Dataset Information

A prospective, observational, multicentre study comparing tenecteplase facilitated PCI versus primary PCI in Indian patients with STEMI (STEPP-AMI).

ABSTRACT:

Objective

To compare the efficacy of pharmacoinvasive strategy versus primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Primary PCI is the preferred treatment for STEMI, but it is not a feasible option for many. A pharmacoinvasive strategy might be a practical solution in the Indian context, although few empirical data exist to guide this approach.

Methods

This is a prospective, observational, multicentre pilot study. Two hundred consecutive patients with STEMI aged 18-75?years, presenting within 12?h of onset of symptoms and requiring a reperfusion strategy, were studied from five primary PCI capable centres in South India. Patients who opted for pharmacoinvasive strategy (n=45) formed group A. Group B consisted of patients treated with primary PCI (n=155). One patient was lost to follow-up at 1?year. The primary end point was a composite of death, cardiogenic shock, reinfarction, repeat revascularisation of a culprit artery and congestive heart failure at 30?days.

Results

The primary end point occurred in 11.1% in group A and in 3.9% in group B, p=0.07 (RR=2.87; 95% CI 0.92 to 8.97). The infarct-related artery patency at angiogram was 82.2% in group A and 22.6% in group B (p<0.001). PCI was performed in 73.3% in group A versus 100% in group B (p<0.001), and a thrombus was present in 26.7% in group A versus 63.2% in group B (p<0.001). Failed fibrinolysis occurred in 12.1% in group A. There was no difference in bleeding risk, 2.2% in group A versus 0.6% in group B, (p=0.4).

Conclusions

This pilot study shows that a pharmacoinvasive strategy can be implemented in patients not selected for primary PCI in India and hints at the possibility of similar outcomes. Larger studies are required to confirm these findings.

Trial registration number

TRIAL IS REGISTERED WITH CLINICAL TRIAL REGISTRY OF INDIA, CTRI NUMBER: REF/2011/07/002556.

SUBMITTER: Victor SM

PROVIDER: S-EPMC4189336 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

A prospective, observational, multicentre study comparing tenecteplase facilitated PCI versus primary PCI in Indian patients with STEMI (STEPP-AMI).

Victor Suma M SM Subban Vijayakumar V Alexander Thomas T G Bahuleyan C BC Srinivas Arun A S Selvamani S Mullasari Ajit S AS

Open heart 20140820 1

<h4>Objective</h4>To compare the efficacy of pharmacoinvasive strategy versus primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Primary PCI is the preferred treatment for STEMI, but it is not a feasible option for many. A pharmacoinvasive strategy might be a practical solution in the Indian context, although few empirical data exist to guide this approach.<h4>Methods</h4>This is a prospective, observational, multicentre pilot st ...[more]

PMID: 25332825

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Project description:ObjectivesTo describe the prehospital and in-hospital delays to care and factors associated with the delays among patients with ST-segment elevation myocardial infarction (STEMI) in non-percutaneous coronary intervention (PCI) hospitals in China.Design, setting and participantsWe analysed data from a large registry-based quality of care improvement trial conducted from 2011 to 2014 among 101 non-PCI hospitals in China. A total of 7312 patients with STEMI were included. Prehospital delay was defined as time from symptom onset to hospital arrival >120 min, first ECG delay as time from arrival to first ECG >10 min, thrombolytic therapy delay as time from first ECG to thrombolytic therapy >10 min and in-hospital delay as time from arrival to thrombolytic therapy >30 min. Logistic regressions with generalised estimating equations were preformed to identify the factors associated with each delay.ResultsThe rates of prehospital delay, first ECG delay, thrombolytic therapy delay and in-hospital delay were 67.1%, 31.4%, 85.8% and 67.8%, respectively. Patients who were female, older than 65 years old, illiterate, farmers, onset during late night and forenoon, had heart rate ≥100 beats/m at admission were more likely and patients who had history of myocardial infarction, hypertension or SBP <90 mm Hg at admission were less likely to have prehospital delay. First ECG delay was more likely to take place in patients arriving on regular hours. Thrombolytic therapy delay rate was lower in patients who had prehospital delay or first ECG delay but higher in those with heart rate ≥100 beats/m at admission. In-hospital delay rate was lower in patients with a history of dyslipidaemia and those who arrived during regular hours.ConclusionChinese patients with STEMI in low medical resource areas suffered severe prehospital and in-hospital delays to care. Future efforts should be made to improve the prehospital delay among vulnerable populations with low socioeconomic status.Trial registration numberNCT01398228; Post-results.

Project description:BackgroundCoronary physiology-guided PCIs are recommended worldwide. However, invasive coronary physiology methods prolong the procedure, create additional risks for the patients, and prolong the fluoroscopy time for an interventional cardiologist. Otherwise, there is a noninvasive coronary physiology evaluation method, QFR, that can be safely used even in STEMI patients.MethodsA total of 198 patients admitted with STEMI and at least one intermediate (35-75%) diameter stenosis other than the culprit artery between July 2020 and June 2021 were prospectively included in this single-center study. All patients were randomized into one of two groups (1 - QFR-guided PCI; 2 - visual-estimation-only guided PCI). A 12-month follow-up with echocardiography, exercise stress test, and quality of life evaluation was performed in all included patients. For the QOF evaluation, the Seattle Angina Score Questionnaire was chosen. Statistical analysis was performed using the Kolmogorov-Smirnov test, Student's t-test, Mann-Whitney U test, Pearson's chi-squared test and Kaplan-Meier estimator.ResultsNinety-eight (49.5%) patients were randomized to the first group, and 100 (50.5%) patients were included in the second group. Statistically, significantly more patients had a medical history of dyslipidemia (98 vs. 91, p = 0.002) and slightly better left ventricular ejection fraction (42.21 ± 7.88 vs. 39.45 ± 9.62, p = 0.045) in the QFR group. Six fewer patients required non-culprit artery revascularization within the 12-month FU in the QFR group (1.02% vs. 6%, p = 0.047). Survival analysis proved that patients in the Angio group had a more than 6-fold greater risk for death within a 12-month period after MI (OR 6.23, 95% CI 2.20-17.87, p = 0.006), with the highest mortality risk within the first two months after initial treatment.ConclusionUsing QFR in non-culprit lesions in patients with ST-elevation myocardial infarction reduces mortality and revascularization at the 12-month follow-up and improves the quality of life of the patient.Trial registrationThe study was approved by the Regional Bioethical Committee and conducted under the principles of the Helsinki Declaration and local laws and regulations.

Dataset Information

A prospective, observational, multicentre study comparing tenecteplase facilitated PCI versus primary PCI in Indian patients with STEMI (STEPP-AMI).

Objective

Methods

Results

Conclusions

Trial registration number

Publications

A prospective, observational, multicentre study comparing tenecteplase facilitated PCI versus primary PCI in Indian patients with STEMI (STEPP-AMI).

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