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Journal of Bangladesh College of Physicians and Surgeons Vol. 26, No. 1, January 2008

Percutaneous Transluminal Coronary Angioplasty (PTCA) and Stenting Study of 100 Cases
F RAHMANa, S BANERJEEb, CM AHMEDc, MS UDDINd, KHIRUL ANAMe MS ALAMf, KMHS S HAQUEg Summary:
This prospective ongoing study conducted in University Cardiac Center, BSMMU, Dhaka from July2004 to April2006. 100 patients (mean age 52.46.2 years) underwent Percutaneous Transluminal Coronary angioplasty and stenting (PTCA & stenting) were evaluated. This study was designed to evaluate the short term angiographic and clinical results of stentangioplasty during hospital stay. The study group of 100 patients consisted of 88 (88%) men and 12 (12%) women. About risk factors 36 (36%) had hypertension, 30 (30%) were smoker, 20 (20%) suffered from diabetes mellitus, 14 (14%) had family history of ischaemic heart disease. Average Left ventricular ejection fraction was 54.27. Target vessel PTCA were done on 130 vessels, intracoronary stent implanted in 124 vessels, direct stenting was done in 80 cases, failed PTCA were in 4 (4%) cases, and three patients had dissection. The native vessels had a mean reference diameter of 2.89 mm and their luminal diameter increased significantly after percutaneous coronary intervention (PCI). Thombolysis in myocardial infarction (TIMI) flow analysis showed most of the patients had TIMI-1 flow (95,73%) before the procedure and maximum patients achieved TIMI-3 flow (91, 70%) after the procedure with significant clinical improvement. All the patients were discharged by one to three days of the procedure with improvement of their clinical condition. So PTCA and Stenting is a safe and effective technique with high procedural success rate and good short-term (hospital) clinical results in the native coronary artery lesions. Key words: Coronary artery diseases; PTCA and stenting. (J Bangladesh Coll Phys Surg 2008; 26: 26-31)

Introduction: Percutaneous coronary intervention (PCI) is widely used to relieve angina and ischaemia because it is effective in this role. Since the introduction of coronary balloon angioplasty into the clinical practice in 19771 improvement in equipment design and operator experience have permitted this procedure to be applied to the treatment of a broad spectrum of coronary artery disease (CAD). Advances in coronary
a. b. c. d. e. f. g. Dr. F Rahman, MD, Associate Professor (Intervention Cardiology. Prof. S Banerjee, MD, Professor of Cardiology. Dr. CM Ahmed, MD, Associate Professor of Cardiology. Dr. MS Uddin, MD, Associate Professor of Cardiology. Dr. Khirul Anam, Asstt. Professor. Dr. MS Alam, MBBS, MD- Card Student. Prof. KMHS S Haque, FCPS, Professor of Cardiology.

Department of Cardiology, University Cardiac Center, BSMMU, Dhaka. Address of correspondence: Dr. Fazlur Rahman, Assoc. Prof. (Intervention Cardiology), Department of Cardiology, University Cardiac Center (UCC), Bangabandhu Sheikh Mujib Medical University, (Room # 231, Block # B) Shahabag, Dhaka, Bangladesh, Telephone: 01715-540407, 9344496 (R) Received: 30 November, 2006 Accepted: 23 September, 2007

based interventions, especially the use of bare-metal stents (BMS) and drug eluting stents (DES), have improved the efficacy and safety profile of percutaneous revascularization observed for patients undergong PTCA. Coronary angioplasty (PTCA) as a primary method for establishing coronary patency in patients with acute myocardial infarction is the riding crest of a wave of enthusiasm that threaten to engulf us and carry us off into the uncritical adoption2. Primary percutaneous coronary angioplasty (PTCA) has recently been advocated as the treatment of choice for patients with acute myocardial infarction3. Direct PTCA has been shown to have a high primary success rate (90%-99%) with few procedural complications and a low in-hospital mortality. It can establish TIMI grade III flow in upto 95% of patients within two hours of hospital admission4. Thrombolytic agents can not achieve this. Angioplasty has a more rapid action and greater success because it can dislodge and mechanically disrupt thrombus as well as reduce any residual coronary stenosis caused by atheroma. These actions reduce the risk of recurrent ischaemia, reocclusion and reinfarction4.

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With the combination of sophisticated equipment, experienced operators and modern drug therapy, PCI has evolved into an effective non- surgical modality of treatment. The efficacy of PTCA has recently improved by coronary stenting and adjunctive pharmacological therapy, such as aspirin5,6,7, clopidogrel8.9 and glycoprotein IIb/IIIa receptor blocker10. The outcomes of PCI are measured in term of success and complications and related to the mechanism of the employed procedure. The aim of the study was to evaluate the immediate (short-term) clinical and angiographic outcome following PTCA and stenting in patients with coronary artery disease. (CAD). Methods: Study Patients Between July 2004 to October 2006, 100 consecutive patients underwent PCI at University Cardiac Center (UCC), Banghabandhu Sheikh Mujib Medical University, Dhaka. The study group of patients consisted of 88 (88%) men and 12 (12%) women. With mean age of the patients was 52.46.2 years. (Table-01). Clinical inclusion criteria were symptomatic coronary artery disease with angina class I to IV and potential indication for coronary artery bypass surgery. Stenting procedure PTCA was done by technique as described by Gruentzig through femoral arterial approach according to modified seldinger technique. Outer diameter of guiding catheter was 7 to 8 French and 0.014 J steerable guidewire were used and dilatation was attempted using balloon catheter with 20-30 x 23 mm balloon size and balloon mounted stents were implanted at the target site. The balloon inflation pressure ranged from 4 to 14 atmosphere. Predilatation was performed using undersized, conventional angioplasty balloon before stenting. Stenting was not performed in a vessel with a diameter 2.5 mm, if the lesion was longer than 40 mm, in case of extreme vessel tortuousity, if a large thrombus was visible at lesion site. Medications, sheath removal and discharge All patients received aspirin (75 mg daily) indefinitely and clopidogrel (75 mg daily) 72 hours

before the procedure up to six month to one year after procedure. Intravenous heparin 10,000 unit IV was given as bolus during procedure and APTT was monitored. Sheath was removed after 4-6 hours and uncomplicated patients were discharged on next day. Outcome: The outcome of PCl are measured interms of success and complication and are related to the mechanism of the deployed devices as well as the clinical and anatomical patient-related factors. Complications can be divided into two categories; Those common to all arterial catheterization procedures and Those related to the specific technology used for the coronary procedure. With increased operator experience, new technology and adjunctive pharmacotherapy, the overall success and complication rate of angioplasty have improved. Definitions of PCI Success: The success of a PCI procedure may have the following components- angiographic success, procedural success and clinical success. Angiographic success- A successful PCI produces substantial enlargement of the lumen at the target site. Previously defination was the achievement of a minimum stenosis diameter reduction to <50% in the presence of grade 3 TIMI flow11. With the advent of advanced adjunct technology, including coronary stents, a minimum stenosis diameter reduction to <20% has been the bench mark of an optimal angiographic result. Procedural success- A successful PCI should achieve angiographic success without in hospital major clinical complications eg. death, myocardial infarction, emergency coronary artery bypass surgery during hospitalization 11,12. Clinical success- clinically successful PCI includes anatomic and procedural success with relief of signs and or symptoms of myocardial ichaemia after the patient recovers from the procedure13,14. Definitions of procedural complications. According to the 1998 coronary interventional document13 27

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procedural complications are dovided into six basic categories: death, MI, emergency CABG, stroke, vascular access site complications and contrast agent nephropathy. Results: In this study 36 (36%) patients had history of hypertension, 30 (30%) were smokers, 20 (20%) were diabetic, 14 (14%) had family history of ischaemic heart disease. Average left ventricular ejection fraction (LVEF) was 54.2 7 (Table-I). Among these cases coronary vessel involved in 147 cases, target vessels were 130, PTCA was done in 124 and intracoronary stent deployed in 124 patients (Table-II). Most of the patients in study presented as a case of post MI angina (38%) followed by stable angina pectoris (18%) (Table-I) Single vessel disease was 60 (60%), double vessel disease was 33 (33%). triple vessel disease was 7 (7%). (Table-II). Majority of the patient had Type A Lesion 81 (62.3%). 93 (93%) patients had clinical success, 95 (95%) patient had angiographic and procedural success (Table-VI). All the stent implantation procedures were successful except1 five. In particular, there was one stent displacement. Intracoronary stent implanted in LAD 71 (57.3%), (Fig 1.a.b) LCX 24 (19.4%), RCA 16(12.9%) (Fig-2, a,b). Diagonal 10 (8.07%) and Marginal 3 (2.4%) (Table-03). Failed PTCA were in five cases due to tortuousity of vessels or total occlusion not crossed by PTCA wire or balloon. Bere metal stents (BMS) were deployed in most of the patient (71.8%) (Table-IV). with mean diameters (mm) 2.89+02 and mean leangth of 14.68 mm+2. TIMI Grade 03 flow was in 91 patients (70%) (Table V). Three patients developed coronary artery dissection during the procedures who needed immediate intracoronary stent deployment. Stentangioplasty were successfully done in 12 patients with CTO and failed in 3 (three) patient due to failure in crossing guide wire. Three patients developed ischaemic pain and two patients developed heart failure and six patients developed major arrhythmias (Table-VII). 28

Table-I Baseline charectersties of study population (n=100) Demography/other features Mean age (year) Male Female Risk Factors Smoking Hypertension DM Dyslipidaemia Positive F. History Clinical Diagnosis Stable angina pectories Unstable Angina AMI (Ant and Inf) Recent MI (Ant. Sept & Inf.) Post MI Angi na. Anierior MI INferior MI Combined Ejection fraction (mean) N (% SD) 52.4+6.2 88 (88%) 12 (12%) 30 (30%) 36 (36%) 20 (20%) 13 (13%) 14 (14%) 28 (28%) 18 (18%) 09 (09%) 07 (07%) 38 (38%) 24 (24%) 08 (08%) 06 (06%) 54.207

Table-II Angiographic diagnosis of study population (n =100)

Vessels Total diseased vessels Total target vessel Single vessel disease Double vessel disease Triple vessel disease Total Number 147 130 60 33 7 Percentage (%) 60 33 7

Table-III Site of stent deployment in the target vessel (n = 124) Site LAD LCX RCA Diagonal Marginal Total number 71 24 16 10 3 Percentage (%) 57.3 19.4 12.9 8.07 2.4

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Table-IV Characteristic of deployed stents in the target vessels (n =124)

Parameters Types Bare metal Drug coated Drug eluting Diameter 2.5 mm 2.75 mm 3.00 mm 3.5 mm 4.0 mm Mean diameter = 2.89 2 (mm) Length (mm) : Range ( 0-10) Range (10-19) Range (20-29) Range (30-39) Meanlength = 14.68mm 2 26 78 18 2 21 63 14.5 1.6 35 26 45 15 3 28.2 21 36.3 12.1 2.4 89 32 3 71.8 25.8 2.4 Dissection Acute stent thrombosis Acute MI Acute LVF Failed PTCA Major arrhythmias (e.g. VT. VF) Death Total no Percentage %

Table-VII In-hospital clinical outcome of study population (n = 100).

Parameters Total number Patient 3 0 3 5 4 6 1 Percentage (%) 3 0 3 5 4 6 1

Discussion: Based on our result, we believe that all types of PTCA and intracoronary stenting can play an important role in the treatment of symptomatic coronary artery diseases. Our in hospital mortality rate was one (%) comparing favorably with the results obtained in the previous angioplasty trials15,16,17. The mean age of our study population was 52.4 6.2 years, which is earlier age than other studies16, 18. Early recurrent ischaemia occurred in 4 (4%) patients in our series. Grines LC et al and Moreno R et al showed early recurrent ischaemia after PTCA in 5.1% and 6.5%, cases in their series15,18, which are very close to our study and other studies in our country13,14. Chest pain without changes on ECG just after PTCA occurred in cases which simulate the results of other study15. Two patients had reappearance of symptoms within 1 month. Check angiogram of them were done which showed normal functioning of the stents. Thrombus containing lesions have been considered as contraindication for stentangioplasty. Stents were successfully deployed in two patients containing thrombus in LAD (Proximal) and LCX (distal) after treatment with low molecular weight heparin. Studies have shown that presence of angiographicaly visible thrombus as a risk factor for subsequent stent thrombosis16. However, other have represented coronary stenting as safe and effective therapy for thrombus containing lesion17,18. 29

Table-V TIMI flow of the target vessels (n= 130)

Parameter (TIMI flow) Before procedure Number (%) 10(8%) 95(73%) 25(19%) 0(0%) After procedure Number (%) 6(4.6%) 0(0%) 33(25.4%) 91(70%)

Grade -0 Grade -1 Grade -2 Grade -3

Table-VI Result of stentangioplasty of study population (n =100) Results Clinical success Angiographic success Procedural success Total number 93 95 95 Percentage % 93 95 95

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Elective stenting was done in most (80%) of patients. Similar elective stenting have also been reported by Moussa et al, Colombo et al20 and Kimura et al21 (70%, 67% and 71% respectively). This study showed stenting as modality of treatment for suboptimal PTCA, acute vessel closure, dissection during PTCA and restenosis following PTCA similar to those reported as an indications for stenting by various authors14,22,23,27. Hence unlike PTCA, this success of intracoronary stenting is not influenced by lesion morphology. Recently developed drug eluting stents have reduced the incidence of restenosis drastically to 8 to 10%. Ten years follow up of initial Cohort of patients treated PTCA revealed 89.5% survial rate (95% with single vessel disease, 81% in-patients with multivessel disease24). In patients undergoing with the 1985-1986 NELBL PTCA registry25 a five year survival was 92.9% for double vessel disese and 86.5% for triple vessel disease. In patients with multivessel disease undergoing PTCA in BARI26 5 year survival was 86%. infarct free survival was 78.7%. Specifically 5 year survival was 84.7% with TVD, 87.6% with DVD (Double vessel disease). Percutaneous intervention (PCI) of the chronic total occlusion (CTO) lesion present great challenge including reduced success rate, prolonged procedure time, large amount of contrast use, high occlusion rate, and costs. The goal of intervention in CTO is to penetrate the total occlusion and pass the wire in the true luman of the distal vessel without causing stent angioplasty intimal dissection, Accordingly we have successfully done stentangioplasty in 12 patients with CTO and failed in three patient due to failure of passing the wire. Limitation of the Study: This is single center observational prospective study to assess the safety and short-term clinical and angiographic outcome of small number of patients. Further randomized trial may be needed for the better result. Conclusion: Percutaneous coronary intervention (PCI) have revolutionized the effective management of coronary artery disease and their symptoms. It has been 30

increasingly demonstrated to reduce the risk of adverse events in patients with acute coronary syndrome (ACS). Intracoronary stent implantation in coronary artery stenosis following PTCA is a valid strategy with good clinical and angiographic inhospital results. This very study is an initial experience in a new center with small number of patients may serve as an impetus for future large scale study in home and abroad. Acknowledgment: As authors we really appreciate the help and efforts of Dr. Nargis Akhtar, Farzia Hasan Mumu, Mr. Shahanewj, Master Pronto and the concerned catheterization lab team of UCC, BSMMU for their help to make this article. References:
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