Table 2.
Primary and Secondary Angiographic and Electrocardiographic Outcomes
| Outcome | Randomly Assigned Groups |
Odds Ratio (95% CI) |
p Value† | Registry (N = 310) |
|
|---|---|---|---|---|---|
| Immediate Stenting (n = 49) |
Deferred Stenting (n = 51)∗ |
||||
| Primary outcome | |||||
| No- or slow-reflow (TIMI 0 to 2)‡ | |||||
| Yes | 14 (28.6) | 3 (5.9) | 0.16 (0.03–0.63) | 0.005 | 45 (14.5) |
| Secondary angiographic outcomes | |||||
| No-reflow (TIMI grade 0 or 1) | |||||
| Yes | 7 (14.3) | 1 (2.0) | 0.12 (0.03–1.02) | 0.052 | 16 (5.2) |
| Final TIMI coronary flow grade post-PCI§ | |||||
| 3 | 39 (79.6) | 50 (98.0) | 273 (88.6) | ||
| 2 | 6 (12.2) | 0 (0.0) | 0.08 (0.01–0.65) | 0.018 | 25 (8.1) |
| 0/1 | 4 (8.2) | 1 (2.0) | 10 (3.2) | ||
| Final TIMI myocardial blush grade post-PCI‖ | |||||
| Missing | 0 | 1 | |||
| 3 | 26 (53.1) | 40 (80.0) | |||
| 2 | 18 (36.7) | 9 (18.0) | 0.28 (0.11–0.65) | 0.004 | — |
| 0/1 | 5 (10.2) | 1 (2.0) | |||
| No- or slow-reflow (TIMI grades 0–2), with MBG ≤1 | |||||
| Missing | 0 | 1 | |||
| Yes | 5 (10.2) | 1 (2.0) | 0.18 (0.00–1.72) | 0.195 | |
| No- or slow-reflow (TIMI grades 0–2), with MBG ≤2 | |||||
| Missing | 0 | 1 | |||
| Yes | 12 (24.5) | 2 (4.0) | 0.13 (0.01–0.64) | 0.007 | |
| All intraprocedural thrombotic events | 28 | 9 | — | — | 68 |
| Patients with at least 1 intraprocedural thrombotic event | 16 (32.7) | 5 (9.8) | 0.23 (0.06–0.73) | 0.010 | 63 (20.3) |
| Distal embolization | 10 (20.4) | 1 (2.0) | 0.08 (0.02–0.60) | 0.006 | 5 (1.3) |
| Other secondary outcome | |||||
| ECG: resolution of ST-segment elevation 60 min post-PCI | — | ||||
| Complete, ≥70% | 19 (38.8) | 26 (50.0) | |||
| Partial, 30% to <70% | 21 (42.9) | 15 (28.8) | 0.77 (0.37–1.6) | 0.484 | |
| None, ≤30% | 9 (18.4) | 11 (21.2) | |||
Values are n (%). At the end of the final PCI, the percentage of diameter stenosis, final stent diameter, reference vessel diameter ratio, and corrected TIMI frame count were similar in both groups. In the deferred group, TIMI coronary flow grade, reference vessel diameters, final corrected TIMI frame count, and myocardial blush grade at the start of the second procedure compared with the end of the first procedure were similar in both groups.
CI = confidence interval; MBG = myocardial blush grade; other abbreviations as in Table 1.
One of the patients in the deferred group did not have a second procedure because of failed vascular access; therefore, data from 51 participants in the deferred group have been included in the intention-to-treat analysis.
The p value is the comparison between the immediate stenting group and the deferred group. Compared with the immediate stenting group, a lower proportion of patients in the registry group experienced no-/slow-reflow (45 [14.5%] vs. 14 [28.6%]; p = 0.01).
No- or slow-reflow was assessed at any time during or at the end of PCI.
TIMI coronary flow grade was assessed post-PCI, at the end of the procedure, and was not assessable in 2 patients in the deferred group. The odds ratios for coronary flow grade post-PCI are the odds ratio for achieving a lower score in the deferred group relative to the immediate stenting group. The odds ratio calculations are described in the Methods section.
TIMI MBG was assessed post-PCI, at the end of the procedure, and was not assessable in 2 patients in the deferred group. The odds ratios for TIMI MBG post-PCI are the odds ratio for achieving a lower score in the deferred group relative to the immediate stenting group. Corrected TIMI frame count was not assessable in 9 patients in the immediate stenting group and in 3 patients in the deferred group (data not shown).