A randomized controlled clinical trial of prolonged balloon inflation during stent deployment strategy in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a pilot study

Abstract

Background Primary percutaneous coronary intervention (PPCI) is the standard procedure for reperfusion for ST-segment elevation myocardial infarction (STEMI), but the occurrence of the no-reflow phenomenon remains common and is associated with adverse outcomes. Aims This study aimed to evaluate whether prolonged balloon inflation in stent deployment would lessen the occurrence of the no-reflow phenomenon in PPCI compared with conventional rapid inflation/deflation strategy. Methods Patients were randomly assigned to either the prolonged balloon inflation in stent deployment group (PBSG) or conventional deployment strategy group (CDSG) in a 1:1 ratio. A subset of patients was included in the cardiac magnetic resonance (CMR) assessment. Results Thrombolysis in MI (TIMI) flow grade 3 was found in 96.7% and 63.3% of the patients of the PBSG and CDSG, respectively (P = 0.005). The results of the PBSG and CDSG are respectively shown as follows: 0% versus 30% no-reflow or slow flow (P = 0.002); 90% versus 66.7% ST-segment resolution ≥ 50% (P = 0.028); 35.6 ± 14.5 frames versus 49.18 ± 25.2 frames on corrected TIMI frame count (P = 0.014); and 60% versus 20% myocardial blush grade 3 (P = 0.001). At 1 month, the major cardiovascular adverse event (cardiovascular mortality) rate was 3.3% in both groups; at 1 year, the rate was 3.3% and 6.7% for the PBSG and CDSG, respectively (P = 1.00). In the CMR subset of cases, the presence of microvascular obstruction (MVO) was detected in 6.7% and 50% of the patients in the PBSG and CDSG, respectively (P = 0.023). Conclusion In our pilot trial, prolonged balloon inflation during stent deployment strategy in PPCI reduces the occurrence of the no-reflow phenomenon in patients with STEMI and improved the myocardial microcirculation perfusion (ClinicalTrials.gov number: NCT03199014; registered: 26/June/2017).

Clinical Characteristics of Patents who Developed Slow Flow/ no-reflow After Post-dilatation with Non-compliant Balloon during Primary Percutaneous Coronary Intervention

“…3,4,[11][12][13][14]17 It has been postulated that inability of achieving postdilatation with NC balloon within the stent boundary can result in edge dissection, coronary perforation, microvascular injuries, and distal embolization, resulting in slow flow/no-reflow. 18,22 A single-center, randomized, single blinded, pilot trial of 50 patients with 30 cases and 20 controls by Ma M et al, 23 compared conventional rapid inflation/deflation strategy with prolonged balloon inflation strategy and reported the prolonged balloon inflation strategy to be associated with lower incidence of slow flow/noreflow and improved myocardial perfusion.…”

“No-Reflow” Phenomenon: A Contemporary Review

“…Ischemic preconditioning is the most powerful endogenous mechanism capable of reducing the extent of myocardial infarction by cycles of coronary balloon occlusion and reperfusion [5]. However, although the recent CONDI-2/ERIC-PPCI study did not demonstrate the efficacy of ischemic preconditioning on clinical endpoints [85], as already shown in other large trials [26], a recent randomized trial showed encouraging results regarding the incidence of NR by prolonged balloon inflation during stent deployment [86]. Although ischemic postconditioning has been shown to reduce no-reflow in small studies [87], larger randomized trials of POST, DANAMI-3-iPOST, POSTEMI, and LIPSIA CONDITIONING have not supported its choice in clinical practice [26].…”

Dilation of the Infarct-Related Coronary Artery to Reduce the Incidence of the No-Reflow Phenomenon in STEMI Patients

“…Больные в исследуемых подгруппах были сопоставимы по степени тяжести, локализации и характеру поражения коронарных артерий (табл. 3,4). ЧКВ были выполнены на ангиографическом комплексе Azurion 7 (Philips, Нидерланды).…”

“…При полном восстановлении антеградного кровотока в инфаркт-связанной коронарной артерии (ИСКА) не всегда гарантировано полное восстановление миокардиальной перфузии. Это зависит от степени выраженности микроваскулярной окклюзии, которая в свою очередь имеет прямую корреляционную связь с размером зоны ишемического поражения миокарда и является предиктором клинически неблагоприятных исходов [3].…”