Promote Patency Trial India’s first Randomized Controlled Trial in Cardiac Surgery is Published

This landmark study, Promote Patency Trial, was presented by Dr. Lokeswara R Sajja Star Hospitals Hyderabad on behalf of the group at the 98th Annual meeting  of the American Association for Thoracic Surgery (AATS) held at San Diego between April 28–May1,2018, where cardiac surgeons from all over the world participated. The study was well received and appreciated by the international community of cardiac surgeons. This trial got published in Indian Journal of Thoracic and Cardiovascular Surgery.

Coronary artery bypass surgery is done to treat the blocks in coronary arteries. Traditionally bypass surgery is done by stopping the heart and using heart lung machine. Recently a new technique was developed to perform bypass surgery on beating heart. About 1,50,000 bypass surgeries are done annually in India and about 60% done on beating heart and 40% done with the aid of heart lung  machine.

India, along with Japan and few South American countries performs majority of Bypass surgeries without the aid of heart lung machine, which is known as Off Pump CABG. In contrast to 60-65% Off Pump CABGs in India, USA does about 15% and European countries have an Off Pump CABG rate of 12%. The main advantage of Off Pump CABG is in reduction of complications. Some studies conducted in USA and Europe had been skeptical about the quality of Off Pump CABG.

To get clarity on this issue, 7 Indian cardiac surgeons collaborated to conduct a unique ‘Randomized Controlled Clinical Trial’. The question that they sought to answer was ‘Is the quality of anastomosis done on a beating heart as good as the one done on a still heart?’

The participating 7cardiac surgeons across India who conducted this study were, - Dr. Lokeswara Rao Sajja (Star hospital, Hyderabad), Dr. Kunal Sarkar (Medica Hospital, Kolkata), Dr. Gopichand Mannam (Star Hospital, Hyderabad), Dr. Krishna Kumar (KIMS, Hyderabad), Dr. P. Chandrashekar (GKNM Hospital, Coimbatore), Dr. Sanjeeth Peter (DDMM Heart Institute, Gujarat) and Dr. Anvay Mulay (Fortis Hospital, Mumbai). The study was supported by Sajja Heart Foundation, Hyderabad and Clinical Research Associate Miss. Prashanthi Beri and Mr. Nadamuni Naidu, a trustee, coordinated the Promote Patency Trial.

A total of 320 patients had Bypass surgery either by conventional method (On Pump) or Off Pump and they were investigated with angiography at three months to evaluate the quality of grafting. Postoperative angiography confirmed grafting results that were comparable to the best published results of On Pump CABG.

This study validated the quality of Cardiac Surgery in general and Coronary surgery in particular, in the international scientific community. As it was done according to the strictest scientific methodology, it will also be considered when the Guidelines for Coronary Surgery are updated. ‘Promote patency’ is a milestone in academic and scientific validation of the clinical works that in being done in our country. We hope this inspires other surgeons and specialties to come up with more such serious scientific endeavors.