PCI bests lysis; door-to-balloon times always matter

A thorough analysis of available clinical studies has led Timothy Henry, MD, to determine that every patient with ST-elevation myocardial infarction (STEMI) should have percutaneous coronary intervention (PCI), and that door-to-balloon times always matter.

Henry, from the department of internal medicine and interventional cardiology at the Minneapolis Heart Institute, also concluded that transfer for PCI is better than lysis, especially if it is done in a timely manner, as presented in the DANAMI trial.

Henry, who spoke at the Cardiovascular Revascularization Therapies (CRT) 2008 meeting in Washington, D.C., last week, detailed his meta-analysis.

• In the DANAMI trial, researchers showed the composite endpoint of 14% with frontloaded tPA-lysis and 8.5% with PCI, indicating similarity with regards to the magnitude of the improvement. The meta-analysis showed almost identical results in MI and stroke.
  
  
• In the REACT trial, rescue PCI appeared to be better than PCI, resulting in a significant reduction in repeat PCI. Henry said there are a number of meta-analyses that support this method.
  
  
• In the SIAM 3 trial, immediate PCI was found to be better than full-dose lysis and delayed PCI or lysis alone. The CAPITAL AMI trial also supported this pattern.

Henry also approached the controversial topic of facilitated PCI, and discussed its role. In the previous examples, the PCI therapy is compared to a lytic therapy, and in these cases, there are two PCI therapies compared to each other.

“Patients with PCI centers nearby should absolutely receive PCI,” Henry said.

But he also questioned the various options for patients with prolonged transfer times:

• Full dose fibrinlytic with elective transfer for a rescue;
• Full dose fibrinlytic with routine transfer, and rescue as needed (an aggressive rescue policy);
• Facilitated PCI (still a subject for debate);
• Primary PCI, no matter how long it takes;
• All of the above, depending on which time of day it is, and which cardiologist is on call.

“Unfortunately, number five is what usually happens in the United States,” Henry said.

• The CARESS trial, which he defined as “very well designed,” compared facilitated PCI to a rescue approach. In the rescue arm, the event rate of death, MI and ischemia was 11.1% compared to 4.1% in the facilitated PCI. Based on this trial, Henry concluded that facilitated PCI, which a class 2b recommendation, is better than lytic plus rescue, which is a class 1 indication.
  
  
• The FINESSE trial, which Henry said is “the best trial design to look at long-distance transfer,” had more than 3,000 patients and the same medication regimen as the CARESS trial. Unfortunately, the FINESSE trial was stopped prematurely due to slow enrollment, so it was relatively underpowered. The primary endpoint, however, indicated no significant difference between primary PCI (10.7%) and facilitated PCI (9.8%). Death actually favored PCI alone; and there was increased bleeding, which led Henry to ask whether all regimens are created equal.

In a general evaluation of only PCI hospitals, he pointed out that less than 35% of the patients undergoing PCI are being treated in less than 90 minutes (the suggested cutoff), and another 50% are being treated in less than 120 minutes.

“In general, transfers are at a dismal two-and-a-half-hours door-to-balloon time,” he said.

In non-transfer patients, 41% are meeting the 90-minute guideline, and in transfer patients, only 5% are currently meeting guidelines, he said.

He stressed that the goal should not only be to perform PCI faster, but to accrue timely access to PCI.

Henry listed several barriers to superior PCI treatment times:

• no integrated healthcare system
• lack of standardized protocols
• no inter-hospital transport systems
• inferior reimbursement policies, and
• hospital bed capacities.

In his conclusion, Henry suggested that a more integrated localized healthcare system, as he and his colleagues have organized in Minnesota, can actually achieve lower door-to-balloon times.