1022-107 Outcome of Different Reperfusion Strategies in Thrombolytic “Eligible” versus “Ineligible” Patients with Acute Myocardial Infarction

Pts considered “not eligible” for inclusion in most early U.S. thrombolytic trials because of advanced age, late presentation, prior CABG or shock have avery poor prognosis; thus, some have suggested broadening the criteria for lyric eligibility. To examine the role of different reperfusion strategies in pts traditionally considered lytic “eligible” vs. “ineligible” (age>70, MI onset>4 hours, or prior CABG), we examined the PAMI database in which 395 pts of any age within 12 hours onset of MI were randomized to t-PA or primary PTCA (pts with shock were excluded). Compared to lyric eligible pts, ineligible pts were o1der(67 vs. 56 yrs, p<0.0001). more frequently female (38% vs. 20%, P<0.0001), diabetic (17% vs. 10%, P=0.03), had prior CABG (8% vs. 0%, P<0.0001), presented later (4.4 vs. 2.2 hours, p<0.0001), and were more likely to present in CI-1F (20% vs. 11%, P=0.01). Endpoints included death (D), reinfarction (R), recurrent ischemic events (RIE) and stroke:Thrombolytic eligibleThrombolytic ineligiblePTCA (n=127)t-PA (n=117)PPTCA (n=68)t-PA (n=83)Pin-hosp. D2.4%1.7%NS2.9%13.3%0.025in-hosp. D or R5.5%9.4%NS4.4%15.7%0.026in-hosp. RIE11.8%29.1%0.00087.4%26.6%0.002in-hasp. stroke0%1.7%NS0%6.0%0.046 month D3.9%1.7%NS2.9%15.7%0.0096 month D or R8.7%12.8%NS7.4%22.9%0.009In conclusion: Pts traditionally considered thrombolytic eligible comprise a low risk cohort, and have a favorable prognosis whether treated with primary PTCA or t-PA. In contrast, pts historically excluded from most early lytic trials because of advanced age, late presentation or prior CABG are at increased risk, and may have improved survival with primary PTCA rather than thrompresented laterbolysis

1022-103 Does Primary Angioplasty Improve the Prognosis of Patients with Diabetes and Acute Myocardial Infarction?

To examine the effect of different reperfusion modalities in pts with DM, the multicenter PAMI database was analyzed, in which 395 pts within 12 hours onset of acute MI were prospectively randomized to treatment with t-PA (n=200) vs. primary PTCA (n=195). DM was present in 50 (13%) pts. Compared to pts without DM, pts with DM were older (65 vs. 59 yrs, p=0.002), more often female (40% vs. 25%, p=0.03), more frequently had HTN (68% vs. 39%, P=0.0001), prior CHF (8% vs. 1%, P=0.0001). multivessel disease (76% vs. 51%, P=0.01) and presented later (3.8 vs. 3.0hours, p=0.03).In-hospital mortality was 10.0% in pts with DM vs. 3.8% in pts without DM (p<0.05). By multivariate analysis of 16 variables, however, advanced age and treatment by PTCA rather than t-PA, but not DM correlated with in-hospital mortality.Mortality stratified by treatment appears in the graph. Despite the apparently improved prognosis of pts with DM treated with PTCA vs. t-PA, the p value forthe x2 test for interaction effect between DM and treatment modality was 0.86; most of the benefit of PTCA was present in the elderly population.In conclusionPts with DM and acute MI have increased mortality, primarily because of advanced age. The outcome after PTCA compared to t-PA is improved in DM largely because of PTCA's beneficial effect in the elderly

A Randomized Comparison of the Endeavor Zotarolimus-Eluting Stent Versus the TAXUS Paclitaxel-Eluting Stent in De Novo Native Coronary Lesions 12-Month Outcomes From the ENDEAVOR IV Trial

ObjectivesThe ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES).BackgroundFirst-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results.MethodsThis is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.ResultsAmong a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (pnoninferiority≤ 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756).ConclusionsThese findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269

Prophylactic versus standby cardiopulmonary support for high risk percutaneous transluminal coronary angioplasty

AbstractObjectives. Data from a national registry of 23 centers using cardiopulmonary support (CPS) were analyzed to compare the risks and benefits of prophylactic CPS versus standby CPS for patients undergoing high risk coronary angioplasty.Background. Early data from the CPS registry documented a high angioplasty success rate as well as a high procedural morbidity rate. Because of this increased morbidity some high risk patients were placed on standby CPS instead of prophylactic CPS.Methods. Patients in the prophylactic CPS group had 18F or 20F venous and arterial cannulas inserted and cardiopulmonary bypass initiated. Patients in the standby CPS group were prepared for institution of cardiopulmonary bypass, but bypass was not actually initiated unless the patient sustained irreversible hemodynamic compromise.Results. There were 389 patients in the prophylactic CPS group and 180 in the standby CPS group. The groups were comparable with respect to most baseline characteristics, except that left ventricular ejection fraction was lower in the prophylactic CPS group. Thirteen of the 180 patients in the standby CPS group sustained irreversible hemodynamic compromise during the angioplasty procedure. Emergency institution of CPS was successfully initiated in 12 of these 13 patients in <5 min. Procedural success was 88.7% for the prophylactic and 84.4% for the standby CPS group (p = NS). Major complications did not differ between groups. However, 42% of patients in the prophylactic CPS group sustained femoral access site complications or required blood transfusions, compared with only 11.7% of patients in the standby CPS group (p < 0.01). Among patients with an ejection fraction ≤20%, procedural morbidity remained significantly higher in the prophylactic CPS group (41% vs. 9.4%, p < 0.01), but procedural mortality was higher in the standby group (4.8% vs. 18.8%, p <0.05).Conclusions. Patients in the standby and prophylactic CPS groups had comparable success and major complication rates, but procedural morbidity was higher in the prophylactic group. When required, standby CPS established immediate hemodynamic support during most angioplasty complications. For most patients, standby CPS was preferable to prophylactic CPS during high risk coronary angioplasty. However, patients with extremely depressed left ventricular function (ejection fraction < 20%) may benefit from institution of prophylactic CPS

Supported Angioplasty: A New Contribution for Extra-Corporeal Circulation Technology

To date there have been no fewer than seven palliative treatments for atherosclerotic coronary artery disease. The expanding role of interventional cardiology in the treatment of patients with severe coronary artery disease will result in a mandatory and significant allocation of perfusion services dedicated to the catheterization laboratory. Historical, and now more recent data, indicate that femoro-femoral bypass can be utilized as a resuscitative tool and as an adjunct to interventional cardiology techniques. The role of the perfusion team in the catheterization lab will evolve and expand along with the growing application of interventional cardiology techniques

Late Safety, Efficacy, and Cost-Effectiveness of a Zotarolimus-Eluting Stent Compared With a Paclitaxel-Eluting Stent in Patients With De Novo Coronary Lesions 2-Year Follow-Up From the ENDEAVOR IV Trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions)

ObjectivesThe aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions.BackgroundEarly drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials.MethodsThe ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES.ResultsThe TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non–Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar.ConclusionsAfter 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269

Initial report of the National Registry of Elective Cardiopulmonary bypass supported coronary angioplasty

Relative contraindications to coronary angioplasty have been large amounts of jeopardized myocardium and poor left ventricular function. To prevent possible hemodynamic collapse after balloon occlusion or acute vessel closure in such high risk patients, a cardiopulmonary bypass system capable of providing up to 6 liters/min output was employed prophylactically. This technique, termed supported angioplasty, results in reductions of preload and afterload and allows prolonged balloon inflations in critical coronary vessels. A National Registry of 14 centers performing elective supported angioplasty was formed to collate the initial experience with high risk patients. Suggested indications were ejection fraction 75 years of age and had left main coronary artery stenosis. Patients without these two factors had a hospital mortality rate of 2.6%. Symptomatic improvement (lessening of New York Heart Association chest pain classification by at least two classes) occurred in 91% of the patients surviving hospitalization. During the follow-up period of 1 to 12 months, three patients died of cardiac complications. This multicenter experience suggests that supported angioplasty can be safely performed with the expectation of good symptomatic improvement and short-term survival in high risk patients other than elderly individuals with left main coronary artery stenosis