Figure 1
Flowchart of Patient Recruitment. A total of 1,237 STEMI patient were included in all-inclusive registry between September 2014 and September 2015; 646 patients underwent primary PCI with follow-up of 84% at one year. 290 patients underwent PhI with one year follow-up of 82%. We excluded 301 subjects who received lysis therapy only.
Table 1
Patients Baseline Characteristics.
| Characteristic | Primary PCI (n = 646) | PhI (n = 290) | p-value |
|---|---|---|---|
| Age | |||
| Overall (years), mean (SD) | 53.7 (10.2) | 52.3 (10.2) | 0.055 |
| ≥ 75 year, n (%) | 20 (3.1%) | 10 (3.4%) | |
| Female sex, n (%) | 41 (6.3%) | 17 (5.9%) | 0.88 |
| Weight (kg), mean (SD) | 78.9 (14.5) | 80.4 (14.0) | 0.16 |
| BMI (kg/m2), mean (SD) | 27.7 (4.6) | 27.7 (4.4) | 0.96 |
| Heart Rate (beats/min), mean (SD) | 83.1 (19.4) | 79.3 (17.7) | 0.005 |
| Systolic BP (mmHg), mean (SD) | 136.7 (29.5) | 135.3 (28.6) | 0.56 |
| Creatinine (mg/dl), mean (SD) | 1.0 (0.6) | 0.9 (0.2) | 0.01 |
| Hemoglobin (g/dl), mean (SD) | 15.3 (7.3) | 15.4 (8.5) | 0.89 |
| Killip Class I at Time of Arrival, n (%) | 575 (89.0%) | 275 (95.2%) | 0.001 |
| Anterior MI, n (%) | 342 (52.9%) | 143 (50.7%) | 0.53 |
| Time from symptom onset to hospital arrival <3 hours, n (%) | 452 (70.0%) | 209 (72.1%) | 0.54 |
| Risk factors, n (%) | |||
| Previous PCI | 62 (9.6%) | 21 (7.2%) | 0.26 |
| Previous CABG | 7 (1.1%) | 3 (1.0%) | 0.99 |
| Previous MI | 73 (11.3%) | 32 (11.1%) | 0.99 |
| Peripheral Arterial Disease | 9 (1.4%) | 2 (0.7%) | 0.52 |
| Previous Stroke | 20 (3.1%) | 1 (0.3%) | 0.007 |
| Hypertension | 249 (38.5%) | 112 (38.6%) | 0.99 |
| Diabetes Mellitus | 225 (34.8%) | 92 (31.7%) | 0.37 |
| Dyslipidemia | 181 (28.0%) | 73 (25.2%) | 0.38 |
| Current or Recent Smoker | 325 (50.3%) | 140 (48.3%) | 0.57 |
[i] CABG = coronary artery bypass graft; MI = myocardial infarction; PCI = percutaneous coronary intervention; PhI = pharmacoinvasive; SD = standard deviation.
Table 2
Key Time Intervals in primary PCI and pharmacoinvasive groups.
| Unit | Primary PCI (n = 646) Median [IQR] | PhI (n = 290) Median [IQR] | p-value | |
|---|---|---|---|---|
| Time from symptom onset to first hospital arrival | Minute | 115 [60, 201] | 113 [60, 196] | 0.67 |
| Time from hospital arrival to first ECG | Minute | 5 [4, 10] | 12 [7, 19] | <0.001 |
| Door-to-balloon time among all primary PCI group | Minute | 68 [45, 100] | NA | NA |
| Patients presenting to primary PCI facility n = 482) | Minute | 58 [40, 84] | NA | NA |
| Patients presenting to non-primary PCI facility (n = 150) | Minute | 99.5 [79, 137] | NA | NA |
| Door-to-needle time | Minute | NA | 35 [23, 55] | NA |
| Time from administration of fibrinolytic therapy to catheterization among all PhI group | Hours | NA | 16.6 [9.5, 22.5] | NA |
| Time from symptom onset to catheterization lab | Hour | 3.3 [2.2, 5.1] | 19 [12.5, 27.0] | NA |
[i] IQR = interquartile range; NA = not applicable; PCI = percutaneous coronary intervention; PhI = pharmacoinvasive.
Table 3
Details of Procedures Performed.
| Primary PCI (n = 646) | PhI (n = 290) | p-value | |
|---|---|---|---|
| PCI Performed | 635/646 (98.4%) | 233/288 (80.6%) | <0.001 |
| Stent(s) Placed | 613/643 (95.3%) | 229/273 (83.9%) | <0.001 |
| Access Site | |||
| Brachial | 1 (0.2%) | 0 (0.0%) | <0.001 |
| Femoral | 290 (45.0%) | 72 (25.0%) | |
| Radial | 354 (54.9%) | 216 (75.0%) | |
| Access Site Complications | |||
| Hematoma | 12 (1.9%) | 0 (0%) | 0.023 |
| Occlusion | 2 (0.3%) | 0 (0%) | 0.99 |
| Pseudoaneurysm | 1 (0.2%) | 1 (0.3%) | 0.52 |
| Peripheral embolization | 0 | 0 | NA |
| AV fistula | 0 | 0 | NA |
| Culprit artery | |||
| LM | 6 (0.9%) | 2 (0.7%) | 0.06 |
| LAD | 342 (53.1%) | 142 (49.1%) | |
| Circumflex | 86 (13.4%) | 34 (11.8%) | |
| RCA | 197 (30.6%) | 95 (32.9%) | |
| Others | 13 (2.0%) | 16 (5.5%) | |
[i] AV = arteriovenous; LAD = left anterior descending; LM = left main; NA = not applicable; PCI = percutaneous coronary intervention; PhI = Pharmacoinvasive; RCA = right coronary artery.
Table 4
In-hospital and at Follow-up Outcomes.
| Primary PCI n/N (%) | PhI n/N (%) | p-value | |
|---|---|---|---|
| In-hospital composite Outcome of death, reinfarction, stroke, or CHF | 27/646 (4.2%) | 7/290 (2.4%) | 0.12 |
| Death | 11/646 (1.7%) | 3/290 (1.0%) | 0.57 |
| Reinfarction | 7/645 (1.1%) | 3/285 (1.1%) | 1.00 |
| Stroke | 2/634 (0.3%) | 0/279 (0%) | 1.00 |
| CHF | 10/597 (1.7) | 1/271 (0.4%) | 0.19 |
| Any Bleeding | 13/646 (2.0%) | 4/290 (1.4%) | 0.61 |
| Major Bleeding* | 10/646 (1.5%) | 2/290 (0.7%) | 0.36 |
| Transfusion | 11/646 (1.7%) | 0/290 (0%) | 0.02 |
| Composite outcome: death, reinfarction, stroke or CHF at follow up | |||
| 1 month | 16/595 (2.9%) | 3/260 (1.2%) | 0.77 |
| 6 months | 11/537 (2.0%) | 6/244 (2.5%) | 0.79 |
| 12 months | 16/493 (3.3%) | 8/224 (3.6%) | 0.83 |
| Total loss to follow-up (over study period) | 99/619 (16%) | 50/283 (17.7%) | 0.56 |
[i] CHF = congestive heart failure; PCI = percutaneous coronary intervention; PhI = Pharmacoinvasive.
* Any overt sign of hemorrhage that is actionable and requires diagnostic studies, hospitalization or treatment by health care professional.
Figure 2
Subgroup analyses for the risk of developing in-hospital composite outcome comparing the two interventions. There was no difference between primary PCI and PhI in terms of in-hospital composite outcome (death, reinfarction, CHF and stroke) in the overall group and subgroup analysis using following categories: age, sex, diabetes, dyslipidemia, smoking status, Killip score, MI location, duration from symptom onset to hospital arrival and hypertension. All models were adjusted for baseline systolic blood pressure, baseline heart rate and baseline BMI.
Figure 3
One-year follow-up: Poisson Proportional Hazard Model. No difference was found between primary PCI and PhI in terms of the incidence rate of the composite outcome at one year using survival model looking, after sorting the total of person-days contributed by each individual for three time intervals at 1, 6, and 12 months.