August 31, 2009 (Barcelona, Spain) — Primary angioplasty is "probably" superior to thrombolysis for seniors 75 years and older with acute MI (AMI), according to the hard-fought Tratamiento del Infarto Agudo de Miocardio en Ancianos (TRIANA) trial conducted by Spanish researchers and presented here at the European Society of Cardiology 2009 Congress.
"We found that primary angioplasty is better in reducing the need for future revascularization, with a trend in favor of reducing death and myocardial infarction, but we were underpowered, so we cannot say our results are definite," Dr Hector Bueno (Hospital General Universitario Gregorio Marañón, Madrid, Spain) told heartwire .
Clinicians were reluctant to refer their patients for randomization into the trial, largely because of concerns about bleeding from thrombolytic therapy, he said. Despite going on for an extra year (the study, begun in March 2005, was due to end in December 2006 but was extended until December 2007), it managed to enroll just 266 patients, instead of the 570 patients it had hoped to recruit.
Dr Carlo Di Mario (Royal Brompton Hospital, London, UK), who moderated the session at which the TRIANA results were presented, lauded Bueno and colleagues for conducting the trial. "Some centers pulled out from the study because they decided it was unethical to use lytics," he told heartwire . "That being said, we need randomization, we need trials. It's true that we don't have strong studies indicating that primary angioplasty is better. It's logical, but we don't have the evidence, so I think they should be congratulated for having tried, even though there is no p value."
Only the Really Elderly Need Apply
TRIANA randomized patients with STEMI or left bundle branch block (LBBB) of six hours or less in duration to thrombolysis with tenecteplase (TNK) and unfractionated heparin (UFH) or to primary angioplasty. Patients who were randomized to the thrombolytic arm of the study were "optimal" candidates for lytic therapy and were contraindicated if they had a history of stroke, a single blood-pressure measurement of 180/110 mm Hg or greater, or cardiogenic shock on admission to the hospital.
The mean age of the patients was 81 years (range 76 to 85 years); 56% were men.
Thrombolysis was given as weight-adjusted tenecteplase with unfractionated heparin. Clopidogrel was given without a loading dose for 28 days at a dose of 75 mg/day, "since the change in the guidelines as of December 2006," Bueno explained.
Patients randomized to thrombolysis received rescue PCI if there were no reperfusion criteria met within 90 minutes, and coronary revascularization was recommended only if there was evidence of recurrent myocardial ischemia, either spontaneous or provoked.
Primary angioplasty was performed with anticoagulation with UFH; abciximab was given according to the operator's discretion, and clopidogrel was given at a loading dose of 300 mg plus a median dose of 75 mg/day.
The primary end point was a composite of death, MI, or disabling stroke at 30 days, and all patients underwent follow-up for 12 months.
The secondary end points included recurrent ischemia requiring emergency cath at 30 days, all-cause mortality at 30 days, major bleeding, death, disabling stroke, or new heart failure at 30 days and during 12 months.
Primary Angioplasty Trumped Thrombolysis in Every Way
Patients who received thrombolysis fared worse in all primary-end-point components: death (odds ratio 1.31; 95% CI 0.67–2.56; p=0.43); reinfarction (OR 1.60; 94% CI 0.60–4.25; p=0.35); and disabling stroke (OR 4.03; 95% CI 0.44–36.5; p=0.18). Most disabling strokes were ischemic and not hemorrhagic in origin, Bueno pointed out.
TRIANA: 30-Day Results, Thrombolysis vs Primary Angioplasty
|End point||Thrombolysis, n=134 (%)||Primary angioplasty, n=132 (%)||Odds ratio (95% CI)||p|
|Composite of death, MI, or disabling stroke at 30 d||25.4||18.9||1.46 (0.81–2.61)||0.21|
Recurrent ischemia requiring coronary angiography was significantly greater in patients who received thrombolysis compared with primary angioplasty (OR 14.1; 95% CI 1.8–39; p<0.001).
Major bleeding was actually lower in the thrombolysis group than in the angioplasty group (OR 0.72; 95% CI 0.29–1.77; p=0.47), Bueno noted. "This is reassuring for those who have no option but to give thrombolytic therapy. If you can choose it, do primary angioplasty. But if you can't, you can give thrombolysis safely. We did weight-adjusted TNK and unfractionated heparin, and we started to use clopidogrel without a loading dose in 2007."
At 12 months, the superiority of primary angioplasty with regard to recurrent ischemia continued to be significant, he added.
TRIANA: 12-Month Outcomes, Thrombolysis vs Primary Angioplasty
|Outcome||Thrombolysis, n=134 (%)||Primary angioplasty, n=132 (%)||OR (95% CI)|
|Death/re-MI/disabling stroke||32.1||27.3||1.26 (0.74–2.14)|
|Disabling stroke||3.0||0.8||4.03 (0.44–36.5)|
Primary Angioplasty: No Age Limits
"I think that this is the confirmation that we should consider primary PCI as the first line for elderly patients with STEMI. It reinforces the SENIOR PAMI trial, which was done in the US with elderly patients, and confirms the guidelines of no age limits for primary PCI," discussant Dr Dariusz Dudek (Institute of Cardiology, Krakow, Poland) told heartwire .
He added: "TRIANA is important because some people still have concerns about which therapy should be applied for patients who are elderly. Primary PCI is the predominant way of reperfusion, but when patients are 80 years old, people still think to avoid PCI and give them drugs. Now, it definitely looks as if elderly patients should undergo an invasive assessment and angioplasty. There are no age limits. I would like to congratulate the investigators for doing this trial."
The study was funded by the Ministry of Health, Spain, and Sanofi-Aventis, Boston Scientific, Guidant, Johnson & Johnson, and Medtronic.
Heartwire from Medscape © 2009 Medscape, LLC
Cite this: Primary Angioplasty Bests Thrombolysis in Very Elderly AMI Patients: TRIANA - Medscape - Sep 01, 2009.