Major clinical cardioprotection studies of mechanical interventions in patients with AMI
| Study | n | Patient criteria | Cardioprotection protocol | Main outcome | Notes |
|---|---|---|---|---|---|
| Ischemic postconditioning | |||||
| Staat et al., 2005 | 30 | LAD/RCA STEMI ≤6 h ischemic time TIMI 0 pre-PPCI | 4 × 1 min inflations and deflations of angioplasty balloon upstream of stent Direct stenting | 36% reduction in MI size (72 h AUC CK) Better myocardial blush grade | First clinical study to translate ischemic PostC into clinical setting |
| Staat et al., 2005; Thibault et al., 2008 | 38 | LAD/RCA only ≤6 h ischemic time TIMI 0 pre-PPCI | 4 × 1 min inflations and deflations of angioplasty balloon upstream of stent Direct stenting | 40% and 47% reductions in MI size (72 h AUC CK and troponin I) 39% reduction in MI size (SPECT at 6 months) 7% increase in LVEF (echo at 1 year) | First clinical study to demonstrate long-term benefit with ischemic PostC |
| Freixa et al., 2012; Heusch, 2012; Tarantini et al., 2012 POST-AMI | 78 | All STEMI <6 h ischemic time TIMI 0–1 pre-PPCI No collaterals | 4 × 1 min inflations and deflations of angioplasty balloon within the stent Direct stenting and no thrombectomy performed | No difference in MI size (MRI 30 days)—trend to increase with ischemic PostC | First study to suggest possible detrimental effects with ischemic PostC |
| Freixa et al., 2012; Heusch, 2012; Tarantini et al., 2012 | 79 | All STEMI TIMI 0–1 pre-PPCI No collaterals | 4 × 1 min inflations and deflations of angioplasty balloon within the stent Direct stenting | No difference in MI size (MRI at 1 week or 6 months) Less myocardial salvage with ischemic PostC | First study to show detrimental effect of ischemic PostC in terms of less myocardial salvage |
| Engstrøm et al., 2017 DANAMI 3 | 1,252 | All STEMI TIMI 0–1 pre-PPCI | 4 × 0.5 min inflations and deflations of angioplasty balloon at site of lesion | No difference in primary endpoint of all-cause death and HHF at median follow up time of 38 months | Largest outcome study to date with no beneficial effects of ischemic PostC |
| Remote ischemic conditioning | |||||
| Bøtker et al., 2010 CONDI | 142 | All STEMI | 4 × 5 min inflations/deflations of cuff on upper arm in the ambulance before PPCI | Increase in myocardial salvage index at 30 days No difference in MI size (SPECT or peak troponin) | First study to show beneficial effect of RIC on myocardial salvage |
| Crimi et al., 2013 | 100 | Anterior STEMI only | 3 × 5 min inflations/deflation of cuff on thigh at onset of reperfusion | 20% reduction in 72 h AUC CK–MB | First study to show beneficial effects of RIC started at onset of reperfusion |
| White et al., 2015 ERIC-STEMI | 83 | All STEMI | 4 × 5 min inflations/deflations of cuff on upper arm at the hospital before PPCI | 27% reduction in MI size by MRI 19% reduction in myocardial edema by MRI | First study to show beneficial effects of RIC on MI size and myocardial edema assessed by MRI |
| Eitel et al., 2015; Stiermaier et al., 2019 LIPSIA conditioning | 333 | All STEMI | 4 × 5 min inflations/deflations of cuff on upper arm at the hospital before PPCI plus ischemic PostC | Increased myocardial salvage with RIC + ischemic PostC versus control No difference in MI size or MVO | Improved myocardial salvage when ischemic PostC combined with RIC, but effect of RIC alone not tested |
| Verouhis et al., 2016 | 93 | Anterior STEMI within 6 h chest pain | Variable number of 5 min cycles (7–9) of inflations/deflations of cuff on upper arm | No difference in MI size or myocardial salvage at MRI scan at day 4–7 | First neutral study with RIC in STEMI |
| Vanezis et al., 2018 DREAM | 73 | STEMI with LVEF <45% | 4 × 5 min inflations/deflations of cuff on upper arm in started day 3 post-PPCI and continued daily for 28 days | No difference in MI and LV remodelling at 4 months post-PPCI | First study to test effects of daily RIC post-STEMI |
| Gaspar et al., 2018 RIC STEMI | 516 | All STEMI | 3 × 5 min inflations/deflations of cuff on thigh before PPCI | Primary endpoint of cardiac mortality and HHF at 12 months reduced by 35% Preserved LVEF at 6 months | First prospective study to show benefits on clinical outcomes |
| Hausenloy, Kharbanda, et al., 2019 CONDI-2/ERIC-PPCI | 5400 | All STEMI | 4 × 5 min inflations/deflations of cuff on upper arm before PPCI | No difference on primary endpoint of cardiac death and HHF at 12 months | Largest clinical study to investigate the effects of RIC on clinical outcomes |
| Cheskes et al., 2020; Hausenloy et al., 2020 | 1726 | All STEMI | 4 × 5 min inflations/deflations of cuff on upper arm before PPCI | No difference in MACE at 90 days although benefit seen in patients presenting with cardiogenic shock or cardiac arrest | Not RCT but pre- and post-implementation designed study |
| Therapeutic hypothermia | |||||
| Erlinge et al., 2014 | 120 | All STEMI within 6 h chest pain | Therapeutic hypothermia using IV infusion of cold saline to achieve <35°C for 1 h | No difference in myocardial salvage Possible benefit in anterior STEMI patients | 9 min delay to PPCI with intervention |
| Nichol et al., 2015 VELOCITY | 54 | All STEMI | Therapeutic hypothermia using intraperitoneal infusion of cold saline for 3 h post-PPCI | No difference in MI size at 3–5 post-PPCI and significant increase in adverse events at 30 days | 15 min delay to PPCI with intervention |
| Noc et al., 2021 COOL AMI EU Pivotal Trial | 111 | Anterior STEMI patients | Therapeutic hypothermia using IV infusion of cold saline to achieve 33°C for 1 h post-PPCI | No difference in MI size at 4–6 post-PPCI and significant increase in adverse events (cardiogenic shock) at 30 days | Prematurely stopped due to 44 min delay to PPCI with intervention |
| LV unloading with Impella CP | |||||
| Kapur et al., 2019 DTU STEMI pilot | 50 | Anterior STEMI patients | LV unloading by using the Impella CP | No difference in MI size with 30-min delay to reperfusion | Feasibility study for efficacy study; DTU STEMI |
| PICSO | |||||
| De Maria et al., 2018; Egred et al., 2020 OXAMI-PICSO | 105 | Anterior STEMI patients | PICSO | Smaller MI size on MRI at day 2 and 6 months. Improved coronary microvascular perfusion 48 h | |
| De Maria et al., 2018; Egred et al., 2020 | 92 | Anterior STEMI patients | PICSO | Smaller MI size on MRI at day 5 | |
| De Maria et al., 2018; Scarsini et al., 2022 | 108 | All STEMI patients | PICSO | Improved coronary microvascular perfusion and vasodilatory activity and less MVO and smaller MI size at 48 h on MRI | |
AUC, area under curve; CK, creatine kinase; HHF, hospitalization for heart failure; LAD, left anterior descending artery; LV, left ventricle; LVEF, left ventricular ejection fraction; MACE, major adverse cardiac events; MI, myocardial infarction; MVO, microvascular obstruction; PISCO, pressure-controlled intermittent coronary sinus occlusion; PostC, postconditioning; PPCI, primary percutaneous coronary intervention; RCA, right coronary artery; RIC, remote ischemic conditioning; SPECT, single-photon emission computed tomography; STEMI, ST-segment elevation myocardial infarction; TIMI, thrombosis in myocardial infarction.