Comparison of immediate invasive, delayed invasive, and conservative strategies after tissue-type plasminogen activator. Results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II-A trial.

Abstract

To assess the value and timing of percutaneous transluminal coronary angioplasty (PTCA) after thrombolytic therapy for acute myocardial infarction (AMI), 586 patients in the Thrombolysis in Myocardial Infarction Study Phase II-A were randomized among three treatment strategies, one using immediate coronary arteriography followed by PTCA if appropriate (immediate invasive strategy group, n=195), a second that deferred angiography and PTCA for 18-48 hours (delayed invasive strategy group, n=194), and a third, more conservative, approach in which PTCA was used only if ischemia occurred spontaneously or at the time of predischarge exercise testing (conservative strategy group, n=197). Predischarge contrast left ventricular ejection fraction, the primary study end point, was similar among the patients in all three treatment groups and averaged 49.3%. The finding of a patent infarctrelated artery at the time of predischarge arteriography was equally common among the patients in the three groups (mean, 83.7%); however, the mean residual infarct artery stenosis was greater in the patients in the conservative strategy group (67.2%) as compared with the patients in the immediate invasive (50.6%) and the delayed invasive strategy groups (47.8%) (p<O.OOl). Immediate invasive strategy led to a higher rate of coronary artery bypass graft surgery (CABG) after PTCA (7.7%) than did delayed invasive and conservative strategies (2.1% and 2.5%, respectively; p<0.01). Furthermore, among patients not undergoing CABG during the first 21 days, blood transfusion of more than 1 unit was used in 13.8% of the patients in the immediate invasive strategy group, 3.1% of the patients in the delayed invasive strategy group, and 2.0% of the patients in the conservative strategy group (p<0.001). At 1-year follow-up, the three treatment groups had similar cumulative rates of mortality (8.7%, pooled over all groups), fatal and nonfatal reinfarction (8.5%), combined death and reinfarction (14.5%), and CABG (17.2%), although the cumulative performance rate of PTCA remained higher in the invasive groups (immediate invasive strategy group, 75.8%; delayed invasive strategy group, 64.3%; and conservative strategy group, 23.9%; p<0.001). Thus, because conservative strategy achieves equally good short-and long-term outcome with less morbidity and a lower use of PTCA, it seems to be the preferred initial management strategy.

Coronary angioplasty performed within the thrombolysis in Myocardial Infarction II study.

“…2 Contraindications to PTCA attempts included a residual lesion less than 60% in the infarct artery, left main stenosis greater than 70%, situations in which abrupt closure would likely cause hemodynamic collapse, and (at operator discretion) lesion morphology poorly suited to PTCA (excessive length, tortuosity, or involvement of a major bifurcation). Except for patients in the immediate invasive arm, protocol design discouraged PTCA of totally occluded infarct arteries not prompted by recurrent ischemia.…”

Angioplasty Strategies in ST-Segment–Elevation Myocardial Infarction

“…The results of studies evaluating the routine strategy of PCI immediately after fibrinolysis compared with fibrinolysis with more conservative revascularization approaches in the balloon angioplasty era, before the introduction of stents, thienopyridines, glycoprotein IIb/IIIa inhibitors, or even routine aspirin use, 16 were mixed. Six trials performed nearly 2 decades ago examined the utility of routine immediate balloon angioplasty compared with routine delayed PCI, 16 -21 selective deferred PCI for ischemia, 16 and/or conservative care.…”

“…Six trials performed nearly 2 decades ago examined the utility of routine immediate balloon angioplasty compared with routine delayed PCI, 16 -21 selective deferred PCI for ischemia, 16 and/or conservative care. 19,20 Four trials included patients with an occluded IRA (rescue PCI), 16 -18,20 whereas 2 required a patent IRA.…”

“…Whereas several of these studies showed improved left ventricular function and/or decreased early rates of recurrent ischemia and reinfarction with immediate PCI, 17,19 others showed no benefit 18,21 or increased rates of bleeding, ischemia requiring urgent coronary artery bypass graft surgery, and mortality. 16,20 In contrast to these historical studies, 7 contemporary prospective, modest-sized randomized trials have been published and collectively demonstrate that routine PCI with stent implantation in the early hours after fibrinolysis may be beneficial compared with a strategy of delayed routine or ischemia-driven PCI. [22][23][24][25][26][27][28] In the Primary Angioplasty in Patients Transferred From General Community Hospitals to Specialized PTCA Units With or Without Emergency Thrombosis (PRAGUE) trial, 300 patients within 6 hours of STEMI onset were randomized at hospitals without PCI facilities to streptokinase alone, streptokinase plus transfer for immediate PCI, or transfer for primary PCI.…”

“…42 Whether routine delayed angioplasty (regardless of the presence of symptoms or ischemia) within days to weeks of fibrinolysis in stable patients would be beneficial was tested in 6 trials in the balloon angioplasty era. [43][44][45][46][47][48][49] In the largest of these studies, the TIMI-II trial, 3262 patients treated with recombinant tissue plasminogen activator within 4 hours of STEMI onset were randomized to coronary arteriography 18 to 48 hours after fibrinolysis with routine balloon angioplasty if the coronary anatomy was suitable or to angiography and revascularization only in patients with spontaneous or exercise-induced ischemia. The rates of death or reinfarction in the invasive and conservative groups were similar at 42 days (11.1% and 10.1%; Pϭ0.31) and 1 year (14.7% and 15.2%; Pϭ0.…”