DEPARTMENT OF PHARMACY PRACTICE

SULTAN UL ULOOM COLLEGE OF PHARMACY

(Approved by AICTE & PCI, Affiliated to JNTUH)
Mount Pleasant, Road No.3,Banjara Hills, Hyderabad 500 034

Project Protocol Review

PROJECT TOPIC –COMPARISON OF POST SURGICAL MANAGEMENT OF

PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY AND CORONARY ARTERY
BYPASS GRAFT
PHARM D- PB (2nd
year)
ZOHRA MUSHARRAF- 19455T0010 SUFIYA FATIMA - 19455T0007

Under the guidance of -Dr. MIR MANSOOR SULTAN

(Assistant professor – sultan ul uloom college of
pharmacy)
 INTRODUCTION

Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical

technique for treating obstructive coronary artery disease, including unstable angina, acute myocardial
infarction (MI), and multivessel coronary artery disease (CAD) PTCA, or percutaneous transluminal
coronary angioplasty, is a minimally invasive procedure that opens blocked coronary arteries to improve
blood flow to the heart muscle.
CABG may be performed as an emergency procedure in the context of an ST-segment elevation MI
(STEMI) in cases where it has not been possible to perform percutaneous coronary intervention (PCI) or
where PCI has failed and there is persistent pain and ischemia threatening a significant area of
myocardium despite medical therapy.

Indications
PTCA
Persistent chest pain (angina) Blockage of only one or two coronary arteries.
CABG
The chief anatomical indications for CABG are the presence of triple-vessel disease, severe left
main stem artery stenosis, or left main equivalent disease (ie, 70 percent or greater stenosis of
left anterior descending and proximal left circumflex artery)—particularly if left ventricular
function is impaired.
Complications PTCA

Bleeding at the catheter insertion site

Blood clot or damage to the blood vessel at the insertion site Blood clot within the vessel treated by ptca/stent
Infection at the catheter insertion site
Cardiac dysrhythmias/arrhythmias (abnormal heart rhythms)
Myocardial infarction
Rupture of the coronary artery, requiring open-heart surgery

Complications CABG

Bleeding during or after the surgery.

Blood clots that can cause heart attack,
stroke, or lung problems.
Infection at the incision site.
Pneumonia.
 LITERATURE REVIEW.

Sean van Diepen, MD, MSC, et al. (2018) published an observational study titled "Dual Antiplatelet Therapy Versus Aspirin monotherapy in
Diabetics With Multivessel Disease Undergoing CABG," which found that the usage of DAPT in diabetic patients after CABG was high in our
sample. There were no changes in cardiovascular or bleeding outcomes between DAPT and aspirin monotherapy, suggesting that routine use
of DAPT may not be therapeutically required.
 
In 2014, Fang zhouliu et al published a retrospective study titled Mortality within 24 Hours of Coronary Intervention is Greater in Women than
Men, which found that mortality within 24 hours of PTCA in patients who did not have emergency CABG is more than three times higher in
women than men, despite similar age, extent of coronary disease, and procedural reduction of luminal stenosis. Non-cardiac problems in
women may be a significant factor, despite the fact that the cause of the increased mortality in women is unknown.
 
Kaneez Fatima, Mohammad ul-Islam, Mehreen Ansari, Faizan Imran Bawany, Muhammad Shahzeb Khan, Akash Khetpal, Neelam Khetpal,
Muhammad Nawaz Lashari, Mohammad Hussham Arshad, Raamish Bin Amir, Qaiser Hasan Zaidi and others following a systematic review of
post-procedural quality of life following cabg and pci in this study, we've assembled the most essential literature comparing cabg with
angioplasty in terms of postprocedural qol. Our data suggest that, whereas angioplasty may provide a better short-term qol due to its less
invasive nature, CABG is preferable in the long run.
 AIMS AND OBJECTIVES

AIM:
The aim of the research is to study the comparison of post surgical management of percutaneous
     transluminal coronary angioplasty and coronary artery bypass graft
 
OBJECTIVES:

The objective of the study is

1. To evaluate the frequency of use of drugs used in post surgical management of PTCA and
CABG

2. To evaluate complications, mortality rates of PTCA and CABG in our study setup

3. To perform cost analysis in PTCA vs. CABG and Type of vessel disease

4. To compare efficacy of DAPT in PTCA vs. CABG

5. Post operative length of hospital stay in PTCA vs. CABG

6. To evaluate the outcome of patient counseling in cardiac revascularization outcome questioning

 MATERIALS AND METHODS

 
Study Design:
This is a Retrospective study performed in Department of cardiology.
 
Study site:
The study was conducted in century super specialty hospital Banjara hills rd. no 12
 
Study Duration:
The study was performed for a period of six months from December                   2020 to May 2021
 
Sample Size:
The sample size is 70 patients out of which 48 patients are undergoing PTCA and 22 patients of CABG are taken into consideration for the
study.
 
Inclusion Criteria:
Patients of either sex of age above 18 who had undergone PTCA and CABG
Patients with and without Diabetes and hypertension 50% each, both male and female
 
Exclusion Criteria:
1. Pregnant women.
Patient age below 18 years.
Patients with Chronic Kidney Disease.
Patients on Dialysis.

Study Materials:
1. Annexure – I (Patient Data Collection Performa).
2. Annexure – II (Lab Investigation Table).
Study Procedure:
The following data was collected:
 Patient details like age, gender, medical history

 Frequency of medication use, patient procedure (PTCA, CABG),ejection fraction after

procedure

 Length of hospital stay, cost benefit analysis (PTCA vs. CABG)

 Type of vessel disease

 Patients were counseled about understanding post procedure and its complications,
management, lifestyle modifications and diet.
 CROQ was designed to access post procedure response of patient (positive/negative)

Sources of Data:
 Patient’s case sheets and treatment charts.

 Patient data collection form.

 Verbal Information from the patient during counselling.

 CROQ questionnaire.

Statistical analysis:
In the statistical analysis, the patient data were analyzed using average means, standard

deviation and correlation between variables was found using the Pearson’s correlation
coefficient Pearson Chi-Square Fisher's Exact Test and comparison of means was done
using one- way ANOVA. Then post –hoc analysis was done using the Tukey HSD test.
All the above analyses were done using statistical software SPSS and a p-value of less
than 0.05 was considered to be statistically significant.
DISCUSSION
Correlation between length of hospital stay and procedure (PTCA ,CABG) was performed using the
Pearson correlation coefficient (with a two-tailed test of significance) for each pair of variables i.e.
length of hospital stay and procedure(PTCA ,CABG). The mean for CABG was found to be 5.73, STD
deviation 2.763, and the mean for PTCA was found to be 1.90, STD deviation 0.805. The results
demonstrated that the length of hospital stay and procedure with correlation value (r=
0.0000000000005490075) and sig. (2 tailed) p-value is less than 0.05 that is it is statistically
significant.

CABG outperforms angioplasty in terms of improving quality of life at 6 and 12 months after
surgery, as well as in the long term, according to our findings. While angioplasty may provide
ahigher QOL in the short term due to its less invasive nature. Higher percentage (90.9%) of
subjects shows better quality of life in CABG than PTCA

Patient counseling results show intervention group has lesser complications than control group.
Counseling, in particular, reduced post-discharge issues and hospital readmissions significantly
CROQ had a high number of positive responses before PTCA and a large number of negative
replies after PTCA. The number of positive CROQ PRE CABG responses was high, whereas
the number of negative responses was also significant after CABG.
In PTCA (58%) and CABG (54%) patients, dual antiplatelet treatment was more effective than aspirin
monotherapy in decreasing major adverse cardiovascular events (MACE) For each pair of variables,
i.e. age and procedure undergone PTCA, CABG, the Pearson correlation coefficient (with a two-tailed
test of significance) was used to determine the correlation between age and procedure undergone in
CABG and PTCA patients. The mean for CABG was 59.23, with a standard deviation of 10.56, and
the mean for PTCA was 60.25, with a standard deviation of 14.48. The findings revealed that age and
PTCA, CABG procedures are significantly positively connected (r= -0.394) and thatthe sig. (2 tailed)
p-value is less than 0.05, indicating that it is statistically significant
REFERENCES

1. Favaloro RG. Saphenous vein autograft replacement of severe segmental coronary artery occlusion: operative
technique. Ann Thorac Surg 1968;5: 334-9.
2. 2. The Veterans Administration Coronary Artery Bypass Surgery Cooperative Study Group. Eleven-year survival
in the Veterans Administration randomized trial of coronary bypass surgery for stable angina. N Engl J Med
1984;
3. 311:1333-9. 3. Varnauskas E, European Coronary Surgery Study Group. Twelve-year follow-up of survival in the
randomized European Coronary Surgery Study. N Engl J Med 1988;319:332-7.
4. 4. Alderman EL, Bourassa MG, Cohen LS, et al. Ten-year follow-up of survival and myocardial infarction in the
randomized Coronary Artery Surgery Study. Circulation 1990;82:1629-46.
5. 5. Detre KM, Peduzzi P, Murphy M, et al. Effect of bypass surgery on survival of patients in low- and high-risk
subgroups delineated by the use of simple clinical variables: Veterans Administration cooperative study of
surgery for coronary arterial occlusive disease. Circulation 1981;63:1329-38.
6. 6. The BARI Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel
disease. N Engl J Med 1996;335:217– 35.
7. 7. Jones RH, Kesler K, Phillips HR III, et al. Long-term survival benefits of coronary artery bypass grafting and
percutaneous transluminal angioplasty in patients with coronary artery disease. J Thorac Cardiovasc Surg
1996;111: 1013–25.
8. 8. The Writing Group for the Bypass Angioplasty Revascularization (BARI) Investigators. Five-year clinical and
functional outcome comparing bypass surgery and angioplasty in patients with multivessel coronary disease: a
multicenter randomized trial. JAMA 1997;277:715–21.
9. 9. Califf RM, Harrell FE, Lee KL, et al. The evolution of medical and surgical therapy for coronary artery
disease: a 15-year perspective. JAMA 1989;261: 2077–86. 10. Favaloro RG. Direct myocardial
revascularization: a
10. 10 year journey. Myths and realities. Louis F. Bishop Lecture. Am J Cardiol 1979;43:109–29.
 CONCLUSION
A questionnaire containing 16 questions was designed to assess the patient’s cardiac revascularization
outcomes and evaluated forthe positive and negative response. The number of patients showing positive,
negative and neutral responses for each question was analyzed for positive and negative responses. The
results are distinguished as pre PTCA and post PTCA and pre CABG and post CABG. Cardiovascular
surgery patient counselling has been shown to improve patients' post-discharge results. Patients and their
familiesrequire counselling to gain the information and skill to manage their post-cardiac surgery issues
because self-management abilities are rarely innate. Counselling, in particular, resulted in a significant
In patients undergoing PTCA and CABG, we have compared the readings of cost and type of vessel
disease and correlation between them was found using Paired T-Test and Pearson’s coefficient. As the
p- value is less than 0.05 there is a significantdifference between cost and type of vessel disease. The
cost of the procedure rises as the number of occluded vessels (single, double, multiple) rises, as
additional drug-eluting stents or grafts may be required depending on the treatment.

In patients undergoing PTCA and CABG, we have compared the readings of length of hospital stay
and procedure underwent and correlation between them was found using Paired T-Test and Pearson’s
coefficient. As the p- value is less than 0.05 there is asignificant difference, association between length
of hospital stay and procedure underwent. Patients undergoing coronary artery bypass graft surgery are
undergoing extensive surgery. The length of a patient's stay is determined by a number of criteria,
including their age and risk profile, problems (even mild ones). Variables that determine the length of
stay may also rise when the profiles of patients undergoing CABG surgery change as a result of
increased age and concomitant condition, as well as the effects of invasive cardiology treatments in
CABG. Additionally, the presence of specific postoperative risk factors in patients contributes to
patients spending more time in the hospital following CABG
Both PTCA and CABG showed a significant improvement in LVEF over baseline. At 6 months, patients
who had CABG had ahigher LVEF than those who had PCI. CABG should remain the revascularization
strategy of choice in patients with LVEF lessthan 40% and multivessel triple vessel CAD, according to
our findings; however, PTCA also shows a significant, albeit more moderate, increase in LVEF, and
may be considered in patients with single vessel and double vessel disease or in patients whorefuse
CABG or are deemed unsuitable for surgery.

In patients undergoing PTCA and CABG, we have compared the readings of cost and type of vessel
disease and correlation between them was found using Paired T-Test and Pearson’s coefficient. As the
p- value is less than 0.05 there is a significantdifference between cost and type of vessel disease. The
cost of the procedure rises as the number of occluded vessels (single, double, multiple) rises, as
additional drug-eluting stents or grafts may be required depending on the treatment.

For one month following CABG, dual antiplatelet therapy with aspirin and clopidogrel was not as
effective as DAPT used in PTCA. In the PTCA trial, dual antiplatelet medication with aspirin and
clopidogrel was found to be an effective treatment for reducing thrombotic problems and significant
adverse cardiovascular events in a wide range of patients who had coronary artery stenting.
THANK YOU