting stents (DESs) were designed to target in-stent restenosis caused by neointimal hyperplasia. To this end, coronary artery stents were coated with a polymer allowing controlled local delivery of a pharmaceutical agent with antineoplastic and anti-inflammatory properties.

Subsequently, DESs replaced BMSs in the majority of PCI procedures. However, as the use of DESs expanded beyond the well-studied indications of the randomized controlled trials, concern arose regarding the safety profile of the first-generation DESs.[10],[11]

DESs were based on the concept of local drug release at the site of tissue injury to resist smooth muscle proliferation. The astonishing results of the first studies performed with rapamycin and paclitaxel-eluting stents confirmed the concept that a high local concentration was essential to control the excessive proliferative response.[8]

The past 10 years witnessed the extraordinary promise of DES and several stents with different types of drugs were tested. Some drugs, such as paclitaxel, can be coated directly on a metal stent, whereas the majority of the drugs need to be attached to a polymer, which acts as a drug reservoir.[12] With this aim, we conducted a study to see the outcome of Supraflex sirolimus eluting coronary stents for the treatment of CAD. The objectives of the study were to determine major adverse cardiovascular and cerebrovascular events (MACCEs): TVR; target lesion revascularization (TLR); cerebrovascular accident (CVA); cardiac death; and heart failure.


  Materials and Methods Top


The study will be undertaken in the Department of Cardiology of Batra Hospital and Medical Research Center, New Delhi, India. It was a prospective observational study. All consecutive patients who had undergone PCI with Supraflex sirolimus eluting coronary stents in our hospital from May 2019 to May 2020 recorded in our coronary intervention registry were enrolled in the study. The sample size was calculated based on the previous study[13] in which the prevalence of CAD was 11%. Now taking level of significance at 5% and margin of error at 10%, we get sample size as 40 which was considered to be sufficient for our study. However, we planned to include 100 patients. We included patients who have undergone coronary artery stenting with Supraflex sirolimus eluting stent for any of the following reasons: (a) Patients who had stable angina, (b) Patients who had unstable angina, (c) Patients who had ST elevation MI or non-ST elevation MI, and (d) All such patients who had single vessel/multivessel disease on coronary angiography and who underwent coronary artery stenting with supraflex sirolimus eluting stents. We excluded those who had underwent coronary artery stenting with stents other than supraflex sirolimus eluting stent.

Procedure

The baseline clinical and coronary artery lesion characteristics of the patients were recorded as available in the records and were summarized as per the protocol drafted for the study. Clinical follow-up of all these patients was done at 6 months, 1 year after the index procedure. This was carried out by the following measures.

  1. Selected patients who visited the follow-up clinics. Their status was recorded by clinical history, physical examination, laboratory tests, and coronary angiography if required and indicated
  2. Patients who do not report for follow were telephonically interviewed. For this, a questionnaire was drafted and validated.


Variables used in the study

MACE is term applied to Major Adverse Cardiaovascular Events. The SPIRIT trials used MACE as an endpoint in their study[14] and we planned to do the same. Major adverse cardiac vascular events were be described as: Death; all deaths were considered cardiac unless documented otherwise. MI; it was defined as an elevation of troponin above the upper range limit in combination with at least 1 of the following: Symptoms of ischemia. Electrocardiography changes indicative of new ischemia (ST_T-wave changes or new left bundle branch block), or the development of pathological Q waves on electrocardiography.[15],[16] The ST-T wave changes indicative of new ischemia were followed as shown.[16] TVR was defined as repeat revascularization of a lesion in the same epicardial vessel treated in the index procedure.[16] TLR: TLR was defined as a repeat intervention in the stent or within 5 mm proximal or distal to the stent or CABG of the target vessel.[16]

TVR and TLR were available only if follow-up CAG was done. CVA: Heart failure: We planned to look for MACCE.

Operational definitions

  1. Angiographic success will be defined as residual stenosis <20% in the presence of thrombolysis in MI flow grade 3[17]
  2. The coronary lesions will be classified as per the AHA/ACC guidelines for percutaneous coronary angioplasty[18]
  3. Hypertension will be defined as blood pressure >140/90 mm Hg or the use of anti-hypertensive medications[19]
  4. Stent thrombosis will be defined as “acute” if within 24 h of the procedure, “subacute” at 1–30 days, and “late” after 30 days. The definition of ST will be in accordance with the Academic Research Committee definitions of definite, probable, and possible ST)[16]
  5. Electrocardiogram manifestations of acute myocardial ischemia[16] (in absence of LBBB or LVH).


ST elevation

New ST elevation at j point in two contiguous leads with the cutoff points; ≥0.2 mV in men and ≥0.15 mV in women in leads V2– V3 and/or ≥0.1 mV in other leads.

ST depression and T wave changes

New horizontal or down sloping ST depression ≥0.05 mV in two contiguous leads and/or T inversion ≥0.1 mV in two contiguous leads with prominent R wave or R/S ratio

Description of the study stent

Supraflex stent has L605 Co-Cr alloy as its stent platform having strut thickness of 60 μm with biodegradable polymers and drug load of 1.4 μg/mm2. About 70% of drug is released within 7 days and remaining drug is released over a period of 48 days. The coating layer comprises of drug sirolimus blended together with biodegradable polymeric matrix. This matrix includes different biodegradable polymers – poly l-lactide, 50/50 poly-dl-lactide-co-glycolide, and polyvinyl pyrrolidone to control the drug elution from stent coating. After releasing the drug within 48 days, these polymers eventually degrade naturally and are excreted from the body in the form of their metabolites. The average coating thickness of supraflex stent is between 5 and 6 μm. The supraflex stent was made available in lengths of 8, 12, 16, 20, 24, 28, and 32 mm, and available diameters were 2.5, 3.0, and 3.5 mm. It is a C. E mark stent.

Statistical method used

The categorical variable was expressed as frequency, proportions (%), and continuous variable as mean ± standard deviation or median (inter quartile range), when skewed in distribution. The continuous variable was compared using the t-test. Categorical variable was compared using Fisher's exact test or Chi-square test as appropriate. The study will be compared with the similar type of studies in the literature and analyzed statistically using P < 0.05 as significant. Data were tabulated in MS Office Excel worksheet. Descriptive statistics were computed for all the numerical data. All statistical analyses were performed by using software SPSS version 26.0.

Institutional ethics committee

This study design, tools for data collection, consent forms, and patient information sheets were reviewed by the Institutional Ethics Committee at our institute as a part of the procedure involved for all research requiring human participation. The study was conducted after the approval of the Institutional Ethics Committee.

Informed consent forms

Appropriate consent forms were designed for seeking written consent which the IEC approved at our institute. The participants have explained the study's details and requirements, in fact with particular reference to technical aspects such as specific scientific/medical terms used.


  Results Top


All consecutive patients who have undergone PCI with supraflex sirolimus eluting coronary stents in our hospital from May 2019 to May 2020 serially recruited. Total 108 patients recruited in this study. 8 patients lost during follow up. All patients were managed as per standard treatment guideline, discharged on guideline driven medical therapy. Clinical follow-up of these 100 patients was done at 6-month, 1 year after the index procedure. The age of patients ranges from 45 years to 78 years, with mean age 62.32 ± 6.6 years with male patients dominating with 62% sample in total as shown in [Table 1].
Table 1: Demographic characteristics of the studied patients

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A total of 35% patients of our study were hypertensive, 38% patients were diabetic, and 52% patients have history of tobacco abuse, 2% of patients have history of CABG, 6% have history of prior PCI and 6% have history of MI and not treated with any revascularization method. Further 81% of patients in our study were having no evidence of renal injury, while 14% patients were having Stage 1, and 4 were having Stage 2, and 1 patient was having Stage 3 kidney injury [Table 2].
Table 2: Baseline comorbid conditions among the studied patients

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A total 61% patients had normal lv function, 23% patients had mild LV Systolic dysfunction, 13% patients had moderate LV Systolic dysfunction, 3% patients had severe LV Systolic dysfunction Most common mode of presentation was unstable angina 33%, followed by anterior wall STEMI 23%., Stable angina was mode of presentation in 21% patients, 13% patients present with inferior wall STEMI, 10% patients were presented with NSTEMI as shown in [Table 3].
Table 3: Mode of presentation to the cardiac physician/ emergency room found among the studied patients

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Procedural and angiographic characteristics of the studied patients is shown in [Table 4]. Most of the patients have Type B lesion (68%), while 32 patients have Type C lesion. most of patients have double vessel disease (46%) while single vessel disease was in (44%) triple vessel disease was found in (10%). Most common vessel stented was LAD > RCA > LCX, Graft vessel was stented in only (1.6%). None of our study patients have bifurcation or left main stenting. Single vessel stenting was done in 78% cases while multi vessel stenting was done in 22% of cases. Mean stent length of first stented vessel was 26.6 ± 6.01 mm, and mean stent diameter of first stented vessel was 3.01 ± 0.37 mm, while Mean stent length of second stented vessel was 20.4 ± 3.2 mm, and mean stent diameter of second stented vessel was 2.86 ± 0.24 mm. Further 3% of patients were required IABP support, 3% patients were required TPI support, inotropic support was required in 4% patients, and defibrillation was required in 3% of patients.
Table 4: Procedural and angiographic characteristics among the studied patients

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Treatment outcome among the studied patients is described in [Table 5]. Procedure remained uncomplicated in 93% of case. 2 patients developed slow flow. Two patients developed CIN managed medically with guidance of nephrologist. Flow limiting dissections occurred in 3%, all of which were managed with a stent. There was no death, stroke or periprocedural MI.
Table 5: Treatment outcome among the studied patients

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One patient presented with NSTEMI at 4 months, had angiographic evidence of in stent restenosis. His TLR was done.

A Total 7% patient presented with post stenting angina, out of which 6 patients subjected to stress imaging, out of which 4 patients showed evidence of ischemia. These 4 patients were subjected to repeat coronary angiography out of which two patients found to have evidence of in stent restenosis underwent TLR. One patient found to have new disease in same vessel underwent TVR.

Other two patients were found to have no evidence of provocable myocardial ischemia on stress imaging, managed with optimization of treatment. One patient was found to be severely anaemic. Her symptoms improved after correction of anemia.

A total 2 patients were developed heart failure in first 6 month; TVR was done in one patient another one is managed with optimization of medicine. One patient develops ischemic stroke at 4 month which was partially recovered on follow up.

Between 6 and 12 month 3 more patients presented with post stenting angina all of them subjected to stress imaging out of which one patient had evidence of Provocable ischemia underwent coronary angiography, and found to have evidence of in stent restenosis, hence underwent TLR. Other two patients were found to have no evidence of provocable ischemia on stress imaging managed with optimization of treatment. A total three patients were developed heart failure between 6 and 12-month duration, out which one patient underwent TVR. Rest two were managed with optimization of treatment.

No additional CVA and death occurred in 6–12 month follow up.

At the end of 1 year the incidence of TLR was 4%, and incidence of TVR 3%. One patient developed CVA at 4-month post procedure. No cardiac death or stent thrombosis occurred during entire follow up. A cumulative MACCE RATE was 11%

Incidence of MACCE in different sub group of studied patients is described in [Table 6]. Age and sex did not affect MACCE in our cohorts. Diabetes, hypertension, kidney dysfunction, and LV Function strongly correlate with outcome (MACCE). While length of stent, diameter of stent, and type of lesion did not affect MACCE in our cohorts.
Table 6: Incidence of major adverse cardiovascular and cerebrovascular events in different sub group of studied patients

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  Discussion Top


The introduction of SES was a major breakthrough for interventional cardiology. Large, randomized, clinical trials using SES have shown a remarkable reduction in angiographic restenosis and TVR compared with BMS and comparable result with other DESs. The results of these trials also appear to be supported by evidence from everyday practice and noncontrolled clinical trials.

However, there is only limited data on outcome of Indian patients treated by DES of Indian origin, so aim of this study is to provide an evaluation of performance of Indian origin sirolimus eluting stent (supraflex) in Indian population.

Our study was a prospective observational study in specialized tertiary cardiac centre in north India. Of total 108 enrolled patients follow up was complete in100 (92%) patients while rest patients were lost during follow up and excluded from study.

Mean age of patients in our study was 62.32 ± 6.6 years which is comparable to other Indian studies. In study of Seth et al.[20] mean age was 58 ± 10 years, in study of Lemos PA.[21] mean age was 61.6 ± 10 years. The age of patient's ranges from 45 years to 78 years, with maximum patients was in range of 55–75 years

The proportion of male patients in our study was 62% as in most Indian and western studies, male patients had significant proportion of patients as compared to female.

Prevalence of diabetes was 38% which is comparable to study of Seth et al.[20] 39%, slightly higher as compare with study of Lemos PA.[21] as 23%, Prevalence of hypertension was 35% which is slightly lower as compared to studies of Seth et al.[20] and Lemos PA.[21] History of tobacco abuse was 52% in our study cohort, which was higher than study of Seth et al.[20] 30% and Lemos PA[21] was 7.1%.

Kidney injury was present in 19% of our patients out of which 14% of patients was in stage 1, and 4 were having stage 2, and 1 patient was having stage 3 kidney injury. Study of Seth et al.[20] excluded patients with impaired renal function.

23% of patients in our study patients had mild LV Systolic dysfunction, 13% patients had modrate LV Systolic dysfunction, 3% patients had severe LV Systolic dysfunction. in study of Seth et al.,[20] Shetty et al.[22] patients with EF <30% was excluded from study.

Most of patients in our study have type B lesion (68%), type C lesion was present in 32% patients which higher than study of Seth et al. and lower than study of Lemos PA et al. In study of Seth et al.[20] type C lesion was 7%, ain study of Lemos P. A.[21] type C lesion was 57%.

Most common target coronary artery was LAD in our study%, which is comparable to study of Seth et al.[20] and study of Lemos P. A.[21] SVG graft intervention was performed in 1.6% case in our study while in study of Lemos P. A.[21] SVG graft intervention was performed in 1.1%.

Mean stent length was 26.6 ± 6.01in our study, was 19.72 ± 9.2In study of Seth et al.,[20] and was 26.6 ± 9.3in study of Lemos P. A.[21] Mean stent diameter was 3.01 ± 0.37 in our study and was 3.1 ± 0.4 in study of Lemos P. A.[21]

In our study over all MACCE (11%), Target lesion and TVR, were higher than most of the other studies, this might due to that fact that study of Seth et al., excluded patients'. Patients with impaired renal function and studies of Seth et al. and Shetty et al. excluded patients with severe LV systolic dysfunction.

CVA occurred in 1 patient similar to study of Seth et al. No death occurred during entire follow up period despite of high MACCE rate may be an incidental finding.

Diabetes–diabetes was an important predictor of MACCE in our study with 9% MACCE rate (P = 0.02). Similar trend was observed in study of Kuchulakanti et al.[23]

Kidney dysfunction-was also an important predictor of MACCE in our study (P = 0.02) similar trend was observed in study of Arampatzis, et al.[24]

Hypertension-was an important predictor of MACCE in our study with 10% MACCE rate (P = 0.01).), although it was not directly found to be correlated in study by Lingman et al.[25]

LV dysfunction-was also an important predictor of MACCE in our study (P = 0.01). This was also observed in study by Mamas et al.[26]

While age, sex, stent length and diameter did not influence 1-year MACCE rate.

Recommendations

The key recommendations from study are

  1. A large multicentre randomized study needed to better delineate outcome of Indian origin stent in Indian population
  2. MACCE criteria should be standardized for better comparison of studies from different geographic region
  3. Since the study also confirm poor outcome among Indians with risk factor such as diabetes, hypertension, kidney disease, it brings out the need for intense screening and treatment of risk factors in the community
  4. Community awareness to be done regarding life style modification by information, education and communication.


Limitations

It is a nonrandomized observational analysis with total number of patients being small, a single center study which can have a selection bias. We also did not look at risk scores of study population as it was out of the objectives of the study and study follow-up was mere 1 year only due to protocol boundaries.


  Conclusion Top


This 1-year prospective single centre observational study for outcome of supraflex sirolimus eluting coronary stents for the treatment of CAD at tertiary cardiac centre in North India, showed high MACCE rate as compared available data in spite standard care of treatment. Diabetes, hypertension, kidney dysfunction, and LV Function strongly correlate with outcome (MACCE). Age, sex length of stent, diameter of stent, and type of lesion did not affect MACCE in our cohorts.

Acknowledgments

The authors would like to thank all the authors whose studies have been consulted while framing this manuscript. Also, Authors would like to the thank all the patients who particates out of their own will in this study, also we would like to pay our regards to the staff and administration of Batra Hospital and Medical Research Centre, New Delhi for their support during the study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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