Angiographic no-reflow during primary PCI procedures occurs at relatively high rate (25%) and is associated with worsening of long term morbidity and mortality. The exact mechanism of no-reflow is not fully understood, yet it is believed to be multifactorial including microvascular plugging with activated platelets and thrombotic debris in addition to the microvascular dysfunction from the ischaemia-reperfusion injury.
Despite a theoretical advantage of glycoprotein IIb/IIIa inhibitors (GPi) (like; Tirofiban) to suppress the intense platelets' activation/reaction; their use did not lead to a significant net benefit, because it was opposed by increased risk of bleeding.
However, the bleeding that plagued GPi use was predominantly related to vascular access in the era femoral approach was the default. Moreover, there are some recent data suggesting that small intracoronary bolus of GPi was non-inferior to intravenous bolus-infusion dose with less bleeding events.
This study plans to assess upfront premedication with small doses of GPi + Nitroglycerin ± Verapamil, with staged restoration of flow (repeated balloon inflation) to reduce angiographic no-reflow and CMR assessed microvascular occlusion (MVO).
STEMI patients with time from symptom onset of < 24 hours duration.
Large thrombus burden confirmed after initial wiring.
Radial vascular access.
STEMI patients receiving successful fibrinolytic therapy.
TIMI flow ≥ 1 or TIMI thrombus grade ≤ 3 at initial wiring.
Refusal to participate int the study, or unable to be consented (unconscious or comatose patients).
Femoral access.
Parallel
Upfront preparation of microcirculation to minimize risks of no-reflow and reperfusion injury
Other interventionTirofiban (intra-coronary bolus of 25µg/Kg) + Nitroglycerin (intracoronary 100-200 µg) + Verapamil (intracoronary 100-200 µg, yet excluding patients with 2nd or 3rd degree AV block, HR \< 60, or SBP \<100 mmHg) + 2 cycles of intermittent balloon inflation
Efficacy endpoint: Reducing rates of suboptimal PCI results
Sub-optimal PCI results defined as any of: 1. Final TIMI flow \< 3, TIMI myocardial blush grade \< 3, corrected TIMI flow count (cTFC) \< 20, 2. Occurrence of TIMI flow \< 3 during stenting/post dilation, (no reflow) 3. ST elevation resolution \< 50% in the index lead assessed within 30m from the procedural end.
Safety endpoint: Occurrence of intrahospital BARC types 3 or 5 bleedings
Occurrence of intrahospital BARC types 3 or 5 bleedings
Occurrence of slow flow/no reflow after stent deployment or stent optimization (TIMI flow < 3)
occurrence of TIMI flow \< 3 after stent deployment or post stent optimization
Final TIMI flow
TIMI flow at the end of the procedure
Final TIMI myocardial blush grade
TIMI myocardial blush grade at the end of the procedure
NT-BNP at 90 days
N-terminal pro brain natriuretic peptide
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Cairo University
Lead sponsor
Aswan Heart Centre
Collaborator
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