NEJM: Facilitated PCI does not prove its clinical benefits
Early treatment with reteplase (Retavase) and abciximab (Reopro) before PCI did not improve outcomes in patients with STEMI, according to the FINESSE trial published in the May 22 issue of the New England Journal of Medicine.
Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, according to the researchers.
Stephen G. Ellis, MD, from the department of cardiovascular medicine at the Cleveland Clinic, and colleagues hypothesized that PCI preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI), or with abciximab alone (abciximab-facilitated PCI), would improve outcomes in patients with acute STEMI, as compared with abciximab administered immediately before the procedure (primary PCI).
In the 20-country, double-blind, placebo-controlled trial, the researchers randomly assigned STEMI patients, who presented six hours or less after the onset of symptoms, to receive
combination-facilitated PCI, abciximab-facilitated PCI or primary PCI.
All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI, according to the investigators.
The authors noted that the primary endpoint was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock and congestive heart failure during the first 90 days after randomization.
Ellis and colleagues randomly assigned a total of 2,452 patients to a treatment group. They noted that significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9 percent) than with abciximab-facilitated PCI (33.1 percent) or primary PCI (31 percent).
The researchers found that the primary endpoint occurred in 9.8 percent, 10.5 percent and 10.7 percent of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group and primary-PCI group, respectively; 90-day mortality rates were 5.2 percent, 5.5 percent and 4.5 percent, respectively.
“It is time to abandon the routine use of combination-facilitated percutaneous intervention until a regimen for facilitated pharmacologic treatment that improves the clinical outcome and minimizes the risk of bleeding when it is administered before percutaneous intervention is identified,” Jane Leopold, MD, of Brigham and Women's Hospital and Harvard Medical School of Boston, wrote in an accompanying editorial.
The results "provide what may be considered the definitive evidence to date of the limitations associated with facilitated percutaneous coronary intervention," Leopold noted.
The authors noted that the study was limited by its early termination for slow enrollment.
Regardless of acknowledged imitations, the researchers said that “the use of a facilitated pharmacologic strategy for reperfusion…cannot be justified by the results of this trial.”
Centocor of Horsham, Pa., which manufactures reteplase and abciximab, and the Indianapolis-based Eli Lilly, which distributes abciximab as ReoPro, funded the study.
Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, according to the researchers.
Stephen G. Ellis, MD, from the department of cardiovascular medicine at the Cleveland Clinic, and colleagues hypothesized that PCI preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI), or with abciximab alone (abciximab-facilitated PCI), would improve outcomes in patients with acute STEMI, as compared with abciximab administered immediately before the procedure (primary PCI).
In the 20-country, double-blind, placebo-controlled trial, the researchers randomly assigned STEMI patients, who presented six hours or less after the onset of symptoms, to receive
combination-facilitated PCI, abciximab-facilitated PCI or primary PCI.
All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI, according to the investigators.
The authors noted that the primary endpoint was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock and congestive heart failure during the first 90 days after randomization.
Ellis and colleagues randomly assigned a total of 2,452 patients to a treatment group. They noted that significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9 percent) than with abciximab-facilitated PCI (33.1 percent) or primary PCI (31 percent).
The researchers found that the primary endpoint occurred in 9.8 percent, 10.5 percent and 10.7 percent of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group and primary-PCI group, respectively; 90-day mortality rates were 5.2 percent, 5.5 percent and 4.5 percent, respectively.
“It is time to abandon the routine use of combination-facilitated percutaneous intervention until a regimen for facilitated pharmacologic treatment that improves the clinical outcome and minimizes the risk of bleeding when it is administered before percutaneous intervention is identified,” Jane Leopold, MD, of Brigham and Women's Hospital and Harvard Medical School of Boston, wrote in an accompanying editorial.
The results "provide what may be considered the definitive evidence to date of the limitations associated with facilitated percutaneous coronary intervention," Leopold noted.
The authors noted that the study was limited by its early termination for slow enrollment.
Regardless of acknowledged imitations, the researchers said that “the use of a facilitated pharmacologic strategy for reperfusion…cannot be justified by the results of this trial.”
Centocor of Horsham, Pa., which manufactures reteplase and abciximab, and the Indianapolis-based Eli Lilly, which distributes abciximab as ReoPro, funded the study.