AIMS: In patients with acute myocardial infarction and ST-segment elevation (STEMI), primary angioplasty is frequently not available or performed beyond the recommended time limit. We designed a non-inferiority, randomized, controlled study to evaluate whether lytic-based early routine angioplasty represents a reasonable reperfusion option for victims of STEMI irrespective of geographic or logistical barriers. METHODS AND RESULTS: A total of 212 STEMI patients were randomized to full tenecteplase followed by stenting within 3-12 h of randomization (early routine post-fibrinolysis angioplasty; 104 patients), or to undergo primary stenting with abciximab within 3 h of randomization (primary angioplasty; 108 patients). The primary endpoints were epicardial and myocardial reperfusion, and the extent of left ventricular myocardial damage, determined by means of the infarct size and 6-week left ventricular function. The secondary endpoints were the acute incidence of bleeding and the 6-month composite incidence of death, reinfarction, stroke, or revascularization. Early routine post-fibrinolysis angioplasty resulted in higher frequency (21 vs. 6%, P = 0.003) of complete epicardial and myocardial reperfusion (TIMI 3 epicardial flow and TIMI 3 myocardial perfusion and resolution of the initial sum of ST-segment elevation > or = 70%) following angioplasty. Both groups were similar regarding infarct size (area under the curve of CK-MB: 4613 +/- 3373 vs. 4649 +/- 3632 microg/L/h, P = 0.94); 6-week left ventricular function (ejection fraction: 59.0 +/- 11.6 vs. 56.2 +/- 13.2%, P = 0.11; endsystolic volume index: 27.2 +/- 12.8 vs. 29.7 +/- 13.6, P = 0.21); major bleeding (1.9 vs. 2.8%, P = 0.99) and 6-month cumulative incidence of the clinical endpoint (10 vs. 12%, P = 0.57; relative risk: 0.80; 95% confidence interval: 0.37-1.74). CONCLUSION: Early routine post-fibrinolysis angioplasty safely results in better myocardial perfusion than primary angioplasty. Despite its later application, this approach seems to be equivalent to primary angioplasty in limiting infarct size and preserving left ventricular function.
RCT Entities:
AIMS: In patients with acute myocardial infarction and ST-segment elevation (STEMI), primary angioplasty is frequently not available or performed beyond the recommended time limit. We designed a non-inferiority, randomized, controlled study to evaluate whether lytic-based early routine angioplasty represents a reasonable reperfusion option for victims of STEMI irrespective of geographic or logistical barriers. METHODS AND RESULTS: A total of 212 STEMI patients were randomized to full tenecteplase followed by stenting within 3-12 h of randomization (early routine post-fibrinolysis angioplasty; 104 patients), or to undergo primary stenting with abciximab within 3 h of randomization (primary angioplasty; 108 patients). The primary endpoints were epicardial and myocardial reperfusion, and the extent of left ventricular myocardial damage, determined by means of the infarct size and 6-week left ventricular function. The secondary endpoints were the acute incidence of bleeding and the 6-month composite incidence of death, reinfarction, stroke, or revascularization. Early routine post-fibrinolysis angioplasty resulted in higher frequency (21 vs. 6%, P = 0.003) of complete epicardial and myocardial reperfusion (TIMI 3 epicardial flow and TIMI 3 myocardial perfusion and resolution of the initial sum of ST-segment elevation > or = 70%) following angioplasty. Both groups were similar regarding infarct size (area under the curve of CK-MB: 4613 +/- 3373 vs. 4649 +/- 3632 microg/L/h, P = 0.94); 6-week left ventricular function (ejection fraction: 59.0 +/- 11.6 vs. 56.2 +/- 13.2%, P = 0.11; endsystolic volume index: 27.2 +/- 12.8 vs. 29.7 +/- 13.6, P = 0.21); major bleeding (1.9 vs. 2.8%, P = 0.99) and 6-month cumulative incidence of the clinical endpoint (10 vs. 12%, P = 0.57; relative risk: 0.80; 95% confidence interval: 0.37-1.74). CONCLUSION: Early routine post-fibrinolysis angioplasty safely results in better myocardial perfusion than primary angioplasty. Despite its later application, this approach seems to be equivalent to primary angioplasty in limiting infarct size and preserving left ventricular function.
Authors: Santanu Guha; Rishi Sethi; Saumitra Ray; Vinay K Bahl; S Shanmugasundaram; Prafula Kerkar; Sivasubramanian Ramakrishnan; Rakesh Yadav; Gaurav Chaudhary; Aditya Kapoor; Ajay Mahajan; Ajay Kumar Sinha; Ajit Mullasari; Akshyaya Pradhan; Amal Kumar Banerjee; B P Singh; J Balachander; Brian Pinto; C N Manjunath; Chandrashekhar Makhale; Debabrata Roy; Dhiman Kahali; Geevar Zachariah; G S Wander; H C Kalita; H K Chopra; A Jabir; JagMohan Tharakan; Justin Paul; K Venogopal; K B Baksi; Kajal Ganguly; Kewal C Goswami; M Somasundaram; M K Chhetri; M S Hiremath; M S Ravi; Mrinal Kanti Das; N N Khanna; P B Jayagopal; P K Asokan; P K Deb; P P Mohanan; Praveen Chandra; Col R Girish; O Rabindra Nath; Rakesh Gupta; C Raghu; Sameer Dani; Sandeep Bansal; Sanjay Tyagi; Satyanarayan Routray; Satyendra Tewari; Sarat Chandra; Shishu Shankar Mishra; Sibananda Datta; S S Chaterjee; Soumitra Kumar; Soura Mookerjee; Suma M Victor; Sundeep Mishra; Thomas Alexander; Umesh Chandra Samal; Vijay Trehan Journal: Indian Heart J Date: 2017-03-23
Authors: JoEllyn M Abraham; C Michael Gibson; Gonzalo Pena; Ricardo Sanz; Amjad AlMahameed; Sabina A Murphy; Jesús Blanco; Juan Alonso-Briales; Juan Lopez-Mesa; Federico Gimeno; Pedro L Sánchez; Francisco Fernández-Avilés Journal: J Thromb Thrombolysis Date: 2008-03-11 Impact factor: 2.300