PCI improves angina symptoms vs. sham procedure in patients with stable CAD: ORBITA-2
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Key takeaways:
- PCI improved angina symptoms at 12 weeks vs. a sham procedure in patients with stable angina, ischemia and severe coronary stenosis.
- The patient population was taking little to no antianginal medication.
PHILADELPHIA — In patients with stable angina and evidence of ischemia, PCI improved angina symptoms at 12 weeks compared with a sham procedure, according to the results from the ORBITA-2 trial.
As Healio previously reported, in the original ORBITA trial, PCI did not increase exercise time compared with a sham procedure in patients with medically treated angina and severe coronary stenosis. The ORBITA-2 trial, presented at the American Heart Association Scientific Sessions and simultaneously published in The New England Journal of Medicine, was conducted in a slightly different population: patients with stable angina or anginal-equivalent symptoms, evidence of ischemia based on stress imaging or invasive physiology and severe coronary stenosis who were receiving little or no antianginal medication.
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“The current stable coronary artery disease guidelines will tell us that for patients with stable angina, our first-line approach should be to optimize the antianginal medication,” Rasha Al-Lamee, MBBS, PhD, reader (equivalent to associate professor) in cardiology, British Heart Foundation intermediate research fellow and interventional cardiology consultant at Imperial College London and Imperial College Healthcare NHS Trust, said during a press conference. “Only when they remain refractory with ongoing symptoms should we consider angioplasty procedure as an add-on therapy. However, these guidelines may not reflect our real-world clinical practice. In fact, the vast majority of patients coming to cath labs for elective PCI worldwide would have zero or one antianginal agent.”
All patients stopped any antianginal medication and underwent symptom assessment for 2 weeks before randomization. After randomization, 301 patients (mean age, 64 years; 79% men) underwent PCI or a sham procedure. The primary endpoint was angina symptom score (ranging from 0-79, with higher scores representing worse health status related to angina), which was calculated daily based on the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day and clinical events, including the occurrence of unblinding owing to unacceptable angina, ACS or death, Al-Lamee said during the press conference. Patients were followed for 12 weeks.
Most patients (80%) had ischemia in one cardiac territory, but 17% had it in two territories and 2% had it in three, according to the researchers.
Median target vessel fractional flow reserve was 0.63 (interquartile range, 0.49-0.75) and median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55-0.87), Al-Lamee said.
At 12 weeks, mean angina symptom score was 2.9 in the PCI group and 5.6 in the sham group (OR = 2.21; 95% CI, 1.41-3.47; P < .001), Al-Lamee said.
During the study period, ACS occurred in four patients from the PCI group and six patients from the sham group, and one patient from the sham group had unacceptable angina leading to unblinding, according to the researchers.
Canadian Cardiovascular Society class improved in the PCI group compared with the sham group (OR = 3.76; 95% CI, 2.43-5.82; P < .001), Al-Lamee said.
In addition, PCI was associated with a 59.5-second larger increment in modified Bruce protocol treadmill exercise time compared with sham (P = .008), according to the researchers.
Of note, 59% of patients in the PCI group had residual chest pain despite successful PCI and resolution of ischemia, Al-Lamee said.
“What we’ve shown is the first placebo-controlled trial to demonstrate efficacy of PCI for angina relief,” Al-Lamee said. “We have also shown that PCI as an antianginal monotherapy procedure is feasible and effective. However, residual symptoms persist in many. We hope that we’ve now offered a choice of two first-line evidence-based pathways, incorporating the data from ORBITA-1 and ORBITA-2. It’s now an option to use either antianginal medication or PCI as upfront strategies. I believe that the guidelines that currently reserve PCI to those with optimal antianginal therapy medication may systematically select patients with the least to gain.”
“My surgical colleagues have asked me for decades whether or not PCI actually works,” Martin B. Leon, MD, professor of medicine and chief innovation officer and director of the Cardiovascular Data Science Center for the Division of Cardiology at Columbia University Irving Medical Center, and founder of the Cardiovascular Research Foundation, said during a discussion at the press conference. “And now I can say with confidence, with a placebo-controlled trial, that PCI certainly does have an impact on patients with documented angina, severe coronary stenosis and demonstrated ischemia, which to me is extremely important.”
Reference:
Perspective
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Samin K. Sharma, MD, FACC, FSCAI
The original ORBITA trial created so much uncertainty among interventionalists that maybe angioplasty doesn’t work. Its primary outcome was exercise capacity at 6 weeks, and the difference between the PCI and sham groups was only 16 seconds, which missed the performance goal, so therefore the trial was negative. But now, in ORBITA-2, the researchers wanted to see what the quality of life, angina episodes and additional angina medications would be with PCI vs. a sham procedure, and it turned out to be the data showed that PCI did a greater job of relieving angina. Patients who got PCI had many fewer episodes of angina and better health status compared to patients who did not get angioplasty. Anginal medication usage was low in the PCI group as well.
In patients with STEMI, we perform PCI to improve survival. In stable patients, we do it to improve the patients’ conditions. They feel better. They have better exercise tolerance, less shortness of breath, less chest pain and less need for antianginal medications. The ORBITA-2 trial underscores the importance of PCI to improve quality of life in patients with stable CAD.
The ORBITA and ISCHEMIA trials in a way nullified the role of PCI in stable patients. ORBITA-2 will bring it back up for discussion. Whether the use of PCI will be increased in this population remains to be seen, but it should reverse the decline we had. A research report from the Lown Institute recently came out saying that if you are doing a PCI for stable angina, it is inappropriate. It did not consider whether the patient is ischemic. This trial may nullify that statement. Even in stable patients, PCI does a good job for the quality of life. And a lot of things we do are to improve quality of life, not for survival.
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Rajkumar C, et al. LBS.02. Hot topics in management of coronary artery disease/acute coronary syndrome. Presented at: American Heart Association Scientific Sessions; Nov. 11-13, 2023; Philadelphia.
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