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Table 19. Invasive Versus Conservative Strategies in Unstable Angina Patients Patient Study Years Ref n Population Treatment Follow-Up Results Medical PCI Therapy P Comments TIMI-IIIB 1989-1992 (390) 1473 Patients 21 to 76 Medical therapy 6 wk years of age (tPA vs placebo) presenting within and early 24 h of ischemic invasive or discomfort at rest conservative consistent with strategy unstable angina or 1 y non–Q-wave MI 16.2% 18.1% NS combined combined primary primary end points end points 12.4 % 10.6% Although no difference was found in combined primary end points (death, MI, positive ETT), the early invasive strategy was associated with shorter hospital stay and lower incidence of rehospitalization VANQWISH 1993-1996 (391) 920 Patients with an Invasive vs Average 23 mo evolving MI conservative 32.9% 30.3% 0.35 death death and MI and MI Fewer patients treated conservatively had death plus MI or death at hospital discharge at 1 month and at 1 year; the invasive group had a higher CABG mortality rate (11.6% vs 3.4%) FRISC II 1996-1998 (304) 2457 Patient’s ischemic Early invasive 6 mo symptoms in previous therapy or 48 hours accompanied noninvasive by ECG changes or treatment elevated markers strategy. Patients also received dalteparin or placebo for 3 months 9.4% 12.1% 0.031 death death or MI or MI Invasive strategy was associated with 50% lower recurrent angina and hospital readmission rates TACTICS- 1997-1999 (393) 2220 UA and NSTEMI Medical therapy 6 mo TIMI 18 with ECG changes, (aspirin, heparin, elevated levels of tirofiban) and cardiac biomarkers, either early a history of CAD, invasive or or all 3 findings conservative (selectively invasive) treatment strategy 7.3% 9.5% Less than death death 0.05 or MI or MI Significant 22% relative risk reduction in composite end point of death, nonfatal MI, and rehospitalization RITA-3 1997-2001 (302) 1810 Suspected cardiac Medical therapy 1 y chest pain at rest and either early with documented invasive or evidence of CAD conservative (at least 1 of the (selectively following: ECG invasive) changes, pathological treatment Q waves, previous strategy; both arteriogram) groups received enoxaparin in addition to standard medical therapy 7.6% 8.3% NS death death or MI or MI Similar results for death or MI between treatment groups; significant difference in primary end point (death, MI, refractory angina) due to halving of refractory angina in the intervention group CABG indicates coronary artery bypass graft surgery; CAD, coronary artery disease; ECG, electrocardiography; ETT, exercise treadmill test; MI, myocardial infarction; mo, month; n, number; NS, not significant; NSTEMI, non–ST-elevation myocardial infarction; PCI, percutaneous coronary intervention; Ref, reference; tPA, alteplase; UA, unstable angina; wk, week; and y, year.
ACC - www.acc.org AHA - www.americanheart.org SCAI - www.scai.org Smith et al. 2005 ACC/AHA/SCAI Practice Guidelines 45 value of PCI for patients who may not be suitable for fibrinolytic therapy owing to an increased risk of bleeding (401). Primary PCI has been compared with fibrinolytic therapy in 23 randomized clinical trials (361-363,378,380,381,402- 415), including the SHOCK (SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK?) trial (366). The recommendations for primary PCI in patients with cardiogenic shock are discussed and summarized separately in Section 5.4.6. These investigations consistently demonstrate that PCI-treated patients experience lower short-term mortality rates (7.0% vs 9.0%, relative risk 0.73, 96% CI 0.62 to 0.86, P equals 0.0002, and 5.0% vs 7.0%, relative risk 0.70, 95% CI 0.58 to 0.85, P equals 0.003 excluding the SHOCK trial), fewer nonfatal reinfarctions (3.0% vs 7.0%, relative risk 0.35, 95% CI 0.27 to 0.45, P equals 0.0003), and fewer hemorrhagic strokes (0.05% vs 1.0%, relative risk 0.05, 95% CI 0.006 to 0.35, P equals 0.0001) than those treated by fibrinolysis (53), albeit with an increased risk of bleeding (7.0% vs 5.0%, RR 1.3, 95% CI 1.02 to 1.65, P equals 0.032). These results have been achieved in medical centers and by providers experienced in the performance of primary PCI and under circumstances in which angioplasty can be performed promptly after patient presentation. The magnitude of the treatment differences for death, nonfatal reinfarction, and stroke vary depending on whether PCI is compared with streptokinase or a fibrin-specific lytic. The short- and long-term outcomes of patients with STEMI treated by fibrinolysis versus PCI and the numbers of patients who need to be treated to prevent 1 event or to cause a harmful complication when PCI is selected instead of fibrinolysis as the reperfusion strategy are shown in Figure 5 (53,416,417). Time from symptom onset to reperfusion is an important predictor of patient outcome. Two studies (330,418) have reported increasing mortality rates with increasing door-toballoon times. Other studies have shown better LV function and fewer complications when reperfusion occurs before PCI (419,420). An analysis of the randomized controlled trials comparing fibrinolysis with primary PCI suggests that the mortality benefit with PCI exists when treatment is delayed by no more than 60 min (Figure 6) (421). Mortality increases significantly with each 15-minute delay in the time between arrival and restoration of TIMI-3 flow (doorto–TIMI-3 flow time), which further underscores the importance of timely reperfusion in patients who undergo primary PCI (422). Given that the door-to-needle time goal is 30 min, this Writing Committee joins the Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology (423) and the ACC/AHA STEMI Guidelines Writing Committee (332) in lowering the door-to-balloon time goal from 120 to 90 min in an attempt to maximize the benefits for reperfusion by PCI (Figure 7) (418). Importantly, after adjustment for baseline characteristics, time from symptom onset to balloon inflation is significantly correlated with 1-year mortality in patients undergoing primary PCI for STEMI (relative risk equals 1.08 for each 30-minute delay from symptom onset to balloon inflation, P equals 0.04) (424). The enthusiasm for primary PCI has led to the concept of emergency interhospital transfer for catheter-based reperfusion rather than fibrinolytic therapy in the initial hospital (425-427). Five randomized trials have enrolled 2466 patients with favorable results for PCI versus fibrinolytic therapy (378,381,407,412). Mortality was reduced with PCI (6.8% vs 9.6%, relative risk 0.69, 95% CI 0.51 to 0.0.92, P equals 0.01), as was the combined end point of death, nonfatal reinfarction, and stroke (8.5% vs 15.5%, relative risk 0.51, 95% CI 0.39 to 0.65, P less than 0.0001). Importantly, mean time to treatment was delayed only 44 min in these studies (Figure 8) (378,415). In contrast, first hospital doorto-balloon time, as recorded in 1346 patients undergoing hospital transfer before PCI in NRMI-4, was 185 min in the United States in 2002 (Figure 9) (428). Emergency transport in Europe is centrally organized and more efficient than in the United States (Table 20) (378,381,407,412,415). Delays in door-to-balloon time versus door-to-needle time of more than 60 min because of interhospital transfer might negate the potential mortality benefit of transfer for primary PCI over immediate intravenous fibrinolysis demonstrated in these trials (421). However, transfer of patients to PCI-capable centers should be accomplished when fibrinolytic therapy is contraindicated or unsuccessful, when cardiogenic shock ensues, when the anticipated delay is less than 60 min, or when symptoms have been present for more than 2 to 3 h (410,415). To achieve optimal results, a systems approach for rapid triage and transfer must be established. Time from first hospital door to balloon inflation in the second hospital should be as short as possible, with a goal within 90 min. Significant reductions in door-to-balloon times might be achieved by transporting patients directly to PCI centers, rather than transporting them to the nearest hospital, if interhospital transfer will subsequently be required to obtain primary PCI. Central to the success of all of the acute reperfusion strategies is a well-developed process of triage, as discussed in the STEMI guidelines (332,429). Primary PCI with stenting has been compared with fibrinolytic therapy in 12 randomized clinical trials (366,378,380,381,407-412,415,430). These investigations demonstrate that PCI-treated patients experience lower mortality rates (5.9% vs 7.7%, OR 0.75, 95% CI 0.60 to 0.94, P equals 0.013), fewer reinfarctions (1.6% vs 5.1%, OR 0.31, 95% CI 0.21 to 0.44, P equals 0.0001), and fewer hemorrhagic strokes than those treated by fibrinolysis (53). Compared with PTCA, intracoronary stents achieve a better immediate angiographic result with a larger arterial lumen, less reclosure of the infarct-related artery, and fewer subsequent ischemic events (431-433). Primary stenting has been compared with primary angioplasty in 9 studies (64,106,433- 440) (Table 21). There were no differences in mortality (3.0% vs 2.8%) or reinfarction (1.8% vs 2.1%) rates. However, subsequent target-vessel revascularization rates were lower with stenting (440).
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