Efficacy and Safety of a Pharmaco-Invasive Strategy With Half-Dose Alteplase Versus Primary Angioplasty in ST-Segment-Elevation Myocardial Infarction: EARLY-MYO Trial (Early Routine Catheterization After Alteplase Fibrinolysis Versus Primary PCI in Acute

Timely primary percutaneous coronary intervention (PPCI) cannot be offered to all patients with ST-segment-elevation myocardial infarction (STEMI). Pharmaco-invasive (PhI) strategy has been proposed as a valuable alternative for eligible patients with STEMI. We conducted a randomized study to compare the efficacy and safety of a PhI strategy with half-dose fibrinolytic regimen versus PPCI in patients with STEMI. The EARLY-MYO trial (Early Routine Catheterization After Alteplase Fibrinolysis Versus Primary PCI in Acute ST-Segment-Elevation Myocardial Infarction) was an investigator-initiated, prospective, multicenter, randomized, noninferiority trial comparing a PhI strategy with half-dose alteplase versus PPCI in patients with STEMI 18 to 75 years of age presenting ≤6 hours after symptom onset but with an expected PCI-related delay. The primary end point of the study was complete epicardial and myocardial reperfusion after PCI, defined as thrombolysis in myocardial infarction flow grade 3, thrombolysis in myocardial infarction myocardial perfusion grade 3, and ST-segment resolution ≥70%. We also measured infarct size and left ventricular ejection fraction with cardiac magnetic resonance and recorded 30-day clinical and safety outcomes. A total of 344 patients from 7 centers were randomized to PhI (n=171) or PPCI (n=173). PhI was noninferior (and even superior) to PPCI for the primary end point (34.2% versus 22.8%, Pnoninferiority<0.05, Psuperiority=0.022), with no significant differences in the frequency of the individual components of the combined end point: thrombolysis in myocardial infarction flow 3 (91.3% versus 89.2%, P=0.580), thrombolysis in myocardial infarction myocardial perfusion grade 3 (65.8% versus 62.9%, P=0.730), and ST-segment resolution ≥70% (50.9% versus 45.5%, P=0.377). Infarct size (23.3%±11.3% versus 25.8%±13.7%, P=0.101) and left ventricular ejection fraction (52.2%±11.0% versus 51.4%±12.0%, P=0.562) were similar in both groups. No significant differences occurred in 30-day rates of total death (0.6% versus 1.2%, P=1.0), reinfarction (0.6% versus 0.6%, P=1.0), heart failure (13.5% versus 16.2%, P=0.545), major bleeding events (0.6% versus 0%, P=0.497), or intracranial hemorrhage (0% versus 0%), but minor bleeding (26.9% versus 11.0%, P<0.001) was observed more often in the PhI group. For patients with STEMI presenting ≤6 hours after symptom onset and with an expected PCI-related delay, a PhI strategy with half-dose alteplase and timely PCI offers more complete epicardial and myocardial reperfusion when compared with PPCI. Adequately powered trials with this reperfusion strategy to assess clinical and safety outcomes are warranted. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01930682.

Pu J ，Ding S ，Ge H ，Han Y ，Guo J ，Lin R ，Su X ，Zhang H ，Chen L ，He B ，EARLY-MYO Investigators ... -  《-》

STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment-Elevation Myocardial Infarction: A Randomized, Open-Label Trial.

Van de Werf F ，Ristić AD ，Averkov OV ，Arias-Mendoza A ，Lambert Y ，Kerr Saraiva JF ，Sepulveda P ，Rosell-Ortiz F ，French JK ，Musić LB ，Vandenberghe K ，Bogaerts K ，Westerhout CM ，Pagès A ，Danays T ，Bainey KR ，Sinnaeve P ，Goldstein P ，Welsh RC ，Armstrong PW ，STREAM-2 Investigators ... -  《-》

Pharmacoinvasive Strategy Versus Primary Percutaneous Coronary Intervention in Patients With ST-Segment-Elevation Myocardial Infarction: A Propensity Score-Matched Analysis.

The Strategic Reperfusion Early After Myocardial Infarction trial and the French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015 suggested that pharmacoinvasive strategy compares favorably with primary percutaneous coronary intervention (PPCI). We sought to assess the clinical impact of pharmacoinvasive strategy compared with PPCI in real-world patients with ST-segment-elevation myocardial infarction. We used the Korea Acute Myocardial Infarction Registry to identify ST-segment-elevation myocardial infarction patients receiving either pharmacoinvasive strategy defined as fibrinolysis followed by percutaneous coronary intervention (rescue/urgent or routine elective; n=708) or PPCI (n=8878). Patients receiving facilitated percutaneous coronary intervention within 3 hours from fibrinolysis were excluded. Propensity-matched 12-month clinical outcome was compared. In the propensity-matched cohort (n=706 in each group), the pharmacoinvasive group had shorter time to reperfusion therapy (165 versus 241 minutes; P<0.001) and higher rate of pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction grade 3 (50.4% versus 13.7%; P<0.001). Incidences of major bleeding and stroke during hospitalization were not different. Twelve-month rates of death and major adverse cardiac events (composite of death, recurrent myocardial infarction, target-vessel revascularization, and coronary artery bypass graft surgery) were similar between pharmacoinvasive strategy and PPCI: 4.4% versus 4.1% and 7.5% versus 7.8%, respectively. Equipoise between pharmacoinvasive strategy and PPCI for 12-month major adverse cardiac events occurred when percutaneous coronary intervention-related delay was ≈100 minutes. ST-segment-elevation myocardial infarction patients receiving pharmacoinvasive treatment, compared with PPCI, had shorter time to reperfusion, higher culprit-vessel patency, and similar 12-month clinical outcome.

Sim DS ，Jeong MH ，Ahn Y ，Kim YJ ，Chae SC ，Hong TJ ，Seong IW ，Chae JK ，Kim CJ ，Cho MC ，Rha SW ，Bae JH ，Seung KB ，Park SJ ，Korea Acute Myocardial Infarction Registry (KAMIR) Investigators ... -  《-》

Effects of Intracoronary Alteplase on Microvascular Function in Acute Myocardial Infarction.

Maznyczka AM ，McCartney PJ ，Oldroyd KG ，Lindsay M ，McEntegart M ，Eteiba H ，Rocchiccioli P ，Good R ，Shaukat A ，Robertson K ，Kodoth V ，Greenwood JP ，Cotton JM ，Hood S ，Watkins S ，Macfarlane PW ，Kennedy J ，Tait RC ，Welsh P ，Sattar N ，Collison D ，Gillespie L ，McConnachie A ，Berry C ... -  《Journal of the American Heart Association》

Relationship Between Arterial Access and Outcomes in ST-Elevation Myocardial Infarction With a Pharmacoinvasive Versus Primary Percutaneous Coronary Intervention Strategy: Insights From the STrategic Reperfusion Early After Myocardial Infarction (STREAM)

The effectiveness of radial access (RA) in ST-elevation myocardial infarction (STEMI) has been predominantly established in primary percutaneous coronary intervention (pPCI) with limited exploration of this issue in the early postfibrinolytic patient. The purpose of this study was to compare the effectiveness and safety of RA versus femoral (FA) access in STEMI undergoing either a pharmacoinvasive (PI) strategy or pPCI. Within STrategic Reperfusion Early After Myocardial Infarction (STREAM), we evaluated the relationship between arterial access site and primary outcome (30-day composite of death, shock, congestive heart failure, or reinfarction) and major bleeding according to the treatment strategy received. A total of 1820 STEMI patients were included: 895 PI (49.2%; rescue PCI [n=379; 42.3%], scheduled PCI [n=516; 57.7%]) and 925 pPCI (50.8%). Irrespective of treatment strategy, there was comparable utilization of either access site (FA: PI 53.4% and pPCI 57.6%). FA STEMI patients were younger, had lower presenting systolic blood pressure, lesser Thrombolysis In Myocardial Infarction risk, and more ∑ST-elevation at baseline. The primary composite endpoint occurred in 8.9% RA versus 15.7% FA patients (P<0.001). On multivariable analysis, this benefit on the primary composite outcome favoring RA persisted (adjusted odds ratio [OR], 0.59; 95% CI, 0.44-0.78; P<0.001) and was evident in both pPCI (adjusted OR, 0.63; 95% CI, 0.43-0.92) and PI cohorts (adjusted OR, 0.57 95% CI, 0.37-0.86; P interaction=0.730). There was no difference in nonintracranial major bleeding with either access group (RA vs FA, 5.2% vs 6.0%; P=0.489). Regardless of the application of a PI or pPCI strategy, RA was associated with improved clinical outcomes, supporting current STEMI evidence in favor of RA in PCI. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00623623.

Shavadia J ，Welsh R ，Gershlick A ，Zheng Y ，Huber K ，Halvorsen S ，Steg PG ，Van de Werf F ，Armstrong PW ... -  《Journal of the American Heart Association》