麻豆传媒

PARIS -- Drug-eluting stents markedly lowered angina frequency atop optimal medical therapy for chronic total occlusion (CTO) in stable coronary artery disease, the showed.

Stenting improved gain in health status per the Seattle Angina Questionnaire with respect to angina frequency at 12 months (P=0.009). The other components of the primary endpoint -- the five subscales of that quality of life questionnaire -- numerically, but not statistically, favored intervention over optimal medical therapy alone for physical limitation, quality of life, angina stability, and treatment satisfaction.

Even so, the overall distribution of patients by symptom severity (Canadian Cardiovascular Society class) shifted over follow-up to favor percutaneous coronary intervention (PCI, P<0.001), according to Gerald Werner, MD, of Germany's Klinikum Darmstadt, at the here.

"The results of this randomized trial are consistent with older data from registries and highlight several important points," Dimitri Karmpaliotis, MD, PhD, of New York-Presbyterian Hospital/Columbia University Medical Center, said in an interview.

"The main indication for CTO PCI should be symptoms refractory to medical therapy. In carefully-selected patients, CTO PCI is beneficial and improves quality of life," he continued. "In expert hands it is an effective and safe procedure, despite inherent high complexity."

The EuroCTO results starkly contrasted 3-year data from the DECISION-CTO trial. While both were plagued by sluggish enrollment, DECISION-CTO reported at this year's American College of Cardiology meeting no impact on major adverse cardiovascular events or quality of life with PCI added to optimal medical therapy.

"The DECISION-CTO trial is a very controversial study with multiple methodological flaws. The EuroCTO study has superior design and is definitely a more relevant study," Karmpaliotis said.

Werner's group originally planned for a 1,200-person trial but were ultimately only able to enroll 407 over 3 years. An open-label, multicenter trial, EuroCTO included patients who had at least one CTO in a major artery with a reference diameter of at least 2.5 mm. Participants were randomized to optimal medical therapy alone (n=137) or with PCI with a biolimus-eluting stent (n=259).

Patient groups were comparable at baseline, Werner told the audience at the late-breaking trial session.

While there were two deaths in the PCI arm, 1-year rates of deaths and MIs did not significantly differ between treatment arms and this primary safety endpoint was designed to be assessed at 3 years. These two patients had ischemic myopathies from the beginning and "happened to be enrolled in the CTO arm," Werner said.

With the Biomatrix as the main stent used in the trial, CTO PCI was associated with a 86.3% success rate. Operators opted for radial access in one-third of cases.

There was a 2.9% rate of complications during PCI, namely pericardial tamponade, vascular repair, and blood transfusion.

The question of why enrollment was so lackluster despite the near-ubiquitous presence of CTOs in the population was raised by panelist Stéphane Rinfret, MD, SM, of McGill University Health Centre in Montreal.

The presenter's response: "not enough active centers."

Another panelist, Jacques Koolen, MD, of Catharina Hospital Eindhoven in the Netherlands, stressed that participating operators were "highly selected" and cautioned against generalizing the safety data to general operators.

"Randomized CTO trials are very difficult to conduct and the authors should be congratulated for their achievement," Karmpaliotis said. "Obviously, the results should be confirmed by future randomized trials and [in] a U.S-based large randomized trial."

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